Policy and Guidance Directive FC 86-1, Revision 1, "Radioactive Drug Research Committees"

HPPOS-262 PDR-9306070215

See the memorandum from R. E. Cunningham to Distribution dated August 28, 1989.

This directive provides guidance about review of requests from specific licensees (both limited scope and broad scope) that want to administer radioactive materials to humans for research purposes.

Background Information: Some research studies involve the administration of radioactive materials to humans that are within the purview of the Food and Drug Administration's (FDA's) Radioactive Drug Research Committees (RDRCs). The regulations establishing RDRCs and defining their role are found in Section 361.1 of 21 CFR 361 revised April 1985, and are contained in Enclosure 1. The most current listing of FDA-approved RDRCs was revised July 27, 1988, and is contained in Enclosure 2. Enclosure 3 is a letter from FDA to the chair-person of each FDA-approved RDRC, clarifying the role of RDRCs and the types of studies that come within an RDRCs purview. Enclosure 4 contains a sample limited scope license condition, and Enclosure 5 contains a broad scope license condition.

Keep in mind that an RDRC, acting in its official role as a committee approved by FDA, may deal only with research projects involving drugs. Accordingly, research studies that involve a bone mineral analyzer, brachytherapy sources, or other sealed sources are not within the scope of Section 361.1 of 21 CFR 361. Further, Section 361.1 excludes clinical studies with a diagnostic or therapeutic benefit. However, FDA has indicated that "this regulation does not in any way prohibit an institution from involving its Radioactive Drug Research Committee in other policy matters, ... if it so chooses" (40 FR 31304, July 25, 1975).

Every broad scope licensee authorized to perform "medical research" is also authorized to perform human research studies. Therefore, most broad scope licensees are required to confirm access to an approved RDRC as part of the NRC license application or renewal process. Some are only authorized for medical uses and in vitro uses under 10 CFR Parts 35 and 31, respectively, and do not need to confirm access to an RDRC. Note that the FDA allows an RDRC at one institution to review and approve research studies proposed to be done at another institution that does not have its own RDRC. However, an RDRC at one institution is not required, by FDA regulations, to assist a second organization by reviewing its research proposals.

The NRC has received reports that several institutions have decided that they did not want to accept responsibility for having their RDRC review proposals from other organizations.

On occasion, non-medical institutions have proposed to perform Section 361.1 human research studies. Typically, these institutions do not have the required nuclear medicine personnel to perform the studies. In the past, such situations have been resolved after encouraging the institution to associate with, or contract to, a nearby medical institution in order to secure the appropriate personnel and facilities. If the information specified below has been supplied and we are satisfied that all regulations are met, the proposed human research study may be authorized.

Licensing: NRC has authorized its licensees to conduct these types of studies provided certain criteria are met or certain commitments are made.

1. Specific Licenses of Limited Scope - Be sure that:

   1. The proposed authorized user is a physician as defined in paragraph 35.2 of 10 CFR Part 35.

   2. The proposed physician-user has adequate training and experience. Any physician whose training and experience meet or exceed those specified in Section 35.910 or 35.920 of 10 CFR Part 35 has adequate training and experience. Physicians with less training and experience must be considered on a case-by-case basis; contact the Medical, Academic, and Commercial Use Safety Branch staff for assistance.

   3. The proposed research project meets all the requirements of 21 CFR 361.1 and has been approved by an FDA-approved RDRC. If the reviewer is unsure of whether the RDRC has the authority to permit a proposed human research study, as required in 21 CFR 361.1, contact the Medical, Academic, and Commercial Use Safety Branch staff for assistance.

   4. The licensee has adequate facilities, equipment, and radiation safety procedures for handling the radioactive material proposed for use in the research study. In most cases, the licensee will not need to supply additional information because the typical RDRC research study involves use of no more than several millicuries of tritium or carbon-14 or other materials that require radiation safety procedures similar to those required by Section 35.100 of 10 CFR Part 35. Enclosure 4 contains a sample license condition for a limited scope medical license showing how a human research study may be authorized.

2. Specific Licenses of Broad Scope - Be sure that:

   1. The licensee's description of its Radiation Safety Committee's (RSC's) criteria for selecting users should describe criteria for those wanting to administer radioactive materials to humans for research purposes. These proposed users must be physicians as defined in Section 35.2 of 10 CFR Part 35 and must have adequate training and experience. If the licensee proposes to accept training and experience that are less than those described in Sections 35.910 and 35.920 of 10 CFR Part 35, the reviewer must be sure that the criteria are adequate and reasonable in light of the licensee's entire program and should consult with the Regional section leader before accepting the proposed criteria. The section leader may in turn wish to consult with members of the ACMUI before making a licensing decision.

   2. The licensee's description of its RSC's criteria for approving proposed uses of radioactive material shall require, among other things, that research studies involving the administration of radioactive materials to humans are approved by a FDA-approved RDRC. In its review of proposed RDRC studies, it is expected that the RSC will also consider the need for special equipment and facilities or for special radiation safety procedures. Enclosure 5 contains a sample license condition for a broad scope license showing how a human research study may be authorized.

Regulatory references: 10 CFR 31, 10 CFR 35, 21 CFR 361

Subject codes: 1.3, 11.3, 11.5, 12.13

Applicability: Byproduct material