Informed Consent

Informed Consent Requirements

Researchers involved in human subjects research must, with rare exceptions, conduct an effective informed consent process with each subject of the research. All participants and/or their legal guardians must understand the nature of the research in order to make a fully informed and voluntary decision to participate.

Consent must almost always be obtained in writing, and the regulations are explicit about the elements that must be included. Additionally, if the study uses video or audio recordings, separate consent is required for each. If the researcher plans to use images or recordings in a specific way, a release form may be required.

Tips on Informed Consent from OHRP:

The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. The documentation of informed consent must comply with 45 CFR 46.117. The following comments may help in the development of an approach and proposed language by investigators for obtaining consent and its approval by IRBs:

Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). The written presentation of information is used to document the basis for consent and for the subjects' future reference. The consent document should be revised when deficiencies are noted or when additional information will improve the consent process.
Use of the first person (e.g., "I understand that ...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject. Use of scientific jargon and legalese is not appropriate. Think of the document primarily as a teaching tool not as a legal instrument.
Describe the overall experience that will be encountered. Explain the research activity, how it is experimental (e.g., a new drug, extra tests, separate research records, or nonstandard means of management, such as flipping a coin for random assignment or other design issues). Inform the human subjects of the reasonably foreseeable harms, discomforts, inconvenience and risks that are associated with the research activity. If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform subjects as they are recontacted or newly contacted.
Describe the benefits that subjects may reasonably expect to encounter. There may be none other than a sense of helping the public at large. If payment is given to defray the incurred expense for participation, it must not be coercive in amount or method of distribution.
Describe any alternatives to participating in the research project. For example, in drug studies the medication(s) may be available through their family doctor or clinic without the need to volunteer for the research activity.
The regulations insist that the subjects be told the extent to which their personally identifiable private information will be held in confidence. For example, some studies require disclosure of information to other parties. Some studies inherently are in need of a Certificate of Confidentiality which protects the investigator from involuntary release (e.g.,subpoena) of the names or other identifying characteristics of research subjects. The IRB will determine the level of adequate requirements for confidentiality in light of its mandate to ensure minimization of risk and determination that the residual risks warrant involvement of subjects.
If research-related injury (i.e. physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk (see 45 CFR 46.102[g]), an explanation must be given of whatever voluntary compensation and treatment will be provided. Note that the regulations do not limit injury to "physical injury". This is a common misinterpretation.
The regulations prohibit waiving or appearing to waive any legal rights of subjects. Therefore, for example, consent language must be carefully selected that deals with what the institution is voluntarily willing to do under circumstances, such as providing for compensation beyond the provision of immediate or therapeutic intervention in response to a research-related injury. In short, subjects should not be given the impression that they have agreed to and are without recourse to seek satisfaction beyond the institution's voluntarily chosen limits.
The regulations provide for the identification of contact persons who would be knowledgeable to answer questions of subjects about the research, rights as a research subject, and research-related injuries. These three areas must be explicitly stated and addressed in the consent process and documentation. Furthermore, a single person is not likely to be appropriate to answer questions in all areas. This is because of potential conflicts of interest or the appearance of such. Questions about the research are frequently best answered by the investigator(s). However, questions about the rights of research subjects or research-related injuries (where applicable) may best be referred to those not on the research team. These questions could be addressed to the IRB, an ombudsman, an ethics committee, or other informed administrative body. Therefore, each consent document can be expected to have at least two names with local telephone numbers for contacts to answer questions in these specified areas.
The statement regarding voluntary participation and the right to withdraw at any time can be taken almost verbatim from the regulations (45 CFR 46.116 [a][8]). It is important not to overlook the need to point out that no penalty or loss of benefits will occur as a result of both not participating or withdrawing at any time. It is equally important to alert potential subjects to any foreseeable consequences to them should they unilaterally withdraw while dependent on some intervention to maintain normal function.
Don't forget to ensure provision for appropriate additional requirements which concern consent. Some of these requirements can be found in sections 46.116(b), 46.205 (a)(2), 46.207(b), 46.208 (b), 46.209(d), 46.305 (a)(5-6), 46.408(c), and 46.409 (b). The IRB may impose additional requirements that are not specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and local law.

Research involving children:

For purposes of the regulations, children are people who have not attained legal age for consent to
the sort of procedures involved in the research under the applicable law of the jurisdiction in
which the research is conducted. For any research involving children, the researcher must obtain
consent from the parent or legal guardian (there are rare exceptions in which parental permission
is not a reasonable requirement, for example a study of neglected or abused children). In addition,
the researcher must obtain the assent of the children involved in the study, when in the judgment
of the IRB the children are capable of providing assent.

Research involving non-English speaking participants:

The consent process should be conducted in language understandable to the subject or the
subject’s legally authorized representative. Accordingly, written information given to subjects,
including consent forms, must be in the language that the subject reads. Such information or
consent forms should be presented as part of the IRB application, along with translations into
English.

Circumstances under which the requirement of a signed consent form can be waived:

For most human subjects research, the process of informed consent must be documented by a
informed consent form approved by the IRB and signed by the subject or the subject’s legally
authorized representative. (Electronic signatures are acceptable.) The subject is to be given a copy
of the written consent form.

The IRB may waive the requirement of a signed consent form under any of the three circumstances:

(i) If the only record linking the subject to the research would be the informed consent form,
and if the principal risk of harm would be from breach of confidentiality the written
consent can then be waived, but each subject must be asked whether they want
documentation linking them to the study, and their wishes will govern.

(ii) If the research presents no more than minimal risk and involves no procedures for which
written consent is normally required outside the research context (for example, surveys or
interviews with extremely low risk).

(iii)If the subjects are members of a distinct cultural group or community in which signing
forms is not the norm, the research presents no more than minimal risk of harm to
subjects, and there is an appropriate alternative mechanism for documenting that
informed consent was obtained.

In circumstances in which the requirement of signed consent form is waived, the IRB may require
the researcher to provide the subjects (or legally authorized representatives) with a written
statement regarding the research.

Circumstances under which consent requirements can be waived or altered:

The basic principle of respect for persons nearly always demands that research participants give
informed consent, even when the subjects do not sign an official form. It is only in rare
circumstances that the IRB will approve a waiver or alteration of the requirement that subjects
give consent.

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Informed Consent