Winding Down Your IRB Research Program at FDA Approval: A Transition Checklist for Clinic Owners

When retatrutide receives FDA approval, the regulatory landscape changes fundamentally. The IRB research framework that currently authorizes your program will no longer be the primary access mechanism — approved retatrutide can be prescribed directly, without an IRB protocol. Your research program will need to wind down, and your research subjects will need to transition to a commercial prescribing relationship.

This transition is an opportunity, not a disruption — if it is managed correctly.

When you close an IRB research program, you have specific obligations to your IRB and to your research subjects:

Notify the IRB. You must notify your IRB that the study is closing. The IRB will require a final study report summarizing the research — enrollment numbers, adverse events, protocol deviations, and outcomes. The format and timeline for this report will be specified by your IRB.

Retain research records. Federal regulations require that research records be retained for a minimum of three years after the study closes. This includes consent forms, adverse event logs, deviation logs, monitoring visit records, and supply chain documentation. Do not destroy these records.

Notify research subjects. Your research subjects should be notified that the study is closing and that they will be transitioning to a commercial prescribing relationship. This notification should explain what is changing, what is staying the same, and what they need to do (if anything) to continue receiving the compound.

Return or destroy unused compound. Any unused research-grade compound should be returned to the supplier or destroyed in accordance with applicable regulations. Document the disposition of all unused compound.

The transition from a research program to a commercial prescribing relationship is one of the most valuable moments in the lifecycle of a retatrutide program. Your research subjects are patients who have been on the compound, who have achieved results, and who trust you. They are the ideal patients for your commercial retatrutide program.

The transition conversation should be framed as a positive development: "The compound you have been receiving as part of our research program has now received FDA approval. You can continue receiving it as a standard prescription, with the same clinical oversight you have had throughout the program."

Most research subjects who have achieved meaningful results will want to continue. The transition is a retention event, not a churn event — if you manage it proactively.

Before FDA approval, begin building the infrastructure for your commercial retatrutide program:

• Establish relationships with commercial distributors or compounding pharmacies that will supply the approved product
• Update your consent and intake documentation for the commercial prescribing context
• Review your billing and coding approach for the commercial program
• Update your marketing materials to reflect the approved status of the compound

The practices that have been running IRB programs will have a significant head start on this infrastructure — they already have the clinical protocols, the monitoring systems, and the patient relationships. The transition is an evolution, not a rebuild.

Research records and clinical records are governed by different regulatory frameworks. When a research subject transitions to a commercial patient, their research records remain subject to the research record retention requirements (minimum three years after study closure). Their ongoing clinical records are subject to standard medical record retention requirements.

Maintain clear separation between the research records and the ongoing clinical records. Do not commingle them.