This course will discuss informed consent and key issues related to informed consent. Discussion will begin with the general process of obtaining informed consent during research and how informed consent is intended to protect subjects by clearly explaining the purpose of the study. In some cases, when merely having it known that the subject participated in research presents a risk to those subjects, the signing of the informed consent documents may be waived and there are instances when informed consent may be waived all together. We will look at the uses of Certificates of Confidentiality to prevent the compelled disclosure of information collected from individuals during the research process. The special circumstance of obtaining informed consent when conducting research with children will be reviewed, including parental consent and child assent (See also Research with Children). Finally, we will discuss coercion, undue influence and incentives to participate in research. The module will conclude with a brief quiz. Objectives:
- Identify the required elements of the informed consent process and documentation
- Examine the conditions for waivers of informed consent and waivers of documentation of informed consent
- Examine methods to ensure participants understand informed consent
- Examine child assent and parental consent
- Examine issues related to coercion, incentives and informed consent
The Office of Human Research Protection’s (OHRP) website offers guidance concerning informed consent, its meaning and how it is to be obtained. The process of informed consent must contain three features: disclosure, understanding and voluntariness. First, the researcher must disclose enough information to potential subjects so that they can make an informed decision about whether or not to participate in the research. Second, the researcher must make sure that potential subjects understand the information that has been disclosed. Finally, the first two must promote a voluntary decision about participation in the research. Informed consent must also be legally effective and prospectively obtained. (Video ref 21) Informed consent is really about the communication that occurs between the researcher and potential subjects. The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective subjects or their legally authorized representatives adequately understand the research so that they can make informed choices. This communication begins with the recruitment materials and progresses through the consent form to include questions that the potential subject may ask the researcher to the end of the study. This communication may take place face-to-face, via video, phone, online, or through another means of communication, but regardless of how the communication takes place it is important that potential subjects be given the opportunity to ask questions about the research so they can make the best possible decision about participation—an informed decision. This open communication between researcher and subject extends into the research and allows the subject to also make a decision about continuing participation. (ref 22) The procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms that they can understand. Information about a research project must be presented in such a way that enables each person to voluntarily decide whether or not to participate as a research subject. So, the language used in all consent documents, although containing the same elements across research studies, will be worded very differently when the subjects are homeless individuals or individuals with limited education as opposed to when they are professionals in a business setting. (ref 22)(ref 23)
Information Required Within Informed Consent
CFR 46.116 outlines the basic information that must be contained within the informed consent for research with human subjects. “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.” This makes it clear that the potential subject is participating in research, as opposed to an ordinary course of treatment or other activity. It is also important that the potential subject know how long his or her participation will last. This will be both in terms of how long each session may take and the combined duration of all sessions if there is more than one. The potential subject also must clearly know if any procedures during the research are considered experimental as opposed to tested and widely accepted procedures. (ref 23) “A description of any reasonably foreseeable risks or discomforts to the subject.” While no researcher can anticipate, at the outset of research, any and all possible risks or discomforts, a reasonable attempt must be made to try to anticipate as many as possible. It should also be noted that risks and discomforts are not limited to physical risks and discomforts but also extends to emotional and psychological risks and discomforts. (ref 23) “A description of any benefits to the subject or to others which may reasonably be expected from the research.” Some research will yield a benefit to the individual participants, but more often, benefits can only be expected to the wider population that the individual subject represents. The researcher must be careful not to overstate possible benefits to try to encourage participation by subjects and should only make statements regarding benefits that are highly likely. (ref 23) “A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.” If the subject is participating in research that is designed to examine particular procedures or courses of treatment, that subject must also be made aware of other options that exist. It should never be communicated to the subject that the procedure or course of treatment under study is the only option available unless that is actually the case. (ref 23) “A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.” When confidential information is collected from subjects, that information must be protected from unauthorized access and use by others. This includes protection of both hard copy and digital information. (ref 23) “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.” When subjects are involved in research with more than minimal risk, the research must address, within the consent documents, whether or not there will be compensation to the subject or medical treatments available if injury should occur. It must further be explained what the compensation or medical treatments will consist of or where further information regarding both can be obtained. This is especially important because, in some instances, the subject’s medical coverage (if there is medical coverage), may not cover treatment that is needed as a result of having participated in research. (ref 23) “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.” The potential subject must also be given information regarding whom to contact if there are questions about the research that need to be answered, and questions about research subjects’ rights that need to be answered. The subject must also know whom to contact in the event of a research-related injury. (ref 23) “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.” Finally, there must be a clear statement that participation is voluntary, that refusal to participate will not bring about any form of punishment or loss of benefits to the subject, and that the research can be discontinued at anytime without punishment or loss of benefits. (ref 23) OHRP provides a consent checklist (see box to the right) for researchers to follow so that they have the necessary elements of consent in their research. These are outlined in detail also in 46.116. These are the most basic elements of consent that must be contained in all studies (ref 24) It is a requirement that informed consent be “legally effective” and “prospectively obtained.” For the consent to be legally effective it must be obtained either from the subject (in the case of adults who are not vulnerable to coercion or undue influence) or the subject’s legally authorized representative (in the case of children and other individuals who may be vulnerable to coercion or undue influence). Consent must also be “prospectively obtained,” meaning that the informed consent must occur prior to the subject being involved in the research. (ref 23) The consent must be properly documented in accordance with both the Department of Health and Human Service’s regulations and the laws of the local jurisdiction. Consent can never violate any local, state, or federal laws. CFR 46.117 states that, with only a few exceptions, informed consent must be documented in writing. (ref 23)
