Protection of Human Participants in Research
Q & A Corner

Q. What are the general responsibilities of a Principal Investigator (PI) at the University of Michigan?

The PI and co-investigators, key personnel and other research staff are expected to be knowledgeable about, and comply with, federal and state laws, and University policies and procedures relevant to their research. These include the Common Rule and other laws, as well as University policies and procedures for the protection of human subjects, reporting and managing conflicts of interest, terms and conditions of research agreements with government or private sponsors, and the basic ethical principles that guide human subjects research.

Researchers must complete any educational training required by the University, the relevant IRB and other review units prior to initiating research.

Researchers should undertake responsibility for human subject studies only if they understand these requirements and are willing to be accountable for complying with the relevant standards and protecting the rights and welfare of research participants.

Further, they need to assure that resources, either through internal or external funding, are adequate to fulfill these commitments.

This information is available on the Web in the University's Draft Human Research Participant Protection Program Operations Manual, "Part 6: Roles and responsibilities of Investigators and Research Staff."(April 2005, page 4-13). In pdf format, you can find it on the hrpp Web site at: http://www.research.umich.edu/hrpp/om/om-6.pdf

Find other links to information on the use of human volunteers in research at http://www.research.umich.edu/policies/humans.html

Submit your question to Elizabeth Beattie at ebeattie@umich.edu.