Every MD, MS or DNB thesis that involves patients, healthy volunteers, their samples or their records needs clearance from the Institutional Ethics Committee (IEC) before data collection begins. For many residents this is the first real administrative hurdle of the thesis: forms to fill, signatures to chase, a meeting date to wait for, and then a list of queries to answer.
This guide explains which documents IECs usually ask for, how the three types of review described in the ICMR National Ethical Guidelines (2017) work, the queries committees raise most often and how to answer them, and how to plan your timeline so ethics approval does not eat into your data collection months. One point before we start: every IEC has its own forms, checklists, fees (if any) and meeting schedule. Use this as a map, and always download the current forms from your own committee.
1Why Your Thesis Needs IEC Approval
The IEC exists to protect the rights, safety and well-being of research participants. It checks that your study is scientifically sound enough to justify asking people to take part, that risks are minimised and reasonable, that consent is genuinely informed and voluntary, and that participants' data and samples are kept confidential.
For a PG resident, IEC approval also matters for practical reasons:
- Most universities will not accept a thesis without a copy of the IEC approval letter, and many ask for it at synopsis submission.
- Journals usually ask for the ethics committee name and approval number when you publish from your thesis.
- Data collected before approval generally cannot be used. There is no such thing as retrospective ethics approval for a prospective study.
The ethical principles behind the committee's questions are covered in our post on ethical standards in medical research. Here we focus on the process.
In most institutions the sequence is: guide and department approve the topic and protocol, then the scientific or research review committee (where one exists), then the IEC, then (for interventional studies) CTRI registration, and only then the first participant. Some institutions combine the scientific and ethics review; check how yours works.
2Documents Usually Required
The exact list varies, but most IECs ask for a set close to the one below. Prepare these together, because they must agree with each other: the sample size, objectives, procedures and duration should be identical in the protocol, the information sheet and the application form.
| Document | What it contains | Tips |
|---|---|---|
| Covering letter | Request for review, title, investigator names, list of enclosures | Signed by you and forwarded by your guide and HOD if the IEC requires it |
| IEC application form | The committee's own form: study summary, type of review requested, risk category, vulnerable groups, funding, conflicts of interest | Use the latest version from the IEC office or website; old versions are often returned |
| Study protocol / synopsis | Background, aims and objectives, design, setting, sample size with justification, inclusion and exclusion criteria, methods, outcome measures, statistical plan, ethical considerations, references | See our synopsis writing guide |
| Participant Information Sheet (PIS) | Plain-language explanation of the study for participants | English plus the local language(s) your participants speak |
| Informed Consent Form (ICF) | Consent statements with signature or thumb impression, witness and date lines | Add assent forms for children and LAR consent where relevant |
| Case Record Form (CRF) / proforma | Every variable you will collect | Should match the objectives exactly; no variable without a purpose |
| Questionnaires or scales | Any tool given to participants | Include validated translations and note permission for copyrighted scales |
| Investigator CVs | Brief CVs of you, your guide and co-guides | Many IECs want them signed and dated |
| Training certificates | GCP, research ethics or research methodology course certificates | Requirements differ; some IECs ask only for the guide's, others for every investigator's |
| Undertaking / declaration | Investigator's undertaking to follow the approved protocol and ICMR guidelines, report adverse events and maintain confidentiality | Usually on the IEC's own format |
| Conflict of interest declaration | Any financial or other interest | Write "none" explicitly if there is none |
| Other permissions | Letters from other departments, sites, or a sponsor; regulatory permission for drug or device trials | Needed when you use another department's patients, lab or records |
Put a version number and date in the footer of the protocol, PIS, ICF and CRF (for example, "Version 1.0, 12 January 2026"). When the IEC asks for changes, resubmit as Version 1.1 with a point-by-point reply. The approval letter will then name the exact versions approved, which avoids confusion later.
3Full, Expedited or Exempt Review (ICMR 2017)
The ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) describe three types of review, based mainly on the level of risk to participants. You can indicate which type you think applies, but the decision belongs to the IEC, not to the investigator. Even a study you believe is exempt must be submitted so that the committee (usually the Member Secretary or Chairperson) can record that decision.
Exemption from review
Intended for research with less than minimal risk, where there are no linked identifiers. Typical examples are research on publicly available data or information in the public domain, analysis of anonymised data that cannot be linked back to individuals, and some quality-control or audit activities. Most clinical PG theses do not fall here, because they involve direct contact with patients or identifiable records.
Expedited review
For research that involves no more than minimal risk, where the probability and degree of harm are no greater than those met in routine clinical examination or daily life. Examples include studies using routine non-invasive procedures or routine blood samples, research on existing records with identifiers where confidentiality is protected, and minor amendments to an already approved protocol. Expedited review is done by the Chairperson or a few designated members instead of the full committee, and is usually reported at the next full meeting.
Full committee review
Required for research with more than minimal risk, and commonly for studies involving vulnerable groups (such as children, pregnant women, people with mental illness or those unable to give consent), interventional studies, invasive procedures done for research, and any study that the expedited reviewers feel needs wider discussion. Your study is placed on the agenda of a scheduled IEC meeting, and you may be asked to present it.
| Thesis example | Likely review type |
|---|---|
| Analysis of anonymised data from a published national dataset | Possibly exempt (IEC decides) |
| Cross-sectional study using a questionnaire and routine blood tests already advised for care | Often expedited |
| Retrospective review of hospital case files with identifiers | Often expedited; consent waiver must be requested |
| Randomised comparison of two anaesthetic drugs | Full review |
| Observational study in neonates or children | Usually full review because participants are vulnerable |
These are illustrations only. The same design can be placed in a different category by different committees depending on the details.
4Common IEC Queries and How to Answer Them
Queries are normal. They do not mean your study is weak; they mean the committee has read it. The queries below come up again and again.
| Query | How to answer |
|---|---|
| "Justify the sample size." | Give the formula, every assumption (prevalence, SD, effect size, alpha, power), and the source of each assumption. Our sample size calculator shows the inputs clearly. |
| "PIS is too technical." | Rewrite in short sentences and everyday words; replace terms such as "randomised" with a plain explanation. |
| "Local language version not provided / not matching." | Submit the translation with a back-translation and a translation certificate if your IEC requires one. |
| "Who bears the cost of investigations?" | State clearly which tests are part of routine care and which are extra for the study, and that study-only tests are free to the participant. |
| "Compensation for research-related injury not addressed." | Add a statement on free treatment for research-related injury and how compensation will be handled, in line with institutional policy. |
| "Inclusion and exclusion criteria unclear." | Make each criterion objective and measurable (age range, diagnostic criteria, time frame). |
| "Confidentiality and data storage." | Explain coding of participants, who has access, where data are stored, and for how long. |
| "Request for waiver of consent not justified." | Explain why the research is not practicable without the waiver, why risk is minimal, and how identity will be protected. |
| "Inconsistency between documents." | Check sample size, duration, objectives and procedures across all documents and correct every copy. |
Writing your reply
Answer in a table with three columns: the query as written, your response, and where the change was made (document, page and version). Highlight changes in the revised documents if the IEC allows. Never argue in a defensive tone; if you disagree, explain your reasoning politely and with evidence.
Do not recruit, consent, screen or collect data "while the approval letter is being typed". Approval is effective from the date on the letter (or as the letter states). Data collected earlier can make your thesis unacceptable and is a serious ethical violation.
5Planning Your Timeline
NMC regulations and university rules set deadlines for synopsis and thesis submission, and ethics approval sits between them. Work backwards from your intended start of data collection.
- Find the IEC calendar early. Many committees meet on a fixed schedule and have a submission deadline a few weeks before each meeting. Ask the IEC office for the dates as soon as your topic is final.
- Prepare documents in parallel. Draft the protocol, PIS, ICF and CRF together once your aims and objectives are final, rather than one after another.
- Allow a buffer for signatures. Guide, co-guide and HOD signatures can take longer than expected, especially around exams and duty rotations.
- Expect at least one round of queries. Plan for resubmission and, for full review, possibly the next meeting.
- Add CTRI time if your study is interventional and needs registration before enrolment.
Book the IEC submission deadline in your calendar like an exam date. Missing one deadline can push your approval to the next meeting cycle, and that delay comes straight out of your data collection period.
6After Approval: Amendments, Reports and Closure
Approval comes with responsibilities that continue until the study ends:
- Amendments: any change to the protocol, sample size, criteria, tools or consent documents needs IEC approval before you implement it.
- Protocol deviations: report them as your IEC requires, with the reason and corrective action.
- Serious adverse events: report within the time frame specified by the IEC (and by regulations, for regulated trials).
- Progress reports: some IECs ask for annual or periodic reports; a thesis lasting more than a year may need one.
- Completion report: inform the IEC when data collection ends, and keep consent forms safely for the period your institution specifies.
Keep a single folder (paper and digital) with every version submitted, every query letter, your replies and the approval letter. You will need these for the thesis appendix, for CTRI and for journal submission.
7Getting Help with Your IEC Submission
An IEC file that is complete and internally consistent usually moves faster. If you would like your protocol, information sheet, consent forms and CRF reviewed together before submission, or help drafting replies to IEC queries, the PubMedico team supports MD, MS and DNB residents with exactly this stage. Message us on WhatsApp at +91 78787 33004.
❓ Frequently Asked Questions
Quick answers to common questions on this topic
Yes, it should be submitted to the IEC. Under the ICMR 2017 guidelines, only the IEC can decide whether a study is exempt or eligible for expedited review. Retrospective studies using identifiable records commonly receive expedited review, and you will usually need to request a waiver of consent with a justification and a plan to protect confidentiality.
No. You may suggest the type of review in your application, but the decision to exempt a study, or to review it by expedited or full process, is taken by the IEC. Submit the study and keep the committee's written decision in your thesis file, because your university and any journal may ask for it.
It depends on your committee's meeting schedule, the review type and how many rounds of queries you receive. Expedited reviews are often quicker than full reviews, but each IEC works differently. Ask your IEC office for meeting dates and submission deadlines early, and plan for at least one round of revisions.
Yes. Any change to the approved protocol, sample size, eligibility criteria, data collection tools or consent documents is an amendment and needs IEC approval before you implement it. Submit the revised documents with a new version number and a short note explaining what changed and why.
It depends on your institution. Some IECs ask every investigator, including the PG resident, for a GCP or research ethics training certificate, while others ask only for the guide's. Many residents also complete a research methodology course required by their university. Check your IEC's checklist and attach whatever it lists.
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