Procedures & University Policies
IRB: SVSU Institutional Review Board for the Protection of Human Research Subjects
Protecting Human Research Subjects
"All research involving human subjects conducted in whole or in part by any individual acting on behalf of SVSU (e.g., full- or part-time employees, students, and volunteers) regardless of the physical location of the data collection, shall be submitted to the SVSU IRB for purposes of oversight and compliance with this policy. This requirement is binding whether the research is externally funded or not and regardless of the source of any such funding."—SVSU IRB Policy & Procedures
Beginning September 6, 2008, all materials must be submitted to the SVSU IRB through the website www.irbnet.org. Before submitting through IRBNet, one must register with the IRBNet site; see the new user registration instructions. One need register only once. There also are separate instructions for submitting materials to the IRB. Questions about either process may be directed to the IRB Chair (Frank Dane, (989) 964-2046, fdane(at)svsu.edu) or the IRB Administrative Assistant (Ann Garcia, (989) 964-4474, agarcia(at)svsu.edu).
Compliance Training
"Any individual conducting human-subjects research at SVSU will have successfully completed an approved training program in the responsible conduct of human research prior to engaging in any such research."—SVSU IRB Policy & Procedures Manual
NIH Posts Human Subjects Tutorial
"Protecting Human Research Participants," an online tutorial from the National Institutes of Health, is available at no cost, and successful completion satisfies the NIH training requirement for human subjects research. The tutorial replaces the National Cancer Institute's "Human Participant Protections Education for Research Teams" course, which was no longer available as of March 1.
Common Questions
- Am I required to submit my research? Download and review the Decision Tree.
- How can I get an application? Download current RPA (Request for Project Approval).
- How do I renew my project? Download the renewal form, complete it, and submit it via www.irbnet.org. Unless exempted from Continuing Review, all ongoing projects must be renewed annually.
- What if I have questions about IRB terminology? Download the IRB Glossary.
- What if I have questions about IRB Policy and Procedures? Download the FAQ document or the entire Policy Manual.
Contacts, Meeting Schedule, and Submission Deadlines
- Meeting Calendar: The IRB meets every third Friday of each month throughout the year. Additional meetings can be scheduled to meet extraordinary requirements.
- Projects must be submitted two or more weeks prior to a scheduled meeting in order to appear on the agenda for that meeting.
- All materials must be submitted via www.irbnet.org. See the instructions for submitting materials. Questions may be directed to the IRB Chair (Frank Dane, (989) 964-2046, fdane(at)svsu.edu) or the IRB Administrative Assistant (Ann Garcia, (989) 964-4474, agarcia(at)svsu.edu).
Federal Regulations and Policy Guidance
- Belmont Report: The 1979 report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in which the basic principles of research ethics are described.
- Code of Federal Regulations: The complete version of 45 CFR 46, the regulatory authority for the IRB
- Guidance by Topic: Additional guidance information for IRB members (and other interested parties) from OHRP
- IRB Member Responsibilities: National Institutes of Health's overview of the responsibilities of IRB members
Links to Human Subjects-Related Offices, Committees, and Organizations
- NIH Office for Human Research Protections (OHRP): "The Office for Human Research Protections (OHRP) provides leadership on human research subject protections and implements a program of compliance oversight for Department of Health and Human Services (HHS) regulations for the protection of human subjects—Title 45, Part 46 of the Code of Federal Regulations (45 CFR part 46)."
- Food and Drug Administration (FDA): The FDA's "current guidance on protection of human subjects of research. It is published as Level 2 guidance in accordance with the FDA 'Good Guidance Practices.'"
- Applied Research Ethics National Association (ARENA): The Applied Research Ethics National Association (ARENA) is the membership division of the organization Public Responsibility in Medicine and Research (PRIM&R) and serves as the primary organization for IRB members and other individuals who are responsible for protecting human or animal research subjects.
- Office of Research Integrity (ORI): The ORI is part of the Office of Public Health and Science with Health and Human Services and facilitates the responsible conduct of research through a variety of educational programs. It also has oversight and monitoring functions.