Issue

d: Se

ptem

ber 2

022

Includes:Australia, Brazil, Canada, Denmark, Finland, France, Germany, Greece,
Italy, Japan, Mexico, Netherlands, Norway, Poland, Russia, South Korea,
Spain, Sweden, Turkey, UK, USA.

2022 CODE OF CONDUCTContents
PRINCIPLES OF THE CODE OF CONDUCT.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 4PURPOSE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
GEOGRAPHIC SCOPE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
EPHMRA MEMBERS’ CODE RESPONSIBILITIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
RELATIONSHIP WITH OTHER CODES OF PRACTICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
COUNTRY CODES & PRIVACY LEGISLATION REFERENCES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.	

WHAT CONSTITUTES MARKET RESEARCH.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 16
DISTINGUISHING MARKET RESEARCH FROM OTHER PURPOSES. . . . . . . . . . . . . . . . . . . . . . . . . 16
Countries Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
MARKET RESEARCH, ETHICS APPROVAL AND NON-INTERVENTIONAL RESEARCH . . . . . . . . . . 21

		

EFPIA Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

		UK NHS Guidance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Key Differences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
 ifferences between Market Research, Patient Support Programs andD
Non-interventional Studies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

NON-MARKET RESEARCH ACTIVITIES AND PURPOSES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Examples of Non-Market Research Activities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
COMBINING RESEARCH AND NON-RESEARCH ACTIVITIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
CONTRACTS AND AGREEMENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.	

DATA PROTECTION AND PRIVACY .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 25
PRIVACY POLICIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
CONSENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
NAMING THE CLIENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
SECONDARY USE OF DATA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
RETENTION POLICIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
SECURITY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
INTERNATIONAL TRANSFERS OF PERSONAL DATA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
DATA PROTECTION IMPACT ASSESSMENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

3.	

MARKET RESEARCH TENETS.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 32
CONFIDENTIALITY AND ANONYMITY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
WAIVING RIGHTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
SEPARATING PERSONAL AND RESEARCH DATA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

2

4.	

BEFORE FIELDWORK .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 35
APPROVAL AND REGISTRATION OF PROPOSALS PRIOR TO FIELDWORK . . . . . . . . . . . . . . . . . . 35
SAMPLE SIZE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
OVER-RESEARCHING MARKET RESEARCH SUBJECTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
DRAWING A SAMPLE FROM A LIST. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

		Information available in the public domain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

		Information shared by other sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

		

Anonymity of Market Research subjects drawn from Lists . . . . . . . . . . . . . . . . . . . . . . . . . . 36

		

Do Not Contact Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Revealing the Source of a List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Correcting Listed Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Adding Personal Data to a Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

		Return or Destruction of Client Databases or Market Research Subject Details. . . . . . . . . 37

RECRUITMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Screening Questions and Questionnaires. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
		Data Collected at Recruitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Snowballing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Re-contacting Market Research subjects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

		Incentives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
		Country Exceptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

		Incentives that are Not Allowed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

		Free Prize Draws. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Confidentiality of Recipients’ Incentive Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Storing Incentive Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

RECRUITING HCPS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Scheduling of Fieldwork Appointments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
		HCPs Recruitment of Patients. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

		Disclosure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
		When disclosure is required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

		When disclosure is not required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Disclosure reporting format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

		Information to be disclosed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

		Country of disclosure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

		Public disclosure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Reporting responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Reporting timetable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5.	

DURING FIELDWORK.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 45
QUESTIONNAIRE DESIGN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

		Sensitive Topics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

STIMULUS MATERIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
		Use of product names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

3

TESTING PRODUCTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
OBSERVATION AND RECORDING OF FIELDWORK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
		Personal data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

		Information to disclose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

				Information to be Communicated to Market Research Subjects when Observedby Client. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

		Consent Required. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

		Observation via one way mirror. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Observation via live streaming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Delayed Observation and Viewing of Fieldwork. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

		When a Market Research Subject Withdraws. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

		Client Awareness of Restrictions on use of Recorded Data. . . . . . . . . . . . . . . . . . . . . . . . . . 51
Protecting Data When it is Transferred. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

		Observers’ Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

		Additional requirements for Germany . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

RESEARCHERS’ RESPONSIBILITIES BY RESEARCH APPROACH. . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
FACE TO FACE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
TELEPHONE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Naming the Agency/Researcher. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
		

Do not call lists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Special Precautions When Contacting Mobile Phones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

		

Use of Unsolicited Texts for Recruitment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

COUNTRY SPECIFIC GUIDANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
ETHNOGRAPHIC/OBSERVATIONAL APPROACHES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
		Constraints. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
ONLINE & MOBILE MARKET RESEARCH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
		Informed Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

		Privacy and Data Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

		Market Research Subject Costs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Researcher or Agency Contact Details. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Protecting Personal and Company Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

		Cookies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
		Interview Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Disclosing List Sources from Website Registration Databases. . . . . . . . . . . . . . . . . . . . . . . 56

		

Use of Unsolicited Emails for Recruitment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

		

Use of Apps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Using Identification and Tracking Technologies/Software. . . . . . . . . . . . . . . . . . . . . . . . . . . 58

SOCIAL MEDIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Accessing Social Media Content including Website Terms and Conditions. . . . . . . . . . . . . 59
Anonymising Quotations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

4

Passive Market Research i.e., digital listening, scraping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Active Market Research i.e., engaging with participants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Adverse Event Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
ADVERSE EVENT REPORTING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6.	

AFTER FIELDWORK. .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 60
ANALYSIS AND QUALITY CONTROL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
REPORTING MARKET RESEARCH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
PUBLISHING MARKET RESEARCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

7.	

MARKET RESEARCH SUBJECTS.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 62
PATIENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
SIMULATED CONSULTATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
VULNERABLE MARKET RESEARCH SUBJECTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
What to Consider When Interviewing Vulnerable Patients. . . . . . . . . . . . . . . . . . . . . . . . . . . 63
CHILDREN AND YOUNG PEOPLE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

		Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
		Online Market Research with Children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

		Role of the Responsible Adult. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

		Researchers’ Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

		Incentives. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Product Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
		Criminal Record Checks for Interviewers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

OPINION LEADERS, CLINICAL TRIAL INVESTIGATORS AND ADVISORY BOARD MEMBERS. . . . 66
PAYERS AND INFLUENCERS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
ANNEX 1 ADVERSE EVENT REPORTING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
APPENDICES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
PROFORMAS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
OBSERVERS’ GUIDELINES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

5

PRINCIPLES OF THE CODE OF CONDUCTThere are twelve guiding principles that underpin the Code of Conduct. These principles are the foundationstones upon which the specific guidelines are built. They are as follows:
I.	Market Research subjects MUST be able to provide voluntary, informed consent to data collection
and use, based upon a clear understanding of the purpose of the data collection and the use(s) towhich the data will be put.
II.

The rights of Market Research subjects MUST be observed, including rights to confidentiality,
anonymity and the right to withdraw at any stage.

III.

Market Research MUST be kept separate from any form of promotion or selling, it MUST NOT be avehicle for disguised promotion.

IV.	Market Research subjects MUST be treated fairly and reasonably, with care and courtesy.
V.	Market Research subjects MUST be protected for the duration of the study – not harmed, exposed,
disadvantaged or made to feel uncomfortable in any way. Confidence in Market Research MUST NOT
be abused.
VI.

Data collection MUST be adequate, relevant and limited to the purpose (s) for which it is processed.
Researchers MUST be transparent about the personal data they plan to collect, the reason(s) it isbeing collected and who it will be shared with.

VII.

Data MUST be processed fairly and lawfully, and only used for the specific and lawful purposes
for which it was obtained. Personal data must be accurate and up to date. It must be processedin accordance with the rights of individuals within national and international data protection andprivacy legislation.

VIII.

There MUST be no unauthorised or unlawful processing, loss, destruction or damage to personal
data. You must take appropriate technical and organisational measures to keep data safe.

IX.	Data can only be transferred, to a third party or internationally, when adequately protected.
X.

Personal data MUST NOT be kept beyond the time required to fulfil the immediate purposes of thestudy.

XI.

Researchers MUST behave ethically; they MUST NOT undermine or damage the reputation ofhealthcare Market Research. They MUST NOT disparage or appear to disparage competingcompanies or products.

XII.	Researchers MUST conduct Market Research accurately, transparently, objectively and of appropriatequality.

PurposeThe Code of Conduct provides comprehensive and up-to-date key ethical and legal guidance to support
EPHMRA members when they carry out multi-country, primary and secondary healthcare Market Research.
• This includes ad hoc and syndicated work upon pharmaceutical drugs, biologics, medical devices anddiagnostics (available with or without prescription).
• Within the Code the umbrella term ‘products’ refers to drugs, biologics, devices and diagnostics unlessspecified otherwise e.g. medicinal products refer only to drugs and biologics.
It is an industry-sponsored code that aims to define and safeguard the rights of Market Research subjects,
protecting data integrity alongside the rights of Market Research subjects.

Geographic Scope
The Code provides international guidelines, although its development has focused upon – Australia, Brazil,
Canada, Denmark, Finland, France, Germany, Greece, Italy, Japan, Mexico, Netherlands, Norway, Poland,
Russia, South Korea, Spain, Sweden, Turkey, UK and the USA plus the European Union (EU).
It offers international guidelines rather than country specific detail however key inter-country differences
are highlighted where they exist.

6

EPHMRA Members’ Code Responsibilities
EPHMRA strongly recommends that all members adhere to the Code of Conduct and ensure that all
personnel employed or sub-contracted on their Market Research studies understand and agree to abide by
the Code.
EPHMRA also recommends that contracts include a clause committing all parties engaged in the Market
Research study – the commissioning company, the Market Research agency and any sub- contractors – toadhering to the EPHMRA Code, including adverse event reporting guidelines.
All Market Research MUST comply with international and national law including the EU General Data
Protection Regulation (GDPR).
Whilst incorporating relevant legislation, neither the Code of Conduct nor EPHMRA will be a source of legal
advice. The information within EPHMRA’s Code of Conduct is not intended and should not be construed
as or substituted for legal advice. It is provided as a reference for best practice. If legal advice is needed itshould be sought independently.

Relationship with other Codes of Practice
EPHMRA’s Code of Conduct complements other professional codes of conduct/practice e.g. the ICC/ESOMAR
International Code on Market, Opinion and Social Research and Data Analytics Where appropriate readers
are referred to complementary/ additional sources of information. Local codes should be observed.
EPHMRA’s Code covers healthcare Market Research and must be distinguished from Promotionof Medicinal Products activities covered by other pharmaceutical industries codes e.g. IFPMA, The
International Federation of Pharmaceutical Manufacturers & Associations or EFPIA European Federation of
Pharmaceutical Industries and Associations.

Country Codes & Privacy Legislation References
Australia
The Research Society (TRS)
Code of Professional Behaviour
https://researchsociety.com.au/standards/code-of-professional-behaviour
Medicines Australia (MA)
Code of Conduct
https://www.medicinesaustralia.com.au/code/about-the-code/code-of-conduct-current-edition/AustralianPrivacy Principles Guidelines
https://www.oaic.gov.au/privacy/australian-privacy-principles-guidelines/
BrazilAssociação Brasileira de Empresas de Pesquisa (ABEP)
Código de Auto-Regulamentação da Atividade de Pesquisa de Mercado, de Opinião Pública e de Mídia
http://www.abep.org/codigos-e-guias-da-abep
INTERFARMA
Código de Conduta
https://www.interfarma.org.br/condigo-de-conduta/
Lei Geral de Proteção de Dados Pessoais (LGPD)
http://www.planalto.gov.br/ccivil_03/_Ato2015-2018/2018/Lei/L13709compilado.htm
CanadaCanadian Research Insights Council (CRIC)
Code of Market, Opinion, and Social Research and Data Analytics
https://canadianresearchinsightscouncil.ca/standards/

7

Innovative Medicines Canada (IMC)
Code of Ethical Practices
http://innovativemedicines.ca/ethics/code-of-ethics/
Canada Privacy Laws
https://www.priv.gc.ca/en
Denmark
Lif The Danish Association of the Pharmaceutical Industry (LIF)
Guide on Market Researchhttps://www.enli.dk/en/rules/
FinlandFinnish Association of Marketing Research Agencies (FAMRA)
Code of Ethics
https://www.markkinatutkimusliitto.fi/eettiset_saannot
Pharma Industry Finland (PIF)
Code of Ethics
https://www.pif.fi/responsibility/marketing/ground-rules-for-marketing.html
FranceAssociation des Sociétés d’étude de l’Opinion et du Comportement dans le domaine de la Santé
Bonnes pratiques and règles (ASOCS)
http://www.asocs.info/pratique/generalites/
Les Entreprises du Médicament (LEEM)
Transparence et déontologie
https://www.leem.org/transparence-et-deontologie
Germany
Arbeitskreis Deutscher Markt- und Sozialforschungsinstitute e.V.(ADM)
https://www.adm-ev.de/en/standards-guidelines/#anker6
GreeceThe Market Research and Public Opinion Companies Association (SEDEA)
https://sedea.gr
Hellenic Association of Pharmaceutical Companies (SFEE)
Code of Ethics
https://www.sfee.gr/sfees-code-of-ethics/?lang=en
Italy
ASSIRIMIl Codice delle Ricerche
https://www.assirm.it/qualita-delle-ricerche/codice-di-etica-professionale/
FARMINDUSTRIA
Codice deontologico
https://www.farmindustria.it/english-content/8

JapanJapan Marketing Research Association (JMRA)
https://www.jmra-net.or.jp/Portals/0/aboutus/en/index.html
Japan Medical Marketing Research Group (JMMRG)
Handling Personal Information When Conducting Market Researchhttps://www.medi-ken.org/en/index.html
Act on the Protection of Personal Information and Amendment Act
https://www.ppc.go.jp/en/legal/
On 24 March 2021, the Japanese government released the effective dates of substantial amendments to
the Japanese Act on the Protection of Personal Information (“APPI”). The revised Act (Act No. 57 of 2003
as amended in 2015) will fully come into effect on 1 April 2022; however, parts of the amendments are
effective earlier. Effective 1 October 2021, use of the “opt-out” exception for data subjects’ consent will be
restricted; in effect since 12 December 2020 are the amended provisions that raised penalties to fines of up
to 100,000,000 JPY (about USD 1 million) in case of violation of an order from the authority or illegitimate useof data.
MexicoAsociación Mexicana de Agencias de Inteligencia de Mercado y Opinión AC (AMAI)
Estándar de Servicio para la Investigación de Mercados en México
https://www.amai.org/descargas/ESIMM_3_0.pdf   
Consejo de Ética y Transparencia de la Industria Farmacéutica (CETIFARMA)
https://www.cetifarma.org.mx/codigos/
Netherlands
Expertise Center voor Marketing-insights, onderzoek en analytics MOA
https://www.moa.nl/
https://www.moa.nl/profgroep-healthcare.html
Dutch innovative pharmaceutical sector Codehttps://publicaties.vereniginginnovatievegeneesmiddelen.nl/magazine/code-uk/code_values_and_standards/
NorwayThe Strategy and Analysis Association - formerly the Norwegian Market Analysis Association (NMF)
http://www.analysen.no/om-oss
The Association of the Pharmaceutical Industry 2021 (LMI)The Rules
http://reklameregler.lmi.no/wp-content/uploads/2017/01/LMI-Industry-Rules-2021.pdf
PolandOrganizacji Firm Badania Opinii i Rynku (OFBOR)
Kodeks Dobrych Praktyk
https://www.ofbor.pl/index.php/standardy#kodeks
The Employers’ Union of Innovative Pharmaceutical Companies (INFARMA)
Code of Good Practices valid from 1 January 2021 (first edition)
https://en.infarma.pl/ethics/code-of-good-practices/9

Russia
Association of International Pharmaceutical Manufacturers Code of Practices (AIPM) http://www.aipm.org/
en/ethics/aipm-code/
Data Protection Legislation is composed of the following
Federal Law of 27 July 2006 No. 152-FZ; an unofficial English version as of 2019 is available here
The Amendments came into force on 1 March 2021 and significantly change the legal landscape with regard
to the use of publicly available personal data, while also clarifying the conditions of consent to the further
processing of such data.
Federal Law of 27 July 2006 No. 149-FZ;
Code of 30 December 2001 No. 195-FZ; andCriminal Code of 13 June 1996 No. 63-FZ.
Federal Law of 30 December 2020 No. 519-FZ
Federal Law of 24 February 2021 No. 19-FZ on Amendments to the Russian Code of Administrative
Offences), increasing administrative penalties for the breach of personal data laws.
South Korea
Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA)
Code of Practices
https://www.kpbma.or.kr/attach/englishResource/Code_of_Practices(KPMA).pdf
Personal Information Protection Act (PIPA)
https://www.privacy.go.kr/eng/laws_view.do?nttId=8186&imgNo=3
Spain
Insights + Analytics España (I+A)
Códigos autorregulación
https://ia-espana.org/codigos-de-autorregulacion/
CODIM Código de Conducta para el tratamiento de datos de carácter personal por organizaciones deInvestigación de Mercados
http://www.codim.es/codim/index.php
FARMAINDUSTRIA
Código de Buenas Prácticas de la Industria Farmacéutica 2021
https://www.codigofarmaindustria.org/servlet/sarfi/elcodigo.html
SwedenEthical Rules for the Pharmaceutical Industry in Sweden  (LIF)
https://www.lif.se/globalassets/etik/dokument/ler-english-version-2020-0501-jd-24apr-pdf.pdf
TurkeyThe Turkish Market Research Association (TUAD)  
https://tuad.org.tr/en
Association of Research-Based Pharmaceutical Companies (AIFD)
Code of Good Promotional Practice 7th Edition Effective as of January 1st, 2019https://www.aifd.org.tr/wp-content/uploads/2019/10/AIFD-Code-of-PracticeENG2019.pdf
United Kingdom
Market Research Society (MRS)MRS Code of Conduct
https://www.mrs.org.uk/pdf/MRS-Code-of-Conduct-2019.pdf

10British Healthcare Business Intelligence Association (BHBIA)
Legal and Ethical Guidelines for Healthcare Market Researchhttps://www.bhbia.org.uk/guidelines-and-legislation/legal-and-ethical-guidelines
United States of America
In USA privacy law is a complex patchwork of national privacy laws and regulations that address particularissues or sectors, state laws that further address privacy and security of personal information, and federal
and state prohibitions against unfair or deceptive business practices. Members are required to double checkstate by state guidance.
The Insights Association (IA)Code of Standards and Ethics for Marketing Research and Data Analytics
https://www.insightsassociation.org/Tools-Resources/Codes-of-Standards
The Physician Payments Sunshine Act
The Physician Payments Sunshine Act: The Insights Industry Position (insightsassociation.org)
FAQs: Compliance with the Physician Payments Sunshine Act (insightsassociation.org)
Maine:
Maine Finalizes Pharmaceutical Regulations, Clarifying the Legality of Research Respondent Incentives for
Physicians (insightsassociation.org)
Minnesota:
Minnesota Restrictions on Pharmaceutical Marketing Research with Medical Practitioners(insightsassociation.org)
EUROPEEFPIA Relationships & codes
https://www.efpia.eu/relationships-code/

11

DEFINITIONS

Ad hoc Market Research - Is designed and paid for by just one company, the research is exclusive to thecommissioning company, who own the resulting data.
Agency - Any individual, organisation or department, which is responsible for, or acts as, a supplier on all orpart of a Market Research project.
Anonymisation - The process of removing, obscuring, aggregating or altering identifiers to prevent thelikely identification, using reasonable means, of the individuals to whom the data originally related.
Anonymity has two interpretations:- Non-disclosure of a client’s identity;- Protection of a MR subject’s identity.
Carer - Professionals or unpaid relatives/friends who provide care for those who because of illness or
disability require support, this care may be medical and non-medical.
Children - Means individuals for whom permission to participate in research must be obtained from aparent or responsible adult. Definitions of the age of a child vary substantially and are set by national laws
and self-regulatory codes.
Client - Any individual or organisation that commissions (including requesting or subscribing) all or part of aMarket Research project.
Confidential Research - Research projects for the purposes of Market Research that do not disclose
personal details at an identifiable level.
Consent - The freely given and informed agreement by a person to take part in Market Research and theprocessing of their personal data.
Consultant - Any individual or organisation that provides research services. Consultants can also be a subcontractor in the research relationship.
Data Controller - A person who alone, jointly or in common with others determines the purposes forwhich and the manner in which any personal data are processed and is responsible for ensuring that theprovisions of Data Protection legislation are complied with.
Data Processor - Any person (other than an employee of the Data Controller) who processes data on behalfof the Data Controller.
Data subject / Participant / Respondent - Any individual whose personal data is used for Market
Research.
Digital listening - The process of extracting data from social media data for analysis. This can be automatedor done manually.
Harm - The tangible and material harm (such as physical injury or financial loss), intangible or moral harm(such as damage to reputation or goodwill), or excessive intrusion into private life, including unsolicited
personally-targeted marketing messages.
Healthcare professional (HCP) - Any licensed member of the medical, dental, pharmacy or nursing
professions or any other person who, in the course of their professional activities, may administer,prescribe, purchase, recommend or supply a medicine. Non-HCP could include a patient, sufferer, carer,family member or member of the public.
Identity - The identity of a Market Research subject includes, as well as their name and/or address anyother information which offers a reasonable chance that they can be identified by any of the recipients of
the information.
Interview - Any form of contact with a Market Research subject to collect information for Market Research
purposes.
Interviewer - The person who collects data from Market Research subjects for Market Research purposes.
Masking - A technique whereby the original social media data such as comments, photos or videos isaltered to a point that it cannot be traced back or attributed to the original user (e.g. using a search engine).
Market Research subject - An individual or organisation that is approached for interview or from which
information is collected for the purposes of a Market Research project, whether they are aware of it or not.

