# Presentation: 602937

## Core IRB Responsibilities

- 	Marisue Cody, PhD
- 	November 15, 2006
- 	Washington, DC

## Objectives

- Review findings from AAHRPP site visits regarding VA IRBs
- Describe what needs to be in IRB Standard Operating Procedures
- Examine areas of IRB Chair responsibilities

## What is covered? 

- All research involving human subjects that is conducted completely or partially in VA facilities, conducted in approved off-site locations, facilities, and/or conducted by VA researchers while on official VA duty time.

- VHA Handbook 1200.5, p. 6, Scope

## Research

- 38 CFR 16.102(d)

## Human subject

- ...means a _living individual_ about whom an investigator (whether professional or student) conducting research obtains(1) data through intervention or interaction with the individual, or
- (2) identifiable private information

## Policies and Procedures

- Describe your process to provide determinations:
- When to ask
- What information to submit
- The persons/offices that have the authority to make a determination
- Criteria by which determinations are made
- Communication of the decision

## Conflict of Interest

- Does the IRB have to review ALL financial disclosure forms?

## COI Regulations

- The IRB must ensure that steps to manage, reduce or eliminate potential or real conflicts of interest (financial, role (investigator/patient relationships), and/or institutional) have been taken.

- VHA Handbook 1200.5, p. 12

## Policies and Procedures

- Describe how the organization evaluates conflicting interests
- Describe the COORDINATION with the IRB for the disclosure, evaluation, and management of conflicts of interest
- Describe when disclosure of an investigator’s COI to participants during the consent process is appropriate

## Non-compliance

- Does the IRB have to be responsible for:
- Determining whether an allegation is substantiated?
- Managing minor or sporadic non-compliance?
- Reviewing all reports of non-compliance?
- Determining whether non-compliance is serious or continuing?

## Regulations

- Written procedures for ensuring prompt reporting to the IRB...any serious or continuing non-compliance
- Reporting promptly to the IRB regarding non-compliance by study personnel
- Notifying medical center officials and VA Central Office of any instance of serious or continuing non-compliance

- 38 CFR 16.103(b)(5)(i)

- VHA Handbook 1200.5, p. 13-14

## Policies and Procedures

- Define serious, continuing, minor, sporadic non-compliance
**Report** everything to IRB, determine what needs to be **reviewed** by the IRB
- IRB decides whether non-compliance is serious or continuing
- Describe the materials that should be provided to and reviewed by IRB members in its determination

## Reporting Policy

- Who drafts the report
- The content of the report
- Who approves the report
- The distribution of the report
- The maximum time allowed between the recognition of a reportable event and fulfilling reporting requirements
- Coordination with reporting by the affiliate IRB (when appropriate)

## Unanticipated Problems Involving Risks to Participants or Others

- Are adverse event policies sufficient?
- Does the IRB have to see every adverse event and problem?

## Regulations

- ...must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and any supporting department or agency head of any unanticipated problem involving risks to subjects or others.

- 38 CFR 16.103(b)(5)

## Difference between AEs and Unanticipated Problems

## Slide 17

## Policies and Procedures

- Define terms
- Describe types of problems investigators need to report and the timeframe to report
- Describe the review of problems (IRB does not need to review everything)
- Describe materials to be reviewed by IRB
- Also evaluate AEs, complaints, protocol deviations to determine if these were unanticipated problems

## IRB Review Procedures

- Approval criteria for continuing review and modifications
- Materials the IRB members need to make a determination
- Expiration of approved research

## Approval criteria

- Risks to subjects minimized
- Risks reasonable in relation to benefits
- Equitable selection of subjects
- Prospective informed consent
- Document informed consent
- Adequate provisions for safety monitoring
- Adequate provisions to protect privacy and confidentiality
- Protection of Vulnerable Subjects
- 9.   Conflict of Interest
- 10.  Ensure Investigator educational requirements and certifications

- 38 CFR 16.111

- VHA Handbook 1200.5, p. 12

## Policies and Procedures

- Any primary reviewer system used
- A list of specific documents distributed to primary reviewers (if applicable) and to all other IRB members
- Any process (e.g., a subcommittee procedure) that may be used to supplement the IRB’s review
- Specific criteria used to determine which projects require review more often than annually
- Specific criteria used to determine which protocols need verification from sources other than the PI that no material changes occurred since last IRB review

## Materials needed for initial review

- Full protocol
- Proposed consent forms
- Recruitment materials
- Recruitment procedures
- Enrollment procedures
- Selection of participants
- Provisions to protect privacy
- Provisions to protect confidentiality
- Additional safeguard for vulnerable subjects

- Investigator’s brochure
- Any relevant grant applications
- DHHS-approved sample consent and protocol (if one exists

- OHRP Compliance Activities:
- Common Findings and Guidance,
- #3, 14, 15

## Materials needed for continuing review

- Full protocol
- Status report on progress of the research that includes:
- # of subjects accrued
- Adverse events since last IRB review and/or DSMB report
- Any unanticipated problems
- Withdrawal of subjects
- Complaints
- Relevant recent literature

- Interim findings
- Amendments or modifications
- Current approved consent
- Any proposed consents
- Gender & minority status
- # considered vulnerable

- OHRP Compliance Activities:
- Common Findings and Guidance, #5

- VHA Handbook 1200.5, p. 15

## Materials needed for amendments

- Sufficient information about proposed modifications to previously approved research to determine whether the modified research continues to fulfill the criteria for approval, including a complete description of the proposed modification

- OHRP Compliance Activities:
- Common Findings and Guidance,
- #5, #24

## Expiration of approved research

- When does the approval expire?
- Suspension?
- Holds?

## Regulations

- The period of approval for research starts on the date of the convened meeting at which the IRB approved the protocol or approved the research with modifications
- The IRB conducts continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.

- VHA Handbook 1200.5, p. 12;
- OHRP Compliance Activities, #7

- 38 CFR 16.109 (e)

## Policies and procedures

- Define the expiration date
- Last date that the research was approved, or
- First date that the research is no longer approved
- All research activities must stop unless the IRB or IRB chair, in consultation with the COS, found it in the best interest of individual participants to continue
- Investigator must submit to the Chair a list of participants for whom stopping research activities would cause harm

## Suspension or hold?

- Such expiration of IRB approval does not need to be reported to OHRP
- The research is automatically suspended. The local research office is responsible for promptly notifying the PI of the suspension

- OHRP Guidance on Continuing Review

- VHA Handbook 1200.5, p. 15

## IRB Chair responsibilities

- Policies and procedures
- Triage system
- Determinations of the IRB
- Documentation
- Communication

## Slide 30