Objective

• To contribute to the effective functioning of the Ethics Committee (EC)
• To establish a standard, consistent ethical review mechanism for research in health and biomedical sciences involving human subjects.
• To ensure the conduct of research as prescribed by the Ethical guidelines of Indian Council of Medical Research (ICMR) for biomedical research on human subjects.
• It may be ensured that no research proposal shall be started unless Ethics clearance is obtained by the Institution Ethics Committee

No retrospective / post facto Ethics approval can be incorporated to research proposals which was not submitted properly to the Institution Ethics Committee.

Scope of application

• All research proposals / studies involving human subjects conducted at or in collaboration with the Regional Centre for Biotechnology (RCB).

Role of the EC

The EC shall review all research proposals involving human subjects to be conducted at the RCB, irrespective of the funding agency and ensure that the approved studies are conducted according to the ICMR and Good Clinical Practice (GCP) guidelines.

All types of research proposals involving human participants shall be reviewed and approved with the overarching responsibility of safeguarding the dignity, rights, safety and well being of all the study participants/ volunleers.

The EC shall ensure that the cardinal principles of research ethics (autonomy, beneficence, non-maleficence and justice) are considered at every stage, including the planning, conduct and reporting of the proposed studies. Towards this end, the EC shall evaluate the aspects of informed consent process, risk benefit ratio, distribution of burden and benefits, and provisions for appropriate compensations wherever required.

The EC shall review the proposals before start of the study as well as any amendments made in the proposal during the conduct of the study.

The EC will monitor the research throughout the study, until and after completion of the study through appropriate well documented procedures for example half yearly progress reports, annual reports, final reports and site visits if found to be necessary, etc.

The committee shall also examine compliance with all regulatory requirements, applicable guidelines and laws accordingly by the ICMR.

Composition of EC

• The RCB Ethical Committee shall be multidisciplinary and independent with competence as its hallmarks.
• The EC will contain around 9 members with a minimum of 6 and a maximum of 15 members.
• Members of the RCB Ethical Committee shall have individials of clinical, scientific and social activists including the lay public with the majority being from outside the Institute, to reflect the differed viewpoints. The EC should include epidemiologist(s), sociologist(s), lawyer(s), theologian, statistician(s), clinician(s), basic scientists, pharmacist(s)/clinical pharmacologist(s) etc.
• These members shall be appointed by the Executive Director of the RCB based on their competence and integrity, and could be drawn from any public or private Institute from anywhere in the country. However, the Member Secretary, who will conduct the business of the Committee, must belong to RCB. Adequate representation of age, gender, community, etc. shall be ensured in order to safeguard the interests and welfare of all sections of the community / society.
• The Chairperson of the RCB Ethical Committee shall be a nominated member from outside the Institution.
• The suggested composition of the EC may be as follows:

1. Chairperson (nominated from outside RCB)
2. 1-2 basic biomedical scientists
3. 1-2 clinicians from various Institutes
4. One legal expert or retired judge
5. One social scientist / representative of non-governmental voluntary agency
6. One philosopher / ethicist / theologian
7. One lay person from the community

Member-Secretary (from RCB)

Authority under which EC is constituted

The Executive Director of the RCB will constitute the Institutional Ethical Committee.

Membership requirements

• Members shall be appointed for an initial duration of 2-3 years.
• At the end of this tenure, the committee shall be reconstituted with 50% of the new members replaced by a defined procedure of the RCB.
• A member can be replaced in the event of long-term non-availability or death or for any action not commensurate with the responsibilities laid down in the guidelines and deemed unfit for a member.
• A member can tender resignation from the committee.
• All members should maintain absolute confidentiality of all discussions during the meeting and sign a confidentiality form.

Members of the EC should declare any conflict of interest related to any discussed/approved proposals.

Quorum requirements

A minimum of 5 members are required to compose a quorum.

All decisions shall be taken in meetings and not merely by circulation of project proposals except for revised proposals where the Member Secretary may be authorized by the EC to take a decision.

Offices

The meetings of the EC shall be conducted by the Chairperson and, in case of his/her non-availability, the Deputy Chairperson or an alternate Chairperson as elected from the members, by the members present.

The Member Secretary is responsible for organizing the meetings, maintaining the records and communicating with all concerned. He/she will prepare the minutes of the meetings and get it approved by the Chairman before communicating it to the applicants/researchers.

Independent experts

The EC may call upon independent subject experts who may provide special review of selected research protocols, if necessary. These experts may be specialists in ethical or legal aspects, specific diseases or methodologies, or represent specific communities, patient groups or special interest groups; such as cancer, infectious diseases (such as AIDS, etc) or ethnic minorities.

These experts or patient representatives are required to give their specialized views but are not party to the decision making process of the EC.

Application Procedures

All proposals should be submitted to the RCB Ethical Committee in the prescribed application format along with all relevant documents.

Ten hard copies of the proposal along with an electronic version are required to be submitted for review, duly signed by the Principal Investigator (PI) and Co-investigators / Collaborators, and forwarded by the Head of the Institution.

The Principal Investigator may be called upon to present and offer clarifications if required.

The decision of the EC shall be communicated in writing by the Member Secretary to the Principal Investigator.

If revision is to be made, the revised document in required number of copies (including electronic version) should be submitted within a stipulated period of time as specified in the communication or before the next meeting.

No fee shall be prescribed.