12This term individuals and organisations who that are involved actively or passively and replaces the use of
the term Market Research subject and participant.
MROC (Market Research Online Community) - An online community created specifically for the purposesof market, social and opinion research. Others include DORC (Dedicated Online Research Community).
Participant / Data subject / Respondent - Any individual whose personal data is used for Market
Research.
Passive social media monitoring - The extraction of data from social media for analysis, there is nointeraction with the contributor. It is also known as digital listening or scraping.
Personal data - Information relating to an identified or identifiable living person, who can be identified
directly or indirectly by that data on its own or together with other data. Personal data includes postal
codes, cell phone numbers and email addresses as well as full names and postal addresses. Personal data
may be a single piece of information or a series of pieces of information including other information or data
sets available to the holder, which together would allow identification of an individual or infer their identity.
Personal data includes data in a range of formats - alphabetical, numerical, graphical, photographicalor acoustic. It includes information kept on paper, as well as information stored in a computer memory bymeans of binary code, or on a videotape, for instance. Personal data includes video-streams (relayed live
or delayed and non-anonymised recordings. Whether an audio recording is considered personal data may
depend on whether the surnames of the individuals are recorded or whether the voice alone could lead tothe identification of the individual.
Once personal data has been irreversibly anonymised is no longer covered by the EU GDPR. Researchers
may use a unique identifier (e.g. a serial number) to identify a Market Research subject (a process referred
to as pseudonymisation) but the file linking personal data to the unique identifier MUST be stored entirely
separately from the anonymised Market Research subject data. Pseudonymisation is only a security
measure, the data is still classified (under GDPR) as personal data. In addition. Researchers must make surethat pseudonymised data cannot be traced, or an individual’s identity inferred by deduction

NOTE on definition of Personal Data:• In the USA the definition of personal data varies widely by regulation. The Federal Trade
Commission considers information that is linked or reasonably linkable to a specific individual,
which could include IP addresses and device identifiers, as personal data. The California
Consumers Protection Act defines personal information as any information that identifies,
relates to, describes, is capable of being associated with, or could reasonably be linked, directly
or indirectly, with a particular consumer or household. The definition specifically includes contact
information, government IDs, biometrics, genetic data, location data, account numbers, education
history, purchase history, online and device IDs, and search and browsing history and other online
activities, if such information is linked or linkable with a particular consumer or household. Under
the law, consumer is broadly defined as any resident of California. The definition of sensitive
personal data Varies widely by sector and by type of statute. Generally, personal health data,
financial data, credit worthiness data, student data, biometric data, personal information collected
online from children under 13, and information that can be used to carry out identity theft or
fraud are considered sensitive. For example, state breach notification laws and data security
laws generally apply to more sensitive categories of information, such as Social Security numbers
and other government identifiers, credit card and financial account numbers, health or medical
information, insurance ID, online account credentials, digital signatures, and/or biometrics.
• Comment: The California Privacy Rights Act (CPRA), a ballot measure approved by California
voters in November 2020, and known as Proposition 24 was approved by California voters on Nov.
3, 2020. It significantly amends and expands the CCPA, but most of the provisions revising the CCPA
won’t become “operative” until Jan. 1, 2023. The CPRA will take effect in Connecticut, Utah, Virginia
and Colorado. Enforcement of the CPRA will not begin until July 1, 2023, and enforcement will apply
only to violations occurring on or after that date. It should be noted, however, that the CCPA’s
provisions remain in effect and enforceable until that date.
Primary Market Research - Is original data generated and collected to solve the problem in hand, data iscollected directly from Market Research subjects. Primary data is derived from new and original research
designed to address a specific purpose.

13

Privacy notice/policy - Published summary of an organisation’s privacy practices, it describes the ways inwhich the organisation gathers, uses, discloses and manages a data subject’s personal data.
Processing of personal data - Is Any operation or set of operations performed on personal data, including,but not limited to, collecting, recording, organising, storing, adapting or altering, retrieving, consulting, using,disclosing by transmission, disseminating or otherwise making available, aligning or combining, blocking,erasing or destroying, whether automatically or otherwise.
Public Domain - Information, which is published and generally accessible or available to the public, content
that is not owned or controlled by anyone, intellectual property being not protected under patent or
copyright, in Market Research context it refers to information that is freely available, without restriction.
Public Place - Environment in which the public has free access and where an individual reasonably could
expect to be observed and/or overheard by other people (e.g. in a shop or on the street).
Pseudonymisation - The processing of personal data in such a manner that the personal data can nolonger be attributed to a specific data subject without the use of additional information, provided that such
additional information is kept separately and is subject to technical and organisational measures to ensurethat the personal data are not attributed to an identified or identifiable natural person. (Article 4(5) GDPR)
Record - Any brief, proposal, questionnaire, Market Research subject identification, check list, record sheet,audio or audio-visual recording or film, tabulation or computer print-out, EDP disc or other storage medium,
formula, diagram, report, etc. in respect of any marketing research project, whether in whole or in part. It
covers records produced by the client as well as by the researcher.
• Primary records are the most comprehensive information on which a project is based, including not
only original data records but also anything needed to evaluate those records e.g. quality control
documents;• Secondary records are any other records about the Market Research subject and the research
results.
Recruiter - The person or organisation who identifies and invites Market Research subjects to take part in aMarket Research project.
Research - Includes all forms of market, opinion and social research and data analytics, is the systematicgathering and interpretation of information about individuals and organisations. It uses the statistical andanalytical methods and techniques of the applied social, behavioural and data sciences to generate insights
and support decision-making by providers of goods and services, governments, non-profit organisations
and the general public.
Researcher - An individual or organisation carrying out, or acting as a consultant on, a Market Research
project, including those working in client organisations.
Respondent / Participant / Data subject - Any individual whose personal data is used for Market
Research.
Secondary Market Research - Collecting and using data that already exists. This data is re-used andreanalysed; it is data already gathered for one use that is then utilised for another purpose.
Sensitive or special category personal data - Personal information which identifies a living individual andincludes reference to: the racial or ethnic origin of the data subject; their political opinions; their religious
beliefs or beliefs of a similar nature; whether they are a member of a trade union; their physical or mental
health or condition; their sexual life; the commission or alleged commission by them of an offence; or any
proceedings for any offence committed or alleged to have been committed by their and the outcome. The
definition of health data has been expanded to include biometric and genetic data.
Scraping - A process of extracting data from social media data for analysis. This can be automated or done
manually.
Social media data - Information (photos, comments, etc.) that users generate or share while engaged in orwith social media. It often includes personally identifiable data.

14

Stimulus material - Material shown or referred to or read out to a Market Research subject during
fieldwork.
Sub-Contractor - Any individual or organisation that undertakes a part of a research project (such as thefieldwork).
Syndicated Market Research - Market Research shared - both the findings and the costs - by a number ofclients, however the data is owned by the Market Research agency.
Transparency - Ensuring individuals have a very clear and unambiguous understanding of the purpose(s)for collecting the data and how it will be used.
Walled garden - Online service which requires users to register or apply for membership before being
permitted to participate. A walled garden can only be accessed after the user has obtained a login and/or
password, even if entry is automatic.

15

1.	 WHAT CONSTITUTES MARKET RESEARCHDistinguishing Market Research from other purposes

1.1	Market Research, which includes all forms of opinion and social research and data analytics, is thesystematic gathering and interpretation of information about individuals and organisations. It uses
the statistical and analytical methods and techniques of the applied social, behavioural and data
sciences to generate insights and support decision-making by providers of goods and services,
governments, non-profit organisations and the general public.
1.2

It is defined by the following key characteristics1:• The identity of Market Research subjects will not be revealed to the user of the information without
explicit consent, Market Research has no interest in the individual identity of Market Researchsubjects;• Cooperation is voluntary and is based on adequate, and not misleading, information about thegeneral purpose and nature of the project;• No direct action e.g. a sales approach will be taken in relation to individuals or organisations as aresult of the Market Research (except following up adverse events when permitted);• Market Research is not a commercial communication or a selling opportunity.

The term ‘Market Research’ is used throughout the Code, but it is recognised that the Market Researchfunction may go under different names in different organisations e.g. consumer/market insight, business/
commercial intelligence, marketing/data analytics, customer science. Market Research is used in this Codeas an ‘umbrella’ term that describes the work meeting the definition above.
With the broadening of Market Research options both in terms of new methods e.g. behavioural economics,
co-creation, new mediums e.g. mobile devices and new data sources, it is important to be clear that
EPHMRA’s Code is applicable to both traditional and the newer or non-traditional approaches such as digital
listening the use of observational/ethnographic approaches and work carried out online via mobile devices.
Advisory boards may or may not qualify as Market Research depending how they are run. An advisory board
is generally a group that provides non-binding strategic advice to the management of an organisation e.g.
providing expert advice on new drugs and opportunities. If the advisory board is recruited and operated as
Market Research - meeting the definition above - then it is Market Research. However, Ad’ boards do notoften offer anonymity, may not be systematic in their approach or supported by a basis in the applied social
or behavioural sciences and may not be entirely non-promotional.
Country Specifications
In Australia: Market research must be an initiative to collect relevant information to enhance the quality
use of medicines and must not be used as a mean to promote to and/or reward participants. Market
research should not be implemented as competitions or quizzes or in any other manner that could leadto confusion as to the purpose of the Market Research.2 Participants’ co-operation in a project is entirely
voluntary at all stages. Members must not mislead participants when asking for their co-operation.3
Professional activities must be legal, and conform to all relevant legislation, including in particular thePrivacy Act 1988 and the Australian Privacy Principles (APPs). Comment: The requirements to ensurecompliance under the APPs include practices, procedures and systems and the need to have a privacy policy
which is readily available to participants from whom information is being collected.
In Brazil: All companies must comply with national and international laws ABEP – Brazilian Association of
Research Companies and ICC / ESOMAR rules governing the activity of research, consonant to good market
practices. Market research must never be a) Biased; b) Used as a means of promoting sales; c) Used for offlabel promotion purposes; d) Used to influence the opinions of interviewees; e) Carried out in a way that can
reduce trust in the company.4
In Canada: Market research links the consumer, customer and public to the marketer through the gatheringof anonymised respondent information – for the sole purpose of pointing out and defining marketing
opportunities and issues; generating, refining, and evaluating marketing programs; monitoring marketing
performance; identifying patient and prescriber needs and improving understanding of the marketing
process. Market research details the information needed to address these issues, designs the method(s) by
1 Based upon the definition of Market Research contained in the ICC/ESOMAR International Code on Market, Opinion and Social Research and Data
Analytics. 2 MA. 3 TRS. 4 Interfarma.

16which anonymised respondent information is to be collected, manages and/or implements the datacollection process, analyses the collective results, and communicates the findings and their implications.
Market research should always be conducted for the sole purpose of collecting legitimate market
information, following proper and accepted principles guiding the collection and dissemination of Market
Research information and the treatment of the respondent(s) and the information they provide. The Market
Research questionnaire or program should not be designed in a manner that could be interpreted asleading to a specific response or product conclusion. More specifically, the Market Research program should
not be designed to sway the opinion(s) of the participant(s) directly or indirectly about Member Prescription
Medicines and should not be used to convince or promote the use of Member Prescription Medicines, as a
disguise for selling or developing sales contacts, or as a substitute or disguise for clinical research. Members
are committed to separating Market Research from other types of activities unrelated to the sole purpose ofgathering of legitimate market information.5
In Denmark: Pharmaceutical Market Research studies are characterised by being a structured collectionof data that, e.g. can be used to investigate the market in relation to specific medicines, medicines groups,
areas of disease, etc. Market research typically has a commercial purpose and can be used to support
commercial and product specific decisions and strategies. A company can, by means of Market Research,get the reasons why sales of a medicine are more or less successful. Market research may include payment
for the service provided by the healthcare professional, who can receive a fee for their participation in thesurvey. Market research aims to investigate market conditions and will typically be used for the company’s
internal use. If a Market Research study does not contain information on medicines, either directly or
indirectly, and only mentions health and illness at a general level, there will in principle be no advertising.
The fact that medicinal product names are mentioned in a Market Research does not automaticallymean that the Market Research is regarded as advertising. Whether the Market Research is consideredan advertisement will depend on a specific assessment of, among other things, the setup and wording/content of the questions in the study. The person who prepares the questions for a Market Research study
must, among other things, be aware of whether the questions are leading, including whether you in the
study, e.g. place the company’s own medicine in a particularly favourable light. However, it is noted that itis the form and content of the Market Research that form the basis for the overall assessment of whether
advertisement is involved. If the purpose is to promote the prescription, delivery, sale or consumptionof medicines, this will be an advertising activity. If, on the other hand, the purpose is merely to acquire
knowledge for, e.g. to support commercial and product-specific decisions and strategies, there will not
be the same presumption that this is an advertising activity. A market research study may have several
purposes.
In Finland: Market research also comprises opinion polls. Market research can be used to obtain
information, e.g. about medicinal behaviour, use of medicines and treatment practices, with the objective ofpromoting patient safety and the correct use of medicines. Market research cannot include any marketing
elements.
In Germany: Studies in market, opinion and social research are considered to constitute scientificresearch within the meaning of Article 5 Paragraph 3 of the German Constitution (Grundgesetz für die
Bundesrepublik Deutschland) as well as Article 13 of the Charter of Fundamental Rights of the European
Union and Article 179 of the Treaty on the Functioning of the European Union. In principle, they aim to
obtain generalisable findings and they must be carried out in accordance with the object of research and theinterest in those findings, using appropriate methods and techniques of empirical research (requirement toadhere to scientific methods).
• Studies in public health service for purposes of market and social research are subject to the same
ethical and professional rules of conduct and methodological quality standards as all studies inmarket and social research. The principles and rules of professional conduct in market and social
research require, among other things, that the voluntary nature of participation be clearly pointed
out, the anonymity of the participants be strictly safeguarded, and the market and social research
be clearly differentiated from other activities.
• That means in concrete that no personal data of the participants will be transferred to the clientof the study or any other third parties [in a form that allows identification]. The research findings
will be transferred only in a form which does not allow for conclusions being drawn about single
participants. Moreover, these rules mean in concrete that neither before, during or after conducting
a study the selected participants will be specifically and individually contacted for non-research
5 IMC.

17

purposes of information, advertising or sales promotion nor certain attitudes in terms of the way they carryout their profession will be expected.
In Greece: Market research refers to any systematic data collection and analysis of opinions or positionsof persons or organisations with the application of the methods of the applied social sciences aiming tosupport people or bodies in making a decision. Market research is a valid method for recording the dataand characteristics of the pharmaceutical market. Market research is different from the non-interventional
studies), have a commercial purpose and are intended for internal use. Market research must be unbiased,must not be focused on promoting sales, and must not aim at influencing the opinion of the participants
and is conducted for exclusively commercial purposes. Market Research shall be a snapshot, even if it refers
to past or future intentions, always to random/representative sample of population.
In Japan: The Japan Medical Marketing Research Group published Guidelines on Handling Personal
Information When Conducting Market Research (available here https://www.medi-ken.org/en/index.html)
meant to support both pharmaceutical companies and Market Research agencies to maintain and develop
pharmaceutical Market Research without creating any misunderstandings. It is specified that:• Market research is not sales promotion, it is essential that the research content not be slanderous,
offensive, or excessive;• Qualitative/quantitative research results that could lead to the identification of individuals will not
be provided in the deliverable data will not be delivered;• Considerations of Identifiable Personal Information		• Data that could lead to the identification of individuals such as names, facility names, and DCF
codes, will not be included in the deliverable data (it is allowed within the research, but the data
will not be delivered);		• Answers from university hospital/advanced treatment hospital physicians that include data on
their location, job title, or age, will not be included in the deliverable data (it is allowed within
the research, but the data will not be delivered);		• If combining multiple flags could lead to personal identification, those flags will not be includedin the deliverable data (it is allowed within the research, but the data will not be delivered);		• The deliverables will be tabulated data;		• In principle, KOL surveys should not be conducted within quantitative research. Please conduct
questions about KOLs after consulting the research agency.
e.g. Even if they are a doctor, it is unlawful in most cases to publicly release their name without
consent, unless they are a public figure Note: Executive positions (e.g. president, hospital
director) are public figures; medical department heads are private figures• Considerations when Observing (Qual. Research)		• Receive a signed consent agreement from the research participant (pharmaceutical company)prior to conducting the research;		• Be very careful as to not let the observer (pharmaceutical company) and MR subject come into
contact;		• Please make sure that the pharmaceutical company also has a thorough understanding ofobserver-related issues;		• Please make it a practice to receive a signed consent form for participation via Focus Vision;		• If a respondent (e.g. physician) and a participant (observer) accidentally see each other at theinterview facility, the participant is to be excluded from observing the interview;		• Participants are forbidden from using media (e.g. internet) to look up physicians or facilities
during the interview;		• If the participant discloses the search results to another participant, please immediately havethat participant removed from the venue;		• A participant who knows of the respondent can still participate provided they do not disclosethat information;		• Hard copies, notices, and other documents containing the name of the research agency, are to18

be examined. Pharmaceutical companies are also advised to raise awareness of this internally(especially to non-research depts).
• Considerations of Recorded Media Deliverables		• Visual/audio recordings should generally not be delivered. If delivering: 1) both must be alteredand edited; 2) a consent form specifying the terms of use must be made;		• Visual/audio recordings should generally not be delivered. If they need to be delivered, theymust be blurred and/or edited;		• Visual/audio materials may be viewed at a facility specified by the research agency. However,these materials may not be ‘lent out’ to be returned later;		• Please limit the internal viewing and sharing of delivered DVDs/recordings (only in a closed
environment);		• External use of recorded media requires the consent of the MR subject, so please receive
confirmation from the research agency;		• The research agency may require confirmation as to who will hear/see the deliverables inadvance;		• If pictures are to be delivered (e.g. office visits or photo researches), anything in the backgroundthat legibly shows the hospital or physician’s name must be edited out;		• When conducting research from overseas (global pharmaceutical/medical device /agencies),
there must be a guarantee that the recorded media will not be delivered or provided to a
Japanese subsidiary;		• Confirm whether there is a possibility that information on the physician (regardless of format)
could be provided to the MRs of the Japanese subsidiary;		• Requests for audio/visual deliverables are very common in research intermediated byadvertisement agencies/consulting firms. It is common to hear, ‘I got them last time’ or ‘Other
agencies will do it for me’. Therefore, please do not forget to have the pharmaceutical/medical
device companies be very careful when conducting research intermediated by advertisement
agencies/consulting firms;
		• When creating hypothetical Q&As to be used in interviews, please make sure the originalcontent is altered, and is not used as is.
In Norway: Market surveys are a means of acquiring knowledge of the marketplace and of preparing
promotional and informational activities. Market surveys should not be carried out for purpose of
influencing respondents, communicating promotional messages or encouraging promotional relationships.
In Russia: AIPM defines Marketing study - a study designed to obtain information about the market andto explore the behaviour and perceptions of consumers and interested parties in said market; Marketingstudies should not be used for the purposes of: promoting or selling of any pharmaceutical products or
managing the opinions or conduct of the participants of the study. For that reason, it is necessary to avoid
references to the trade name of the relevant pharmaceutical product unless the purpose of the study
requires otherwise; gathering the personal data of patients; conducting the follow-up studies of the efficacy
or safety of any pharmaceutical product; pre-registration promotion for any pharmaceutical product or theindications for its use that are subject to registration; obtaining confidential information about competitors;
discrediting the pharmaceutical products of any competitor or otherwise causing detriment to any
competitors.
In South Korea: KPBMA members may conduct Market Research for the purpose of collecting marketrelated materials
In Spain:6 Market research (including social and opinion research) consists of the systematic compilationand interpretation of information on individuals and organisations using statistical and analytical methods
and social science techniques that are applied in order to obtain new perceptions or to provide elementsthat support decision-making.
In these studies, the identities of the interviewees are not revealed to the user of the information without
their expressed consent, nor are interviewees contacted for sales activities that result from the information
they provide.
6 Farmaindustria.

19Notwithstanding applicable legislation, there is a general ethical framework within which Market Researchmust be conducted, as shown in the ICC/ESOMAR International Code for the Practice of Social and Market
Research from the European Society of Marketing and Opinion Research (ESOMAR). In the specific caseof the pharmaceutical industry, the Self-Regulation framework on this material consists of the European
Pharmaceutical Market Research Association (EPHMRA) Code of Conduct.
This regulation does not presume to replace the EPHMRA Code, but instead establishes certain mechanismsthat guarantee the appropriate execution of these studies in the application of this Code. The EPHMRA Codewill be of subsidiary application for the appropriate interpretation of this Code.
All Market Research studies are subject to this article if they are conducted at a pharmaceutical company’s
initiative, the initiative of several pharmaceutical companies that share business strategies for a product orwhen a pharmaceutical company hands the study to a third party (research institute, scientific society, etc.)that has undertaken the work at its own initiative.
Market research studies must meet the following requirements:a) Blinding of the identity of the persons participating in the study. The pharmaceutical company
will not have the ability to learn before, during or after the study, the identity of the individuals
participating in the study.
b) Anonymous nature of the information collected. The pharmaceutical company will not have theability to associate the data or opinions obtained with the names of the participants.
c) Aggregate handling of the responses or data obtained.
d) Proportionality between the universe and the sample. Quantitative Market Research studies
pursue a level that is representative of the universe. When calculating sample size, if parameters
other than those generally used in Market Research studies (simple random sample, 5% marginof error, 95% confidence level and 50% level of heterogeneity), the prior approval of the Code ofPractice Surveillance Unit will be necessary.
e) The individual who participates in the study does not know, a priori, and does not have theopportunity to link the study with the pharmaceutical company or with a specific product.
Therefore, the pharmaceutical company’s sales network cannot play any role in developing
and conducting the study. If for legal reasons (General Data Protection Regulation) the person
participating in the study must be informed of the identity of the pharmaceutical company
sponsoring the study (as the data controller), and provided that the participant agrees to be
informed of said identity, pharmaceutical companies shall adopt the necessary measures toensure that such communication is limited to the extent strictly required, and occurs at the end of
their participation in the corresponding study.
f) he results of the study and the data obtained will not be advertised or used in promotionalTmaterials.

