Faculty Handbook & Constitution - Lee University

_LEE UNIVERSITY FACULTY HANDBOOK & CONSTITUTION2. Require information given to subjects as part of informed consent to be inaccordance with Par. 46.116 of Title 45 CFR Part 46. The IRRB may require thatinformation, in addition to that specifically mentioned in Par. 46.116, be given tosubjects when in the IRRB's judgment the information would meaningfully add tothe protection of the rights and welfare of subjects.3. Require documentation of informed consent or may waive documentation inaccordance with Par.46.117.4. Notify investigators and the institution in writing of its decision to approve ordisapprove the proposed research activity, or of modifications required to secureIRRB approval of the research activity. If the IRRB decides to disapprove aresearch activity, it shall include in its written notification a statement of thereasons for its decision and give the investigator an opportunity to respond inperson or in writing.5. Conduct continuing review of research covered by this policy at intervalsappropriate to the degree of risk, but not less than once per year, and shall haveauthority to observe or have a third party observe the consent process and theresearch.6. Advise appropriate University officials of current federal regulations or proposedchanges in federal regulations pertaining to the protection of human subjects, andadvise on University policy development and regulation changes which will bestinsure the safety and health of human investigative subjectsV. OfficersA. ChairpersonThe Chairperson shall be elected annually from and by the IRRB membership at thelast meeting of the academic year. The chairperson shall:1. Preside at all meetings or designate a member to serve in his/her absence.2. Prepare and distribute a tentative agenda to IRRB members at least threeworking days prior to the meeting.3. Call special meetings and appoint ad hoc subcommittees (or give individualassignments) when necessary.4. Assume responsibility of execution of IRRB policies.5. Assume chief responsibility to be familiar with federal guidelines. This can includebut not be limited to attending seminars given on human subject research by theNIH.B. SecretaryThe secretary shall be determined by the chairperson and may be either appointedfrom the committee members or selected from student workers or department secretaries(with the knowledge and approval of the specific departmental chairperson). If thesecretary is not a committee member, they do not have voting privileges. The secretaryshall:1. Record the minutes of all IRRB meetings. By federal law this includes keeping anactual numerical count of the votes pro and con on each proposal. It does notinclude keeping names associated with votes.2. Assist with the preparation of the agenda.3. Forward copies of all research proposals reviewed, scientific evaluations if anythat accompany the proposals, approved sample consent documents, progressreports submitted by investigators, and reports of injuries to subjects to the vice-7 - 41 Academic Policies and Procedures