Chapter 4: Ethical clearance procedure
4.3 Prepare
1. Research proposal, copies with name of applicant and institute.
2. Curriculum vitae of investigator.
3. Approval of head of department or institution.
4. Ethical issues in the study and plan to address them.
5. Informed consent
6. All relevant pre clinical animal data, and clinical trial data from other
centers.
7. Any regulatory clearance.
8. Source of funding and financial requirements for the project.
9. Other financial issues including those related to insurance
10.An agreement to report only Serious Adverse Events (SAE) to
institutional ethical committee.
11.Statement of conflicts or of interest, if any.
12. Agreement to comply with the relevant national and applicable
international guidelines.
13. A statement describing any compensation for study participation
(including expenses and access to medical care) to be given to
research participants.
14. A description of the arrangements for indemnity, if applicable (in
study-related injuries).
15. A description of the arrangements for insurance coverage for research
participants, if applicable.
16. All significant previous decisions(e.g., those leading to a negative
decision or modified protocol) by other ethical committee or regulatory
authorities for the proposed study (whether in the same location or
elsewhere) and an indication of the modification(s) to the protocol
made on that account. The reasons for negative decisions should be
provided.
17. Plans for publication of results – positive or negative- while
maintaining the privacy and confidentiality of the study participants.
18. Any other information relevant to the study.
4.4 Elements of ethical review
1. Ethical issues in the design of the study.
2. Examination of predictable risks/harms.
3. Examination of potential benefits.
4. Procedure for selection of subjects in methodology including inclusion/
exclusion, withdrawal criteria and other issues like advertisement details.
5. Management of research related injuries, adverse events.
6. Compensation provisions.
7. Justification for placebo in control, if any.
8. Availability of products after the study, if applicable.
9. Patient information sheet and informed consent form in local language
(See chapter 5).
10. Protection of privacy and confidentiality.
l1. Involvement of the community, wherever necessary.
12. Plans for data analysis and reporting.
13. Adherence to all regulatory requirements and applicable guidelines.
14. Competence of investigators, research and supporting staff.
15. Facilities and infrastructure of study sites.
16. Criteria for withdrawal of patients, suspending or terminating the study.
4.5 Application
1. Apply to the NHREC secretariat with all the required documents.
2. Reviewal expenses fees should be paid.
3. Receival letter accrediting application will be issued.
4. The researcher will be informed about the date of the committee
meeting so as to be available for any clarification.
4.6 Review procedures
1. The meeting of the NHREC should be held on scheduled intervals as prescribed
and additional meetings may be held as and when the proposals are received for
review.
2. The Directorate of Research will submit the research proposals for technical
review one month before submission to the ethics committee.
3. Scientific approval will be made according to the technical guidelines.
4. Two members from the national ethics committee will be assigned by the
raporteur to review proposals in details.
5. A report about the ethically reviewed proposals will be presented by the two
members to the full members of the committee and will be sent to members at
least 2 weeks in advance.
4.7 Expedited review
The committee may delegate a mini-committee of five of its specialized members for the tentative approval of the research that requires issuance of the ethics license urgently, provided that shall take place at the recommendation of the committee reporter and after getting the approval of the committee’s chairman or who represents him and the research proposal shall be presented in the nearest meeting of the committee.
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4.8 Decision making
1. Members will discuss the various issues before arriving at a consensus
decision.
2. A member should withdraw from the meeting during the decision
procedure concerning an application where a conflict of interest arises and
this should be indicated to the chairperson prior to the review of the
application and recorded in the minutes.
3. Decisions will be made only in meetings where quorum is complete.
4. Only members can make the decision. The expert consultants will only
offer their opinions.
5. Decision may be to approve, reject or revise the proposals. Specific
suggestions for modifications and reasons for rejection should be given.
6. In cases of conditional decisions, clear suggestions for revision and the
procedure for having the application re-reviewed should be specified.
7. Modified proposals may be reviewed by an expedited review committee
members.
8. Procedures for appeal by the researchers should be clearly defined.
4.9 Communicating the decision
1. Decision will be communicated by the rapporteur in writing.
2. Suggestions for modifications, if any, should be sent by NHREC.
3. Reasons for rejection should be informed to the researchers.
4. The schedule / plan of ongoing review by the NHREC should be communicated to the Principle investigator.
4.10 Follow up procedures
1. Reports should be submitted at prescribed intervals for review.
2. Final report should be submitted at the end of the study.
3. All SAEs and the interventions undertaken should be reported.
4. Protocol deviation, if any, should be informed with adequate
justifications.
5. Any amendment to the protocol involving new ethical issues should
be resubmitted for renewed approval.
6. Any new information related to the study should be communicated.
7. Premature termination of study should be notified with reasons
along with summary of the data obtained so far.
8. Change of investigators / sites should be informed.
