Elements of Ethical Review of Study Documents Dr.C.H.Shashindran Director-Professor & Head Department of Pharmacology JIPMER

Review  All properly submitted applications should be reviewed in a timely fashion and according to an established review procedure.

ECs should meet regularly on scheduled dates that are announced in advance. The meeting requirements should include the following: 1. Meetings should be planned in accordance with the needs of the workload 2. EC members should be given enough time in advance of the meeting to review the relevant documents 3. Meetings should be minuted; there should be an approval procedure for the minutes; Contd… Meeting Requirements

4. The applicant, sponsor, and/or investigator may be invited to present the proposal or elaborate on specific issues 5. Independent consultants may be invited to the meeting or to provide written comments, subject to applicable confidentiality agreements. Meeting Requirements

Elements of the Review The primary task of an EC lies in the review of research proposals and their supporting documents, with special attention given to »The informed consent process » Documentation »The suitability » Feasibility of the protocol.

Elements of the Review –Scientific Design and Conduct of the Study –Recruitment of Research Participants –Care and Protection of Research Participants –Protection of Research Participant Confidentiality –Informed Consent Process –Community Considerations

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

Criteria for prematurely withdrawing research participants Criteria for suspending or terminating the research as a whole The manner in which the results of the research will be reported and published Scientific Design and Conduct of the Study

Recruitment of Research Participants The characteristics of the population »gender, »age, »literacy, »culture, »economic status, »ethnicity The means of – initial contact and recruitment –Conveying information Inclusion & exclusion criteria for research participants;

Care and Protection of Research Participants The suitability of the investigator(s)’s –qualifications and experience Any plans to withdraw or withhold standard therapies and the justification The medical care to be provided to research participants during and after the course of the research; Contd…

The adequacy of medical supervision Steps in case of voluntary with-drawal The arrangements for informing family doctor Description of any plans for continued care Care and Protection of Research Participants Contd…

The rewards and compensations for research participants » Money » services » Gifts The provisions for compensation/treatment The insurance and indemnity arrangements Care and Protection of Research Participants

Protection of Research Participant Confidentiality A description of the persons who will have access to personal data and biological samples The measures taken to ensure the confidentiality and security of personal information

Informed Consent Process A full description of the process including the identification of those responsible for obtaining it The adequacy, completeness, understandability of written and oral information Clear justification for the intention to include in the research individuals who cannot consent

Community Considerations The impact and relevance of the research on the local community The steps taken to consult with the concerned communities during the course of designing and course of research A description of the availability and affordability and accessibility of the successful study product to the community

DECISION-MAKING Any member with conflict of interest should not take part. Only ethics committee members should take part. Only members who participate in the review should participate in the decision; Contd…

There should be a predefined method for arriving at a decision –by consensus, –by vote It is recommended that decisions be arrived at through consensus, where possible; When a consensus appears unlikely, it is recommended that the EC vote; DECISION-MAKING Contd…

DECISION-MAKING Decision should be communicated within two weeks of the meeting In the case of a negative decision, clearly stated reason (s) for the negative decision;

EC Decision Matrix BENEFICENCEJUSTICE RESPECT FOR PERSONS  Privacy & Confidentiality  Protection of subjects (especially vulnerable populations)  Informed consent  Surrogate consent  Assent  Risk/Benefit Analysis  Experimental Design  Qualifications of PI  Subject selection  Inclusion/exclusion  Recruitment J. Cooper, Albany Medical Center