A critical component of the conduct of behavioral intervention research, regardless of phase along the pipeline, is the informed consent process. This involves preparing and administering an informed consent document to potential participants that has been preapproved by an IRB. The informed consent document operationalizes the principles described in the Belmont Report discussed previously. It describes what individuals need to know about their involvement in a behavioral intervention research study, including risks and benefits, in order to make an informed decision regarding consent to participate in the study. The informed consent document must include all essential information about the study, not be overly long or complex, and be written in lay language in an understandable way. In fact, most IRBs stress that an informed consent document must be written at an eighth-grade reading level or below. The Federal Government requirements for an informed consent document are presented in Table 13.1. In addition to these requirements, each institution usually has language that is required for an informed consent document. Therefore, it is always important to check with an institution’s research or regulatory office prior to preparing an informed consent document. In addition, these documents must be approved by an institution’s IRB before a study can commence.
The process of obtaining informed consent from potential study participants also needs careful consideration. It is critically important that participants understand what is contained in the document with respect to their involvement in the intervention study including the type of activities that they will be expected to perform, location of the study, time commitments, potential risks and benefits, and if there is compensation for participation. As an aside, compensation or an honorarium for participating in interviews or completing a study is common practice; however, the amount of compensation must be modest or reasonable and cannot appear to be or act as a form of coercion to participate. If there is any doubt that an individual is unable to comprehend what is in the document, it is advisable to read the document aloud to the person or ask him or her to summarize what is stated in the document. This might be accomplished by asking participants a series of questions. Common practice is to provide participants with a point-by-point verbal summary of the document before asking them to read and sign the form. Providing participants with the consent form prior to the face-to-face review can also facilitate the consenting process. In addition, as the PI’s name and phone number are provided, he or she must always be available to answer any questions in person or by telephone. The member of the research team who has oriented and received the consent of the study participant must also sign and date the consent form. If the person is unable to speak English, the form should be in that person’s preferred language and a team member who speaks that language should be available to answer questions. Consents that undergo translation into a language other than English need to be approved by the IRB and a certificate must be provided from a translational service indicating the methodology that was used.
In some studies, it may be necessary for a participant to sign a HIPAA (Health Insurance Portability and Accountability Act) Research Authorization form. Whereas the consent document reflects a participant’s agreement to participate in a study, the authorization form allows an investigator to use or disclose the participant’s protected health information (e.g., health status, birth date, address) to others delineated in the authorization form (e.g., funder, insurance company to obtain medical records). This form must also be signed and dated at the time that written consent for participation in the study is obtained.
TABLE 13.1 Federal Requirements for an Informed Consent Document
Eight Specific Areas That Must Be Addressed
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 which 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, which may reasonably be expected from the research.
- 4. A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject including the alternative not to participate.
- 5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- 6. An explanation as to whether any compensation is provided 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, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Additional Elements of Informed Consent When Appropriate
- 1. 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), which are currently unforeseeable.
- 2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
- 3. Any additional costs to the subject that may result from participation in the research.
- 4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- 5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
- 6. The approximate number of subjects involved in the study.
Source: U.S. Department of Health and Human Services (2009).
In addition, an IRB may require the use of an impartial third party to observe the consent process and verify that study participants fully understand a study; this procedure is typically used when enrolling vulnerable populations or for intervention protocols that are invasive or high risk. This might also be the case if a study involves participants with cognitive impairment or children. In general, vulnerable populations include children, prisoners, pregnant women and their fetuses, individuals with cognitive impairment or of lower socioeconomic status, students, or individuals in a subordinate role. In this case, the third-party person
(a responsible party or proxy) must be someone who is independent of the potential participant and charged with protecting the individual’s rights. A related point is that consideration should be given for re-consenting individuals with cognitive impairment or for those individuals who show cognitive decline over time in a study. Study participants may need to be re-consented to ensure that at each testing occasion there is an understanding of study procedures, that participating in the study is on a volunteer basis, and that the information they provide is confidential (Black, Kass, Fogarty, & Rabins, 2007; Black, Rabins, Sugarman, & Karlawish, 2010).
Finally, if there is a change in the research protocol or an investigator discovers new risks associated with study participation or that risks have increased or benefits decreased, it is usually necessary to re-consent study participants. In such cases, it is important to check with an institution’s IRB office as to whether this is required and what procedures need to be used.
Federal requirements also state that study participants be given a copy of the signed consent document. The original informed consent documents must be stored in a secure location in the research office that is separate from the area where other study documents that contain de-identified participant information are filed (e.g., questionnaires, surveys, observation checklists, interview notes).