Procedures for Reviewing Research Requiring Administration of Radioactive Substances to Healthy Human Volunteers

Any administration of radioactive substances to healthy human volunteers requires the Nuclear Medicine laboratory to have a research license issued by the Canadian Nuclear Safety Commission (CNSC). The license specifies that applicable protocols undergo an appropriate independent scientific review with respect to the associated radiation risks and that these risks are appropriately documented in the informed consent document. As with any research project, the study is also subject to an ethical review to assure that the study and proposed use of nuclear substance respect current moral and ethical standards.

In an effort to streamline the review process required of the CNSC licence, the Bannatyne Research Ethics Boards in collaboration with the RNSC have developed the following policy to be used when reviewing research requiring administration of radioactive substances to human healthy volunteers.

2.1 CNSC Canadian Nuclear Safety Commission

2.2 BREB Biomedical Research Ethics Board

2.3 RNSC Radionuclide Safety Committee

2.4 HRRSC Human Research Review Subcommittee,
a subcommittee of the RNSC

2.5 WRHA Winnipeg Regional Health Authority

3.1 Research Requiring Administration of Radioactive Substances to Healthy Human Volunteers, WRHA, July 8, 2004.

3.2 Draft Regulatory Guide C-292-Applying for a Licence – Diagnostic Nuclear Medicine, Therapeutic Nuclear Medicine, Human Research Studies. April 2002. Canadian Nuclear Safety Commission Web site:

http://www.nuclearsafety.gc.ca/eng/regulatory_information/documents/draft.cfm

3.3 University of Manitoba Policy 1406: The Ethics of Research Involving Human Subjects. May 25, 2000.

3.0 SUBMISSION REQUIRMENTS:

The researcher is required to submit the following additional documents to the BREB when the research proposal involves the administration of radioactive substances to human healthy volunteers:

· 1 additional copy of the REB submission form, which is submitted to the RNSC Chair.

· 1 additional copy of the protocol or amendment/amendment summary, which is submitted to the RNSC Chair.

· 1 additional copy of any informed consent documents, which are submitted to the RNSC Chair.

· 2 copies of the RSC HRRSC Research Proposal Summary Form.

· 2 copies of the Annual Study Status Report when requesting annual approval.

4.0 PROCEDURES:

• The Research Ethics submission form will specifically ask researchers to identify whether the proposal involves the use of radioactive substances in healthy human volunteers and provide instructions to submit the appropriate HRRSC forms with their application to the BREB.
• On receipt of a research submission which includes administration of radioactive substances to healthy human volunteers, as identified on the research submission form, the BREB office will forward a copy of the proposal to the Chair of RNSC for radiation protection review by the HRRSC.
• The BREB shall conduct a full board review of the initial proposal and document in writing the conditions of approval to the researcher specifically indicating that approval of the HRRSC is also required.
• The HRRSC will review the initial proposal and any subsequent amendments per the WRHA policy titled, "Research Requiring Administration of Radioactive Substance to Healthy Human Volunteers" and provide written documentation to the REB Chair, documenting their finding and if given the HRRSC approval to administer radioactive substances to healthy human volunteers.
• The BREB Chair will review in an expedited manner the recommendations/approval of the HRRSC and document in writing to the researcher any conditions of approval made by the HRRSC. These recommendations may be directly communicated to the researcher by the HRRSC.
• Any major amendments to the research proposal or requests for annual approval shall be forwarded to the HRRSC for review and approval.
• Final approval of the entire initial research proposal, subsequent amendments or annual approval is granted by the BREB.The BREB will forward one copy of the final research proposal/amendment and certificate of approval to the HRRSC so that appropriate records will be kept in the Nuclear Medicine laboratory.

6.0 FORMS:

6.1 RSC HRRSC Research Proposal Summary Form