Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes
Conditions: Type II Diabetes
Sponsor: Johns Hopkins Bloomberg School of Public Health

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
PCORI 90056532 
Measuring the Priorities of Patients With Type II Diabetes Using Likert Scale and Best-worst Scaling 
NCT02637609 
9/26/2014 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
 
 
 
JHSPH IRB Research Plan for New Data Collection  
 
 
PI Name: John F.P. Bridges 
Study Title: Advancing stated-preference methods for measuring the preferences of patients with type 2 diabetes. 
IRB No.:  6001 
PI Version No./Date: Version 2/ 9-26-14 
 
 
I. 
Aims of the Study: Describe the aims/objectives of the research and/or the project’s research questions or 
hypotheses.  
 
“Advancing stated-preference methods for measuring the preferences of patients with type 2 diabetes” focuses on 
advancing methods for patient and community engagement in patient-centered outcomes research (PCOR) and 
has three objectives. First, we will demonstrate good practices for patient and community involvement in PCOR 
projects by applying principles of community-based participatory research (CBPR) to engage an advisory board, the 
Diabetes Action Board (DAB), comprised of community- and national-level stakeholders. Second, we will address 
methodological gaps pertaining to the use of stated-preference methods in PCOR. These include identifying the 
best methods for identifying patient priorities (Aim 1), the best method for designing a preference study (Aim 2), 
and comparing stratification versus segmentation strategies for analyzing preference heterogeneity (Aim 3). We 
also seek to assess the relevance of stated preference methods to patients and stakeholders using both qualitative 
and quantitative methods (Aim 4). Third, we will demonstrate good practices for applying stated-preference 
methods by studying the priorities and preferences of patients with type 2 diabetes. This will provide an important 
case study for future researcher wanting to apply these methods in PCOR. 
 
Research can be segmented into three phases: 
 
Phase 1: Qualitative interviews and focus groups with community members (n=50) to develop the survey, which 
will be used in part 2 of the project. 
Phase 2: Local (n=10) and national (n=50) pilot surveys, implemented in the first year of the project.  The pilot 
surveys will guide the national survey (n=1000), implemented during the second year of the project. 
Phase 3: Local pilot of a follow-up survey (n=20) to assess research subjects’ attitudes towards the importance 
and validity of survey results and thereafter a national follow-up survey (n=300).  Part 3 will be implemented in 
the third year of the project. 
 
While the work in parts 2 & 3 will take place on both local and national levels, the general survey design and 
implementation methods will be similar. The main difference is the mode of survey delivery (local surveys will be 
primarily paper surveys, while national surveys will be electronic surveys) and appearance (GfK’s 
KnowledgePanel’s® online survey will have a slightly different format than the surveys used with the local 
community).  
 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
This application will describe only the work to be done in Phase 1. Amendments will be submitted for Phases 2 and 
3 as preparations for them are developed. 
 
II. Background and Rationale: Explain why this study is being done.  Summarize briefly what is already known about 
the issue and reference previously published research, if relevant. 
 
This project aims to address gaps in the understanding and applications of methods to conduct patient-centered 
outcomes research (PCOR) and is focused on advancing methods for engaging patients and community 
stakeholders in PCOR. Despite the clear need to engage patients and stakeholders as part of any PCOR research, 
current PCORI methodology guidelines give little detail on how this should be done.  
 
Based on current international best practices, there are two main strategies that can be applied to identify and 
measure the values of patients and stakeholders (Facey et al, 2010). First, patients and stakeholders can be actively 
engaged through consultation or included in decision-making panels (Barham, 2011; Vogt et al, 2006). Second, 
qualitative and quantitative research methods can be used to scientifically study what factors patients and 
stakeholders value the most (Rotter et al, 2012; Bridges 2006; Bridges & Jones, 2007; Lee et al, 2008). Such 
methods are often referred to as stated-preference methods as they aim to document the priorities and 
preferences of patients and stakeholders (Bridges, 2003). 
 
