Fundamentals of IRB Review

Regulatory Role of the IRB• Authority to approve, require modifications in (to secure

approval), or disapprove all research activities covered by this policy.

• Require that information given to subjects as part of informed consent is in accordance with §46.116.

• Require documentation of informed consent or may waive documentation in accordance with §46.117.

Regulatory Role of the IRB• Notify investigators and the institution in writing of its

decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity.

• Conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

• Determine whether research meets the criteria for approval.

Criteria for Approval

• Foundation of IRB review• IRB must determine that all of the

requirements are satisfied • If not, research must be tabled or

disapproved

• Criteria for approval should be considered for every action (NS, AMD, CR)

• All IRB provisions should be founded in the criteria for approval

Criteria for Approval1. Risks to subjects are minimized:

• (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and

• (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. • Consider only those risks and benefits that may result from the

research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).

• The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

Criteria for Approval3. Selection of subjects is equitable. In making this assessment the IRB

should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.

• Unless the IRB approves a waiver or modification of consent.

5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

• Unless the IRB approves a waiver of documentation of consent

6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

Approval

• Requires majority vote of quorum• Quorum: majority of members present,

including one nonscientist

• Voting:• Calls For, Against, Abstained• Consensus is not required• If you disagree with any part of the motion,

please vote against

Approval• IRB can determine and document that the criteria for

approval are met• Provisional approval is an approval – criteria must be met

• Some revisions may be requested (PA):• Confirmation of specific assumptions or understandings on the part of

the IRB regarding how the research will be conducted (e.g., confirmation that the research excludes children);

• Submission of additional documentation (e.g., certificate of ethics training);

• Precise language changes to protocol or informed consent documents; or

• Substantive changes to protocol or informed consent documents along with clearly stated parameters that the changes must satisfy.

Table/Disapprove• IRB cannot determine that criteria for approval

are met• Specifically:

• is unable to make the required determinations about research risks and benefits, the adequacy of privacy and confidentiality protections, or the adequacy of the informed consent process because the research protocol provides insufficient information related to these aspects of the research, and

• is unable to specify changes to the research protocol that if made would allow the IRB to make these required determinations.

• IRB can approve some components and table/disapprove others

Procedures for Tabled Studies

• At meeting: IRB member designated by Board to be available to study team for consultation regarding Board’s provisions

• After meeting: • HSO staff will draft minutes within 48 hours of meeting

and send to designated IRB member for review and approval

• IRB member asked to provide any feedback to HSO staff within 24 hours

• Minutes sent to study team by HSO staff

Procedures for Tabled Studies• After minutes are sent:

• HSO staff will request availability from study team for conference with IRB member

• HSO staff will coordinate phone conference if desired by study team (typically within 1 week of meeting)

• Review of response:• Response must be sent to next IRB meeting – may be

posted up to 4 days before meeting• Study team encouraged to attend meeting where tabled

response is discussed to address any questions or concerns of Board

• If response cannot be Provisionally Approved or Approved, study will be disapproved at second review

Takeaways

• Focus on the criteria for approval when reviewing research protocols

• Should dictate whether a protocol is provisionally approved or tabled

• Should be the basis for all provisions• Changes to the RVC coming in April