1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to describe which clinical research projects can be exempted from ethics review and do not require the approval of the Medical Research Ethics Committee (MREC). The Exemption Form AX 01/SOP 05-C/V5 is designed to standardize the process of exemption.

2. Scope

This SOP applies to the all protocols submitted for exemption from review by the MREC. The specific points in the Exemption Form should guide the Chairperson of MREC to determine whether the protocol qualifies for exemption from review. The decision should be taken by the Chairperson in consultation with the Vice Chairperson and should be informed to the Members in the forthcoming MREC meeting.

3. Responsibility

It is the responsibility of the MREC Chairperson or whom he/ she will delegate to consider the decision in the Exemption Form with reasons. The MREC Secretariat is responsible for recording and filing the decision including the reasons for that decision. The Chairperson/ Vice Chairperson must sign and date letter conveying the decision AX 01/SOP 05-C/V5.

4. Flow chart

5. Detailed instructions

5.1  Receive the submitted documents

• The Secretariat will receive the Exemption from review Application Form AX 01/SOP 05-C/V5,

Protocol and other documents submitted by the investigators.

5.2  Determining the protocols eligible for exemption from review

The proposal submitted for initial review or where investigator have requested for the exemption from review stating the reason in the ‘Review Exemption Application Form’ to the MREC will be evaluated for the exemption from review.

Proposals which involve less than minimal risk fall under this category.

Minimal risk would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities of the general population or during the performance of routine physical or psychological examinations or tests. However, in some cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but this may be within the range of minimal risk for the research participant undergoing these interventions since it would be undertaken as part of current everyday life.

The MREC Member will determine whether a protocol qualifies for exemption from review based on the following criteria. Final decision will be made by the Chairperson.

The research proposals which do not involve live human participants or data derived from them are exempt from ethics review. For example,

• Audits of educational practices
• Experimental Research on non-human non-animal cells
• Research on microbes cultured in the laboratory
• Research on immortalized cell lines
• Analysis of data freely available in public domain

In some circumstances research which appears to meet low risk criteria may need to be reviewed by the MREC. This might be because of requirements of:

• The publisher of the research
• An organization which is providing funding resources, existing data, access to participants etc.

5.3 Recording the decision on Exemption Form in consultation with the Chairperson

• If the protocol and related documents satisfy the criteria as listed in 5.2, the assigned Member in consultation with the Chairperson will review the brief summary of the project and the Exemption Form. The Member will record the decision

5.4  Communicate the decision to the Investigator & MREC members in forthcoming meeting

• The reviewing member will communicate the decision to the Principal Investigator within 5 working days after the decision regarding the exemption is taken.
• The reviewing member will inform the MREC members about the decision at the next full board meeting and minute it in the meeting notes.
• The reviewing member / Chairperson may keep the application for review and decision regarding exemption at the next full board meeting.
• Any changes to the protocol must be brought to the notice of the MREC prior to implementation by the investigator. Any correspondence with the MREC office regarding this action should mention the allocated study number indicated at the top of this letter. The MREC will determine if requested protocol changes alter the risks: benefits analysis of the study, thereby requiring a change in review or exemption category. In such cases investigator will have to resubmit the study protocol and related documents for change review process.

6. Glossary

Exemption from review: A research study is said to be exempt from review when it does not require the Medical Ethics Committee approval for its conduct

7. References

[1]WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (6^th September 2022)

8. Annexure

Annexure 1     AX 01/SOP 05-C/V5     Application for Review Exemption Form

Annexure 2      AX 02/SOP 05-C/V5     Approval of Exempt Review Document

Please check that your application / summary has discussed:

• Procedures for voluntary, informed consent
• Privacy & confidentiality
• Risk to participants
• Needs of dependent persons
• Conflict of interest
• Permission for access to participants from other institutions or bodies
• Inducements

In some circumstances research which appears to meet low risk criteria may need to be reviewed by the MREC. This might be because of requirements of:

• The publisher of the research
• An organization which is providing funding resources, existing data, access to participants etc.

N.B.: No research can be counted as low risk if it involves:

1. Invasive physical procedures or potential for physical harm
2. Procedures which might cause mental/emotional stress or distress, moral or cultural offence
3. Personal or sensitive issues
4. Vulnerable groups
5. Cross cultural research
6. Investigation of illegal behavior(s)
7. Invasion of privacy
8. Collection of information that might be disadvantageous to the participant
9. Use of information already collected that is not in the public arena which might be disadvantageous to the participant
10. Use of information already collected which was collected under agreement of confidentiality
11. Participants who are unable to give informed consent
12. Conflict of interest e.g., the researcher is also the lecturer, teacher, treatment-provider, colleague or employer of the research participants, or there is any other power relationship between the researcher and the research participants.
13. Deception
14. Audio or visual recording without consent
15. Withholding benefits from “control” groups
16. Inducements
17. Risks to the researcher

This list is not definitive but is intended to sensitize the researcher to the types of issues to be considered. Low risk research would involve the same risk as might be encountered in normal daily life.