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Resources & References for Designing & Planning Clinical Research

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Determining if an Investigational New Drug (IND) application is needed

U.S. Law regulates the interstate commerce of products used to prevent, diagnose, or treat people for diseases or conditions by requiring a license. By applying for an exemption from the licensing requirement for shipping the product—known as an IND—investigators can study biological or drug products that are either investigational or products that are licensed for one use, but are being developed for a potentially different use for which the risks and benefits are not known. This IND is issued by the Food and Drug Administration (FDA).

The FDA is organized into centers based on the type of regulated product and the applicable regulations. Many therapeutics are classified as either:  

  • Biologicals, with the Public Health Service Act and the Code of Federal Regulations Title 21 Parts 300 and 600 as the regulatory basis, or
  • Drugs with the Food Drug and Cosmetic Act as Amended and Title 21 Part 300 of the Code of Federal Regulations as the regulatory basis.

The applicable IND regulations for biological and drug products are available in the Requirement for an IND section and the IND Content and Format section of the FDA Code of Federal Regulations. 

The FDA has additional information on the preparation of IND applications for drugs and biologicals.

Requirements for medical devices, which fall under different laws and regulations, are available in the Device Advice section of the FDA Center for Devices and Radiological Health.

Resources for writing a study protocol

A study protocol is a document that describes in detail the plan for conducting a clinical study. Protocols for products studied under an IND should follow the format outlined in the IND Content and Format, item 6 “Protocols” section, of the FDA Code of Federal Regulations.

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issues General Considerations for Clinical Trials External Web Site Policy (PDF - 182 KB). These considerations, together with Section 6 of the document on Good Clinical Practice External Web Site Policy (PDF - 380 KB), form an internationally accepted basis for preparing a study protocol. For additional guidance from the ICH, please consult Choice of Comparator External Web Site Policy (PDF - 311 KB) and Statistical Considerations for Clinical Studies External Web Site Policy (PDF - 285 KB).

The Role of the Institutional Review Board (IRB)

The IRB is one of several mechanisms intended to maintain responsibility, protection, and respect for participants in the clinical research process. In the United States, the Office for Human Research Protection (OHRP) regulates federally funded research and IRBs and the FDA regulates research and IRBs related to FDA-regulated products.

The OHRP IRB Regulations and the FDA IRB Regulations have some differences and, depending upon the study, both sets of regulations may apply.  In general, IRB approval is required before a study may begin, but in some cases the FDA may waive the requirement for an IRB to approve a study (PDF - 35 KB).

When IRBs review federally funded research they must follow the regulations for outlined in Title 45 Part 46 of the Code of Federal Regulations.  When IRBs review FDA-regulated research they must follow the regulations outlined in Title 21 Part 50. Both sets of regulations describe the protections afforded to participants in clinical research with special provisions for particular populations, especially children, but there are slight differences between the OHRP and FDA texts.

NIH Standards for Clinical Research

The NIH Intramural program has developed standards for clinical research that complement the NIH intramural guidelines for intramural clinical research.

The NIH Intramural standards apply to six areas of clinical research:

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Last Updated Date: 02/09/2011
Last Reviewed Date: 02/09/2011
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