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
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
Member-Secretary (from RCB)
Authority under which EC is constituted
The Executive Director of the RCB will constitute the Institutional Ethical Committee.
Members of the EC should declare any conflict of interest related to any discussed/approved proposals.
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.
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.
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.
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.
All research proposals should be submitted with the following documents:
Any other information relevant to the study.
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:
Availability of products after the study, if applicable
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.
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:
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.