Human Subjects
What is considered Human Subjects Research?
A living individual about whom an investigator (whether professional or student) conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens
OR
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Intervention means
- physical procedures by which information or biospecimens are gathered
- manipulations of the subject or their environment, performed for research purposes
- Interaction means communication or interpersonal contact between investigator and subject.
- Private information includes
- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place
- information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record)
- Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
According to the Code of Federal Regulations (CFR) (abridged)
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Exempt research: Certain research activities are exempt from the general requirements of human subjects protections policies, but may still need to comply with certain requirements specified for the exemption category and therefore should still seek IRB approval. Exempt research activities may include:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices (this includes most research on instructional strategies and effectiveness of instructional techniques, curricula, or classroom management methods.)
- Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (specific criteria apply–consult with the IRB)
- Research involving benign behavioral interventions (e.g. playing a game, solving a puzzle, decision scenarios, etc. ) in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording if the subject prospectively agrees to the intervention and information collection (specific criteria apply–consult with the IRB)
- Secondary research for which consent is not required–secondary research uses of identifiable private information or identifiable biospecimens (specific criteria apply–consult with the IRB)
Unregulated activities: For purposes of this policy, scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected are deemed NOT research and therefore not regulated under this policy.
According to the Code of Federal Regulations (CFR) (abridged)
Video Presentation: discussion of when an activity is or is not considered ‘research’, and who is or is not a ‘human subject’ (Health & Human Services Office of Human Research Protections)
Human Subjects Required Training for Researchers
The PEERRS Human Subjects Module is required training for any researchers who conduct human subjects research. Please note that training must be re-certified periodically. Check the status of your PEERRS training using the PEERRS Certifications Lookup database (must use authenticated UMICH log in).
Getting Approval: Institutional Review Board (IRB) Application Process
Paying Human Subjects
- In order to obtain payment for research subjects, your IRB application must indicate your intent to compensate project participants
- Request for subject payments must go through the Human Subjects Incentives Program (HSIP) process; the Post-Award Services team will assist you with this (submit your request)
- Several options for paying subjects are available, including cash, check, or gift card. Funding for subject payments should be disbursed within 30 days of the request
- You will be need to submit documentation of payments made to your project participants--depending on several factors, the form and content of documentation will vary; your Post-Award administrator will provide you with the necessary information
Single IRB for Multi-site and Cooperative Projects
- Most UM-Dearborn projects will fall under the definition of a “cooperative study.”
- Definitions:
- Cooperative studies involve investigators from two or more institutions who work together to conduct a research project. Participants are NOT normally enrolled at each site; instead, one institution conducts the research interaction with participants and the other investigators/sites may be involved in assisting with the data collection or analysis, or other elements of the research.
- Multi-site studies involve investigators from two or more institutions who work independently to conduct a larger research project, with each investigator conducting the same research procedures at different sites, each site being under the direction of a local participating investigator and each site enrolling and interacting with a different set of participants.
- U-M guidance
- Single IRB Process for collaborative projects
Contact for Assistance
For questions regarding IRB application requirements (e.g., policy, procedure, science), contact IRB Health Sciences and Behavioral Sciences
Phone: 734-936-0933 Fax: 734-936-1852 [email protected]