The Institutional Review Board (IRB) for Human Subjects Research serves the entire WNMU community by encouraging researchers and supporting the research process, while protecting the rights of all human research participants.

The IRB must approve any plans for research or investigations that involve human participants and are (1) conducted at WNMU facilities by faculty, students, staff, or others associated with WNMU (2) for investigations conducted elsewhere by any representative of WNMU, or (3) funded by grants.

The guidelines adopted by WNMU define research as

“any systematic investigation designed to develop or contribute to generalizable knowledge.”

Accordingly, IRB must approve any student researcher’s plan before they collect data from, or about, human subjects, if that plan includes generalizing from those results to a wider population, or includes presentations at a conference, or publishing the results.

All student researchers must have a faculty mentor who will guide the research process and oversee the IRB application, in case students have questions. See guidelines for faculty mentors and student researchers below.

Typically, academic course-related research exercises do not meet the IRB’s definition of research because they will not contribute to generalizable knowledge and will not be disseminated outside the classroom. Therefore, such research does not require review. However, research methods instructors should be cognizant of relevant issues such as voluntary participation and confidentiality of information when designing activities involving human subjects.

Please note: If an instructor anticipates possibly publishing or presenting results from classroom research exercises – research as defined above, he/she must file for IRB review prior to initiating the project. IRB approval cannot be granted retroactively.

At WNMU, faculty who supervise student research are called Faculty Mentors. Faculty Mentors play an important role in human subjects protections. The Faculty Mentor bears ultimate responsibility for the ethical conduct of research carried out by the student. The time and effort Faculty Mentors dedicate to their students has considerable impact on student projects, quality data, and the time required for IRB approval.

Faculty Mentors Must:

• Determine whether projects require IRB review and assist students with the application process.
• Discuss research ethics with the students.
• Familiarize themselves and students with ethical and regulatory mandates for human subjects research.
• Complete Human Subjects Training – online at CITI or NIH, and maintain certification (https://phrptraining.com/register)
• Ensure student applications are complete and describe all study procedures to be conducted; all sections are accurate and all relevant materials (e.g., instruments, consent documents, recruitment materials, etc.) are uploaded.
• The IRB Office will return incomplete/inadequate applications to students and require Faculty Mentors to assist them with the contingency responses requested.
• Faculty Mentors who repeatedly allow students to submit incomplete/inadequate applications will have applications returned to their students without an IRB review in order to allow the Faculty Mentors to fulfill their responsibilities.
  • The WNMU IRB Office may require additional training/education for those Faculty Mentors.
• Monitor student projects focusing on maintaining confidentiality, privacy, the level of risk, voluntary participation and withdrawal, and informed consent.
• Assure prompt reporting to the IRB of any event that requires reporting in accordance with the IRB policies and procedures for Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.

• Work with the Faculty Mentor to develop a study design with merit
• Meet regularly with the advisor to report their progress
• Send an email to wnmu-irb@wnmu.edu to take the free, internal, humans subjects protection training or take an online human subjects education training (CITI or NIH training https://phrptraining.com/register)
• After the Faculty Mentor approves, submit an application to the IRB
• Obtain IRB approval before initiating any research activities
• Inform the IRB of all proposed changes or additions to the previously approved study before implementing them

The IRB committee operates all year, including during summer months. Applications are due by the 5th of each month to be reviewed by the 15th of the month (excluding weekends). The 21 day review process begins the day the application is submitted. This timeline allows the coordinator to prepare paperwork and board members to have sufficient time to complete reviews.

The IRB encourages investigators to consider submitting up to one draft proposal, about which they might like initial feedback.

Please contact the Coordinator through the IRB email account if you need an expedited review due to a grant deadline: wnmu-irb@wnmu.edu. Full review will still be required after the grant is awarded.

Students applying for IRB approval:

1. must have a faculty mentor who reviews their application before submission.
2. must hold current certification in the use of human subjects. Student’s Faculty Mentor must also have current certification in the use of human participants. Please make sure your training is complete and that your certificate is no more than 3 years old. Send and email to wnmu-irb@wnmu.edu to request being added to the free, internal, human subjects protection training canvas course.
3.  complete the “Submit a Proposal” form (see link below or upper tab).
4. must have a faculty mentor who reviews their application before submission.
5. once the application is submitted, faculty mentor will receive an email requesting a brief letter of support [The IRB application will not be reviewed by the committee until the letter of support is received.]
6. within 21 days, investigator will typically either gain approval or a receive a request for revisions.
7. IRB approval is typically granted for 1 year of data collection.
8. If for some reason investigator needs to make a significant modification to the approved protocol after the study begins, they submits a notice of modification to the IRB using the “notice of protocol modification” form provided below.

Once the study is complete:

1. when the approval period expires (usually one year), the investigator submits a “summary report” form asking if the study has been terminated or if an extension is needed. If no changes to the original approved protocol are needed, then studies are granted extension. If changes are needed, the investigator submits the modification form for approval before an extension can be granted.
2. In order to avoid a lapse in study approval, submit modifications and requests for extensions at least two weeks before study period ends.

BDSM and Counseling Experiences IRB application

BDSM and Counseling Experience Informed Consent.docx (1) (2)

1. If the coordinator determines that the application is complete and conforms to the preparation guidelines, the application will be forwarded to IRB board members for full review.
2. Applicants are notified by email that their applications were received.
3. In the case of an expedited provisional review, such as for grant funding purposes, a decision can be made by the Coordinator in consultation with at least one other member of the board within 3-5 days.
   • In the case of expedited review, full board approval will be required after the grant funding is awarded, but before the project starts.
4. Applicants will be given an official decision by email within 21 days of submission.
5. The goal of the IRB is to reach consensus, but in the event consensus is not reached, the Board’s decision will be based on majority agreement with 5 or more members voting. The board will recommend
   1. Approve
   2. Approve with revisions (IRB must receive revisions within two weeks of initial decision)
   3. Reject with suggestion of substantive revisions and re-submission
6. Applicants may request discussion of a decision in written format (by email) or meet with the Coordinator if they have questions. A special meeting of the board members may also be requested by the applicant if their concerns are not adequately addressed by the Coordinator.

IRB Application Status Since February 2016

IRB Coordinator Log-in