Documentation

All research proposals should be submitted with the following documents:

• Name of the applicant (Principal Investigator) with designation and his/her relevant role.
• Names and signatures of all Co-investigators / Collaborators with their designation and relevant roles/responsibilities.
• Curriculum vitae of all the investigators with relevant publications.
• Proposal should be forward by the Head of the Institution.
• Detail research proposal.
• Proposal should be submitted with all relevant enclosures like proformae, case report forms, questionnaires, follow up cards, etc.
• Name of the Institute/ Hospital / Field area where research will be conducted.
• Informed consent process, including patient/volunteers information sheet and informed consent form in English and the local language(s).
• Ethical issues in the study and plans to address these issues.
• For any drug / device trial, all relevant pre-clinical animal data and clinical trial data from other centres within the country or outside the country, if available. All relevant product information, particularly on safety; including the 'product insert'.
• Any regulatory clearances required/ already obtained.
• Source of funding and financial requirements for the project.
• Other financial issues including those related to insurance.
• An agreement to report Serious Adverse Events (SAE) to EC. http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm
• Statement of conflicts of interest, if any.
• An undertaking by the PI to comply with the ICMR as well as international guidelines of biomedical research.
• A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants; a description of the arrangements for indemnity, if applicable (in study-related injuries); a description of the arrangements for insurance coverage for research participants, if applicable.
• Progress/status in process of obtaining ethical clearance from other collaborative institute/institutes.
• All significant previous decisions (e.g. those leading to a negative decision or modified protocol) by other ECs or regulatory authorities for the proposed study (whether in the same location or elsewhere) should be provided; and an indication of the modification(s) to the protocol made on that account. The reasons for negative decisions should also be provided.
• Plans for publication of results (positive or negative) while maintaining the privacy and confidentiality of the study participants.

Any other information relevant to the study.

Review procedures

The meeting of the RCB Ethical Committee should be held as and when the proposals are received for review.

The proposals will be sent to members at least 2 weeks in advance.

Decisions will be taken by consensus after discussions.

Researchers may be invited to offer clarifications if need be.

Independent experts may be invited to offer their opinion on specific research proposals if needed.

Minutes of the decisions shall be kept and the Chairperson's approval taken in writing.

Elements of review

The members of the RCB Ethical Committee shall review every proposal critically, particularly with regard to the following aspects:

• Scientific design and conduct of the study
• Approval of appropriate scientific review committee
• Examination of predictable risks/harms
• Examination of potential benefits
• Procedure for selection of subjects in methodology including inclusion/ exclusion, withdrawal criteria and other issues like advertisement details
• Justification for placebo control, if any
• Patient information sheet and informed consent form in English and local language(s)
• Protection of privacy and confidentiality of study participants
• Involvement of the community, wherever necessary
• Management of research related injuries, adverse events
• Compensation provisions
• Criteria for withdrawal of patients, suspending or terminating the study
• Methods and plan for data analysis and reporting
• Facilities and infrastructure of study sites
• Adherence to the required regulatory requirements and applicable guidelines
• Competence and role of investigators, research and supporting staff

Availability of products after the study, if applicable

Expedited review

Proposals that have been revised and re-submitted shall be examined by an expedited review method, unless specifically required to go to the main committee. This review shall be conducted by a meeting of identified members convened by the Chairperson to expedite decision making. Expedited review may also be taken up in cases of nationally relevant proposals requiring urgent review. The nature of the applications, amendments, and other considerations that will be eligible for expedited review should be specified.

Decision-making

Decisions shall be made only in meetings where quorum is complete.

Members shall discuss the various issues before arriving at a consensus decision.

Only members can make the decision; the independent experts will only offer their opinions.

A member should withdraw from the meeting during the discussion of that proposal concerning an application where a conflict of interest arises. This should be indicated to the chairperson prior to the review of the application, and recorded in the minutes.

Decision may be to approve, reject or revise the proposals. Specific suggestions for modifications and reasons for rejection should be given.

In cases of conditional decisions, clear suggestions for revision and the procedure for having the application re-reviewed should be specified.

Modified proposals may be reviewed by an expedited review through identified members.

Investigators may seek a review/ an appointment to personally present their case before the EC.

Communicating the decision

The Member Secretary shall communicate the decision of the EC to the Principal Investigator in writing. If the proposal has been rejected, reasons for rejection should be informed to the researchers. The communication shall include suggestions for modifications, if any, and the schedule or plan of review.

Follow up procedures

Principal investigators of on-going approved proposals are required to:

• Communicate to EC when the study was initiated (date of receiving sanction order from funding agency)
• Submit reports at half yearly intervals for review (or 4 monthly progress reports if the duration of the study is < 12 months)
• Submit the final report at the end of study
• Intimate all serious adverse events (SAEs) and the steps undertaken to deal with the SAEs
• Inform regarding protocol deviation, if any, with adequate justifications
• Resubmit any amendment to the protocol for renewed approval.
• Communicate any new information related to the study
• Notify regarding premature termination of study, along with reasons, and the summary of the data obtained so far

Inform change of investigators / sites

Record keeping and Archiving

The following records shall be archived at RCB under the supervision of the Member Secretary:

Curriculum Vitae (CV) of all members of EC

Attendance records of the EC members

A copy of all study protocols with enclosed documents, progress reports, and SAEs

Minutes of all meetings duly signed by the Chairperson

Copy of all existing relevant national and international guidelines on research ethics and laws along with amendments

Copy of all correspondence with members, researchers and other regulatory bodies, and

Final report of the approved projects.

Revision of guidelines

Members should discuss any relevant new guidelines that come up from time to time, in order to be aware of the latest developments in this area. They should consider attending national and international training programs in research ethics for maintaining quality in ethical review.