Tuberculosis Research of INA-RESPOND On Drug Resistance
Conditions: Lung Tuberculosis, MDR TB
Sponsor: Ina-Respond

INA 102 
Version 5.0 
10/02/2017 
PROTOCOL 
 
 
 
 
Protocol Number: INA-102 
 
 
 
RESEARCH TITLE: 
TUBERCULOSIS RESEARCH OF INA-RESPOND ON 
DRUG RESISTANCE (TRIPOD) 
 
 
 
 
A Multicenter Study of the Indonesia Research Partnership on 
Infectious Disease (INA-RESPOND) 
 
 
Sponsored by: 
 
The Center for Health Resources and Services Research and Development,  
National Institute of Health Research and Development Indonesia 
The National Institute of Allergy and Infectious Diseases, United States 
 
 
 
Confidentiality Statement: 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or 
institutional review boards. The contents of this document shall not be disclosed to others without 
written authorization from NIAID or NIHRD. 
 
 
Version: 5.0 
Oct 02, 2017 
 
 
 
 
 

INA 102 
Version 5.0 
10/02/2017 
1 | P a g e  
 
 
 
 
Contents 
GLOSSARY................................................................................................................................................ 3 
Table of Figures ....................................................................................................................................... 4 
Table of Tables ........................................................................................................................................ 4 
RESEARCH SUMMARY .............................................................................................................................. 5 
1. BACKGROUND ..................................................................................................................................... 7 
2. RESEARCH BENEFITS ........................................................................................................................... 8 
2.1 
Scientific Benefits .................................................................................................................... 8 
2.2 
Community Benefits ............................................................................................................... 8 
2.3 
Policy Benefits ......................................................................................................................... 8 
3. OBJECTIVES ......................................................................................................................................... 8 
3.2 
Primary Objective.................................................................................................................... 8 
3.3 
Secondary Objective ............................................................................................................... 8 
4. METHODS ............................................................................................................................................ 9 
4.1 
Study Plan ............................................................................................................................... 9 
4.2 
Sites and Duration ................................................................................................................... 9 
4.3 
Type and Design of Study ...................................................................................................... 11 
4.4 
Population and Sample Size .................................................................................................. 11 
4.5 
Inclusion and Exclusion Criteria ............................................................................................ 13 
4.6 
Instruments and Data Collection’ ......................................................................................... 14 
4.7 
Data Management and Analysis ........................................................................................... 19 
5. SAFETY MONITORING AND REPORTING ........................................................................................... 21 
5.1 
Definition of an Adverse Event ............................................................................................. 21 
5.2 
Definition of an Serious Adverse Event ................................................................................ 21 
5.3 
Definition of an Unanticipated Problem ............................................................................... 22 
5.4 
Reporting Procedures to the IRB .......................................................................................... 22 
5.5 
Study Monitoring .................................................................................................................. 22 
5.6 
Safety Monitoring Plan ......................................................................................................... 23 
6. ETHICAL CONSIDERATIONS ............................................................................................................... 23 
6.1 
Informed Consent Process .................................................................................................... 23 
6.2 
Illiterate Participant .............................................................................................................. 24 
6.3 
Premature Withdrawal of Participant ................................................................................... 24 
6.4 
IRB Review ............................................................................................................................. 24 
6.5 
Participant Confidentiality .................................................................................................... 24 
6.6 
Rationale for Subject Selection ............................................................................................. 24 
6.7 
Benefits ................................................................................................................................. 24 
6.8 
Compensation ....................................................................................................................... 25 

INA 102 
Version 5.0 
10/02/2017 
2 | P a g e  
 
 
 
 
6.9 
Risk and Discomforts ............................................................................................................. 25 
6.10 
Recording/Documentation ................................................................................................... 25 
7. PROTECTION OF INTELLECTUAL PROPERTY (IPR), MATERIAL TRANSFER AGREEMENT (MTA), AND 
GENETIC RESOURCES AND TRADITIONAL KNOWLEDGE (GRTK) ........................................................... 26 
7.1 
Protection of Intellectual Property ....................................................................................... 26 
7.2 
Publication and Dissemination of Research Results ............................................................. 26 
7.3 
Material Transfer Agreement ............................................................................................... 27 
7.4 
Genetic Resources and Traditional Knowledge .................................................................... 27 
8. RESEARCH TEAM ............................................................................................................................... 28 
APPENDIX A. List of Study Procedures and Timeline ............................................................................ 29 
APPENDIX B. Operational Definition ..................................................................................................... 31 
APPENDIX C. Science and Technology agreement between the Government of the Republic of 
Indonesia and the Government of the United States of America. ....................................................... 35 
APPENDIX D. SOP INA-RESPOND, Specimen Ownership, Access, and Use ........................................... 35 
REFERENCES .......................................................................................................................................... 36 
 
 
 

INA 102 
Version 5.0 
10/02/2017 
3 | P a g e  
 
 
 
 
GLOSSARY 
AE 
Adverse Event 
AFB 
Acid-Fast Bacilli 
ALT 
Alanine Amino Transferase 
AST 
Aspartate Amino Transferase 
BCG 
Bacille-Calmette–Guérin 
BMI 
Body Mass Index 
BW 
Body Weight 
CBC 
Complete Blood Count 
CRF 
Case Report Form 
DM 
Diabetes Mellitus 
DOTS 
Directly Observed Treatment, Short course 
DR-TB 
Drug-Resistant Tuberculosis 
DS-TB 
Drug-Susceptible Tuberculosis 
DST 
Drug Susceptibility Testing 
DNA 
Deoxyribonucleic acid 
EC 
Ethics Committee 
EOS 
End of Study 
ESR 
Erythrocyte Sedimentation Rate 
GCP 
Good Clinical Practice 
HIV 
Human Immunodeficiency Virus 
ICH 
International Conference on Harmonization 
ICF 
Informed Consent Form 
INA-RESPOND 
Indonesia Research Partnership on Infectious 
Disease IPR 
Intellectual Property Rights 
IRB 
Institutional Review Board 
MDR-TB 
Multidrug-Resistant Tuberculosis 
MGIT 
Mycobacteria Growth Indicator Tube 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIAID 
National Institute of Allergy and Infectious Diseases 
NIHRD 
National Institute of Health Research and Development 
NTP 
National Tuberculosis Program 
OHRP 
Office for Human Research Protections 
PBMC 
Peripheral Blood Mononuclear Cell 
PI 
Principal Investigator 
PMDT 
Programmatic Management of Drug-Resistant TB 
SAE 
Serious Adverse Event 
SoC 
Standard of Care 
TB 
Tuberculosis 
WHO 
World Health Organization 
XDR-TB 
Extensively Drug Resistant Tuberculosis 
 
 
 
 
 

INA 102 
Version 5.0 
10/02/2017 
4 | P a g e  
 
 
 
 
 
Table of Figures 
 
Figure 1. The Study Plan .................................................................................................... 10 
  
Table of Tables 
 
Table 4.4. 1 Expected confidence bounds based on observed MDR proportions amongst 
previously treated TB cases. ............................................................................................... 12 
Table 4.4. 2 Expected confidence bounds based on observed MDR proportions amongst new 
TB cases. ............................................................................................................................ 12 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

INA 102 
Version 5.0 
10/02/2017 
5 | P a g e  
 
 
 
 
RESEARCH SUMMARY 
 
Title 
INA102 – Tuberculosis Research Of INA-RESPOND on Drug 
Resistance (TRIPOD) 
Study Type 
Prospective Observational Study 
Principal Investigator  
Dr. dr. Erlina Burhan, M.Sc, SpP(K) 
dr. Anis Karuniawati, SpMK,PhD  
Sample Size 
This study will analyze 500 participants bacteriologically 
confirmed TB (250 new cases and 250 previously treated 
cases). To obtain the numbers, we estimated that we need to 
enroll 1357 presumptive TB patients as participants (1000 new 
cases and 357 previously treated cases). These numbers were 
made based on our estimation that 25% of presumptive new TB 
cases and 70% of presumptive previously treated TB cases will 
be bacteriologically confirmed. 
Study Population 
Presumptive TB patients, ≥ 18 years old 
Study Duration 
Up to 4.5 years 
Accrual Period 
Up to 2 years 
Study Design 
This study is a prospective observational cohort study of TB 
patients who are treated or evaluated at 1 0  study sites. 
Patients presenting with cough for 2 weeks or longer with at 
least one additional TB symptom and a chest X-ray suggestive 
of TB, will be invited to be enrolled in the study. The signed 
informed consent will designate their willingness to participate 
on this study. Enrolled participants will produce the sputum 
for bacteriological examination of M. tuberculosis by AFB, 
culture and Xpert. The sputum will also be tested by Xpert 
for drug resistance test. If the culture is positive, conventional 
DST will be performed, and M. tuberculosis isolates will be 
stored for spoligotyping and for future research on TB. All 
participants treated by TB drugs regimen will be followed for 
outcome assessment. For all enrolled participants, chest X-Ray 
results, demographic data, co-morbidities, symptoms, nutritional 
status, treatment regimens, compliance and outcome will be 
collected. In addition, sputum, blood, urine, and saliva will also 
be collected for related TB future testing. 

INA 102 
Version 5.0 
10/02/2017 
6 | P a g e  
 
 
 
 
Primary Objective 
To estimate the proportion of MDR-TB amongst new and 
previously treated TB cases.  
Secondary Objectives 
1. To evaluate accuracy of clinical diagnosis by comparing 
clinically defined TB to laboratory confirmed TB. 
2. To compare AFB and Xpert MTB/RIF as TB diagnostic 
tests against culture result. 
3. To estimate the sensitivity and specificity of Xpert MTB/RIF 
in detecting Rif susceptibility against DST. 
4. To estimate the proportion of cured, completed, failed, 
died and lost to follow up as treatment outcomes on 
DS-TB and DR-TB cases 
5. To evaluate the association of treatment success (cured 
or completed) with the following data: 
a. Demographics (age, sex) 
b. TB contact history 
c. Smoking habit 
d. Treatment seeking behavior 
e. Co-morbidities (HIV, DM, cancer) 
f. Primary and secondary drug resistance 
g. Symptoms 
h. Cavitary disease 
i. 
Nutritional status 
j. 
Treatment regimens 
 
 
 
 
 

INA 102 
Version 5.0 
10/02/2017 
7 | P a g e  
 
 
 
 
1. BACKGROUND 
Tuberculosis (TB) continues to be a major health problem in the world, especially in 
developing countries. Despite the use of anti-TB treatments and Bacille-Calmette-Guérin 
(BCG) vaccination, TB incidence continues to rise. It was declared a global health 
emergency by the World Health Organization (WHO) in 1995.1 In 2015, WHO estimated 
that there were 10.4 million new TB patients with mortality rate of 1.8 million patients 
per year throughout the world.2 
Based on the WHO Report 2016, Indonesia ranked second in the world with an 
estimated incidence in 2015 is 1,020,000 cases with mortality number 126,000.2 This 
condition is exacerbated by the increasing incidence of diabetes mellitus (DM) and Human 
Immunodeficiency Virus (HIV) as TB comorbidities and the growing number of cases with 
Multidrug- Resistant TB (MDR-TB) or even Extensively Drug-Resistant TB (XDR-TB). This 
situation will lead to an epidemic of TB that is difficult to manage and continues to be a major 
public health problem.1,2,4 Previous TB drug resistant surveys conducted across Indonesia 
revealed that in Timika district, Papua (2004), 2% of new TB cases are MDR-TB cases, 
in Central Java province (2006), 1.8% of new TB cases and 17.1% of previously treated 
TB cases are MDR- TB, and in Makassar (2007) 4.1% of new TB cases and 19.2% of 
previously treated TB cases are MDR-TB. WHO Report 2016 estimation in 2015 for 
Indonesia gave a number of incidence which are 2.9% of new TB cases and 16% 
of previously treated TB cases are MDR-TB cases.2,5,7 
The Indonesia Health Profile study reported 194,000 new TB cases in 2011 based 
on positive smear results.8 TB control efforts were implemented in Indonesia starting in 
1969 and Directly Observed Treatment Short-course (DOTS) began in 1995. Nevertheless, 
these efforts to date have not eliminated the TB burden.9 In 2009 Ministry of Health started 
the implementation of Programmatic Management of Drug-Resistant Tuberculosis (PMDT) 
for MDR-TB patients. 
Treatment success is known to be associated with several factors.  These include 
patient related factors, such as age,10 gender,11 smoking habit,12 nutritional status, 
comorbidities (DM and HIV). M. tuberculosis characteristics are also associated with 
outcome, including number of bacteria and M. tuberculosis strain (e.g Beijing strain).13 
Data on the prevalence of drug resistance among new or previously treated TB 
cases is limited to several centers in Indonesia.5-7 This study will be the first to follow new 
and previously treated TB patients in hospitals in Indonesia. Prevalence data for drug-
susceptible and MDR-TB, along with corresponding treatment outcomes, will be beneficial 
to inform national tuberculosis programs (NTP). Additionally, data collected from this study 

INA 102 
Version 5.0 
10/02/2017 
8 | P a g e  
 
 
 
 
will be useful for planning future TB research studies in Indonesia, such as evaluating novel 
diagnostic test, evaluating markers of response to treatment and identifying new therapies. 
 
