Find my IRB Coordinator

Start at your Institute and find out if you have protocol navigator services available to assist you in submitting ot IRBO. If you do not, please contact Dr. Gini Guptill in the ORSC: orscprotocolsupport@nih.gov.

Work with your protocol navigator to submit a change in PI to the IRB.

All submissions to the IRBO will occur via NIH iRIS. Your protocol navigator can assist you.

We are adding materials to the website as they are being developed.  All available NIH Policies, Procedures, and SOPs can be found here: Policies & Guidance .

New studies submitted to the IRBO after January 21, 2019 are affected by the changes to the Common Rule. The IRBO will review your submission and ensure the required information is there. Mostly the IC is affected and a template is posted for use: Templates & Forms.

Federal and state Right to Try laws generally permit the use of unapproved, experimental drugs and biological products by individuals diagnosed with a life-threatening condition who (1) have exhausted approved treatment options, and (2) are unable to participate in clinical trials involving the product.

However, NIH is a federal research agency. Therefore, it cannot provide an unapproved drug or biological product to an individual unless the subject is enrolled in an NIH protocol. Further, Right to Try laws do not establish a “right” to participate in a clinical trial or protocol, i.e., the laws do not entitle patients to participate in an NIH-sponsored clinical trial.

If you are unable to enroll in an NIH protocol involving an unapproved drug or biological product, the Right to Try Act may provide another option. Interested individuals should speak to their home-based treating physician about the possibility of receiving an unapproved drug or biological product from a source other than the NIH through the Right to Try pathway. The federal Right to Try Act became law on May 30, 2018. More information is available at https://www.congress.gov/bill/115th-congress/senate-bill/204/text.

Please discuss this at the IC level. There is an NIH requirement that the IC hold the IND. Usually there is a regulatory expert that can assist with this. If your IC does not have this expertise, please contact Dr. Gini Guptill in the ORSC: orscprotocolsupport@nih.gov. 

Protocol templates can be found on the Templates & Forms page.

Consent templates can be found on the Templates & Forms page.

The Clinical Center has Recruitment Services available: Recruitment Services.

Please email: IRB@od.nih.gov or call 301-402-3713.