4.2.4 Committee on Human Subjects Research (for Federal Purposes: Institutional Review Board)

Lewis & Clark College requires that all research conducted by staff, or students supervised by staff, that involves human subjects be reviewed and approved by the Committee on Human Subjects Research before any of the research is performed.

Research involving students required for most or all students involved in a particular class does not, in general, require review by the committee. Instructors wishing guidance should consult the committee chair. Student independent study projects involving human subjects, however, must be reviewed by the committee.

Currently, the following kinds of research involving human subjects are specifically regulated by federal or state law:

• Research involving human subjects in general;
• Research that involves human subjects and is funded in any way by the Department of Health and Human Services;
• Research supporting an application for FDA approval of products it regulates;
• Research involving administration to a human subject of any experimental drug (which may include established drugs used for new purposes).

The committee shall review, approve/disapprove, and audit research projects involving human subjects as required by federal and state law and College policy, and serve as a resource to researchers seeking information on legal requirements, by:

• Monitoring the legal requirements governing research on human subjects and serving as a resource to researchers and others on campus seeking such information.
• Developing and adopting forms and procedures for committee approval of projects involving human subjects.
• Reviewing and approving or rejecting proposed research projects involving human subjects; promoting compliance with federal and state legal criteria and ethical criteria in project design and controls, subject selection, subject consent mechanisms, record keeping, and confidentiality.
• Receiving and reviewing reports at least annually from researchers with approved projects to ensure compliance with terms agreed upon for a given project; suspending or terminating approval for research or activities that are not in compliance with regulations or that may cause serious unexpected harm to subjects.
• Meeting the administrative requirements imposed by law on Institutional Review Boards, including preparations and maintenance of Institutional Review Board records, reports to the institution on Institutional Review Board activities, and reports to and audits by federal and state agencies.

Membership By law this committee must consist of five or more members with varying backgrounds. Its purpose is to promote complete review of the research activities commonly conducted at the College and to ensure that they are in compliance with institutional goals and commitments and standards of professional conduct.

By law, the committee must have among its members:

• a diversity of races, sexes, occupations, and cultural backgrounds;
• individuals who ensure sensitivity to community attitudes;
• one or more members with professional competence to review specifics of anticipated research projects;
• one or more members with competence to interpret and apply applicable law, regulations, and ethical standards;
• one or more members primarily concerned with the welfare of any vulnerable category of subjects regularly involved in projects at the College;
• one or more members whose primary concern is in a nonscientific area;
• at least one member who is not affiliated with the institution and not a part of the immediate family of a person affiliated with the institution.

At Lewis & Clark, the Committee on Human Subjects Research consists of:

• The dean of the chapel;
• A lawyer from the Law School, named by the dean of the Law School;
• A faculty member from the Graduate School who has experience in psychological, social, or educational research, named by the dean of the Graduate School;
• A faculty member from the College of Arts and Sciences who has experience in psychological, social, or educational research, named by the dean of the College;
• Additional members, including at least one public member, not currently affiliated with the institution (personally or through family). These members are chosen by the dean of the Graduate School to assure compliance with legal criteria regarding race, sex, occupation, vulnerable subject group advocacy, and community criteria if these are not met through other appointments. The dean of the Graduate School will appoint the chair from among the members.

Special Quorum and Majority Vote Requirements When the committee is considering approval of research projects involving human subjects, a majority of members (including at least one member whose primary concerns are in nonscientific areas) must be present to constitute a quorum. Approval of a project requires the affirmative vote of a majority of the members present at a meeting with a quorum.

Faculty needing to submit proposals for review by the Committee on Human Subjects Research should consult the office of the dean of the Graduate School for further information, forms, and deadlines. The committee meets several times per semester as needed.