Informed Consent

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Based on the governing principles of human research outlined in “The Belmont Report,” investigators have key responsibility for ensuring voluntary participation of research subjects.

Any prospective research subject (or his/her legally authorized representative) should be able to understand as completely as possible the procedures to be performed, risks, benefits, alternatives, and confidentiality measures. Individuals should be given the opportunity to make the choice to be in a study without pressure or undue inducement to participate. Voluntary informed consent is not a one-time event, but rather is an ongoing process. For more information regarding the procedures for obtaining and documenting informed consent, please see HRP-90 and HRP-91.

With few exceptions, researchers must obtain and document consent from the prospective research subject before initiating any study procedures. Any exceptions must be reviewed and approved by the IRB beforehand.

The requirement for informed consent is one of the central protections defined by the:

  • Department of Health & Human Services (HHS) regulations at 45 CFR part 46
  • Food and Drug Administration (FDA) regulations at 21 CFR part 50

Types of Consent

Written Consent

Participants sign a consent form to indicate that they agree to participate in a study. May also include electronic signatures.

Commonly used for: Face-to-face research regardless of the overall risk of the study. Research involving greater than minimal risk to subjects.

Form: Written Consent (HRP-588)

Additional Consent Requirements

Consent is required beyond standard written consent.

Commonly used for: Studies involving the use of drugs or devices, clinical trials, or for other FDA-regulated research. Use in addition to HRP-588.

Additional Consent Requirements for Research Involving the Use of Test Articles (HRP-587)

Waiver of Documentation

Participants consent to be in a study (verbally, online, or implied), but do not sign a consent form.

Commonly used for: Minimal risk research involving surveys sent through the mail or conducted over the internet; telephone interviews. Additionally, when the only record linking the subject and the research would be the consent document and the primary risk to participants would be a breach of confidentiality.

Form: Waiver of Written Documentation of Consent (HRP-589)

Waiver or Alteration of Consent

Consent will not be obtained or consent will not contain all of the information that is typically required. It is rare that the IRB will approve a complete waiver of informed consent.

May be used for: Situations in which it may be approved include deception or analysis of existing data.

Consent for Research that may be Determined Exempt Research

The IRB does not typically review and approve informed consent forms or recruitment materials for exempt research studies, except for studies collecting sensitive, identifiable information that require a Limited IRB Review or fall under the EU General Data Protection Regulation (GDPR) requirements. It is ethically necessary to ensure that subjects are fully informed about the nature of the research project so they can make an informed decision about participation. If an exempt research study involves interactions with subjects (whether the interactions occur in person or not), there must be a consent process in place that will disclose the information required in HRP-590: ORP Consent Guidance for Exempt Research.

The IRB will review the consent process as outlined in the study protocol.

General Tips for Informed Consent

Reading level

Informed consent documents should be written in plain language at a level appropriate to the subject population.  A best practice is to have a colleague or friend read the informed consent document for comprehension before submission to the IRB.  Always:

  • Tailor the document to the subject population.
  • Avoid technical jargon or overly complex terms.
  • Use straightforward language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented to the IRB.

  • Use the second person (you) to present the study details.  Avoid use of the first person (I). 
  • To avoid inconsistency, do not repeat information.
  • Format the document for ease of reading. Consider the use of graphics, bullet points, charts, the inclusion of additional spacing, font size, etc. 

Key Elements of Informed Consent

All required elements of consent are in the appropriate templated. Below are five main aspects of consent. 

  1. A statement that research is being conducted and participation is voluntary.
  2. A summary of the research, including: purpose, duration, and procedures.
  3. Information on reasonable, foreseeable risks or discomforts.
  4. Information on reasonable, expected benefits. Compensation is NOT considered a benefit.
  5. List of alternative procedures or course of treatment, if any (applies primarily to clinical research).