Stated-preference methods can be qualitative, using interviews, focus groups, direct observation or meta-synthesis 
methods to document priorities and preferences (Kinter et al, 2009; Bridges, Gallego & Blauvelt 2011; Hansen et al, 
2011). Stated-preference methods can also incorporate quantitative survey approaches including rating and 
ranking (Phillips et al, 2002; Bridges, Lataille et al. 2012), willingness-to-pay (Johnson, Manjunath et al, 2006), 
conjoint analysis (Casciano et al, 2011), and best-worst scaling (Louviere & Flynn, 2010). Of these, choice-based 
conjoint analysis (also known as discrete-choice experiment) has become the most common (Ryan & Gerard, 2003; 
Bridges et al, 2008; Marshall et al 2010), and clear guidelines have emerged for utilizing them (Bridges, Hauber et 
al, 2011; Viney et al, 2002; Lancsar & Louviere, 2008). 
 
While the active engagement of patients and stakeholders and the application of stated-preference methods to 
measure the values of patients and stakeholders are both important (Facey et al, 2010) and complementary 
(Bridges, 2003), stated-preference methods have several important advantages. First, stated-preference methods 
can incorporate both qualitative and quantitative data on priorities and preferences. Second, stated-preference 
methods can include large, diverse, and often hard to reach patients and stakeholders. Third, the validity, reliability 
and generalizability of the priorities and preferences of patients and stakeholders can be evaluated statistically. 
Fourth, the preferences of different sub-groups of patients and stakeholders can be identified and compared using 
stratified analysis. Fifth, stated-preference methods can be used to identify groups/clusters of individuals with 
similar preferences and descriptive statistics can be used to describe the membership of these groups. 
 
III. Study Design 
A. Provide an overview of your study design and methods.   
 
Phase 1 of the study will be guided by the Diabetes Action Board (“DAB”) and will follow community based 
participatory research principles.  The DAB is comprised of 22 individuals that are experts in type 2 diabetes 
research, community outreach and stated-preference methods. The objective is to solicit patient priorities and 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
preferences topics from these focus groups.  Information gathered will guide the development of the pretest 
instruments. Phase 1 will involve focus groups held with people with diabetes 2. These sessions will be audio-
recorded and the recording will be destroyed after transcription. If a participant does not wish to be recorded 
they will not participate in the focus group.  
 
Pilot surveys in phase 2 of the study will involve a preliminary administration of the survey instrument to 
participants with type 2 diabetes. With permission of the participants, these preliminary sessions will be audio-
recorded (after transcription, the recording will be destroyed).  The objective is to solicit feedback on the level of 
understanding of the purpose of the instrument and its structure as well as the accessibility of the language 
used.  This feedback will then be used to revise and finalize the survey instrument, which will be administered by 
GfK’s KnowledgePanel®. Four types of conjoint analysis surveys will be utilized.    
 
Pilot surveys in phase 3 of the study will again solicit feedback on the level of understanding of the purpose of 
the follow-up study and it’s structure and language.  The results from these pilot surveys will inform the surveys 
distributed by GfK’s KnowledgePanel®, which aim to engage participants to evaluate the relevance of stated-
preference methods.  
 
This application will describe only the work to be done in Phase 1. Amendments will be submitted for Phases 2 
and 3 as preparations for them are developed. 
 
B. Provide a sample size and a justification as to how you arrived at that number.  If you use screening procedures 
to arrive at a final sample a table may be helpful.    
 
 
Local 
National 
Total 
Sample type 
Qualitative 
work (focus 
groups) 
Pilot Survey 
Pilot Survey 
Survey 
 
 
Phase 1 
50 
0 
0 
0 
50 
Phase 2 
0 
10 
50* 
1000** 
1060 
Phase 3 
0 
20 
0 
300 
320 
 
 
 
 
 
1430 
*The national pilot survey includes subsets of African American participants (n=10) and Latino participants (n=10). 
**The national survey includes subsets of African American participants (n=200) and Latino participants (n=200). 
 
In phase 1, we will seek to develop the instruments with 50 participants.  Given the qualitative nature of the 
study, the sample size will be guided by the expected number of persons needed to reach saturation of 
feedback necessary to develop survey instruments that measure patient priorities and preferences. 
 
IV. Participants 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
 
A. Inclusion criteria: Adults (at least 18 years old) with type 2 diabetes.  
 
B. Exclusion criteria: Individuals younger than 18 years old and individuals without a type 2 diabetes diagnosis. 
 
V. Study Procedures   
In this section, provide details of your procedures, particularly as they relate to human subjects. If this is a multi-
center study, make the role of JHSPH clear.  If the JHSPH will serve as data coordinating center, indicate in the 
sections below which procedures JHSPH will not be performing.  Additional information regarding data coordinating 
centers is requested in a later section.  If your study will develop in phases, address each item below by phase. 
 
