Institutional Ethics Committee

It is mandatory, as per the Chapter II of the ICMR Ethical Guidelines for Biomedical Research On Human Participants that all proposals on biomedical research in IIT Madras involving human participants should be cleared by an appropriate the Institutional Ethics Committee, in this case, the IEC - IITM 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 programmes 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 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 through appropriate Technical Review Committee.

The major aspects that IITM-IEC focusses on are as follows:

 

1.    To ensure that any research using human beings as participants in IITM shall follow the standards and principles prescribed for such trials in the ICMR Ethical Guidelines for Biomedical Research on Human Participants, 2006; and

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 local community values and customs.

4.    To assist in the development and the education of a research community responsive to local health care requirements.

 

Composition

IITM-IEC is multidisciplinary and multisectorial in composition. The composition of the IITM-IEC committee with effect from 01-01-2016 is as follows:

 

·         Dr. Subbulakshmy Natarajan        – Chairperson

·         Dr. S. Krishnakumar                        – Member

·         Dr. R. Ramakrishnan                      – Member

·         Dr. K. Prabakaran                            – Member

·         Ms. Swapna Sundar                       – Member

·         Dr. Shobha Raghuram                   – Member

·         Mrs. Radhika Ethayaraja                – Member

·         Swami Athmashraddanandaji       – Member

·         Ms. Tara Gandhi                              – Member  

·         Dr. Madhulika Dixit               – Member Secretary

Review Procedures

The IEC shall review every research proposal for biomedical research on human participants in accordance with the SOPs to be formulated, prior to initiation of the research. It shall ensure that a scientific evaluation has been completed before ethical review is taken up. 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 the justice issues. The IEC’s member-secretary or secretariat shall screen the proposals for their completeness and depending on the risk involved categorize them into three types, namely, exemption from review, expedited review and full review (See Ethical Guidelines for Biomedical Research on Human Participants, 2006 Page 11-15).

An investigator cannot decide that her/his protocol falls in the exempted category without approval from the IEC. All proposals will be scrutinized by the secretariat to decide under which of the three categories it will be considered.

 

Submission of applications

Applications for ethical committee clearance and technical committee (contact: Prof. R.S. Verma, Biotechnology department) clearance should be submitted simultaneously. The applications will be then scrutinized by the Chairperson and the Member Secretary and categorize it among the three categories as described above. The applications shall be then forwarded to IEC members who will have a minimum period of 3 weeks for review. IEC will immediately (in a week’s time) conduct a meeting for ethical clearance to the projects that have obtained technical clearance.

Note:Research involving stem cells should get prior clearance from Institutional Committee for Stem Cell Research and Therapy (IC-SCRT). Projects involving probiotics shouldstrictly adhere to the ICMR-DBT’s “Guidelines for Evaluation of Probiotics in Food” (PDF).

 

Checklist for submission of applications

Checklist for submission of documents for IEC approval:

·         A copy of the project proposal in the prescribed format (Enclosed below)

·         Technical Committee approval letter along with the comments and responses

·         Detailed CV of PI and collaborators involved in the work and a clearly defined role of each investigator

·         Participant recruitment procedures, brochures, inclusion exclusion criteria for entry of participants

·         Format of volunteer information sheet and consent form (Including assent forms where young adults or mature 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.)

·         Ethical clearance certificate for the project from the participating Institute/Organization (if applicable)

·         MoU/MoA signed between PIs and collaborators outside IIT (if applicable)

·         Approval from Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) (if applicable)

·         A statement of conflicts of interest (if any)

·         Bio Banking Repository Committee clearance (if any)

·         Compensation, remuneration, reimbursement and information on what is to be done in case of Adverse Event (AE) and Serious Adverse Event (SAE)

 

Review process

The IEC shall meet periodically at frequent intervals, in accordance with the frequency stipulated in the SOP, to review new proposals, evaluate annual progress of ongoing ones, 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.

 

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.

 

Interim 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 EC and appropriate action taken when required.

·         To download the SOPs for IEC-IITM, click here.

·         To download the ethical guidelines for biomedical research involving human participants by ICMR, click here.

·         To download the prescribed format for proposals, click here.

·         To download the checklist for submission of proposal for IEC clearance, please click here.

·         To download the annual progress report form, click here



 

 

For more details, contact

 

Institutional Ethics Committee
IC& SR Building 2nd Floor,
IIT Madras, Chennai 600 036

 

Phone: +91 (44) 2257 4929
E-mail:
iec@iitm.ac.in

 

Prof. Sathyanarayana N. Gummadi
Member Secretary, IEC
Applied and Industrial Microbiology Laboratory, IIT Madras, Chennai 600 036
Phone: +91 (44) 2257 4114; Fax: 4102

 

 

 

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