2. RESEARCH BENEFITS 
2.1 
Scientific Benefits 
• 
This study will observe and record TB, drug susceptibility profiles and treatment 
outcomes of new and previously treated cases. 
• 
The study will observe and record patient demographics, smoking habits, 
nutritional status, clinical history, bacterial factors (the numbers of bacterial and 
the infecting strain), and attempt to determine the association between these 
factors and the success of treatment. 
• 
The study will provide data that is useful for planning future studies in 
tuberculosis, e.g. basic research, improved diagnostics or clinical trials on newly 
developed drugs. 
• 
The study will collect samples from participants and may lead to identification 
of a novel or virulent strain associated with disease and with treatment 
success. Such information could be extremely important for public health 
prevention programs. 
2.2 
Community Benefits 
• 
The study may assist in the development of improved diagnostic and 
treatment algorithms and processes within hospitals for providing care that 
can improve patient outcomes. 
2.3 
Policy Benefits 
• 
Results of this study may provide information that would be valuable to the 
Ministry of Health and the national tuberculosis program in developing a more 
effective strategy for treatment and prevention. 
 
3. OBJECTIVES 
3.2 
Primary Objective 
To estimate the proportion of MDR TB amongst new and previously treated TB cases. 
3.3 
Secondary Objective 
• 
To evaluate accuracy of clinical diagnosis by comparing clinically defined TB 

INA 102 
Version 5.0 
10/02/2017 
9 | P a g e  
 
 
 
 
to laboratory confirmed TB. 
• 
To compare AFB and Xpert MTB/RIF as TB diagnostic tests against culture 
result. 
• 
To estimate the sensitivity and specificity of Xpert MTB/RIF in detecting Rif 
susceptibility against Drug Susceptibility Test (DST). 
• 
To estimate the proportion of cured, completed, failed, died and lost to follow 
up as treatment outcomes in drug susceptible TB (DS-TB) cases and drug 
resistant TB (DR-TB) cases. 
• 
To evaluate the association of treatment success (cured or completed) with 
the following data: 
1. Demographics (age, sex) 
2. TB contact history 
3. Smoking habit 
4. Treatment seeking behavior 
5. Co-morbidities (HIV, DM, cancer) 
6. Primary and secondary drug resistance 
7. Symptoms 
8. Cavitary disease 
9. Nutritional status 
10. Treatment regimens 
11. Patient reported compliance 
12. Numbers of bacteria by AFB test 
13. TB strains (e.g., Beijing) 
 
4. METHODS 
4.1 
Study Plan 
The brief explanation of the study plan will be captured on figure 1. 
4.2 
Sites and Duration 
This study will be conducted at hospitals in the INA-RESPOND network: 
1. Persahabatan hospital, Jakarta 
2. Prof. Dr. Sulianti Saroso Infectious Diseases hospital, Jakarta 
3. Dr. Hasan Sadikin hospital, Bandung 
4. Dr. Kariadi hospital, Semarang 
5. Dr. Soetomo hospital, Surabaya 
6. Sanglah hospital, Bali 

INA 102 
Version 5.0 
10/02/2017 
10 | P a g e
7. Dr. Sardjito hospital, Yogyakarta
8. Dr. Wahidin Sudirohusodo hospital, Makassar
9. Gatot Subroto Army hospital, Jakarta
10. H. Adam Malik Hospital, Medan
Figure 1. The Study Plan 
The Study will enroll eligible participants for a period of up to 2 years.  Participants will 
be followed up until 6 months’ post treatment. For drug susceptible TB, this will be 
approximately 12 months after enrollment/treatment start, but it may be longer if they 
have drug resistant TB or require longer treatment regimen for other reasons (e.g. 
Category 2 treatment, diabetes, etc). For those participants, the study will follow them 
for maximum 30 months after enrollment/treatment start. Stored specimens will be 
investigated during the study and/or after study completion.  
•
Patients suspected of having pulmonary TB 
o
Cough ≥ 2 weeks
o
At least 1 other TB clinical symptoms (fever, unexplained weight loss, loss of appetite, 
hemoptysis, shortness of breath, chest pain, night sweats, fatigue)
•
Suggestive TB on chest x-ray based on pulmonologist or internist consultant of pulmonology opinion 
•
Age ≥18 years old
•
Participants (with or without TB treatment history) are screened whether they meet the following 
criteria:
o
Willing to be treated or evaluated at study site
o
Willing to have specimens stored for use in future studies
o
Patient denies having TB treatment for maximum 7 days in the last 1 month 
o
Pregnancy or any serious condition include, but are not limited to, liver disease, chronic kidney 
disease, and psychiatric illness, that might interfere with study compliance  
Signing Informed Consent Subject ID 
No sputum produced 
Sputum for AFB, Xpert, and Culture 
End of study 
AFB and/or Xpert and/or 
culture positive 
AFB and Xpert, and 
culture negative 
Treated 
Not treated 
End of study 
Follow study 
procedures 
Follow study 
procedures 

INA 102 
Version 5.0 
10/02/2017 
11 | P a g e  
 
 
 
 
4.3 
Type and Design of Study 
 
This study is a prospective observational cohort study of new and previously treated 
TB patients. Patients will be treated as per standard of care according to national TB treatment 
guidelines and each study site policy by each patient’ physician. This study will collect data 
and specimens as outlined in Appendix A. Additional blood, sputum, urine, and saliva 
specimens will be obtained for TB examinations and stored for related TB future testing. 
Study participants will continue to be managed in accordance with the DOTS or PMDT 
strategy by the patients’ physician.  Clinical care or treatment for all participants is 
provided by the healthcare facility based on the National Guidelines or clinician 
decisions. No intervention either treatment or behavior, applied for this study. 
4.4 
Population and Sample Size 
This is a descriptive study with the goal of estimating rates MDR in two separate 
cohorts (new and previously treated TB cases). WHO global report in 2013 estimated 1.9% 
MDR TB cases in new TB cases and 12% MDR TB cases in previously treated TB cases 
for Indonesia. This study will analyze 250 bacteriologically confirmed new TB participants 
and 250 bacteriologically confirmed previously treated participants. We estimate that 25% of 
presumptive new TB participants who satisfy study entry criteria will be bacteriologically 
confirmed TB. Similarly, we estimate that 70% of previously treated cases will be 
bacteriologically confirmed TB. Therefore, to obtain 500 bacteriologically confirmed TB 
cases, 1,000 presumptive new cases and 357 presumptive previously treated cases will be 
enrolled, for a total of 1,357 enrolled. The proportion of confirmed TB cases amongst new 
and previously treated cases is an estimation and will be re-evaluated during the course 
of the study. Refer to the interim analysis section below for details. 
Table 4.4.1 describes the expected precision (confidence bounds and width) for 
observed proportion of MDR amongst previously treated cases. With 250 participants and 
an observed MDR proportion of 12%, the confidence interval will be (0.085, 0.162). The 
precision of the estimated proportion of MDR does not improve considerably when 
increasing the sample size to 300. The confidence interval for a sample size of 300 with 
an MDR proportion of 12% is (0.085, 0.162), while decreasing the sample size to 200 has a 
more striking impact on the bounds increasing the lower bound to 0.078 and the upper 
bound to 0.173. 
When considering the sample size for new TB cases, we note that the precision 
of binomial confidence intervals based on  exact  Clopper  Pearson  method increases as the 
proportion gets closer to  zero. As a  result,  we  find  the  true MDR rate is more precisely 
estimated with a sample size of 250 for new TB cases (compared to previously treated 
cases, where the MDR rate is expected to be around 12%). With a sample size of 250 

INA 102 
Version 5.0 
10/02/2017 
12 | P a g e  
 
 
 
 
new TB cases, the expected 95% confidence interval is (0.007, 0.046). (Table 4.4.1) 
Exact Clopper Pearson binomial confidence interval method formula: 
 
 
 
Table 4.4. 1 Expected confidence bounds based on observed MDR proportions amongst 
previously treated TB cases. 
 
Sample Size 
Observed proportion 
Bounds of 95% confidence interval* 
Actual width 
150 
0.12 
(0.073, 0.183) 
0.110 
0.15 
(0.097, 0.217) 
0.120 
200 
0.12 
(0.078, 0.173) 
0.095 
0.15 
(0.104, 0.207) 
0.104 
250 
0.12 
(0.082, 0.167) 
0.084 
0.15 
(0.108, 0.200) 
0.092 
300 
0.12 
(0.085, 0.162) 
0.077 
0.15 
(0.112, 0.196) 
0.084 
400 
0.12 
(0.090, 0.156) 
0.066 
0.15 
(0.116, 0.189) 
0.072 
* CIs based on Exact Clopper-Pearson method 
 
Table 4.4. 2 Expected confidence bounds based on observed MDR proportions amongst new 
TB cases. 
 
Sample size 
Observed proportion 
Bounds of 95% confidence interval* 
Actual width 
150 
0.01 
(0.001, 0.042) 
0.041 
0.02 
(0.004, 0.057) 
0.053 
0.03 
(0.009, 0.072) 
0.062 
0.05 
(0.021, 0.098) 
0.077 
200 
0.01 
(0.001, 0.036) 
0.034 
0.02 
(0.005, 0.050) 
0.045 
0.03 
(0.011, 0.064) 
0.053 
0.05 
(0.024, 0.090) 
0.066 
250 
0.01 
(0.002, 0.032) 
0.030 
0.02 
(0.007, 0.046) 
0.040 
0.03 
(0.013, 0.059) 
0.047 
0.05 
(0.027, 0.085) 
0.058 
300 
0.01 
(0.002, 0.029) 
0.027 
0.02 
(0.007, 0.043) 
0.036 
0.03 
(0.014, 0.056) 
0.042 
0.05 
(0.028, 0.081) 
0.053 

INA 102 
Version 5.0 
10/02/2017 
13 | P a g e  
 
 
 
 
400 
0.01 
(0.003, 0.025) 
0.023 
0.02 
(0.009, 0.039) 
0.03 
0.03 
(0.016, 0.052) 
0.036 
0.05 
(0.031, 0.076) 
0.045 
* CIs based on Exact Clopper-Pearson method 
The sampling method in this study is purposive sampling. The study will stop recruiting 
participants when 1,000 new presumptive TB cases and 357 previously treated TB cases had 
enrolled.  
 
