Establishment of the IRB

 

The Provost established the Charleston Southern University IRB in January 2003 as a University standing committee in response to an increase in the number of research projects being conducted on campus. The committee’s mandate was to establish policies and procedures for the IRB.

A. Membership The IRB is composed of at least six members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.

Appointment by the Vice President of Academic Affairs assures that the Board is representative of the academic departments conducting research. 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, cultural backgrounds and sensitivity to such issues as community attitudes in order to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review the specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law and standards or professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, 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 those subjects.

The IRB maintains a list of current members by name, earned degrees, representative capacity and indications of experience (including board certifications and licenses) sufficient to describe each member's chief anticipated contributions to IRB deliberations. In addition, any employment or other relationship between each member and the institution, i.e., full-time employee, stockholder, unpaid consultant or board member, is indicated on the membership list. IRB membership is reported to the head of the department or agency supporting or conducting the research, unless the department or agency has accepted the existence of a Department of Health and Human Services (DHHS)-approved Assurance. A current membership list is provided to DHHS's Office for Human Research Protections (OHRP). When an IRB member is also an investigator on a research project or activity, the investigator-as-member cannot participate in the review and approval process for any project in which he or she has a present or potential conflict of interest. Where the investigator-member has a conflicting interest, he or she is present only to provide information requested by the IRB. He or she is absent from the meeting room during the discussion and voting phases of the review and approval process and IRB minutes reflect that these requirements are met.

The IRB chairperson is selected by the voting IRB membership. One of the Chair's tasks is to make the IRB a respected part of the institutional community. The Chair must be fair and impartial, immune from pressure either by the institution's administration, the investigators whose protocols are brought before it or other professional and nonprofessional sources. It is the Chair's responsibility to determine when a proposal requires expedited, exempt or full review or to call meetings of the IRB when the need arises.

B. Record Keeping The IRB prepares and maintains adequate documentation of IRB activities. In addition to the written IRB procedures and membership lists, copies of all research proposals reviewed, minutes of IRB meetings, records of continuing review activities, copies of all correspondence between the IRB and investigators and statements of significant new findings provided to subjects are maintained by the IRB. Minutes of IRB meetings contain attendance at each meeting, actions taken by the IRB, the vote on actions taken (including the number of members voting for, against and abstaining), the basis for requiring changes in or disapproving research and a written summary of the discussion of controversial issues and their resolution. These records are retained for three years. Records pertaining to research that is conducted are retained for three years after completion of the research. All records are accessible for inspection and copying by authorized representatives of the department or agency supporting or conducting the research at reasonable times and in a reasonable manner.

C. Institutional Responsibilities Charleston Southern University's IRB will review and approve research at its facilities involving human subjects. Before any human subject research is conducted, the IRB will provide the department or agency conducting the research a written Assurance that it will comply with requirements of the Policy. The Assurance must be approved by the department or agency. CSU must certify to the department or agency head that the research has been reviewed and approved by the IRB. The IRB is guided by the principles expressed in the Nuremberg Code (1947), The Declaration of Helsinki (1950) and The Belmont Report (1979) (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) and: Title 45 CFR, OHRP Protection/Human Subjects; 21 CFR 50, Food and Drug Administration (FDA) Protection of Human Subjects; 21 CFR 56, FDA Institutional Review Board; 21 CFR 312; 21 CFR 812, OHRP Guidebook and CSU's Assurance of Compliance with DHHS. These documents are available to IRB members and investigators.

Specification of quality standards in the conduct of research is an important function of CSU's leadership. Insistence upon well-conceived and well–conducted research is evident both in written policies and actions of CSU's officials, i.e., the IRB. Research that is conducted so poorly as to be invalid exposes subjects and CSU to unnecessary risk. Approval procedures are devised such that CSU supports well-designed and properly executed research.

D. The Assurance As CSU is involved in biomedical and/or behavioral research, it has a set of principles and guidelines in place that govern the institution, faculty, staff and students in the discharge of responsibilities for protecting the rights and welfare of human subjects taking part in research conducted at, or sponsored by, CSU, regardless of the source of funding. CSU's Assurances applicable to federally supported or conducted research contain a statement of principles formulated by CSU that meet the standards of The Belmont Report. The set of principles is readily available to all staff or faculty personnel who have need of it and it is part of the staff or faculty manual. It is written in clear, concise and unambiguous language that is understandable to its intended audience.

E. Staff, Space and Supplies The University will provide the IRB with meeting space and staff support sufficient to sustain the IRB's review and record keeping duties.

F. Communication The University assures that open channels of communication are maintained at all levels. This communication is important so that staff, subjects and other interested parties have a means of communicating information about the conduct of a research project directly to appropriate institutional officials. It is vital that IRB members, department heads and other officials with responsibility for oversight of research have open and ready access to the highest levels of authority within the institution.

G. Institutional Procedures and Guidelines

1. Federal Policy Requirements CSU will prepare written procedures and guidelines to be followed by the IRB when conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the administration of the institution. These procedures provide guidance for determining which projects will require review more often than annually and which projects require verification from sources other than the investigator that no material changes have occurred since the last IRB review. The guidelines delineate procedures for ensuring prompt reporting to the IRB by the investigator of proposed changes in a research activity. Also included are procedures for ensuring that such changes in approved research during the period for which IRB approval has already been given may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.

The institution's written procedures ensure prompt reporting to the IRB, appropriate institutional officials and the department or agency head of: (1) any unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance with the Federal Policy or the requirements or determinations of the IRB; and (2) any suspension or termination of IRB approval.

2. The Authorized Institutional Official The point of responsibility for the oversight of research and IRB functions is the Vice President for Academic Affairs. The Vice President for Academic Affairs has the legal authority to act and speak for the institution and ensures that the institution is effectively fulfilling its research oversight function. The Vice President for Academic Affairs appoints the members of the IRB who are delegated the responsibility for oversight of research.

3. Other Institutional Personnel Training new personnel is a basic responsibility of CSU. All new personnel are trained in the applicable institutional policies and mechanisms for the approval of research and for reporting problems with research projects in progress. Personnel involved in the conduct of research will receive additional training in institutional expectations and specific regulations pertaining to research. Training designed to enhance the development of high quality proposals is encouraged. IRB members and others charged with responsibility for reviewing and approving research will receive detailed training in the regulations, guidelines and policies applicable to human subject research. Attendance at workshops and other educational opportunities focused on IRB functions are encouraged and supported to the fullest extent possible. Training in good research practices and in methods for minimizing risk is provided. Since research conducted by others may have a bearing on research projects conducted by or at the institution, journals and other research-related materials are available to staff either in the library or thorough the IRB.

4. Internal Audits Internal audit procedures of the IRB assure CSU's administration that its policies and procedures are being adhered to and that they are proper in scope and content. Evaluation of activities and functions is an accepted management tool, and the monitoring of institutional high-risk areas such as research is good policy. Audits allow the early identification and correction of problems. CSU ensures that reporting of noncompliance is accomplished and that appropriate follow-up measures are taken. CSU has developed IRB policies to provide for the following:

• Institutional policies that are in compliance with applicable regulations and that promote appropriate review and approval.

• Open channels of communication that are relevant to the process.

• Comprehensive procedures for monitoring research and conducting audits of the research process.

• Thorough training of personnel in policies and procedures\related to research with human subjects.

• Institutional support of educational activities related to the design, conduct and approval of research.

Principal Investigators