Institutional Review Board

The mission of the Wheeling University Institutional Review Board (IRB) is to protect the rights and welfare of human research participants.

The Institutional Review Board provides assistance to faculty and staff to promote the protection of the participants of research, provide guidance to investigators in the proposal process, and review research for compliance with applicable federal law and local policies.

This web site provides resources and information useful for research staff, research participants, members of the IRB, and other individuals interested in the protection of human participants of research.

Important Links

Applications

Exempt Application
Expedited Application
Formal Application
Resubmit Application

Training

IRB Member Training

• All Wheeling University IRB members are required to complete IRB training.
• Required Training Link
• Registration is required under the WU CITI account.- Each member is to save or print a certificate upon completion of each training to turn into the IRB chair.
• Training must be completed every 4 years.
• IRB Committee members are to complete the following trainings:  GCP – Social and Behavioral Research Best Practices for Clinical Research (9 modules)Health Sciences (RCR) (10 modules)Conflict of Interest (2 modules)IRB Committee Members (30modules)
• Registration is required, training is free.
• Each member is to print a certification upon completion of the training
• This certificate is to be sent to the IRB Chair within two months of being appointed to the committee.
• A new certificate is not needed each year from each committee member.
• Certificate safekeeping is the responsibility of the Chair; the certificates will be provided to the newly elected Chair upon completion of the previous Chair’s term.

Researcher Training

• Primary researchers (which includes students) and student project supervisors are required to submit training certificates with submission of IRB application.
• Required Training Link
• Registration is required under the WU CITI account.
• Training must be completed every 4 years.

Primary researchers and project supervisors are to complete the following trainings:GCP – Social and Behavioral Research Best Practices for Clinical Research (9 modules)Health Sciences (RCR) (10 modules)Conflict of Interest (2 modules)

When creating your CITI account, please follow these directions:

Question 1:  Human Subjects Research – choose appropriate:  Supervising Faculty- Administration, Students Completing Research, IRB Committee Member
Question 2: Blank
Question 3: Denote if public health research or note (Ours is for PT)
Question 4:  Not at this time.
Question 5:  Select:  GCP social and behavioral research best practices
Question 6: COI – yes
Question 7: Health Sciences RCR or as appropriate
Question 8: Not required for now
Question 9:  Blank unless appropriate

HIPPA Training

The Privacy Rule regulates the way certain health care groups, organizations, or businesses, handle the individually identifiable health information known as protected health information (PHI) Researchers should be aware of the Privacy Rule because it establishes the conditions under which covered entities can use or disclose PHI for many purposes, including for research. Although not all researchers will have to comply with the Privacy Rule, the manner in which the Rule protects PHI could affect certain aspects of research.

Training is required if research involves the Privacy Rule. The cost for training varies. Please see the following link for more information on HIPAA.

Regulatory and Guidance Links

FDA 21 CFR 50 Protection of Human Subjects
HHS.gov IRB information
Office of Research Integrity

Frequently Asked Questions

Does the IRB need to look at this project?

The institution relies on the IRB to make this assessment due to the complexity of the rules. investigator communicate with the IRB initially, even if the answer is No. You can reach out to the IRB Chair, Dr. Alison Kreger; by email at IRB@wheeling.edu with questions.

Also, several decision charts are available to help you prepare for the question that will need to be addressed to make determination. The decision charts are available under the Investigator Resource – Getting Started section or you can go directly to the Office for Human Research protections (OHRP) website at http://www.hhs.gov/ohrp/. these graphic aids are intended to assist IRBs, institutions and investigators in the decision-making process to determine the review requirements fro a particular activity.