4.5 
Inclusion and Exclusion Criteria 
The following inclusion and exclusion criteria are used when determining eligibility 
patients into the study: 
4.5.1 Inclusion Criteria 
• 
Patients suspected of having pulmonary TB 
• 
Cough ≥ 2 weeks 
• 
At least one other TB clinical symptom 
- 
Fever 
- 
Unexplained weight loss 
- 
Loss of appetite 
- 
Hemoptysis 
- 
Shortness of breath 
- 
Chest pain 
- 
Night sweats 
- 
Fatigue 
• 
Suggestive TB on chest x-ray based on pulmonologist or internist 
consultant of pulmonology opinion 
• 
Age ≥ 18 years’ old 
• 
Willing to be treated or evaluated at study site 
• 
Willing to have specimens stored for use in future studies 
• 
Patient denies having TB treatment for more than 7 days in the last 1 
month (30 days). 
4.5.2 Exclusion Criteria 
Pregnancy or any serious condition includes, but not limited to, liver disease, chronic 
kidney disease, and psychiatric illness that might interfere with study compliance 
(based on the clinician judgment). In order to assess participant’s pregnancy status, 
the attending clinician will ask the participant’s first day of last menstrual period. The 

INA 102 
Version 5.0 
10/02/2017 
14 | P a g e  
 
 
 
 
final decision about participant’s pregnancy status will be up to the attending clinician.. 
4.5.3 End of study criteria 
• 
Study completion (six months after end of treatment or six months after 
month 24th visit). 
• 
Participant desires to leave study or withdraw consent. 
• 
No sputum specimen for the examinations of AFB, Gene Xpert, and 
culture at baseline and enrollment visit. 
• 
No longer treated as TB patients.  
• 
Treatment interruption of two months or greater.  
• 
Death 
• 
Transfer to other health facility where follow up/evaluation is no longer 
possible. 
• 
Based on investigator’s discretion it is in the participant’s best interest to be 
discontinued from the study. 
• 
Participants who cannot be reached to complete the 6 months’ post 
treatment by phone or direct visit. 
• 
Termination of study 
 
 
4.6 
Instruments and Data Collection’ 
The following instruments and data collection methods will be used in this study.  
Further information may be found in protocol sections 4.6.2-4.6.5. 
4.6.1 Instruments: 
 
a. Forms 
i. 
Informed consent 
ii. 
Source documents 
iii. 
Case report forms (CRFs) 
iv. 
Screening Log 
v. 
Enrollment Log 
b. Databases 
i. 
OpenClinica 
ii. 
INA-RESPOND specimen database 
c. INA-RESPOND portal 
4.6.2 Eligibility determination and enrollment:  
Enrollment and baseline visit (visit 1) 
Potential participants will be referred by physicians at participating hospitals. 

INA 102 
Version 5.0 
10/02/2017 
15 | P a g e  
 
 
 
 
Following referral, research assistant will check the eligibility criteria. Thus, the 
potential participant will be offered information on the study. If the patient 
agrees, he/she will sign the informed consent document and will be considered 
enrolled in the study. All baseline procedures should be done in five working 
days, although the result may come later. Enrollment day is considered as Day 
0.  
Demography, clinical data, and physical examination results including body 
weight and height will be obtained. The initial data collection will take time about 
30-60 minutes. 
Participant should bring enough sputum that can be considered 
eligible for AFB, Xpert MTB/RIF, and culture examination. Sputum induction 
by inhalation medicine will be considered for participants that have difficulty 
to produce sputum according to site SoC. The remaining sputum will be stored 
for TB related future testing. Participant who cannot provide enough sputum for 
those examinations will be considered as end of study and stop following the 
study procedures.  
20 cc blood will be drawn for assessment of comorbidities (HIV test and 
HbA1c), for other examinations needed either for study or for SoC. Such as 
Hb, ureum, creatinine, AST, and ALT. Left over specimen will be used for future 
TB related examinations and repository. Less blood volume because 
unanticipated problem related to blood draw such as collapsing vein would 
not be considered as protocol deviation. 10 cc of urine will also be collected 
and stored for future TB related tests. Saliva will also be collected for storage.  
After the sputum culture shows positive results of M.tuberculosis, the 
M.tuberculosis isolate will be tested for  DST and also be stored. New TB 
cases with Rif susceptible Xpert MTB/RIF result will be tested for first line DST, 
continue by second line if first line DST result shows drug resistant TB. New TB 
cases with Rif resistant Xpert MTB/RIF will be directly tested for first and second 
line DST. Previously treated TB cases will be directly tested for first and second 
line DST. 
DS-TB participants who decide to take the TB treatment in puskesmas 
(primary health care) may not come to visit(s) except for study visit which the 
study gives compensation for participant’s attendance. So that for those 
participants, study will provide a record, named “TRIPOD Diary”, to be 
completed on each visit at Puskesmas. The TB program manager or designee 
at the Puskesmas will give their signed as a verification of this record. TRIPOD 
Diary will be mentioned further in MOP.   

INA 102 
Version 5.0 
10/02/2017 
16 | P a g e  
 
 
 
 
4.6.3 Ongoing monitoring and evaluation 
 
During treatment, participants will be seen every month for 6 months and then 
every 2 months until end of treatment or maximum at month 24th. Then participants 
also will be assessed 6 months after end of treatment. In general, participants will have 
between 1 to 16 numbers of follow up visits. Study will also record the data of several 
participants who may need month 7 and/or month 8 and/or month 9 visits, for example 
participant receiving category 2 treatment, participant with diabetes comorbid. 
Study visits will occur at the same time as clinical visit. If the participant does not come 
for a clinical visit it will not be considered a deviation from the protocol. 
Except 6 months post treatment visit, every study visit will collect data 
on each comorbidity include HIV, diabetes, and cancer. Study will also collect 
data on weight, TB symptoms, TB treatment compliance, sputum examination 
results (if available), and treatment regimen. Participants’ compliance will be 
measured by counting how many medications still left in the blister pack (if available) 
or based on participant report if the patient does not bring the blister. TRIPOD diary 
will assist the research assistant to measure participant compliance who is 
taking the medication in the primary health care/puskesmas.  
All participants will have follow up for treatment of TB and routine testing as 
mandated by the National Guidelines and provided by the hospital in accordance with 
Appendix A. Additional AFB tests on month 1, culture test on month 1 and 2, and chest 
x-ray at the end of treatment visit, will be conducted for all drug susceptible 
participants. 
Sputum induction by inhalation medicine will be offered to participants that have 
difficulty to produce sputum. 
4.6.4 End of treatment visit 
The End of Treatment Visit will take place when the participant completes 
his/her prescribed TB treatment regimen. This visit approximately will be held on 
month 6th or 7th for participants with DS TB category 1 therapy, on month 8th or 9th 
for participants with DS TB category 2 therapy, and between month 18th to 24th for 
those with MDR. However, the end of treatment visit might be different for some 
participants depend on their comorbidity or any other condition such as the new 
regimen for TB patient.  
The following data and evaluations will be collected and performed: 
 
TB related symptoms 
 
Treatment compliance 
 
Comorbidities  
 
Weight 

INA 102 
Version 5.0 
10/02/2017 
17 | P a g e  
 
 
 
 
 
Chest X-ray 
 
AFB (if available) 
 
Sputum culture (if available) 
 
Store whole blood (PAXgene, PBMCs, plasma) 
 
Store urine 
 
Store sputum and Mtb isolate (if available) 
 
Store saliva 
4.6.5 6 Months Post-Treatment Visit 
The final study visit will be conducted 6 months after the participants’ prescribed 
TB treatment is completed. The data of TB related symptoms, weight, and chest X-
Ray will be obtained by direct visit. If the participants unable to come for this visit, 
phone call should be made to obtain the data of TB related symptoms. 
4.6.6 
Study Disposition Status 
Study disposition status will be completed with the Research Assistant when 
the participants considered as end of study. The final outcome of treatment will be 
determined. 
Participants followed until 6 months post treatment visit will be considered as 
completing the study procedure and end of study. The rest of the participants will be 
considered as end of study at the following time point: 
1. Participant withdraws consent. 
2. Participant who is unable to provide enough sputum at baseline/enrollment 
visit for the examinations of AFB, Gene Xpert, and culture. 
3. Participant is no longer treated as TB patients. 
4. Participant has treatment interruption of two months or longer after she/he 
starts TB treatment. 
5. Participant died. 
6. Participant transfers to other health facility for their TB treatment where 
follow up/ evaluation is no longer possible. 
7. Based on investigator discretion. 
8. Participant who cannot be reached to complete the 6 month post treatment 
by phone or direct visit. 
9. Termination of study. 
At this visit the final outcome of treatment status will be determined. 
All study procedures will be outlined in Appendix A 
 4.6.7 TB Management 
Participants who are not diagnosed with MDR-TB will be managed according 

INA 102 
Version 5.0 
10/02/2017 
18 | P a g e  
 
 
 
 
to the Indonesia MoH 2011 national TB guidelines, and those diagnosed as 
MDR-TB cases will be managed in accordance to Indonesia Programmatic 
Management of Drug- Resistant TB (PMDT) 2013. Other drug resistant TB cases will 
be managed in accordance to each site clinician decision. Treatment for tuberculosis 
is provided free of charge by the National TB Program. 
 4.6.8 Handling of Samples 
Sputum specimen will be collected at special booth at each site. Culture and 
DST will be performed at laboratories which capable to perform culture, bacterial 
identification and DST according to international standard, and have passed Quality 
Assurance by TB supranational laboratory. All sputum specimen and Mtb isolate 
will be processed in biosafety cabinet level 2. Blood and urine specimen will be 
collected in Pathology Clinic at each site. Blood and urine specimen collection and 
handling will be up to each hospital and/or Pathology Clinic laboratory safety 
procedure at each site. 
Transport of biological samples 
 
As the transmission of TB can occur through contact with sputum specimens, 
contact and respiratory precautions will be employed by all personnel involved with 
sputum collecting, shipping and handling for this study. 
Archived Biological Materials 
 
Samples collected under this protocol may be used to study TB and related 
conditions such as spoligotyping. Participants must be willing to allow storage of 
sputum, Mtb isolate, whole blood (PAXgene blood, plasma, PBMC), and urine on 
baseline, month 1, month 2, and end of treatment visit, and saliva on baseline 
and end of treatment visit for use in future studies (for example, host response, 
spoligotyping, and genetic tests). Serum and whole blood for DNA are collected on 
baseline visit only. 
All samples will be stored at the NIHRD, Mtb isolate, plasma, saliva and urine 
will also be stored at each site. Samples will be coded with a unique identifier that 
does not contain any information capable of linking the sample to the study 
participants. A code that links the unique identifier with the study sample will be 
kept on a locked file cabinet in a secured room. Only authorized personnel will 
have access to the code. Only investigators will have access to the samples. All 
samples will be logged and tracked using INA-RESPOND system.  
Some of the specimens collected under this protocol will be stored for 

INA 102 
Version 5.0 
10/02/2017 
19 | P a g e  
 
 
 
 
repository. The used and destruction of the archived specimens in the future, 
will be determined per INA-RESPOND SOP of Specimen Ownership, Access, 
and Use (see appendix D).   
Additional testing on study samples 
 
Based on the clinical presentation and laboratory data the researchers will 
determine further testing to be done on samples. This testing could be performed 
for:  a) existing diagnostic methods that may not have been accessible at the time 
of the collection of samples, b)  research tests to identify and/or confirm etiologic 
agents, c) to study immune markers that might enable better management or 
prediction of outcomes for patients, d) to be used to study pathogenicity, and e) 
genetic testing. 
IRB approval must be sought prior to any sharing of samples and/or data. Any 
clinical information shared about the sample would similarly require prior IRB 
approval. At the completion of the protocol (termination), samples and data will 
either be destroyed, or after IRB approval, transferred to another existing protocol.  
Reporting the Loss or Destruction of Samples/Specimens/Data to the IRB 
Any loss or unanticipated destruction of samples or data (for example, due 
to freezer malfunction) that compromises the scientific integrity of the data collected 
for the study will be reported to the IRB.  
Additionally, participants may decide at any point not to have their samples 
stored. In this case, the principal investigator will destroy all known remaining samples 
and report what was done to both the participant and to the IRB. 
4.7 
Data Management and Analysis 
 4.7.1 Data Management 
Data which are collected under this protocol may be used to study TB and 
related conditions. Participant will be coded with a unique identifier that does not 
contain any information capable of linking the data to the study participants. A code 
that links the unique identifier with the study participants will be kept in a locked 
file cabinet in a secure room. Only authorized personnel will have access to the 
code and the data. Data will be keyed and tracked using the OpenClinica.  
Data will be periodically sent to the central data management center. Site 
and national data will be analyzed by all investigators. 
 4.7.2 Analysis 

INA 102 
Version 5.0 
10/02/2017 
20 | P a g e  
 
 
 
 
This is an observational study to describe rates of MDR TB amongst new and 
previously treated TB cases in Indonesia. Risk factors for MDR will be evaluated as 
a secondary objective. Additional secondary objectives include a description of 
treatment outcomes (cure, failure, death, completed treatment) and evaluation of 
associated risk factors for poor outcome, comparison of diagnostic accuracy of 
AFB and Xpert MTB/RIF (relative to culture) and an estimation of Xpert MTB/RIF 
Rif susceptibility testing sensitivity and specificity relative to standard DST. Research 
objectives will be analyzed as described below. 
Primary objective 
 
