Review PROCESS, decision making PROCESS and communication BY

Review PROCESS, decision making PROCESS and communication BY ethics committee Dr. Reneega Gangadhar, Professor & Head Department of Pharmacology Govt. Medical college Trivandrum

Outline Review process Meeting requirements for review Elements of review Decision making process Communication from EC to Principal investigator DCGI Participant Reporting timelines of SAE

The Twin Pillars of Protection in Biomedical Research

Does this research study have adequate concern for the safety and welfare of its participants? REVIEW PROCESS

Review Process Scientific evaluation before ethical review Method of review should be stated in the SOP All reviewers Primary reviewers EC should approve proposals before initiating the study Ethical review through formal meetings and decision not through circulation of proposals

REVIEW PROCESS- BEFORE MEETING The member secretary shall screen the proposals for their completeness Based on the risk involved categorize them into three types exemption from review expedited review and full review

Exemption from Review Studies which present less than minimal risk to subjects do not require review Whether a proposal is exempt from review or not is decided by EC and not by the investigator

Expedited Review Process Expedited review is done by the Member secretary and Chairperson/member nominated by the Chairperson Minutes of expedited review is ratified in full review If consensus is not reached the Chairperson reverts the study back for a full review

Administrative amendments for expedited review Inclusion or deletion of name/s of coinvestigator(s) Request for change in PI or hand over of trials/ projects Minor amendments in the protocol, CRF Change in contact details of PI and EC Chairperson/member secretary provisionally approve & decision ratified at next full review

Full Review - Meeting Requirements ECs should meet regularly on scheduled dates Meetings should be planned according to the workload EC members should be given sufficient time for reviewing the relevant documents

Full Review - Meeting Requirements The investigator may be invited to present the protocol or provide clarifications in the meeting or respond to queries raised by committee Subject experts could be invited They should not take part in decision making process

Full Review During Meeting Review new proposals Evaluate annual progress of ongoing projects and final reports of all protocols Review serious adverse event (SAE) report

Elements of Review During Meeting Scientific Design and Conduct of the Study Selection of participants & their protection Informed consent process Protection of their privacy & confidentiality Community considerations

Scientific Design and Conduct of Study The appropriateness of study design methodology sample size calculation The justification of Risk benefit ratio Use of control arms

Selection of Participants Purpose of equitable participant selection is to ensure Distributive justice : risks of research are spread out over groups of individuals who are expected to benefit from the findings EC will scrutinize eligibility criteria and recruitment methods

Protection of Research Participants EC should ensure the suitability of the investigator(s) s qualifications and experience

Protection of Research Participants EC should ensure risks to participants are justified & minimized if possible expected benefits, any undue inducement provisions for compensation in SAE /treatment in case of injury clearances from regulatory authorities DCGI, BARC etc. Registration in CTRI

Protection of Research Participants Conduct continuing reviews of ongoing trials at intervals For continued protection of the rights and welfare of research subjects. address a wide range of issues new information which may affect participants no. of participants enrolled adverse events reporting protocol deviations need for changes to ICD

Protection of Research Participant s Confidentiality Ensure that subjects' privacy & confidentiality are protected to prevent Identification of the participants Especially related to safeguarding research data While publishing data it should be taken care of

Informed Consent Process EC should ensure Sufficient information given to participant informed consent is obtained or appropriately waived and documented

Community Considerations In order to respect and protect communities EC should examine whether any negative effects on communities such as stigma are minimized ensure promoting positive effects on communities

DECISION MAKING PRocess A decision should not be kept pending for more than 3-6 months This may be defined in the SOP

Decision Making Process Decisions taken preferably by a broad consensus after quorum requirements are fulfilled to recommend recommend with suggestions reject for unethical study When a consensus appears unlikely, then decision may be taken by majority vote

Decision Making Process Any conflict of interest (COI) of a member involving a project submitted in writing to the chairperson before review meeting recorded in the minutes If any member has his own proposal for review or has any COI then he should withdraw from EC while the project is being discussed

Decision Making Process Only members who review should participate A negative decision should always be supported by clearly defined reason EC may decide to reverse its positive decision on a study if it receives information that may adversely affect the risk/ benefit ratio Analyzes SAE & gives opinion on compensation

Decision Making Process EC would order the trial to be discontinued if it finds that the goals of the trial have already been achieved midway or unequivocal results are obtained In case of premature termination of study - reasons Meetings are to be minuted, approved and signed by Chairperson

Communication from EC to PI, DCGI, and participant

Communication from EC to PI Seek clarifications if any from PI Based on SOP invite PI to present EC should be informed any amendments to protocol /ICD with proper justification protocol deviation/ violations serious and unexpected AEs any new information that may influence study study discontinuation with reasons

Communication from EC to PI Member secretary communicates decision in writing within a reasonable time Reasons for rejection Suggestions for modifications, if any If proposal requires waiver of review/ consent

Communication from EC to PI The schedule / plan of ongoing review by EC The report of the trial status annually or more frequently if requested Final report on completion/ termination of the project

Communication from EC to DCGI EC shall forward its report on serious adverse event to DCGI, after due analysis along with its opinion on financial compensation to be paid by sponsor within 21 days(30 days w.e.f 13 th May 2015) Any change in composition of Ethics Committee Change of PI

Communication from EC to Research Participants In the event of written complaint received from patient an expedited or full committee meeting to be held based on the EC SOP Decision taken will be communicated in writing and redressal action taken in consultation with institutional head

Communication from EC to Research Participants l When a participant raises doubts about a protocol or its practice... l Answer all the questions honestly and fully, in a language that she/ he can understand

Reporting Timelines for SAE Who to Whom? When? Investig ator Spons or EC Investigator Spo nsor EC DCGI, EC, Head of Instituti on Sponsor DCGI, EC, Head of Instituti on DCGI [Chairma n of Exp. Committe e For death case] Initial: <24hr s Full report: within 10/ 14 calend ar days 10/ 14 calen dar days 21/ 30 calen dar days 1/29/2015 35

Format for Approval of Ethics Committee

Steps In IEC Review http://icmr.nic.in/bioethics/cc_biothics/presentations/haryana/session11.pdf

Conclusion EC should evaluate the possible risks to the participants These risks should be justified The expected benefits should be looked into EC should evaluate documents to ensure privacy, confidentiality and justice issues

Thank You