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For most human subjects research, the process of informed consent must be documented by a
informed consent form approved by the IRB and signed by the subject or the subject’s legally
authorized representative. (Electronic signatures are acceptable.) The subject is to be given a copy
of the written consent form.

The IRB may waive the requirement of a signed consent form for non-exempt research under any of the three circumstances:

(i) If the only record linking the subject to the research would be the informed consent form,
and if the principal risk of harm would be from breach of confidentiality the written
consent can then be waived, but each subject must be asked whether they want
documentation linking them to the study, and their wishes will govern.

(ii) If the research presents no more than minimal risk and involves no procedures for which
written consent is normally required outside the research context (for example, surveys or
interviews with extremely low risk).

(iii)If the subjects are members of a distinct cultural group or community in which signing
forms is not the norm, the research presents no more than minimal risk of harm to
subjects, and there is an appropriate alternative mechanism for documenting that
informed consent was obtained.

In circumstances in which the requirement of signed consent form is waived, the IRB may require
the researcher to provide the subjects (or legally authorized representatives) with a written
statement regarding the research.

Circumstances under which consent requirements can be waived entirely or altered:

The basic principle of respect for persons nearly always demands that research participants give
informed consent, even when the subjects do not sign an official form. It is only in rare
circumstances that the IRB will approve a waiver or alteration of the requirement that subjects
give consent.

Assent form template is being developed. Please contact the irb@bowdoin for more information.

For purposes of the regulations, children are people who have not attained legal age for consent to
the sort of procedures involved in the research under the applicable law of the jurisdiction in
which the research is conducted. For any research involving children, the researcher must obtain
consent from the parent or legal guardian (there are rare exceptions in which parental permission
is not a reasonable requirement, for example a study of neglected or abused children). In addition,
the researcher must obtain the assent of the children involved in the study, when in the judgment
of the IRB the children are capable of providing assent.

The consent process should be conducted in language understandable to the subject or the
subject’s legally authorized representative. Accordingly, written information given to subjects,
including consent forms, must be in the language that the subject reads. Such information or
consent forms should be presented as part of the IRB application, along with translations into
English.