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) 964-4484, agarcia(at)svsu.edu).

IRBNet Updates

IRBNet has recently introduced a new tool to accelerate work flow between investigators and the compliance office. You will find this update intuitive and highly valuable. This feature is found at the top of the Designer page in each project submission and is also 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 Ann Garcia or Frank Dane if you have any questions.

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

CITI Program

All investigators conducting human-subjects research as well as IRB Members are required to complete appropriate training no less frequently than every three years.  All such training is now accomplished through the Collaborative Institutional Training Initiative (CITI) hosted by University of Miami.  The training is free; your access to the training is underwritten by SVSU.  Investigators can download instructions for registering and completing the training by clicking on CITI Training (PowerPoint) or CITI Training (PDF).  The training can be accessed via the URL www.citiprogram.org.  The CITI Program also contains modules that may be useful to those teaching either a research methods course or a clinical practicum.  Questions about the CITI Program may be directed to the IRB Chair (Frank Dane, (989) 964-2046, fdane(at)svsu.edu) or the IRB Administrative Assistant (Ann Garcia, (989) 964-4484, agarcia(at)svsu.edu). 

Most investigators should complete either the "Biomedical Research Investigators" or the "Social & Behavioral Research Investigators" curriculum.  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. 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.

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.
  • What needs to be included in a consent form? Download the Consent Document Development Checklist.

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) 964-4484, 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.

For IRB Members