Human Subjects

Policies & Guidance

Informed Consent

In addition to concerning itself with risk, the IRB must consider the subject's consent to participate in the research project. An underlying ethical principle of the federal regulations is that human subjects enter into research voluntarily and with adequate information. (Also see External Link The Belmont Report, 1979.) Thus, consent must be informed and voluntarily given. A subject's consent is "informed" if he/she has a reasonable comprehension of that to which he/she is consenting. The investigator must use language appropriate to the subject's ability to comprehend. Generally, the consent form should be written at the 8th-grade reading level. Nondisclosure of information to subjects must not be used simply to assure their participation in the research. It is desirable but not mandatory that the investigator, rather than an assistant, obtains the consent.

To ensure that subjects' consent is voluntary, the IRB considers whether any undue pressures will be brought to bear on potential subjects. Such pressure may be subtle as, for example, when a teacher asks his/her own students to become subjects of his/her research.  Excessive compensation or no partial payment for withdrawals is viewed by the IRB as pressure.

In order to obtain informed consent the investigator must provide an informed consent statement. An Informed Consent Statement Template is available on the IRB Forms & Templates page to assist investigators in the preparation of the consent form. The template reflects both the requirements of federal regulations and customary language adopted by the HSO. Use of the template will facilitate the review process. Each subject must be given a copy of the signed consent form.

Upon approval, the consent statement will be electronically stamped. See Electronic Stamp for more information.

Subjects who are willing to participate in research should sign a copy of the IRB-approved and electronically stamped informed consent statement. Subjects may provide verified signature in lieu of a physical, “wet” signature via encrypted digital signature, electronic signature pad, voice print, digital fingerprint, or signature made with a fingerprint on a touchscreen.

For additional information regarding informed consent, please view the IU IRB SOP on Informed Consent available on the Policies & Guidance page.

Who can give consent?

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Waivers or Alterations of Consent:

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Waivers of Documentation of Consent:

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See Consent and Assent in Research Enrolling Minors.

Decisionally/Cognitively Impaired:

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