Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in BetterBirth
Conditions: Perinatal Death, Neonatal Death, Stillbirth
Sponsor: Harvard School of Public Health (HSPH)

Instructions: Complete this template to provide IRB members and designated reviewers with 
sufficient information to conduct a substantive review of human research. If applicable, submit a 
Sponsor’s Protocol in addition to this document.  Detailed instructions for preparing this 
template can be found in the Investigator’s Manual.  If the proposed human research is eligible 
for an Exemption Determination, see Appendix F of the Investigator Manual.  
 
GENERAL INFORMATION 
Protocol/ESTR Record Number (if assigned):  
Version Number/Date: 30 January 2018 
Principal Investigators: Dr. Katherine Semrau  
Protocol Title: Verbal Autopsy of Maternal Deaths, Stillbirths, and Neonatal Deaths in 
BetterBirth 
 
1. Specific Aims 
 
To conduct Verbal Autopsies of stillbirths and neonatal deaths identified in the BetterBirth 
trial to identify their potential causes, timing, and social determinants. 
 
2. Background and Significance 
2.1 Provide the scientific background and rationale for the research. 
 
The BetterBirth trial was conducted to study the impact of the Safe Childbirth 
Checklist-based approach on maternal morbidity, maternal mortality, stillbirths and 
neonatal mortality for facility based deliveries in low resource settings. The trial was 
implemented in 120 health facilities (60 intervention and 60 control) spread across 24 
districts in Uttar Pradesh. 
  
The data collection for the BetterBirth trial completed in January 2017 and currently 
data analysis is in progress. On 2 March 2017, the preliminary findings were presented 
to Scientific Advisory Committee (SAC) appointed for the study. There were a total of 
150 early maternal deaths, 7,455 stillbirths and early neonatal deaths out of the 157,689 
mother-infant pairs that participated in the trial. It was observed that there was wide 
geographic variability in mortality across the study area. The Scientific Advisory 
Committee noted that it was essential to understand the causes, timing and social 
determinants of these deaths to better interpret the study results. Hence, the committee 
recommended undertaking verbal autopsies of deaths tracked in the study. Further, this 
exercise is also aimed to address potential misclassification of deaths (stillbirths and 
early neonatal deaths). 
 
2.2 Describe the significance of the research, and how it will contribute to 
generalizable knowledge. 
 
The verbal autopsy findings will be helpful to understand the result of the BetterBirth 
Trial. In addition, the findings will inform future investigations of maternal and 
newborn harm, especially those further upstream in health system and policy design. 
 

3. Research Sites and Study Team 
3.1. Identify and describe the sites or locations where the research will be conducted or 
overseen by the Harvard PI.  
 
The BetterBirth Trial was a facility-based study. However, the verbal autopsies of 
deaths identified during its course will be conducted at the current residence of the 
study participants. 
 
3.2. Is this a multi-site study? 
No 
Yes: If yes, describe plans for communication among sites regarding 
adverse events, interim results, protocol modifications, monitoring of data, etc. 
 
This study involves four Principal Investigators from two institutions: Drs. Vishwajeet 
Kumar and Aarti Kumar at Community Empowerment Lab (CEL) in Lucknow, Uttar 
Pradesh, India and Drs. Atul Gawande and Katherine Semrau at the Harvard TH Chan 
School of Public Health in Boston, MA, USA. The primary roles of the investigators 
are outlined below.  
 
• Investigators from CEL (Drs. V. and A. Kumar) will oversee the research in the 
field and ensure the research is conducted in accordance with the protocol. 
• Investigators from the Harvard Chan School (Drs. Gawande and Semrau) will 
provide key technical guidance to CEL and PSI–India.  
o Note: Population Services International (PSI) India, the primary 
implementation partner of the parent study, will be utilized as needed for 
recruitment purposes, as described in Section 18.4.  
 
All investigators will be responsible for overall supervision of the research activities 
carried out by CEL in coordination with PSI–India. To this end, investigators will be in 
regular contact with each other and with project management and field staff. 
 
3.3. Is the research conducted outside the United States?  
No 
Yes: If yes, describe local laws, regulations, and/or customs affecting the 
research. 
 
There will be no significant differences between the regulation of this study in the 
United States and India. 
 