Waiver of Signed Informed Consent
There are special circumstances in which an IRB can waive the requirement that the investigator obtain a signed consent in two instances. (CFR 46.117) The first is when the actual signed inform consent document is the only link between the subject and the research and that link in and of itself is the principal risk to protecting the subject from harm. Second, the research presents no more than minimal risk and does not involve any sorts of procedures that would normally require consent outside of a research context. (ref 23)
Waiver of Informed Consent
There are two circumstances in which an IRB may waive the requirement for informed consent all together. The first is when the research is aimed at studying certain aspects of public benefit or service programs. The second is when the IRB finds that the study is of no more than minimal risk, the waiver will not adversely affect the rights and welfare of the subjects, the research could not be carried out without waiver, and, when possible, the subjects will be debriefed after participation. (ref 25)
Certificates of Confidentiality
In certain circumstances, researchers may apply to the National Institutes of Health (NIH) for a Certificate of Confidentiality to protect against compelled disclosure of information about subjects who are involved in sensitive research topics. The Certificate of Confidentiality serves as protection against compelled disclosure from all levels of government—local, state and federal. It is intended to encourage participation in research by subjects who might otherwise fear that their identity would be revealed and they would suffer negative consequences as a result of their involvement in the research. This can be especially important to institutions and individuals who engage in research on sensitive topics such as genetic information, sexual information, substance abuse, and illegal behaviors. The protections afforded by the Certificate of Confidentiality begin when the certificate is issued or at the time the research commences and the data is protected in perpetuity. (ref 26) Researchers should keep in mind that there is information that cannot be protected through a Certificate of Confidentiality; such as disclosure of child abuse, threats of harm to self or others, reportable communicable diseases, and the subject’s own disclosure of information. The extent of the protection of the Certificate of Confidentiality should be made clear to the potential subject. (ref 26)
Informed Consent When Conducting Research with Children
The Code of Federal Regulations permits research to be conducted with child subjects under three circumstances. The first involves research which presents no more than minimal risk to the child. The second involves research which presents more than minimal risk but offers direct benefit to the individual child-subject. The third involves research which presents no direct benefit to the individual child-subject but consists only of a minor increase over minimal risk. Research with children that falls outside of these three circumstances cannot be permitted. (ref 28) (Video ref 33) Children are considered vulnerable to coercion and undue influence and legally are not considered able to engage in contracts. Obtaining informed consent when conducting research with children is different from the consent process utilized with adult non-vulnerable subjects. Research with children, except under very special circumstances must involve obtaining the permission of the child’s parent(s) or guardian(s). The Code of Federal Regulations discusses and differentiates “child assent” and “parental permission.” CFR46.402(b) defines “child assent” as “a child’s affirmative agreement to participate in research.” This must be an active assent and not simply a failure to object to participation in the research. The IRB that is overseeing the research must determine whether or not the child is capable of providing assent. Some children, because of age or cognitive deficits cannot assent. The IRB must also assure that permission from the child subject’s parent(s)/guardian(s) is obtained. CFR46.402(c) defines parental permission as “the agreement of the parent(s) or guardian to the participation of their child or ward in research.” (ref 27)
Freedom to Consent
Each research subject must be free to consent or not to consent to participate in research. This means that they must be free of coercion and undue influence. This also means that any incentives to participate in research must be appropriate for the amount of time and effort expended by subjects while engaging in study related activities.
Subjects must not be coerced to participate in research. Coercion occurs when there is an overt or implicit threat of harm to the potential subject. If the research directly or indirectly lets the subject know, for example, that participation can result in an unfavorable outcome at a parole hearing, or loss of necessary health services, or withdrawal of psychological services, or even a reduction in a course grade, or loss of a job, then the researcher is coercing the subject into participation. Coercion can occur in many ways, both subtle and not-so-subtle. For example, although the researcher might not tell the subject directly that any of the previously mentioned will happen, if the subject thinks that they might—this is still coercion. (ref 22)
Undue Influence and Incentives
Researchers also cannot exercise undue influence over potential subjects by offering excessive or inappropriate reward or incentives to secure participation. There are no hard-and-fast rules for what constitutes “excessive” or “inappropriate.” This must be determined by individual IRBs for each research project depending upon the situation of the subjects and the nature of the research study. Offering $50 for participation may be coercive for a homeless individual who has few resources, but to secure a medical doctor’s participation it might be considered appropriate. Likewise, to offer non-vulnerable subjects $250 to participate in medical research that involves only time and no more than minimal risk may be appropriate, but to offer them $250 to participate in a highly risky study would not be appropriate. Undue influence can also occur when the researcher has a previous relationship to the potential subject. If the potential subject is also a patient or student or client of the researcher, then the possibility of undue influence needs to be considered. The possibility for undue influence is highly individualized and must be examined by each IRB for each research study.
This Module presented informed consent and important issues related to informed consent, beginning with a discussion of the general process of obtaining informed consent during research and how informed consent is intended to protect subjects by clearly explaining the purpose of the study. In some cases, IRBs allow the signing of informed consent documents to be waived or may waive the requirement of informed consent completely. Certificates of Confidentiality may be obtained in some research to prevent the compelled disclosure of sensitive information collected from subjects participating in research. It is possible to conduct research with children, although the consent process is very different from research with non-vulnerable adults. Finally issues of coercion, undue influence, and incentives were discussed.