Research ethics approval for a PhD in India: when you need it and what to submit

Does my PhD study need ethics committee approval?

If you are collecting anything from people, assume yes until the committee tells you otherwise.

For health research the rule is clear. The ICMR guidelines apply to “all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data”, and section 4 says every such proposal must be reviewed by an ethics committee before it is conducted.

Outside health it thins out. A management scholar surveying bank employees isn’t doing research for health, and as far as we can find there is no binding national ethics code for social science equivalent to ICMR’s (ICSSR has not, to our knowledge, issued one). So your university’s policy decides. Many now require clearance for every study with human participants, questionnaires and interviews included; some accept a supervisor’s declaration. Ask the research cell before you print a single questionnaire.

Think your study is harmless? Section 4.8.3 of the ICMR guidelines says a researcher cannot decide their own proposal is exempt. You submit it, argue for exemption, and the committee decides in writing.

One common case doesn’t need a committee. A February 2024 ICMR addendum says a systematic review or meta-analysis that follows standard guidelines and is registered prospectively in a recognised registry needs no ethics clearance. Our systematic review guide covers registration.

Which committee reviews it: IEC, IHEC, CDSCO or IAEC?

For almost every PhD scholar it is your own institution’s committee, whatever it is called locally. If you collect data in a hospital, that hospital’s committee may also need to approve it.

The registration rules come from the New Drugs and Clinical Trials Rules, 2019. Committees approving drug trials register with the Central Licensing Authority (CDSCO) under rule 8. Committees reviewing biomedical and health research register under rule 17 with the authority the Department of Health Research designates, through the Naitik portal (the National Ethics Committee Registry for Biomedical and Health Research). Rule 16(3) says such research must be approved by a committee registered this way.

Drug trials must also be registered on the Clinical Trials Registry of India (CTRI) before the first participant is enrolled (rule 25). ICMR calls CTRI registration voluntary for other health research, while noting that major Indian biomedical journals publish only registered trials. If your PhD includes an intervention, register it.

Animal work goes to the Institutional Animal Ethics Committee (IAEC), under CCSEA, the national committee earlier called CPCSEA. The consent material below doesn’t apply to it.

As for UGC, the 2022 PhD Regulations mention ethics only in clause 9(1), which makes the RPE course compulsory.

Exempt, expedited or full review: how does the committee decide?

The member secretary screens each proposal and assigns a type of review based on risk.

Low risk doesn’t guarantee light review. ICMR sends research on vulnerable populations to full review “even if the risk is minimal”, and its list (Box 6.2) is wider than people expect. Besides children, pregnant women, tribal communities and people with mental illness, it includes anyone with diminished autonomy because of a hierarchy: students, employees, healthcare workers, prisoners.

So if you teach in a college and plan to survey your own students, your participants may not feel free to refuse. Committees will usually want someone else to distribute the forms, or an anonymous link so nobody knows who declined. Build that into your sampling plan now.

What documents do you submit to the ethics committee?

Work from your committee’s own checklist. ICMR’s model list (Box 4.4) has 25 items because it covers sponsored drug trials; a PhD survey or interview study needs far fewer:

• A cover letter and the committee’s application form, signed by you and your supervisor.
• The protocol: objectives, design, sample and recruitment, data collection, analysis, risks and how you reduce them, and data storage.
• The participant information sheet and consent form in English and each local language you will use, with translation and back-translation certificates if asked.
• The final questionnaire or interview guide (see our questionnaire design guide), plus any recruitment posters or messages.
• Short CVs, a conflict-of-interest statement, and permission letters from the sites where you will collect data if the committee wants them now.

A Good Clinical Practice (GCP) certificate, preferably from the last five years, is listed by ICMR for investigators on clinical trials. For a questionnaire study it isn’t normally required, though some committees ask everyone for a basic research ethics training certificate. The SOP will say.

What should an informed consent form contain?

ICMR splits the consent document in two: a participant information sheet explaining the study, and a short informed consent form the participant signs. Box 5.1 of the guidelines lists the essential elements, which give you these sections:

• A statement that this is research, with its purpose and methods in simple language.
• How long participation takes, how often you will contact them, how many people are taking part and what data you collect.
• Expected benefits (“no direct benefit to you” is an acceptable answer) and any foreseeable risk or discomfort.
• How far confidentiality can be protected, and its limits.
• Any payment, reimbursement, or compensation for research-related injury.
• That taking part is voluntary and they can withdraw at any time without penalty.
• Contact numbers for you and for the committee’s chairperson or member secretary.
• Where relevant: how long data will be stored, whether it will be shared, and how results will be published.

Write it the way your participants speak. Section 5.2.1 asks for language that is simple and suited to the participant’s social and cultural context. A word-for-word translation from academic English into formal Hindi or Tamil can be as opaque as the original, so read it aloud to two or three people like your participants first.

A worked example

Take an illustrative study: an education scholar surveying about 300 government school teachers in rural Tamil Nadu on workload and stress. The information sheet, in Tamil and English, says the survey takes about 20 minutes, is anonymous and any question can be skipped. Because the teachers are employees, it states that the head teacher and the department will never see individual answers and that declining has no effect on their job.

Two special cases. If a participant cannot read, ICMR requires an impartial literate witness. For children, a parent consents and the child assents: oral assent from 7 to 12 and written assent from 12 to 18 (Box 6.6). If you record interviews, ask for separate consent to record; our guide to qualitative interviews covers the rest.

How does the approval process work, and how long does it take?

1. 1

   Finish the design first

   The committee reviews a protocol, not an idea. Fix objectives, sample, instrument and analysis plan, and get DC or RAC approval of the synopsis if your university requires it first.

2. 2

   Get the committee’s own forms

   Ask the member secretary’s office or research cell for the current application form, document checklist, meeting calendar and submission deadline.

3. 3

   Submit the full set

   Protocol, consent documents in each language, questionnaire or interview guide, CVs and certificates, with the type of review you are requesting.

4. 4

   Attend if called, then answer queries

   You may be asked to present. Most proposals come back with changes; minor ones are usually checked by the member secretary, major ones go back to the full committee.

5. 5

   Collect the approval letter

   Note the reference number, date and approved version of every document. Only then start recruiting.

6. 6

   Keep the approval alive

   Send progress reports as asked, and get amendments approved before you change the protocol, tools or consent form.

Timing depends mostly on how often your committee meets; ICMR sets no fixed turnaround. Some university committees meet monthly, others every two or three months, and a submission that misses a deadline waits for the next meeting. An exempt or expedited proposal can clear in a few weeks, while a full review with major revisions can take two to three months. I’d plan for three.

ICMR allows four outcomes: approved, approved after minor changes, resubmit with major changes, or not approved with reasons. You can reply to the committee, and the head of the institution hears appeals. Approval may cover the whole study or run a year at a time, so check your letter; a lapsed approval in year three is an avoidable headache.

Can you get ethics approval after collecting data?

No, and don’t plan on it. Rule 16(2) of the 2019 Rules says the committee reviews research “before initiation”, and ICMR makes consent mandatory before any study procedure (section 5.1.4). The system is built on review coming first.

It catches up with you later. Journals in health, psychology and education routinely ask for the committee’s name, approval number and date, and some compare that date with the data collection period in your methods. Examiners do too, so keep the approval letter and approved forms together. Our guide to writing the methodology chapter shows where the approval details go.

If you already collected data without approval, tell your supervisor and the committee now. Options might include a fresh approved round of data collection or, for de-identified records, a request for a consent waiver, which ICMR permits for some retrospective studies. Neither is guaranteed.