1) To estimate the rate of MDR-TB amongst new and retreated TB cases. 
Proportions of MDR will be estimated, along with exact 95% confidence intervals 
based on a binomial distribution. Case definitions of MDR, new and previously 
treated TB are provided in Appendix B. 
Secondary objective 
 
1) To estimate treatment outcomes (cured, failed, died, treatment completion, and 
lost to follow up) according to susceptibility pattern. Proportions of participants 
within each category will be estimated along with confidence intervals. 
Definitions of treatment outcomes are provided in appendix B. 
2) To evaluate risk/protective factors for treatment success (cured or completed 
treatment vs failed or died or loss to follow up). These factors include: 
demographics (age, sex), TB contact history, smoking habit, treatment seeking 
behavior, co-morbidities (HIV, DM), primary drug resistance, symptoms, no 
cavity in the lung, nutritional status, treatment regimens, compliance, numbers 
of bacteria and TB strains (e.g., Beijing). Logistic regression models will be 
used to describe associations of treatment success with these factors. 
3) To evaluate risk/protective factors for treatment interruption (loss to follow up vs 
other treatment outcome). These factors include: demographics (age, sex), TB 
contact history, smoking habit, treatment seeking behavior, co-morbidities (HIV, 
DM, and other comorbidities), primary drug resistance, symptoms, cavity in the 
lung, nutritional status, treatment regimens, compliance, numbers of bacteria 
and TB strains (e.g., Beijing). Logistic regression models will be used to evaluate 
associations of treatment interruption with these risk factors. 
4) To compare clinically defined TB against laboratory confirmed TB. Accuracy 
will be estimated along with 97.5% confidence intervals. 
5) To compare the sensitivity and specificity of AFB and Xpert MTB/RIF relative 

INA 102 
Version 5.0 
10/02/2017 
21 | P a g e  
 
 
 
 
to culture result. Sensitivity and specificity will be estimated along with 97.5% 
confidence intervals. McNemar’s statistic will test whether the sensitivity and 
specificity differ between AFB and Xpert MTB/RIF. 
6) To estimate sensitivity and specificity of Rif susceptibility results in Xpert 
MTB/RIF against result in DST as gold standard along with 97.5% confidence 
intervals. 
More specific plans for these analyses will be developed prior to the start of 
enrollment, and the plans may be adjusted during the course of the study. 
Interim Analyses 
 
Amongst presumptive new TB cases, we estimate that 25% will have 
confirmed TB, while amongst presumptive previously treated cases, we estimate 
that 70% will have confirmed TB. In order to ensure adequate numbers of TB cases, 
the accuracy of these estimates will be evaluated at 6 and 12 months after the 
study commences. Because of the expected two months waiting period for culture 
results, earlier looks at the data may not be informative. 
 
5. SAFETY MONITORING AND REPORTING 
5.1 
Definition of an Adverse Event 
An adverse event (AE) is any untoward or unfavorable medical occurrence in a 
human participant that occurs within 48 hours of a study-related blood draw that is 
possibly, probably, or definitely related to the blood draw. Any event outside of this 48 
hours window period will not be considered an AE for this study.  
No adverse event to be considered since sputum collection is a non-invasive 
procedure. 
5.2 
Definition of an Serious Adverse Event 
Serious adverse event is any adverse event that:  
• 
results in death; 
• 
is life-threatening (places the participant at immediate risk of death from the event as it 
occurred); 
• 
results in inpatient hospitalization or prolongation of existing hospitalization; 
• 
results in a persistent or significant incapacity; 
• 
results in a congenital anomaly/birth defect; or based upon appropriate medical judgment, 
may jeopardize the participant’s health and may require medical or surgical intervention to 

INA 102 
Version 5.0 
10/02/2017 
22 | P a g e  
 
 
 
 
prevent one of the other outcomes listed in this definition. 
• 
results in death; 
 
• 
is life-threatening (places the participant at immediate risk of death from the event 
as it occurred); 
• 
results in inpatient hospitalization or prolongation of existing hospitalization; 
 
• 
results in a persistent or significant incapacity; 
 
• 
results in a congenital anomaly/birth defect; or based upon appropriate medical 
judgment, may jeopardize the participant’s health and may require medical or surgical 
intervention to prevent one of the other outcomes listed in this definition. 
5.3 
Definition of an Unanticipated Problem 
An unanticipated problem is defined as any incident, experience, or outcome that is 
defined as: 
1. Unexpected in terms of nature, severity, or frequency in relation to: 
 
• 
the research risks that are described in the research protocol and informed 
consent document or other study documents; and 
• 
the characteristics of the participant population being studied; and 
 
2. Related or possibly related to the participation in the research; and 
 
3. Places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized or 
is an SAE. 
5.4 
Reporting Procedures to the IRB 
All unanticipated problems and SAEs, regardless of relationship, will be reported by 
the site PI to the IRB within 7 working days of the investigator’s awareness. 
All reportable adverse events (events that occur within 48 hours of the research 
blood draw and are possibly, probably, or definitely related to the research blood draw) 
will be reported in the summary form to the IRB at the time of Continuing Review. 
5.5 
Study Monitoring 
The study will be conducted in compliance with this protocol, International 
Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) and any 
applicable regulatory requirement(s). Independent monitors, under contract by the 
Sponsor, will visit the clinical research site to monitor all aspects of the study in accordance 
with the appropriate regulations. The objectives of a monitoring visit will be: 

INA 102 
Version 5.0 
10/02/2017 
23 | P a g e  
 
 
 
 
1. To verify the prompt reporting of all data points, including reporting SAEs, and also 
check the availability of a signed informed consent form (ICF). 
2. To review the consistency of each participant’s records with the source documents. 
 
3. To ensure compliance with the protocol, and accuracy and completeness of records. 
The monitors also will inspect the clinical site regulatory files to ensure that regulatory 
requirements are being followed. During the monitoring visits, the site investigator (or 
designee) and other study personnel will be available to discuss the study progress and 
monitoring visit. 
The site investigator (or designee) will make study documents (e.g., ICFs and CRFs) 
and pertinent hospital or clinical records readily available for inspection by the local 
institutional review board/ethics committee (IRB/EC), the local and national regulatory 
authorities, and the site monitors for confirmation of the study data. 
5.6 
Safety Monitoring Plan 
The investigators will monitor protocol data that could affect patient safety or 
confidentiality, including AEs, documentation of patient evaluation, treatment, and 
disposition, and coding of patient data and samples. Additionally, independent monitors will 
conduct visits based on a mutually agreed schedule to monitor study documents. 
 
6. ETHICAL CONSIDERATIONS 
6.1 
Informed Consent Process 
Informed consent is a process in which information is presented to enable persons to 
voluntarily decide whether to participate as a research participant. It is an ongoing 
conversation between the human research participant and the researchers covering the 
essential information about the study which begins before consent is given and 
continues until the end of the participant’s involvement in the research. 
All volunteers will sign an ICF after discussion of essential information about the 
research by the study staff. This will include the purpose of the study, duration, 
procedures, alternatives, risks, and benefits. Participants will have the opportunity to ask 
questions about the study and have their questions answered. 
All participants in the study will sign/thumb print an appropriate informed consent 
document prior to any procedures being done specifically for the study. The participants may 
withdraw consent at any time throughout the course of the study. A copy of the informed 

INA 102 
Version 5.0 
10/02/2017 
24 | P a g e  
 
 
 
 
consent document will be given to the participants for  their  records. The researcher will 
document the signing of the consent form in each participant’s study record. 
6.2 
Illiterate Participant 
If the volunteer is illiterate, oral consent will be obtained. The administrator of the oral 
consent will sign and date the form. The adult volunteers will thumbprint the consent form. 
An impartial witness should be present during the entire informed consent discussion 
and should sign and date the consent form. 
6.3 
Premature Withdrawal of Participant 
Participants may voluntarily withdraw from the protocol at any point in the study. 
Attempts will be made to determine the reason that the subject wishes to withdraw. 
6.4 
IRB Review 
Prior to the implementation of the protocol, the protocol and ICF for this study will be 
submitted for approval to the appropriate IRB. Any change to the protocol, ICF, will only 
be implemented after approval from the IRB. Records of the IRB review and approval of 
all the documents pertaining to the study will be kept on file by the site investigator and 
are subject to inspection at any time during the study. Continuing reviews or study progress 
report will be submitted according to the requirement of the appropriate IRB, but once a year 
at a minimum. 
6.5 
Participant Confidentiality 
All records will be kept confidential to the extent provided by the law. The study 
monitors and other authorized representatives may inspect all documents and records 
required to be maintained by the site investigator, including, but not limited to, medical 
records. Records will be kept in a locked cabinet, and all computer entry and networking 
programs will be done with coded numbers only. Clinical information, attributable to the 
subject, will not be released without written permission of the subject, except as 
necessary for monitoring, the EC/IRB, or Office for Human Research Protections (OHRP). 
The results of the research study may be published according to the INA-RESPOND 
policy, but subject names or identities will not be revealed. 
6.6 
Rationale for Subject Selection 
Children and teenagers under age 18 are excluded from participating in the study 
due to concerns regarding long term study compliance. 
6.7 
Benefits 
This study is meant to provide knowledge on the TB drug resistant in new and 

INA 102 
Version 5.0 
10/02/2017 
25 | P a g e  
 
 
 
 
previously treated TB cases in study hospitals and to identify areas of potential research 
in the future. It may not provide direct benefit to participants. Patients participating in this 
study will receive additional diagnostic and drug susceptibility testing not currently provided 
routinely. 
The Site study team will share results with the study participants related to their 
medical care. 
6.8 
Compensation 
This study will not provide any compensation for any visit schedules that are in 
accordance to national TB treatment guidelines. Patients who were diagnosed as DS-TB 
will receive Rp 150,000 as compensation at baseline visit, month 1, 2, end of treatment 
visit, and 6 months post treatment visit during study. Patients who were diagnosed as 
MDR-TB will receive Rp 150,000 as compensation at baseline visit, month 1, 2, 12, 18, 
end of treatment visit, and 6 months post treatment visit during study. This compensation 
to compensate longer time taken and any inconveniences due to more study procedures. 
6.9 
Risk and Discomforts 
This is a minimal-risk, observational study and does not involve experimental 
interventions. The only study intervention is a blood draw and all other procedures are 
considered as part of standard care for TB patients.  
The hazards of blood drawing are minimal and consist of mild discomfort and or 
bleeding at the venipuncture site, bruising and rarely fainting and local infection. In case of 
any immediate serious side effect like fainting, the patient will be stabilized by the study team 
if needed. 
The hazards of sputum collection are minimal and consist of mild discomfort when 
participants tried to produce sputum to be collected. 
Each drug susceptible subject in this study will undergo one additional chest x-ray at 
the end of study. The purpose of this x-ray is to determine if the subject has improved chest 
x-ray. The amount of radiation the subject will receive is 0.040 rem (which is below the 
guideline of 5 rem per year allowed for research participants by the NIH Radiation Safety 
Committee). The hazard of an additional (maximum two with 6 months interval) chest x-
ray are minimal and consist of mild discomfort and radiation exposure when participants 
undergo the chest x-ray process. 
6.10 Recording/Documentation 
At each contact with the subject, assessment information will be elicited by 
appropriate questioning and examination, and they will be recorded on source documents. 
Source documents may include worksheets, progress notes, laboratory reports, consult 

