Clinical Trials Administrative Start-Up Handbook

SECTION 5

Review Requirements

Any protocol that involves the use of experimental radiotherapy at University of Washington-licensed facilities requires review by the UW Radiation Safety Committee. (UW-licensed facilities include the University of Washington Medical Center and Harborview Medical Center, but not the Seattle Cancer Care Alliance or Children's Hospital and Regional Medical Center.) IRB reciprocity agreements do not apply to the use of radiation and radioactive materials when used at a UW site.

Radiation Safety Committee review is required in the following circumstances:

• RSC review is required for any radiation procedures performed during the study, either standard or experimental, that are required solely for research purposes. The reasonably forseeable risks of these procedures must be described in the consent form.
  
  
• RSC review is required if the protocol design dictates the procedure provided to the subject. The reasonably forseeable risks associated with that procedure must be described in the consent form.
  
  
• RSC review is required if the protocol design restricts the ability of the subject or the subject's care provider to choose the procedure or treatment (type or frequency) that the subject will receive. The reasonably forseeable risks of these procedures must be described in the consent form.

For examples that illustrate whether RSC review is required, visit Risks of Harm from Standard Care at the Human Subjects Division Web site.

Radiation and Pregnancy

In the first trimester of development, the unborn fetus shows greater sensitivity to the effects of radiation. For this reason, the RSC strongly discourages (and usually does not allow) the entry of potentially pregnant persons into research protocols that involve exposure to radiation. To ensure non-pregnancy, female subjects of childbearing age should be given a serum or urine pregnancy test prior to exposure to any radiation.

The RSC understands that most clinical protocols do require pregnancy screening at some point prior to the initiation of treatment. Often, however, the protocol flow charts show that a pregnancy test is not scheduled until after other screening exams (some involving radiation exposure, such as chest x-rays and CT scans) have been completed. The RSC considers that it is the responsibility of the investigator and his/her research team to ensure proper pregnancy testing prior to any screening exams that may involve exposure to radiation.

RSC Application Forms

For new studies, the RSC has two application forms:

• RSO Form 30     [RSO Form 30: PDF Version]
• RSO Form 31     [RSO Form 31: PDF Version]

The "short form" (RSO Form 31) should be used only for diagnostic x-rays of adults (subjects age 18 and older), not for fluoroscopy or for scans done in Nuclear Medicine.

The completed RSC package for a new study should include:

• RSO Form 30 or 31
• A copy of the appropriate IRB application (UW/WIRB/Cancer Consortium)
• All consent forms
• The study protocol

Renew your RSC approval annually, even if you have not enrolled any subjects. To renew, use RSO Form 32, [Form 32: PDF Version] "Renewal Application for Authorization To Use Radiation with Human Subjects."

Renewal with the Radiation Safety Committee will not be required after all study-related radiographic procedures have been completed on all enrolled subjects and the study is closed to enrollment. Note also that renewal is not required for long-term clinical followup, nor is it required for data analysis. You may inform the Radiation Safety Office about your study's status either by memo or by forwarding copies of the IRB documents that confirm that status.

Best Practices for Completing the RSC Application Forms

• Submit the RSC and the appropriate (UW/WIRB/Cancer Consortium) IRB application concurrently, not consecutively. The IRB application and consent form submitted with the RSC application can be "pending" review, rather than approved. Note: When submitting to WIRB or CC-IRB, be sure to submit your UW/WIRB or UW/CC-IRB cover sheet both to the UW Human Subjects Division and to the RSC.
• Include all of the requested information. Commonly omitted items include the P.I.'s credentials, e.g., "M.D., Board Certified," his/her date of birth (DOB) and Social Security number (SSN).
• Use the same study title that you used on the IRB application.
• Include the consent form, either pending review or approved by the IRB.
• When writing the consent form, explain all procedures that involve the use of radiation and the risks associated with such use. The RSO (Radiation Safety Office) staff will help you prepare the risk statement according to current guidelines. Click here for examples of Consent Form Radiation Risk Statements. Use these risk statements as guidelines only -- they are revised regularly.
• Obtain the signature of the department chair.
• Know which studies qualify for review by RSO staff and plan your time accordingly.

  Studies qualified for RSO staff review include:

  • Common radiation therapy on adult patients.
  • Standard clinical procedures associated with the care of adult patients.
  • "Generic studies" on adult patients done by an investigator when similar studies have been previously approved by the RSC.
  • Annual review of previously approved studies without changes.

  Studies that always require full review include:

  • Studies involving children (subjects <18 years old).
  • Studies involving normal subjects.
  • Studies involving nonstandard procedures.

• Call the RSO for advice about the review of protocol amendments. Methods for RSO review of amendments will vary, depending upon the complexity of the amendment.

Administrative Start-up Checklist
Radiation Safety Committee

Click to Download Checklist in Word

Key Contact

Rick H. Hudson
Health Physicist
Box 354400
Phone: 206-685-5313
Fax: 206-543-3351

Web site: http://www.ehs.washington.edu

Timeline

RSC meetings are held the second Wednesday of alternate months, beginning in January. For review, applications must be received two weeks prior to the meeting. Applications are received and assigned continuously either for review by the full committee or, if qualified, for review by RSO staff.

Time required for review by the full Radiation Safety Committee will vary with the complexity of the study but may take as long as two months from time of submission. Under normal circumstances, a staff review can be done within a week. However, depending on the number of applications in queue for review, even a staff review may take two or three weeks from the time that you submit the application.

Knowing which studies qualify for review by RSO staff will help you plan your time accordingly. Refer to "Best Practices for Completing the RSC Application Forms" for a list of qualifying studies.