The following information and guidance are adapted from the FDA and OHRP and are not meant to be exhaustive when considering the contents of an Informed Consent Document or describing the process of obtaining the participant’s consent.
Please email us if you would like a copy of the PrimeIRB Informed Consent Template.
To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with:
- adequate information to allow for an informed decision about participation in the clinical investigation.
- facilitating the potential participant's understanding of the information.
- an appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.
- obtaining the potential participant's voluntary agreement to participate.
- continuing to provide information as the clinical investigation progresses or as the subject or situation requires.
To be effective, the process must provide sufficient opportunity for the participant to consider whether to participate. That usually means allowing sufficient time for participants to consider the information and providing time and opportunity for the participant to ask questions and have those questions answered. The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence.
What is “Informed Consent”?
Informed Consent is not a Document, it is a Process.
As new medical products are being developed or behavioral intervention being explored, no one knows for sure how well they will work, or what risks they will find. Clinical trials are used to answer questions such as:
- Are new products or interventions safe enough to outweigh the risks related to the underlying condition?
- How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),
- How effective is the medical product at relieving symptoms, treating or curing a condition.
The main purpose of clinical trials is to “study” new medical products in people. It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient.
While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:
- may not benefit from the clinical trial,
- may be exposed to unknown risks,
- are entering into a study that may be very different from the standard medical practices that they currently know
To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:
- what will be done to them,
- how the protocol (plan of research) works,
- what risks or discomforts they may experience,
- participation being a voluntary decision on their part.
This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.
A central part of the informed consent process is the informed consent document. Federal regulations do not dictate the specific language required for the informed consent document, but the regulations do require certain basic elements of consent be included.
Basic Elements of an Informed Consent Document [45 CFR 46.116(b)]
At a minimum, an Informed Consent Document should include the following:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others that may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
- A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
Additional Elements of an Informed Consent [45 CFR 46.116(c)]
In addition to the Basic Elements, the Informed Consent Document may need to include the following:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent
- Any additional costs to the subject that may result from participation in the research
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
- A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject
- The approximate number of subjects involved in the study
- A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
- A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)
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, friend or 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.