WVSOM is committed to working with human subjects in an ethical manner. WVSOM holds a Federalwide Assurance with the Office of Human Research Protections (FWA00007632).
Before any research projects with human subjects can proceed, an Institutional Review Board (IRB) must approve any research project involving the use of human subjects including social-behavioral, educational or bio-medical research. Investigators should contact the IRB chair for details regarding IRB submission. The WVSOM IRB will only review research projects that have received Institutional approval from the ORSP (completion of ORSP-1).
All individuals engaging in human subjects research must have appropriate training and be approved by the IRB prior to engaging in human subjects research (HSR). Being "engaged" in HSR means interacting with humans for research purposes, including recruitment purposes. "Engaging" in HSR also includes viewing, utilizing, or analyzing private, identifiable data, even if you do not interact with human subjects.
Keep an eye out for faculty development sessions through-out the year. The Office of Assessment and Educational Development will post such trainings on their website. Additionally, WVSOM conducts training with individuals, groups, and through on-line resources.
To schedule an individual training session, please contact email@example.com. WVSOM's online training software is through CITI. At a minimum, all WVSOM personnel interacting with human subjects will need to affiliate with WVSOM and complete a Human Subjects Research course appropriate to the protocol. This may either be the Biomedical course or the Social, Behavioral, Educational course. Additional courses may be required, and will be indicated in the Institutional research project approval email, or in the response to the request to add additional personnel.
The federal government oversees research with human subjects, in order to ensure the ethical treatment of all persons participating as subjects. IRBs were established to review research protocols involving human subjects to ensure the following criteria are met:
An exempt study is a human subjects research project that is exempt from the Revised Common rule
In order to be eligible for exempt review, studies MUST be minimal risk. Studies that may meet the criteria for exempt review include:
An expedited study is a human subjects research project that undergoes expedited review.
In order to be eligible for expedited review, studies MUST be minimal risk. Studies that may meet the criteria for expedited review include:
A full board study is one that is reviewed by the convened IRB.
Any greater than minimal risk studies will be reviewed by the full IRB.
Any studies not falling into the above categories (exempt or expedited) will be reviewed by the full IRB. Any IRB member may request an expedited study to undergo full board review.
Informed consent is not just a document, it is a process for ensuring subjects have all information that a reasonable person would need to make a decision about participating in the research. Basic informed consent must include a discussion of the following, and the informed consent document should reflect this information:
Yes, the ORSP oversees any post-approval monitoring. The ORSP may also conduct audits, random or for-cause, to ensure continuing compliance with approved protocols. Information from these audits or monitoring is provided to the IRB for review.
Continuing review is required at least annually, but may be required more regularly. The default Federal rules indicate the following do not require continuing review:
The WVSOM does permit other IRB's to review WVSOM research projects. In order to permit this, WVSOM must have an active IRB Authorization Agreement (IAA) with the Institution whose IRB will be reviewing the research. WVSOM has several agreements in place, including one with Marshall, WVU, and CAMC. WVSOM requires a copy of the IRB approval letter prior to WVSOM personnel engaging in research. Your WVSOM research project still requires institutional review (through the ORSP-1 process). If you want another IRB to review your project, you must contact the WVSOM IRB to discuss.
Office of Research and Sponsored Programs
Administrative Assistant Senior
Peter Feltman, MS
Office of Research and Sponsored Programs
Research Integrity and Compliance Administrator
Kristie Bridges, PhD
Professor, Biomedical Sciences
James W. Nemitz, PhD Office of the President President (304) 647-6200
Office of Human Research Protections
Revised Common Rule (45 CFR 46)