C. Policy Concerning Investigations Involving Human Subjects
Faculty Handbook Revision Approved by the Executive Committee May 1981
- STATEMENT OF PRINCIPLES
Any research procedure, including research, class assignments, demonstrations, or experiments, which use humans as subjects shall protect the dignity and welfare of the subjects.
The following paragraphs elaborate the principle stated above.
- Voluntary participation: All participation must be voluntary. The investigators shall respect the individual's right to decline to participate in and to withdraw from the research at any time without actual or implied pressure.
- Protection from harm: Care shall be taken to protect participants from physical, psychological, or social injury as a consequence of participation. No procedure may be used if it is likely to cause serious or lasting harm to a participant. All reasonable measures shall be taken to minimize risks of harm recognizing that some risk is inherent in any human action. The investigator shall inform the participant of the risks in participation.
- Informed consent: In seeking informed consent, the investigator shall inform each participant of all aspects of the procedure which may influence willingness to participate, and shall answer fully any questions about any of the procedure. Consent may be given by the participant if of legal age and by the responsible adult in the case of children or a mentally impaired person.
- Deception or concealment: Openness and honesty are highly desirable in the relationship between the investigator and the subject. Before using a procedure involving deception or concealment, the investigator has a responsibility to: (i) justify the study against scientific educational values, (ii) determine whether alternatives are available that do not use deception or concealment, and (iii) insure that participants are given explanation as soon as possible.
- Sharing information with participants: After people have participated as subjects, they shall be informed by the investigator about their role in the project, the nature of the study, and any deception that was part of the project.
- Confidentiality: Personal information obtained about the participant in a study is confidential. Unless agreed to by the subject in writing in advance no information from which the subject could be identified may be released.
The following shall be submitted for approval by the Protection of Human Subjects Board before being undertaken: (a) all proposals for human beings as subjects or respondents; (b) those classroom demonstrations or course assignments which involve significant risk to the human subjects.
When reviewing proposals, the Board's responsibility is to see that the research is acceptable in terms of state and federal regulations and in terms of the standards of Knox College as set forth above. The burden of establishing that such is the case rests with the investigator.
In all cases requiring Board review, informed consent shall be secured in writing. The investigator shall submit to the Board a sample copy of the request for informed consent. The basic elements of information necessary for such consent are: (1) a fair explanation of the procedures to be followed, and their purposes, including identification of any procedures which are experimental; (2) a description of any attendant discomforts and risks reasonably to be expected; (3) a description of any benefits reasonably to be expected; (4) a disclosure of any appropriate alternative procedures which might be advantageous for the subject; (5) an offer to answer any inquiries concerning the procedures; and (6) an instruction that the person is free to withdraw consent and to discontinue participation in the project or activity at any time without prejudice to the subject.
If the Board finds a proposal is in any way questionable, it shall bring it to the attention of the Dean before proceeding. The Dean will enlarge the Board when extra expertise is needed or when required by government regulations.
If a member of the Board has a proposal before the Board, that member shall not participate in the evaluation of the proposal.
The Board provides a written statement of its determination to the individual proposing the project and maintains a file of proposals received and determination as made.