Any exception to these requirements must receive prior approval of the Code of Practice Surveillance Unit.
In particular, the requirements of i, ii and v are included in the Supplementary Rules for Market Researchstudies associated with a product.
In addition, in order to guarantee that the marketing research studies do not represent an inducement
to prescribe, or may contain an incentive that is prohibited under the Code, pharmaceutical companies
undertake to:a) Communicate the study prior to its commencement, in accordance with the provisions of Title II
Rules of Procedure for the Control Bodies.
b) Ensure that the study does not modify the physician’s prescribing habits or the pharmacist´sdispensing habits.
c) To have a written protocol that clearly establishes the objectives, methodology, anticipated results
and use. In this regard, written agreements will be formalised with the professionals and/or
entities with whom the studies will be conducted on the one hand and the company sponsoring
the study on the other, specifying the nature of the services to be rendered, the conditions forparticipation and remuneration to the professionals, etc.

20d) Remuneration to participating professionals must follow market criteria and be in accordancewith the time spent, the work performed and the responsibilities assumed. In addition, it must be
appropriately formalised. Remuneration must be monetary. In exceptional cases and with the priorauthorisation of the Code of Practice Surveillance Unit, remuneration may be provided in kind.
e) Guarantee that the conduction of the study does not constitute an inducement to recommend,prescribe, purchase, supply, sell or administer medicines.
f) Be approved, prior to execution, by the pharmaceutical company’s scientific department or by theCompliance Officer stipulated in article 12.12 of the Code.
These requirements will be applicable regardless of the methodologies, sources or techniques applied to
implement them, for example: survey method, observation, experimental designs, ethnographic techniques,expert groups, qualitative techniques, etc.
In Sweden: Market research comprises questionnaires, interviews and focus groups with different goals
and structures, and may only have the purpose of obtaining information, opinions and attitudes. Market
research may not have the purpose of influencing the respondent, or to supply sales promotional contacts.
When companies subject to these cooperation rules have Market Research conducted, the person
participating in the research shall comply with the ethical guidelines for Market Research in accordance with
ICC/ESOMAR.

Market Research, Ethics Approval and Non-Interventional Research
1.3

Market Research as defined in rule 1.1 does not require Clinical Research Ethics Committee or
Independent Review Board approval.7

	Key regulators have made it clear what distinguishes ‘research’ that requires ethics approvali.e., clinical/medical research from ‘research’ that does not i.e., Market Research.
EFPIA Requirements
EFPIA defines non-interventional study as:

Non-Interventional Study (NIS): is a study where the Medicinal Product(s) is (are) prescribed in the usual
manner in accordance with the terms of the marketing authorisation. The assignment of the patient to aparticular therapeutic strategy is not decided in advance by a trial protocol but falls within current practiceand the prescription of the Medicinal Product is clearly separated from the decision to include the patientin the study. No additional diagnostic or monitoring procedures must be applied to the patients andepidemiological methods must be used for the analysis of collected data.
EFPIA require non-interventional research studies to meet specific criteria that are not required of Market
Research:a. There is a written study plan (observational plan/protocol);b. In countries where ethics committees are prepared to review such studies, the study plan must be
submitted to the ethics committee for review;c. The study plan must be approved by the Member Company’s scientific service and the conduct of
the study must be supervised by the Member Company’s scientific service;d. The study results must be analysed by or on behalf of the contracting Member Company andsummaries thereof must be made available within a reasonable period of time to the Member
Company’s scientific service, which service must maintain records of such reports for a reasonable
period of time. The Member Company must send the summary report to all HCPs that participatedin the study and must make the summary report available to industry self-regulatory bodies and/or committees that are in charge of supervising or enforcing Applicable Codes upon their request.
If the study shows results that are important for the assessment of benefit-risk, the summary
report must be immediately forwarded to the relevant competent authority; ande. Medical Sales Representatives may only be involved in an administrative capacity and such
involvement must be under the supervision of the Member Company’s scientific service that will

7 Institutional Review Board in the USA.

21a lso ensure that the Medical Sales Representatives are adequately trained. Such involvement mustnot be linked to the Promotion of any Medicinal Product.
For further details upon the characteristics of non-interventional studies see EFPIA’s Code of Practice https://www.efpia.eu/relationships-code/the-efpia-code/
UK NHS Guidance
The UK National Health Service Health Research Authority (NHS HRA)8 provides a decision support tool tohelp determine whether a study should be classified as ‘research’ or not.
It also provides a leaflet ‘Defining research’ that is designed to help you decide if a project is research, which
normally requires review by a Research Ethics Committee (REC), or whether it is some other activity such as
audit, service evaluation or public health surveillance, Available here
http://www.hra-decisiontools.org.uk/research/docs/DefiningResearchTable_Oct2017-1.pdf
UK’s Governance arrangements for research ethics committees, 2020 edition describes how NHS/HSC
Research Ethics Committees function and specifies when review by an NHS/HSC Research Ethics Committee
is required.

“2.3.15 Market research may be undertaken by professional Market Researchers, e.g. for public healthresearch or on behalf of pharmaceutical or medical device companies. Where such research is conductedby professional Market Researchers in accordance with the principles set out in the Market ResearchSociety Code of Conduct or with the Legal and Ethical Guidelines issued by the British Healthcare BusinessIntelligence Association (BHBIA), it does not require REC review, except where otherwise required by law,e.g. if it requires approval under the Mental Capacity Acts.”
Key Differences
EPHMRA provides a detailed overview of the differences between Market Research (MR), non-interventional
studies (NIS) and patient support programs (PSP).
Market Research

Non-Interventional Studies(or post marketing authorisation studies)

Commercial focus/purpose (market
behaviour and opportunities) –internal focus

Clinical or medical focus/purpose (safety, efficacy or
pharmacokinetics) – external focus
Epidemiological methods must be used to design the study
and analyse the data
Must generate scientifically significant evidenceManaged by company’s scientific/medical service (rather
than commercial)Market Research is carried out for acommercial purpose i.e. to investigate
market behaviour and opportunities toinform business decision making, clinicalendpoints are not needed for Market
Research

Non-interventional research studies involve the collectionof “additional data post-authorisation, as it is necessary
from a public-health perspective to complement theavailable data with additional data about the safety and, incertain cases, the efficacy of authorised medicinal products.
Such post-authorisation measures (PAMs) may be aimed
at collecting data to enable the assessment of the safety or
efficacy of medicinal products in the post-approval setting.”(EMA definition9)
Non-interventional research is carried out for a clinicalpurpose i.e. to assess safety, efficacy or tolerability, its
ultimate purposes are to advance science, the treatment ofdisease, and improve patient outcomes.

8 https://www.hra.nhs.uk/
9 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000037.jsp

22

Confusion between Market Research and clinical/medical research can arise because they sometimes
address the same audience, may use a similar tool – a questionnaire, and can ask similar questions.
Even Market Research that involves the collection of anonymised patient data detailing conditions,
symptoms and treatments this does not mean it is non-interventional research. Market Research using
anonymised patient record data is analysed in aggregated form to generate information upon market
patterns.
The distinction between Market Research and non-interventional research applies whether the Market
Research involves prospective or retrospective patient data.
The following table distinguishes between the characteristics of Market Research, patient support programs
and non-interventional studies.
Differences between Market Research, Patient Support Programs and Non-interventional Studies

MR

PSP

NIS

Information gathering tool

Y

N

Y

Patient or carer service

N

Y

N

Participants remain anonymous

Y

N

Y/N

Commercial focus/purpose

Y

Y

N

Clinical focus/purpose

N

N

Y

Direct patient benefit

N

Y

N

Promotional tool

N

Y

N

Directly impacts clinical care

N

Y

N

Pooled processing of information generated

Y

N

Y

Participants are generally financially incentivised

Y

N

N

Impacts patient directly and immediately

N

Y

N

Generally, generates scientifically significant information

N

N

Y

Requires clinical research ethics committee approval

N

N

Y

Can be prospective or retrospective

Y

N

Y

Always involves marketed medicinal product

N

Y

Y

Managed by company’s scientific service (rather than commercial)

N

Y/N

Y

Generally, includes patient prescribed a company’s medicinal
product in the usual manner

N

Y

Y

Epidemiological methods must be used to design the study andanalyses the data

N

N

Y

23

Non-Market Research Activities and Purposes
1.4	It is not Market Research when data are collected for any other purpose than that described in rule
1.1.
1.5

Members must never undertake any activities, under the guise of research, which aim to manipulate,misled or coerce individuals. This applies throughout the research process including proposal, datacollection, analysis and reporting.

1.6

Market Research MUST NOT be used to obtain confidential information about competing products
and companies from Market Research subjects who are bound by confidentiality agreements withthose companies.

1.7

Researchers must not use data gathered in the context of a MR project for database building.

Examples of Non-Market Research Activities
Non-Market
Research projects’characteristics:• Anonymity and confidentiality are not guaranteed;• If the data are collected on an identifiable basis, direct action (such as selling or
direct marketing) will or may be taken;• The exercise aims primarily to encourage people in general or at random toexpress views, rather than to achieve robust data based on systematicallytargeting specific sectors of the population or on the whole range of views froma representative sample of the relevant population;• The exercise promotes the aims or ideals of a client or organisation;• The exercise promotes the products or services of a client or organisation.

Disguised
Promotion

Judgement by regulators as to whether a Market Research survey is disguised
promotion is likely to be based on the impact of a series of factors, alone or in
combination.
To avoid exercises being classified as disguised promotions, Researchers mustensure that:• At recruitment and in the introduction to the Market Research explain clearly
what is involved;• There is a justifiable business need and Market Research objectives are clearly
documented;• The minimum sample size and an appropriate sample structure is used;• Appropriate incentives to the time, tasks and types of Market Research subject
are given;• Any guides/questionnaires and stimulus designs are balanced;• There is no unnecessary use of company or brand names or over-emphasis
upon claims or product messages, particular care should be taken if the namesof unlicensed products are to be used;• The use of stimulus is clearly sign-posted at recruitment and in the introduction
to the Market Research;• Market Research subjects are made aware that the stimulus is non-promotionaland for the purposes of the Market Research alone;• If stimulus materials refer to a marketed or an unlicensed product this is madeclear;• The number of times the stimulus is shown is limited to the minimum;• If repeated exposure is required, explain why this is necessary• Only essential personal data is collected and the necessity for this is explained;• Market Research is not run alongside a non-research exercise.

These definitions are based upon the UK’s Market Research Society’s Regulations for Using ResearchTechniques for Non-Research Purposes June 2020.10
10 https://www.mrs.org.uk/pdf/MRS%20Regulations%20Using%20Research%20Techniques%20for%20Non-Research%20Purposes%202020.pdf

24Combining Research and Non-Research Activities
1.8

When researchers are fulfilling their role as researchers, they MUST NOT conduct other non-research
activities without the prior informed consent of Market Research subjects.
1.8.1

In Germany: The Market Research industry guidelines state that Market Research may not
be combined with non-research activities. Market Research should be clearly separated anddistinguished from any other activity.

Contracts and Agreements
1.9

In terms of the EPHMRA Code of Conduct the client is the commissioning party and the agency
executes the study on their behalf.

Generally, but not necessarily the client is a manufacturer of pharmaceuticals, devices or diagnostics
and the agency is a Market Research specialist.
1.10

It is recognised that for some studies there may be more than one ‘client’ (e.g. different offices may
be involved) and more than one ‘agency’ involved (e.g. a coordinating global agencies and local
fieldwork suppliers). In these cases, for the purposes of the EPHMRA Code, the following definitions
apply:• Client - commissioning company head office or regional office or local affiliate/office, these may
be pharmaceutical medicine manufacturers, producers of devices, diagnostics or over-the-counter
medicines etc.
• Agency - full-service Market Research agency, fieldwork agency, independent recruiter, freelance
researcher or interviewer – these may be the main contractor or a sub-contractor. Agencies may
also include marketing or management consultancies, PR or advertising companies that run Market
Research studies.

1.11

Clients must be informed if any part of the study is to be sub-contracted outside of the agency. If
requested the identity of the sub-contractor should be provided.
1.11.1

1.12

In Australia: Researchers must inform clients, prior to work commencing, when any part of
the work for them is to be subcontracted outside the Member’s own organisation (including
the use of any outside consultants). On request, clients must be told the identity of any suchsubcontractors.

All parties involved must be bound in a chain by a contract and a data processing agreement
1.12.1

In Denmark: A pharmaceutical company gets an analytics/consulting firm to conduct theMarket Research, a data processor agreement must be drawn up.11

			
E.G., if pharma company X’s HQ has commissioned international full service agency Y tocarry out a multi-country Market Research study on their behalf and agency Y has subcontracted fieldwork to fieldwork agency Z who has in turn sub-contracted recruitment ofMarket Research subjects to recruiters A, B and C in three different countries – then, it isexpected that the full service agency Y will be under contract to company X, the fieldwork
agency will be under contract to agency Y, and finally the recruiters A, B and C will be undercontract to fieldwork agency Z and appropriate data processing agreements are in place.
1.13

Sub-contractors must be bound by the same legal and ethical requirements as the main contractor.

1.14

Agencies may not transfer Market Research subjects’ personal data to the client without the explicit
consent of the Market Research subjects.

2.	 DATA PROTECTION AND PRIVACY
2.1

National and international data protection and privacy requirements MUST be adhered to.

2.2

Data Protection Legislations are a work in progress. Researchers MUST check against latest updates
and developments in each Country they intend to cover.

2.3	Only personal data that is NECESSARY to the research should be collected and processed.
11 ENLI.

25

Privacy Policies
2.4	Market Research subjects MUST be provided with an easily accessible privacy notice and be madeaware of:• Legal basis for the data processing and, if appropriate, the legitimate interests of the data controller
or third party;• Details of the data protection officer (if there is one);• How long their personal data will be stored;• If their data will be shared or transferred to third countries;• Their data subject’s rights
o The right to be informed;o The right of access;o The right to rectification;o The right to erasure;o The right to restrict processing;o The right to data portability;o The right to object;o Rights in relation to automated decision making and profiling.
2.5

Market Research subjects have the right to withdraw from the interview at any time. This right MUST
be made very clear to children.

2.6

Privacy notices must be made available by the individual/organisation processing personal data (ofthe controller, joint controller, and processor – i.e., the client, the agency and any sub-contractor) andmust be honoured.
2.6.1

In Mexico: The privacy disclaimer (aviso de privacidad) has to be provided (in writing
or read) to the Market Research subject, or a source for it given (i.e., hyperlink). Market
Research subjects must consent to the terms of the privacy disclaimer. Data controllers
must inform data subjects, prior to collecting their personal data, of the characteristics ofthe processing. The document must include, at a minimum, the following information: theidentity and address of the data controller; the purposes of the processing; the options
and means offered by the data controller to the data subject to limit the use or disclosureof his/her data; the means for exercising the rights of access, rectification, cancellation,and objection (‘ARCO rights’); the means for exercising the right to revoke consent to theprocessing; the transfers of data that the data controller intends to make, if any; andthe procedure and means by which the data controller will notify the data subject of any
changes to the privacy notice.

2.6.2

In Russia: The Roskomnadzor has published Recommendations on Drafting the Data
Processing Policy.

2.6.3

I n the USA: Per the Insights Association Code of Standards & Ethics:  researchers musthave a privacy policy that is easily accessible and publicly available (if appropriate), is easily
understood and clearly states their data protection and privacy practices.

Consent
2.7

Members MUST ensure that Market Research subjects give their informed consent before
information is collected from them. When collecting and processing special categories of personal
data explicit consent must be obtained12.
• Consent must be a clear, unambiguous, affirmative action. It must be confirmed in a clear andspecifically worded statement.

12 See art. 9 GDPR.

26

• Consent should be ‘purpose-specific i.e., limited to one specific purpose. Consent must detail all
the key ‘terms and conditions’ including data protection requirements associated with the Market
Research.
2.8

Consent must be collected from all Market Research subjects, both HCPs and non-HCPs.
2.8.1	This is compulsory for GDPR countries (researchers should investigate territorial scope ex.
Art.3), and a Code requirement in Australia, Brazil, Canada, Mexico, Turkey and USA.
2.8.2

In Australia: When collecting identifiable research information from participants, including
passive data, researchers must ensure that:
a) participants are informed of the name and contact details;
 ) participants are informed of the Member’s privacy policy and that the privacy policybcontains information about; i. how the participant may access their identifiable research
information being collected and seek to have it de-identified or destroyed, ii. the process ofhandling complaints of a breach of the Australian Privacy Principles (APPs) and iii. the extent
to which the participant’s identifiable research information may be disclosed overseas;c ) participants are aware of the purpose of the collection; and d) participants are aware of
any quality control activity involving re-contact13. Companies must provide individuals withaccess to their personal information held by the organisation upon an individual’s request.
Additionally, individuals have a right to correct inaccurate, out-of-date, and irrelevant
personal information held by an organisation.

2.9

2.8.3

In Japan: When handling personal information, a business operator must specify to thefullest extent possible the purpose of use of the personal information (‘Purpose of Use’).
Once a business operator has specified the Purpose of Use, it must not then make anychanges to the said purpose which could reasonably be considered to be beyond thescope of what is duly related to the original Purpose of Use. In addition, when handlingpersonal information, a business operator shall not handle the information beyond thescope that is necessary for the achievement of the Purpose of Use without a prior consent
of the individual. The Purpose of Use must be made known to the data subjects when
personal information is collected or promptly thereafter and this can be made by a publicannouncement (such as posting the purpose on the business operator’s website). Whenpersonal information is obtained by way of a written contract or other document (includinga record made in an electronic or magnetic format, or any other method not recognisable tohuman senses), the business operator must expressly state the Purpose of Use prior to thecollection.

2.8.4

In Germany: Informed consent should be refreshed at regular intervals (e.g. 6 monthly
intervals) if long term or longitudinal research is being undertaken.

The consent form must include:a) the name of the organisation(s) or individual responsible for data collection;b) the general subject of the data collection;c) the purpose of the data collection;d) the type of data collected, particularly special category and/or criminal convictions data;e) the right to withdraw at any time;f) whether the data collection is to be recorded and/or observed;g) who is likely to have access to live or recorded information;h) date, time, location and duration of fieldwork;i) the likely length in minutes of the data collection;j) any costs likely to be incurred by a participant;k) any incentive offered (nature, rate, etc.);l) the use of automated decision making (if used);

13 TRS.

27m) transfer of data to a third country;n) retention periods or criteria used to determine retention periods;o) the right to complain;p) adverse event and product complaint reporting obligations if appropriate.
2.10

Consents must be verifiable. Records MUST be kept to demonstrate:• Who consented (name of individual, or another identifier);			• When they consented;

			• What they were told;			• How they consented;

			• Whether they have withdrawn consent and if so when.

2.10.1I n the USA: The HIPAA Privacy Rule is a federal regulation which gives the individual rights
over their health information (i.e. name, address, health status and other information thatcan be linked to an individual) and sets limits upon how this information can be used ordisclosed by “covered entities” (primarily health care providers and health insurers). This
regulation also now applies directly to “business associates,” which are service providers tothese covered entities. Unless a use or disclosure is permitted by the HIPAA Privacy Rule,it can only be made subject to an individual’s authorisation. There is no restriction upon
the use or disclosure of this “protected health information” if it has been de-identified inaccordance with the standards set by the Privacy Rule (see 19.3). The US Marketing Research
Association’s Best Practice Guidelines on HIPAA state that “As a general matter, survey
research entities are NOT covered entities under HIPAA, but may be business associates.
The HIPAA Privacy Rule applies when a business associate collects, uses or maintains
personal health information for a covered entity.”

2.10.2

In Russia: Personal data may be processed by a “data operator” only with prior written
notification to the Roskomnadzor. The notification must occur prior to the first processing of
personal data. Processing of personal sensitive data and biometric data requires obtaining
the prior consent of data subjects. Such consent may be required to be provided in the formof a written hardcopy. Data Localisation Law implies that once personal data is collected,
it shall be placed in the database located in Russia, i.e. the primary database so that all
mentioned operations on data should be carried out locally. Afterwards, the data can betransferred abroad for further processing, i.e. to the secondary database.

Naming the Client
2.11

To meet GDPR requirements, the end client or the commissioning client company must be named inthree situations:a) If they are a data controller or joint data controllerorb) If they are the source of personal data e.g. they supply a list of names to be used for samplingorc) If they receive personal data e.g. they receive non-anonymised audio/video files – live or delayed
These three situations all operate independently.

2.12	The source of the personal data and recipients of personal data must also be named at the time that
personal data is obtained.
2.13

If the end client is receiving personal data, they must be named before any transfer takes place.

28

2.14

If naming the end client before the interview would undermine the integrity of the work, this may bedone at the end of the interview BUT Market Research subjects must be made aware at recruitment
that:•

the client will be named at the end of the interview;•

they can withdraw their consent at any point;•

the justification for this should be documented.

The requirements for naming the client when observation and recording are taking place aredetailed later.
2.14.1

In Australia: Researchers must disclose the identity of the client unprompted, no later
than the end of the collection of information, except where the Member and the client
have reasonable grounds to decide that there are genuine research concerns or anothercompelling reason not to do so (e.g. it may expose one of the parties to legal action).

 omment: Where a TRS Member is relying on such an exception to depart from the generalC
rule, they should make a written record of the reasoning behind this decision. Protocols forrevealing the client’s identity should be agreed in advance and made clear in the instructions
to interviewers or recruiters. These should include: whether the client’s identity may berevealed; if so, at what point during the project it would be acceptable to reveal it andprocedures for dealing with participants’ requests for such detail when it has been decided
not to reveal it.
 or Medicine Australia: Market research studies must be clearly identified as such whenF
the initial approach is made to participants. It must be clear to a participant that the Market
Research is being conducted by or on behalf of a pharmaceutical company, but the name ofthe pharmaceutical Company need not be disclosed. It is recognised that the disclosure of
the name of the Company may bias the research.
2.14.2In Denmark please refer to point 3.3.2.

