Sangath IRB stands for Sangath’s Institutional Review Board, also referred to as the Institutional Ethics Committee (IEC), Ethics Committee (EC), or Research Ethics Committee (REC). It is an independent body constituted under the mandate of the Sangath Chairperson. The IRB is responsible for the ethical review and ongoing oversight of all research activities conducted under Sangath, in line with national ethical guidelines. This includes reviewing new studies, amendments, continuing reviews, adverse events, and other ethics-related submissions.

At present, the Sangath IRB accepts submissions via email. Please send your submission to the official IRB email ID (irb@sangath.in), ensuring that: - The subject line clearly mentions the type of submission (for example, new study, amendment, continuing review) - All required documents are attached, as per the relevant template Incomplete submissions may delay review.

Yes. You may proceed with the study or approved amendment once you receive a formal written communication (email) from the IRB confirming approval. The approval email serves as authorisation to begin the approved research activities. The formal decision letter will follow for documentation and records.

In general, submissions without a 'Participant Information Sheet' and 'Consent Form' are not permitted, as these are core documents required for ethical review. However, the IRB may consider such submissions only with adequate justification. An acceptable justification may be when participant recruitment and consent activities are scheduled to begin at a later stage, but IRB approval is required earlier (for example, for funder clearance or administrative purposes). Any such request must be clearly explained at the time of submission.

Yes. Investigators may formally request a waiver of IRB fees by writing to the IRB. Please refer to IRB SOP No. 9 (especially Section 9.6) for details on applicable fees and waiver criteria. All waiver requests are reviewed on a case-by-case basis.

No. The Sangath IRB does not ordinarily review proposals from external individuals or organisations. Please refer to IRB SOP No. 21 for details on the limited circumstances under which exceptions may be considered.

Yes. Investigators are welcome to seek pre-submission or procedural guidance from the IRB. Please write to the IRB via email outlining your query, and the secretariat will respond or guide you on the next steps.

Yes. Any document that will be used to seek participant consent or provide study-related information must be submitted in all languages in which it will be administered. This includes translated versions of the Participant Information Sheet, Consent Form, and any other participant-facing materials.

Yes. In many cases, a written confirmation from the IRB stating that the proposed study would be eligible for ethical review if funded is sufficient for funder requirements. If a formal IRB review or approval is still required prior to funding, the Sangath IRB may consider your application for review. Please clearly indicate the funding status at the time of submission.

For studies with multiple stages or phases, the appropriate submission pathway depends on how clearly the later stages are defined at the time of initial submission. - If all stages are conceptually linked, well-defined, and foreseeable at the outset, investigators are encouraged to submit a single comprehensive protocol that clearly describes each stage, its objectives, methods, risks, and timelines. In such cases, subsequent stages may be reviewed as amendments, provided there are no substantial changes to risk, consent, or study population - If later stages (such as a trial or quantitative component) are not yet fully developed, rely on findings from earlier stages, or involve new methods, populations, or risk profiles, these should be submitted as separate protocols when they are ready for review. The IRB will determine, on a case-by-case basis, whether a later stage qualifies as an amendment to an existing approval or requires independent ethical review. With regard to IRB fees, these are generally linked to the type and number of formal IRB submissions, rather than to the overall project title. Fee applicability will therefore depend on whether subsequent stages are reviewed as amendments or as new submissions. Investigators are encouraged to consult IRB SOP No. 9 and may seek clarification from the IRB in advance.

Congratulations. Please retain a copy of the approval letter for your records and carefully review it to ensure that all details are accurate. As approval letters are prepared manually, inadvertent errors may occasionally occur. If you notice any discrepancies, please inform the IRB so they can be corrected. It is important to comply with the IRB’s reporting requirements. You are required to submit an annual progress report for the study each year. If your study is completed within one year of approval, please submit an end-of-study report instead.

An amendment is any proposed change to an IRB-approved study that alters what was originally reviewed and approved. Common examples of amendments include changes to: - Study procedures or methodology - Recruitment strategies or eligibility criteria - Sample size or study duration - Participant-facing documents (for example, information sheets, consent forms, questionnaires) - Study sites or data collection settings - Data collection tools or instruments - Study team members - Plans for data handling, storage, or analysis, if these differ from what was approved. Amendments may be minor or substantive, and the level of IRB review (expedited or full board) will depend on the nature of the change and the level of risk involved. Investigators must obtain IRB approval for an amendment before implementing the change, except where immediate changes are required to eliminate an apparent hazard to participants, in which case the IRB should be informed promptly.