3.4. Are there any approvals or permissions that must be obtained from cooperating 
institutions, community leaders, government officials, including approval from 
another IRB or local research ethics committee? 
No 
Yes: If yes, list the approvals/permissions and upload copies to the 
“Supporting Documents” page in ESTR.  
 
Ethics approval for verbal autopsy has been submitted to the Institutional Review 
Boards at: 
 

• Community Empowerment Lab, Lucknow, Uttar Pradesh, India 
• Harvard School of Public Health, Boston, Massachusetts, United States 
• Population Services International, Washington, DC, United States* 
 
*With request to cede review to CEL.  
 
The protocol will be registered with clinicaltrials.gov.  
 
The parent study, “BetterBirth: Trial of the WHO Safe Childbirth Checklist Program” 
(Protocol #21975, ClinicalTrials.gov Identifier NCT02148952), received ethics 
approval with annual reviews from five Institutional Review Boards and the Indian 
Council for Medical Research (ICMR). Our local partner confirmed that ICMR 
approval is not required for this study. 
 
3.5. Describe the Principal Investigator’s experience conducting research at the study 
site(s) and familiarity with the local research context. 
 
Drs. Gawande and Semrau began working in Uttar Pradesh as co-Principal 
Investigators of BetterBirth: Trial of the WHO Safe Childbirth Checklist Program. Dr. 
V. Kumar and Ms. A. Kumar are native to India and currently reside in Uttar Pradesh. 
They co-founded Community Empowerment Lab (CEL), a scientific research and 
innovation organization based in Lucknow, Uttar Pradesh, India in 2011.  CEL has 
expertise in conducting qualitative assessments (including verbal autopsies) in health 
care settings in Uttar Pradesh. Dr. V Kumar and Ms. A Kumar have been working in 
these communities and conducting research for over a decade. They have lead large 
studies which included conducting maternal and neonatal verbal autopsies. Dr. V. 
Kumar was a co-Principal Investigator of BetterBirth: Trial of the WHO Safe 
Childbirth Checklist Program. 
 
3.6. Describe how the Principal Investigator will ensure that sufficient time is devoted 
to conducting and completing the research. 
 
A detailed study timeline has been developed. Principal Investigators will ensure 
adherence to this timeline by closely coordinating with program managers and research 
staff. 
 
3.7. Describe how all research staff members are trained to ensure that they are 
adequately informed about the protocol and study-related duties. 
 
Data collectors will be trained by verbal autopsy experts at CEL on the standardized 
study tools and processes described in Section 4.6. 
 
3.8. Describe the minimum qualifications for each research role (e.g., RN, social 
worker, phlebotomist, statistician), their experience in conducting research, and 
their knowledge of the local research context.   
 

All data collectors will have a university-level degree (i.e., Bachelor’s degree) in a 
research-related field such as social sciences. Coding of verbal autopsies will be 
completed by physicians holding MBBS and/or MD degrees. Data collectors and 
coders will be fluent in Hindi. 
 
4. Study Design 
4.1. Describe the study design type. 
 
Verbal autopsy is a technique used to determine the cause of death by asking 
caregivers, friends or family members about signs and symptoms exhibited by the 
deceased in the period before death. This is usually done using a standardized 
questionnaire that collects details on signs, symptoms, complaints and any medical 
history or events. The cause of death, or the sequence of causes that led to death, are 
assigned based on the data collected by this questionnaire and on any other available 
information. The social autopsy tool is used in conjunction with the verbal autopsy tool 
to explore the non-biological factors contributing to a death, including the social, 
behavioural and health systems determinants of maternal and child deaths. This 
additional line of questioning has been identified as an important step to understand 
modifiable factors present in the home, community and health system, which can 
inform policies and practices for increasing access to and use of preventive and curative 
services. Rules and guidelines, algorithms or computer programmes, may assist in 
evaluating the information. 
 
4.2. Does the study involve more than one participant group?  
No 
Yes: If yes, identify each group here and throughout all applicable 
sections.  
 
 
Respondents for the neonatal deaths and stillbirths include mother or the family 
members of the baby. Mothers had consented to follow-up as part of the BetterBirth 
Trial. 
 
4.3. Indicate the duration of a participant’s involvement. 
 
Participant involvement will be approximately 60 to 120 minutes.  Participants may end 
the interview at any time and may request that the interview be completed in multiple 
sessions. Additional visits may be needed for data verification. 
 
4.4. Indicate the total number of participants to be screened (if applicable) and/or 
enrolled (i.e., signed consent form).  If the proposed research involves secondary 
data analyses only, indicate the number of data, documents, records, and/or 
specimens that will be obtained. 
 
The mothers and/or family member(s) and community members of a subset of our 
perinatal mortality cases (170 cases) will be asked to participate.  
 

4.5. List inclusion and exclusion criteria, and describe the screening process. 
 
In order to be included in this study, one must be the mother or family member of an 
individual who was enrolled in the BetterBirth Trial and died. Women who did not 
consent to follow-up in the BetterBirth study will be excluded. 
 
4.6. Describe study procedures.  
 
The study will be conducted primarily by the study team at CEL with guidance and 
oversight provided by the study team HSPH. HSPH will be involved in tool design and 
revision, coding of social autopsies, and analysis plan development and execution.   
 
The study team at CEL will adhere to the following study procedures for data 
collection, monitoring, and coding.    
 
Data collection 
Data will be collected using the WHO standard tools for conducting maternal, stillbirth 
or neonatal verbal autopsies, modified for the local context. A section on social 
autopsy will also be incorporated in the existing study instrument. These tools are 
standardized and adapted to use in these settings and have been implemented before in 
other studies in similar communities in U.P. (example: “AMANHI” and “Impact of 
topical application of cold-pressed sunflower seed oil with improved massage 
practices on neonatal mortality: a cluster randomized controlled trial in rural North 
India”). A team of specially trained data collectors (given the sensitive nature of the 
verbal autopsy questionnaire) will collect the data on existing Android based data 
collection platform. 
  
Data will be collected by specially trained data collectors. They will collect the data at 
participants’ homes. Participants will include the mother (in case of neonatal death) 
and any additional person who was present during the events that led to the death. 
Additional interviewees may include the delivered mother’s husband, mother, mother-
in-law, other family member, neighbor, etc. The delivered mother will be asked which 
individuals, if any, should be included in the interview. The mother and the individuals 
they indicate will be consented individually but interviewed together.  
 
Each interview will take approximately 60 minutes.  
 
The following data collection tools will be used together for interviews regarding 
neonatal deaths:  
• Verbal Autopsy-Neonatal Death (NND) Tool 
• Social Autopsy Tool 
• Socioeconomic Status Tool 
 
 
Data quality and safety 

A team of specially trained data collectors will be hired. Data will be collected on 
tablets using a data collection platform that has in-built checks of missing values, 
range checks, skip patterns etc. to minimize the error in data collection. A GPS 
monitoring of location of interview will be conducted. The data will be checked at an 
aggregate level for heaping, interviewer-specific patterns, etc. Forms identified with 
errors will be sent back for verification and re-entry, but audit-trail will be captured to 
ensure that the full trail from original data and changes will be maintained with 
timestamp, GPS and user information. On-site quality assurance would involve both 
real-time data checks as well as GPS verification of the location of data collection. 
Data access will be restricted by users, with different privileges for data collectors, 
supervisors and study investigators. All personal identification information including 
names, etc. will be encrypted, and only a unique identification number to identify 
individuals will be made available for analysis. Data will be hosted over a secured 
network. 
  
Physician coding 
Every case will be coded for assigning underlying cause of death, antecedent causes 
and timing of death by trained and certified physicians. A WHO standard software and 
coding protocol will be used by these physicians to assign causes of death.  The data 
collected through tablets will be sent to the central server. The narratives of every case 
will be collected on paper and a scan of the narrative will be sent along with the data. 
This entire data will be uploaded on the physician coding software from which the 
verbal autopsy cases will be allotted to physicians for coding. Each case will be 
independently coded by two physicians and in case of mismatch in the underlying 
cause of death between the two physicians, a third physician will independently code 
for the cause of death. Finally, if none of the three underlying causes of death match, a 
higher level physician arbitrator will resolve the case – this will be done to minimize 
unclassified deaths. A physician coordinator, who has extensive prior experience of 
coding verbal autopsy data will oversee the entire process and resolve issues with the 
help of supervisors of the data collection team. All the cases will be de-identified 
before uploading on the software for coding. 
 
