Wis. Admin. Code Department of Health Services DHS 157.59 - General requirements

(1) MAINTENANCE OF RECORDS. A record required by this subchapter shall be legible throughout the specified retention period. The record may be the original, a reproduced copy or a microform, provided the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored electronically with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings and specifications, shall include all pertinent information such as stamps, initials and signatures. A licensee shall maintain adequate safeguards against tampering with and loss of records.

(2) PROVISIONS FOR RESEARCH INVOLVING HUMAN SUBJECTS. A licensee may conduct research involving human subjects using radioactive material provided all of the following requirements are met:

(a) A licensee shall apply for and receive approval of a specific amendment to its radioactive materials license before conducting the research. A licensee shall obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an "Institutional Review Board" or equivalent under the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.

Note: The definition and responsibilities of an Institutional Review Board are described on 45 CFR Part 46 which may be downloaded from the following website: http://www.access.gpo.gov/nara/cfr/waisidx_00/ 45cfr 46 _00.html.

(b) The research involving human subjects authorized in par. (a) shall be conducted using radioactive material authorized for medical use in the license.

(c) Nothing in this subsection relieves a licensee from complying with the other requirements in this subchapter or from complying with applicable FDA or other federal requirements governing radioactive drugs or devices.

(3) IMPLEMENTATION.

(a) If the requirements of this subchapter are more restrictive than the existing license condition, a licensee shall comply with this subchapter unless exempted by par. (c).

(b) Any existing license condition that is not affected by a requirement in this subchapter remains in effect until there is a license amendment or license renewal.

(c) If a license condition exempted a licensee from a provision of this subchapter on the effective date of August 1, 2002, the exemption shall continue until the department amends, suspends or revokes the license.

(d) If a license condition cites provisions in this subchapter that are later deleted, the license condition remains in effect until a license amendment or renewal modifies or removes the license condition.

Notes

Wis. Admin. Code Department of Health Services DHS 157.59

CR 01-108: cr. Register July 2002 No. 559, eff. - see Note at the start of the chapter.