§ 221.15. Use of X-rays in research on humans.

 (a)  Registrants conducting research using X-rays involving human subjects are exempted from the requirements of this section if the research is conducted, funded, regulated or supported by a Federal agency which has implemented the Federal policy for the protection of human subjects or if the research is carried out in an institution which conducts other Federally funded or supported human research and follows all Federal requirements for protocol review and research subject protection.

 (b)  If not exempted under subsection (a), a person shall submit, in writing, the following information and evaluation to the Department and receive approval by the Department before conducting the research. If the information submitted to the Department becomes invalid or outdated, the person shall immediately, in writing, notify the Department.

   (1)  The name and address of the applicant and, if applicable, the names and addresses of agents within this Commonwealth.

   (2)  A description of the population to be examined in the research program, age, sex, physical condition and other appropriate information.

   (3)  An evaluation of all known alternate methods that could achieve the goals of the research program and why these methods are not used in preference to the X-ray examinations.

   (4)  An evaluation by a qualified expert of the X-ray system to be used in the research program. This evaluation shall show that the system satisfies the requirements of this article. The evaluation shall include a projected measurement of individual and cumulative patient exposures from the X-ray examinations to be performed.

   (5)  A description of the diagnostic X-ray quality control program.

   (6)  A copy of the technique chart which specifies the information for the X-ray examination procedures to be used if exposure parameters are set manually or a description of how exposure parameters are determined.

   (7)  The qualifications of all individuals who will be operating the X-ray system.

   (8)  The qualifications of the physician who will be supervising the operators of the X-ray systems. The extent of supervision and the method of work performance evaluation shall be specified.

   (9)  The name, address and qualifications of the individual who will interpret the data.

   (10)  A copy of the research protocol authorized by a committee consisting of at least three qualified persons. At least one of the committee members shall be knowledgeable in radiation effects on humans.

   (11)  The provisions for independent institutional review.

 (c)  Proposed subjects or their legal representative shall sign a statement acknowledging that they have been informed of their anticipated radiation exposure and possible consequences arising from this exposure.

Authority

   The provisions of this §  221.15 issued and amended under sections 301 and 302 of the Radiation Protection Act (35 P. S. § §  7110.301 and 7110.302); and section 1920-A of The Administrative Code of 1929 (71 P. S. §  510-20).

Source

   The provisions of this §  221.15 adopted October 2, 1998, effective October 3, 1998, 28 Pa.B. 4894; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3238. Immediately preceeding text appears at serial pages (249287) to (249288).

Cross References

   This section cited in 25 Pa. Code §  221.11 (relating to registrant responsibilities); and 25 Pa. Code §  221.35a (relating to fluoroscopic X-ray systems).



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