When evaluating a research application, the IRB considers the researcher’s commitment to several ethical principles.
These include the following, as further explained below:
Middlebury’s IRB has a written policy that is reviewed and updated regularly. This policy is the basis for all IRB actions and all content on the IRB website. For more information, download the IRB Policy.
The principal investigator must explain to subjects, before they participate in any research activities, the objectives of the research, the procedures that will be followed, any associated risks, and any potential benefits. Investigators must not use individuals as subjects unless they are satisfied that the subjects, or others legally responsible for the subjects’ well-being, freely consent to participate and understand the consequences fully.
To signal that they agree to participate, subjects must either sign a written consent form or provide oral consent. A researcher who plans to obtain oral consent must make the case for using oral instead of written consent. The requirement for written consent may be waived if:
- the research involves no or only minimal risk
- the consent form will 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, but the survey form must start with the same explanation of the research protocol that would be used for a written consent form. The subject’s decision to complete and return the survey implies consent to participate.
Research that involves deception compromises subjects’ ability to give truly informed consent. If your research involves intentional deception, the Institutional Review Board will consider requests to waive some of the requirements for informed consent, but only if the study design meets all of the following criteria:
- the research cannot be done without the deception
- the potential value of the research outweighs any potential risks to the subject
- the subjects are informed of the true nature of the research as soon as possible
- the research involves no more than minimal risk (federal requirement)
Investigators must respect their subjects’ privacy. Investigators must protect confidential information given to them and must advise subjects in advance of any limits on 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 becomes responsible for either ensuring that it is destroyed or archiving it with his or her data. If the student plans to go on to graduate school and wants to continue the research or use the data in future projects, they must request permission from the IRB to retain the data. Permission is contingent upon the student demonstrating adequate procedures to protect the confidentiality of the data.
Lack of Coercion
Subjects, including students who participate in classroom experiments or faculty scholarship, must 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 participating should be in line with the burden imposed by participating, to avoid undue influence on a person’s ability to freely choose to participate (or not).
Researchers must inform subjects that they are free to withdraw from active participation in the research at any time. Subjects who indicate a desire to withdraw must be allowed to do so promptly and without penalty or loss of benefits to which any subject is otherwise entitled. At the minimum, this right must be clearly stated as part of the informed consent statement.