» Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what’s involved so the person can decide if they want to participate. This process is one of the central components of the ethical conduct of research with human subjects.

The consent process typically includes providing a written consent document containing the required information (i.e., the elements of informed consent under the 2018 Common Rule) and the presentation of that information to prospective participants.

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document a person’s consent to participate) unless the IRB has waived the requirement to consent or the requirement to document consent (e.g., signature). (See Waiver of Informed Consent Guidelines)

Even in situations where the IRB may waive the documentation (signature) requirement (e.g., for a telephone interview or online survey), investigators must present participants with the required key elements of informed consent and with a copy of the written consent document (or a link to download/print the consent form).

General Information and Tips for Preparing a Consent Document

Reading Level

Informed consent documents should be written in plain language at a level appropriate to the participants, typically at an 8^th grade level. A best practice is to have a colleague or friend read the informed consent document for comprehension before submitting the IRB application. Always:

Tailor the document to the participants
Avoid technical jargon or overly complex terms.
Use straightforward, understandable language.

Writing Tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

Use the second person (you) or third person (he/she/they) to present the study details. Avoid the use of the first person (I).
Include a statement of agreement at the conclusion of the informed consent document.
Be consistent with the information that is described in the IRB application.

Informed Consent Templates

Although the requirements set forth in the Common Rule provide the elements of informed consent, the research team must determine the most pertinent information about the study to provide, the most effective way to communicate that information, and the most accurate way to assess if the research participant understood the information. Additional information must be included in informed consent documents for clinical trials.

The IRB may make recommendations or edits to consent forms to ensure all identified risks are clearly stated. The IRB may also provide ideas of what a reasonable person would want to know and what might be the most helpful information for the person’s decision about whether or not to participate. Of course, the IRB must also help ensure all of the required elements are included per the federal regulations. The following templates should be used when researchers develop consent documents.

Information sheet for exempt studies – The IRB may request use of this template for minimal risk studies that undergo exempt review when only a brief consent process is possible (e.g., online studies).
Adult Informed Consent Template (.docx) – use this template for most studies with adult participants.
Additional Elements of Consent (.doc) – this document provides consent language for studies involving electroencephalogram (EEG), Transcranial direct current stimulation (tDCS), collection of biospecimens (e.g., saliva collection, blood draws), certificates of confidentiality, and when clinical trial studies will be registered on ClinicalTrials.gov.
Child Assent Template (.docx) – use this template for studies involving minors between ages 7-17.

Debriefing

Under certain conditions (§46.116(d)), the IRB may approve a research study that involves deception or incomplete disclosure. In this case, participants must be “debriefed” or provided additional information about the study once it ends. The debriefing process should provide participants with an explanation of the study’s purpose, the procedures in which deception occurred, and why it was necessary for deception to occur. Participants must also choose whether or not the researchers may use their data collected prior to debriefing.

Debriefing Form Template

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Basic Elements of Informed Consent – to be included in all protocols that receive expedited or full review unless the IRB makes an exempt determination.

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 (length of time for participation).
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 may 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.

Elements of informed consent for clinical trials

A statement explaining that the study involves research.
An explanation of the purposes of the research.
The expected length of time for participation.
A description of all the procedures that will be completed during enrollment on the clinical trial.
Information about all experimental procedures that will be completed during the clinical trial.
A description of any predictable risks.
Any possible discomforts (e.g., injections, frequency of blood test, etc.) could occur as a result of the research.
Any possible benefits that may be expected from the research.
Information about any alternative procedures or treatment (if any) that might benefit the research subject.
A statement describing:
1. the confidentiality of information collected during the clinical trial,
2. how records that identify the subject will be kept,
3. the possibility that the FDA may inspect the records.
For research involving more than minimal risk information, including:
1. an explanation as to whether any compensation or medical treatments are available if injury occurs,
2. what they consist of, or
3. where more information may be found.
4. questions about the research,
5. research subjects' rights,
6. injury related to the clinical trial.
Research subject participation is voluntary.
Research subjects have the right to refuse treatment and will not lose any benefits for which they are entitled.
Research subjects may choose to stop participation in the clinical trial at any time without losing the benefits for which they are entitled.
Contact information will be provided for answers to questions about the research.
An explanation of whom to contact with questions about subjects’ rights.

In addition, when appropriate, one or more of the following elements of information must also be provided in the informed consent document:

A statement that the research treatment or procedure may involve unexpected risks (to the subject, unborn baby, if the subject is or may become pregnant).
Any reasons why the research subject participation may be ended by the clinical trial investigator (e.g., failing to follow the requirements of the trial or changes in lab values that fall outside of the clinical trial limits).
Added costs to the research subject that may result from participating in the trial.
The consequence of leaving a trial before it is completed (e.g., if the research and procedures require a slow and organized end of participation).
A statement that important findings discovered during the clinical trial will be provided to the research subject.
The approximate number of research subjects that will be enrolled in the study.

A potential research subject must have an opportunity to:

read the consent document,
ask questions about anything they do not understand.

Usually, if one is considering participating in a clinical trial, he or she may take the consent document home to discuss with family, a friend, or an advocate.

An investigator should only get consent from a potential research subject if:

enough time was given to the research subject to consider whether or not to participate,
the investigator has not persuaded or influenced the potential research subject.

The information must be in language that is understandable to the research subject.

Informed consent may not include language that:

the research subject is made to ignore or appear to ignore any of the research subject's legal rights,
releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.

Participating in clinical trials is voluntary. You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully. Ask questions about any information you don’t understand or find confusing.

FDA Draft Guidance: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors