Human Subjects

Take home message: If you anticipate conducting research for which you interact with people or use private personal information, Institutional Review Board (IRB) approval is required before you start the research (or recruit any subjects) – and you must maintain approval for the duration of the research.

U-M Policy and helpful links

  • Standard Practice Guide (SPG) 303.05, the Policy for Research with Human Participants, applies to all human research conducted (or directed) by members of the University community, using University facilities or resources, or involving use or disclosure of identifiable private information created or maintained by the University. The Policy reinforces U-M’s commitment to conducting all human research in accordance with the ethical principles of the Belmont Report and in accordance with applicable laws.
  • U-M’s Human Research Protection Program (HRPP) ties together the different processes, committees, experts and efforts related to human research compliance and management. Links to policies, regulations and guidance on human subjects is on the HRPP site.
  • The HRPP Operations Manual is a comprehensive reference guide for U-M human subjects research.
  • What constitutes “research with human subjects”? Read the U-M Operations Manual on human subjects to determine if your activity meets the regulatory definition.
  • Human subjects research training is required before IRB approval can be granted. The training module can be found in the PEERRS system (U-M’s Program for Education and Evaluation in Responsible Research and Scholarship).
  • Paying research subjects: Standard Practice Guide (SPG) 501.07-1 contains U-M’s Policy on Research Subject Incentives. If you are providing any type of incentives (such as cash, checks, visa cards or coupons) to human subjects in exchange for participating in research, you must request the incentives through the Human Subjects Incentives Program (part of the Treasurer’s Office). See also the Internal Controls guidelines for human subject incentives.
  • The Michigan Institute for Clinical and Health Research (MICHR) provides a range of education and support services to U-M researchers involved in clinical and health research, including regulatory compliance support. They can help you plan your research, and connect you with people to help manage your project, including compliance aspects.

Things to remember

  • Failure to obtain approval for a human research project can compromise your ability to publish research findings, affect grant funding, and even lead to professional disciplinary action or being barred from conducting further human research.
  • Human subjects research can extend far beyond the clinical environment – any research that involves collecting data or personal information from or about a living subject may constitute “human” research. If your research has any human interface, you should check whether it might require approval. Human subjects can extend far beyond the biomedical or clinical environment.
  • Approval for research involving humans is required BEFORE you start the research or recruit any subjects. It’s never too early to start thinking about whether you need approval, and talk to someone about the process involved.
  • If you are doing clinical or health research, utilize the resources available through the Michigan Institute for Clinical and Health Research (MICHR), especially their consultations to help you plan your research – and to better arm you with contacts and information for managing your projects, including the compliance aspects.
  • If you are conducting clinical research, make sure you understand the rules relating to clinical billing in grant funded research.
  • IRB approval may not be the ONLY approval required for human subjects research – if your project involves drugs, radiation, tissue, biomedical devices or a range of other technologies or agents, you may need to get additional approval. See the Research Compliance Overview for a checklist of issues requiring special consideration or approval.
  • If you are providing any type of payment or other incentives to your subjects, you must request the incentives through the Human Subjects Incentives Program.

People to talk to

The Institutional Review Boards review all proposed human subjects research, and are experts in what requires review, and what types of issues might arise during (and after) review. The IRB staff are always happy to talk to you about whether a project might require approval.

The Human Research Protection Program (HRPP) staff can also answer general questions, or talk about concerns with you, and can be contacted by email.

If you have questions related to research subject payments or other incentives, contact theĀ Human Subjects Incentives Program by calling (734) 615-4661 or emailing them.

To report compliance concerns, or unanticipated problems that arise during human subjects research, contact the Institutional Review Board with jurisdiction over the relevant research protocol, email the HRPP staff, or see our Report a Concern page for more options. [Refer also to Part 12 of the HRPP Operations Manual for further guidance on managing human subjects compliance concerns].

For legal assistance or advice relating to human subjects research, contact Maya Kobersy (University) or Kara Morgenstern (Health System) in the Office of the General Counsel.

Established 3/4/11, last updated 2/22/17 – Contact us if you believe any information is incorrect or outdated