Radiation Risks Language Policy
Effective April 15, 1996
Responsibility for Determining Radiation Risks
It is expected that any Principal Investigator (PI) presenting a research proposal to the Health Sciences Institutional Review Board (HS IRB) that includes radiation (PET, nuclear medicine, or X-rays) should have sufficient understanding of the radiation used in his/her research protocol to be able to describe the risk and benefit to the subject. The PI should have this experience or collaborate with an expert, or a radiation expert to supervise those parts of the protocol using radiation.
Categories of Protocols Using Radiologic Techniques PET Protocols
- PET Protocols
- Protocols where the radiation dose is an integral part of the research, so a radiation expert collaborator or a letter from an expert is required (all research radiopharmaceutical protocol and some X-ray technique protocols).
- Protocols where the radiologic/nuclear medicine procedure is an integral part of patient management, and while important for the research, the diagnostic test or therapy might be required anyway. In this letter case a radiation expert is not required as collaborator, nor is an expert letter required, but the consent form must reflect easily understandable terms, e.g., BERT - background Equivalent Radiation Time (Cameron JR. The BERT: A radiation unit for the public. Physics and Society 1991, 20.2) or the estimated dose equivalent (EDE) as previously provided by Dr. Perlman to the HS IRB.
Suggested Requirements of Human Research Investigators Using Radiation
- All PET projects (as identified by HS IRB staff) require one of the PET authorized users (currently Scott Perlman, Doug Brown, or Chuck Stone) to be named on the HS IRB form. All IND projects (e.g., fluorodeoxyglucose (FDG) and N-13 ammonia) studies require Dr. Perlman's name as he is the sole IND sponsor.
- Projects with radiation being a major project component (as identified by HS IRB staff):
- Radiopharmaceuticals: All projects requiring non-PET radiopharmaceuticals (RPh) in a research role (new application, new interpretive role, new patient population for the RPh, etc) requires an authorized user as the radiation expert (currently nuclear medicine physicians) named on the protocol as a collaborator.
- X-ray: All projects requiring X-ray dose to the patient in non conventional applications (e.g., tests of the X-ray procedure itself, etc) require a knowledgeable expert collaborator (e.g., radiologist) or outside expert (e.g., medical physicist) that adequately addresses all the HS IRB radiation issues.
- In the above, the consent forms should include the radiation estimates in the HS IRB determined conventional descriptions (BERT, EDE). These will usually be written by the collaborator or an outside expert - hence assuring their understandability. Here the collaborator or outside expert is the radiation stafety screener for the committee, and provides the appropriate radiation risk assessment for the risk-benefit analysis the HS IRB makes. This expert should be identified on the HS IRB form, and a space provided for their signature to attest to their involvement.
- When radiation doses would normally be part of the clinical care no review will be necessary, but if additional radiation is required for research purposes then this should be included in the consent form and review is necessary. The consent forms must include the radiation dose, and must be written in an understandable form by the PI or outside coordinating group (e.g., drug company).
Here the radiologist HS IRB member can be the screening mechanism for the HS IRB, and it is implicit that the radiation component is not significant to the risk-benefit analysis. If the PI cannot provide the radiation description in an acceptable format, he or she must obtain an expert witness statement (e.g., medical physicist imaging expert) to do this. Such a task is not the responsibility of the HS IRB radiologist member, the Radioactive Drug Research Committee (RDRC), or the Medical Center Radiation Safety Committee (MCRSC).
Radiation Risk Assessment
The radiation protocols and the provided description of the radiation risks should be in a format to allow a reviewer to determine the PI has provided the HS IRB with data that allows three judgments:
- The PI's estimate of radiation risk seems reasonable
- The protocol's radiation dose is "as low as reasonable achievable" (ALARA)
- The protocol does not exceed any federal and the local generally accepted dose limits (5 rad pers whole body dose, gonad, blood forming organs, 15 rads per critical or target organ).
In the case when there is a disagreement between the PI and the reviewer's estimates, then the HS IRB can refer the matter to the next RDRC (PET non-IND projects) or MCRSC (IND PET, nuclear medicine and radiological projects) meeting. These meetings occur at a 3-monthly intervals and contain sufficient expertise to adjudicate these problems. If a more timely response is required by the PI, then an outside expert (medical physicist) opinion can be obtained by the PI in an attempt to satisfy the appropriate reviewer. At no time is it anticipated the reviewer will need to do literature search or detailed analyzes to establish the exact radiation dose involved in the protocol.
In the event that any reviewer feels a potential conflict of interest, or any reason feels uncomfortable in deciding without wider review by other radiation experts, the chair of the MCRSC can decide the issue or appoint an ad hoc subcommittee to adjudicate.