4.7. Does the study involve the use of existing data, documents, records, and/or 
specimens for secondary analysis?  
No 
Yes: If yes, indicate how, when, where, and from whom data, documents, 
records, and/or specimens will be obtained. 
 
This study involves the use of existing data from the BetterBirth Trial (Protocol # 
21975).  Specifically, we will use mortality data collected as part of the BetterBirth 
Trial to identify cases of stillbirth/neonatal death.  We will extract the names and 
contact information of patients who consented to be contacted for follow-up in order to 
re-contact patients to ask if they agree to participate in the verbal autopsy. 
 
4.8. Are there provisions for medical and/or psychological support resources available 
to participants (e.g., in the event of incidental findings, research-related stress)? 
No 
Yes: If yes, describe the provisions and their availability. 

 
4.9. Is there a data and safety monitoring plan (required for greater than minimal risk 
studies)? 
No 
Yes: If yes, describe this plan. 
 
4.10. Are there any anticipated circumstances under which participants will be 
withdrawn from the research without their consent? 
No 
Yes: If yes, describe the circumstances for withdrawal as well any 
associated procedures to ensure orderly termination, appropriate referrals, and/or 
follow-up care. 
 
 
5. Recruitment Methods 
5.1. Does the study involve the recruitment of participants? 
No:   If no, skip to the next section. 
Yes: If yes, indicate how, when, where, and by whom participants will be 
recruited.  
 
Participants will be recruited based on the inclusion criteria described in Section 
4.5.Study staff members will first attempt to make contact with Accredited Social 
Health Activists (ASHAs), who are appointed by the National Rural Health Mission 
and act as conduits between patients and the health system. The data collector will attempt 
to call the relevant ASHA worker and request her assistance in establishing contact with the 
mother. The ASHA will be asked to provide a telephone number at which the mother can 
be reached, if possible.  After this, the family will be initially contacted by study staff 
members via telephone. Individuals will be asked to participate in verbal autopsy, and, 
if they agree, a date and time for the interview will be determined. A data collector 
from CEL or PSI will visit the participant’s home on an agreed-upon date and written 
consent will be obtained.  
 
Final attempts at contact will be made via home visit if participants cannot be reached 
either via telephone or with ASHA engagement. Individuals who are reached at home 
will be introduced to the study and asked to participate using the appropriate 
recruitment script. For those individuals who agree to participate, data collectors will 
schedule a time to return to participants’ homes for interviews to be conducted. (Note: 
Home visits are a culturally acceptable practice in this context; for example, home 
visits were used in the BetterBirth Trial for collection of 7-day outcomes of mothers 
and newborns.) 
 
5.2. Are there any materials that will be used to recruit participants, e.g., emails, 
posters, and/or scripts? 
No 
Yes: If yes, provide a list of the materials and upload copies to the 
“Consent Forms and Recruitment Materials” page in ESTR. 
 
Scripts will be used to recruit participants (see Stillbirth/Neonatal Death Recruitment 
Script).  
 

6. Consent Process 
6.1. Will participants be invited to take part in the research? 
No:  If no, explain why not. 
Yes: If yes, describe the consent process and upload consent materials to the 
“Consent Forms and Recruitment Materials” page in ESTR. 
 
A written informed consent will be administered to every participant prior to collection 
of data and standard consenting procedure followed. Consent will be obtained by the 
data collector at the participant’s home at the start of the scheduled visit. Data 
collectors will discuss all topics included in the consent form with the participant and 
answer any questions that the participant may have. All parties participating in an 
interview will be required to sign their own forms (except in cases involving illiterate 
participants*). Husbands, mothers, mothers-in-law, etc. of the delivered woman cannot 
consent on her behalf; she is free to consult her family in her decision to participate but 
ultimately must consent herself.  
*In cases involving illiterate participants, the name and signature/thumbprint of a 
literate witness will be obtained, as is required by the local IRB.  
 
6.2. Will the consent process involve obtaining signature?  
Yes 
No:  If no, explain why not. 
 
6.3. Will signature be documented by another method, e.g., thumbprint?  
No 
Yes:  If yes, describe this method and explain how this is appropriate 
given the local research context, population, etc.   
 
