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Informed Consent Options

What are the different options for informed consent

The informed consent process can take various forms depending on the type of review your protocol is undergoing and based on the potential pool of participants.

  1. Research Participant Notification Form

This form should be used if your project is undergoing exempt review. A Research Participant Notification form gives potential participants all of the information required for informed consent without requiring a signature.

We have two template Research Participant Notification forms – one with audio/visual language and one without. Make sure you choose the one applicable for your study.

  1. Full Informed Consent

Signed full informed consent is the standard in research with human participants. This is in the form of a document that has all the the elements of informed consent, signed and dated by the participant and kept as a record by the researcher.

If your project is expedited or full board, you will need a full informed consent. You can use our template Over 18 Informed Consent linked in the protocol or on our website.

In research with children (individuals under 18 years old), parental permission is required and depending on the age of the children, child assent may also be required. You can use our Under18 informed Consent form for parental consent (indicating they are consenting for their under 18 child to participate). We also have a template Child Assent linked into the protocol. Make sure you have both uploaded.

  1. Informed Consent Alternatives

In some circumstances, investigators can seek alternatives to standard informed consent procedures, such as:

  • A waiver of using a signed consent form (e.g., giving participants an informed consent sheet but not collecting signatures on it)
  • A waiver of written consent (e.g., using oral consent procedures)
  • A waiver of some or all of the elements of informed consent (e.g., in research that involves deception)

If you think you need a waiver of informed consent, please make sure it’s clear in your protocol you need to waive an element of informed consent and then sufficiently justify why within the protocol. This could be because:

  • You are administering a survey over the phone due to the rural nature of the population you want to survey and informed consent needs to be read aloud;
  • The population of your potential participants are members of a community where signing forms is not the norm;
  • Your project is completely online where signature is difficult to obtain but documented consent can be done in an alternative way OR not collecting signatures would better protect the confidentiality of the participants in your study.
  • You projects requires deception of participants and need to have some of the elements of informed consent

 

References:

Protections of Human Subjects Regulations Sections 45 CFR 46. 116 and 117.

Office for Human Research Protections Informed Consent FAQs on Waiver of Informed Consent.