Investigators involved in human subjects research must, with rare exceptions, conduct an effective informed consent process with each subject of the research. All participants or their legal guardians must understand the nature of the research in order to make a fully informed and voluntary decision to participate.
For any human subjects research that is not deemed exempt from the regulations, consent must normally be obtained in writing, and the regulations are quite explicit about the elements that must be included. (See a template for a written informed consent form here). See the "What happens after I submit an application?" section below for more information on what research is deemed exempt, and note that a protocol must be submitted to the IRB even if you expect it to be deemed exempt. However, if you think that your research will be deemed exempt, you do not need to include a written consent form as part of your application.
Elements of informed consent
Except as provided below, the following information should be provided to each subject or legally authorized representative:
(1) 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;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others that may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
(6) 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;
(7) 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;
(8) 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
(9) One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
(i) 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
(ii) 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.
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 written 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 three sorts of 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. 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 PI 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.
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 most research, that will mean a cutoff of age 18. 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 speakers
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 a language that the subject reads. Such information or consent forms should be presented as part of the IRB application, along with translations into English.