IRB Manager Julie Decker, (989) 964-4941, email@example.com or IRB Chair Maric Cassar, (989) 964-4779, firstname.lastname@example.org. 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
Informed consent assures that prospective human participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate
Are there different ways that I can obtain informed consent?
The long form (STRONGLY RECOMMENDED)
The short form with oral presentation
What information needs to be in the informed consent form?
(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 I have to get the informed consent signed and dated?
In most cases yes the informed consent document has to be signed and dated
The IRB can determine if the research meets the criteria for waiving documentation (signed informed consent)
Is it possible to get a waiver of informed consent or elements of informed consent?
In most cases some form of informed consent is required
The IRB can determine if certain elements of informed consent can be waived or the entire process of obtaining informed consent
Where can I find samples of informed consent forms?
The ORC website under IRB forms
Would you like a sample approved consent form or IRB application?
Contact the IRB representative in your department to obtain a copy of one of their approved studies. If you do not haven IRB representative on the list, please contact the ORC for assistance.
What options do I have for obtaining my training? CITI (online module)
Which CITI modules are accepted by the IRB? Most investigators should complete either the "Biomedical Research Investigators" or the "Social & Behavioral Research Investigators" curriculum, depending on the type of research conducted (click How to access Basic and Refresher Courses in CITI (16kB) (18kB) to learn how to access courses required for IRB review). Investigators who are conducting FDA research should also complete "Good Clinical Practice" curriculum. Additional curricula, such as "Students conducting no more than minimal research" and "Research with data or laboratory specimens only" might be useful for introducing students to ethical research issues, but do not qualify as sufficient training for human-subjects research undergoing IRB review. Those who wish to know more about the IRB, are contemplating serving on the IRB, or are actively serving on the IRB should complete the "IRB Members" curriculum.
How long is my training certificate valid? 3 years
Does everyone on a research project need a certificate of training? Yes, the Principal Investigator, Faculty Advisor, and any other researchers listed on the IRB Application must complete training.
If I conduct research in the school system do I need approval from the district or just the school in which I plan to conduct the research?
All school systems don’t follow the same rules regarding conducting research in their school and the PI should discuss the policy with the school. Some school systems require an independent review of the research by a research review committee similar to an IRB. While others only need the principal to review and approve the research.
If both the school system and SVSU IRB need to review the protocol, who do I submit to first?
This decision is up to the investigator, however SVSU recommends the PI submit the protocol to either SVSU or the school system for review first, but not simultaneously.
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