INA 102 
Version 5.0 
10/02/2017 
26 | P a g e  
 
 
 
 
notes, and data collection tools. Data is to be transcribed onto CRFs from source documents 
on an ongoing basis during the study. The study monitor may review and audit all 
documents and records required to be maintained by the site investigator. 
Any type of corrections to study documents should be initialed and dated by the 
person who is making the correction. The site investigator is responsible for ensuring that 
the data collected are complete, accurate, and recorded in a timely manner. All CRFs 
should be reviewed, initialed and dated by the site investigator or designee. CRFs will be 
maintained and kept in locked cabinets at the site for at least 5 years after study completion. 
Each subject’s name will be paired with a numeric code in the enrollment log. Access 
to data identifying participants will be kept in a locked file, accessible only by study staff. 
Finally, the importance of subject confidentiality will be impressed upon all research staff. 
The site investigator is responsible for the accuracy and completeness of the data reported. 
7. PROTECTION OF INTELLECTUAL PROPERTY (IPR), MATERIAL 
TRANSFER AGREEMENT (MTA), AND GENETIC RESOURCES AND 
TRADITIONAL KNOWLEDGE (GRTK) 
7.1 
Protection of Intellectual Property 
Publication of the results of this study will be governed by the INA-RESPOND 
publication policy. Any presentation, abstract, or manuscript will be made available for 
review by the supporters prior to submission. 
7.2 
Publication and Dissemination of Research Results 
These will be guided by the Protection of Intellectual Property (IPR) terms as outlined 
in Article X and Annex I of the Science and Technology agreement between the 
Government of the Republic of Indonesia and the Government of the United States of 
America. Article X (Protection of Intellectual Property) states: 
1. Provisions for the protection and distribution of intellectual property created or furnished 
in the course of cooperative activities under this Agreement are set forth in Annex I, 
which shall form an integral part of this Agreement. 
2. Scientific and technological information of a non-proprietary nature resulting from 
cooperation under this Agreement (other than information which is not disclosed for 
commercial or industrial reasons) shall be made available, unless otherwise agreed, to 
the world scientific community through customary channels and in accordance with 
normal procedures of the participating agencies and entities. 
And under Paragraphs III.A and III.B(1), (2)(a), (2)(b), (2)(c) of Annex I, Intellectual Protection  

INA 102 
Version 5.0 
10/02/2017 
27 | P a g e  
 
 
 
 
Rights, of  the Science and Technology agreement between the Government of the 
Republic of Indonesia and the Government of the United States of America. 
7.3 
Material Transfer Agreement 
Research materials used in the collaborations under this protocol may, on agreement 
of the participants, be transferred using Material Transfer Agreements (MTAs) as appropriate 
in the particular collaborations, as outlines in Article VIII of the Science and Technology 
Agreement. 
7.4 
Genetic Resources and Traditional Knowledge 
The collection, conservation and exchange of genetic resources and associated 
traditional knowledge under this protocol shall be subject to Article VI of the S and T 
Agreement and will be based on the following considerations: 
Obtaining informed consent from appropriate authority/institutional review board prior 
to accessing genetic resources collected during the conduct of this protocol. 
Equitably sharing the benefits arising from the use of traditional knowledge and 
genetic resources. 
The complete Science and Technology agreement between the Government of the 
Republic of Indonesia and the Government of the United States of America is in Appendix C. 
 
 

INA 102 
Version 5.0 
10/02/2017 
28 | P a g e  
 
 
 
 
8. RESEARCH TEAM 
Role 
Name, Institution and 
Location 
Expertise 
Contact Information 
Coordinator 
Dr. Siswanto, MHP, DTM 
NIHRD, Jakarta 
Head of CAHTCE 
Phone: +62 811 335 017 
Email: siswantos@yahoo.com 
Principal 
Investigator 
Dr. dr. Erlina Burhan, SpP(K), 
MSc. 
RSUP Persahabatan, Jakarta 
Pulmonologist 
Phone : +62 816 162 8471 
Email : erlina_burhan@yahoo.com 
Co-Principal 
Investigator 
Dr. Anis Karuniawati, SpMK, 
PhD 
Microbiology Dept. University 
of Indonesia, Jakarta 
Microbiologist 
Phone: +62 811 935 207 
Email: akaruniawati@yahoo.com 
Investigator 
dr. Muhammad Karyana, 
M.Kes 
NIHRD, Jakarta 
Health Economist 
Phone: +62 816 789 817 
Email: mkaryana@gmail.com 
Investigator 
Drs. Bambang Heriyanto, 
M.Kes 
NIHRD, Jakarta 
Public Health 
Phone: +62 812 811 6693 
Email: 
bambang_heriyanto@gmail.com 
Investigator 
dr. Retna Mustika Indah 
NIHRD, Jakarta 
Infectious Diseases 
Phone : +62 811 987 432 
Email : cagivaluvers@gmail.com 
Investigator 
Agus Dwi Harso, S.Si 
NIHRD, Jakarta 
Infectious Diseases 
Phone : +62 857 262 10557 
Email : agusdh08@gmail.com 
Investigator 
dr. Herman Kosasih, PhD 
INA-RESPOND, Jakarta 
Infectious Diseases 
Phone : +62 811 987 432 
Email : herman_kosasih@yahoo.com 
Investigator 
dr. Nugroho H Susanto, 
M.KM 
INA-RESPOND, Jakarta 
Public Health 
Phone: +62 818 0202 2299 
Email: nhsharhar@gmail.com 
Laboratory 
Team Specialist 
dr. Dewi Lokida, SpPK 
RSU Kab Tangerang, 
Tangerang 
Widoretno, S.Si, M.Si 
NIHRD, Jakarta 
Clinical Pathologist 
Molecular Biologist 
Phone: +62 81 662 06 05 
Email: lokidadewi@s-3.com 
Phone: +62 81 311 114 433 
Email:w_r3tno@yahoo.com 
Data Manager 
dr. Delima, M.Kes 
NIHRD, Jakarta 
Kanti Laras, S.Si, M.Kes 
INA-RESPOND, Jakarta 
Drg. Tince Jovina, M.Kes 
NIHRD, Jakarta 
Agnita Triyoga 
NIHRD, Jakarta 
Eni Yuwarni 
NIHRD, Jakarta 
Public Health 
  
Public Health 
 
Public Health  
 
Infectious Diseases 
 
Infectious Diseases 
Phone: +62 816 482 4070 
Email: delimatie@yahoo.com 
Phone:+62 812 803 0425 
Email: klaras@s-3.com 
Phone: +62 811 874 508 
Email: t.a.jovina@gmail.com 
Phone: +62 996 822 959 
Email: agnita.triyoga@gmail.com 
Phone: +62 996 822 959 
Email: eniyw@yahoo.co.id 

INA 102 
Version 5.0 
10/02/2017 
29 | P a g e  
 
 
 
 
APPENDIX A. List of Study Procedures and Timeline 
Procedures 
BL 
Mo1 
Mo2 
Mo3 
Mo4 
Mo5 
Mo6 
Mo7 
Mo8 
Mo9 
Mo10 
Mo12 
Mo14 
Mo16 
Mo18 
Mo20 
Mo22 
Mo24 
6Mos 
Post Tx 
 
 
 
 
 
 
End of Treatment 
 
 
 
 
End of Treatment 
Screening Log 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Enrollment Log 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed 
Consent 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demography 
SOC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SOC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TB history & 
contact history 
SOC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SOC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Smoking Habit 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment 
seeking 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HIV, DM, cancer 
comorbid data 
ST,IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
 
ST,IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
 
Symptoms 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
Treatment 
Compliance 
 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
 
 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
ST 
 
Height 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
 
 
 
 
 
 
 
 
ST 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
ST 
Chest X-Ray 
SOC 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
ST 
SOC 
 
 
 
 
 
SOC 
 
 
 
 
SOC 
 
 
SOC 
 
 
ST 
ST 
AFB 
ST 
ST 
SOC 
IA 
 
IA 
SOC 
 
 
 
 
 
 
 
 
 
ST 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
IA 
 
Xpert MTB/RIF 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SOC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sputum Culture 
ST 
ST 
ST 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
SOC 
 
1st DST 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SOC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2nd DST 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

INA 102 
Version 5.0 
10/02/2017 
30 | P a g e  
 
 
 
 
Procedures 
BL 
Mo1 
Mo2 
Mo3 
Mo4 
Mo5 
Mo6 
Mo7 
Mo8 
Mo9 
Mo10 
Mo12 
Mo14 
Mo16 
Mo18 
Mo20 
Mo22 
Mo24 
6Mos 
Post Tx 
 
 
 
 
 
 
End of Treatment 
 
 
 
 
End of Treatment 
Hb, HbA1C, 
HIV exams 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ureum, Creatinin, 
AST, ALT 
IA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SOC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stored Whole 
Blood (DNA) 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stored Plasma 
ST 
ST 
ST 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
Stored PBMC 
ST 
ST 
ST 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
Stored Serum 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stored Paxgene 
ST 
ST 
ST 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
Stored Urine 
ST 
ST 
ST 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
Stored Sputum 
ST 
ST 
ST 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
Stored Mtb 
Isolate 
ST 
ST 
ST 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
ST 
ST 
ST 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
Stored Saliva 
ST 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
ST 
 
 
 
 
 
 
 
 
 
 
 
 
 
ST 
 
 
*ST for HIV and DM, If available for other comorbidities 
Blue   
: Information for DS-TB 
Red 
 
: Information for MDR-TB 
ST  
 
: Procedure required by study that might be different from the site SoC 
SoC     
: Procedure must be done regularly on site 
IA 
 
: Procedure might be done on site for all or some groups of participants 
All available data must be recorded for study  
 
 

INA 102 
Version 5.0 
10/02/2017 
31 | P a g e  
 
 
 
 
APPENDIX B. Operational Definition 
Variables 
Measurement 
Operational definition 
New TB cases 
Patient report 
TB patients who never have TB 
treatment or already have TB 
treatment less than one month 
(4 weeks) 
Previously treated TB cases 
Patient report 
A patient who has been treated 
for one month or more with 
anti TB drugs in the past 
Presumptive TB 
Clinical and X-Ray evaluation 
Patient who presents with 
symptoms or signs suggestive 
of TB on the basis of X-ray 
suggestive TB  
Bacteriologically confirmed TB  
Laboratory evaluation 
A participant whom a biological 
specimen is positive by AFB or 
culture or WRD (such as Xpert 
MTB/RIF) 
Clinically diagnosed TB 
Clinical and X-Ray evaluation 
Participant who does not fulfil 
the criteria for bacteriological 
confirmation but has been 
diagnosed with active TB by a 
clinician or other medical 
practitioner who has decided 
to give the patient a full course 
of TB treatment, includes cases 
diagnosed on the basis of X-ray 
abnormalities  
Pulmonary TB 
Clinician judgement  
Any 
bacteriologically 
confirmed or 
clinically 
TB 
involving the lung parenchyma 
or the tracheobronchial tree, 
including miliary TB, patient 
with both pulmonary and 
extrapulmonary TB should be 
classified as a case of PTB. 
Extrapulmonary TB 
Clinician judgement 
Any 
bacteriologically 
confirmed 
or 
clinically 
diagnosed case of TB involving 
organs other than the lungs, 
e.g. pleura, lymph nodes, 
abdomen, genitourinary tract, 
skin, joints 
Drug Sensitive/susceptible TB 
By the result of Drug 
susceptibility test (DST) 
Negative DST result 
MDR TB 
By the result of Drug 
susceptibility test (DST) 
DST result positive resistant to 
isoniazid and rifampicin 
Rif Resistance TB 
By the result of Drug 
susceptibility test (DST) 
DST result positive resistant to 
rifampicin 

INA 102 
Version 5.0 
10/02/2017 
32 | P a g e  
 
 
 
 
Monoresistance TB 
By the result of Drug 
susceptibility test (DST) 
DST result positive resistant to 
one of 1st line TB drug other 
than rifampicin 
Polydrug resistance TB 
By the result of Drug 
susceptibility test (DST) 
DST result positive resistant to 
more than one of 1st line TB 
drugs, 
in 
addition 
to 
combination of isoniazid and 
rifampicin 
Extensive drug resistance TB 
By the result of Drug 
susceptibility test (DST) 
DST result positive resistant to 
any fluoroquinolone and to at 
least one of three second-line 
injectable drugs (capreomycin, 
kanamycin and amikacin), in 
addition 
to 
multidrug 
resistance. 
Treatment outcome DS-TB 
Cured 
Attending TB team report 
Smear or culture negative in 
the last month of treatment 
and on at least one previous 
occasion 
Completed treatment 
Attending TB team report 
Completed treatment without 
evidence of failure but with no 
records to show that sputum 
smear or culture negative in the 
last month of treatment and on 
at least one previous occasion 
were negative, either because 
tests were not done or results 
are unavailable 
Died 
Attending TB team report 
Died from any cause during 
treatment 
Failed 
Attending TB team report 
Sputum smear or culture is 
positive at month 5 or later 
during treatment 
Loss to follow up 
Attending TB team report 
Did not start treatment or 
treatment was interrupted 
for two consecutive months 
or more 
Not evaluated 
Attending TB team report 
No treatment outcome is 
assigned. This include cases 
‘transferred out’ to another 
treatment unit as well as 
cases 
for 
whom 
the 
treatment 
outcome 
is 
unknown. 
Successfully treated 
Attending TB team report 
The sum of cured and 
completed treatment. 

