- Recombinant DNA and Gene Transfer Approval
Food and Drug Administration (FDA) Drug or Device Studies Approval
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
- Stem Cell Study Approval
National Institutes of Health (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
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
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.
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
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) or IDE
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
Investigational Device Exemption (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.
similar to an IND, this allows an unapproved medical device to be used for investigational purposes.
If your study proposal
Proposal involves an investigational
device, you may find more information at FDA
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.
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