Policies and Procedures

Policy

Use of Human Subjects

Category(ies)
Faculty Handbook Listed as 7.700 within Faculty Handbook
Related Document(s)
Title 45, section 46
Public Welfare

General Policy

This policy regarding the use of human subjects recognizes the responsibility to protect the rights, well-being and personal privacy of individuals, to assure a favorable climate for the conduct of academic-oriented inquiry and to protect the interests of The Evergreen State College. The following practices and procedures have been established for the conduct of activities involving human subjects.

Practices and Procedures

1. No activity involving human subjects shall be undertaken unless a Human Subjects Review Board has reviewed and approved such activity. This review shall determine whether these subjects will be placed at risk and, if so, whether:

a. the risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks;

b. the rights and welfare of any such subjects will be adequately protected; and

c. legally effective informed consent will be obtained by adequate and appropriate methods.

2. Definitions:

a. "Subject at risk" means any individual who may be exposed to the possibility of injury, including physical, psychological or social injury, as a consequence of participation in any activity which departs from the application of those established and accepted methods necessary to meet the subject's needs, or which increases the ordinary risks of daily life.

b. "Informed consent" means the knowing consent of any individual or of a legally authorized representative. The consent is to be a free-will choice obtained from the subject or representative without undue inducement or any element of constraint or coercion. The basic elements of information necessary to such consent include:

(i) a description of the procedures to be followed, including an identification of those which are experimental;

(ii) a description of the attendant risks and discomforts:

(iii) a description of the benefits to be expected or the knowledge hoped to be gained;

(iv) a disclosure of appropriate alternative procedures that might be advantageous to the subject;

(v) an offer to answer any inquiries the participant has concerning the activity;

(vi) an instruction that the subject is free to withdraw at anytime without penalty;

(vii) an assurance that the subject's identity will remain confidential;

(viii) a disclosure of what costs the subject may immediately or immediately or ultimately be forced to bear, and what reimbursement of costs or other compensation the subject will receive.

c. "Substantial experiment" means any activity involving risk to human health, but would exclude all those activities relating solely to the gathering of data, material and information.

3. Activities subject to review:

a. all activities supported by non-college funds in which such action is required by the grantor;

b. other activities which involve the likelihood of risk or substantial stress or discomfort to the subject;

c. activities which include the administration of personality tests, inventories or questionnaires of a personal and sensitive nature;

d. activities involving health care procedures of any kind which are not principally for the benefit of the subject, or which include diagnostic or therapeutic measures that are not yet standard;

e. other activities in which the subject is not fully informed as to the procedure to be followed.

4. Responsibilities:

a. Responsibility for review and approval of proposed activities is vested in the Human Subjects Review Board.

b. The appropriate dean or director under whose program the proposed activities emanate is responsible for determining if any of the above criteria apply to the proposed activities and, if so, to forward the proposal to the Human Subjects Review Board.

c. It is the obligation of the investigator to bring any proposed activity involving the use of human subjects to the attention of the respective faculty member, supervisor or dean.

5. Minimum Risk Proposals - Expedited Review:

Research activities which involve no more than minimal risk and in which the only involvement of human subjects as outlined below may be reviewed and approved by the Human Subjects Review Board through its expedited review procedure. Under this procedure, the review is carried by the chairperson of the board or, in the chairperson's absence, by a member of the board designated by the chairperson. In reviewing research under this procedure, the reviewer may not disapprove the research. A research activity can only be disapproved after review by the full Board.

The following activities shall be eligible for expedited review:

a. Minor changes in previously authorized research during the period for which approval is authorized

b. Research involving survey or interview procedures where all of the following conditions occur:

• Responses are recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects.

• The subject's responses, if they become known outside of the research, would not place the subject at risk of civil or criminal liability or be damaging to the subject's financial standing or employability.

• The research does not deal with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, and is not likely to cause the subject undue stress, fatigue, or any other psychological reactions.

• The research proposal makes adequate provision for obtaining the informed and voluntary participation of subjects.

If, in the reviewer's judgment, the proposal goes beyond the criteria for expedited review, either in letter or spirit, it shall be subject to full board review and approval.

The chair shall provide to the Human Subjects Review Board summaries of research proposals certified through expedited review procedures and copies of review disposition letters to investigators.

All other cases require a full board review.

Human Subjects Review Board

1. The purpose of the Human Subjects Review Board is to conduct initial and continuing reviews of the use of human subjects in accordance with the policy.

2. Review board composition and qualifications:

a. The review board must be composed of not less than five persons with varying backgrounds.

b. The review board must be sufficiently qualified through the maturity, experience and expertise of its members and diversity of its membership to insure respect for its advice and counsel for safeguarding the rights and welfare of human subjects.

c. The review board must be able to ascertain the acceptability of application and proposals in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice and community attitudes.

d. No review board member shall be involved in either the initial or continuing review of an activity in which the respective member has a conflict of interest.

e. The quorum of the review board shall be defined, but in no event will be less than a majority of the total membership.

f. Members of the review board are to be appointed by the president of the college for two-year renewable terms.

3. Responsibilities of the Human Subjects Review Board:

a. The review board will develop and maintain procedures which the college will follow in its initial and continual review of applications, proposals and activities.

b. The review board will develop and maintain procedures to:

(i) provide advice and counsel to activity directors and investigators with regard to the review board's actions;

(ii) insure prompt reporting to the review board of proposed changes in an activity and of unanticipated problems involving risk to subjects or others; and

(iii) insure that any such problems including adverse reactions to biologicals, drugs, radioisotope labeled drugs or to medical devices are promptly reported to the appropriate authority.

c. The review board will develop and maintain procedures which the college will follow to maintain an active and effective review board and to implement its recommendations.

d. Policies and procedures established by the review board will be in compliance with federal (specifically’ Title 4 5, section 46), state and local laws, as well as college policies and procedures.

4. Executive responsibility of the college:

a. Review board approvals, favorable actions and recommendations are subject to review and disapproval or further restrictions by the president, provost, the vice president for finance and administration, and the vice president for student affairs.

b. Where it is a requirement of receipt of funds for the activity, review board disapprovals, restrictions or conditions cannot be rescinded or removed, except by action of the review board.

c. The president shall review all approvals by the review board for experiments involving human subjects and if, in his determination, it is a substantial experiment, prior to its commencement, it shall be submitted to the Board of Trustees for final approval.