Requirements for obtaining informed consent

Guidelines

Obtaining informed consent from participants fulfills the ethical requirement of “respect for persons” discussed in the Belmont Report. Consent is a process, not a signature on a form. Once the consent form is signed, consent continues through ongoing communication with the subject throughout the study. Unless waived by the IRB, consent from subjects must be obtained freely without coercion and/or undue influence.

Investigators are strongly encouraged to recruit and include all segments of the community in research. This complies with the Belmont Report principle of ‘justice.’ In addition, subjects should be presented with a consent document in a language understandable to them. If subjects are being targeted for recruitment and they may not speak or read English, then documents must be translated into a language they understand.

Researchers must be aware of any real or perceived power differential between researchers and potential subjects (such as doctor/patient, employer/employee, or teacher/student relationships), in which case(s) the recruitment and consent process must be modified accordingly (such as relying on a trained independent third-party on the research staff to recruit and consent subjects).

Parental permission is required for all Human Research involving minors (in Arizona this is any person under the age of 18) unless waived by the IRB. In addition, minor assent must be obtained from subjects unless waived by the IRB. When the minor reaches the age of majority (age 18) they should be consent as an adult to continue participation in the Human Research project. See HRSP Guidance, Children, for more information.

Creating a consent document

Informed consent documents should:

  • Written at a sixth (6th) to eighth (8th) grade level and in a language the subject will understand. The HRPP maintains an Informed Consent template to use when writing a consent document, however use of the template is not required.
  • Informed consent documents must contain all of the required and additional elements of informed consent as appropriate.
  • Information regarding the Genetic Information Nondiscrimination Act (GINA) must be included in the consent form if genetic testing will occur as part of the research.

Always date the revisions of consent documents to ensure that the most recent version approved by the IRB is used. All versions of the consent documents in every language used must be approved by the IRB prior to use.

Documenting consent

Consent must be documented in writing unless waived by the IRB.

The following are requirements for written consent documents:

  • The subject or representative signs and dates the consent document
  • The individual obtaining consent signs and dates the consent document (this is best practice)
  • Whenever required by the IRB, the subject’s or a representative’s signature is to be witnessed by an individual who signs and dates the consent document
  • For subjects who cannot read, and whenever required by the IRB or the sponsor, a witness to the oral presentation signs and dates the consent document
  • A copy of the signed and dated consent document is provided to the subject

What is the short form informed consent?

The regulations allow, in certain circumstances, the use of a short form consent process (45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2)). The IRB must determine that the short form process is appropriate before it may be used to consent potential subjects.

Examples of appropriate requests for use of the Short Form Informed Consent Process

  • A study population is seeking Hispanic males, then Spanish translated documents must be submitted to the IRB for review and approval. A short form process will not be approved in this instance.
  • If the study seeks to enroll a single individual* who happens to meet the eligibility criteria, but the subject does not read or speak English, then a short-form process may be approved. A request must be submitted to the HRPP before the subject is enrolled in the study.

*If the IRB receives continued requests for use of the short-form process, for the same language as previously approved by the IRB, then the IRB will require that the project be amended to provide fully translated consent forms to be used with this population.

Documents required to obtain IRB approval for short form informed consent process

The use of the short form is reviewed on an individual IRB protocol basis. Investigators can include the request in the initial submission, or may submit an amendment if a subject presents that meets the requirements for use of the short form.

  • Justification for use of the short form.
  • Summary of what will be presented to the subject (this can be the English version of the informed consent document).
  • Text of the short form – This document highlights that the basic elements of consent will be obtained from subjects.

Documenting the short form informed consent process

The short form process provides the elements of informed consent to the potential subject in a language they understand, a witness is required to be present, and a translator is used.

  • If the Person Obtaining Consent (POC) is not fluent in the participant’s language, an interpreter must be present to assist in the consent process.
  •  The interpreter must be fluent in English and the language of the participant. A family member may be the interpreter only if the participant has declined use of a hospital interpreter.

Required signatures:

  • Short Form (translated): Participant or the participant’s legally authorized representative [LAR] and Witness*
  • Summary Form (English): Person Obtaining Consent (POC) and Witness*

* A member of the study staff acting as interpreter and POC cannot also act as witness. The witness may be the interpreter (including the hospital interpreter), study staff, a family member, or other person conversant in both English and the participant’s language.

  • The participant should be given a copy of both the translated Short Form and the Summary Form.

PHI Authorization and the short form informed consent process

If the IRB finds it appropriate, they may grant an alteration of the required PHI elements (e.g. the signature). The IRB expects that all elements of the authorization will be presented to the subject, but in the short form process, the alteration of PHI can be used to document that PHI authorization was obtained orally, but a signature will not be obtained on an actual PHI authorization form.

Documenting unwritten, oral, or electronic informed consent

Unwritten, oral consent also requires documentation. Be thinking of how to verify human subject oral consent if required to produce verification. This can be accomplished in a variety of ways, including these:

  • Audio recording
  • Video recording
  • Photographs
  • Drawings
  • Witnesses
  • Thorough field notes

Informed consent form guidelines

Regardless of the consent template used, all the required and additional elements of informed consent (if applicable) must be included in all written consent materials unless waived by the IRB.

Consent resources

Consent templates

Simplification of consent forms

Toolkits

 

Version 2019-8 

Human Research Protection Program (IRB)
Location
Building 20, 4th floor
Science Annex
525 S Beaver Street
Flagstaff, AZ 86011-4087
Mailing Address
PO Box 4062
Flagstaff, AZ 86011-4087