Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers.
This requirement is founded on the principle of respect for persons, one of the 3 ethical principles governing human subject research described in the Belmont Report. The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected. The requirement for informed consent is one of these 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
Potential participants must be provided with information about the research project that is understandable and that permits them to make an informed and voluntary decision about whether or not to participate. The amount of information and the manner of presentation will vary depending on the complexity and risk involved in the research study. Informed consent is an ongoing educational interaction between the investigator and the research participant that continues throughout the study.
You must describe your process for obtaining informed consent for participation in human research. The process you employ for obtaining informed consent will depend on the research setting and your participant population. An in-depth description of the Process to Obtain Informed Consent has been provided for reference as you write the study protocol.
Types Of Consent
To assist you in choosing the right type of consent process for your study, read the descriptions below. Upload the proposed consent document in the Consent Form and Recruitment Materials section in the New Study application.
For Studies Using PHI: Research that is using or disclosing Protected Health Information (PHI) must be conducted in accordance with the Privacy Rule of the Health Insurance Portability and Accountability Act(HIPAA) and requires completion of the HIPAA section of the study protocol.
Templates may be downloaded from the Templates and Forms section.
- Standard Written Consent (HRP-314 Item 7)
Definition: Participants sign a consent form to indicate that they agree to participate in a study.
When it may be used: Face-to-face research regardless of the overall risk of the study.
- Short Form Written Consent (HRP-317)
Definition: Participant signs a shortened, non-English consent document in a language the participant understands.
When it may be used: When the prospective participant has limited English proficiency and there is not enough time to translate the approved English version of the consent document into a language the participant understands.
- Waiver of Documentation of Consent (aka “Verbal” or “Online” consent) (HRP-411)
Definition: Participants consent to be in the study, but do not sign a consent form.
When it may be used: Minimal risk research involving surveys sent through the mail or conducted over the internet, telephone interviews, or the collection of sensitive information without a written record that could identify participants.
- Waiver or Alteration of the Requirements for Informed Consent (HRP-410)
Definition: The research is conducted without obtaining consent from the participant.
When it may be used: Medical chart reviews; analysis of existing data; or, in rare cases, when secondary participants may be involved and it would be either prohibitive or potentially dangerous to obtain consent.
- General Requirements for Informed Consent
- Suggested Consent Language
- Research Related Injury Language
- Guidance for Use of Gadolinium-Based Contrast Agents (GBCAs)
- Emergency Exemption for Investigational Test Articles
- Exception from Informed Consent for Planned Emergency Research
- In Vitro Diagnostic Device Studies