How to File RTI with ICMR for Clinical Trial Approval, Research Grants and COVID-19 Serosurvey Data

The Indian Council of Medical Research (ICMR) is India's apex body for the formulation, coordination, and promotion of biomedical and health research. Established under the ICMR Act and substantially funded by the Central Government through the Ministry of Health and Family Welfare, ICMR sets national priorities for medical research, sponsors and conducts multi-centre clinical trials, manages India's clinical trials registry, and disburses hundreds of crores in research grants to institutions across the country. Because ICMR is substantially financed by Central Government funds and performs statutory public functions, it is a public authority under Section 2(h) of the RTI Act, 2005.

Citizens, patients, researchers, public health advocates, and journalists can use RTI with ICMR to obtain information about how public research money is spent, how clinical trial approvals are granted, what COVID-19 serosurveys actually found, and whether ethics committees are constituted as required under ICMR's own guidelines.

What ICMR Does and What You Can Access via RTI

ICMR's mandate spans four domains that generate disclosable public records:

Clinical Trial Approvals and Oversight — ICMR sponsors and co-sponsors clinical trials in India and, through its institute network, participates in reviewing trial protocols. The criteria and committee composition used to evaluate trial proposals are administrative records that are fully disclosable. Decisions to approve, defer, or reject a trial are also accessible. Some underlying data submitted by a private pharmaceutical sponsor as part of a trial application may be exempt under Section 8(1)(d) of the RTI Act (commercial confidence / trade secrets), but ICMR's own evaluation process and the outcome of that evaluation are not commercially sensitive and must be disclosed.

Research Grant Disbursement — ICMR disburses research grants to medical colleges, public health institutions, and hospitals under various schemes (Task Force projects, Extramural Research, Centres for Advanced Research, etc.). Because these are public funds, the details of grants sanctioned and disbursed — recipient institution, project title, amount, and duration — are fully disclosable. RTI is a powerful tool to track whether grant money reached the intended institutions, whether project deliverables were met, and whether any grants were returned or revoked.

COVID-19 Research and Serosurveys — ICMR conducted multiple rounds of national COVID-19 seroprevalence surveys to estimate population-level exposure to the virus. The methodology (sampling frame, stratification, testing protocols) and aggregate seroprevalence results are public-interest data. Because these results are aggregated and anonymised, they do not attract the personal privacy exemption under Section 8(1)(j) of the RTI Act. RTI can be used to obtain serosurvey methodology documents and aggregate data that may not have been published in full.

Ethics Committees and Research Governance — ICMR's Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) prescribe the composition and functioning of ethics committees at ICMR institutions. Whether a particular Institutional Ethics Committee (IEC) or the Central Ethics Committee on Human Research (CECHR) is constituted in compliance with these guidelines — including whether a lay member is included — is an administrative fact that can be verified through RTI.

Key Legislation and Guidelines You Should Know Before Filing

What Specific Information Can You Ask ICMR?

Clinical trial approval criteria and committee composition:

1. The evaluation criteria and scoring framework used by ICMR's Scientific Advisory Committee(s) for approving clinical trial proposals — by period and disease area
2. The composition (by designation) of the committee that reviewed trial proposals during a specified year, and the number of proposals approved, deferred, and rejected
3. Whether any ongoing or completed trial registered on CTRI was the subject of a safety signal review or protocol amendment initiated by ICMR, and the outcome of that review

Research grant disbursement: 4. Institution-wise and year-wise list of research grants sanctioned and disbursed by ICMR under specify scheme for specify disease area during specify period 5. For a specific sanctioned project: amount disbursed to date, utilisation certificates received, and whether any instalment was withheld or returned 6. Number and total value of Task Force / Extramural Research projects currently active in specify disease area

COVID-19 serosurvey data: 7. The sampling methodology, sample size, and stratification design for each round of the national COVID-19 seroprevalence survey conducted by ICMR 8. Aggregate seroprevalence estimates (with confidence intervals, if available) by age group, sex, and urban/rural category for each survey round 9. Any data-sharing agreements or inter-agency protocols between ICMR and State health departments or WHO for the serosurvey programme

Vaccine trial safety committee minutes: 10. Minutes (or a summary of decisions) of the DSMB / Safety Monitoring Committee for ICMR-sponsored vaccine trials — with commercially sensitive third-party data severed under Section 10 11. Whether any safety halt, dose modification, or protocol amendment was directed by ICMR for a specified trial, and the date and grounds for that decision

Research ethics committee composition: 12. Current composition (by designation and professional category) of the Central Ethics Committee on Human Research (CECHR) or of the IEC at specify ICMR institute 13. Whether the IEC at institute has a lay / non-scientific member as required under the ICMR Ethical Guidelines 2017, and whether it is registered with the Central Drugs Standard Control Organisation (CDSCO)

Honest Limitations: What ICMR May Legitimately Withhold

RTI with ICMR has real and honest limitations that applicants should know upfront.

Section 8(1)(d) — Commercial Confidence: Where a private pharmaceutical company has submitted a proprietary clinical trial data package (preclinical data, formulation details, biomarker data) to ICMR, that information belongs to the third-party company and is likely exempt as commercial confidence or trade secrets. ICMR is entitled to withhold that specific data. However, the exemption is not blanket — ICMR's own evaluation observations, the committee's decision, and the conditions of approval are not trade secrets. If ICMR refuses your entire request citing Section 8(1)(d), challenge it in a First Appeal, specifically invoking Section 10 (severability).

Section 8(1)(e) — Fiduciary Relationship: Where ICMR holds information as a co-investigator or oversight partner in a trial conducted primarily by another institution, it may claim that some information was shared in a fiduciary capacity. This exemption is narrowly interpreted by the CIC and cannot be used to withhold all information about a government-funded trial.

Aggregate vs. Individual Data: RTI is most productive when you ask for aggregate, anonymised, or procedural information. Requests for individual patient data from clinical trials will be refused under Section 8(1)(j) (personal privacy) and rightly so. Frame all requests for serosurvey and trial data in terms of aggregates, summaries, and committee-level decisions.

Where to File

File online at rtionline.gov.in:

1. Select Ministry of Health and Family Welfare → Indian Council of Medical Research (ICMR)
2. Address the application to the CPIO, Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi – 110029
3. Pay the ₹10 fee online (net banking, debit card, or UPI). BPL cardholders are exempt from the fee — attach a copy of your BPL card.

ICMR has a network of national institutes (NIIH, NIOH, NIRT, NCDIR, NIRRH, and others). If your query relates specifically to a particular institute's records — for example, the ethics committee of the National Institute for Research in Tuberculosis (NIRT), Chennai — you may also address the application to the CPIO of that institute. For national-level policy decisions, grant schemes, and serosurvey data, file at ICMR Headquarters in New Delhi.

Appeals

First Appeal (Section 19(1)): File with the First Appellate Authority (FAA) at ICMR, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi – 110029, within 30 days of the date of decision or expiry of the 30-day response period, whichever is applicable.

Second Appeal (Section 19(3)): File with the Central Information Commission (CIC) within 90 days of the date of the First Appellate Authority's decision or expiry of its response period. ICMR is a Central Government body — the second appeal always goes to the CIC, not any State Information Commission. Persistent non-response can attract a penalty of up to ₹25,000 on the CPIO under Section 20 of the RTI Act.