Authority

The President of Capitol Technology University has delegated authority, through the Vice President for Academic Affairs (the designated Institutional Official) to establish the Capitol Technology University Institutional Review Board (IRB) to review initially and periodically and to approve, require modifications to (to secure approval) or disapprove all research activities falling under the human research protection program of Capitol Technology University.

The Capitol Technology University’s human research protection program encompasses all human subject research wherein Capitol Technology University faculty, students, staff or facilities are engaged in the conduct of the research or the human subject research involves the private records of the University.

The Vice President for Academic Affairs will serve as the Chair for the IRB with a Vice Chair appointed by Vice President for Academic Affairs. Members of the IRB will hold earned doctoral degrees within their academic disciplines, serve on the college faculty (full time or adjunct), and have a proven successful history of research and peer reviewed publications. The terms of appointment of the IRB Chair, IRB Vice-Chair, and Members of the IRB committee are initially appointed to a term of three years. Committee members may be requested to accept reappointment to the IRB for an additional term of three years. There will be a minimum of three members and a maximum of seven IRB members. IRB committee members do not receive any additional direct monetary compensation for participation on the board.

Authority of the IRB

The IRB shall review and have the authority to approve, require modifications in (to secure approval), or disapprove all research activities involving human subjects that fall under its authority, including research that qualifies for “exempt” status.

  1. Research activities approved by the IRB are subject to further appropriate review and approval or disapproval by the Official of Sponsored Programs and Research. However, this office may not approve human subject research to be conducted that has not received prior approval by the IRB.

  2. Unresolved questions or issues between the IRB and human subject investigators shall be referred to the Office of the Vice President for Academic Affairs for additional discussion. Comments and recommendations of the Vice President shall be considered by the IRB in its subsequent decision to approve or disapprove the respective human subject research.

The IRB shall have the authority to determine that a project submitted by an investigator does not meet the regulatory definition of human subject research under 45 CFR 46.102(f) and 21 CFR 56.102(f).

The IRB shall have the authority to require progress reports from investigators and to conduct continuing reviews of approved human subject research studies at intervals appropriate to the degree of risk, but not less than once per year. Research studies qualifying for “exempt” status in accordance with 45 CFR 46.101(b) will not be subject to continuing review.

The IRB shall have the authority to approve prospectively all modifications to previously approved research protocols and/or informed consent documents; the only exception being a protocol deviation that may be necessary to eliminate an apparent immediate hazard to a given research subject.

The IRB shall have the authority to observe or have a third party observe the conduct of approved human subject research studies, including the informed consent process.

The IRB shall have the authority to suspend or terminate the approval of, human subject research activities that are not being conducted in accordance with the IRB’s requirements or have been associated with unexpected serious harm to subjects.

The IRB shall have the authority to place restrictions on human subject research activities.