 
A. Recruitment Process: 
1. Describe how you will identify, approach, and inform potential participants about your study.  Include 
details about who will perform these activities and what their qualifications are. 
 
Participants for phase 1 will be drawn from individuals known to the investigators and the DAB and, using a 
snowball approach, persons they nominate as knowledgeable about type 2 diabetes. Recruitment will be 
conducted by e-mail or telephone, depending on the information available.  DAB members and their 
associates who contact focus group participants have experience in community outreach efforts.  Further, 
they also have knowledge of type 2 diabetes, connections with type 2 diabetes support systems and 
knowledge of this project. Recruitment flyers will be posted in appropriate community settings (no clinical 
settings will be used) (A recruitment flyer and phone/email script is attached.) 
 
2. Address any privacy issues associated with recruitment.  If recruitment itself may put potential participants 
at risk (if study topic is sensitive, or study population may be stigmatized), explain how you will minimize 
these risks. 
 
We do not anticipate any privacy issues during any phases of the study.  During phase 1, focus group 
participants will by identified only by their first names or by special identifiers (e.g. numbers).   
 
B. Consent Process:   
1. Describe the following details about obtaining informed consent from study participants.  If a screening 
process precedes study enrollment, also describe the consent for screening. 
• 
Who will obtain informed consent, and their qualifications 
o During phase 1 of the study, study investigators, serving as interviewers, will obtain 
informed consent.  These interviewers will have completed the Human Research Curriculum 
offered by the Collaborative Institutional Training Initiative (CITI). 
• 
How, where, and when the consent discussion(s) will occur 
o Consent discussions will occur at the beginning of focus group meetings. The consent 
discussion will occur in person at the site of the focus group.  
• 
The process you will use to determine whether a potential participant meets eligibility criteria 
o Participants will self identify as adults with type 2 diabetes. 
• 
Whether you will obtain a signature from the participant or will use an oral consent process 
o This study, and more specifically phase 1, will use an oral consent process. We request a 
waiver of signature as that would be the only identifier linking individuals with the research.  
• 
Whether you will obtain a legally authorized representative’s signature for adults lacking capacity 
o We do not anticipate research with any adult participants lacking capacity. 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
• 
If children are included in the study, if and how you will obtain assent from them 
o No children will be included in the study. 
• 
If children are included in the study, how you will obtain permission for them to participate from their 
parent, legal guardian, or other legal authority (if child is in foster care or under government 
supervision.)  
o No children will be included in the study. 
• 
If you are seeking a waiver of informed consent or assent, the justification for this request 
o NA 
• 
Whether you will include a witness to the consent process and why 
o The moderator will ask participants for oral consent. The note taker will be present to 
witness this oral consent as a safeguard that oral consent was obtained. 
• 
If the language is unwritten, explain how you will communicate accurate information to potential 
participants and whether you will use props or audio materials. 
o No props or audio materials will be used.  The qualitative protocol (focus group guiding 
material) will communicate accurate information to participants.  
 
2. Identify the countries where the research will take place, and the languages that will be used for the consent 
process.   
 
Country 
Consent Document(s) 
(adult consent, parental permission,  
youth assent, etc.) 
Languages 
USA 
Adult oral consent, qualitative 
protocol, contact information for 
principal investigator. 
English 
 
 
C. Study Implementation: 
      Answer the following: 
1. Describe the procedures that participants will undergo.  If complex, insert a table below to help the reviewer 
navigate.   
 
During phase 1, semi-structured interviews in the form of focus groups will be conducted in person. Focus 
groups will take place at JHSPH and appropriate locations in the community as identified by stakeholders. 
The interview will be audio recorded and will be attended by 2 study staff, the interviewer and a note-taker. 
When they arrive, each participant will be handed an information sheet that they can read before the start 
of the focus group and can take home. The interviewer will begin the session by explaining the study and by 
obtaining oral consent. They will then proceed by asking about the informants’ backgrounds and 
experiences in the treatment of type 2 diabetes and the priorities of participants with type 2 diabetes (see 
Qualitative Protocol and Information sheet).  
 
