Policy on Protection of Human Subjects
IV. General Principles
All researchers conducting original research are responsible for protecting their subjects from the risk of unreasonable harm.
The principal investigator has initial responsibility for determining whether such a risk exists. A faculty member is responsible for supervising research undertaken by students in the context of his/her courses or departmental/program curriculum.
If there is any doubt about risks, or if the research involves any of the circumstances outlined in IV.B. or IV.C. below, the principal investigator should contact the IRB chair or a member of the IRB.
The principal investigator should refer to and follow the guidelines of the relevant professional organizations and, where appropriate, those of governmental funding and regulatory agencies. Faculty members supervising student research have a responsibility for introducing the students to Middlebury College's guidelines.
At the minimum, research activities should conform to the following.
1. The principal investigator has a certificate on file with the Institutional Review Board showing that they have completed the National Institutes of Health Human Participant Protections Education for Research Teams. (http://cme.nci.nih.gov)
2. Subjects should be made fully aware of any risks.
- 3. The principal investigator shall explain to subjects, prior to their participation, the objectives of the research, the procedures to be followed, and the risks and potential benefits. In general this explanation should also be offered in writing. Investigators shall not use individuals as subjects unless satisfied that the subjects, or others legally responsible for the subject's well-being, freely consent to participation with a full understanding of the consequences. The Institutional Review Board may waive these requirements only if all of the following three criteria are met.
a) The committee is persuaded that the research cannot otherwise be done.
b) The committee is convinced that the potential value of the research outweighs any potential risks to the subject.
c) The research involves minimal risk.
In general, subject consent is indicated in writing on an "informed consent" form. Please note that written consent is required even for totally anonymous questionnaires.
4. If the data gathered by a student researcher is not anonymous, the faculty research sponsor should ensure that the data are properly archived or destroyed. The IRB recommends that student data be turned over to the faculty sponsor, who would then become responsible for either ensuring that it is destroyed, or for archiving it with his or her data, in cases where it is related to the faculty member's research. In a case where a student is planning to go on to graduate school, and may want to continue the research or use the data in future projects, he or she may petition to retain the data. Permission would be contingent upon agreement to protect the confidentiality of the data.
5. Investigators shall respect the privacy of their subjects. Investigators shall protect confidential information given them, advising subjects in advance of any limits upon their ability to ensure that the information will remain confidential.
6. Subjects, including students who are participating in classroom experiments or faculty scholarship, shall not be induced to participate by means or in circumstances that might affect their ability to decide freely. When course credit is offered for participation in research, some other mechanism to "earn" that credit must also be made available to those students who choose not to participate as human subjects. Rewards for participation should be in line with the burden imposed by participation.
7. It shall be made clear to subjects that they are free to withdraw from active participation in the research at any time. Subjects who indicate a desire to withdraw shall be allowed to do so promptly and without penalty or loss of benefits to which any subject is otherwise entitled. At the minimum, this shall be clearly stated as part of the informed consent statement.
8. Teachers who assign or supervise research conducted by students are responsible for ensuring that these students are qualified to safeguard adequately the well-being of the subjects.
9. Subjects of human research are generally provided the opportunity of access to the benefits of that research at its conclusion.
10. An investigator shall disclose to a subject, upon request, the source of support for the research.