LITERATURE REVIEW
2.1 INFORMED CONSENT AND THE NEED FOR TRIAL PARTICIPANTS’ UNDERSTANDING
• The eleventh section reviews and discusses previous studies that have introduced interventions aimed at improving understanding.
• The twelfth section presents a summary of the literature reviewed and some of the important lessons learned from the previous studies.
For each study, the study methods and a summary of the main findings and lessons learned are presented, including in some cases brief discussions on the strengths and weaknesses of the study methods.
2.1 INFORMED CONSENT AND THE NEED FOR TRIAL PARTICIPANTS’ UNDERSTANDING
The right to self determination is one of the fundamental human rights and an established tenet of research ethics and clinical practice (Dunn & Jeste, 2001). It is generally agreed that adequate informed consent consists of three elements; namely full information, voluntary participation and capacity to make an autonomous decision (Appelbaum et al., 1987). Capacity for decision making is composed of four abilities namely the ability to understand relevant information, the ability to appreciate the nature of the situation and its likely consequences, the
ability to reason with the information and weigh options logically, and the ability to
communicate the choice in a clear manner (Grisso & Appelbaum, 1998). An important goal of informed consent is to present information to individuals so that they can decide which option they want to take according to their values (Ubel & Loewenstein, 1997). Lindegger and Richter (2000) note that informed consent requirements in research have been driven by two different agendas: a legal agenda and a moral agenda. While the legal requirements may be aimed at protecting human research participants, researchers and institutions may simply use these as a way of avoiding lawsuits. The moral agenda on the other hand is aimed at
empowering the potential research participant so that they can make an informed decision. An informed decision is a guarantee that the likelihood of regretting after one has joined a study out of ignorance is minimised. Good quality informed consent is about ensuring that individuals’ decisions to enroll or not to enroll, are based on understanding of information whilst poor quality informed consent is that which aims at getting an individual to sign a document without adequate understanding. There is therefore a difference between the information provided for reasons of legal liability and information provided for the sake of empowering an individual and facilitating informed decision making. A researcher who emphasises the legal side would ensure that he or she has included all essential elements in the informed consent document and also that the participant has signed. A researcher who strongly believes in the moral justification would try by all means to ensure that they provide
information in a way that is understandable, that the individual has understood and that the decision to join is voluntary and based on the adequate understanding of the provided information.
Wendler and Grady (2008) opine that for participants to give valid informed consent, they need to understand the potential risks involved, the benefits, procedures and alternatives. The authors conducted an analysis of individuals' interests and point out that research participants
also want to know about their contribution to research – in other words, that researchers will be relying on the participants to gather generalisable knowledge, as well as the impact of the research on themselves. The authors suggest that research participants may not want to know everything about a study but may want to know about issues that are of relevance to them and their health. The authors further suggest that tests to assess understanding should include questions that focus on the participants' contributions to research, their role in generating new information, and the impact of the research on them as individuals.
A significant volume of literature has documented a variety of problems related to
understanding. Some research participants may also fail to appreciate the fact that research is designed to advance the interests of others. Numerous studies have also shown that consent forms packed with technical jargon are difficult to read and participants often misunderstand the purpose of the research and the implications for their individual care (Siminoff, 2003). In these circumstances, participants are less likely to distinguish between routine medical care and medical research (Emanuel & Miller, 2001; Freedman, 1990; Shapiro & Meslin, 2001; Spiro, 1986; Way, 1984).
Another area that is identified as a problem in informed consent is that participants often do not understand key components of the studies in which they will be participating (Agre & Rapkin, 2003). The US Code of Federal Regulations specifies eight elements required in all informed consent forms and six additional requirements, where deemed appropriate. The eight elements according to 45 CFR 46 (US Department of Health and Human Services, 2009) include the following:
1. A statement that the study involves research, an explanation of the research, and the expected duration of the subject’s participation, a description of the procedures to be followed, an 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, which 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/or medical treatment 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 participants’ 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.
The US regulations also list six additional elements which researchers need to include in the informed consent documents as appropriate. The six elements include the following:
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 presently unforeseeable
2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
3. 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 without prejudice to the subject. In all instances where abrupt withdrawal would be hazardous to the subject (e.g., medication regimens which require gradual reduction) appropriate safe
discontinuation procedures will be followed and the subject advised
5. A statement that major 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 participants involved in the study; and the number of participants planned to be involved at the local research site.
The eight elements as well as the six additional elements are aimed at fulfilling legal
requirements of informed consent. This is understandable if one bears in mind the past cases involving abuse of individuals who would not have given their consent to participate in research as well as the various cases of litigation in the US (Beauchamp & Childress, 2001).
Researchers and institutional review boards (IRBs) or research ethics committees (RECs) have to ensure that these eight essential pieces of information are included in informed consent documents. Yet, ethically valid informed consent demands more than just disclosure of the eight pieces of information (Flory & Emanuel, 2004). It is generally agreed that informed consent in its true sense requires more than the satisfaction of legal formalities such as the signing of informed consent forms (Lindegger et al., 2006). Data suggesting limited levels of understanding among trial participants have prompted calls for investigators and ethics committees to find ways to improve research participants’ understanding (Lavori, Sugarman, Hays & Feussner, 1999; Siminoff, 2003).
Debates over improving informed consent have unfortunately not been guided by empirically derived information needs of potential research participants. Limited data is available concerning the type of information as well as presentation methods that are most effective in improving understanding. It is now known and agreed that while the provision of information is important, the information should not be provided in a haphazard fashion (Siminoff, 2003).
Researchers should not make any assumptions about trial participants’ understanding of key points in the consent document. They have responsibility to assess individuals’ understanding thoroughly (Agre & Rapkin, 2003). After conducting an initial part of a study aimed at developing a model informed consent process for a genetic study, Bernhardt et al. (1997) concluded that research participants vary greatly in terms of their informational and counselling needs. They therefore suggested that informed consent processes should be individualized, taking into account participants’ perceptions and preferences. Sreenivasan (2003) discusses the importance of comprehension in informed consent and argues that, at a minimum, prospective research participants should be able to comprehend the information that they receive. Miller and Boulton (2007) opine that the informed consent processes have to change in response to the increasing sophistication of information. Improved informed consent processes become even more important in view of the fact that risky clinical trials often rely on the socially and
economically less empowered in society (Elliott & Abadie, 2008). Richter, Lindegger, Abdool Karim and Gasa (2002) emphasise culturally appropriate approaches of obtaining informed consent. They argue that for any approach to be effective, it has to be culturally appropriate to be acceptable to the community and individuals.