General MRSC Review
1. When is an MRSC review required?
All study protocols that include the administration of radiation to human subjects require an MRSC review. This included both standard of care and beyond standard of care procedures.
2. What is the difference between Standard of Care (SOC) procedures vs Beyond Standard of Care (BSOC) procedures?
As standard of procedure is one that a patient would normally receive as part of routine care, whether or not they are enrolled in a research protocol. Beyond standard of care is a procedure conducted solely for research purposes. Note that screening and end-of-treatment procedures are typically considered beyond standard of care.
3. Who determines whether a radiation procedure is SOC or BSOC?
The PI indicates whether each radiation procedure involved in the study is considered SOC or BSOC. Do note, however, that the IRB can disagree with their determination.
4. Do I need to submit to the MRSC/RDRC if all procedures are standard of care?
Yes. Both standard of care and beyond standard of care procedures are reviewed.
5. Do webIRB amendments need a new MRSC review?
If changes to the radiation procedures are indicated in the amendment, a new MRSC review must be conducted through SafetyNet. As with new applications, an amendment must be initiated in webIRB before it is created in SafetyNet.
6. What are some common procedures that are NOT appropriate for radiation review?
MRIs, ultrasounds, and echocardiograms do not use radiation, and are not appropriate for MRSC review.
7. What are examples of procedures involving radiation producing machines?
Radiation producing machines include but are not limited to the following: X-ray, CT, mammography, bone densitometry and fluoroscopy.
8. What are examples of procedures involving radiopharmaceuticals or radioactive materials?
Procedures involving radiopharmaceuticals or radioactive materials include but are not limited to the following: nuclear medicine, PET and PET/CT.
1. What qualifies for RDRC Review?
The radiopharmecutical used does not have an IND, ANDA or FDA approval.
2. What are the guidelines that determine approval of an RDRC submission?
The research is considered basic science research and is done for the purpose of advancing scientific knowledge. This type of research is:
- intended to obtain basic information regarding the metabolism (including kinetics, distribution, dosimetry, and localization) of a radioactive drug or regarding human physiology, pathophysiology, or biochemistry,
- not intended for immediate therapeutic, diagnostic or similar purposes (e.g. preventive benefit to the study subject from the research), and
- not intended to determine the safety and effectiveness of a radioactive drug in humans.
Visit https://www.fda.gov/drugs/scienceresearch/ucm574897.htm for more information regarding requirements and guidelines for RDRC research.
1. Who can create or edit an MRSC/RDRC application?
PIs and PI Proxies are able to create and edit the applications.
2. Can PI Proxies submit MRSC/RDRC applications?
No, only the PI can complete the PI Assurances and submit the application for review.
3. What supporting documents are required for an MRSC/RDRC application?
The Informed Consent Form and Schedule of Procedures must be included in the application before it can be submitted. The Informed Consent Form will automatically be transferred to SafetyNet from webIRB.
4. What is the Schedule of Procedures?
The Schedule of Procedures is a table or list of all procedures a subject will undergo during the study. It is usually found in the study protocol. Other common names for it include Schedule of Events, Schedule of Assessments, and Schedule of Evaluations.