Some clinical trials involve procedures or agents that require review by a committee other than the IRB and CSEC. This section describes the steps involved in navigating the submission process for these committees.
Radiation Safety Committee (RSC)
Studies that involve the use of radioisotopes or other sources of ionizing radiation (e.g. x-ray machines, CT, cardiac catheterization, radiation therapy, etc.) for diagnostic or therapeutic determinations, for purposes other than the standard of care, require submission to the Radiation Safety Committee.
For RSC review, submit the following with a cover memo to Peter Capetelli at firstname.lastname@example.org:
a) PDF of the completed eIRB protocol application
b) Sponsor Protocol
c) ICF (must contain the mandatory radiation safety language as outlined below)
Contact Peter Capetelli at email@example.com for assistance in calculating the dosimetry prior to submitting the protocol to the IRB or to Radiology for review.
Mandatory RSC Language for the ICF
Text for Risk Section
Imaging studies (e.g., CT, MRI, X-ray exams, US, etc.) studies might involve unsuspected, incidental findings that might or might not be a sign of disease and might or might not lead to further medical work-up. This further medical work-up (if it is performed) might have associated risks, potentially cause anxiety and may incur costs to you and/or your insurer.
Text for Confidentiality Section
Please also note that your imaging studies (e.g., CT, MRI , X-ray exams, US, etc.) that are done as part of this study will be read and interpreted by a WCM Department of Radiology radiologist and the report will be provided to the PI. If there are any findings that you should know about, the PI will share the findings with you or a physician who you may designate. Incidental findings noted on the imaging studies might or might not have clinical significance and might or might not lead to further medical tests or treatments. It will be up to you and your designated physician to determine if any further testing or treatment is necessary on the basis of this information.
Text for Cost Section
If unsuspected, incidental findings are noted in the review of the imaging studies (e.g., CT, MRI, X-ray exams, US) performed during this research study that necessitate further medical tests and/or treatments, such further medical care is no longer considered part of the study and therefore would be billed to you or your insurer. You should expect no compensation or reimbursement for these costs or any risks and anxieties associated with any such follow up care. You or your insurance company will also be charged for any continuing medical care and/or hospitalization that are not a part of the study.
Institutional Biosafety Committe (IBC)
- Intial Laboratory Registration
- Laboratory Registration Amendment
- Laboratory Training and Inspections
- Human Gene Transfer Protocol Review
- Human Gene Transfer Protocol Amendment
- Adverse Event and Emergent Risk Review for Human Gene Transfer Protocols.
- Work with Biological Agents ProtocolWork with Biological Agents Protocol Amendment