Congratulations! We recommend starting by visiting the Sangath IRB Page, which hosts: - Templates for different types of IRB submissions - The Standard Operating Procedures (SOPs), which explain IRB processes in detail - The IRB calendar, which provides information on upcoming meetings As researchers working primarily in socio-behavioural research, we also recommend familiarising yourself with the ICMR National Ethical Guidelines (2017) for conceptual and overarching ethical guidance.

The timeline depends on what is submitted and when it is received. - Most new studies and substantive amendments undergo full board review. - Full board reviews are tabled at the IRB meeting, which is usually held on the last Tuesday of every month. - During the meeting, IRB members discuss the submission and may either approve it, or provide queries or comments requiring clarification or modification. The IRB’s decision is generally communicated within one week of the meeting. In cases of urgency, the secretariat may expedite communication. If you receive queries or comments, you are expected to submit a written response addressing them. The IRB does not send reminders at this stage. Once your responses are submitted, the IRB typically takes up to five working days to review them. Overall, researchers should plan for a 4 to 6 week timeline from submission to final approval.

The IRB generally issues a formal decision letter within approximately three weeks of approval. This timeline may be shorter depending on the workload. If you require the decision letter sooner (for example, for funder or institutional reporting), please inform the IRB or the secretariat in advance, and the team will make reasonable efforts to expedite issuance.

IRB fees should be paid after you have made a formal IRB submission. The IRB secretariat typically writes to investigators within two weeks of submission, requesting fee payment. You may choose to pay earlier and inform the IRB, but payment should not be made before submission.

You may request an expedited review at the time of submission (for example, for a new study or an amendment). Please note that the decision to grant expedited review rests entirely with the IRB and depends on: - The nature of the submission - The level of risk involved - The availability of IRB members outside scheduled meetings Very minor administrative changes (such as spelling or formatting corrections in participant-facing documents) may be reviewed and approved at the secretariat level within a few days. However, determinations regarding expedited review are best left to the IRB, in keeping with its independent mandate.

For IRB review purposes, a sub-study is a research activity derived from an already approved parent study that: - Uses the same or a subset of participants, data, or samples, and - Introduces a new or more focused research question, analytic objective, or procedure that was not explicitly covered in the original protocol. A sub-study may involve secondary data analysis, additional data collection, or targeted examination of a specific subgroup. It is typically treated as a sub-study rather than a simple amendment when it: - Alters the scope or intent of the original study - Changes the risk profile, or - Raises new considerations related to consent, privacy, or dissemination. In such cases, the IRB usually requires a brief standalone protocol that references the parent study and clearly distinguishes what remains unchanged from what is new, to ensure appropriate ethical oversight.

Up-to-date information on IRB membership and the secretariat is available on the Sangath IRB Page.

No. IRB applications must be submitted and formally coordinated by a Sangath-based investigator. The Principal Investigator (PI) may designate another Sangath-based colleague who is part of the study team to coordinate IRB correspondence. Non-Sangath collaborators may be copied in email communications; however, the IRB primarily engages with the PI or the designated Sangath-based coordinator for all official communication.

All relevant IRB information required for HMSC applications, including: IRB composition as per ICMR guidelines Registration details is available on the Sangath IRB website.

No. An End of Study Report should be submitted only after all study-related activities have been completed. For IRB purposes, a study is considered complete when: - All data collection activities have ended - All data analysis related to the approved objectives has been completed - There is no further participant contact, data use, or study-related activity planned under the approved protocol. If data collection is complete but analysis is ongoing, the study should be considered ongoing, and the appropriate submission (for example, continuing review, if applicable) should be made instead of an end-of-study report. Investigators should submit the end-of-study report once the study has been fully completed, including analysis.

An annual report (also referred to as a continuing review or progress report) is a study-level requirement, not a submission-level requirement. An annual report provides the IRB with an update on the overall status of an approved study, including: - Progress of recruitment and data collection - Any adverse events or protocol deviations - Amendments approved during the reporting period Current risk–benefit assessment - Plans for continuation, modification, or closure of the study. Annual reports are required once per year for each active study, unless otherwise specified in the approval letter or SOP. Amendments do not have separate annual reports. Approval of an amendment does not reset the annual reporting clock and does not require an additional annual report. Instead, all amendments approved during the year should be summarised in the next scheduled annual report for the parent study. If a study is completed before the one-year reporting period, an end-of-study report should be submitted in place of an annual report.