Elements of Informed Consent

Introduction

The Final Rule to update federal regulations at 45 CFR 46 includes a list of basic required elements of informed consent.

Not all of these items are relevant for all studies and some may need “reinvention” to be useful.

Protocol ID Number

Every protocol in the Campus IRB database is assigned a protocol ID number. The Protocol ID# is an 8-digit number that begins with a four-digit year followed by a four-digit number (for example: 2020-0100).

Include the Protocol ID# in each consent process to help participants identify the study in case they need to contact the research team or IRB with any questions.

Basic Elements of Consent

A statement that the study involves research.

An explanation of the purpose of the research.

A description of the procedures to be followed.

The expected duration of the study.

A description of any foreseeable risks or discomforts.

A description of the benefits to the subjects or others that may result from the research.

A statement to describe the extent, if any, to which confidentiality of records identifying the subject will be maintained.

A statement to inform subjects whether any identifiers associated with their data might be removed and made public or used/not used for future research purposes.

An explanation that participation is voluntary and that the subject discontinue at any time.

An explanation of whom to contact with questions about the research.

An explanation of whom to contact with questions about subjects’ rights.

Concise Summary

The subheading “Key Information” should be included early in the consent process if consent language is about a page or shorter. Consent processes that are longer in length should include a concise summary of key information that individuals contemplating participation in a particular study should know, including the purpose of the research, commitment length, and any risks and benefits to participation. If appropriate, the key information included in the concise summary can be presented as bullet points.

Consent processes that were approved prior to January 21, 2019 must be revised to include the new required elements of informed consent.

Terms of Payment as a Required Element

The Campus IRB requires the following element of consent:

Terms of payment and conditions under which subjects will receive no or partial payment.

Informed Consent for the Collection of Biospecimens

If you are collecting biospecimens (samples of saliva, blood, hair or fingernail clippings, etc.) from participants, the informed consent process should include a statement to inform participants whether the research will or might include genome sequencing with the intent to generate the genome, or its exomes, sequence.

Additional Elements of Informed Consent

The following additional elements were designed primarily for biomedical research and are usually not applicable, but may be relevant for particular circumstances.

Identification of any procedures that are experimental, and a description of appropriate alternative procedures or courses of treatment that might be advantageous to the subject.
Anticipated circumstances under which the subject’s participation may be terminated by the investigator.
Any additional costs to the subject that may result from participation in the research.
A statement to inform subjects whether their information may be used for commercial purposes and the subject will/will not be compensated.
A statement to inform subject that clinically relevant research results, including individual research results, will/will not be disclosed to subjects, and if so, under what conditions.
For research that presents more than minimal risk:

An explanation about whether any compensation is offered and/or whether medical treatments are available if injury occurs, and where further information may be obtained.
An explanation of whom to contact in the event of research-related injury.

If you are unsure if the additional elements of informed consent apply to your research, please contact the IRB office.