2. Describe the number and type of study visits and/or contacts between the study team and the participant, 
how long they will last, and where/how they will take place. 
 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
During phase 1, participants will only be contacted once and these contacts will occur in person. We expect 
focus group meetings to last between 1 – 1.5 hours. 
 
3. Describe the expected duration of the study from the perspective of the individual participant and duration 
overall. 
 
The study duration is 3 years.  Phase 1 will be completed between 9/1/2014 and 12/31/2014.  From the 
perspective of individual participants the duration of phase 1, in the form of focus group meetings and 
individual interviews, will last between 1 – 1.5 hours.  
 
4. Provide a brief data analysis plan and a description of variables to be derived.  
 
Phase 1 will identify the priorities of patients with type 2 diabetes.  This component will gather basic 
baseline information about demographic (age, gender) and disease characteristics (diagnosis of T2D given by 
a physician, time since diagnosis, severity of disease symptoms). Information gathered in phase 1 of the 
study will guide the formation of a national survey regarding the preferences and priorities of patients with 
type 2 diabetes. 
 
5. Describe whether you are collecting or storing personal identifiers, and if yes, why you need them, and 
when and how you plan to dispose of them.  Signatures on consent forms are considered to be identifiers. 
 
Personal identifiers (in the form of first name and contact information) will be stored in order to schedule 
focus group meetings. These identifiers will not be used during the focus group, will not be used in any data 
collection, and will be destroyed immediately after the focus group.  
 
 
6.  Answer the following if they are relevant to your study design: 
 
a.  If the study has different arms, explain the process for assigning participants (intervention/control, 
case/control), including the sequence and timing of the assignment. 
b. If human biospecimens (blood, urine, saliva, etc.) will be collected, provide details about who will collect 
the specimen, the volume (ml) and frequency of collection, how the specimen will be used, stored, 
identified, and disposed of when the study is over.  If specimens will be collected for use in future 
research (beyond this study), complete the Biospecimen Repository section below. 
c. If genetic/genomic analyses are planned, address whether the data will be contributed to a GWAS or 
other large dataset.  Address returning unanticipated incidental genetic findings to study participants. 
d.  If clinical or laboratory work will be performed at JHU/JHH, provide the JH Biosafety Registration 
Number. 
e. If you will perform investigational or standard diagnostic laboratory tests using human samples or data, 
clarify whether the tests are validated and/or the lab is certified (for example is CLIA certified in the 
U.S.).  Explain the failure rate and under what circumstances you will repeat a test.  For all human 
testing (biomedical, psychological, educational, etc.), clarify your plans for reporting test results to 
participants and/or to their families or clinicians.  Address returning unanticipated incidental findings to 
study participants. 
f. 
If your study involves medical, pharmaceutical or other therapeutic intervention, provide the following 
information: 
• 
Will the study staff be blind to participant intervention status? 
• 
Will participants receive standard care or have current therapy stopped? 
• 
Will you use a placebo or non-treatment group, and is that justifiable? 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
• 
Explain when you may remove a participant from the study. 
• 
What happens to participants on study intervention when the study ends? 
• 
Describe the process for referring participants to care outside the study, if needed. 
 
 
 VI. Data Custody, Security, and Confidentiality Protections 
The sections below describe types of data sources and how they will be protected. For the type(s) of data you will 
have, put an “X” in the appropriate box to the left of the section that best describes how you will minimize the risk 
of a breach of confidentiality for your study.  Note, as appropriate, how you will record/store data.  These 
descriptions represent MINIMAL measures; you may add more stringent protections and other relevant information 
in B.  
Confidentiality: The LOSS OR THEFT of 1) original/duplicate version of physical data collection instruments (forms, 
tapes, etc) or 2) physical devices containing electronic data (i.e. laptop/mobile device, external flash drive(s), is a 
threat to subject confidentiality.  Risk of such a loss/theft is increased during movement/transport of data (in any 
format), such as in a vehicle or other move.  Be sure to train anyone (co-investigators, staff, students, etc.) who might 
be engaged in the oversight of data handling/storage about this problem.  Some typical risk-mitigation strategies 
would include: 
• 
minimizing the physical movement of data and/or devices containing data 
• 
encrypting electronic data (especially when stored on any mobile device, including flash memory tools, 
phones, tablets, etc, or when transferring across networks) 
• 
making use of reliable courier services (FedEx, DHL, etc) when physical transport of bulk data forms is 
necessary 
• 
minimizing the transfer of identifiable data in physical or electronic form (i.e. removing/separating/destroying 
identifiable data, when physical transfer of data is necessary) 
 
A. Data Storage  
1.  Hard Copies of Data Collection Forms.   
X 
This activity will not involve receiving and/or accessing hard copies of data 
 
 
Data collection forms RECORD NO PERSONAL IDENTIFIERS connecting study participants, and there are 
no codes providing a link.  Data are anonymous. 
 