Secondary Use of data
2.15	If the secondary use of data includes personal data, there must be a lawful basis for the further
processing.
•Its intended use MUST be compatible with the purpose for which the data was originallycollected;•

 he intended use must not be specifically excluded within the privacy notice provided at the timeTof the original data collection;•

Other aspects to take in consideration are: ) The context in which the data was originally collected (in particular the relationship betweenaparticipants and the original data collector);b) The consequences of the proposed secondary processing;c) The existence of safeguards.
 ) The data was not collected in violation of restrictions imposed by law, through deception, or indways that were not apparent to or reasonably discernible and anticipated by the data subject

2.15.1 (e) Any requests from individual data subjects that their data not be used for other purposes
are honoured. In South Korea: Personal information may be used for a new purpose
or if doing so does not infringe the interests of a data subject and one of the following
conditions is satisfied: (i) the data subject consents; (ii) special provisions exist in any other
Act; or (iii) where it is obviously necessary for the physical safety and property interests of adata subject or a third person and it is not possible to obtain consent.
2.15.2In the USA14: When using secondary data, researchers must:a) Ensure that the use is not incompatible with the purpose for which the data was originallycollected;

14 IA.

29b) Ensure that the data was not collected in violation of restrictions imposed by laws or
regulations, or in ways that were not apparent to or reasonably understood or anticipatedby the data subject;c) Ensure that the use is not incompatible with the purpose for which the data was originallycollected.;d) Ensure that use of the data will not result in any harm to research subjects and there aremeasures in place to guard against such harm;

Retention Policies
2.16	Personal data MUST be kept NO LONGER than is required for the purpose for which it was collected.
2.16.1In Germany: In the case of one-off studies, the data must be deleted as soon as the quality
controls for the data collection and, if applicable, the data check have been completed. In
the case of follow-up or repeat studies, the address data must be kept separate from thedata collected until the end of the entire investigation.

2.16.2

In Greece: Pharmaceutical companies are not entitled nor have any legal right under thelaw to keep lists of patient names.

2.16.3

In Russia: Personal data should not be stored for longer than it is needed for processing
unless the personal data retention period is established by a federal law or a contract.

Security
2.17

Researchers are responsible for the safe handling, processing, storage and disposal of Market
Research and personal contact data.
2.17.1

2.18

In Australia: Researchers must take reasonable steps to protect identifiable research
information: a) from misuse, interference and loss; and b) from unauthorised access,modification or disclosure.

Adequate precautions MUST be taken to protect personal data, any special category data andconfidential information against unauthorised access. This would include using the appropriatetechnological and organisational measures to protect data when it is collected, transferred or stored
e.g. reliable encryption systems, firewall and user identification and password access.
2.18.1	In Australia: Researchers must ensure the security of all information relating to a project.

			Comment: Researchers should set a data retention policy for all information and allow forvariation of it on a project by project basis according to client requirements. In default of
any agreement to the contrary, in the case of ad hoc projects primary field records should
be retained for one year after completion of the fieldwork and the research data should be
retained for possible further analysis for at least two years.
2.19

All those processing personal data should have a data breach notification policy in place.

	
For more information on data breaches please see the EPHMRA guide ‘GDPR Data Security’ available
to members on the EPHMRA website.
2.20

The data disposal method should be appropriate to the sensitivity and confidentiality of the data.

2.21

If video streaming has been used to allow remote viewing of fieldwork it is possible that the video
transmission system used delivered a copy of the recording to the receiving computer. If this was
the case the researcher MUST take steps to ensure that any copy of the video stream saved on theobserver’s computer is deleted.
I n the USA: In addition to the EU GDPR, the US HIPAA (Health Insurance Portability andAccountability Act) requirements that personal data be appropriately protected, certain states havelegislation requiring specific security safeguards (e.g. Virginia Consumer Data Protection Act “VCDPA”;
California Consumer Privacy Act “CCPA” (please see NOTE on definition of Personal Data forfurther information) Massachusetts “General Right to Privacy Law”) for any organisation in the stateor holding data of a state resident, and various regulators (including the Federal Trade Commission

30and, recently, the Federal Communications Commission), impose broad overall security safeguards
subject to enforcement within their jurisdiction.

International Transfers of personal data
2.22	If personal data is to be transferred from one country to another, the data protection requirementsof both countries MUST be met.
2.23	Researchers are advised to acquire the consent of the data subjects prior to transfer datainternationally unless they rely on and record an exception under specific country legislation.
2.24	The GDPR15 restricts transfers of personal data outside the EEA. Any transfer of personal data froman EEA country to a third country, and any onward transfer, shall take place only if the appropriate
safeguards foreseen by the GDPR are in place. These are:•Countries covered by an “Adequacy Decision”16;•

 inding Corporate Rules – these are data protection policies adhered to by companies
Bestablished in the EU for transfers of personal data outside the EU within a group of undertakingsor enterprises, submitted to and approved by the European Commission;•

 tandard contractual Clauses – these are clauses that the European Commission deems sufficientS
safeguards on data protection for the data to be transferred internationally. Available here
https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/
standard-contractual-clauses-scc_en;•

 n EDPB/European Commission approved GDPR Code of Conduct together with binding andA
enforceable commitments of the controller or processor in the third country to apply theappropriate safeguards, including as regards data subjects’ rights;•

 n EDPB/European Commission approved certification mechanism together with binding andA
enforceable commitments of the receiver outside the EEA;•Derogations under Article 49 GDPR.

2.24.1

In Australia: Particular care must be taken to maintain the protection of individuals’
identifiable research information under the APPs when identifiable research information isdisclosed to an overseas recipient17.

2.24.2

In Brazil: The transfer of personal data to other jurisdictions is allowed only subject tocompliance with the requirements of the LGPD.

2.24.3

In Japan: Personal Data (meaning Personal Information stored in a database) may not be
disclosed to a third party without the prior consent of the individual, unless an exception
applies. The prior consent of the data subject to a transfer of its personal data (including
sensitive information) is not required if the transfer is permitted by law; if after the period
necessary for the data subject to exercise its opt-out right has expired and has been
notified. Under the APPI, in addition to the general requirements for third party transfer,prior consent of data subjects specifying the receiving country is required for transfers
to third parties in foreign countries unless the foreign country is white-listed under theenforcement rules of the APPI or the third party receiving Personal Data has establishedsimilarly adequate standards for privacy protection as specified in the enforcement rules of
the APPI (e.g. EEA Countries).

2.24.4

In Mexico: Where the data controller intends to transfer personal data to domestic or
foreign third parties, other than to the data processor, it must provide them with its privacy
notice and the processing purposes the data subject consented to. To legally transfer
personal data, data transfer agreements must be signed. In addition, all data transfers to
third parties, not processors, need to be informed through the privacy notice and consented
to by data subjects (unless one of the exceptions to the obligation to obtain consent for
the transfer applies). For transferring personal data to data processors, consent from data
subjects is not required and it is not necessary to provide information about these transfersin the privacy notice. A data processing agreement should be executed (or data protection
clauses included in an agreement with the data processor).

15 For more information please refer to https://ec.europa.eu/info/law/law-topic/data-protection_en  16 Cases in which the European Commission has
decided that the third country, a territory or one or more specified sectors within that third country, or the international organisation in question ensures
an adequate level of protection.  17. TRS and see https://www.oaic.gov.au/privacy/australian-privacy-principles-guidelines/31

2.24.5

In Russia: Unless authorised by Russian law or international treaties to which Russia is aparty, data transfer is only possible if performed on the basis of an agreement concluded
between a company transferring data (data controller) and the company receiving it for
further processing (other data controller or data processor). Data controllers must ensurethat the consent of individuals for the transfer of their data to any third party is executed inaccordance with the provisions prescribed by the Law on Personal Data. This also applies toany cross-border transfer, if data is transferred outside Russia.

2.24.6

In Turkey: The LPPD distinguishes between the transfer of personal data to third parties
in Turkey and the transfer of personal data to third countries. Transfer of personal data
to third parties: in principle, personal data can be transferred to third parties with theexplicit consent of the data subject. The conditions and exemptions applied to collection
and processing of personal data also apply to the transfer of personal data to third parties.
Transfer of personal data to parties in third countries: in addition to the conditions andexemptions applied to the transfer of personal data to third parties, one of the following
conditions shall exist for transfer of data to parties in third countries: the country to which
personal data will be sent shall have sufficient level of protection; the data controllers
in Turkey and in the target country shall undertake protection in writing and obtain the
Personal Data Protection Board’s permission; The Personal Data Protection Board shalldeclare the countries having adequate level of protection. So far, the Personal Data
Protection Board has not announced any country.

2.24.7I n South Korea: The data subject must be notified of (i) of the person receiving the personal
information; (ii) of the purpose of processing personal information; (iii) of the items of
personal information provided; (iv) of the retention period; and (v) that the data subject may
refuse to give consent and the consequences of refusal.

Data Protection Impact Assessments
2.25

When preparing a proposal and considering the use of personal data within a Market Research
project that falls within the scope of the GDPR a Data Protection Impact Assessment (DPIA) may beneeded.

DPIAs are only needed in certain circumstances, to find out more about the when DPIAs are needed
and how they should be carried out see the BHBIA’s guide to Risk and Privacy Impact Assessment
available at https://www.bhbia.org.uk/guidelines/gdprupdates.aspx
CNIL (French data protection authority) released an open source PIA software that helps to carry out
data protection impact assessment. Available here https://www.cnil.fr/en/open-source-pia-softwarehelps-carry-out-data-protection-impact-assesment

3.	 MARKET RESEARCH TENETS
Confidentiality and anonymity
3.1

It MUST be clear to Market Research subjects that all personal data collected during a Market
Research project will be treated confidentially and are purely for the purposes of Market Research
unless adverse event reporting is required or separate consent for transfer of personal data for thispurpose has been given.

3.2

Physicians have a duty of confidentiality towards their patients. Information about a patient may beobtained for Market Research from patient records without patient authorisation only if these data
are fully anonymised.

3.3	Market Research subjects’ anonymity MUST be strictly preserved. It is important to note thatwithholding a Market Research subject’s name is not necessarily sufficient to protect their anonymity
especially when Market Research subjects belong to small high-profile universes.
3.3.1

In Canada: When a consent form is signed, the confidentiality and anonymity ofparticipant(s) and their individual responses must be preserved to the fullest extent

32 ossible. The identity of the participant(s) must not be revealed for purposes of promotingpPrescription Medicines to them in the future. The purpose of the Market Research as wellas the way the responses (individually or aggregated) will be transmitted to the Researcher
should be transparently stated in the consent form18.
3.3.2

In Denmark: It is stated in the Danish Medicines Agency’s guide to the Association Orderthat anonymous Market Research, in which the study is conducted by a third party/external
agency, and where the pharmaceutical company and the healthcare professional do notknow each other’s identity, are not considered an association. It is a requirement thatthe anonymity between the actual pharmaceutical company and the physician, dentist or
pharmacist, respectively, is maintained before, during and after the survey (double blindedstudies). It is ENLI’s opinion that the fact that a market study only deals with one medicine,where the healthcare professional may be able to figure out who the sender company is,does not necessarily mean that anonymity is considered broken. In such cases, one will notnormally have to apply for permission to participate in an interview. However, it is crucial
here that the anonymity between the contributing healthcare professional and the actual
pharmaceutical company is maintained both before and after the study has been carriedout19.

3.3.3

In France: Respondents must be assured of anonymity. In order to preserve anonymity,
the details relating to the identity of the respondent must be physically separated from the
documents containing the information about them, after the necessary quality checks in thefield have been carried out20.

3.3.4

In Germany: Data that are collected from natural or legal persons, through questioning,observation, recording or by other means, may only be passed on or made available tothe client or to other third parties (including internal departments) in a form that does
not permit the participants in the study to be recognised or identified (requirement ofanonymity).
• Accordingly, the data collected may only be used in an anonymised or pseudonymised
form;

			

• The requirement of anonymisation shall apply irrespective of whether, from the point ofview of data privacy legislation, the personal data are collected in the context of a research
agency acting as the responsible data controller and the data processor simultaneously or
acting as a commissioned data processor only;			• No personal data of the participants will be transferred to the client of the study or any
other third parties [in a form that allows identification]. The research findings will betransferred only in a form which does not allow for conclusions being drawn about single
participants.

3.3.5

In Greece: Data from HCPs referring to patients shall be collected and delivered fully
anonymised and in aggregate form.

3.3.6

In Italy: Personal or confidential information that is provided during an investigation will not
be disclosed without the data subject’s consent. It will only be expressed in such a form thatallows identification.

3.3.7

In Spain: Blinding of the identity of the persons participating in the study is required. The
pharmaceutical company will not have the ability to learn before, during or after the study,
the identity of the individuals participating in the study. Pharmaceutical companies may only
access the identity of participants for the purpose of supervising and controlling the qualityof the study. For this purpose, access to this data will be temporary while quality control
activities are being conducted and no record of data from participants may remain in thepossession of the pharmaceutical company.

18 IMC. 19 ENLI Is it a requirement that a market survey be blinded so that participants do not know who is behind the survey? A: No, a Market Research is
not required to be anonymised. If the Market Research is not anonymised / blinded between the pharmaceutical company and the interviewed (most often
a doctor), the rules on association must be observed for both the pharmaceutical company and the doctor. This means that the doctor must apply to theDanish Medicines Agency for permission to be associated with the pharmaceutical company. (This also applies if the physician does not receive a fee forhis services) and the pharmaceutical company must report annually to the Danish Medicines Agency, on doctors, dentists and pharmacists in accordancewith the rules in the Order on Association. If, on the other hand, the study is double-blinded by a third party (agency) and the anonymity be- tween thepharmaceutical company and the doctor is maintained, it is not considered as an association with the company, cf. section 4.1 of the Danish Medicines
Agency’s guide to doctors, dentists and pharmacists regarding association to pharma and MedTech companies. Note that in the case of an advertisement,
there can be no double-blind market survey. 20 CNOM.

33

Waiving Rights
3.4

The Market Research subject’s right to confidentiality can be waived by the Market Research subject
if specific consent has been sought and granted providing Market Research subjects have been madeaware of:•

To whom they will be identified;•

What will happen to the information they give;•

What, if anything, will happen to them as a result of this waiver.

3.4.1

In Australia: Researchers must obtain consent if they intend to disclose participants’
identifiable research information. They must inform participants to whom the information
will be supplied and the purpose for which it will be used. Researchers must informparticipants at the beginning of the project whether the project is being conducted on
an anonymous or identifiable basis and: a) if anonymous, participants’ anonymity must
be strictly preserved. b) If identifiable, participants must be informed at this stage ofthe purpose and the recipient of the identifiable research information, unless there aremethodological reasons not to do so at this point. Researchers must inform participants ofthe purpose and recipient again at the end of the collection of information and ask them toreconfirm their consent for disclosure21.

3.4.2

In Denmark: Researchers MUST ensure that information identifying the Market Researchsubject (e.g. recruitment questionnaires, attendance lists) is not passed to the client without
the Market Research subject’s consent.

3.4.3

In Finland: The identity of the data subjects must be kept strictly confidential. If the data
subject has consented to forward the data in such a way that their identity can be revealed,researchers must first state to whom the information is to be provided and for what
purpose and must ensure that the data are not used for any non-research purposes andthat the recipient of the data has undertaken to comply with the provisions of the FAMRA
Code22.

3.4.4

In Germany: The requirement of anonymity cannot be overturned by the person concerned
agreeing to the data being passed on, supplied or used in a personalised form [a form
that allows for identification]. In view of the precedence of anonymity, it is not permissible
to obtain such consent in the context of market, opinion and social research. Even whenparticipants in a study explicitly request that the data concerning them should be passed onor made available to the client and other third parties (including internal departments) in apersonalised form (as well) [a form that allows for identification], this request must not becomplied with. In this case, participants may only be given an address to contact so that they
can approach themselves the client or another third party. In order for this approach to bepermissible, it is essential that participants spontaneously and of their own volition request
the collected data to be passed on or made available in a personalised form [a form thatallows for identification], without the research agency / research institution being involved inthis in any way and without its pointing out the possibility of the collected data being passedon or made available in a personalised form [a form that allows for identification].

			• The collected data may only be passed on or made available in a non-anonymous form
between private-sector and public-sector research agencies and research institutions,and only for scientific purposes. This must be agreed on beforehand by contract between
the research agencies or research institutions involved. The persons concerned must be
informed, considering methodological aspects, about the transmission, provision and useof the personal data concerning them and must consent to this.

Separating Personal and Research Data
3.4.5

In Germany: For Market and Social research the collected data and the address data must
be separated from each other, and the latter deleted as soon as possible. In single studies
the deletion must happen as soon as the quality checks on data collection and if necessary,

21 TRS.
22 FAMRA.

34

t he data editing have been completed. In follow-up or repeated studies, the address data
must be stored separately from the collected data until the end of the entire project.

4.	 BEFORE FIELDWORK
4.1

Researchers must refer to Chapter 2 for privacy and data protection obligations, including disclosureof information and acquiring consent prior to project start.

4.2

Proposals should include and address key data protection and privacy issues.

Approval and Registration of Proposals Prior to Fieldwork
4.3	Researchers MUST inform clients if any of the work to be carried out for them is to be combined orsyndicated with work for other clients (any other clients do not need to be named and MUST not be
named without their permission).
4.3.1	This is a TRS code requirement in Australia.

Sample Size
4.4	The size of the sample should be appropriate to meet the Market Research objectives. If the sample
size is unnecessarily large, the Market Research may be considered a promotional vehicle.
4.4.1

In Finland: Market Research projects must be limited in their extent, such as one-off
telephone interviews or mail, email or web-based questionnaire studies. The opinion of thehealthcare professionals must not be repeatedly probed, considering both the frequency ofthe contacts in general as well as the number of contacts related to individual surveys23.

4.4.2

In Greece: Market Research shall be a snapshot, even if it refers to the past or future
intentions, always to random/representative sample of population.

4.4.3

In Norway: The number of respondents must not exceed the number necessary to ensure agood result.

4.4.4

In Spain: It is required proportionality between the universe and the sample. Quantitative
Market Research studies pursue a level that is representative of the universe. Whencalculating sample size, if parameters other than those generally used in Market Researchstudies (simple random sample, 5% margin of error, 95% confidence level and 50% level ofheterogeneity), the prior approval of the Code of Practice Surveillance Unit will be necessary.

4.4.5

In Sweden: A request for participation in Market Research may only be sent by e-mailor post, unless otherwise agreed in the particular case. If necessary, the respondent is
responsible for obtaining the employer’s consent. In case of remuneration for participatingin Market Research which has a connection with the participant’s practice of its profession,consent from the employer should always be obtained.

Over-Researching Market Research subjects
4.5

Researchers should manage and monitor the frequency with which potential Market Researchsubjects participate in Market Research and try to avoid over-researching individuals.
4.5.1

In Australia: Where a Researcher discloses identifiable research information to a client forthe purpose of regulating frequency of research-related contact with the individual, theymust ensure: a) only that part of the information considered necessary for the purpose isdisclosed; b) if the purpose could be achieved using de-identified data, it is de-identified
prior to disclosure; c) the information being disclosed relates to the individual’s researchstatus and cannot be linked to any research data; and d) the client has agreed to use theindividual’s research status only for the purpose of regulating frequency of contact with theindividual. Comment: Participant consent is not required as the Member is disclosing theidentified information for a research purpose related to the initial reason for data collection.

23 PIF.

35			
Comment: The Member may only disclose this information to the client after the projectis completed, as its use is only for the regulation of contact with the individual for a future
research purpose.

Drawing a Sample from a List
Information available in the public domain
4.6	Lists may be drawn from sources readily available within the public domain, but personal data stillrequire a lawful basis for collection and processing. It might not be the consent of the data subject if  
researchers, in their professional judgment, identify another one.
	If, for instance, a list of healthcare professionals (HCPs) was drawn up from health centre websitesthat listed the HCPs working there, this would not necessarily require the HCPs prior consent if alegitimate interests assessment made clear that it was in the data controller’s legitimate interests toprocess data in this way.
4.6.1

In Russia: Researchers intending to use publicly available personal data, may either:
rely on the consent obtained by the controller when making the data publicly available,considering the rules of such use defined by that controller; rely on the consent provided byan individual to the Roskomnadzor, via a dedicated web-based platform to be set up under
the law, but also considering the rules of data use defined by the Roskomnadzor; or ensure,on their own, that they have appropriate legal grounds for the use of such publicly available
personal data.

Information shared by other sources
4.7

If a list containing personal data (e.g. a detailed list of physicians) is passed to the agency by theclient – the client must have the consent for sharing these data and for processing the data forMarket Research purposes. The agency must still identify a legal basis for their own collecting andprocessing. It might not be the consent of the data subject if researchers, in their professional
judgment, identify another one.
4.7.1

In Italy: Data that is used that is not publicly available should be ‘certifiable’ – those that
hold the data MUST have the consent of the individual and evidence of how they obtained
the data. It is also strongly recommended by EPHMRA that the responsibilities of list
suppliers are made explicit and agreed to in writing within some form of project agreement,such as the contract.

Anonymity of Market Research subjects drawn from Lists
4.8	The client company MUST NOT be informed of the identity of Market Research participants, i.e., whoon the list was interviewed.
Do Not Contact Status
4.9	Market Research subjects that have chosen to opt-out of or not be contacted for Market Researchmust be excluded.
Revealing the Source of a List
4.10	When lists of named individuals are used for sample selection, the source of the list must be
revealed to potential Market Research subjects24. If providing the name of source of the personal
data would impact the integrity of the Market Research it may be withheld until the end of theinterview, but Market Research subjects must be made aware at recruitment that:•

The client will be named at the end of the interview;•

They can withdraw their consent at any point;•

The justification for this should be documented.

24 Under GDPR, the source of the list MUST be named.

36

4.10.1

In Australia: Researchers must disclose the source of the research sample to participantsno later than the end of the collection of information, except where the Member and theclient have reasonable grounds to decide there are genuine research concerns or anothercompelling reason not to do so (e.g. it may expose one of the parties to legal action).

Correcting Listed Information
4.11	Researchers have a responsibility to make sure that any personal data they process is accurate andup to date. Reasonable steps must be taken to correct or erase inaccurate data promptly.
Adding Personal Data to a Database
4.12	Personal data can be added to the database only if researchers have a lawful basis for this e.g. theMarket Research subject consented to at the time of data collection. Market Research subjects MUST
also be told why and for what purposes the data will be used, and that under no circumstances will it
be released or used for any non-research purpose.
•

4.13

 n entry recording that a particular individual was interviewed or contacted on a given survey,Aor that they do not wish to be contacted for further research, is permitted if the purpose of theentry is solely to ensure that that individual will not be unnecessarily approached for research atsome later date, except in Germany.

