Is my research under IRB jurisdiction?
Is a research project conducted by my students in the classroom for instructional purposes under IRB jurisdiction? (HTML or DOC)
Where can I get help drafting an Informed Consent Form?
Where can I find University of Michigan and Federal policies related to Human Subjects?
Do I need PEERRS certification in order to conduct research on human subjects?
How do I know which IRB to use?
Whether or not your research falls under the jurisdiction of the the IRB-Dearborn and thus requires IRB approval, depends on three things:
1. Is the activity "regulated research"?
2. Are there "human subjects"?
3. Is the University of Michigan "engaged"?
A special situation arises when the research is conducted in a classroom. See the University of Michigan Policy on Classroom Research, for more information.
Research (that is, research under IRB jurisdiction) means a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities." 45 CFR 46.102(d)
Generally, if you intend to publish the results of your study "outside the walls" of the University, or your study is not a single "case study," journalism, or oral histories, then your study is regulated research and under IRB jurisdiction. You will need IRB approval for your research if it involves human subjects.
For further guidance, click here.
Human subject refers to a living individual about whom an investigator (whether professional or student) conducting research (whether funded or not) obtains:
1. data through intervention or interaction with the individual or
2. identifiable personal or private information
Examples:
- A survey of individuals requesting personal information (information that is sensitive or could be damaging if made public, such as tendencies toward depression or past illegal behavior) or private information (social security number, home address, medical information).
- Measuring blood pressure and heart rate with a simple, commonly-used cuff and finger clamp.
- Having K-12 students take a pre- and post-test to evaluate the effectiveness of a particular teaching method that the investigator wishes to report on in a scholarly journal.
Click here for further guidance.
The University is engaged when:
- the investigator is a UM-Dearborn faculty or staff member or a student conducting research as a requirement for a degree requirement or under the supervision of a UM-Dearborn faculty member;
- the research is conducted on the campus using UM-Dearborn facilities or utilizes closely held resources such as equipment, personnel, or student data.
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Program for Education and Evaluation in Responsible Research and Scholarship
1. Human Subjects Certification Requirement
Researchers (students and faculty) applying to the IRB Dearborn for approval to use human subjects in research are required to complete one Human Subject module. Note that the PEERRS system labels 3 modules (a, b, and c, below) as "Required." These three modules are not required for IRB approval but certification in a human subjects module is.
All members of the project team are required to become certified in PEERRS.
Certification formally involves passing the short test (6 out of 6) that comes with the module. While there is no requirement to review the module before taking the test, passing the test does not exempt PIs/Co-Is and other members of the research team from knowing and following all UM, state and federal policies and regulations related to protection of human subjects in research.
2. PI/PD on an External Grant or Contract
All PIs and Co-Is on new and competing renewals of sponsored projects with a start date of June 1, 2005 or later must be certified in the following modules (the first three are required; d and e as appropriate) before their spending authority on the new/competing renewals will be given.
a-- Foundations (required for grants and contracts)
b-- Research Administration (required for grants and contracts)
c-- Conflict of interest (required for grants and contracts)
d-- Human subjects research (only if the project involves human subjects)
e-- Animal research (only if the project involves animals)
In addition, it is the PI's responsibility to see that all key personnel are appropriately certified.
Certification formally involves passing the short test that comes with each module. While there is no requirement to review each module before taking the test, passing the test does not exempt PIs/Co-Is and other members of the research team from knowing and following all UM, state and federal policies and regulations.
All research in which 1) a UM-Dearborn faculty or staff member or student or other trainee is the principal investigator or 2) the research uses UM-Dearborn facilities or private information (e.g., Dearborn students) should be reviewed and, if approved, monitored, by IRB-Dearborn. There are some exceptions to this rule. (See UM HRPP Operations Manual Part 5, Section I, B. IRB-Dearborn.)
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