Data collection forms INCLUDE IDENTIFIERS.  The forms are locked in a secure cabinet or room with 
limited access by authorized individuals.  Forms will be kept in study team’s possession during 
transport and will not be left unattended in a vehicle.  When possible, de-identified copies will be used 
for coding and analysis. 
 
Data collection forms ARE CODED with study participants’ random study ID numbers.  Codes/links 
between study IDs and identifiers are stored securely in a separate place (locked storage cabinet or 
secure electronic database.)   
 
Other: 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
2.   Electronic Data 
X 
The data do not contain personally identifiable information 
 
 
These data are stored on a secure server protected by limited access and strong password systems.  
Data are coded when possible.  Portable electronic devices will not contain identifiable information 
unless encrypted. 
 
Other:   
3.   Other Identifiable Data Storage, Retention, and Destruction (Audiotapes, videotapes, photographs, etc.) 
will be retained and stored securely (locked in cabinet or room) until: 
X 
Transcription is complete, then will be destroyed. 
 
Analysis is complete, then will be destroyed. 
 
Study is complete and file is closed. 
 
Indefinitely.  Provide justification for indefinite retention: 
 
4.  Existing Biospecimens to be used in this study: 
 
HAVE NO PERSONAL IDENTIFIERS. 
 
INCLUDE IDENTIFIERS AND ARE CODED; the PI will not have access to the link or code connecting the 
identifiers to the specimens.  
 
INCLUDE IDENTIFIERS, and the PI has access to those identifiers or to the link/code connecting 
specimens to individuals.  The identifiers and/or code will be stored securely until the study is 
complete. 
 
B. Certificate of Confidentiality 
Will the study data stored in the United States be protected by a Certificate of Confidentiality?  If yes, explain 
who will apply for and maintain the Certificate. (http://grants.nih.gov/grants/policy/coc/appl_extramural.htm) 
 
We will not apply for a Certificate of Confidentiality. 
 
C. Data Security and Sharing 
PIs have the responsibility for responsible stewardship of data and protecting data confidentiality. This 
responsibility includes protecting physical custody of the data, storage and sharing with appropriate data use 
agreements that contain the appropriate security provisions.  Describe any additional plans beyond those 
identified in the table that you have for storing and sharing the study data and/or materials, and how 
responsibility for the data will be managed.  Include the following details: 
 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
1. Where will the study data be stored? 
 
In the office of the principal investigator, Dr. John F.P. Bridges. 
 
2. Who controls access to the data? 
 
The principal investigator, Dr. John F.P. Bridges. 
 
3. Will data be shared only if de-identified?  
 
Yes. 
 
4. What additional (if any) security controls will be in place? 
 
 
All data will be anonymous. Additionally, data will be stored on password protected computers with access 
restricted to study investigators. 
 
VII.  Risks of the Study 
A. Describe the risks, discomforts, and inconveniences associated with the study and its procedures, including 
physical, psychological, emotional, social, legal, or economic risks, and the risk of a breach of confidentiality.  
These risks should be described in the consent documents. 
 
Risks are exceedingly minimal. Focus group participants could possibly find some questions about challenges in 
the self-management of their diabetes a bit distressing. There will be no questions about sensitive, personal or 
private topics during any part of the project.  
 
B. Describe the anticipated frequency and severity of the harms associated with the risks identified above; for 
example, if you are performing “x” test/assessment, or dispensing “y” drug, how often do you expect an 
“anticipated” adverse reaction to occur in a study participant, and how severe do you expect that reaction to 
be?   
 
Distress about the topics of discussion is likely to be quite rare. 
 
C. Describe steps to be taken to minimize risks.  Include a description of your efforts to arrange for care or referral 
for participants who may need it. 
 