The Market Research subject has the right to request the deletion of any or all of their personal datafrom the database at any time.

Return or Destruction of Client Databases or Market Research Subject Details
4.14	Client databases MUST be returned to the client or destroyed at the end of the project – unless
instructed differently. Market Research subject requests to have their personal data removed from alist or database must be respected.

Recruitment
Screening Questions and Questionnaires
4.15

Screening questions MUST only be used pre-screen potential Market Research subjects forparticipation in the research, they MUST NOT be used to collect additional data.

Data Collected at Recruitment
4.16	Data collected at recruitment MUST NOT be used for any purpose other than the purpose for whichconsent was granted. Seeking consent for other uses retrospectively is not allowed. Consent must be
specific to a single purpose.
Snowballing
4.17

When asking people to supply other people’s names for the purposes of developing a list from whichto draw a sample (a technique commonly referred to as ‘snowballing’ and used to identify opinion
leaders) to meet the obligation to be transparent, the person being recruited MUST be told how theirname was obtained.

This means for example that when trying to recruit an opinion leader the recruiter MUST tell the
doctor that they were suggested by another physician.
Re-contacting Market Research subjects
4.18	Under GDPR, it is possible to re-contact Market Research subjects only there is lawful basis in place
for this e.g. consent. So, if researchers think they might wish to contact a Market Research subject
again (even if only for simple clarification), they MUST obtain their consent before the end

37of the interview. When children are researched consent for re-contact should be sought from theresponsible adult and the child separately.
4.19

Consent for re-contacting purposes must include information of the purpose of re-contact and who
will make it. Re-contact questions should reflect the possible reasons for the re-contact, such as for asecond stage of the study, to ask a question missed or further explore a particular issue.

	The question “May we contact you for future research?” is not sufficient to allow re-contact, this typeof standard question is really panel building question as it asks about any other projects occurring at
an unspecified future time.
4.20	Consent is not necessary for quality control purposes or data validation, if researchers, in theirprofessional judgment, identify another legal basis.
4.20.1

In Australia: Researchers may use identifiable research information to make further contact
with participants for a research purpose provided that: a) If re-contact of an individual
who initially declined to participate is involved, the Researcher and the client have genuine
research concerns that warrant such recontact; and b) If re-contact of an individual who
has participated in a project is involved: i. the individual was informed of this likelihood at
the time the information was collected, except where the Researcher and the client havereasonable grounds to decide that there are genuine research concerns that justify not
so notifying; or ii. any individual who, at the time of collection, indicated a wish not to be
re-contacted for research purposes is excluded unless the Researcher and the client havereasonable grounds to decide that there are genuine research concerns that warrant theindividual’s inclusion.

4.20.2

In Germany: If personal data is stored for re-contact for which informed consent has been
given, the personal data MUST be stored separately from any additional data about theindividuals. The merging of data for the specific selection of Market Research subjects isdone by means of a code number.

Incentives
4.21

4.22

4.23

An ‘incentive’ is any benefit given to a Market Research subject to encourage participation in a Market
Research study and should be:• ependent only on the completion of a questionnaire/interview and not on any additionalD
conditions in the case of one-off surveys;•

Kept to a minimum;•

Appropriate to the time involved;•

No more than the fair market value for that individual’s professional consultancy or advice;•

Appropriate to the Market Research subject type;•

Appropriate to the task(s);•For patients/members of the public it is a token of appreciation – not a fee for time;• andled only by the agency however if the Market Research is conducted by a company’sHin-house researchers, Market Research subjects’ personal data MUST NOT be accessible tocompany personnel outside the field research team or the research agency.

Market Research subjects must be clearly informed:•

Who will administer the incentive;•

What the incentive will be;•

When the participant will receive the incentive;•

If any conditions are attached e.g. completion of specific tasks or quality control checks.

Panel members should be made aware of the approximate level of commitment and/or length oftime required before the incentive will be paid.

38

Country Exceptions
Please refer to Incentives Overview Country Differences and Summaries by Market
Published in 2019 and available at www.ephmra.org
Incentives that are Not Allowed
4.24

Incentives are not allowed in the following situations:•That could influence opinion or behaviour e.g. to encourage use of a drug; excessive
payments that could be seen as an attempt to buy good opinion or reward use;•

That require the Market Research subject to spend money;•

That are made up of the sponsoring client’s goods, services or vouchers for these;•

As a covert means (alongside supposed Market Research questions) to collect personal data.

4.24.1In Canada: Members of IMC should take appropriate steps to ensure Health Care
Professionals do not leave any Market Research meetings with any kind of promotional
material.

4.24.2

In Germany: The awarding of incentives must be conditional only to the formally correct
participation in the study, not to any further requirements. Incentives are only a stimulus
and a “thank you” for participation and must not be a motive for participation. The lattermust be excluded by the agency as far as possible.

			• In studies in public health service incentives should preferably awarded as a certain sumof money. As a stimulus and “thank you” incentives must be of neutral nature with respect
to the study and the target group. Hence their value must be chosen socially adequate
and staggered by professional position and time spent of the participants in a way thatawarding them neither bias the sample nor influence the behaviour of the participants.
The professional scales of fees (e. g. the scale of fees for physicians) shall be taken as aframe of reference.

			• Incentives must not be awarded in form of products or services of the client of the study
or in form of such connected with them. Incentives must be awarded only by the research
agency conducting the study, not by the client commissioning it.

Free Prize Draws
4.25

With regard to free prize draws, i.e. a draw where prizes are allocated by chance, with no payment
to enter, Market Research subjects MUST NOT be required to do anything (other than participate
in the Market Research) to be eligible for entry to a free prize draw. ‘Free’ includes any method ofcommunication (post, telephone or other) at a standard rate.

	
National laws governing free prize draws vary widely in Europe, so care must be taken to ensure theprize draw is carried out in compliance with local law, including registering the draw with the relevant
authority and arranging for the draw to be administered by public notary or other official as requiredby local law.
4.25.1I n the UK: MRS Regulations for Administering Incentives and Free Prize Draws25 provide
further details of the rules.

4.25.2

In Mexico: The Secretary of Governance is responsible for authorising prize draws. There
are specific requirements including registration for prize draws open to the public. Legalcounsel should be obtained in order to determine if a prize draw or raffle within a specificsurvey population should be considered a public or private / closed event.

4.25.3I n the USA: ‘Rules Governing Sweepstakes’ are provided by the Insight Association andavailable to members here: https://www.insightsassociation.org/News-Updates/Articles/
View/ArticleID/15523 It specifically states that “this is an evolving body of law” and that “itis not possible to construct a set of rules and practices that we can guarantee will comply
with every applicable law. Anyone running sweepstakes, especially online, should have theircounsel carefully monitor state and federal legislation and court decisions in this area.”

25 https://www.mrs.org.uk

39

Confidentiality of Recipients’ Incentive Data
4.26

The personal data of Market Research subjects eligible for incentives are confidential, so cannot bepassed to clients without a lawful basis such as consent, this consent MUST NOT be linked to receipt
of an incentive.

Storing Incentive Details
4.26.1

 ational tax laws may require storing of personal information related to receiving incentivesNfor a determined amount of time. Researchers should:• Keep data in a form that shows the date of participation, but does not allow merging withthe data collected (this is compulsory in Germany);• Check against specific country’s legislation.

Recruiting HCPs
4.27

When recruiting HCPs researchers must refer to Chapter 2 for privacy and data protection
obligations.
4.27.1In Canada: The number of experts surveyed should be reasonable in light of the total
number of Health Care Professionals part of that specialty26.

4.27.2

In Denmark: When a pharmaceutical company wishes to conduct a Market Research study,
a written agreement must be entered between the pharmaceutical company/consulting
agency and the healthcare professional, where the benefits and the basis for any payment
are stated27. If a doctor, dentist or pharmacist is associated with a pharmaceutical company,
e.g. by participating in a market study, they must apply for association with the company at
the Danish Medicines Agency prior to participation. The reason for this is that participation
in a market survey is regarded as counselling that requires prior permission from the Danish
Medicines Agency. The pharmaceutical companies have an obligation to provide information
to healthcare professionals and must notify the Danish Medicines Agency of which doctors,
dentists and pharmacists are associated with the company. You can read more about therules of association on the Danish Medicines Agency’s website28.

4.27.3

In France: Public servants including physicians who work in hospitals MUST haveauthorisation from their university hospital that they may participate in ‘incidental activities’
including Market Research. For more detail, please see http://www.ephmra.org/CountryNews

4.27.4In Italy: The Transparency Act (art. 53 165/2001) requires that: Physicians employed bypublic entities should have the permission of their employers before they participate inMarket Research if they are paid an incentive. If no incentive is paid (even if expenses e.g.
for travel, are reimbursed), employer permission is not required but the employer should
be informed. It is the responsibility of the physician to gain their employer’s permission (notthe Market Research agency). Market Research should take place outside public entities
office/clinic hours and not on a public employer’s premises unless the premises are used for
private practice too.

4.27.5

In Norway: Where market surveys are carried out amongst health authority employees,
the exercise should be cleared with the employer. It is the responsibility of the Healthcare
Professional to ensure that such clearance exists.

4.27.6

In Poland: It is allowed to recruit HCPs if there is a contract in place; there exists a legitimate
need for the services which has been clearly identified and documented; the number ofservice providers retained and the extent of the service are not greater than reasonably
necessary to achieve the identified need. Limited Market Research, such as one-off phoneinterviews or mail/e-mail/internet questionnaires are excluded from the this, provided
that the HCP, HCO Personnel member or PO Representative is not consulted in a recurring
manner (either with respect to the frequency of calls generally or of calls relating to thesame research) and that the remuneration for participation in research complies withmarket terms.

26 IMC.
27 ENLI.
28 ENLI.

40

4.27.7

In Russia: The following requirements should be observed while engaging healthcare
professionals to provide services:• There should be a written contract describing the substance of the services to be rendered
and the terms of payment for these services;			• Compensation for the services should be reasonable and consistent with their fair market
value;

			• There should be a reasonable need for the services; there should be a direct connection
between the criteria used to select the healthcare professionals to render services and the
purpose to be achieved when these services are rendered;• The number of the healthcare professionals engaged to render services should correspondto the number actually needed to achieve the relevant purpose; and• The existence of the services contract should not directly or indirectly oblige the healthcare
professional to recommend or prescribe any pharmaceutical product.

4.27.8In Spain: There are Market Research studies that have the objective of learning theopinion of Healthcare Professionals on a specific medicine, to study interest in a productbased on its strong or weak points, or, for example, to analyse materials that will be
used to provide information about the product’s characteristics, etc. In these cases, theHealthcare Professional who participates knows, or may know, a priori, the pharmaceuticalcompany that is developing said study and, in addition, when the aim is to test the content,
comprehension, design, ease of presentation or interest in the materials used by companies
to promote their medicines, personnel from the pharmaceutical company’s marketing or
sales departments may also be involved.

4.27.9In Sweden: If necessary, the respondent is responsible for obtaining the employer’s
consent. In case of remuneration for participating in Market Research which has aconnection with the participant’s practice of its profession, consent from the employer
should always be obtained.

EFPIA members and members of EFPIA-affiliated associations MUST29
		•In Market Research carried out face to face document an agreement between agency or
client company and the healthcare professional Market Research subject in advance offieldwork i.e., at recruitment) for all;		• ongitudinal studies and panels MUST also be covered by a written agreement irrespectiveLof methodology;		• ingle stage Market Research studies conducted online, by telephone or by post that involve
S
only minimal remuneration do not require a written agreement in advance of fieldwork.
EFPIA member associations provide guidance on the meaning of minimal.

Scheduling of Fieldwork Appointments
4.27.10	 In Italy, Norway and Sweden: The ADM/BVM, ASSIRM, and LIF respectively, recommendthat Market Research appointments with healthcare professionals (HCPs) should be madeoutside working hours and that those HCPs that are employees are not interviewed on theiremployer’s premises. However, the preferences of the HCPs can be taken into account. In
Italy: This refers to HCPs when employed by the national health service (SSN) only.30
4.27.11 In Germany: When arranging an appointment for the participation the agency conducting
the study or else the persons or organisations acting on its behalf – i.e., in particularinterviewer and fieldwork organisations – should make appointments outside the working
hours of the participants. Moreover, the participation of privately or publicly employedpersons should happen outside their employer’s premises where they normally performtheir duties. These regulations must be explicitly pointed out to the commissioned persons
or organisations by the research agency. However, the concrete wishes of the participants
regarding place and time of the participation must also be taken into account.
29 This ruling is based upon Article 14 of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code on the Promotion of
Prescription-Only Medicines to, and Interactions with, Healthcare Professionals http://transparency.efpia.eu/uploads/Modules/Documents/efpia-hcpcode-2014.pdf 30 Guideline for Studies in Public Health Service for Purposes of Market and Social Research ASSIRM, Directive on the interviews withmedical staff for purposes of Market Research and social.

41			In the case of privately or publicly employed participants if necessary - i.e., if a participant
proposes to participate during the working hours and/or in the working rooms – theconcerning duties resulting from their employment contract must be re-minded. This
reminder must be documented appropriately.
HCPs Recruitment of Patients
4.28

Physicians may act as intermediaries to recruit patients by inviting patients to take part or passing onquestionnaires on behalf of the agency, they MUST however:•

Ensure that patients understand that their participation is voluntary;•

Not disclose the patient’s identity to the agency until the patient has consented to this.

4.29

Reimbursement should not be dependent on the number of patients successfully recruited. Agencies
should beware of placing pressure upon patients and try to minimise this e.g. by issuing a written
rather than a face to face invitation.

4.30

If the patients reply directly to the agency, which is preferable, the doctor should not be told which
patients are going to/have participated.
4.30.1I n Germany and Brazil: Physicians are only allowed to pass on and return completed
questionnaires if there are no means by which to identify the patients detailed (e.g. name oraddress).

4.30.2I n the Netherlands: MOA affiliated researchers MUST make sure that an invitation to apatient to participate in Market Research that is given via a HCP must be in writing (mail oremail).

Disclosure
4.31

 FPIA Disclosure Code31 requirements apply to EFPIA and EFPIA affiliated association members andE
all those that have agreed to adhere to EFPIA or national associations’ code of practice.

	
The Disclosure Code applies to prescription only medicines and only to over the counter medicines
if they are dispensed on prescription. Consequently, pharmaceutical companies will need to disclose
payments made to healthcare professionals (HCPs) for a range of activities including participation inMarket Research (MR) when (and only when) the pharmaceutical company is aware of the identity of
the HCP. These payments are referred to in the Disclosure Code as Transfers of Value (ToV).
4.32

Other industry regulations or relevant legislation may require for disclosure of transfer of value to
HCPs – please refer to the “Country of Disclosure” paragraph within this Code.

When disclosure is required
4.33	For Market Research, disclosure is required when pharmaceutical companies are aware of theidentities of those participating in Market Research it has commissioned and ToVs have been
made to HCPs (i.e., Market Research related payments incentives and expenses). In these cases,
the payments made to individual named HCP Market Research subjects MUST be disclosed,
whether they’ve paid them directly or indirectly via an agency. This information will be made publicly
available.
4.34	If a sample is to be drawn from a list of HCPs supplied by the pharmaceutical company, the identityof those actually interviewed will not be known and so disclosure is not required. However, if all
those on the list are to be interviewed, then the company will be aware of the identity of the HCPs
involved in the Market Research and disclosure will be required.
4.35

HCPs whose identity will be known to the commissioning pharmaceutical company MUST beadvised that disclosure will take place and asked for their consent to pass on their personal dataand payment information for this purpose. This must take place as soon as practical, generally at
recruitment.
As with any request for consent for the use of personal data, the following must be made clear:•

The purpose for which their personal data will be used – why it is requested;

31 https://www.efpia.eu/relationships-code/42•The consequences of giving or not giving consent (how their personal data will be used);•

Their agreement or refusal must be recorded.

4.36

If this consent is not given, Market Research payments MUST still be disclosed but on an aggregate
basis. So, if HCP Market Research subjects do not consent to their personal data being used fordisclosure, they may still participate in the Market Research.

4.37

When securing consent to transfer personal data to the pharmaceutical company for disclosure
the GDPR requires that the recipient company is identified. As disclosure reporting is a separate
processing operation (to the Market Research), consent for this may be secured at the end of theinterview.

4.38

Market Research agencies MUST keep records of the required disclosure information to pass to thepharmaceutical company.

4.39	Pharmaceutical companies MUST keep records of the required disclosure information, collate it, thencomplete and upload the appropriate data collection template.
When disclosure is not required
4.40	If the HCP’s identity is not known to the pharmaceutical company disclosure is not required.
	EFPIA have stated that if a HCP’s identity becomes known to the company only as a result of an
adverse event where reporter contact details are provided, disclosure is not required.
Similarly, if during viewing of non-anonymised fieldwork, a Market Research subject is recognised(and identified) by client company personnel, disclosure may not be required.
Disclosure reporting format
4.41

EFPIA have provided a ‘Model of a Standardised Template’ – the suggested reporting format fordisclosure data. EFPIA country associations may provide their own template based upon the EFPIA
one.

Information to be disclosed
4.42

The following types of data MUST be recorded for a full calendar year on the appropriate templateand disclosed:
For each individual HCP that gives consent for their personal data to be used in this way:		•

Full name and address of principal practice;		•

Fee for service and consultancy – Market Research incentive;		•Market Research-related expenses.

 here only aggregate data can be given (where consent has not been given for personal data to beWused in this way):• ggregate amount attributable to transfers of value to recipients i.e. the incentives andA
expenses (separate totals) for Market Research;•

Number of recipients in the aggregate disclosure;• of recipients included in the aggregate disclosure as a proportion of the total number of%recipients disclosed (individual and aggregate).

Country of disclosure
4.43

Disclosures MUST comply with the national (EFPIA member) code of the country where the HCP
receiving payment has their principal practice. The address of the HCP’s principal practice should be
used as the reference when determining in which country the data should be disclosed.
4.43.1

In Australia: Where a Company is aware of the specific named individual healthcare
professionals to participating in Market Research, payments must be disclosed in .		
transparency reports in accordance with Medicines Australia’s Code of Conduct.

43

4.43.2

In Denmark: Legislation stipulates that any non-double-blinded (i.e., the identity of thecommissioning client company in not known to the HCP Market Research subject and theidentity of the HCP is not known to the commissioning client company) and the contact
between a HCP and a pharmaceutical company or manufacturer of medical devices must be
declared to the Danish Health authorities as consultancy. The registration of contact must
be made by both the HCPs and the end-client (Pharmaceutical Company or Medical Device
Manufacturer).

4.43.3

In France: Two different legislations regulate disclosure: Loi Bertrand and Loi Anti-Cadeaux.
Information may be found within the Country News section of EPHMRA’s website.

4.43.4

In Greece: The Disclosure of Transfers of Value by Pharmaceutical Companies to Healthcare
Professionals and Healthcare Organisations applies.

4.43.5

In Russia: Each pharmaceutical company shall document and disclose transfers of value
it makes, directly or indirectly, to or for the benefit of any healthcare professional or
healthcare organisation being a recipient. Disclosures shall be made on an annual basis andeach reporting period shall cover a full calendar year.

4.43.6

In Turkey: To protect the integrity of the research when a Market Research is conducted,
the company name may not be revealed, but it shall certainly be indicated that this researchis conducted with the request or support of a pharmaceutical company.

4.43.7

In the UK: See the BHBIA Guidelines section on Disclosure requirements.

4.43.8I n the USA: Generally the federal Sunshine Act does not include mandatory disclosure ofsurvey incentives made by pharmaceutical companies or their agents to doctors. Whilesurvey payments were included in initial versions of the law and have been the subject ofongoing debate in Congress, the law generally excludes thank you payments for taking
part in surveys provided the company sponsoring the research is unaware of the Market
Research subjects’ identity. However, some state laws are different. IA and Intellus haveadvised that to their knowledge the Sunshine Act does not require agencies to identify toclient companies the names of healthcare professionals who report adverse events.

			For further information see: https://www.insightsassociation.org/News-Updates/Articles/
View/ArticleID/15541
			 https://www.insightsassociation.org/Portals/INSIGHTS/Docs%20to%20link/industry_positionphysician_payments_sunshine_act.pdf?ver=XN60XEunp_0tghsS7V56uw%3d%3d			For further details upon US state Sunshine laws see: http://www.policymed.com/2014/04/
physician-payments-sunshine-act-review-of-individual-state-reporting-requirements.html
Public disclosure
4.44	EFPIA have advised that public disclosure can be via either:•

The relevant Member Company’s website or• central platform provided by a government, regulatory or professional body or an EFPIA
A
member/country association.

		
Individual country/member associations decide upon the route.
Reporting responsibility
4.45	Pharmaceutical companies MUST complete and post the disclosure data on their company website
or forward it to a central platform - as required in their country.
Reporting timetable
4.46

Disclosures MUST be made in the first six months after the end of the calendar year in which theMarket Research payment was made.

44

5.	 DURING FIELDWORK
5.1

Before fieldwork starts all information detailed in Chapter 2 MUST be communicated to Market
Research subjects.

