Do I have to get informed consent?

Researchers may only involve human subjects in research if legally effective informed consent is obtained from the subject or the subject’s legally authorized representative (LAR). Any exception to or modification of the informed consent requirements must be reviewed and approved by the IRB, such as by granting a waiver.

There are several specific requirements for obtaining legally effective informed consent, including:

• Informed consent must be sought only under circumstances that give the prospective subject or legally authorized representative enough opportunity to discuss and consider whether or not to participate, and minimize the possibility of coercion or undue influence.
• Researchers must provide the prospective subject (or LAR) with the information that a reasonable person would want to have in order to make an informed decision about whether or not to participate in the study, and an opportunity to discuss that information.
• The information that is provided about the study, whether orally or in writing, should be provided in language that is understandable to the prospective subject or LAR.
• The informed consent form, as a whole, must present information in a way that helps the prospective subject (or LAR) understand the reasons why one might or might not want to participate. Specifically, the form should include sufficient detail about the research, and should not just provide lists of isolated facts. 
• The informed consent form cannot contain any language through which the subject (or LAR) waives or appears to waive legal rights, or that releases (or appears to release) researchers, research sponsors, the institution, or others from legal liability for negligence.

For complete policy information regarding informed consent, please review the RCHRPP Policy - Informed ConsentHuman Research Protection Program Informed Consent policy RC HRPP Policy - Informed Consent .

Can I get a waiver?

In some circumstances, IRB may grant a waiver of the requirement of informed consent, and/or approve modifications to the informed consent requirement. Some of the specific criteria that researchers must meet to be granted a waiver or be approved to make modifications include:

• The research must involve no more than minimal risk to the subjects.
• The research could not practicably be carried out without the waiver or alteration.
• The waiver or modification must not adversely affect the rights and welfare of the subjects.
• Whenever appropriate, the subjects (or LARs) should be provided with additional relevant information after participation.

For full details regarding informed consent and obtaining waivers, please review Section 2.2 Waiver or Alteration of Informed Consent of the RCHRPP Policy - Informed ConsentHuman Research Protection Program Informed Consent policy RC HRPP Policy - Informed Consent policy.