irbchair@svsu.edu
(989) 964-7488
(989) 964-4941
Marie Cassar
Julie Decker
Wickes 314
Upcoming Meeting: April 20, 2018
Submission Deadline: April 6, 2018
irbchair@svsu.edu
(989) 964-7488
(989) 964-4941
Marie Cassar
Julie Decker
Wickes 314
Upcoming Meeting: April 20, 2018
Submission Deadline: April 6, 2018
1. Where is the IRB administrative office?
Wickes Hall 314
2. Who do I contact if I have questions?
IRB Manager Julie Decker, (989) 964-4941, jadecker@svsu.edu or IRB Chair Maric Cassar, (989) 964-4779, irbchair@svsu.edu. You can also come to IRB Office, hours 8:00 a.m. - 4:30 p.m. Monday through Friday
3. What rules must the IRB follow?
Federal guidelines "The Common Rule (45 CFR 46)" is the foundation for IRB rules.
Additional rules/laws are applied by the state of MI
4. What guidelines does the IRB follow?
The institutional IRBPoliciesAndProcedures (38kB)
Significant Changes
Minor Changes
All minor changes must meet both of the following criteria:
(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
(2) a description of any reasonably foreseeable risks or discomforts to the participant;
(3) a description of any benefits to the participant or to others which may reasonably be expected from the research;
(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
(5) a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
(6) for research involving more than minimal risk, an explanation as to whether any compensation will be made and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) an explanation of whom to contact for answers to pertinent questions about the research and research participants' rights (Eric Allen , Director of Office of Research Compliance, 256-1482); and
(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Do individuals that are not currently employed or enrolled at SVSU need IRB approval before conducting the study?
If I am leaving the university and I have an open protocol, what should I do?
The PI will need to complete a IRB Renewal/Close-out Form (116kB)and submit it to the IRB. If leaving the university to work or attend another institution, then the PI/Student will need to seek approval for that study at the new institution since SVSU will no longer be responsible for the protocol
What should a PI do if a participant is physically injured, suffers personal loss, or psychologically traumatized when participating in an approved research study?
The PI is responsible for reporting any unexpected project outcomes or events to the IRB. See the Adverse Event Tree for guidance on how to report an event.
Please see the OHRP site for further guidance
Some of the most frequently asked questions about the SVSU Institutional Review Board are answered below.