IRB Member Toolbox

Meeting attendance

• All members will receive an email invitation generated through iStar to attend full board committee meetings. Each member is required to respond to the meeting invitation via iStar and indicate whether they will be attending the meeting.
• If you have indicated you will be in attendance, and you cannot make the meeting, please inform Ben Martinez as soon as possible, this allows us to make sure we still have a quorum.

Who will lead the convened meetings?

• Meetings will be led by the Chair assigned to the board unless another Chair is asked to lead the meeting or take over the meeting when/if the assigned Chair becomes indisposed.
• The Associate Director of the IRB or a designee will host or co-host the meeting to ensure that the members are admitted to the meeting, are able to participate successfully, and to support the Chair to manage the technology during the meeting.

Zoom Expectations

During the meeting, each member is expected to:

1. Join and attend the meeting preferably, on camera.
2. Be fully present, participate in the discussion (including via chat), and vote using the “raise hand” function.
3. Keep audio on mute if the member is not presenting or discussing a study.
4. Vote using the “raise hand” function.

If assistance with  or training with computer resources is required, please reach out to Ben and we will try to accommodate your request.

Reviewing Assigned Protocols

• The staff will try to only assign reviews to those who have indicated their intention to attend; however, if attendance is limited or specific expertise is required for the review, a member may be assigned to review a study, regardless of if the member will attend the convened meeting.
• Members review all IRB application materials, including the reviews for all matters on the agenda, including the meeting minutes and expedited actions, in advance of the meeting so that they can participate fully in the meeting discussions.
• Once assigned a study, the member should try to post the review by noon the day prior to the convened meeting. Posting by noon the day prior gives the IRB Analysts the time to follow up with any communication with the study teams. Reviews are expected to be posted prior to the meeting. This gives the other members time to read the review prior to the meeting.

What if I have an emergency and/or cannot complete my review?

• If a member is assigned as a reviewer that person will be expected to complete the review unless extenuating circumstances make it impossible (e.g., work or family emergency). Under those circumstances, the member should inform the IRB analyst as soon as possible so the study can be assigned to another reviewer.

How should I conduct my review?

1. Briefly summarize the study for the other members.
   • Example: “This is an investigational study with 2 investigative arms, which include previously approved drugs, etc.”

2. Next, review each section of the study and discuss any identified risks.

Review plan for new study being presented:

1. What is the objective of the study?
2. Is the study design appropriate to learn about the objectives?
3. How is the study team finding participants (recruitment)?
4. If there are treatment groups, what are they doing?
5. What are the outcome measures and endpoints?
6. Address sub-categories, if applicable: Device, Drug, Minors, Pregnant Women/neonates, Prisoners
7. Are the risks reflected in participant facing materials (Informed Consent, etc)

Tips for Presenting Review:

Review the IRB Analyst review and contact the IRBA if there are additional questions, clarifications, or concerns.

Consider:

• Are there ways to alleviate the risk?
• Are there conflicts of interest that should be considered?
• Is the inclusion criteria and recruitment methods equitable?
• If applicable, are there proper site permissions?
• Is there deception/coercion in the study?
• Does it affect the risk determination?
• How do the above factors make a difference in risk?

Continuing Review:

1. Brief summary of study.
2. What continuing review number is this (ie, how many prior CR’s have
there been?)
3. Summary of any changes that have happened since the last year
through amendments.

• • Change in participants?
  • If applicable, any dosing changes in drugs?
  • Additional new drugs/devices/treatments?
  • Etc.

4. What is the enrollment?

• • If enrolling participants that speak something other than English, how many participants have been enrolled?

5. Does the study team need to update any participant facing materials (ICF/recruitment/surveys) because of non-English Speaking participants?

6. Any changes to the Informed consent form that should be noted?

• • Does the ICF need to be updated to reflect new risks?

7. Please pay special attention to any reportable events over the last year.

• • What were they? Were they resolved or still ongoing?
  • Were there any CAPA’s (corrective and preventive action plans)?

• A day in the life of Biomedical Sr. Analyst
• Getting a study ready for a full board meeting
• Process of full board meeting minutes

• Research with Psychedelics
• Emergency Use
• IRB Member Conflict of Interest
• Human Research Protection Foundational Training
• Privacy and Confidentiality in Research
• Humanitarian Use Devices
• FDA Regulatory Update
• Noncompliance and Process
• IRB Criteria for Approval
• IRB Actions

SB IRB Member Education

• Initial Review
• Continuing Review
• Amendments
• Criteria for Approval
• IRB Actions
• Board Considerations

• IRB Member Email and iStar Notifications
• HRPP/IRB Announcements and Latest Updates

IRB members are evaluated annually at the end of the Fiscal Year (June) with the IRB Associate Directors and/or the HRPP Director. Performance is assessed according to the criteria outlined in the USC Member Standards and Responsibilities.  IRB members will be re-appointed if expectations are met, and written feedback is provided to all members about their performance.

• IRB Chair Self-Evaluation Survey
• IRB Member Self-Evaluation Survey

If you are experiencing issues with joining an IRB meeting please contact hrpp@usc.edu or call (323) 442-0114. 

Please view our Contact Information Sheet for all contact information.