Human Volunteers in Research
Information for the Community
Research involving living individuals contributes to the development of everything from new medicines and surgical procedures to innovative education programs, social policies, laws, business practices, technologies, and architecture.
Assuring the safety and confidentiality of human volunteers in research
The proper conduct of University of Michigan research involving human participants is guided by
-
fundamental ethical principles
- University policy, and
- federal regulations.
It is the policy at the University of Michigan that every research study under its jurisdiction involving human subjects will be reviewed appropriately before it is allowed to begin.
Principal Investigators (project directors) bear primary responsibility for proper treatment and safeguards of human subjects, but all members of the research team are expected to conduct research in accordance with approved ways of protecting human subjects.
UM requires that researchers be educated about the protection of human subjects. A training program provides the required certification.
Also responsible for protecting the rights and well being of human subjects are the Institutional Review Boards (IRBs), the University, the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP).
At the University of Michigan, a study is reviewed by one of eight Institutional Review Boards (IRBs). This review protects the rights and welfare of human subjects involved in research activities. No research involving human subjects can begin until the IRB has reviewed and approved the proposed activity. The IRB is comprised of individuals with at least five members of varying backgrounds, experience, and expertise.
In their deliberations, the IRBs consider:
Read more about the IRBs
Informed Consent
A bedrock ethical principle is that any participant in a study has "autonomy" -- is acting freely to volunteer. The informed consent process is critical in research involving human subjects. Potential participants in research must be provided with relevant information about what the project entails; they must understand this information; and they must be free to decide whether or not to volunteer.
Vulnerable subjects such as children, prisoners, or the elderly with cognitive declines may need special safeguards to protect them from coercion or undue influence.
Read more about the ethical principles
Other Offices Involved
The Office of the Vice President for Research (OVPR):
- oversees UM compliance with federal laws and regulations and any related University policies for human research subjects' protection
- conducts informal inquiries and formal investigations related to any concerns raised about human subjects protections or possible regulatory violations
- sponsors
- is the administrative home for Institutional Review Boards, IRB-Health and IRB-Behavioral Science
The UM-Dearborn and UM-Flint campuses provide the administrative home for their respective IRBs.
The University of Michigan Medical School is the administrative home for the IRBMED, which houses four IRBs on the Medical campus.
