SUBJECT:

Regulations Governing the Conduct of Human Subjects Research

As part on an ongoing effort to inform the UCSD research community of important federal, state, and local regulations that govern the conduct of human subjects research, we would like to call your attention to a few items:

First, it is important to ensure that persons responsible for conducting the informed consent process are listed, by name, on IRB-approved documents, such as the research plan. Please remember that informed consent is a process that ensures that a participant is fully informed about all aspects of the research. Participants must have an opportunity to ask questions and voice concerns and have these questions and concerns accurately addressed by a knowledgeable member of the research team.

Second, it is important to submit applications for renewals of protocols in a timely way so as to prevent a gap in approvals. PIs are reminded that conducting research procedures with an expired or unapproved protocol is a serious violation of federal policy and can result in campus-wide sanctions. While many PI’s continue to rely on the HRPP office to notify them in advance of their expiration dates, federal and institutional policies state that PIs are ultimately responsible for ensuring that their protocols are valid. The HRPP assists the PI in this effort by sending courtesy notices.

Lastly, we would like to remind faculty, departments, schools, centers, and research units that the HRPP provides educational in-services focusing on human subjects research. Topics that may be covered include, but are not limited to, informed consent process, IRB application and review processes, vulnerable populations in biomedical research, human subjects research ethics, and use of investigational devices. If you are interested in arranging for an educational in-service session, please contact HRPP at 858-455-5050.

Thank you for your cooperation.

David Brenner Vice Chancellor - Health Sciences Arthur B. Ellis Vice Chancellor - Research