Section 1670. General requirements

Article 2. General Information

A. Licensees may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.

B. If the research is conducted, funded, supported, or regulated by another agency that has implemented a policy for protection of human subjects, the licensee shall, before conducting research:

1. Obtain review and approval of the research from an authorized review board; and

2. Obtain informed consent, in writing, from the human research subject.

C. If the research will not be conducted, funded, supported, or regulated by another agency that has implemented an appropriate protection policy, licensees shall, before conducting research, apply for and receive a specific license amendment to its medical use license. The amendment request shall include a written commitment that licensees will, before conducting research:

1. Obtain review and approval of the research from an authorized review board; and

2. Obtain informed consent, in writing, from the human research subject.

D. Nothing in this section relieves licensees from complying with other requirements of this part.

E. Nothing in this part relieves licensees from complying with applicable FDA, federal, and other state requirements governing radioactive drugs or devices.

F. When a requirement in this part differs from the requirement in an existing license condition, the requirement in this part shall govern.

G. Licensees shall continue to comply with any license condition that requires it to implement procedures required by 12VAC5-481-2043 and 12VAC5-481-2046 until there is a license amendment or renewal that modifies the license condition.

H. Each record required by this part shall be legible throughout the specified retention period. The record may be the original, a reproduced copy, or a microform if 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 in electronic media 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. Licensees shall maintain adequate safeguards against tampering with and loss of records.

Historical Notes

Derived from Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Statutory Authority

§ 32.1-229 of the Code of Virginia.