INA 102 
Version 5.0 
10/02/2017 
33 | P a g e  
 
 
 
 
Treatment outcome MDR-TB 
Cured 
Attending TB team report 
Treatment 
completed 
as 
recommended by the national 
policy without evidence of 
failure AND three or more 
consecutive cultures taken at 
least 30 days apart are negative 
after the intensive phase. 
Completed treatment 
Attending TB team report 
Treatment 
completed 
as 
recommended by the national 
policy without evidence of 
failure BUT no record that three 
or more consecutive cultures 
taken at least 30 days apart are 
negative after the intensive 
phase. 
Failed 
Attending TB team report 
Treatment terminated or need 
for permanent regimen change 
at least two anti-TB drugs 
because of: 
• 
Lack of conversion at 
the end of intensive 
phase; or 
• 
Bacteriologocial 
reversion in the 
continuation phase 
after conversion to 
negative; or 
• 
Evidence of additional 
acquired resistance to 
fluoroquinolones or 
second-line injectable 
drugs; or 
• 
Adverse drug 
reactions 
Died 
Attending TB team report 
Died for any reason during 
course of treatment 
Loss to follow up 
Attending TB team report 
Treatment was interrupted for 
two consecutive months or 
more. 
Not evaluated 
Attending TB team report 
No treatment outcome is 
assigned. This include cases 
‘transferred out’ to another 
treatment unit as well as cases 
for 
whom 
the 
treatment 
outcome is unknown. 
Treatment success 
Attending TB team report 
The 
sum 
of 
Cured 
and 
completed treatment. 

INA 102 
Version 5.0 
10/02/2017 
34 | P a g e  
 
 
 
 
Demographics 
Age 
Patient report 
Last birthday 
Sex 
Patient report 
male and female 
Patient’s history 
TB close contact 
Patient report 
Living in a same house with 
person who has TB 
Smoking habit 
Patient report 
Smoking status of  participants 
Treatment seeking behavior 
Patient report 
History of health facility that 
been visited for treating these 
TB symptoms 
Co Morbidities 
HIV 
Clinical 
and 
laboratory 
evaluation 
support 
HIV 
evidence 
Positive result of HIV test 
Diabetes mellitus 
Clinical 
and 
laboratory 
evaluation support diabetes 
evidence 
glucose 
test 
according to site SoC 
Positive result of diabetes 
Symptoms 
Patient report 
Presence of TB symptoms from 
previous visit to current visit 
Nutritional status 
BMI calculation based on data 
of Height and weight 
< 18.5  
: Underweight 
18.5 - 24.9 
: Healthy weight 
25 - 30 
: Overweight 
30 to 35 
: Obese 
Treatment regiment 
Source documents 
Regiment of anti TB drugs given 
to the patients according to SoC 
Compliance 
Patient report or blister count 
Percentage 
of 
scheduled 
medication 
minus 
any 
medication left in the blister or 
based on patient report 
 
 
 

INA 102 
Version 5.0 
10/02/2017 
36 | P a g e  
 
 
 
REFERENCES 
 
1. 
World Health Organization W. Global Tuberculosis Control, Surveillance, Planning and Financing. 
Geneve: 2006. 
2. 
World Health Organization W. Global Tuberculosis Control 2010. Geneve: 2010. 
3. 
World Health Organization W. Global Tuberculosis Report 2016. Geneva: World Health 
Organization; 2016. 
4. 
Departemen Kesehatan Republik Indonesia. Pedoman Nasional Penanggulangan Tuberkulosis. 
Jakarta2007. 
5. 
Massi MN, Wahyuni S, Halik H, Yusuf I, Leong FJ, Dick T, et al. Drug resistance among 
tuberculosis patients attending diagnostic and treatment centres in Makassar, Indonesia. Int  J Tuberc 
Lung Dis. 2011;15(4):489-95. Epub 2011/03/15. 
6. 
Zignol M, van Gemert W, Falzon D, Sismanidis C, Glaziou P, Floyd K, et al. Surveillance of anti- 
tuberculosis drug resistance in the world: an updated analysis, 2007-2010. Bulletin of the World Health 
Organization. 2012;90(2):111-9D. Epub 2012/03/17. 
7. 
Kelly PM, Ardian M, Waramori G, Anstey NM, Syahrial H, Tjitra E, et al. A community-based TB 
drug susceptibility study in Mimika District, Papua Province, Indonesia. Int J Tuberc Lung Dis. 
2006;10(2):167-71. Epub 2006/02/28. 
8. 
Ministry of Health RoI. Indonesia Health Profile 2011. Jakarta: Ministry of Health Republic of 
Indonesia; 2012. 
9. 
Kementerian Kesehatan Republik Indonesia. Strategi Nasional Pengendalian  TB  di Indonesia 
2010-2014. Jakarta2011. 
10. 
Chung WS, Chang YC, Yang MC. Factors influencing the successful treatment of infectious 
pulmonary tuberculosis. The international journal of tuberculosis and lung disease. 2007;11(1):59- 64. 
11. 
Feng JY, Huang SF, Ting WY, Chen  YC, Lin  YY, Huang RM, et al. Gender differences in treatment 
outcomes of tuberculosis patients in Taiwan: a prospective observational study. Clinical Microbiology 
and Infection. 2012;18(9):E331-E7. 
12. 
Dujaili J, Syed Sulaiman S, Awaisu A, Muttalif A, Blebil A. Outcomes of tuberculosis treatment: 
a retrospective cohort analysis of smoking versus non-smoking patients in Penang, Malaysia. J Public 
Health. 2011;19(2):183-9. 
13. 
Parwati I, Alisjahbana B, Apriani L, Soetikno RD, Ottenhoff TH, van der Zanden AG, et al. 
Mycobacterium tuberculosis Beijing genotype is an independent risk factor for tuberculosis treatment 
failure in Indonesia. J Infect Dis. 2010;201(4):553-7. Epub 2010/01/13. 
 

Sample Information Sheet and Consent Form (English) 
Tuberculosis Research of INA-RESPOND On Drug Resistant (TRIPOD) 
Voluntary Consent for Adult Patient 
 
INTRODUCTION 
We invite you to take part in a TB study. The doctor in charge of this study at this site is (insert 
name of Site Investigator). Before you decide if you want to be a part of this study, we want you 
to know about the study.  
This is an information sheet. It gives you information about the study. The study staff will inform 
you about the study. You are free to ask questions about this study at any time. If you agree to 
take part in this study, you will be asked to sign the consent form. You will get a copy of the 
information sheet and informed consent of this study.  
 
WHERE AND WHY IS THIS STUDY BEING DONE? 
The Indonesia Research Partnership for Infectious Diseases (INA-RESPOND) consisting of 8 
hospitals: Persahabatan hospital and Penyakit Infeksi Prof. Dr. Sulianti Saroso hospital, Jakarta; 
Dr. Hasan Sadikin hospital, Bandung; Dr. Kariadi hospital, Semarang; Dr. Soetomo hospital, 
Surabaya; Sanglah hospital, Denpasar; Dr. Sardjito hospital, Yogyakarta; Dr. Wahidin 
Sudirohusodo hospital, Makassar; and the National Institute of Health Research and 
Development (NIHRD) is conducting a study on the proportion of MDR TB cases in new and 
previously treated TB patients. 
The purposes of this study are: to find out the proportion of MDR TB in new TB and previously 
treated TB patients. Results of this study, proportion of MDR TB in new TB and previously 
treated TB patients in Indonesia, is beneficial because it can provide data for National . This 
study may also help to understand the factors that related to treatment outcomes in drug 
sensitive TB cases and MDR TB cases. 
 
WHAT DO I HAVE TO DO IF I AM IN THIS STUDY? 
1. Screening 
This evaluation will be conducted to see whether you are eligible to take part in this study. The 
screening evaluation will take about 2-5 days. 
You may be enrolled into this study if you meet the following criteria: 
• 
You are eighteen years of age or older  
• 
You have cough and at least one other TB clinical symptoms.  
• 
You are not on TB treatment in the last 2 months 
• 
Clinician indicates that you have pulmonary TB based on chest X-ray results 

• 
You are willing to let us store blood, urine and result of sputum culture test for use in 
future studies, and willing to be treated or evaluated at the hospital that is part of our 
study sites.  
However you may not be enrolled into this study if the clinician: 
• 
Find out that you are pregnant 
• 
Find out that you have liver disease and/or chronic kidney disease 
• 
Decides you have a problem to comply with study procedure.  
If you agree to join this study, you will be asked to sign this informed consent.  
2. Entry (This evaluation may be combined with the Screening evaluation) 
This evaluation may take about hours. At this evaluation, you will have the following done:  
• 
We will check your TB related symptoms and you will have a physical exam including but 
not limited to height and weight measurement, unless these are already done by the 
doctor treating you. 
• 
About 10 mL (approximately two teaspoon) of your blood will be drawn to diagnose other 
diseases beside TB and to test the condition of your blood. You will be told the results of 
these tests as soon as this information becomes available. 
• 
The total amount of blood to be drawn will not be more than the allowed limits and the 
rest of the blood after being used for examination will be stored. 
• 
About 10 ml of your urine will be collected for storage. 
• 
About 3 containers of your sputum will be drawn to diagnose TB by culture tests and 
drug resistance test. 
3. Study Follow-Up Visits during TB treatment  
a. At month 1, 2, 3, 4, 5 (Five Visits) of treatment 
This visit may take about 30 minutes.  At this visit, you will have the following done:  
• 
We will check your TB related symptoms and you will have a physical exam 
for weight measurement unless these are already done by the doctor treating 
you. 
• 
We will count how many pills that you missed to take during treatment by 
counting the blister or based on your recall if you forgot to bring the blister 
• 
About 2 containers  of sputum will be collected for smear and culture  
b. At month 6 (One Visit) of treatment 
This visit may take about 90 minutes.  At this visit, you will have the following done:  
• 
We will check your TB related symptoms and you will have a physical exam 
for weight measurement unless these are already done by the doctor treating 
you. 
• 
We will count how many pills that you missed to take during treatment by 
counting the blister or based on your recall if you forgot to bring the blister 
• 
We will performed chest x-ray to monitor TB progress in your lung. 
• 
About 2 containers of sputum will be collected for smear and culture. 

• 
If this is your last clinical visit, you will be asked to drawn 6 mL of blood 
(approximately one teaspoon) and 10 ml of urine for storage. 
 
c. At month 7,8,9 (Three Visits) of treatment 
This visit may take about 90 minutes.  At this visit, you will have the following done:  
• 
We will check your TB related symptoms and you will have a physical exam 
for weight measurement unless these are already done by the doctor treating 
you. 
• 
We will count how many pills that you missed to take during treatment by 
counting the blister or based on your recall if you forgot to bring the blister 
• 
We will performed chest x-ray to monitor TB progress in your lung. 
• 
About 2 containers of sputum will be collected for smear and culture. 
• 
If this is your last clinical visit, you will be asked to drawn 6 mL of blood 
(approximately one teaspoon) and 10 ml of urine for storage. 
d. At month 8, 10, 12, 14, 16, 18, 20, 22, 24 (Nine Visits) of treatment 
This visit may take about 60 minutes.  At this visit, you will have the following done:  
• 
We will check your TB related symptoms and you will have a physical exam 
for weight measurement unless these are already done by the doctor treating 
you. 
• 
We will count how many pills that you missed to take during treatment by 
counting the blister or based on your recall if you forgot to bring the blister 
• 
About 2 containers of sputum will be collected for smear and culture. 
• 
If this is your last clinical visit, you will be asked to drawn 6 mL of blood 
(approximately one teaspoon) and 1 pot of urine for storage. 
Chest X-ray  
You will be asked to have an x-ray of your chest. This test involves standing in front of 
an x-ray machine as a picture of your chest and lungs is taken. A complete x-ray exam 
will take about 10 minutes. 
Risks of Chest X-ray  
This research study involves exposure to radiation from 1 chest x-ray. This radiation 
exposure is not standard of care and is for research purposes only. The amount of 
radiation you will receive in this study is 0.040 rem (which is below the guideline of 5 rem 
per year allowed for research subjects by the NIH Radiation Safety Committee.) The 
average person in the United States receives a radiation exposure of 0.3 rem per year 
from natural sources, such as the sun, outer space, and the earth's air and soil.  
While there is no direct evidence that the amount of exposure received from participating 
in this study is harmful, there is indirect evidence it may not be completely safe. There 
may be a very slight increase in the risk of cancer.  
Unless you are pregnant, this level of radiation is generally considered safe. A 
pregnancy test will be performed prior to the x-ray if you are a female of child-bearing 
potential. If the test is positive, you will not receive a chest x-ray but you may still 
participate in the study. 

