Informed Consent: Templates & Additional Information

Participants must be provided with a copy of the approved consent document, regardless if signed or implied consent is used. For phone interviews, phone surveys, or verbal consent, a copy may not necessarily need to be provided. For online surveys, participants should be informed that they can print the consent form for their records.

For guidance on developing consent forms, please see Guidelines, Templates and Sample Consent Forms.

What does "informed consent" mean?

Being fully informed is a basic requirement in all research with human participants. Ethically and legally, consent is not considered to be "informed" unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate in a research protocol. This applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies.

What types of informed consent exist?

Three types of informed consent exist: (1) signed informed consent; (2) waiver of documentation of informed consent and (3) waiver of informed consent. 

• Signed Informed Consent- Used most commonly, signed informed consent allows prospective participants to document their agreement to take part in research activities by signing and dating the consent document.

• Waiver of Documentation of Informed Consent- A waiver of documentation of informed consent is a request whereby a signed consent document is not required. Examples include implied and verbal consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:

  1. The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation) OR

  1. The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews)

  PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.

• Waiver of Informed Consent- A waiver of informed consent could: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:

  1. The research involves no more than minimal risk

  1. The waiver of informed consent will not adversely affect the rights and welfare of the subjects

  1.  It is not practicable to conduct the research without the waiver or alteration

  1. Whenever appropriate, participants will be provided with additional pertinent information after their participation

  Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, studies of existing pathology specimens, ethnographic research, studies that require deception or passive (opt-out) consent.

PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.

For additional information regarding informed consent, please see the Informed Consent topic in our Frequently Asked Questions.

Getting Started → Preparing a New eSubmission Application → The Review Process → Ongoing Actions Post Approval → Closing the Study