How Is My Proposal Reviewed By MRPC?
The MRPC is charged with overseeing research uses of radiation and radioactivity in human subjects. The overarching principles of MRPC review are:
- Radiation procedures and use of radioactivity in human subjects research should be performed with sound scientific justification, and
- Research-related radiation dose should be as low as reasonably achievable.
In its review, the MRPC will focus on the following areas:
- Safety of the procedures for subjects
- Safety of the procedures for involved personnel
- Technical and scientific appropriateness of procedures
- Appropriateness of the number of subjects, i.e. sufficient to ensure valid results while minimizing exposure to radiation
- Accurate quantification of radiation dose and radiation risk
- Communication with Subjects
How Can I Help Ensure My Proposal Is Reviewed By MRPC In A Timely Manner?
The most common problems that delay approval of applications by MRPC are listed below. Please use this list of potential problems and appropriate solutions to prepare your application.
1. Applications frequently do not clearly distinguish between research and clinical procedures.
The Committee is charged with overseeing research-related radiation only. It is important to distinguish between procedures performed as standard of care and procedures done for research purposes. The appropriate test of whether a radiation procedure is a research-related or clinical care-related procedure is whether or not that would have been done at that particular time regardless of whether the subject was in the research study. Even standard radiological procedures are considered research-related procedures when they are performed in excess of the clinical standard of care.
Solution: Clearly isolate and enumerate the research-related component of radiation procedures in the Procedures section of the application. Include both standard of care and research-related procedures in the Table, and perform dose calculations and tailor radiation risk statements to the research component only.
2. The number of exposed subjects cannot be clearly determined from the application.
In balancing benefits vs. risks, radiation exposure should be limited to a sufficient but not excessive number of subjects.
Solution: Be sure the number of subjects exposed is clearly and consistently stated in the application materials (MRPC, IRB, Consent Document). The number of subjects should be justified -- large enough to conduct a successful study but not superfluous. For multicenter studies, the application should report the anticipated number of subjects in the entire study, and also the number of subjects who will be enrolled at the University of Iowa.
3. It is unclear how the information from research-related radiation procedures will be used and/or that it will be sufficient to answer the research questions.
Solution: Measures derived from research-related radiation procedures, and personnel interpreting these studies must be clearly stated. When appropriate, provide power calculations for the Committee’s review.
4. A Protocol Modification requests additional numbers of subjects or radiation procedures without clear justification.
Solution: Clear justification (attrition, new experiments, etc) , including preliminary results and/or power calculations when appropriate, are necessary for the review of such modifications.
5. Inaccurate research-related radiation dose calculation. The Committee needs accurate radiation dose calculations from all internal and/or external sources.
Solution: Contact the MRPC's medical physicist dose consultant at email@example.com. But keep the last sentence of this paragraph the same. Preparing the Table on the Procedures page, mentioned in #1 above, is an absolute pre-requisite to this step, and will facilitate the production of the consultant’s letter.
6. Poor wording for research-related radiation risk. The consent document needs to convey the risk accurately, adequately, and understandably to the subject.
Solution: MRPC guidelines for radiation risk statements in the informed consent document are specific. Please follow hem.
7. Poor wording for description of radiation procedure(s). The consent document needs to convey the radiation procedure(s) accurately, adequately, and understandably to subjects.
Solution: Early consultation with appropriate specialists (e.g., radiology, radiation oncologist, nuclear medicine physician) will aid in writing this portion of the consent document. In projects involving more extensive radiation, novel radiation procedures, or special image analysis, invitation of that specialist to become an investigator may be appropriate.
8. It is unclear who bears responsibility for the cost of research-related radiation procedure(s).
Solution: It should be stated clearly under the Costs section of the informed consent document whether the subject is responsible for the costs of research-related radiation procedures. This is one reason the Committee considers it essential to distinguish clearly between standard of care clinical procedures and procedures driven entirely by the research protocol (See #1 above).
9. Inadequate handing of pregnancy-related issues. Unintentional radiation exposure of an embryo/fetus is to be avoided; hence, pregnancy must be ruled out with a high degree of certainty.
Solution: Female subjects with childbearing potential MUST have pregnancy testing before every research-related radiation exposure. Verbal confirmation alone is not adequate for research procedures. MRPC guidelines for pregnancy testing and risk statements in the informed consent document are specific. Please follow them.
10. Training requirements not met. University policy and State regulations require exposed personnel to receive annual radiation training.
Solution: If you and/or your personnel will be exposed to radiation in the course of the research, complete the required training prior to MRPC review. This training is available only through UI Environmental Health & Safety. Contact Environmental Health & Safety at 5-8501 or visit the EHS website for guidance.
11. Missing signatures.
Solution: Make sure that the authorized user form and the MRPC cover page signatures are furnished to the EHS. If facilities external to the primary UIHC, College of Dentistry or VAMC are to be used, submit the signed Radiation Facilities Form from the MRPC application. Hard copies by campus mail or signed pdfs to HawkIRB are acceptable. Note that the PI must sign, not a designee. A tenure track faculty member must sign on behalf of non-permanent faculty applicants.
12. Short form application is used when standard form is needed.
Short forms may be used only for projects involving routine diagnostic x-rays of the extremities, head, neck, teeth, chest, or DEXA bone density scans in adult subjects.
Solution: Use the standard (long) form if the project involves other x-rays, fluoroscopy, CT, nuclear medicine procedures, radiotherapy, radiation exposure to minors or pregnant women, or projects involving off-site procedures.
13. What about subjects who have research-related radiation exposure in separate research projects?
Solution: A primary goal of the MRPC is that exposure of individuals to research-related radiation be minimized, compatible with good science. The following statement is required as part of the radiation risk statement in the informed consent document: "This dose estimate takes into account only the exposure to research procedures in this project. If you have participated in other research studies involving radiation exposure, you should be aware that the risk of effects of radiation exposure is thought to add up across all your exposures (including studies performed as part of your medical care)." Subjects may therefore identify themselves to the person obtaining consent as having had past exposure and inquire as to the implications. Exposures less than 5 rem annually have not been demonstrated to be associated with measurable risk, but nevertheless, consistent with the principle of minimizing risks to individual subjects, MRPC recommends that such subjects be discouraged from participating if there is no potential benefit to them, and alternative subjects are available.
14. Additional Questions.
Contact Gordon Axt, Interim Radiation Safety Officer, at 335-8503 or firstname.lastname@example.org