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What other approvals are needed?

  • Recombinant DNA and Gene Transfer Approval
  • FDA Drug or Device Studies Approval
  • Stem Cell Study Approval

The NIH Guidelines for Recombinant DNA state that no research participant will be enrolled in gene transfer studies (Phase I, II, or III) until the Recombinant DNA Advisory Committee ( RAC ) review has been completed, Institutional Review Board and Institutional Biosafety Committee ( IBC ) approvals have been obtained, and an Investigational New Drug request has been authorized. NIH Guidelines apply to investigators conducting gene transfer research that are supported by NIH or performed at an Institution that receives NIH support for any type of recombinant DNA research.

FDA approvals are required for studies that use:

  • An unapproved or unlicensed drug or device.
  • An FDA licensed drug or device used in a manner for which it has not been licensed (“off label use”).
  • A drug or device formulated or developed by an organization that does not hold an FDA license for its manufacture.
  • An unapproved or unlicensed gene delivery vector containing a gene or DNA product.

You may need to obtain an IND or IDE approval for your study drug or device. A physician who both initiates and conducts an investigation in which an investigational drug is administered or dispensed may submit an Investigator IND.  For more information, see the FDA website on the Investigational New Drug Application Process.

If your study proposal involves an investigational device, you may find more information at FDA Device Advice.

Studies that involve stem cells or human fetal tissue must comply with established federal policies. Stem Cell Information is available from NIH and includes federal policy, guidelines and FAQ's. Human Embryo Research, Cloning and Transplantation describes the policy for NIH funding in this area.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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