Research ethics approval procedure

Ross Woods, 2020, '21

1. When a research supervisory committee has given preliminary approval to a research proposal, its chairperson shall send the proposal to the members of the Institutional Review Board (IRB) members.
2. The IRB chairperson shall appoint a subcommittee and a subcommittee chairperson to evaluate the proposal.
3. Within seven days, each subcommittee member shall:
   1. evaluate the proposal and
   2. recommend in writing a decision to other subcommittee members with the reasons for their recommendation. They may include advice on improvements and corrections.
4. As a minimum, the subcommittee must evaluate each of the following:
   1. Procedural compliance with legislation (Part 46—Protection of Human subjects).
   2. Research is one of the categories of research auspiced by the institution.
   3. Subjects are not placed at undue risk.
   4. Subjects will receive appropriate information before being asked to give consent.
   5. Subjects will voluntarily agree to participate in writing.
   6. Subjects may withdraw at any time without penalty.
   7. Subjects' identities will be removed from the data.
   8. Subjects cannot be re-identified from the data.
   9. Data will be secure.
   10. Data will be be destroyed or deleted after a specified period.
5. The proposed research meets any other applicable standards. (E.g. specific professions, specific organizations, non-US requirements for research done outside the U.S.)
6. Their recommendations shall be one of the following:
   1. Expedited and approved: The proposed research does not involve individual subjects and is not subject any other ethical standards. (For example, it involves only documentary studies or analysis of existing data sets.)
   2. Approved: The proposed research clearly complies with ethical standards and has no issues of concern and no unacceptable risks.
   3. Approved: The proposed research is approved subject to specific conditions.
   4. Rejected: The proposed research does not clearly comply with ethical standards.
   5. Rejected: The proposed research might comply with prescribed ethical standards but has other issues of concern and/or unacceptable risks.
7. If any subcommittee member recommends a rejection for any reason, other subcommittee member shall respond in order to achieve a consensus decision.
8. The subcommittee chairperson shall determine when a consensus has been attained.
9. When a consensus decision has been attained, the subcommittee chairperson shall refer the proposal and recommendation to the IRB.
10. The IRB will make the final decision and enter it in its formal records.
11. The IRB chairperson shall inform the researcher and the chairperson of the research supervisory committee of the IRB’s decision in writing and the reasons for the decision.
12. The IRB shall add any new lessons learned to a document of satisfactory and unsatisfactory practices in research ethics.

Comments

The IRB, not the subcommittee, must make the final decision. However, subcommittees can be necessary for several reasons:

1. Subcommittees can collaborate, so that evaluations are not left to individuals to work alone.
2. Subcommittees are necessary when they need expertise in various specific fields.
3. Subcommittees are necessary when the workload is too large for all the IRB members to do as a committee.
4. Some subcommittee members have a specific field of expertise as a condition of appointment to their position.