4. Stored Samples and Future Research  
During of your first and end of study visits, the result of sputum culture test, blood, and urine 
may be collected for future TB related tests and genetic test. In general, future research that 
uses your samples will not help you, but it may help us to have a better understanding about 
TB. This research may also help us provide better treatments for TB and improve the 
management of TB. Any results relevant to your care will be shared with you and communicated 
to your physician.  
Genetic test is one of test in future studies that could be tested on your blood. This test including 
analysis on your several gene (carrier characteristics) to see if the TB infection that you got and 
the progress of the disease is related with this hereditary factor. You could choose not to 
participate in this genetic test and it will not affecting your enrollment in this study. 
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 
About 1357 people will take part in this study. 
 
HOW LONG WILL I BE IN THIS STUDY?  
You will be in this study for the duration of the treatment, it depends on the diagnose of your TB, 
or for 24 months if your treatment duration is longer than 24 months.   
 
 
WHY WOULD THE DOCTOR TAKE ME OFF THIS STUDY EARLY? 
You may withdraw from the study at any time. You will not be asked for further information or 
collected further data.  
The study doctor may need to take you off the study early without your permission if: 
• 
The study is cancelled or terminated by the sponsors or the site’s Institutional Review 
Board (IRB)/Ethics Committee (EC).  
• 
You are not able to attend the study visits as required by the study. 
• 
It will be harmful for you if you continue in this study. 
 
WHAT ARE THE RISKS OF THE STUDY? 
The researchers believe that the risks or discomforts to you are minimal and includes the risks 
associated with obtaining blood and producing sputum.  These include slight pain and redness 
or bruising at the site where the blood is drawn and in rare cases, fainting and discomfort during 
producing sputum.   

Bruising may be alleviated by a warm compress.  There is a very small chance the site where 
the blood is drawn may become infected.  This is unlikely since the person drawing the blood 
will clean the site with alcohol before blood is taken and use a sterile blood drawing material.   
If you have difficulty to produce sputum, we could help you by providing inhalation medicine that 
might help you to produce sputum. 
 
WHAT OTHER CHOICES DO I HAVE BESIDES THIS STUDY? 
The alternative is not to participate in this study. If you decide not to participate in this study you 
still get treatment for TB symptoms.  
 
ARE THERE BENEFITS TO TAKING PART IN THIS STUDY? 
The study will covered all the tests cost during treatment that are not paid by the government.  
This study will provide xxxx at the beginning and end of study for your time spent and 
incoveniences. The study will not provide costs for routine care or hospitalization that are 
required by the government. The results of this study may help your clinician to provide better 
treatments and improve the management of your TB infection.  
 
WILL I RECEIVE ANY PAYMENT? 
You will receive no payment for taking part in this study.   
 
WHAT ABOUT CONFIDENTIALITY? 
All information about you will be kept confidential and will not be shared with anyone who is not 
responsible for your care. Your medical record will only be reviewed by those who are working 
on this study.   
All the research documents and samples will be labeled using your study number. Your name 
will not be used for labeling samples and your name will not appear in study related reports or 
scientific publications.  
 
WHAT HAPPENS IF I AM INJURED? 
We will provide immediate medical care for study related injuries e.g. an infection where blood 
has been taken. The study cannot pay for long term disability that may have resulted from the 
subject’s illness.   
 
WHAT ARE MY RIGHTS AS A RESEARCH PARTICIPANT? 

Your participation in this study is completely voluntary.  If you do not want to participate, you will 
still get standard treatment.  You may discontinue your participation in this study at any time you 
choose.  
We will tell you about new information from this or other studies that may affect your health, 
welfare, or willingness to stay in this study.  If you want the results of the study, let the study 
staff know. 
 
WHAT DO I DO IF I HAVE QUESTIONS OR PROBLEMS? 
If you have questions regarding this study, you may contact:  
• 
insert name of the investigator or other study staff 
• 
telephone number of above  
 
 

SAMPLE ADULT CONSENT FORM 
 
Tuberculosis Research of INA-RESPOND On Drug Resistant 
 
I have read the study information sheet or this information sheet has been read to me. I have 
had the opportunity to ask questions about it and any questions I have asked have been 
answered to my satisfaction. I have been explained that I may withdraw from this study at any 
time. 
I freely and voluntarily choose to participate in this study. I will be given a copy of this 
information sheet and signed consent form to keep for my reference.  
I agree to the storing of my result of culture test from my sputum for genetic testing to see 
whether specific genetic factors play a role in the occurrence of TB and its progression.  
___YES 
___NO 
 
Name of Subject: __________________________________     Age: __________ 
 
 
Signature*: __________________________                   Date: ____/____/____                        
 
                                                                           
 
(dd/mm/yy)             
*A thumb print can be used of the patient who cannot write. 
 
 
Name of the Investigator: ___________________ Signature: ______________________    
 
Date: ____/____/____       
 
 
 
 
          (dd/mm/yy) 
 
 
Name of Witness: _______________________ 
Signature: ______________________    
 
Date: ____/____/____                                               
             (dd/mm/yy) 
 
 

Appendix D: Contoh Lembar Penjelasan dan Formulir Persetujuan (Bahasa Indonesia) 
Penelitian Tuberculosis oleh INA-RESPOND Mengenai Kekebalan Obat 
Persetujuan untuk ikut dalam penelitian dengan sukarela, untuk pasien dewasa 
 
PENGANTAR 
Kami mengharapkan anda untuk ikut serta dalam suatu penelitian mengenai TB karena anda 
saat ini sedang dicurigai menderita TB. Dokter yang bertugas untuk penelitian ini di RS ini 
adalah  Dr ………………..(tuliskan nama peneliti). Sebelum anda memutuskan untuk ikut dalam 
penelitian ini, kami mengharapkan anda untuk mengetahui terlebih dahulu mengenai penelitian 
ini. 
Ini adalah lembar penjelasan dimana berbagai informasi mengenai penelitian ini akan 
diterangkan. Seorang petugas pada penelitian ini akan memberikan informasi mengenai 
penelitian ini. Anda dapat dengan bebas untuk bertanya mengenai penelitian ini kapan saja. 
Jika anda setuju untuk ikut serta, anda akan diminta untuk menandatangani formulir 
persetujuan. Anda akan mendapatkan salinan dari lembar penjelasan ini dan formulir 
persetujuan.  
 
DIMANA DAN MENGAPA PENELITIAN INI DILAKSANAKAN? 
Kemitraan dalam Penelitian Penyakit Infeksi Indonesia (dalam bahasa Inggris dikenal sebagai 
“The Indonesia Research Partnership for Infectious Diseases”/INA-RESPOND) yang terdiri dari 
8 rumah sakit: RS Persahabatan dan RSPI Prof. Dr. Sulianti Saroso, Jakarta; RS Dr. Hasan 
Sadikin, Bandung; RS Dr. Kariadi, Semarang; RS Dr. Soetomo, Surabaya;, RS Sanglah, 
Denpasar, RS Dr. Sardjito, Yogyakarta, RS Dr. Wahidin Sudirohusodo, Makassar dan Badan 
Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan Republik Indonesia akan 
melaksanakan suatu penelitian mengenai proporsi kasus TB Multi Drug Resistant (TB-MDR) 
pada pasien TB baru dan pasien TB yang pernah diobati sebelumnya.  
Tujuan dari penelitian ini adalah untuk mengetahui proporsi kasus TB-MDR pada pasien TB 
baru dan pasien TB yang pernah diobati sebelumnya. Hasil dari penelitian ini, proporsi kasus 
TB-MDR pada pasien TB baru dan pasien TB yang pernah diobati sebelumnya, adalah berguna 
karena bisa memberikan data untuk Nasional. Penelitian ini juga dapat membantu mengerti 
faktor-faktor yang berhubungan dengan hasil terapi pada kasus TB dan TB-MDR.  
 
APA YANG HARUS SAYA LAKUKAN JIKA IKUT PADA PENELITIAN INI? 
1. Skrining 
Pertama-tama akan dilakukan penapisan untuk melihat apakah anda memenuhi kriteria untuk 
ikut dalam penelitian ini. Evaluasi untuk skrining  ini berlangsung sekitar 2-5 hari.  
 
 

Anda dapat ikut dalam penelitian ini jika :  
• 
Anda berusia 18 tahun atau lebih. 
• 
Anda menderita batuk dan setidaknya satu gejala klinis TB lainnya.  
• 
Anda tidak sedang dalam pengobatan TB dalam 2 bulan terakhir. 
• 
Klinisi menyatakan bahwa anda menderita TB paru berdasarkan hasil ronsen dada 
• 
Anda mengijinkan kami untuk menyimpan darah, air seni dan hasil dari kultur dahak 
untuk digunakan dalam penelitian-penelitian di masa depan, dan bersedia untuk diterapi 
atau dievaluasi di rumah sakit-rumah sakit yang ikut serta dalam penelitian ini. 
Anda tidak dapat ikut dalam penelitian ini jika dokter yang merawat anda :   
• 
Menyatakan anda sedang hamil 
• 
Menyatakan anda menderita penyakit hati dan/atau penyakit ginjal menahun 
• 
Berpendapat anda akan mengalami kesulitan dalam mengikuti prosedur penelitian. 
Jika anda memenuhi kriteria dan setuju untuk ikut serta dalam penelitian ini, anda akan diminta 
untuk menandatangani formulir persetujuan ini.  
2. Evaluasi saat awal penelitian  
Evaluasi ini akan berlangsung kira-kira beberapa jam. Saat evaluasi ini akan dilakukan hal-hal 
berikut ini: 
• 
Kami akan memeriksa gejala-gejala yang berhubungan dengan TB serta melakukan 
pemeriksaan fisik termasuk namun tidak terbatas pada pengukuran tinggi dan berat 
badan, kecuali jika hal ini sudah dilakukan oleh dokter yang menangani anda.  
• 
Kira-kira sebanyak 10 ml (kira-kira dua sendok teh) darah akan diambil untuk 
pemeriksaan diagnosa penyakit lain selain TB dan mengetahui kondisi darah anda. 
Anda akan diberitahukan hasilnya segera setelah hasil pemeriksaan tersedia. 
• 
Jumlah darah yang diambil tidak akan melampaui yang diijinkan dan sisa darah setelah 
yang digunakan untuk pmeriksaan, akan disimpan. 
• 
Sekitar 10 ml wadah air seni akan dikumpulkan untuk disimpan. 
• 
Sekitar 3 wadah dahak akan diambil untuk mendiagnosa TB melalui pemeriksaan kultur, 
dan uji kekebalan obat. 
 
3. Kunjungan-kunjungan penelitian selama terapi TB: 
 
a. Terapi bulan 1, 2, 3, 4, 5 (Lima kunjungan) 
Kunjungan ini mungkin memakan waktu sekitar 30 menit.  Pada kunjungan ini, anda 
akan mengalami pemeriksaan sebagai berikut:  
• 
Kami akan memeriksa gejala-gejala yang berhubungan dengan TB dan 
melakukan pengukuran berat kecuali ini telah dilakukan oleh dokter yang 
memeriksa anda. 

