Informed Consent

The federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representative) before subjects can be included in research.

Keep in mind that obtaining informed consent is a continuous process throughout the research, not just a one-time event when a subject signs a form.

Researchers should:

  • work to communicate clearly and effectively with their participants and to build trust and cooperation with their participants.
  • openly and willingly explain their research and answer questions from subjects and be sensitive to the needs and concerns of their research participants.

Informed Consent Form

Obtaining informed consent is most often accomplished through an informed consent form that each researcher creates for the research project.

Refer to the Informed Consent Guidelines for details, directions, and examples of informed consent forms. Be sure to follow these guidelines carefully so that review of your research is not delayed: The majority of required revisions to applications concern the informed consent form.

Waiver of Informed Consent

Federal Regulations allow an IRB to waive the requirement to obtain written documentation informed consent under certain circumstances:

  1. When the consent document would provide the only link to the subject and the principal risk of the research would be breach of confidentiality; or
  2. When the risk to the subjects is minimal and consent would not be required outside the research context.

In approving a waiver of documentation, the IRB must formally find and document that one of the above conditions applies.

If you would like to request a waiver of informed consent, please do so in your protocol when you discuss your informed consent procedures. Be sure to clearly explain why you believe your research qualifies for the waiver.

Where the IRB has waived documentation of consent, researchers must understand that they are still require to communicate all the required element of informed consent to their subjects and that they obtain the subject's active consent before proceeding with the research.

Examples of projects that might qualify for a waiver of informed consent include online anonymous surveys, telephone surveys and some group research.

Information Sheets

In cases where documentation of consent is waived, the IRB may require investigators to provide subjects with a written statement regarding the research called an Information Sheet.

Most often, the information sheet is tailored very similarly to the Informed Consent Form without asking subjects to sign to document their consent.

Therefore, if you would like to use an information sheet, please use the Informed Consent Guidelines to write this document.

Children

If children (>18) will be involved in research, the provisions for informed consent listed in Subpart D of the regulations must be followed. In general terms, these regulations require documented parental consent and child assent.

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