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Institutional Review Board

About the Institutional Review Board

Federal regulations require that all proposed human research studies undergo review by the Institutional Review Board (IRB). The IRB is responsible for reviewing all human subjects research and ensuring compliance with federal regulations. Clayton State University, through the IRB, is committed to a policy of safeguarding the rights, welfare, and privacy of individuals who volunteer to participate in research, whether such research is federally funded or not.

The President of Clayton State University has designated the Associate Provost as the Institutional Official (IO) with the authority to develop, implement, and monitor all research compliance programs.

Mission

The Clayton State University – University Institutional Review Board (IRB) will process all proposals that require human subject participation, and encourage, educate and promote faculty, students, staff and administration to conduct all types of research, including grants and contracts, that contribute to the enhancement of teaching, literature and community service. In all deliberations, the IRB will adhere to the Belmont Guidelines, and require that research on human subject participation be conducted to protect the rights of individuals against harm. The IRB will maintain a federally registered IRB status to ensure compliance with federal statutes and regulations, and to encourage federal research as well as state and local research.

IRB Announcements

COVID-19

The Clayton State University Institutional Review Board is monitoring the release of information related to COVID-19 and its impact on human subjects research. All in-person interactions should be discontinued until further notice. Laboratory supplies, such as gloves and masks, should be used during essential clinical research. Be aware of any restrictions on access to facilities during this time. If there are any changes to a previously submitted research protocol, please submit a Study Modification Request form. We encourage researchers to continue working on research projects remotely to the full extent possible. All questions regarding COVID-19 and its impact on human subjects research operations should be directed to irb@clayton.edu.

Important IRB Notice:The Revised Common Rule Effective Date

The Office of Human Research Protections (OHRP) announced revisions to the Federal Policy for the Protection of Human Subjects (i.e. Common Rule). Most of the changes will become effective January 19, 2019. Any applications submitted from that date henceforth should use the revised consent and protocol templates that will be available on the IRB website. Current studies will be transitioned to the new templates at the time of continuing review. This does not affect the National Institute of Health (NIH) mandate to use a Single IRB for multi-site research studies, effective as of January 25, 2018.Thank you.

Steps to Submitting a Proposal Application

  1. Review the criteria to determine the type of research planned.
  2. Complete the proposal application.
  3. Submit the completed proposal application to your IRB Committee College Representative (see member list on the website).
  4. Submit your completed application, *current Human Subjects Training certificate, AND the Checklist completed by your IRB Committee College Representative to irb@clayton.edu

*If you are in need of Human Subjects Training, the IRB Chair will provide you with training access once your proposal is reviewed (prior to study approval). After completing the training, forward documentation to the IRB Chair at irb@clayton.edu. Please note that you cannot begin conducting research until you have completed Human Subjects Training and receive an approval letter by the IRB Chair. An approval letter will only be provided after verification of Human Subjects Training.

Once a completed application is received, the primary investigator can expect up to six weeks (30 normal business days during which the university is open and classes are in session) for feedback or a decision from the IRB Chair for a Full Review; 20 normal business days during which the university is open and classes are in session for an Expedited Review; and 10 normal business days during which the university is open and classes are in session for an Exempt Review.

IRB Committee Chair 2019-2020 Institutional Official

Dr. Pinar Gurkas, College of Arts & Sciences
2000 Clayton State Blvd Morrow, GA 30260 irb@clayton.edu

Dr. J. Celeste Walley-Jean Dean, School of Graduate Studies Office of Academic Affairs 2000 Clayton State Blvd Morrow, GA  30260