If a participant is unable to provide a written signature, a thumbprint will be used to 
document consent. In order to facilitate this documentation, the data collector will be 
equipped with an inkpad when deploying to the field. The use of a thumbprint is 
culturally appropriate and equivalent to a signature in this setting; the local IRB 
requires that we offer this method of documentation.  
 
6.4. Will participants be offered a copy of the consent information? 
Yes 
No:  If no, explain why not. 
 
6.5. Will consent information be provided in a language other than English? 
No 
Yes:  If yes, identify the language(s) that consent information will be 
provided, identify who will be responsible for translation, and the provisions for 
communicating this information to participants.  
 
The consent form will be primarily available in Hindi. This Hindi consent form has 
been used in previous studies and has been verified by study partners. 
 
7. HIPAA Privacy Protections 
7.1. Does this research involve the collection or use of protected health information 
(PHI) from a hospital, health center, health plan, or health insurance plan, or the 
Harvard Dental Center?  

No: If no, skip to the next section. 
Yes: If yes, describe plans for obtaining authorization to access protected 
health information or provide the rationale for a waiver of authorization.  
 
This study will utilize PHI from its parent study, the BetterBirth Trial. Drs. V. Kumar, 
Gawande, and Semrau are Principal Investigators on both studies. Therefore, data from 
the BetterBirth Trial will be used at the discretion of the investigators towards 
completing the specific aims of the verbal autopsy work. For example, BetterBirth Trial 
data (i.e., PHI of deceased mothers/infants) will be used to identify, contact, and recruit 
potential participants. PHI may include mother’s name, husband’s name, contact 
number(s), address, date of delivery, and other fields needed to confirm participant’s 
identity at the time of recruitment. 
 
8. Vulnerable Populations 
8.1. Does the research involve vulnerable populations (e.g., children; pregnant women, 
human fetuses, neonates; prisoners; elderly; economically disadvantaged; 
employees or students of the investigator or sponsor; undocumented individuals; 
refugees; illiterate or low-literacy; military personnel; terminally ill; cognitively 
impaired or mentally ill; persons with a stigmatizing disease or condition, e.g. 
AIDS/HIV, etc.)? 
No: If no, skip to the next section. 
Yes: If yes, identify all vulnerable populations and describe safeguards to 
protect their rights and welfare.  
 
Vulnerable populations include: 
• Low-literacy or illiterate individuals 
o To protect the rights and welfare of low-literacy or illiterate individuals, 
the name and signature/thumbprint of a literate witness will be required 
for consent. 
• Bereaved individuals 
o To protect the rights and welfare of bereaved individuals, participation 
in the verbal autopsy will be voluntary and can be refused or withdrawn 
at any time. 
 
9. Risks (Risks may include physical, psychological, social, legal, reputational, and/or 
financial)  
9.1. Describe the reasonably foreseeable risks, discomforts, and/or inconveniences to 
participants and/or the group/community to which they may belong. Indicate the 
probability, magnitude, and duration of each risk. 
 
It may be psychologically or emotionally taxing for mothers or family member(s) to be 
interviewed about the deceased and details about the death. Interviews will take place 
well after the culturally appropriate mourning period of 14-40 days has passed. 
Interviewers will be trained in techniques for the handling of sensitive interviews. 
 

9.2. Identify whether any of the information collected, if disclosed outside of the 
research, could reasonably place the participant at risk of criminal or civil liability 
or be damaging to the participant’s financial standing, employability, insurability, 
or reputation. 
 
It is possible that a verbal autopsy may indicate that an unnatural cause (accidental or 
intentional) contributed to a death. [1] Deaths may have occurred at the hospital at the 
time of childbirth or outside of the hospital up to seven days after childbirth. Disclosure 
of an unnatural death could place participant(s) at risk of criminal or civil liability or be 
damaging to the participant’s financial standing, employability or reputation. Note: In 
CEL’s experience of conducting a large number of verbal autopsies for previous 
studies, no such situation has been encountered. 
 
