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400.3 - Involvement of WSSU Students and Employees as Research Subjects by External Investigators

University Group Policy #400.3

#.  Policy Statement

It is the policy of Winston-Salem State University that all research, involving human subjects, must be reviewed and approved by an Institutional Review Board (IRB), as required by Title 45, Part 46, of the Code of Federal Regulations, prior to commencement of the project in order to protect the rights of human subjects participating in research. In order to address these concerns, the University has developed procedures for the review of all external research activities involving the use of human subjects.

#.    Guidelines

Research Principal Investigators (hereinafter referred to as “PI”) external to WSSU who wish to conduct research on the campus of Winston-Salem State University using WSSU students or employees should seek permission from the Provost and Vice Chancellor for Academic Affairs by submitting a cover letter, copy of the abstract and research methodology, informed consent form, and documentation verifying approval from his or her Institutional Review Board (hereinafter referred to as “IRB”).

External researchers who are not associated with an institution that has an IRB may be able to conduct research on the campus only if the research is found to be exempt under federal guidelines. The proposal and Application for Approval of Research Involving Human Subjects will be sent by the Provost to the Chair of the WSSU IRB for determination of whether or not the proposal is exempt. If the research is exempt, the Provost will be notified and will move forward with his or her recommendation accordingly. If the proposal is determined not to be exempt, then the researcher will not be allowed to use University students and employees as research subjects.

#.    Roles and Responsibilities

The Provost will make a determination about whether or not participation in the research project would be in the University’s best interest and should be made available to students or employees. The Provost may request WSSU faculty members or administrators to read the proposal and make recommendations. The Provost may also send the information to the University’s research compliance officer to review and provide a recommendation. The Provost will then determine that the appropriate protections for human subjects are in place by reviewing a copy of the PI’s signed IRB approval form from the sponsoring university and reviewing the recommendations of the University’s research compliance officer. The PI will be required to sign a document outlining the scope of his or her involvement on the WSSU campus and the uses of the data collected. Principal Investigators from other institutions are encouraged to involve WSSU faculty members as co-investigators on research projects that involve the use of WSSU students or employees as subjects. If a WSSU faculty member is an investigator, then the project is subject to WSSU IRB policies and procedures. The project must be submitted to the IRB through the Office of Sponsored Programs by the WSSU investigator and will be reviewed according to the policies and published schedule.

#.     Applicability

This policy applies to research involving Winston-Salem State University Students and Employees.


Responsible Division: Provost and Vice Chancellor for Academic Affairs

Authority: Board of Trustees

History:

  • Adopted June 19, 2009