As you are aware, we have been allowed by the IRB to perform human studies on normal volunteers aimed at testing new MRI techniques. We have protocols for the 1.5 and 3 Tesla scanners. I serve as PI of these protocols and am responsible for the integrity and safety the work performed using them. In view of the regulatory climate at the University, I have discussed the future of these protocols with Dr Sherwin ( head of the IRB). He is willing to allow us to use these protocols, but suggested that we add procedures to document protocol adherence, adverse events (if any) and activities performed under the protocols. In order to comply with the IRB recommendations, I have instituted guidelines for performing human studies under these protocols.

1. All researchers intending to perform human studies under the technical development protocols must submit a request to CAMRIS in the form of a letter describing the nature of the technical development (no more than 1 page necessary). This should include a brief description of the sequences, equipment used and any unusual risks. Researchers making this request will be added as co-investigators to the protocol so that they may have the right to consent volunteers. In addition, all investigators must show evidence of completing the University's teaching module on Human Studies Research . The certification must accompany the request. These materials should be submitted to Norman Butler. Requests will be reviewed at CAMRIS meetings. A list of approved technical development projects will be posted at each scanner. No other investigators may perform human studies under these protocols.

2. Additional documentation of the research itself is also being required. An eligibility check list and study forms are attached to the consent forms. These forms serve to document eligibility of human subjects and compliance with the protocol. In addition, they will help collect adverse events and document work performed. The forms must be filled out completely. Each eligibility checklist will be numbered with a case number, this needs to be transposed onto all other forms. The completed form packet needs to be given to CAMRIS staff.

3. Investigators performing human subjects research under the technical development IRB protocols will be required to submit a brief progress report yearly to document progress of their research.

I want to thank all CAMRIS users for their compliance with these procedures. It is critical that we work together to ensure the highest standards are applied to technical development performed in CAMRIS.