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 (461kB) . One need register only once. There also are separate instructions for submitting materials (654kB) to the IRB. Questions about either process may be directed to the IRB Chair (David Callejo Pérez, (989) 964-7488, irbchair@svsu.edu ) or IRB Manager (Julie Decker, (989) 964-4941, jadecker@svsu.edu ).
* The Request for Project Approval (RFA) and other forms have been recently updated to include current information. Please verify those are the forms being used.
IRBNet Updates
IRBNet has introduced a new feature, lock status levels, found at the top of the Designer page in each project submission and summarized on the Project Overview page of each submission.
Projects have three separate lock status levels: "Locked" (gray icon), "Unlocked - Revision Pending" (red icon), and "Locked - Revisions Complete" (green icon). On the Designer page you may read your Lock/Unlock History in each project for specific instructions from the office. Note a complete record of lock/unlcok activity is maintained for audit purposes.
The coordinator in the compliance office may choose to unlock a submitted project package if the submission is incomplete and requires simple changes (Unlocked - Revisions Pending"). If this occurs follow instructions for modifying your incomplete submission. When the requested simple changes have been completed the responsible investigator with Full submission access must lock ("Locked - Revisions Complete") the package. This will automatically notify the administrative staff so staff may continue the review in a timely manner. The staff will access the changes for completeness and continue with the regular review process. At this point the status will change to "Locked" (gray icon).
As always contact either David Callejo Pérez or Julie Decker if you have any questions.
Common Questions
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Am I required to submit my research? Download and review the
Decision Tree (16kB) .
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How can I get an application? Download current
Application Form (129kB) (Request for Project Approval). Make sure you are using the newly updated form with current information.
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How do I renew my project? Download the
renewal form (113kB) , complete it, and submit it via
www.irbnet.org . Unless exempted from Continuing Review,
all ongoing projects must be
renewed annually .
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What if I have questions about IRB terminology? Download the
IRB Glossary (38kB) .
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What if I have questions about IRB Policy and Procedures? Download the
FAQ (49kB)
document or the entire
Policy Manual (38kB) .
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Contacts, Meeting Schedule, and Submission Deadlines
Federal Regulations and Policy Guidance
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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.
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Guidance by Topic : Additional guidance information for IRB members (and other interested parties) from OHRP
- Expedited Review of Social and Behavioral Research Activities : Discusses the expedited review procedure allowed under Federal regulations for certain categories of research involving human subjects.
Links to Human Subjects-Related Offices, Committees, and Organizations
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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)." OHRP has educational videos available on the
HHS YouTube channel .
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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.'"
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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.
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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.
For IRB Members
