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, the principal investigator should contact the IRB chair or a member of the IRB.
The principal investigator should 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 a minimum, research activities at the College should conform to the following standards:
1. Informed Consent: The principal investigator shall explain to subjects, prior to their participation, the objectives of the research, the procedures to be followed, the associated risks, and the potential benefits. 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.
In general, subjects should signal their agreement to participate by signing a written consent form, though a researcher may make the case for the use of oral consent instead. The requirement of written consent may be waived under one of the following conditions:
(1.) the research involves no or only minimal risk; or
(2.) the consent form would be the only evidence linking
the subject and the research, and the primary risk of harm
is to the subject's privacy.
Anonymous surveys do not require a written consent form, though the explanations of the research protocol that are standard in a written consent form should be included as a preamble to the survey. Consent to participate is implied in the subject's decision to complete and return the survey.
Research involving deception compromises a subject's ability to give truly informed consent. The Institutional Review Board will consider requests to waive some of the requirements for informed consent for research that intentionaly involves deception, but only if all of the following criteria are met.
a) the research cannot be done without the deception;
b) the potential value of the research outweights any
potential risks to the subject;
c) the subjects are informed of the true nature of the
research as soon as possible;
d) the research involves no more than minimal risk
(federal requirement).
2. Confidentiality: 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.
If the data gathered by a student researcher is not anonymous, the IRB recommends that the data be turned over to the faculty sponsor, who then would become responsible for either ensuring that it is destroyed or archiving it with his or her data. In cases 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 request permission from the IRB to retain the data. Permission would be contingent upon demonstration of adequate procedures to protect the confidentiality of the data.
3. Coercion: 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, so as not to present an undue influence on a person's ability to freely choose to participate (or not).
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.
4. Disclosure: An investigator shall disclose to a subject, upon request, the source of support for the research.