9.3. Outline provisions in place to minimize each risk identified above. 
 
To minimize this risk of psychological or emotional distress, data collectors will be 
trained in conducting sensitive interviews. To minimize the risks associated with 
unnatural death, neither the Principal Investigators nor other study team members will 
report suspicious deaths to local authorities or IRBs. (Note: There are no mandatory 
reporting requirements in India.) Nondisclosure will reduce the risks to participants 
stated above as well as the risk of retribution against the reporter. Additionally, all 
names and identifying information of the deceased and the respondent(s) will be 
removed (i.e., de-identified) prior to uploading to the software for coding. The final 
dataset and transcript will be de-identified and reporting will be done at the aggregate 
level. 
 
10. Benefits  
10.1. Describe the potential benefits to participants and society. 
 
Verbal autopsies may shed light on important public health factors related to deaths in 
the community. This will not offer a direct benefit to the families, it benefits society in 
that we will understand more about causes of death in this population. It will also help 
in the design of new interventions to prevent these deaths. 
  
11. Participant Privacy 
11.1. Describe provisions to protect participants’ privacy (their ability to control and 
limit the extent, timing, and circumstances of sharing information about 
themselves with others, e.g., the use of a private interview room) and to minimize 
any sense of intrusiveness that may be caused by study questions or procedures. 
 
Voluntary Participation 
Participation in the verbal autopsy will be entirely voluntary. It is one’s choice whether 
to participate or not. Individuals will not be penalized in any way should they choose 
not to participate. Individuals may stop participating at any time. 
  
Confidentiality 

All the information that will be collected as a part of the verbal autopsy will be strictly 
confidential. Data will be coded using indirect identifiers. Interviewees’ identifiable 
information will be available only to key members of the research teams at CEL and 
HSPH. Deceased individuals’ information is coded using indirect identifiers in the 
BetterBirth dataset.  
 
Right to Refuse or Withdraw 
Participants do not have to take part in this verbal autopsy if they do not wish to do so. 
They may stop participating in the verbal autopsy at any time they choose. It is their 
choice and all their rights will be respected. 
 
12. Data Confidentiality 
12.1. Indicate the identifiability of the data/specimens: 
 Data/specimens will not contain any direct or indirect identifiers (anonymous 
data). 
 Data/specimens will contain direct or indirect identifiers, but the research team 
will 
remove them upon receipt (de-identified data). 
 Data/specimens will contain indirect identifiers (i.e., number, letter, symbol, or 
 
combination thereof) and the research team will maintain a key that links 
identifiers to  
individual participants (coded data).  
 Data/specimens will contain direct identifiers (identifiable data). 
 None of the above; describe: 
 
12.2. Identify where data will be stored, e.g., on campus at Harvard or remotely, and 
describe the provisions to maintain confidentiality (e.g., password protection, 
encryption, locked filing cabinets, etc.). Refer to the Investigator Manual and the 
Harvard Research Data Security Policy for additional information. 
 
Verbal autopsy data will be hosted by CEL on encrypted server secured under multiple 
layers of cyber security.  The data will be shared with HSPH, where it will also be kept 
on an encrypted server. Signed consent forms will be kept in locked filing cabinets in a 
secure facility maintained by CEL in Uttar Pradesh, India. 
 
12.3. Describe whether any data will be transmitted and, if so, how, when, and to whom. 
 
Data needed to identify, contact, and recruit study participants will be transmitted from 
HSPH to CEL (and potentially PSI, pending their role in the execution of this work) at the 
initiation of research activities via a secure data transfer. Data resulting from the verbal 
autopsies will be transmitted from CEL to HSPH at various intervals as the data are collected 
via a secure data transfer. Additionally, the verbal autopsy narratives will be securely 
transferred between HSPH and translation agencies for the purpose of translation from Hindi 
into English.  HSPH and the translation agency will jointly sign a Data Use/ Non-Disclosure 
Agreement to outline protections for the data and appropriate handling procedures. All HSPH 
staff handling the data are CITI trained and will ensure the translation agency clearly 
understands the requirements about data storage and transfer (as outlined in the DUA/NDA). 

 
12.4. Indicate who is responsible for data management and how the research team 
and/or other collaborators are permitted access to information.  
 
Technical personnel at CEL and HSPH are responsible for data management. Data 
exports from the database will be made accessible to Principal Investigators and key 
members of the CEL and HSPH teams. 
 
