People’s College of Dental Sciences and Research center has  Ethics committee and is presently function according to the requirements laid down in Schedule Y and are guided by the ICH-GCP guidelines, Ethical Principles set forth in the Declaration of Helsinki and the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) and National Ethical Guidelines for Bio-Medical Research Involving Children laid down by the Indian Council of Medical Research.

Those involved in research are required to abide to Guidelines on Code of Conduct for Research Scientists engaged in field of Life Sciences and should know Guidelines for Good Clinical (Laboratory) Practices.

For Good Clinical (Laboratory) Practices training certificate, Investigator can refer to following website: https://gcp.nidatraining.org/

For Online Health Research Fundamental Course, Students, faculties and investigator can refer to following website- https://swayam.gov.in

Member of Ethics Committee:

 

Process of obtaining the Ethics committee approval of Research Project:

Application Process
1. Principle investigator have to submit duly signed application form (Form)  and synopsis proforma (1 Hard copy)  to Institutional ethics committee through the Head of the Departments / Institution ( after obtaining the Institutional Research advisory committee approval)
Format A. Format for preparation of synopsis of Thesis/Dissertation study (for submission to University)- download
Format B. Format for preparation of synopsis of Research project other than Thesis and Dissertation–download
2. The date of meeting will be intimated to the Principle investigator/researcher, to be present, if necessary to offer clarifications.
3. The decision will be communicated in writing. If revision is to be made, the revised document in required number of copies should be submitted within a stipulated period of time as specified in the communication or before the next meeting.
4. Prescribed fee if any, should be remitted along with the application.

Review procedures: (Flow chart for Ethics Review Process of Research Project)
1. The meeting of the IEC 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 proposals will be circulated to members at least 2 weeks in advance.
3. Decisions will be taken by consensus after discussions, and whenever needed voting will be done.
4. Researchers will be invited to offer clarifications if need be.
5. Independent consultants/Experts will be invited to offer their opinion on specific research proposals if needed.
6. The decisions will be minuted and Chairperson’s approval taken in writing.

Element of review:
Ethics committee will consider following elements but not limited to them for review 
1. Scientific design and conduct of the study.
2. Approval of appropriate committees as per need of study.
3. Examination of predictable risks/harms.
4. Examination of potential benefits.
5. Procedure for selection of subjects in methodology including inclusion/ exclusion, withdrawal criteria and other issues like advertisement details.
6. Management of research related injuries, adverse events.
7. Compensation provisions.
8. Justification for placebo in control arm, if any.
9. Availability of products after the study, if applicable.
10. Patient information sheet and informed consent form in local language.
11. Protection of privacy and confidentiality.
12. Involvement of the community, wherever necessary.
13. Plans for data analysis and reporting
14. Adherence to all regulatory requirements and applicable guidelines
15. Competence of investigators, research and supporting staff
16. Facilities and infrastructure of study sites
17. Criteria for withdrawal of patients, suspending or terminating the study

Expedited review:
All revised proposals, unless specifically required to go to the main committee, will be examined in a meeting of identified members convened by the Chairman 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:
1. Members will discuss the various issues before arriving at a consensus decision (minimum quorum requirement will be followed as per ICMR guideline for decision making).
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 will be given.
6. In cases of conditional decisions, clear suggestions for revision and the procedure for having the application re-reviewed will be specified.
7. Modified proposals may be reviewed by an expedited review through identified members.

Communicating the decision:
1. Decision will be communicated by the Member Secretary in writing.
2. Suggestions for modifications, if any, should be sent by IEC.
3. Reasons for rejection should be informed to the researchers.
4. The schedule / plan of ongoing review by the IEC should be communicated to the PI.

Download for Investigators: