About the Committee

It is mandatory, as per the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, Indian Council of Medical Research (ICMR), Government of India that all proposals on biomedical research in Bharathidasan University involving human participants should be cleared by the Institutional Ethics Committee, in this case, the BDU-IEC to safeguard the welfare and the rights of the participants. The IEC is entrusted not only with the initial review of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring of the approved programs to foresee the compliance of the ethics during the period of the project.

The basic responsibility of the IEC is to ensure a competent review of all ethical and technical aspects of the project proposals received by it in an objective manner. IEC will provide advice to the researchers on all aspects of the welfare and safety of the research participants after ensuring the scientific soundness of the proposed research. The major aspects that BDU-IEC focusses on are as follows:

• 1. To ensure that any research using human beings as participants in Bharathidasan University shall follow the standards and principles prescribed for such trials in the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants given ICMR 2017 Ethical Guidelines and as per Medical Devices Rules 2016.
• 2. To protect the dignity, rights and well-being of the potential research participants.
• 3. To ensure that universal ethical values and international scientific standards are expressed in terms of loal community values and customs.
• 4. To assist in the development and the education of a research community responsive to local health care requirements.

Composition (W.e.f. 27.02.2018)

Submission and Review of applications

Applications for ethical committee clearance should be submitted in the prescribed format to the Member Secretary along with the necessary documents. The applications will be then scrutinized by the Chairperson and the Member Secretary and will be categorized among the three categories as described in the guidelines. The applications shall be then forwarded to IEC members who will have a minimum period of 3 weeks for review. The Committee shall evaluate the possible risks to the participants with proper justification, the expected benefits and adequacy of documentation for ensuring privacy, confidentiality and other legal issues. Following the receipt of comments from the IEC members, the faculty/Principle Investigator will be invited to present and defend his/her proposal in front of the IEC.

An investigator cannot decide whether her/his protocol falls in the exempted category without approval from the IEC.

The IEC shall meet periodically at frequent intervals, to review new proposals, evaluate annual progress of ongoing projects, to review serious adverse event (SAE) reports and assess final reports of all research activities involving human beings through a previously scheduled agenda, amended wherever appropriate.

Note: Research involving stem cells should get prior clearance from Institutional Committee for Stem Cell Research and Therapy (IC-SCRT). Projects involving probiotics should strictly adhere to the ICMR-DBT's "Guidelines for Evaluation of Probiotics in Food" (PDF). Similarly, proposals involving recombinant or potentially infectious organisms should have obtained the Institutional Bio-Safety Clearance (IBSC) prior to submission of application to IEC.

Checklist of documents for submission of applications

• 1. Duly filled and signed application in the prescribed  Format
• 2. Detailed CV of PI and collaborators involved in the work and a clearly defined role of each investigator
• 3. Participant recruitment procedures, brochures, inclusion exclusion criteria for entry of participants
• 4. Volunteer information sheet.
• 5. Consent forms in English and native language (Tamil) of the participant. (Including assent forms where young adults or children are proposed as human participants. The information sheet, consent and assent forms should be in different languages depending upon recruitment criteria. Where documents are translated from the language in which they are written, back-translations shall be provided.)  Format
• 6. Ethical clearance certificate for the project from the participating Institute/Organization (if applicable)  Format
• 7. MoU/MoA signed between PIs and collaborators outside BDU (if applicable)
• 8. Material Transfer Agreement (MTA) for international projects which may involve exchange of human material or data.
• 9. Approval from Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) (if applicable)
• 10. Approval from Institutional Bio-Safety Committee (IBSC) (if applicable)
• 11. A statement of conflicts of interest (if any)
• 12. Bio Banking Repository Committee clearance (if any)
• 13. Compensation, remuneration, reimbursement and information on what is to be done in case of Adverse Event (AE) and Serious Adverse Event (SAE)

Periodic review

The ongoing research may be reviewed at regular intervals of one year as specified in the SOP of the IEC.

Continuing Review

The IEC shall continue reviewing approved projects for continuation, new information, adverse event monitoring, follow-up and later after completion if need be.

Intrim Review

In special circumstances, IEC shall decide when an interim review can be resorted to by a sub-committee instead of waiting for the scheduled time of the meeting like re-examination of a proposal already examined by the IEC or any other matter which should be brought to the attention of the IEC. However, decisions taken shall be brought to the notice of the main committee.

Monitoring

Once the IEC gives a certificate of approval it is the duty of the IEC to monitor the approved studies, therefore an oversight mechanism shall be in place. Actual site visits can be made especially in the event of reporting of adverse events or violations of human rights. Additionally, periodic status reports shall be asked for at appropriate intervals based on the safety concerns as specified in the SOP of the IEC. SAE reports from the site as well as other sites are reviewed by IEC and appropriate action taken when required.

•  Download the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants
•  Download the Medical Devices Rules 2016
•  Download the checklist for submission of proposal for IEC clearance.
•  Download the annual progress report form

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