12.5. Indicate how long data will be stored and describe the plans for data at the end of 
the storage period (e.g., is data destroyed, returned to data provider, etc.). 
 
The data will be stored on secure servers at HSPH (Level 4 Compliant) and CEL. As 
per a local requirement set by the Indian Council of Medical Research, the storage 
period is indefinite. It will be maintained for at least seven years in accordance with the 
Harvard requirement.  Hard copies of consent forms will also be kept for seven years in 
locked file cabinets at a storage facility maintained by CEL in Uttar Pradesh. 
 
13. Data/Statistical Analyses Plan 
13.1. Describe plans for analysis (including the statistical method, if applicable). 
 
The physician coded causes of death will be used to understand the cause structure of 
newborn deaths and stillbirths for institutional births. The biomedical cause of deaths 
will be assessed in light of the social determinants as captured in the social autopsy 
component of the questionnaire to further identify gaps in service delivery and potential 
points of intervention. 
 
13.2. Is there a sample size/power calculation? 
No 
Yes:  If yes, describe the calculation and the scientific rationale, and, if 
applicable, by site and key characteristics such as participant demographics.  
 
 
14. Costs and Compensation  
14.1. Identify any costs that participants may incur during the study, including 
transportation costs, childcare, or other out-of-pocket expenses. 
 
Participants will not incur any costs during the study. 
 
14.2. Identify remuneration that participants may receive during the study. Specify the 
amount, timing of disbursement, and method (e.g. money, gift cards, in-kind, 
incentives, raffles, and transportation). Describe how compensation will be 
calculated and paid if a participant withdraws. If any participant will receive a 
single payment more than $100, or $600 or more in one calendar year, Social 
Security Number must be collected. Refer to Harvard University Financial Policy 
on Human Subject Payments. 
 
Participants will not receive any remuneration.  

 
15. Sharing Study Results 
15.1. Is there a plan to share study results with individual participants and/or the 
participant group/community? 
No 
Yes:  If yes, describe the plan. 
 
As per local IRB requirements, data sharing meetings will be held with the facility, 
district and state officials that participated in the BetterBirth Trial to inform relevant 
stakeholders of the verbal autopsy findings (i.e., causes of death in the community). 
After these meetings, we will publish the results so that other interested people may 
learn from the research. At the end of this study, de-identified data from verbal autopsy 
will be shared in a public domain. 
 
16. Device 
16.1. Does the research involve a Device? 
 No:  If no, skip to the next section.   
 Yes: If yes, describe the device, including the generic or common name, brand 
name (if applicable), purpose, function/operation, and whether it is an implant. 
Indicate who is providing this device for research use. 
 
16.2. Indicate the FDA status of the device as it is being used for the proposed research:  
 FDA-approved device being used “on-label” (i.e., FDA-approved purpose,  
      population, manner). 
 FDA-approved device that is being used “off-label” (i.e., for a different 
purpose,  
      population, or in a different manner than approved). 
 Not approved by the FDA. 
 
16.3. Indicate the IDE Status of this device:  
 The use of this device has an IDE.  
 
 The use of the device qualifies for an Abbreviated IDE. 
 
 Not use of the device is exempt from the IDE requirements.  
 
16.4. Has the FDA made a determination as to whether the device is Significant Risk or 
Non-Significant Risk? No 
 Yes:  If yes, indicate the FDA’s determination.  
 
16.5. Describe plans for storage control, and dispending of the product so that (1) only 
authorized investigators will use the product; (2) the product will only be used in 
participants who have provided consent, and (3) there will be documented 
tracking of each product, including unique identifiers and any return/disposal.  
 
 
17. Drug/Biologic 
17.1. Does the research involve a Drug or Biologic? 
 No:  If no, skip to the next section.   

 Yes: If yes, describe the drug or biologic, including the generic or common 
name, brand name (if applicable), dosing, route of administration, number of 
doses, timing of administration. Indicate who is providing the drug, biologic, 
supplement for research use. 
 
17.2. Indicate the IND Status of this drug or biologic: 
 There is an IND approval from the FDA for the use of this item.  
 An IND application has been, or will be, submitted to the FDA. 
 An IND approval is not required.  
 
