Policy Development and Communication for the Human Research Protection Program- PRO110   

Procedure
 

Investigator Responsibilities

• Reviews UAB Human Research Protection Program policies and procedures posted on the IRB web site as part of human subjects research training.
• Checks web site periodically in response to notifications of policy and procedure changes and revisions.
• Asks for advice from the Office of the IRB or IRB when questions arise.

OIRB Responsibilities

Reviewing Staff:

• Relies on IRB policies and procedures when reviewing human research proposals.
• Consults with management staff for guidance on applying policies and procedures.
• Refers any policy that is outdated or no longer applicable to management staff.
• Posts and maintains policies and procedures on IRB web site including newly developed and recently revised policies and procedures.
• Sends communications to all investigators and research personnel when new or updated policies are developed and posted.

 Management Staff:

• Routinely reviews the OHRP and FDA web sites for issuance of new regulations, guidance, and communications from these agencies.
• Attends staff meetings and IRB meetings to assess need for new or revised policies.
• Arranges for or provides educational sessions to IRB members and staff on current policies and procedures.
• Provides regular input to the IRB Chair and OIRB Director on the need for policy review and development.
• Maintains and keeps abreast of IRB policies and procedures.

Administrative Staff:

• Relies on IRB policies and procedures when reviewing human research proposals.
• Consults with senior staff for guidance on applying policies and procedures.
• Refers any policy that is outdated or no longer applicable to senior staff.
• Maintains and keeps abreast of IRB policies and procedures.

OIRB Director:

• Brings the need for policy and procedure review or development to the attention of the Institutional Official.
• Works with the Chair of the Human Research Advisory Committee (HRAC) to obtain input from the research community during the development of new policies, or major revisions to existing policies.
• Ensures all approved policies and procedures are posted on the IRB website.

IRB Responsibilities

IRB Member:

• Keeps abreast of IRB policies and procedures.
• Provides input on the need for policy review and development.

IRB Chair:

• Brings the need for new and revised policies and procedures to the attention of the Institutional Official.

Institutional Responsibilities

Institutional Official:

• Meets at least quarterly with the IRB Chair and OIRB Director, to address the need for updating policies and procedures.
• Ensures all policies and procedures are reviewed on a rolling basis, no less than once every 5 years, and updated as necessary.
• Appoints or authorizes individuals to develop new policies and procedures.
• Approves all policies and procedures not requiring approval by the President under UAB Policy on Policy Development and Communication for the Human Research Protections Program (see POL010).