KCTCS Human Subjects Research Policy
Policy Number: 188.8.131.52.2
Current Effective Date: 08/24/2004
Original Effective Date: 09/12/2001
Revision Dates: 08/24/2004
Revision Number: 1
Responsible Official: KCTCS President
184.108.40.206.2.1 Human Subjects Review Board
The KCTCS Human Subjects Review Board (HSRB) has institutional responsibility for:
- Assurance of protection of human subjects involved in research or related activities;
- Assurance that KCTCS fulfills its contractual and federally mandated obligations relative to protection of human subjects, if applicable; and
- Maintenance of policies and procedures for protection of human subjects which are, at a minimum, in accord with applicable regulations of funding and regulatory agencies.
The KCTCS HSRB is appointed annually by the KCTCS President after consultation with the KCTCS Cabinet. The membership composition of the Board is kept consistent with federal regulations. Chairpersons, ex officio members, and community members of the Board are designated by the KCTCS President. HSRB members with other than ex-officio status shall have staggered three-year appointments. The HSRB reports to the KCTCS Chancellor who serves on the HSRB and is responsible for managing individual protocol reviews; assisting in policy development, agency liaison, federal record keeping and reporting; handling allegation of noncompliance; and assisting the institution in responding to new federal initiatives affecting ethical conduct of research.
Any undertaking in which a KCTCS faculty member, staff member, or student investigates and/or collects data on human subjects for research or related activities may be construed as "involving human subjects". It is the responsibility of each investigator to seek review by the KCTCS HSRB of any proposed study involving human subjects prior to initiation of the project. Also, it is the responsibility of each investigator to ensure that research is implemented and records maintained in accord with KCTCS HSRB policies and procedures.
The specific responsibilities of the designated KCTCS Human Subjects Review Board are to:
- Review all research (or related activity) projects involving human subjects originating from their respective units.
- Recommend appropriate action on these projects within the guidelines set forth by the applicable federal granting and regulatory agencies, if applicable, and the KCTCS HSRB Policy.
- Review all proposed changes in previously approved research studies and recommend appropriate action on these changes within the guidelines set forth by the applicable federal granting and regulatory agencies and the KCTCS HSRB.
- Conduct continuing review of previously approved research projects at intervals appropriate to the degree of risk, but not less than once per year.
- Handle reports of unanticipated problems and allegations of noncompliance concerning protection of human subject regulations and, in cases where corrective action is needed, issue appropriate sanctions including but not limited to requesting minor changes, determining data collected cannot be used for publication, disqualifying investigators from conducting research involving human subjects at KCTCS, and recommending to KCTCS administration that further administrative action be taken.
- Advise appropriate KCTCS officials of current federal regulations or proposed changes in federal regulations pertaining to the protection of human subjects, and advise on KCTCS policy development and regulation changes which best insure the rights and welfare of human research subjects.
- Recommend to the President on membership composition of the Board through the KCTCS Vice President.
- When participating in a cooperative project with another entity, enter into a joint arrangement, rely upon the review of another qualified HSRB, or make similar arrangements in accord with guidelines set forth by the applicable federal granting and regulatory agencies and KCTCS HSRB policy.
Meetings of the HSRB may be regularly scheduled or held upon call of the chairperson.
Copies of the Department of Health regulations for human research subjects and other educational materials are available in the office of the KCTCS Chancellor.