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 . 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, ) or IRB Manager (Julie Decker, (989) 964-4941, ).

* 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

  • Am I required to submit my research? Download and review theDecision Tree (16kB) .
  • 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.
  • How do I renew my project? Download the , complete it, and submit it via . Unless exempted from Continuing Review, all ongoing projects must be renewed annually .
  • What if I have questions about IRB terminology? Download the IRB Glossary (38kB) .
  • What if I have questions about IRB Policy and Procedures? Download the FAQ (49kB) document or the entire Policy Manual (38kB) .
  • What needs to be included in a consent form? Download the Consent Document Development Checklist (15kB) .

Contacts, Meeting Schedule, and Submission Deadlines

  • Meeting Calendar: The IRB meets the third Friday of each month throughout the year.  Meetings are only held if a submitted project requires full board review. 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.
  • Upcoming Meetings: May 17, 2013 with projects submitted by 1:00 May 3, 2013.  June 21, 2013 with projects submitted by 1:00 June 7, 2013.
  • All materials must be submitted via . See the instructions for submitting materials (654kB) . Questions may be directed to the IRB Chair (David Callejo Pérez, (989) 964-7488, ) or IRB Manager (Julie Decker, (989) 964-4941, ).

Federal Regulations and Policy Guidance

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)."  OHRP has educational videos available on the HHS YouTube channel .
  • 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.

For IRB Members