To protect the rights of human participants involved in research.
- To assure the college that human participants used in research or educational programs that monitor human subjects are not at undue risk and that the participants are informed of any risks.
- To advise college administration with the federal guidelines and college policy and procedures regarding the protection of human participants, and to certify to college administration that any research project or activity involving human participants has been reviewed and approved by the IRB.
Principal researchers submitting a protocol for review by CCCC IRB for Human Participant Research, must complete the Application for Research (CCCC) or submit the appropriate approval documents from their host institution. Upon receipt of the appropriate documents, the Institutional Effectiveness/Planning Committee designee will alert the Chairperson or designee of the CCCC Institutional Review Board for Human Participant Research. The Chairperson or designee will determine the review category which is most appropriate for the proposed research, and will advise the Institutional Effectiveness/Planning Committee accordingly.
The Chair will consider the degree of risk the proposed research places upon human participant(s), and whether or not proper safeguards are planned and operational. All proposed research involving human participants, including research deemed to be exempt or expedited, by the IRB Chair, shall be reviewed by the Board for approval. In such instances, approval warrants majority vote but does not necessarily assemble for a full board review. Research found by the IRB Chair to warrant a full board review meets criteria that has the potential for risk of psychological or physical harm to human participants.
If needed, the principal investigator or delegate should attend one or more meetings to present the research and respond to committee questions. The IRB will notify researchers of its decision in writing. The IRB will maintain records of all research requests for a period of six (6) years after the expiration of an approved protocol.
The IRB shall have at least five voting members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. Consideration should be given to including at least one member of the Board who has formal ethical training. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in protecting the rights and welfare of human participants. The IRB shall be able to assess the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If the IRB regularly reviews research that involves a vulnerable category of participants, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these populations.
The IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
The IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
Committee members will be recommended by new or replacement members and approved by the College President in accordance with any applicable regulations.
No IRB member may participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
The IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues, which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. A representative from the Institutional Effectiveness/Planning Committee will serve as a non-voting ex-officio.
The incoming Chairperson is elected every two (2) years by the voting members before the end of the academic year to assume duties at the beginning of the next academic year. The outgoing Chairperson is responsible for coordinating election of a new Chairperson.
The incoming Chairperson is responsible for calling the initial meeting of the Board and relaying all necessary information relating to specific responsibilities and time lines.
Any member who misses more than two regularly scheduled consecutive meetings without cause will be asked to resign.
MEETING SCHEDULING AND AGENDAS:
The Board will meet a minimum of once an academic year and as- deemed by the Chairperson to discuss policy or procedural amendments. The IRB meeting minutes will include the names of those attending, actions taken, decisions made (including vote tallies), the rationale for modifications, and a discussion summary.
TERMS OF APPOINTMENT:
Two-year staggered terms.
Committee Charter will be reviewed annually.
Code of Federal Regulations Title 45 Part 46 - Protection of Human Subjects
RECOMMENDATIONS REPORTED TO: