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, take it that approval is needed till the committee says otherwise.

In health research there is no confusion. The ICMR guidelines cover “all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data”. Section 4 then says every such proposal has to be reviewed by an ethics committee before the work is conducted.

Once you go outside health, the position is less clear. Take a management scholar who is surveying bank employees. That is not research for health. As far as we can find, social science has no binding national ethics code like the ICMR one. (To our knowledge, ICSSR has not issued one.) So here your university’s policy decides. Many universities now want clearance for every study with human participants, and questionnaires and interviews are included in that. Some accept a declaration from the guide. Check with the research cell before you print even one questionnaire.

Some scholars feel their study is harmless and want to skip the committee. Section 4.8.3 of the ICMR guidelines does not allow a researcher to decide by himself or herself that the proposal is exempt. You have to submit it and give your reasons for exemption. After that the committee decides, in writing.

There is one common case where no committee is needed, and that is the systematic review or meta-analysis. ICMR gave an addendum in February 2024 for this. Two conditions are there. You follow the standard guidelines, and your review is registered in some recognised registry before you start. Then no ethics clearance is needed for it. For the registration part, see our systematic review guide.

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

For nearly every PhD scholar this means the ethics committee of your own institution, whatever name it goes by locally. If your data comes from a hospital, the committee of that hospital may also have to approve it.

The registration rules are given in the New Drugs and Clinical Trials Rules, 2019. A committee that clears drug trials has to register with the Central Licensing Authority (CDSCO), that is rule 8. Committees reviewing biomedical and health research register under rule 17, with the authority named by the Department of Health Research. This registration happens on the Naitik portal (the National Ethics Committee Registry for Biomedical and Health Research). And as per rule 16(3), your research can be approved only by a committee which has done this registration.

For drug trials there is one more step. Rule 25 wants your trial on the Clinical Trials Registry of India (CTRI) before you enrol even the first participant. In other health research ICMR calls CTRI registration voluntary. Still, it points out that the major Indian biomedical journals publish registered trials only. If your PhD has an intervention, better you register it.

Animal work goes to the Institutional Animal Ethics Committee (IAEC) instead, and IAEC works under CCSEA. CCSEA is the national committee that was earlier called CPCSEA. The consent part below does not apply to animal work.

What about UGC? In the 2022 PhD Regulations, ethics comes up only in clause 9(1), and that clause is about making the RPE course compulsory.

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

First the member secretary screens every proposal. Depending on the risk, he or she then assigns a type of review.

Please don’t think low risk means an easy review. When your participants are from a vulnerable group, ICMR wants a full review “even if the risk is minimal”. Its list in Box 6.2 is also wider than most scholars expect. Children, pregnant women, tribal communities and people with mental illness are there. It also includes anyone who finds it harder to refuse because of a hierarchy, like students, employees, healthcare workers and prisoners.

Suppose you are teaching in a college and want to survey your own students. They may feel they cannot say no to you. Committees will usually ask that someone else hands out the forms, or that you use an anonymous link so no one knows who refused. Put this in your sampling plan from now itself.

What documents do you submit to the ethics committee?

Always start from your own committee’s checklist. The ICMR model list (Box 4.4) has 25 items, because it is written to cover sponsored drug trials also. For a PhD survey or interview study the list is much shorter.

• A cover letter and the application form of the committee, signed by you and by your supervisor.
• The protocol, covering objectives, design, sample and how you will reach participants, data collection, analysis, the risks and how you reduce them, and where the data will be kept.
• Participant information sheet and consent form in English and in every local language you plan to use. Some committees want translation and back-translation certificates also.
• Your final questionnaire or interview guide (our questionnaire design guide can help here), and any posters or messages you will use for recruiting people.
• Short CVs, a conflict-of-interest statement and permission letters from the sites where data will be collected, if the committee wants them at this stage.

Clinical trial investigators need a Good Clinical Practice (GCP) certificate in ICMR’s list, preferably from the last five years. Normally a questionnaire study does not need it. But some committees want a basic research ethics training certificate from everybody. The SOP of your committee will mention this.

What should an informed consent form contain?

ICMR divides the consent document into two parts. One is the participant information sheet, which explains the study. The other is a short informed consent form that the participant signs. Box 5.1 of the guidelines lists the essential elements, and from them you get these sections.

• A clear statement that this is research, and its purpose and methods explained in simple language.
• How much time taking part needs, how many times you will contact them, how many people are in the study and which data you collect.
• Any good that may come from it (writing “no direct benefit to you” is acceptable), and whatever risk or discomfort you can foresee.
• Up to what level their answers stay private, and when you may have to break it.
• Any payment, any money given back to them for expenses, or compensation if the research causes them harm.
• They join on their own wish only, and can leave anytime with no penalty for that.
• Contact numbers for you and also for the chairperson or member secretary of the committee.
• Where it is relevant, how long the data will be stored, whether it will be shared and how the results will be published.

Use the words your participants use. Section 5.2.1 wants language that is simple and suits the social and cultural background of the participant. If you translate academic English word by word into formal Hindi or Tamil, the result can be as hard to follow as the English one. Read it out to two or three people like your participants first.

A worked example

Here is an illustrative study. An education scholar is surveying around 300 government school teachers in rural Tamil Nadu about workload and stress. The information sheet is in Tamil and English. It tells that the survey takes about 20 minutes, that it is anonymous and that any question can be skipped. Since the teachers are employees, the sheet also says the head teacher and the department will never see anybody’s answers. And it makes clear that refusing will not affect their job in any way.

Two special cases come up many times. When a participant cannot read, ICMR requires an impartial literate witness. With children, the parent gives consent and the child gives assent, oral assent from 7 to 12 and written assent from 12 to 18 (Box 6.6). Recording interviews needs a separate consent for the recording. Other interview points are in our guide to qualitative interviews.

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

1. 1

   Finish the design first

   The committee looks at a full protocol, not just an idea. So first fix your objectives, sample, tool and analysis plan. If your university wants the synopsis approved by DC or RAC before this, get that also done.

2. 2

   Get the committee’s own forms

   Go to the member secretary’s office or the research cell and take the current form. Ask them for the document list, the meeting dates and the last date for submission also.

3. 3

   Submit the full set

   The set has the protocol, consent documents in every language, the questionnaire or interview guide, CVs and certificates. Mention clearly which type of review you are requesting.

4. 4

   Attend if called, then answer queries

   Sometimes you will be called to present. Most proposals come back with some changes. Minor ones are mostly checked by the member secretary, while major ones go again to the full committee.

5. 5

   Collect the approval letter

   Note the reference number, the date and the approved version of each document. Start recruiting only after this.

6. 6

   Keep the approval alive

   Whenever the committee asks, send progress reports. If you want to change the protocol, tools or consent form, get that change approved first and then change it.

How fast you get it depends mostly on how often your committee meets. ICMR has not fixed any turnaround time. Some university committees meet every month and some meet once in two or three months. Miss the deadline and your file waits for the next meeting. When your file is exempt or it is going for expedited review, mostly the letter comes in few weeks time. Full review with major revisions can go to two to three months, so I would keep three months in the plan.

ICMR gives four possible outcomes. The proposal is approved, approved after minor changes, sent back for resubmission with major changes, or not approved with reasons. You can respond to the committee, and appeals are heard by the head of the institution. Read the approval letter properly, because some cover the whole study and some are valid for one year only. An approval lapsing in third year is a problem you can easily avoid.

Can you get ethics approval after collecting data?

No. Don’t plan your work around getting it later. In the 2019 Rules, rule 16(2) clearly puts the committee review “before initiation” of the research. ICMR also makes consent mandatory before any study procedure (section 5.1.4). The full system is designed with review happening first.

This comes back to you later also. Journals in health, psychology and education many times ask for the committee name, approval number and date. Some of them check that date against the data collection period given in your methods. Examiners look at it too. So keep the approval letter and the approved forms in one place. Where the approval details go is shown in our guide to writing the methodology chapter.

If you have already collected data without approval, discuss about it with your supervisor and the committee now itself. Maybe they will tell you to collect the data again after getting the approval. For de-identified records, another way could be asking for a consent waiver, which ICMR permits for some retrospective studies. It depends on the committee, nobody can promise either.