Notice ID: NIHODM9000012022
NIH is seeking an organization to provide administrative, regulatory, and operational support for the single Institutional Review Board (IRB) supporting the All of Us Research Program.
It is anticipated the IRB will review approximately 100-150 submissions per year.
- Manage and provide administrative and regulatory support for scheduled and occasional unscheduled, ad-hoc meetings of the All of Us Research Program IRB, including all administrative tasks involved in the preparation, conduct, and follow-up of meeting actions (includes managing expedited review). These tasks include, but are not limited to, the following:
- Receipt of all All of Us Research Program IRB-required documentation including maintenance of electronic regulatory files for the IRB.
- Advise the IRB of the regulations and their regulatory role during their review of all submissions.
- Complete meeting minutes within 7 business days of convened IRB meetings. Minutes must be compliant with the requirements of applicable regulations and should comply with guidance provided by relevant regulatory agencies.
- Appropriately assign reviewers for each review to be conducted, including initial review, continuing review, amendment review, etc.
- Arrange for a conference call line and all logistics needed for each regularly scheduled and ad hoc All of Us Research Program IRB meeting…
- Create, maintain and periodically evaluate regulatory compliant SOPs for the core functions of the All of Us Research Program IRB including, for example, SOPs pertaining to: initial review of research, review of changes in research, continuing review of research, and review of unanticipated problems and serious or continuing noncompliance.
- Collaborate as requested with the All of Us Research Program to:
- Identify, review and advise on any policies or documentation previously developed to support the All of Us Research Program IRB; and
- Periodically assess current activities, roles, responsibilities and scope of IRB support required…
- Advise and propose best practices for a model for centralized All of Us Research Program IRB activities including:
- Development of processes to address local context considerations, as necessary;
- Management of Authorization/Reliance Agreements with relying sites;
- Helpdesk support for research sites, and to limited extent participant complaints; and
- Advise on potential IT solutions to support the All of Us Research Program IRB, such as utilization of an integrated software suite to support virtual IRB meetings and IRB records tracking…