AIM-AHEAD Regulatory Compliance Office

The AIM-AHEAD Regulatory Compliance Office (RCO) is available to assist all awardees through the regulatory processes required in order to gain access to research data. This includes obtaining appropriate approvals for their research studies such as IRB determination and any applicable Data Agreements. We understand the unique challenges of navigating the regulatory landscape as these processes can vary from one organization to another. The RCO is your primary regulatory resource within AIM-AHEAD, and is composed of regulatory and compliance subject matter experts with the experience and knowledge to help resolve any regulatory issue that arises.

AIM-AHEAD policy requires all awardees to obtain documentation related to regulatory approval/determination from an internal or external regulatory body for their research (Human Subject or Non Humans Subject) studies. Please note that you are still required to follow all policies of your organization in addition to AIM-AHEAD and NIH policies.

The RCO provides one-on-one or group consultations over virtual meetings. Below are informational links regarding a wide range of topics, as well as quick reference links to regulatory literature for your convenience.

Important Information for Awardees

The Regulatory Compliance Office (RCO) serves as the centralized record keeping body of regulatory documents related to AIM-AHEAD funded research projects. The RCO provides guidance related to regulatory and compliance processes such as IRB and DUAs for AIM-AHEAD funded investigators.

The regulatory requirements for all awardees are described below:

• Complete the New Awardee Intake Survey
• Provided to you upon Notice of Award
• IRB Approval
• All projects, regardless of investigator self determination, must be approved by a local (at your organization) or an external IRB.
• Multi-site projects require a single IRB reliance agreement.
• Submit your protocol for IRB review as soon as possible to avoid delays, and contact RCO if you have questions.
• Data Use or Sharing Agreement
• Depending on your data source, you may need a project-specific data use or sharing agreement.
• Check with your data source and/or the RCO to ensure you have the necessary agreements.

Questions

Please contact the RCO directly for assistance through our inbox: Regulatory Compliance Office Inbox