5.2

EPHMRA does not recommend the use of sales representatives as Market Research interviewers.
5.2.1.1 In Canada: Direct contact with the participant(s) in the Market Research project, in which theidentity of the sponsoring company is intentionally masked, should be limited to marketing
research personnel only with no Researcher sales representatives’ influence or involvement.
There should be no follow-up by sales representatives or staff derived specifically fromthese Market Research projects32.
5.2.2

In Greece: Medical sales representatives may not be involved in the conduct of Market
Research. The commercial departments of pharmaceutical companies may not become
involved in Market Research, save in its planning.33

Questionnaire Design
5.3

5.4

Researchers should take reasonable steps to ensure that:•

Questions are fit for purpose and clients have been advised accordingly;•

Questionnaire design and content are appropriate for the audience being researched;• arket Research subjects are able to answer the questions in a way that reflects the view theyMwant to express, including don’t know/prefer not to say where appropriate;•

Market Research subjects are not led towards a particular answer;•

Answers are capable of being interpreted in an unambiguous way;•

Personal data collected is relevant and not excessive.34

5.3.1

In Canada: A Market Research questionnaire or program should not be designed in amanner that could be interpreted as leading to a specific response or product conclusion.
More specifically, the Market Research program should not be designed to sway theopinion(s) of the participant(s) directly or indirectly about Member Prescription Medicines
and should not be used to convince or promote the use of Member Prescription Medicines,
as a disguise for selling or developing sales contacts, or as a substitute or disguise for clinicalresearch.35

5.3.2

In Denmark: The person who prepares the questions for a Market Research study must,
among other things, be aware of whether the questions are leading, including whether you
in the study, e.g. place the company’s own medicine in a particularly favourable light.36

5.3.3

In Spain: The pharmaceutical company’s sales network cannot play any role in developing
and conducting the study.

Market Research materials should not:•Raise unfounded hopes for a treatment;•

Mislead Market Research subjects with regard to the performance of a product;•

 ncourage members of the public to ask a healthcare professional for a particular product orE
healthcare professionals to use or recommend a particular product – disguised promotion isprohibited.

Sensitive Topics
5.5	When a topic is considered sensitive, Market Research subjects MUST be told explicitly the subject
and content of the discussion.
	Comment: Sensitive topics include those that are judged to be sensitive to most people or a specificgroup of people because of the nature of the subject or those that may be sensitive to a particular
individual, because of that individual’s past history.
32 IMC. 33 SFEE.
34 https://www.mrs.org.uk/pdf/2014-09-01%20Questionnaire%20Design%20Guidelines.pdf
35 IMC. 36 ENLI.

45

5.6	When sensitive topics are to be discussed, the Market Research subject MUST be made fully awareof:•

The topic for discussion prior to the interview;•

The fact that they need not answer all of the questions posed;•

Their right to withdraw at any point in the recruitment or interview process.

5.7

In cases where the subject under discussion is gender specific or of a sensitive or potentiallyembarrassing nature, Market Research subjects should be interviewed by interviewers of the samesex or given the choice to be so.

5.8

If collecting information on sex, gender or age may prove sensitive, the following guidance may be
helpful, the UK MRS’s:• uidance Note on Collecting Data on Sex and Gender, July 2020. https://www.mrs.org.uk/
Gstandards/mrs-best-practice-guide-Collecting-Data-on-Sex-and-Gender• uidance Note on Researching Age Bands for Over 65s. https://www.mrs.org.uk/standards/MRSG
Best-Practice-Guide-Age-bands-for-researching-over-65s

Stimulus Material
5.9

Stimulus material includes any material shown during the course of fieldwork e.g. product profiles,
branding concepts, devices, packaging materials.

5.10

Stimulus material should be fit for purpose. Pharmaceutical industry codes of practice generally
require that information claims and comparisons be accurate, balanced, fair, objective, andunambiguous, be an up-to-date evaluation of all the evidence and they should not mislead either
directly or by implication, by distortion, exaggeration or undue emphasis – the same is expected ofstimulus material.

5.11	Within any Market Research care should be taken to ensure that Market Research subjects
understand when they are providing feedback on draft materials, hypothetical scenarios,
assumptions, a product in development or as yet unlicensed.
5.11.1I n the Netherlands: MOA affiliated researchers MUST NOT use stimulus with healthcare
professionals that includes brand names or indications for unlicensed products. The use ofsamples of prescription only medicines is also prohibited in Market Research.

5.11.2I n the UK: Market Research testing of promotional messages or materials (e.g. to assess
reaction to them before or after launch) is allowable – there are no laws or industry
regulations (healthcare or MR) that prohibit it. However, it is essential that the reasons fortheir use are clearly and directly linked to bona fide MR objectives and the work is carriedout in compliance with the BHBIA’s Guidelines. It would also be necessary to make sure
respondents: Understand the nature of the MR and are advised in advance that they will
be asked about their reactions to promotional materials/messages and are protected from
disguised promotion.

5.12

 here it is required (country requirement or company policy) to use stimulus materials in a
W
Market Research project, it should be approved by the client company’s medical department
prior to use (irrespective of format or finish).

5.13

 ompanies may want to consider the need for Market Research subjects to sign some formCof confidentiality or non-disclosure agreement if commercially sensitive information isshared with them and the Market Research subject is made aware of the identity of the end
client company.

5.14	All stimulus materials should be collected at the end of the interview.
Use of Product Names
5.15

The unnecessary or repeated use of brand names should be avoided unless assessing reaction to
the name, or use of the product by name is an essential research objective, particular care should betaken if the names of unlicensed products are to be used.

46

5.15.1

In Italy: The use of brand names when researching hospital ‘H’ drugs with patients although
not explicitly forbidden would be considered unethical.

5.15.2

In Russia: It is necessary to avoid references to the trade name of the relevant
pharmaceutical product unless the purpose of the study requires otherwise37.

Testing Products
5.16

Companies should generally refer to their medical and regulatory departments for guidance on
Market Research surveys that involve testing products.

5.17

It is strongly recommended that placebos are used during Market Research surveys wheneverpractical.

5.18

Guidance for testing products via Market Research varies depending on the category a medication
falls into:•	Licensed prescription-only medicines taken in line with the license can only be taken by a Market
Research subject who is an existing user of the product and if a registered medical practitioner ispresent;•	If a medicinal product is licensed but the Market Research subject is asked to use the productoutside of its approved indication(s)/dosing/formulation i.e. as an ‘investigational product’ duringa Market Research survey, it is recommended that the research is carried out according to Good
Clinical Practice (GCP) guidelines;•	If the medicinal product is unlicensed, Good Clinical Practice (GCP) guidelines MUST be followed
when undertaking a Market Research survey.
5.18.1

In Australia: Market research may be undertaken about an approved or unapproved
product or unapproved indication. For Market Research conducted with members of thegeneral public, the product name and/or molecule should not be disclosed. Market researchundertaken with patients who have been prescribed a particular prescription medicine may
include product-specific questions. Market research studies must be clearly identified assuch when the initial approach is made to participants. It must be clear to a participant that
the Market Research is being conducted by or on behalf of a pharmaceutical Company, but
the name of the pharmaceutical Company need not be disclosed. It is recognised that thedisclosure of the name of the Company may bias the research.

5.18.2

In Denmark: Medicines that have not been approved for the Danish market must not bementioned or otherwise used in Market Research with healthcare professionals .

5.18.3

In Finland: Market research must not focus on a medicinal product which has not obtained
the marketing authorisation.

5.19

If subjects are taking non-prescription drugs (i.e., over the counter - OTC) during Market Research
surveys, it is recommended that an appropriate healthcare professional is present.

5.20

For Market Research involving medical devices or diagnostics only (i.e. there is no active ingredientinvolved), if the device is not CE marked, is an implantable device, is to be used outside the approved
license or could potentially cause a patient harm (e.g. use of a needle is involved), the commissioning
client company’s medical department MUST approve the Market Research approach, confirm
whether the Regulations on Medical Devices (e.g. as applicable in EU or UK or Turkey) need to befollowed and whether an appropriate healthcare practitioner should be present.

5.21

When the client entrusts products to an agency researcher’s care, the client commits them self toproviding products compliant with laws in force and to give all the necessary information on theseproducts, providing in particular correct information on the directions for use, the ingredients list
and the transport and storage conditions. Moreover, the client MUST take the necessary measures toprovide the researcher with any constraints relating to the security of the products.

5.22

Clients are fully responsible for all damage or injury to researchers or respondents caused
by materials or products they have provided to researchers for research purposes unless theresearcher or respondent failed to follow the care instructions provided by the client when thematerials were in the agency’s possession (or the agency breached any other legal obligations as with37 AIPM.

47

stimulus material, all products should be collected at the end of the interview.
5.23

Adverse Event reporting requirements associated with medical products should be checked with theMarketing Authorisation Holder before commencing any Market Research survey.

Observation and Recording of Fieldwork
Personal data
5.24

Researchers must refer to Chapter 2 for privacy and data protection obligations.

5.25

Personal data includes sound and image data, e.g. non-anonymised audio recordings and video
footage of an individual from which it could be possible to identify the individual.

	
Image data will always be personal data, a voice alone, may or may not be. If an individual belongs
to small universe e.g. they are a KOL and have a distinctive accent, then voice alone is likely to be an
identifier; however, a GP’s voice with a non-descript accent listened to out of area is not likely to be
identifiable data in isolation.
Information to disclose
5.26	Market Research subjects MUST be made aware at the time of recruitment if their input is to berecorded or observed (even if it only for analysis purposes by the agency) and why it is proposed.
Market Research subjects MUST always give their consent for this, and consent must be recorded.
5.26.1

5.27

In Germany: Observations of behaviour about which the Data Subjects cannot be told in
advance for methodological reasons (e.g. studying their reading behaviour while browsing
through a magazine) must not take place in a situation where the observed person iscompletely alone in a room and may thus assume themselves to be unobserved. Insteadof asking the person’s consent beforehand, they shall be informed afterwards and asked
afterwards to consent to the recordings or results of the observation obtained by othermeans being used for the purpose of the study. Providing general information before theobservation is made (e.g. asking the individual to come to a studio and take part in a test
there) is not a substitute for requesting the consent to using the observation after the event.

If it is possible that the Market Research subject could be identified by the audio-recording alone
they should not be passed to client companies unless there is a lawful basis in place e.g. the Market
Research subject has given their informed consent.

Information to be Communicated to Market Research Subjects when Observed by Client
5.28

When the end commissioning client is viewing non-anonymised fieldwork live or at a later datevia streaming or video-relay this is a transfer of personal data, consequently in order to meet therequirements of informed consent, Market Research subjects MUST be told:•

The name of the recipient company;•If naming the recipient company is likely to impact on the integrity of the Market Research thecompany name can be withheld until the end of the interview if Market Research subjects agree.
However, if Market Research subjects do not want their non-anonymised input to be viewed this
MUST be respected;•

Why they are viewing – different purposes require separate consents;•

Who (in terms of role/position not names) will see/listen to it;•	Of the countries outside their own to which non-anonymised information will be transferred or
viewed e.g. inform Market Research subjects filmed in France that the film will be viewed in theUSA;•

Of their right to withdraw consent;•

How and who to contact within the Market Research agency with any questions or concerns.

	
In most countries the data protection/privacy regulator will require the name of the company
receiving personal data to be revealed to the Market Research subject. This is a GDPR requirement.

48

Consent Required
5.29

At the start of fieldwork Market Research subjects MUST be informed if their personal data is to bepassed on to the commissioning client company and their consent must be acquired before doing
so.

5.30

Market Research subjects’ documented consent for audio or video recording should be obtained at
the beginning of the interview before recording commences. Where multiple purposes exist or are
possible, separate consent for each purpose should be obtained.

5.31

Recorded data (audio or video that could identify individual Market Research subjects) given toclients without Market Research subject consent MUST be anonymised.
5.31.1

In Australia: Participants must be informed before observation techniques or recording
equipment are used for a project, except where these are openly used in a public placeand no identifiable research information is collected. Comment: Researchers must obtainconsent from participants to disclose their identifiable research information. This includes
disclosure to observers of an interview or group discussion, as people’s faces and voices
are defined as identifiable research information. This applies to all observation techniques
and recordings, whatever the medium: including, but not limited to, face to face, audio orinternet based. If a Researcher has agreed with the client that observers are to be present,
the Researcher must inform all observers about their legal and ethical responsibilities.
Researchers must make clear to participants the capacity in which observers are present;
any clients must be presented as such, even if they are also professional researchers and/orMembers of The Research Society.

5.31.2

In Canada: The purpose of a Market Research program and, if applicable, the use ofrecording devices and presence of research “Viewers” must be made clear to participant(s)at the start of the interview. The research Viewer(s)’s identity must remain anonymous
to participants to preserve respondent objectivity. Due to confidentiality of respondents,
Viewers may not include Researcher sales representatives or any other field-based
personnel who have contact with and the ability to influence respondents/participants.

5.31.3

In Germany: Since audio/video recordings involve the storage of original sound and/or
image data, it is necessary to obtain the consent of the participants in the discussion or the
respondents in the interview (referred to in the following as Data Subjects) to the storageof such data – over and beyond their willingness to take part – before the recording can be
made. The consent form must explicitly include details of the recipients to whom original
sound and/or image data from the audio/video recordings will be transmitted.

			• This consent is only valid in connection with the declarations that must be made in thiscontext towards the Data Subjects, in particular the assurance that research findings will
only be presented in an anonymised form and that data will not be transmitted to third
parties in such a way as to allow individuals to be identified.
• In order to protect the anonymity of the participants in a group discussion during thegroup discussion itself (and hence also while it is being recorded), the data subjects
must not be addressed by their respective last names. The Data Subjects must be told
at the beginning of the group discussion that they must not introduce themselves by
their respective last names. Likewise, the Data Subjects should not introduce themselves
and address each other by their first names, unless this is necessary for methodologicalreasons.
• All the different observation and recordings options require that the data subject(s) is/are not known to the End Client. Should this be found not to be the case, either the data
subject(s) or the End Client must be excluded from the observation. If the End Client is
excluded, the End Client must not receive any recordings either.
• If a representative of the End Client (who is not Market Research agency) wishes toparticipate in the group discussion they must be introduced to all Data Subjects intheir capacity as an End Client [in the beginning]; they, as well as any observers, must sign
the “Declaration of Commitment by End Clients on Observations and Recordings for the
Purposes of Market and Social Research” and the “Personal Declaration of Commitment to49   Comply with the Data Protection Requirements of the General Data Protection Regulation”
and must send them to the agency/studio beforehand. There are no legal reasons against
adopting this procedure, however - depending on the topic - methodological reasons may
exist.
			• If the End Client wishes to participate in the group discussion but does not reveal
themselves as such: this procedure may only be adopted if the participation of the End
Client is necessary in order to achieve the research goal and if compelling methodologicalreasons exist that preclude his or her capacity as a End Client from being made known
during the group discussion. In addition, it is necessary to examine on a case-by-case basis
whether the requirements of a legal basis, such as Art. 6(1)(f) GDPR, are met. Furthermore,this End Client representative and any observers must have signed the “Declaration ofCommitment by End Clients on Observations and Recordings for the Purposes of Market
and Social Research” and the “Personal Declaration of Commitment to Comply with theData Protection Requirements of the General Data Protection Regulation” and have sent
them to the agency/studio beforehand.

Observation via one way mirror
5.32

When live observation takes place via a one-way mirror or sitting in there is no transfer of personal
data to the commissioning client company so the client’s identity does not need to be revealed andshould not be revealed without the company’s permission.
5.32.1In Germany: Market Research guidelines require that the client’s identity must be revealed
if requested.

5.32.2

In Germany:39 The observation of a group discussion by means of a one-way-mirror is aprocedure which is to be treated as equivalent to observing the discussion as live stream.

Observation via live streaming
5.33

When live viewing takes place via video relay/streaming (with and without archiving), organisation(s)viewing must be named before transfer of the personal data takes place.

	So, if for example, the end client is viewing fieldwork live via a video-stream the client’s identity must
be revealed before fieldwork as part of the information communicated to secure Market Researchsubjects’ informed consent.
5.33.1In Germany: If a representative of the End Client (who is not Market Research agency)
observe the event either on site, or via an audio or video conference or via a stream,
is permissible if the Data Subjects have been informed accordingly in advance and havegiven their consent, and if the persons observing the event have signed the “Declaration ofCommitment by End Clients on Observations and Recordings for the Purposes of Market
and Social Research” and the “Personal Undertaking to Comply with the Data Protection
Requirements of the General Data Protection Regulation”, and have sent them to theagency/studio beforehand. In addition, any observations must take place in closed rooms
to which only those persons have access who have signed the aforementioned written
undertakings and have submitted them to the agency/studio beforehand.

Delayed Observation and Viewing of Fieldwork
5.34

When delayed viewing takes place via video relay/streaming (with and without archiving), if the end
client wants to view or listen in to fieldwork after it has taken place, consent for this must be secured
before the interview.
5.34.1In Germany: If the End Client (who is not Market Research agency) receives the audio and/or video recordings for research purposes, it is necessary that:• The End Client has signed the “Declaration of Commitment by End Clients on Observations
and Recordings for the Purposes of Market and Social Research” and the “Personal
Declaration of Commitment to Comply with the Data Protection Requirements of the

39 https://www.adm-ev.de/wp-content/uploads/2018/11/RL01_E_Group-Discussions_2006_%C3%9CBERGANG.pdf

50   General Data Protection Regulation” and sent them to the agency/studio before receiving
the recording; and			• All Data Subjects have been informed in advance, with reference to these written
undertakings, and have given their consent. A sample “Consent to Video/Audio Recordings
and Observations” form.

5.35	To ensure that unauthorised viewers cannot access recorded material EPHMRA recommends thatthe commissioning agency/client ensures that:

5.36

•

Comprehensive security measures are in place;• ccess is password protected and restricted to authorised users (identified through a uniqueAlogin id) and that login ids/passwords are distributed only by the project leader;• uthorised users agree in writing not to allow access to unauthorised personnel (see pro formaA
4 – Client Agreement to Safeguard Confidentiality of Recordings).

Recordings should not be archived for longer than is required to fulfil the purposes of the study.
5.36.1In Germany: Recordings must be deleted no later than 3 months after receipt.

When a Market Research Subject Withdraws
5.37

If a Market Research subject withdraws from the research at any stage e.g. during a group
discussion, their personal data MUST not be processed anymore and their anonymised input should
be withdrawn from the final analysis and reporting, if they request this.

Client Awareness of Restrictions on use of Recorded Data
5.38	Clients should be made aware of the restrictions on the use of recorded data at the start of a project
if they might want to watch, listen to or view copies of recordings during or after the project.
Protecting Data When it is Transferred
5.39

In transferring personal data agencies must comply with chapter 2.

Observers’ Guidelines
5.40

When client observers are introduced, they do not need to be introduced by name. It is sufficient totell Market Research subjects the nature of their roles within their company and in general terms
their reasons for observing. Clients or their sub-contractors MUST NOT be passed off as members of
the Market Research agency.

5.41

Observers should be informed of their responsibilities towards Market Research subjects and agreeto:• ithdraw from observing if a Market Research subject is known to them/recognised to protect
W
the Market Research subject’s anonymity. If an observer knows that they will subsequently
have to deal with a Market Research subject, the attendee MUST also withdraw. However, if
Market Research subjects are made fully aware of the presence of an observer known to themand give explicit consent for that individual to observe then that person may remain at thesession, however care should be taken to ensure that Market Research subjects are completely
comfortable with this.

5.41.1

In Australia: Researchers must inform all observers about their legal and ethicalresponsibilities40.

Additional requirements for Germany
For projects carried out in-home and on the premises of End Clients:•

The interviewer and the data subject must always give their consent to the participation of the

40 TRS.

51 gency / End Client commissioning the research and other participating persons at the time theaData Subjects are recruited;•	Special protective measures must be in place to enforce anonymity, in particular the documented
consent of the interviewers must specifically name the client commissioning the research and/or
the End Client receiving the research findings;•

 he data subject must be informed in the same way as the interviewers, in sufficient time beforeTthe study; the data subject must have given his or her documented consent;• he participating persons must sign the “Personal Declaration of Commitment to Comply withT
the Data Protection Requirements under the GDPR” and send it to the agency conducting the
research beforehand;• he agency/End Client commissioning the research must have signed the “Declaration ofT
Commitment for Research Agencies Commissioning Observations and Recordings for the
Purposes of Market and Social Research” and the “Personal Declaration of Commitment toComply with the Data Protection Requirements of the General Data Protection Regulation” andhave transmitted them to the agency conducting the research before the study is conducted;•

 ll concerns with regard to the protection of minors must be examined and taken into accountA
with special care before the study commences;•	The Data Subjects must be informed before the study is carried out that they can terminate theinterview at any time;•

The addresses of the Data Subjects must not be disclosed to the client;• udio, video, photo and streaming recordings may only be made by the agency conducting theAresearch or by its data processors;•In addition, it is only permissible to conduct in-home observations if the following conditions are
met:

		

• The Data Subjects must be informed before the study is carried out that they can ask theinterviewers present as well as other participants to leave their private home immediately at
any time;• The addresses of the persons interviewed must not be disclosed to the client even if travellingto the location together and conducting the in-home interview together;• Before carrying out the study, the agency conducting the research must ensure that all
identifying features (in particular name plates on doorbells or letter boxes, family photos, etc.)
are removed or covered up;• The presence of the client during in-home observations is only permissible if there arecompelling methodological reasons.

Researchers’ Responsibilities by Research Approach
Face to Face
5.42

It is good practice for the interviewer to provide an identity card to the Market Research subject.

Telephone
5.43

Unless otherwise stated the guidelines below apply to both telephone research using mobile phones
and fixed-line calls.

Naming the Agency/Researcher
5.44

The interviewer MUST give the name of the agency that they represent and MUST give their own oran agreed contact name.

52

Do not call lists
5.45

Do not call lists, specific to Market Research, must be respected.

Special Precautions When Contacting Mobile Phones
5.46

5.47

Researchers should take special care when contacting Market Research subjects via mobile phones(whether by voice, text or email), with regard to Market Research subject safety and privacy:•It is recommended that interviews by mobile/WAP phone are preceded with a question such as“is it convenient to proceed with this interview now?”•

The Market Research subject should be told the likely length of the interview;•It may be more convenient to arrange an appointment to call back at a different time or via aland line;• esearchers should try to establish as early as possible if the number to be contacted / contactedR
is that of a mobile or a fixed-line telephone.

When calling mobile phones researchers should recognise that even where legislation restricts
unsolicited calls for commercial purposes but not Market Research, it is important to consult andapply any existing research-specific do-not-contact lists for mobile and fixed line phones.

