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What other approvals are needed?

  • Recombinant DNA and Gene Transfer Approval
  • FDA 
    Food and Drug Administration (FDA)
    is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Food and Drug Administration Homepage
    Drug or Device Studies Approval
  • Stem Cell Study Approval

The NIH 

National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.
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 
Recombinant DNA Advisory Committee (RAC)
experts whose responsibility it is to review human gene transfer research, receiving NIH funding for recombinant DNA research. Protocols are discussed at quarterly public meetings. RAC Homepage
) review has been completed, Institutional Review Board and Institutional Biosafety Committee ( IBC 
Institutional Biosafety Committee (IBC)
oversight group convened by a research institution under NIH Guidelines for Research Involving Recombinant DNA Molecules to review recombinant DNA research and ensure its legal use. IBCs may also review other biohazardous research, including biodefense select agents.
) 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 

Investigational New Drug (IND)
an application, filed by a drug sponsor with FDA (Form FDA 1571) to conduct clinical trials. It includes detailed descriptions of all trial phases, protocols, IRB members, and investigators
or IDE 
Investigational Device Exemption (IDE)
similar to an IND, this allows an unapproved medical device to be used for investigational purposes.
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 

Proposal
a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out.
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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