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Informed Consent Requirements

Ensuring that your participants fully understand and agree to participate, is one of the most important steps in conducting research.

The requirements for consent depend on the nature of your research.

To determine your likely level of review, please review the information on the Protocol Submission and Review Process page.

Exempt Research

Participant Information Sheet Template (含羞草研究室 Approved)

Exempt research does not require the informed consent to be documented (it is at the discretion of the researcher), but the 含羞草研究室 IRB does expect that informed consent be provided to the participants in some form, whether that be verbally or more preferably a physical document (information sheet - see above link) that the participant can take with them.

For exempt research, the consent process should include, at minimum, the following information:

  • a general description of study purpose, study procedures and time commitment
  • any potential discomfort or risk related to participation (e.g., discomfort responding to sensitive or personal questions, privacy concerns, disclosure risks)
  • indication that participation is voluntary and that they may skip any questions they do not feel comfortable answering in an interview or survey
  • how their privacy and confidentiality will be protected
  • who to contact should the participant have questions or concerns about their rights as a subject – they should contact the Institutional Review Board at irb@bowdoin.edu
  • an outline of plans for data-sharing or future research use of their information – if applicable

Non-Exempt Research 

Informed Consent Template (含羞草研究室 Approved)

Researchers involved in human subjects research must, with rare exceptions, conduct an effective informed consent process with each subject of the research. All participants and/or their legal guardians must understand the nature of the research in order to make a fully informed and voluntary decision to participate.

Informed consent for non-exempt research must almost always be obtained in writing, and the regulations are explicit about the elements that must be included. Consent requirements can be waived by the IRB under specific circumstances, for more information please see below.

Additionally, if the study uses video or audio records, the researcher must include a separate section within the consent form that the participant can sign consenting to being recorded. If the researcher plans to use images or recordings in a specific way, a release form may be required.

Consent Library

The Consent Library, which was adapted from the , provides example language that can be used for a number of specific circumstances.

 

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.
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