Use of Unsolicited Texts for Recruitment
5.48

ESOMAR advises against the use of unsolicited text messages to recruit Market Research study
Market Research subjects and provides a ‘Summary of regulations covering unsolicited contacts(business to consumer). This is available on the ESOMAR website.

Country Specific Guidance
5.48.1

 egulations in force in Canada could potentially establish legal liability for researchersR
contacting potential Market Research subjects via a mobile device. In general, researchers
must not make unsolicited email approaches to potential participants unless individuals
have a reasonable expectation that they may be contacted for Market Research due to apre-existing relationship with an organisation.

5.48.2In Germany and in the UK41: The use of predictive/auto-diallers is restricted.

5.48.3

In France: The use of equipment that directly dials phone numbers and continually callsback a given number until the person answers is prohibited42.

5.48.4

In Germany: Telephone interviews that are in any way directly linked with telephonemarketing are prohibited. For further details upon telephone interviewing in Germany see
Guidelines on Telephone Surveys published by the German Market Research organisations

5.48.5I n the Netherlands: The ‘Onderzoekfilter’ is set up specifically for registering ‘do-not-call’
requests regarding Market Research. Research agencies affiliated to the MOA, the FEB
and the VSO, the associations of the market and policy research, MUST check the available
phone numbers at the ‘Onderzoekfilter’ before starting any unannounced telephonesurveys.

5.48.6I n the USA: Diallers, artificial or pre-recorded voice messages, and SMS text messages are
permitted only if the Market Research subject has given prior explicit consent. When they
are used, “abandoned or silent calls”, (i.e., there is no live interviewer) immediately available,
are not allowed.

5.48.7I n the USA: The Insight Association Code of Standards and Ethics requires researchorganisations to verify that individuals contacted for research by email or text message havea reasonable expectation that they will receive email or text message contact for research(and provide further detail upon what constitutes ‘reasonable expectation’).

41 https://www.mrs.org.uk/pdf/2012-02-23%20Regulations%20for%20Predictive%20Diallers.pdf
42 CNOIM.

53

5.48.8

I n the USA: The Federal Government has recognised the distinct separation between
survey research and telemarketing. The restrictions included in the 1995 Telemarketing
and Consumer Fraud and Abuse Prevention Act, the 1991 Telephone Consumer Protection
Act, and the 2003 National Do Not Call Registry apply to telemarketing and NOT to Market
Research calls. Under the laws, calls made for sales-related purposes MUST comply withthe ‘do-not-call’ request of the person called. Telephone calls for survey research purposes
are not bound by these provisions, although companies should be careful in drawing thisline and should be aware of ongoing debate and concern about survey activities by someregulators and legislators. However, Insight Association members maintain internal donot-call lists of those individuals who have specifically requested not to be contacted bythat company for participation in survey research. FCC Regulations (October 2013), permit
Market Research calls made to mobile phones using an autodial only with the “prior express
consent” of the intended recipient to receive such calls.

5.48.9In the USA: There is a federal prohibition on calling:• A doctor’s office or a healthcare facility where the called party is charged for the callor in such a way that 2 or more telephone lines of a multi-line business are engaged
simultaneously;• Cell/mobile phones with an auto-dialler (any equipment capable of dialling a telephone
number prior to a live operator being available to exclusively handle the call). In addition,
operators of automated dialling equipment need to remove any number classified as apublic safety answering point (PSAP), in line with the Telephone Consumer Protection Act(TCPA).

Ethnographic/Observational Approaches
Definitions
5.49

Observational or ethnographic research are defined as any research form which relies significantly
upon the observation of human behaviour as one of its data sources, whether Market Researchsubjects are openly observed (participant observation) or covertly or indirectly observed (nonparticipant).

5.50

Images of people on film and audio recordings of them would be considered as personal data under
Data Protection legislation Guidelines  

5.51

When conducting ethnographic Market Research researchers are advised to:•Inform Market Research subjects of the overall reasons for the observation of their behaviour;• larify in writing and gain documented agreement as to the precise nature of the research andCthe responsibilities of each party;•

Inform Market Research subjects of the extended nature of ethnographic research at the point of
recruitment before they agree to participate. Timings should be clear;•

Inform Market Research subjects at recruitment of any activities they will be asked to undertake;•Use language that is understandable;•

 xplain significant factors that could influence the person’s willingness to participate (such asErisks, discomfort, adverse effects, or limitations on confidentiality);• uard against unwarranted intrusion; so safeguards and the ability to end the observationG
quickly should be built in – the right to withdraw MUST be respected.

Constraints
5.52

There are a number of constraints upon how covert observational data may be collected and used:• here recordings for Market Research purposes are made in public areas e.g. in store, signs
W
MUST be displayed indicating:•

Who is recording;54

•Purpose of recording;•

Means of contact - phone number.

•

Signage should be displayed with some prominence in a large and readable typeface.

•

Cameras MUST be sited so that they monitor only the intended areas.
 or further information please see MRS Guidelines for Qualitative Research IncludingF
observational, ethnographic and deliberative research and ESOMAR Passive Data Collection,
Observation and Recording43.

Online & Mobile Market Research
Definitions
5.53	Online or internet research refers to research in which a Market research subject or researcher isinvolved in any of the following:

5.54

•

Completing research documentation online regardless of access route;•Downloading research documentation from a server and returning it by email;•Receiving research documentation incorporated into an email and returning by email;•Participating in an online qualitative interview or discussion;•

Taking part in a measurement system which tracks web usage;•

Participating in an online message board;•

Collecting information from social media;•

Any other collection of data in the online environment for the purpose of Market Research.

Mobile Market Research (sometimes referred to as eResearch) involves the collection of information
by mobile device (mobile phones, tablets and other similar mobile computing devices) for Market
Research purposes.
These guidelines apply to Market Research carried out on mobile phones or devices and to browser
based or downloaded applications, passive and active data collection.

5.55

An online ‘access panel’ is defined as a sample of potential Market Research subjects willing toreceive invitations to participate (if selected) in future online interviews. Further guidance forresearch suppliers setting up and managing online panels are available from ESOMAR44.

5.56

A Market Research subject’s email address or other personal identifiers (e.g. screen or username
or device identifier) is personal data where it refers to an individual and therefore needs to beprotected in the same way as other identifiers. A person’s digital image is personally identifiable
data. Geo-location data may be considered personal data too.
5.56.1In Germany: Guideline for Online Surveys applies and should be strictly followed. It isavailable here https://www.adm-ev.de/standards-richtlinien/

Informed Consent
5.57

If relying on informed consent you must provide an easy way for Market Research subjects to supply
and withdraw it.

5.58	Market Research subject consent is required for the installation and use of software such as an app
and Market Research subjects MUST be made aware of its purpose, the type of data it collects andits impact on functioning or performance such as degradation of battery life. For further details see
ESOMAR’s Guideline for Conducting Mobile Market Research.
Privacy and Data Protection
5.59

Researchers MUST post a privacy policy statement. The statement should be easy to find, easy to use
and understand, including by children when appropriate (Refer to Chapter 2).

43 https://www.mrs.org.uk/pdf/2014-09-01%20Qualitative%20Research%20Guidelines.pdf and http://www.esomar.org/uploads/public/knowledge-andstandards/codes-and-guidelines/ESOMAR_Codes-and-Guidelines_Passive_Data_Collection-Observation-and-Recording.pdf
44 https://www.esomar.org/uploads/public/knowledge-and-standards/codes-and-guidelines/ESOMAR_26-Questions-To-Help-Research-Buyers-Of-OnlineSamples.pdf These cover panel recruitment, project management, monitoring, maintenance and data protection issues

55

5.60

Links to data protection; privacy policy or cookie consent statements MUST be given at the start of
the Market Research project. This will ensure that should Market Research subjects fail to complete
the exercise for any reason their rights are protected.

5.61

If a repeat or follow-up survey is intended, a lawful basis for storage of their contact data e.g. consent
is needed. The Market Research subjects MUST be able to refuse further participation in the survey
via a suitable option and to refuse further contact by email in connection with the survey.

5.62	When emails are sent in batches, Market Research subjects’ email addresses MUST be kept
confidential, so for instance blind copying should be used.
Market Research Subject Costs
5.63

Market Research subjects should be alerted to any costs they may incur e.g. online charges andrecompensed appropriately for these.

Researcher or Agency Contact Details
5.64	In addition to the provision of Chapter 2, Market Research subjects should be told of the researcher’s
identity and given contact details. They should also be given the opportunity to find out more about
the research agency carrying out the study, by giving them the name of the organisation together
with an address, a corresponding hyperlink is recommended. When working overtly in social media
sites, researchers should also provide contact details.
Protecting Personal and Company Data
5.65

Researchers MUST use adequate technological and organisational measures to protect personal datawhen collected, transmitted or stored on websites or servers.

5.66

Clients should be made aware of the potential risks of using confidential information in online ormobile surveys (e.g. within product descriptions). Agencies should be required to implement strict
security procedures. Confidential information even if protected by non-disclosure agreements iseasily printed/stored/forwarded and practically impossible to remove from circulation.

Cookies
5.67	In accordance with the European ePrivacy Directive, you must inform your website users that you
place cookies on your website and why, as well as provide clear description of the data collected.
Interview Duration
5.68

Market Research subjects should be told the length of time the questionnaire is likely to take tocomplete under normal circumstances (e.g. assuming connection is maintained and standard
connection speed).

Disclosing List Sources from Website Registration Databases
5.69

Where lists (including client-supplied lists) are used for sample selection, the source of the list MUST
be disclosed. Where these are derived from website registration databases, researchers MUST checkthat registration was voluntary, and that the data are current.

Use of Unsolicited Emails for Recruitment
5.70

Researchers should avoid intruding unnecessarily on the privacy of Market Research subjects.
ESOMAR advises that unsolicited e-mail approaches to potential Market Research subjects should
not be made even in countries where this is permitted by law unless individuals have a reasonable
expectation that they may be contacted for research. ESOMAR provides a ‘Guideline on Duty of
Care45’45 https://esomar.org/uploads/attachments/ckvkpvo7o02c4cn3v5yxes9nl-grbn-guideline-when-processing-secondary-data-for-research.pdf
https://esomar.org/uploads/attachments/cktega1tf037ysptrfe0s7gdq-esomar-grbn-guideline-on-duty-of-care.pdf
https://esomar.org/uploads/attachments/cktim86vi054wsptru81egz40-guideline-on-primary-data-collection-final.pdf

56When receiving email lists agencies should verify that individuals listed have a reasonable
expectation, they will be contacted for Market Research purposes.
5.70.1

In Mexico: Unsolicited email must not be sent unless a previous relationship exists, and therecipient is aware and agrees to that use in the sender’s privacy disclaimer.

5.70.2I n the Netherlands: Article 11.7 of the Telecommunications Act (Telecommunicatie wet)requires prior consent from individuals to be contacted via their email addresses forcommercial (charitable or idealistic) purposes. When an e-mail address is used for sending
invitations for research, or for sending a survey, this is considered not to be commercial(charitable or idealistic) purposes, but purely for research, information gathering, andtherefor prior consent is not required. If, however, under the pretence of Market Research
the intention is to sell something, this exception does not apply.

I n the USA: The Federal CAN SPAM Act and Insight Association ’s mandatory Code of Standards
requires researchers to obtain the research subject’s Obtain the research subject’s consent for
research participation and the collection of personal data or ensure that consent was properly
obtained by the owner of the data or sample source.
prior consent from individuals to be contacted via their email addresses. Insight Association’s Coderequires research organisations to verify that individuals contacted for research by email or text
message have a reasonable expectation that they will receive email or text message contact for
research (and provide further detail upon what constitutes ‘reasonable expectation’). If known at thetime of data collection, inform research subjects of any activities that will involve re-contact. In suchsituations, the researcher must obtain the research subject’s consent to share personal information
for re-contacting purposes. Re-contacting research subjects for quality control purposes does
not require prior notification. Researchers must allow research subjects to withdraw at any time.
Researchers must also obtain consent from the research subject prior to his/her data in a mannerthat is materially different from what the research subject has agreed.
5.70.3I n the UK: Market Research emails are not defined as commercial communications within
the 2011 Amended Privacy and Electronic Communications Regulations. Consequently,
clients can forward customer email addresses to agencies (for recruitment purposes), unlessthe client has included Market Research in their standard data protection opt out policy.

Use of Apps
5.71

Researchers must have a lawful basis e.g. Market Research subject consent for the use of an app
and Market Research subjects MUST be made aware of its purpose, the type of data it collects andits impact on functioning or performance such as degradation of battery life. For further details see
ESOMAR’s Guideline for Conducting Mobile Market Research.

	
It is suggested that legal advice is sought if an app uses a location device or tracks activities without
user engagement (e.g. passive listening) to ensure that data protection and privacy rights are notcontravened.
5.72

Researchers MUST NOT:•Install software that modifies the mobile settings beyond what is necessary to conduct research;•Install software that knowingly causes conflicts with the operating system or cause other installedsoftware to behave erratically or in unexpected ways;•

Install software that is hidden within other software that may be downloaded or that is difficult touninstall;•Install software that delivers advertising content, with the exception of software for the purposeof legitimate advertising research;•Install upgrades to software without notifying users and giving the participant the opportunity to
opt out;•

Install software that inordinately drains battery life;•	Install software that causes any costs to the participant that aren’t reimbursed by the researchorganisation;

57

•Install or utilise geolocation tracking software that would compromise the participant or theirpersonal data;•

Create a risk of exposing personal data during data transmission or storage;•

Change the nature of any identification and tracking technologies without notifying the user;•

Fail to notify the user of privacy practice changes relating to upgrades to the software; or•Collect identifiable data that may be used by the app provider for non-research purposes; or•	Extract information from the mobile device or phone unless this information is part of the
purpose of the study (and informed consent is obtained).
Using Identification and Tracking Technologies/Software
5.73

5.74

Market Research subjects MUST always be told at the first opportunity when software is being used
to collect information about them, they MUST also be told:•

Why it/they are to be used;•

If the data subject’s information is to be shared;•That they can turn them off or remove them.

Consent for downloading software to be used for Market Research purpose should be sought and ameans provided to address questions.

	ESOMAR provides example disclosure statements within its Guidelines https://www.esomar.org/
what-we-do/code-guidelines
5.74.1In Germany: Websites that use analytics tools MUST give users the chance to opt out.

5.74.2 or the USA: The Insight Association provides detailed guidelines with regard to the use ofF
active agent technology within its Code of Standards and Ethics.

Online Access Panels
5.75	Panel members MUST be made aware that they are members of a panel and should be reminded ofthis at regular intervals. Access panels are a sample database of potential Market Research subjects
who declare that they are willing to receive invitations to participate in future online interviews.
At recruitment potential panel members MUST be told that their personal data may be stored forfurther Market Research and there must be a lawful basis for this in place.
ESOMAR provides a series of guidelines https://www.esomar.org/what-we-do/code-guidelines

Social MediaDefinition
5.76

Social media is defined by ESOMAR as internet-based platforms and technologies that permit users“interaction and/or facilitate the creation and exchange of user generated content.”
Widely used examples include:•

Online forums/discussions, communities, blogs, social networks (e.g. Facebook);•

Video/photo sharing (e.g. YouTube);•

Multi-person/group communication and/or collaboration platforms (e.g. Twitter).

5.76.1I n the UK: As with all forms of MR, appropriate AE/PC/SRS reporting processes must be put
into place for MR using social media. In addition to the ABPI/BHBIA’s Guidance notes oncollecting adverse events, product complaints and special reporting situations during Market
Research it may be helpful to consult the ABPI’s Guidance notes on the management ofadverse events and product complaints from digital media available online: http://www.abpi.
org.uk/publications/safety-data-websites

58

Accessing Social Media Content including Website Terms and Conditions
5.77

You must have legal grounds for accessing content on social media, these are likely to be either
consent or legitimate interests. When conducting social media Market Research, researchers arebound by the terms and conditions attached to access of the online services. Many service providers
include intellectual property rights clauses that prohibit copying of material without consent.
Researchers should ensure that they abide by the terms and conditions attached to use of site
content. However, if consent for listening/scraping is not given, researchers can read and précis thecontent.

Anonymising Quotations
5.78	Care should be taken to ensure that anonymous quotations are indeed anonymous and cannot be
traced back to reveal their original source.
Passive Market Research i.e., digital listening, scraping
5.79

Without the data subject’s consent (obtained as part of the terms of use or directly) or another lawfulbasis only anonymised data can be reported. Anonymised data should not reveal any personallyidentifiable information.
5.79.1I n the USA: Per the current Insights Association Code Researchers must obtain consent
when collecting and/or using passive data whenever possible, regardless of method
employed. In such situations, researchers also must provide clear and simple methods
for research subjects to grant and retract their consent. If a device is shared by multiple
individuals, every effort should be made to delete data that is not sourced from theindividual that gave consent. Where it is not possible or practical to obtain consent,
researchers must have legally permissible grounds to collect the data and must remove or
obscure any identifying characteristics as soon as operationally possible.

5.80	No attempt should be made to identify contributors. ESOMAR states that this MUST be a contractual
obligation if the data is passed on to the client or another researcher. If a contributor’s comments
are to be made public (i.e. cannot be covered by contractual obligations) and the contributor is
identifiable, their consent should be sought or the comment disguised or ‘masked’ appropriately.
5.81

Quotations containing personal data can only be provided to the client if there is a lawful basis forthis e.g. the data subject has given their consent for this and it has been made clear that they will not
be subject to promotion as a result of this.
5.81.1

5.82

In Germany: Market Research subject identity must remain anonymous and Market
Research subjects cannot be asked to waive their right to anonymity

In ‘private’ SM spaces (ones in which users would expect their comments to be private), researchers
should seek and gain the consent of contributors to listen in/scrape comments, other lawful bases
are unlikely to be appropriate in these circumstances. Comments given to clients MUST be masked
unless the contributor gives consent for their comments to be passed on verbatim. This assumes
the terms and conditions have not given explicit site owner and site user consent for listening in/scraping.
5.82.1In Germany: It should be remembered that local Market Research guidelines prohibitasking Market Research subject/contributor consent to pass their personal data to the clientcompany.

Active Market Research i.e., engaging with participants
5.83

Consent from the site/service owners and data subjects/users MUST be given.

5.84

Researchers MUST declare their presence; they MUST NOT represent themselves as anything otherthan Market Researchers.

5.85

Data subjects must be told the identity of the research organisation, purpose of the Market
Research, what sort of data will be collected, how their comments will be used and who will haveaccess to it. If processing personal data, you must meet data protection requirements.

59

5.86

Data subjects must be provided with contact information for the researcher or research agency. If
you are processing personal data you must identify data controller(s), recipients of personal data andthe source of the personal data (if it wasn’t obtained directly from the individual).

5.87

Researchers must publish a privacy policy/notice on their website.

5.88

Online space created specifically for Market Research such as MROCs should fulfil the following
criteria:•

 articipants MUST be aware of its function and the use to which their contributions might be putP
and that the data will be shared with the client;•

Any rules for interacting MUST be available;•

Site privacy policy MUST be available;•

The personal identity of participants MUST be protected.

Adverse Event Reporting
5.89

Adverse event reporting requirements are the same when Market Researchers use social media
as a source of Market Research data as any other Market Research medium such as face to faceinterviews. Marketing authorisation holders and their contracted agents have an obligation tocollect and follow-up on the adverse events and product complaints associated with their medicinal
products. This applies to public and private sites, passive and active approaches and to company
sponsored and non-company sponsored websites.

	If a company chooses to listen-in to or ‘scrape’ from non-company sponsored sites, whether public
or private (with consent) it is recommended that the listened to pages should be monitored foradverse events for the period of the listening-in activity only. There is no obligation for researchers tomonitor non-company sponsored sites routinely for adverse events if they are not being used for aMarket Research purpose.

ADVERSE EVENT REPORTING PROFORMASEE ANNEX 1

6.	 AFTER FIELDWORK
Analysis and quality control
6.1

Researchers and agencies should anonymise or pseudonymise personal data as soon as possible
during the Market Research process.
6.1.1

In Australia: When presenting findings or data analytics of a research project conducted on
an anonymous basis, Members must ensure that an individual’s identity cannot be inferred
via deductive disclosure (for example, through cross-analysis, small samples or combination
with other data such as a client’s records or secondary data in the public domain).

6.2	Researchers must when requested by clients allow independent checks on the quality of datacollection.

Reporting Market Research
6.3	Researchers should take reasonable steps to ensure that:•Interpretation and conclusions are adequately supported by the research findings, with
explanation as to which data support the interpretation;•

 he detail necessary to assess the validity of findings is available (including sample size, questionTsource, statistical tests used) and that data tables include sufficient information to enablereasonable assessment of the validity of the results;•	Reports and presentations accurately:60

•

Reflect the findings of the research.

•

Reflect the researcher’s interpretations and conclusions.

• istinguish between factual reporting of data and a researcher’s interpretation. And that theDcontent does not breach any copyrights.

6.4

Combining data is permissible as long as personal data is not released to the client company whendata is combined and combining the data does not enable the client to identify the Market Researchsubject.

6.5

Personal data MUST not be included in reports unless there is a lawful basis for this e.g. consent has
been given. If personal data is included in the report the client as the recipient of personal data willneed to be identified to the data subjects whose personal data is used.

6.6

Data that could lead to the identification of individuals such as names, facility names, and DCF codes,
will not be included in the deliverable data (it is allowed within the research, but the data will not bedelivered).

Publishing Market Research
6.7

The client should not publish any of the results of the survey without the approval of the agency
unless otherwise agreed in advance.

6.8	Researchers should check any client-prepared materials prior to publication to ensure that the
research results are not misleading.
6.9	Full details of the source should be referenced and must include detail that will allow the audience
to assess the quality of the data and the validity of the conclusions. The material included must notbreach copyright.
6.9.1

In the USA: Insight Association members are obliged to:• Always obtain clear approval from clients to release findings publicly ;Ensure that thefindings released are an accurate portrayal of the research data, and that careful checks
are performed on the accuracy of all data presented;• Provide the basic information, including technical details, to permit independent
assessment of the quality and validity of the data presented and the conclusions drawn,
unless prohibited by legitimate proprietary or contractual restrictions ;• Make best efforts to ensure that they are consulted as to the form and content ofpublication when the client plans to publish the findings of a research project. Both theclient and the researcher have a responsibility to ensure that published results are not 		
misleading;• Not permit their name or that of their organization to be associated with the publishing of
conclusions from a research project unless those conclusions are adequately supported by
the data;			• Promptly take appropriate actions to correct information if any public release is found to
be incorrect.