Focus group participants will be informed they needn’t answer any questions they don’t want to. Additionally, 
every effort will be made to protect the confidentiality of participants during phase 1, including assigning 
identification numbers and the use of nicknames and first names in lieu of full names of participants.  
 
D. Describe the research burden for participants, including time, inconvenience, out-of pocket costs, etc.  
 
The focus groups in part 1 will last between 1-1.5 hours. Every attempt will be made to accommodate the 
schedules and meeting locations that best suit local participants.  We do not anticipate any other out of pocket 
costs.   
 
E. Describe how participant privacy will be protected during data collection if sensitive questions are included in 
interviews. 
 

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
During the focus group session, participants will be identified by first name only, and will be asked not to discuss 
what they hear about other participants with people outside the group 
Personal identifiers will not be retained when collecting the priorities of type 2 diabetics in phase 1 of the study.  
 
VIII. Direct Personal and Social Benefits 
A. Describe any potential direct benefits the study offers to participants (“payment” for participation is not a direct 
personal benefit). 
 
There will be no direct benefits to focus group participants 
 
B. Describe potential societal benefits likely to derive from the research, including value of knowledge learned. 
 
The societal benefit from the study overall will be an analysis of which stated-preference methods can best 
assess patient preferences and priorities for the treatment of type 2 diabetes.  
 
IX.  Payment:   
A. Describe the form, amount, and schedule of payment to participants. Reimbursement for travel or other 
expenses is not “payment,” and if the study will reimburse, explain. 
 
During phase 1, participants who attend a focus group meeting or conduct an individual interview with 
researchers will be paid $25.00 in the form of a Visa gift card. Parking vouchers will also be offered. 
 
B. Include the possible total remuneration and any consequences for not completing all phases of the research. 
 
Total remuneration for focus group participants will be a $25 gift card. 
 
X. Study Management 
A. Oversight Plan:  
1. Describe how the study will be managed. 
 
The study will be managed by the principal investigator (PI), Dr. John F.P. Bridges.  
 
2. What are the qualifications of study personnel managing the project? 
 
Tanjala Purnell, PhD and Ellen Janssen will serve as interviewers/note takers during the focus group. 
Dr. Tanjala Purnell is an assistant professor of Surgery, at the Johns Hopkins School of Medicine and has 
experience with community engagement and qualitative research. 
Ellen Janssen is a third year PhD students studying under Dr. Bridges. She focuses on patient preference 
research. 
 
3. How will personnel involved with the data collection and analysis be trained in human subjects research 
protections?  (Use the JHSPH Ethics Field Training Guide on our website.) 
 
All researchers, including the moderators, note takers, and transcribers, involved with the project will have 
completed the Human Research Curriculum offered by the Collaborative Institutional Training Initiative 
(CITI). They will also be familiar with the JHSPH Ethics Field Training Guide.  
 
-

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Research Plan for Phase 1 Diabetes study_v2_26Sept201 
4. If the PI will not personally be on-site throughout the data collection process, provide details about PI site 
visits, the supervision over consent and data collection, and the communication plan between the PI and 
study team. 
 
 
Not applicable 
 
B. Recordkeeping:   
Describe how you plan to ensure that the study team follows the protocol and properly records and stores study 
data collection forms, IRB regulatory correspondence, and other study documentation.  For assistance, contact 
housecall@jhsph.edu. 
 
The study team will be closely monitored by the principle investigator, Dr. Bridges. He will make sure team 
members are aware of the appropriate manner in which to record and store study documentation.  
 
 
C.  Safety Monitoring   
 
 
 
Not applicable 
 
D.  Reporting unanticipated problems/adverse events (AE’s) to the IRB (all studies must complete this section):   
Describe your plan for reporting to the IRB and (if applicable) to the sponsor.  Include your plan for government-
mandated reporting of abuse or illegal activity.  
NOTE:  The IRB does not require submission for all AEs, only those that are unanticipated, pose risk of 
harm to participants or others, and are related to the study. 
 
Any unanticipated problems will be reported to the IRB as soon as possible. 
 
E.  Other IRBs/Ethics Review Boards:   
If other IRBs will review the research, provide the name and contact information for each IRB/ethics review 
board and its Federal Wide Assurance, if it has one (available on OHRP’s website at 
http://www.hhs.gov/ohrp/assurances).   
 
Not applicable 
 
F. Collaborations with non-JHSPH Institutions:    
 
 
Not applicable.