17.3. Describe how dispensing, delivery and administration will be performed, and by 
whom. Include information about control (e.g., locked storage), tracking (e.g., lot 
number, returned pills), documentation, and return/disposal.    
 
 
18. Data or Specimen Banking (Repositories) 
18.1. Does the study include establishing a repository for sharing data or specimens?  
No: If no, skip to the next section 
Yes: If yes, identify what data or specimens will be will be collected for the 
repository and what information will be associated with the data or specimens 
 
A de-identified data repository will hold the verbal autopsy data collected. Please see 
the verbal autopsy tool for data fields. At the end of the study, de-identified data will be 
shared in a public domain. 
 
18.2. Describe where and how long the data/specimens will be stored and whether 
participants’ permission will be obtained to use the data/specimens in other future 
research projects. 
 
In accordance with Indian regulations, the data will be available both at HSPH and with 
the local PI. During the consent process, participant permission will be obtained to 
include their de-identified data from the verbal autopsy in a public domain. 
  
18.3. Identify who may request access to the data/specimens and describe this process. 
 
The Gates Open Access Policy requires unrestricted access of all peer-reviewed 
published research funded by the foundation, including underlying datasets.  All 
requests for data will be routed through HSPH study team.  Co-Principal Investigators 
from CEL will receive IRB approval from the local IRB.  
 
18.4. Will data/specimens be sent to research collaborators outside of Harvard? 
No 
Yes:  If yes, describe the plan and upload any agreements to the 
“Supporting Documents” page in ESTR. 
 
Information needed to identify the mother and/or family member(s) of deceased 
individuals (such as case ID, patient ID, family name, address, phone number, facility 

number, date of admission, date of delivery, and ASHA contact) from the parent study 
will be shared by HSPH to the study partner(s) (CEL and PSI, pending PSI’s role in the 
execution of this work). We have a Data Use Agreement outlining this data transfer. 
 
18.5. Will data/specimens be received from collaborators outside of Harvard? 
No 
Yes:  If yes; describe the plan and upload any agreements to the 
“Supporting Documents” page in ESTR. 
 
Verbal autopsy data collected by CEL will be shared with HSPH.  We will develop a 
Data Use Agreement specifying the plan. 
 
19. Research Related Injuries (required for research posing greater than minimal risk) 
18.1  Are there provisions for medical care and compensation for research-related 
injuries? 
No 
Yes:  If yes, outline these provisions. Although Harvard’s policy is not to 
provide compensation for physical injuries that result from study participation, 
medical treatment should be available including first aid, emergency treatment 
and follow-up care as needed. If the research plan deviates from this policy, 
provide appropriate justification. 
 
 
20. Reportable Events 
20.1. Outline plans for communicating reportable events to the IRB, Sponsor, or others 
as applicable (e.g., adverse events, unanticipated problems involving risks to 
participants or others, breach of confidentiality). 
 
Any reportable new information will be brought to the attention of the IRB in necessary 
instances as determined by the Principal Investigators in India and at HSPH within 5 
days.  
 
21. Regulatory Compliance 
21.1. Describe plans for monitoring regulatory compliance, in order to ensure proper 
record keeping, retention of required regulatory documents, and adherence to the 
IRB-approved protocol and/or IRB policies and procedures.  
 
The co-Principal Investigators at CEL will be primarily responsible for monitoring 
regulatory compliance at the local level. The local co-PIs will oversee the day-to-day 
data collection activities, including monitoring the data collection and storage to ensure 
processes follow the protocol.  They have confirmed that this protocol is in alignment 
with local regulations and will alert co-PIs at HSPH should regulations change. 
Additionally, the HSPH team will hold frequent check-ins with the co-PIs and data 
collection team in India to confirm that activities are moving forward in line with 
ethical guidelines.  The HSPH team will report updates to our regulatory documents to 
our IRBs on a regular basis as required. 
 
22. Clinical Trials 

22.1. Is this an NIH funded clinical trial or an applicable trial (ACT) under the FDA 
Amendments Act?  
No 
Yes:  If yes, describe your plan for registering this project in a clinical 
trials registry, e.g., clinicaltrials.gov. Provide the registry record number, if 
available.