IA Code of Standards and Ethics for Marketing Research and Data Analytics.
Insights Association > Tools & Resources > Codes of Standards
6.9.2

I n the Netherlands: MOA affiliated researchers commit themselves to sending out aresearch framework, when sending out press releases intended to publish research findings.
The request is made to both the external media, and to the internal press services, to add
the framework at the bottom of the article.

6.10	If research is misreported by a client, the researcher should as soon as possible:•

Refuse consent for their name to be used in connection with the misreported findings;•

Publish a statement that the results have been misreported and correct the misreporting.

61

7.	 MARKET RESEARCH SUBJECTS
Patients
7.1

7.2

When researching existing or future potential medical treatments with patients, care should be taken
not to:•Raise unfounded hopes of treatment of specific medical problems;•

Mislead Market Research subjects with regard to the safety of a product;•

Encourage members of the public/patients to ask their doctor to prescribe a product;•

Offer advice on the specific therapy area under discussion.

Health data are classified as special categories of personal data under GDPR: researchers must havethe specific consent of the data subject prior collection and processing. For more information refer
to Chapter 2.
7.2.1

In Denmark: There are certain precautions to be taken regarding a healthcare
professional’s access to patient records. It is clear from section 40 of the Health Act thata patient is entitled, as a starting point, for a healthcare professional not to disclose
information about patients’ health conditions, private matters and similar confidential
information. However, certain exceptions apply, which are stated in sections 41-46 of the
Health Act. Thus, it appears, among other things of section 43 of the Health Act, that incertain circumstances information may be disclosed, among other things the patient’s healthconditions for purposes other than treatment, if the patient has given (written) consent
thereto and the consent is entered in the patient record. It is the healthcare professional
who holds a confidential information that determines whether the disclosure of theinformation is justified. For further information on patient safety, please refer to the Health
Act and the Danish Patient Safety Board.

7.2.2

In Spain: The Royal Decree 957/2020 regulates observational studies with medicines forhuman use. The aim of the Decree is to ease the administrative procedures applicableto observational studies considering adopted requirements from the EU level primarily
the European Medicines Agency-approved guidance on post-authorization efficacy
studies and in Spain with the enactment of Royal Decree 1090/2015 on clinical trials withmedicinal products, which introduced the legal concept of observational studies. The Royal
Decree considers an “observational study with medicines” to be any investigation withthe collection of individual data related to people’s health, provided that it does not meet
any of the conditions required to be considered a clinical trial established in article 2.1.i)of Royal Decree 1090 / 2015, of December 4, and that it is carried out with the purpose ofdetermining the beneficial effects of drugs, identifying or quantifying their adverse reactions
or obtaining information on the patterns of drug use in the population. Observational
drug studies should be aimed at complementing the information already known about the
drug without interfering with routine clinical practice. Therefore, if a project is collecting
anonymised data and/or is not about determining the beneficial effects of drugs, identifying
or quantifying their adverse reactions or obtaining information on the patterns of drug use
in the population these activities would not meet the definition of observational studies andthe Royal decree would not apply.

Simulated Consultations
7.3

Simulated consultations between a patient and a healthcare professional (known or unknown toeach other) are a legitimate research approach however they should be conducted with great carebecause they may lead to misunderstanding with the patient. It is important that participating
patients are fully aware of the nature of the research and that the consultation is a simulation andnot a substitute for a normal consultation.

7.4	There is no restriction upon the use of protected health information if it has been fully anonymised.
Full Anonymisation is particularly difficult to achieve and maintain, researchers must pay extra

62attention to anonymisation techniques and confirm the result is in line with the Principles of thisCode and the EU GDPR previsions.

Vulnerable Market Research subjects
7.5	Vulnerable Market Research subjects are those who for whatever reason could be more susceptible
than normal to physical or mental stress induced by the research process. Patients may well prove to
be vulnerable Market Research subjects because of their age, physical or mental health. A vulnerable
Market Research subject could be someone who is HIV positive or has cancer, a psychiatric illness oris physically handicapped.
	
ESOMAR Guideline on Research and Data Analytics with Children, Young People and other
Vulnerable Individuals are available here https://www.esomar.org/what-we-do/code-guidelines
7.5.1

In Australia: Researchers must take special care when collecting information from people invulnerable circumstances in the community.

			Comment: Such people include, but are not limited to, people with disability, thoseexperiencing homelessness or other disadvantage, people with serious medical conditions
and people from culturally and linguistically diverse backgrounds. Vulnerable circumstances
may be permanent or temporary.
What to Consider When Interviewing Vulnerable Patients
7.6

If the Market Research subjects are considered vulnerable, then the following questions should beconsidered:•Is the Market Research justifiable?

•

Is the nature of interview/tasks involved appropriate?

•

Should a carer be present or on hand if required?

•

Is additional time or the provision of breaks needed?

7.7	When a potentially sensitive issue has been discussed with a vulnerable Market Research subject,members may provide information or relevant helpline information.
7.7.1

I n the UK: The Mental Capacity Act provides codes of conduct on how vulnerable adults
who lack the capacity to consent for themselves should be consented into research. The
Act allows for another adult such as a next of kin or legal representative to consent on theirbehalf, the patient’s doctor cannot give this consent alone. However, there is an onus on the
researcher to withdraw the Market Research subject from the study if they show any sign ofbeing unhappy or distressed by being included in the study.

Children and Young People
7.8

When conducting research with children or young adults, ESOMAR advises that in the absence of anational definition, ‘child’ is a minor 12 years old or less and a ‘young person’ is 13 to 17 years of age.

	ESOMAR Guideline on Research and Data Analytics with Children, Young People and other
Vulnerable Individuals are available here https://www.esomar.org/what-we-do/code-guidelines
7.8.1

In Australia: The consent of a parent or responsible adult must first be obtained before
collecting information from: a) children, defined as under 14 years, and b) young people,
defined as 14-17 years, when sensitive information is being collected.

7.8.2

In Brazil: Child must be defined as under 14 and young as between 14 and 17 years
old. In the case of children under 14, written parental or responsible adult consent isrequired. Between 14 and 17 years old, it is recommended to obtain parental consent forcontroversial issues or products. Children under 18 should not be interviewed for alcoholic
beverages, cigarettes and any other product prohibited by law for this age group46.

46 ABEP Norma ABEP para pesquisa de mercado, opini o e m dia

63

7.8.3	In Canada: A child is to be defined as under the age of 14, a young person as aged 14-17.
7.8.4

In Italy: Researchers need to use special care when interviewing minors, children under theage of 13 and vulnerable individuals. For particularly sensitive topics, the limit is extended toyoung people up to 18 years of age. Informed consent from parents or a responsible adultmust be obtained before interviewing children.

7.8.5

In Mexico: All those under 18 are considered children.

7.8.6

In the UK: The MRS Code of Conduct defines a child as a person under the age of 16 and‘young people’ refers to those aged 16 and 17 years.

7.8.7

I n the USA: The Children’s Online Privacy Protection Act (COPPA) requires verifiable parentalor the legal guardian’s consent for interviewing children below the age of 13 years. If you are
relying on consent as your lawful basis for processing personal data, when offering online
services directly to a child, only children aged 13 or over are able provide their own consent.

7.8.8

I n South Korea: If the data subject is under the age of 14, the consent must be obtained
from the legal guardian.

Consent
7.9	Consent from the responsible adult i.e., an adult responsible for the child’s safety and welfare at thetime of the research, is required to ask the child whether they will participate. Consent of a parent or
responsible adult MUST be obtained before interviewing a child whose definition of the age is set bynational laws and self-regulatory codes in the following circumstances:•

In home/at home (face-to-face and telephone interviewing);•

Group discussions/depth interviews;•

Postal questionnaires;•

Online questionnaires or email;•

Where interviewer and child are alone together;•In public places such as in-street/in-store/central locations unless the child is 14 years or over, inwhich case interviews may take place without the consent of a parent or responsible adult.

7.10

Explicit consent from the child MUST also be given; the child MUST have their own opportunity toagree or decline to participate. When online research is carried out, a notice to children informing
them of the requirement for consent MUST be shown at the point where personal information isrequested.

7.11

Personal information relating to other people MUST NOT be collected from children unless it is to
be used to gain consent from a parent/responsible adult. Where consent is being sought, it may be
preferable for some classification questions to be asked of the parent/responsible adult, rather thanthe child/young person

7.12

Details of the person giving consent (name and role) MUST be recorded.

7.13

The responsible adult MUST be made aware of any observation or recording.
7.13.1In Germany: Children under the age of 11 years must be assumed in principle not to havethis cognitive faculty. This means that recruiting and/or interviewing of children under theage of 11 years is not permissible in principle if the child is not accompanied by a legal
representative, meaning that consent cannot be obtained. When interviewing children
between 11 and 13 years it is the responsibility of the agency conducting the researcheither to have the interviewers discover the cognitive faculty or – to ease the burden on theinterviewer – to assume in general that this age group does not possess the cognitive faculty
and therefore the consent of a legal representative is required. In making such a decision,
the research topic may also be relevant. Irrespective of the alternative “consent of a legal
representative” or “cognitive faculty of the child /adolescent” interviews with minors under
the age of 14 years should not be conducted without the knowledge of an adult present in
the home. This includes that the interviewer should not enter a home if, apart from the child/adolescent under the age of 14 years, no adult is present at that time. Depending on the64

r esearch subject for population samples different age limits are relevant. For adolescents inthe age group of 14 to 17 years the necessary cognitive faculty can be assumed in principle.
If no legal representative is present when interviewing adolescents, the “Declaration on Data
Protection” shall be handed over to the adolescent.
7.13.2

In Mexico: Written consent from the responsible adult must be obtained for all Market
Research with Market Research subjects under 18 years of age.

7.13.3I n the UK: In certain circumstances the responsible adult consent may be waived but onlywith permission from the MRS’s Standards Board.

7.13.4I n the USA: Researchers must take special care when conducting research with children
and other vulnerable individuals. When conducting a research project with such individuals,
researchers must: Obtain verifiable consent from a parent or legal guardian for children orother vulnerable individuals when required. Take special care when considering whether
to involve children and young people (minors) in research. The questions asked must take
into account their age and level of maturity. When working with other vulnerable individuals,
researchers must follow all applicable laws and regulations and ensure that such individuals
are capable of making informed decisions and are not unduly pressured to cooperate inresearch.

Online Market Research with Children
7.14

EPHMRA recommends that online research is not conducted with children under the age of 14.

7.15

For online research with children Market Research subjects should be asked to give their age before
any other personal information is requested. If the age below that set by national laws and selfregulatory codes, the child MUST be excluded from giving further personal information until theappropriate consent from the responsible adult has been obtained and verified.
7.15.1

7.16

I n the USA: Researchers MUST abide by the Children’s Online Privacy Protection Act(COPPA). This federal ruling applies to the online collection of personal information fromchildren under 13. It details what a website operator MUST include in a privacy policy, whenand how to seek verifiable consent from a parent and what responsibilities an operator has
to protect children’s privacy and safety online47.

A notice to the parent/responsible adult should be placed on the website or sent via email asking fortheir consent for the child to participate in online Market Research. ESOMAR provide guidelines upon
the recommended content of such a notice. See ESOMAR Online Research Guidelines 2011.

Role of the Responsible Adult
7.17

Consider the necessity for the presence of a parent/guardian during fieldwork. It is recommended
that when interviewing a child in their own home, a parent/responsible adult is present, notnecessarily in the room but in the house. If a child or the responsible adult asks for an adult to bepresent, this request should be respected.

7.18	The researcher should ensure that the responsible adult has full details of the research venue, nameof moderator, finishing time, etc.
Researchers’ Responsibilities
7.19

No study can ask a child to do something illegal for their age.

7.20

Language on questionnaires should be suitable for the age group.

7.21

Refreshments provided should be suitable for the age group and care should be taken to .avoid
including anything that is known to cause allergic reactions.

7.22

The researcher should take responsibility for safely handing over the child/young person after aninterview or ensuring that arrangements for them to get home safely are in place.

47 http://business.ftc.gov/documents/Complying-with-COPPA-Frequently-Asked-Questions

65

Incentives
7.23

Where incentives are used, they should be suitable and acceptable for the age of the child/young
person and fitting for the task required.

Product Testing
7.24

If a child is going to be asked to test a product, the responsible person should be allowed to see thisand (if they wish) to try it themselves.

7.25

If children/young people are to be asked to take part in any form of product testing, researchers
should take special care to ensure that the products are safe to handle or consume and that thechild/young person does not suffer from any relevant allergy. EPHMRA recommends that active
medicines are not used in Market Research with children.

Criminal Record Checks for Interviewers
7.26	Criminal record checks for interviewers may be necessary in some circumstances but it is notnecessary for all researchers.

Opinion Leaders, Clinical Trial Investigators and Advisory Board
Members
7.27

When recruiting Market Research subjects that have a pre-existing relationship with the company
e.g. clinical investigators, opinion leaders or advisory board members, it is acceptable for the initialinvitation to participate in the Market Research to come from the client company. However, theirdecision to participate or not MUST remain confidential i.e. the client company MUST NOT know who
did or did not participate.

7.28

A senior member of the marketing or clinical department may provide the following information inwriting – an outline of the:• ompany’s aims in undertaking Market Research (e.g. to obtain feedback on the clinicalC
performance of a new drug in trials);• easons why the Market Research subject has been chosen (personal experience of drug,Rexpertise in therapeutic field);• redentials of the researcher/agency undertaking the study and names/contact details ofCpersonnel who will conduct the interview;•

 rocedure for selecting any trial patients for inclusion in the study (via records or interviews) ifPrequired.

	However, it should be noted that in some circumstances or cultures this may be misinterpreted as orconsidered disguised promotion. So, this approach should be used with great care.

Payers and Influencers
7.29

Given the potentially sensitive nature of discussions with payers and influencers, care should betaken to ensure that their professional role is respected, and they are not pressured to impart
inappropriate information.

Please note the guidelines provided within Section Sensitive Topics.
7.30

Breaches of the Code of Conduct and complaints will be investigated in the first instance by
EPHMRA’s Ethics Group, and if necessary, concerns/complaints upheld by EPHMRA may then bereferred to the appropriate regulatory body, following which disciplinary measures may be taken bythese organisations.

7.31

If the relevant Data Protection legislation is breached, action can be taken by the appropriate Data
Protection Authority in the relevant country. For a list of European Data Protection Authorities see https://edpb.europa.eu/about-edpb/board/members_en

66ANNEXPROFORMA
ANNEX 11PROFORMASEPHMRA Adverse Event Reporting Form – TEMPLATE
Market Research Agency and Project Details
MR Agency name:
Full Address:
MR Agency contact telephone number:Country Code:
Number:

MR Agency contact email
Research Interviewer’s name:Research Interviewer’s email address:
Date aware of Adverse Event (*)
Agency MR Project title/reference number
MAH (**) project number / ID
Respondent ID or AE number

Patient Information

Title:First name:Last name:

No. of patients:

Individual patient:(Select 'multiple patients' only if individual identifying
details are not available, otherwise please complete
separate AE reports)

Multiple patients:

Availability of patient information
Age

YES
YEARS

NO

Gender

FEMALEOTHER

MALE
PREFER NOT TO STATEDrug and Event Information

State number of patients if known:

Drug nameIndication drug prescribed
Description of Adverse Event:Please describe as fully as possible
Indication/condition for which drug prescribed
Daily Dose of drug

NOT KNOW

Lot/batch number for drug

NOT KNOW

Frequency of dose of drug

NOT KNOW

Route of administration/form of drug

NOT KNOW

Reported to local regulator?
Does reporter think event might have been related to thedrug?

MR Subject /Reporter details
MR subject / Reporter name
Relation to the patient?

YES
YES

NO
NO

DON’T KNOWDON’T KNOW

Title:First name:Last name:

Reporter type (E.g., doctor, patient / consumer)
Does the MR subject / Reporter agree to provide theircontact details (e.g., address; email/phone optional)?
NOT AGREE TO PROVIDEDoes the MR subject / Report agree to be contacted forfollow up
Is the MR subject / Reporter a patient / consumer?
IF YES:
Doctor’s name:

YES, AGREESIGNATURE
YESNO, DO NOT AGREENO

Doctor’s contact address:

88

67

APPENDICESTHE PROFORMAS PROVIDED IN THE FOLLOWING PAGES PROVIDE TEMPLATES BUT MAY NEED TO BE
ADJUSTED TO TAKE INTO ACCOUNT LOCAL/NATIONAL REQUIREMENTS.
Pro Forma 1

Recruitment Agreement

Pro Forma 2

Receipt of Incentive

Pro Forma 3

Market Research Subject Consent Allowing Client Access to Market Research Fieldwork

Pro Forma 4

Client Agreement to Safeguard Confidentiality of Recordings of Market Research Fieldwork

Pro Forma 5

Observer Agreement

68

69

Pro Forma 2
Receipt of Incentive
Project Details
Project Title:

Project No:

Agency:Agency Contact:

Fieldwork
Date of receipt:

Start Time:

Location: (If online or telephone, pleasestate this)Duration:

Incentive
Incentive Type:(e.g. cash)

Incentive Amount:

Declaration
I confirm that the information I have given during the course of this interview/group
discussion represents my views on the subject matter.
I confirm that I have received the incentive detailed above in appreciation for mycontribution to the project.
Market Research Subject Signature
Signature:

Name (please print)

Market Research Subject Code Number
Code Number

104
70

Pro Forma 3
Market Research Subject Consent Allowing Client Access to Market Research Fieldwork
Project Details
Project Title:

Project No:

Agency:Location of Fieldwork:

Date of Fieldwork:

Start Time of Fieldwork:

Declaration
I understand that the company that commissioned this Market Research study(name of recipient organisation(s) may or may not be required will:
DELETE AS APPROPRIATE- Watch through a one way mirror (watching organisations do not need to be named) but type oforganisation(s) should be specified- Listen to an audio recording at their offices (organisations listening in may or may not need tobe named depending on whether audio information is considered personal data or not)
- Watch a video recording at their offices (watching organisation(s) must be named but naming
may be delayed until the end of the interview if viewing is not live)
I understand that the purpose(s) of the company having access is:
The people in the company who will listen to or view the recordings will be in thefollowing functions/roles:
I understand that all those listening, watching or viewing the recording MUST respect theconfidentiality of all information exchanged in Market Research interviews/groups and that nosales approaches will ever be made to me as a consequence of the company having this access.
I understand that I can withdraw my consent at any stage.
IF APPROPRIATE We would prefer not to reveal the name of the healthcare/pharmaceuticalcompany until the end of the interview, just in case knowing this affects any responses. Is thisacceptable to you or not? YES
NOSignatures
I have read, understand and agree to the terms above.
Market Research Subject Signature:

Name (please print)

Agency Signature:

Name (please print)

Market Research Subject Code Number
Code Number

105
71

Pro Forma 4
Client Agreement to Safeguard Confidentialityof Recordings of Market Research Fieldwork
Project Details
Project Title:

Project No:

Agency:Location(s) of Fieldwork:

Date(s) of Fieldwork:

Start Time(s) of Fieldwork:

Commissioning Client Company
Declaration
On behalf of <the commissioning client company> I can confirm that the recording(s) ofMarket Research fieldwork from the above study will only be used for the following
purpose(s):The only people in the company who will listen to or view the recordings will be in thefollowing functions/roles:
And the recording(s) will be in the secure_____________________________________
care of:On behalf of the commissioning client I can confirm that:- Those listening to or viewing the recording will respect the confidentiality of all informationexchanged in Market Research interviews/groups- No sales approaches will ever be made to MR subjects as a consequence of having thisaccess- No attempt will be made to reverse any anonymisation- The recordings will be stored securely, kept separate and processed in accordance with applicabledata protection/privacy laws and Market Research professional codes- The recordings will be destroyed or handed back to the agency as soon as is required.
- If video streaming has been used to allow remote viewing it is possible that the video
transmission system used delivered a copy of the recording to the receiving computer. If
this is the case any copy of the video stream saved on the observer’s computer MUST be
deleted.
Signatures
I have read, understand and agree to the terms above
Company Signature:

Name (please print)

Agency Signature:

Name (please print)

106

72

Pro Forma 5
Observer Agreement
Project Details
Project Title:

Project No:

Agency:Agency Contact:

Location of Fieldwork:

Date of Fieldwork:
Time of Fieldwork

Declaration
I understand that I MUST be familiar with and adhere to the EPHMRA’s Observers’
Guidelines.
Observer Signature
I have read, understand and agree to the terms
Signature:

Name (please print)

107
73

Observers’ Guidelines
Client observers MUST be introduced openly and honestly to Market Research subjects. Actual company
identity does not necessarily have to be revealed and if it does, it may be withheld until after fieldwork if thisinformation is likely to bias the discussion.
Clients or their sub-contractors MUST NOT be passed off as members of the research agency.
Observers MUST agree to withdraw from observing if any Market Research subject is known to themor recognised to protect the Market Research subject’s anonymity. If an observer knows that they willsubsequently have to deal with a Market Research subject, the attendee MUST also withdraw fromobserving. However, if Market Research subjects are made fully aware of the presence of an observer
known to them and give explicit consent for that individual to observe then that person may remain at thesession, care should be taken that the Market Research subjects are completely comfortable if ‘put on the
spot’ in this way.
Observers MUST respect the confidentiality of all information exchanged in Market Research interviews/
groups. They MUST NOT:• Record any Market Research subject’s personal data or record any information with the specific aim ofestablishing the identity of a Market Research subject.
• Not make any separate identifiable notes or recordings that could be attributed to an individual Market
Research subject.
• Attempt to influence how any Market Research subject is approached in future for sales/promotion.
• Not use information gleaned from the observation to amend or build databases.

74