• 
Kami akan menghitung berapa banyak pil yang anda lupa untuk minum 
selama terapi dengan menghitung bungkus atau berdasarkan ingatan anda 
jika anda lupa membawa bungkus obat 
• 
Sekitar 2 wadah dahak akan diambil untuk pemeriksaan hapus dan kultur. 
b. Terapi bulan 6 (Satu kunjungan) 
Kunjungan ini mungkin memakan waktu sekitar 90 menit.  Pada kunjungan ini, anda 
akan mengalami pemeriksaan sebagai berikut:  
• 
Kami akan memeriksa gejala-gejala yang berhubungan dengan TB dan 
melakukan pengukuran berat kecuali ini telah dilakukan oleh dokter yang 
memeriksa anda. 
• 
Kami akan menghitung berapa banyak pil yang anda lupa untuk minum 
selama terapi dengan menghitung bungkus atau berdasarkan ingatan anda 
jika anda lupa membawa bungkus obat 
• 
Kami akan melakukan ronsen dada untuk mengetahui perkembangan 
penyakit TB di paru-paru anda. 
• 
Sekitar 2 wadah dahak akan diambil untuk pemeriksaan hapus dan kultur. 
• 
Jika ini adalah kunjungan terakhir anda, maka anda akan diminta untuk 
mengumpulkan 6 mL darah (sekitar satu sendok teh) dan 10 ml seni untuk 
disimpan. 
 
c. Terapi bulan 7,8,9 (Tiga kunjungan) 
Kunjungan ini mungkin memakan waktu sekitar 90 menit.  Pada kunjungan ini, anda 
akan mengalami pemeriksaan sebagai berikut:  
• 
Kami akan memeriksa gejala-gejala yang berhubungan dengan TB dan 
melakukan pengukuran berat kecuali ini telah dilakukan oleh dokter yang 
memeriksa anda. 
• 
Kami akan menghitung berapa banyak pil yang anda lupa untuk minum 
selama terapi dengan menghitung bungkus atau berdasarkan ingatan anda 
jika anda lupa membawa bungkus obat 
• 
Kami akan melakukan ronsen dada untuk mengetahui perkembangan 
penyakit TB di paru-paru anda. 
• 
Sekitar 2 wadah dahak akan diambil untuk pemeriksaan hapus dan kultur. 
• 
Jika ini adalah kunjungan terakhir anda, maka anda akan diminta untuk 
mengumpulkan 6 mL darah (sekitar satu sendok teh) dan 10 ml seni untuk 
disimpan. 
d. Terapi bulan 8, 10, 12, 14, 16, 18, 20, 22, 24 (Sembilan kunjungan) 
Kunjungan ini mungkin memakan waktu sekitar 60 menit. Pada kunjungan ini, anda 
akan mengalami pemeriksaan sebagai berikut:  
• 
Kami akan memeriksa gejala-gejala yang berhubungan dengan TB dan 
melakukan pengukuran berat kecuali ini telah dilakukan oleh dokter yang 
memeriksa anda. 
• 
Kami akan menghitung berapa banyak pil yang anda lupa untuk minum 
selama terapi dengan menghitung bungkus atau berdasarkan ingatan anda 
jika anda lupa membawa bungkus obat 
• 
Kami akan melakukan rontgen dada untuk mengetahui perkembangan 
penyakit TB di paru-paru anda. 
• 
Sekitar 2 wadah dahak akan diambil untuk pemeriksaan hapus dan kultur. 

• 
Jika ini adalah kunjungan terakhir anda, maka anda akan diminta untuk 
mengumpulkan 6 mL darah (sekitar satu sendok teh) dan 10 ml air seni untuk 
disimpan. 
 
Ronsen dada 
Anda akan diminta untuk dilakukan foto ronsen di dada. Pemeriksaan ini meliputi berdiri 
di depan mesin ronsen saat gambar dada dan paru-paru anda diambil. Pemeriksaan 
foto ronsen akan berlangsung sekitar 10 menit. 
Resiko Ronsen dada 
Penelitian ini meliputi paparan terhadap radiasi dari 1 kali foto ronsen. Paparan radiasi 
ini tidak termasuk dalam pemeriksaan standar dan hanya untuk keperluan penelitian. 
Jumlah radiasi yang anda terima dalam penelitian ini 0,040 rem (yang mana di bawah 
batas 5 rem per tahun yang diperbolehkan untuk peserta penelitian oleh Komite 
Keselamatan Radiasi Institut Kesehatan Nasional Amerika Serikat.) Rata-rata seseorang 
di Amerika Serikat menerima paparan radiasi sebesar 0,3 rem per tahun dari sumber 
alami sepert matahari, luar angkasa, serta air dan tanah di bumi. 
4. Sampel yang disimpan dan penelitian selanjutnya  
Pada kunjungan pertama dan akhir penelitian, hasil kultur dahak, darah dan air seni mungkin 
akan diambil untuk dilakukan pemeriksaan yang berhubungan dengan TB dan pemeriksaan 
genetik pada penelitian dimasa yang akan datang. Secara umum, penelitian yang 
menggunakan sampel anda dan dilakukan  di masa yang akan datang tidak akan membantu 
anda, namun akan membantu kami untuk lebih mengetahui dengan baik mengenai TB. 
Penelitian ini juga dapat membantu kami untuk memberikan pengobatan yang lebih baik untuk 
TB dan memperbaiki pengelolaan TB. Semua hasil yang berhubungan dengan perawatan anda 
akan diinformasikan kepada anda dan dikomunikasikan kepada dokter anda.  
Pemeriksaan genetik merupakan salah satu jenis pemeriksaan pada penelitian dimasa yang 
akan datang yang mungkin dilakukan pada darah anda. Pemeriksaan ini meliputi analisa 
beberapa gen (pembawa sifat)  anda untuk melihat apakah infeksi TB yang anda dapatkan dan 
perjalanan penyakit tersebut berhubungan dengan faktor keturunan ini. Untuk pemeriksaan 
genetik ini anda dapat memilih untuk tidak ikut dan ini tidak akan mempengaruhi keikutsertaaan 
anda dalam penelitian ini.  
 
BERAPA JUMLAH ORANG YANG AKAN IKUT SERTA DALAM PENELITIAN INI? 
Sekitar 1357 orang akan ikut serta pada penelitian ini.  
 
SAMPAI KAPAN KEIKUTSERTAAN SAYA PADA PENELITIAN INI? 
Anda akan ikut dalam penelitian selama masa terapi, tergantung pada diagnosa TB anda, atau 
selama 24 bulan jika lama terapi anda melebihi 24 bulan. 
 

MENGAPA DOKTER MENGHENTIKAN KEIKUTSERTAAN SAYA DALAM PENELITIAN INI 
LEBIH AWAL DARI YANG DIJADWALKAN?  
Anda boleh mengundurkan diri dari penelitian ini kapan saja. Jika anda berhenti, anda tidak 
akan diminta informasi atau data tambahan untuk penelitian ini.  
Dokter pada penelitian ini dapat pula menghentikan keikutsertaan anda tanpa persetujuan 
anda, jika:  
• 
Penelitian ini dihentikan, atau dibatalkan  oleh pihak penyandang dana atau lembaga 
komisi etik penelitian.  
• 
Anda tidak dapat hadir pada kunjungan yang telah dijadwalkan oleh penelitian.  
• 
Akan berbahaya untuk anda jika melanjutkan penelitian ini. 
 
APAKAH RESIKONYA IKUT PENELITIAN INI? 
Peneliti-peneliti meyakini bahwa resiko atau ketidaknyamanan yang akan anda alami adalah 
sangat ringan, yaitu misalnya keadaan-keadaan yang berhubungan dengan pengambilan darah 
seperti sakit sedikit, kemerahan atau lebam pada tempat pengambilan darah. Lebam dapat 
dikurangi dengan kompres hangat. Ada kemungkinan terjadi infeksi pada tempat pengambilan 
darah, namun karena petugas akan membersihkan tempat pengambilan darah dengan alkohol 
dan alat-alat yang digunakan adalah steril, kemungkinan ini sangat kecil untuk terjadi.   
Jika anda mengalami kesulitan dalam mengeluarkan dahak, kami mungkin membantu anda 
dengan menyediakan obat hirup yang bisa membantu anda untuk mengeluarkan dahak. 
 
APAKAH SAYA MEMPUNYAI PILIHAN LAIN DISAMPING IKUT DALAM PENELITIAN INI? 
Alternatif yang anda miliki adalah untuk tidak mengikuti penelitian ini. Jika anda memutuskan 
untuk tidak ikut dalam penelitian ini, anda tetap akan diterapi untuk gejala TB.  
 
APAKAH ADA  MANFAATNYA UNTUK IKUT DALAM PENELITIAAN INI?  
Penelitian akan membayar semua biaya pemeriksaan selama terapi TB anda yang tidak 
ditanggung oleh pemerintah.  Penelitian ini akan memberikan Rp 150,000; pada awal dan akhir 
penelitian untuk waktu yang terpakai dan ketidaknyamanan anda. Penelitian ini tidak akan 
menanggung biaya perawatan rutin atau rawat inap yang telah dijadwalkan oleh pemerintah. 
Hasil dari penelitian ini dapat membantu dokter anda untuk memberikan perawatan yang lebih 
baik dan memperbaiki tata cara pengelolaan TB.  
 
APAKAH SAYA AKAN MENDAPAT BAYARAN? 
Anda tidak mendapat bayaran untuk ikut serta dalam penelitian ini. 
 

BAGAIMANA DENGAN KERAHASIAAN? 
Semua informasi tentang anda akan dijaga kerahasiaannya dan tidak akan diberikan pada 
orang yang tidak bertanggung jawab untuk perawatan anda. Rekam medis anda hanya akan 
dipelajari oleh mereka yang bekerja untuk penelitian ini. 
Semua dokumen dan sampel yang berhubungan dengan penelitian akan diberi label sesuai 
dengan nomor penelitian anda. Nama anda tidak akan dicantumkan pada label sampel,  pada 
laporan penelitian  maupun pada publikasi ilmiah.  
 
APA YANG AKAN TERJADI JIKA SAYA TERLUKA? 
Kami akan menyediakan dan membayar biaya perawatan yang segera harus dilakukan jika 
terjadi luka yang berhubungan dengan penelitian, misalnya infeksi setelah pengambilan darah. 
Namun, penelitian tidak dapat membayar kecacatan  yang disebabkan oleh penyakit yang anda 
derita.  
 
APAKAH HAK-HAK SAYA SEBAGAI PESERTA PENELITIAN? 
Ikut sertanya anda dalam penelitian ini bersifat sukarela. Jika anda tidak ingin ikut dalam 
penelitian ini, anda tetap akan mendapatkan perawatan standar yang sama dengan mereka 
yang ikut dalam penelitian. Anda boleh berhenti kapan saja dari penelitian ini. 
Kami akan memberitahu anda mengenai informasi baru dari penelitian ini atau dari penelitian 
lain yang dapat mempengaruhi kesehatan anda, kesejahteraan atau keinginan anda untuk tetap 
ikut serta dalam penelitian ini. Jika anda menginginkan hasil penelitian ini anda dapat 
memberitahu kepada petugas penelitian. 
 
APA YANG HARUS SAYA LAKUKAN JIKA SAYA MEMPUNYAI PERTANYAAN ATAU 
MASALAH ? 
Jika anda mempunyai pertanyaan yang berkaitan dengan studi, anda dapat menghubungi:  
-Cantumkan nama peneliti atau staff peneliti lainnya.  
-Cantumkan nomor telepon peneliti atau staff peneliti diatas 
 
 

CONTOH FORMULIR PERSETUJUAN UNTUK ORANG DEWASA 
 
Tuberculosis Research of INA-RESPOND On Drug Resistant 
 
Saya telah membaca formulir persetujuan ini, atau formulir persetujuan ini telah dibacakan 
kepada saya. Saya telah mendapatkan kesempatan untuk bertanya, dan pertanyaan-
pertanyaan yang saya ajukan telah dijawab dengan memuaskan. Saya telah dijelaskan bahwa 
saya dapat mengundurkan diri dari penelitian ini kapan saja.   
Saya, tanpa tekanan apapun dengan sukarela memilih untuk ikut dalam penelitian ini. Saya 
akan diberikan salinan dari lembar penjelasan dan formulir persetujuan yang telah ditanda 
tangani untuk arsip saya.   
Saya setuju untuk menyimpan hasil dari pemeriksaan kultur dahak saya untuk pemeriksaan 
genetik (keturunan) tertentu untuk melihat apakah faktor keturunan berperan untuk terjadinya 
infeksi ini dan perkembangan penyakit ini.   
___YA ___TIDAK 
 
Nama peserta: __________________________________     Umur: _____________________ 
 
 
Tanda tangan*: __________________________                         Tgl: ____/____/____                        
 
                                                                                  
(tgl/bln/thn)             
*cap jempol dapat digunakan untuk yang tidak dapat menulis 
 
 
Nama peneliti: ______________ Tanda tangan: _____________________________________ 
Tgl : ____/____/____                     
             (tgl/bln/thn) 
 
 
Nama saksi: ________________ Tanda Tangan: ____________________________________ 
Tgl : ____/____/____                                         
             (tgl/bln/thn)