Regulatory SIG

The Regulatory SIG is focused on legal, regulatory and policy issues relating to: 

• Human subjects research protections, including requirements for obtaining informed consent under the Common Rule and the FDA regulations on human subjects
• Institutional Review Board (IRB) applications and compliance with local IRB policies
• Requirements relating to patient privacy, including the Health Insurance Portability and Accountability Act (HIPAA), the HIPAA Privacy Rule, state privacy laws and other measures for protection of patient confidentiality
• Requirements concerning data security, including the HIPAA Security Rule, 21 CFR Part 11 and FISMA

The Regulatory SIG is part of the Data Sharing and Intellectual Capital (DSIC) Workspace

Who should get involved

The Regulatory SIG welcomes participation from individuals interested in patient privacy, regulatory compliance and intellectual property issues associated with sharing research data. Participant activities include attending bi-weekly teleconferences and periodic face-to-face meetings, commenting on products under development or review by either SIG or the Workspace as a whole, and conducting more in-depth work in pursuit of Regulatory SIG goals..

Individuals interested in participating in the Regulatory SIG are invited to join the Regulatory SIG Listserv. Information about the bi-monthly conference calls are sent out on the Listserv.

Contact Information

The Regulatory SIG Lead is Elaine Brock, Esq., of the University of Michigan. 
Phone (734) 936-1289
E mail ebrock@umich.edu

Meeting Schedule

Second and fourth Monday of each month at 2 P.M. (Eastern).
For teleconference access information please contact the Regulatory SIG Lead.

You can review prior meeting records to see what they have been working on: Meeting Notes & Agendas

Regulatory SIG Participant Shortcuts

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