The revised Common Rule (45 CFR 46) is in effect (as of January 21, 2019). As a result, the WSU IRB has made significant changes to its processes.
Please review the new investigator training information, SOP's and consent templates posted on the Policies, Procedures and Forms page.
Wright State Institutional Review Board (IRB)
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Wright State University.
The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human subjects. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. It has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and WSU policy.
Human subject research reviewed by the IRB may also be subject to other review and approval or disapproval by officials at WSU. However, those officials may not approve research that has not been approved by the IRB.
The WSU IRB also acts as the main IRB of record for Premier Health and the Dayton VA Medical Center.
Utilizing External IRBS for WSU Research
In certain circumstances, WSU investigators can rely on an external IRB instead of the WSU IRB for review and approval of WSU non-exempt human subject research. However, a reliance agreement between WSU and the external entity must be reviewed and executed before by the WSU investigator can submit a study to the external IRB.
Contact Ellen Reinsch Friese for more information about this institutional process.
What is Human Subject Research?
IRB review is required for all activities that meet both the definition of research and the definition of human subject as defined below:
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Human subjects are living individuals about whom an investigator (whether professional or student) conducting research obtains
- data through intervention or interaction with the individual,
- identifiable private information.
Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject (for example, surveys and interviews).
Private information includes
- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and
- information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.
Required Human Subjects Training
WSU is pleased to offer online human subjects protection training for Principal Investigators and key personnel on projects involving human subjects, and IRB members. This training is available through the Collaborative Institutional Training Initiative (CITI). At the log-in page, either click on "New Users - Register Here" or, if you're already registered, enter your username and password. Identify yourself as affiliated with Wright State University. The succeeding forms to be filled out are fairly self-explanatory. Upon completion of the appropriate modules, a certificate will be generated. The IRB will confirm that all project participants have completed the appropriate training courses prior to the approval of any studies.
While not required, the IRB staff members offer in-person training sessions for classes and other groups, as well as one-on-one training. Please contact the IRB office to arrange for one of these sessions.
Jodi Blacklidge, Human Subjects Program Facilitator
Ms. Blacklidge may be contacted with questions about the IRB. (937) 775-3974 or Jodi.firstname.lastname@example.org
Federal/External Regulations & Guidelines