Which of the following studies would probably require written informed consent?

Kinds of Research

Research with the potential for direct medical benefit: Research that offers the chance of improving the subject's medical condition.

Research with no potential for direct medical benefit: Research that does not offer the chance of improving the subject's medical condition, but will help doctors learn more about the disease under study and thus may help others with that disease.

In general, clinical research is divided into two categories of risk: minimal risk and greater than minimal risk of harm. Minimal risk means that the likelihood and degree of harm that you might experience in the research are no greater than those encountered in everyday life such as routine physical examinations and blood tests.

4 Debriefing: Dehoaxing and Desensitizing

Debriefing refers to the removal of the deception after research participation; it involves two processes: dehoaxing refers to removing any misunderstanding and demonstrating how the deception occurred. If technical deception was involved, an examination of the bogus device is in order. Role deception is dehoaxed by introducing subjects to the real person. Implicit deception is more difficult to dehoax since subjects essentially misinformed themselves; such subjects should be assured that anyone would misinterpret the situation and that the research was designed to produce misinterpretation. The explanation should enable subjects to feel that the research was reasonable, and that appropriate steps were taken to ensure subjects' privacy and safety. Subjects should be given the opportunity to ask questions and discuss the study, and to withdraw their data from the research, especially if private behavior was involved.

Desensitizing means detecting undesirable emotional consequences of the research and restoring subjects to a frame of mind at least as positive as before participation. For example, Milgram's subjects were induced to reveal information about themselves that upset them; it inflicted unflattering self-insight. Milgram desensitized his subjects by explaining that their behavior had been powerfully induced by a demanding supervisor, at a prestigious institution, etc., and that others in the same circumstances behaved similarly. Subjects were offered free psychotherapy sessions in which to examine their concerns and restore their self-assurance and sense of dignity. Since desensitizing efforts do not always succeed (Holmes 1976) studies should not damage self-esteem in the first place.

When studying persons whose typical behavior generally is regarded as negative, desensitizing is unnecessary and dehoaxing harmful. For example, young children typically take things they want. Researchers studying stealing in young children, e.g., by making coins available for stealing, should not tell the child the study was about stealing. The researcher's goal is not to shame, or to accelerate the child's moral development, but only to study how children behave. The researcher must also be mindful of the feedback given to parents. If parents are informed of their child's response, it must be in the context of information about typical behavior of children at that age, and about appropriate parental responses to stealing by children of that age.

Payment Models for Research Participation

Neal Dickert and Christine Grady proposed models of payment for research participation as discussed here. The models run parallel to various ways of conceptualizing payment for volunteers. These are the reimbursement model, the market model, the wage-payment model, and the appreciation model:

The reimbursement model is meant to reflect revenue neutrality in that the aim is to reimburse volunteers for expenses incurred, such as for travel or meals, and even wages forgone as a result of research participation. It is not intended to reward volunteers by allowing them to profit from their decision to participate. At the same time, volunteers should not be made financially worse off because of their decision to participate.

The market model is basically a payment model that respects the laws of demand and supply in a free market economy. Hence, if a particular type of research subject is needed urgently, the demand for them is high and so the price of obtaining the services of these subjects increases in order to push up supply. Money becomes the main motivation and primary means of obtaining subjects for research participation, with the actual amount given indicative of what subjects will accept and researchers will pay.

The wage-payment model conceives of research subjects along the lines of unskilled laborers receiving wages. To pay research subjects for their participation is to compensate them for time and energy expended in the course of the study. Hence, if researchers are to be fair, they ought to pay volunteers the same amount for their participation as is paid as wages for similar unskilled work. Such a practice also shows respect for the value of the volunteers’ contributions.

The appreciation model views payment as a provision of gratitude for research participation. It is usually given at the end of the research period and is not set out to initially influence a person’s decision to participate in the research.

The reimbursement model helps prevent undue inducement, perhaps to a greater extent than the wage-payment model does, because of its revenue-neutral approach. The advantage of the reimbursement model for recruitment is that it cancels out any disincentive that the out-of-pocket expenses may have had on the decision to participate.

The market model recognizes the profit motive that potential volunteers may have and addresses it squarely so that necessary research can proceed. The model allows for the possibility of completion bonuses for staying with the research program, a concept that is sometimes used in the labor market to boost retention rates. However, it does not attempt to address the risk of undue inducement – something that the other payment models attempt to mitigate.

With the wage-payment model, there is an opportunity to address the issue of undue inducement and possibly minimize it because volunteers are paid equally for work seen to be similar in other industries or studies. The level of inducement to which potential subjects are exposed is expected to be the same as that to which they are exposed in other recruitment efforts, thus reducing the significance of any coercive impact of the inducement. The approach is also more egalitarian in that it recognizes a broad economic context while concretely recognizing the contributions of the volunteer. For example, Glenn McGee’s proposal for ‘proportional rewards’ recommends an appropriate amount and kind of compensation to be determined for particular trials in the context of the subject’s particular social situation.

The appreciation model also offers a way to express gratitude to the volunteer but where this expression can be nonmonetary in nature or where it does not need to peg itself against market rates. It is therefore thought to be unlikely to present itself as an inducement to the potential volunteer to participate in research.

The value of characterizing different payment models lies in researchers, volunteers, and the general public being clear about the reasons for payment and the amount of payment that can be expected according to each model. Payment models that try to avoid undue inducement play an important role in sending a public signal of what is appropriate in the recruitment of volunteers. Choosing the payment model that is consistent with the values one wants to uphold can help in maintaining consistency in public policy and offer guidance for institutional review boards or research ethics committees. However, although these different models offer a plausible way to conceptualize payment, the differences between them are difficult to maintain in practice. For instance, both the wage-payment and reimbursement models cannot be totally divorced from market considerations when computing the levels of payment that each model would find acceptable. Furthermore, if a research volunteer were to be reimbursed for his or her time and energy – in addition to out-of-pocket expenses or lost wages – then this would make reimbursement hardly distinguishable from the wage-payment model. The amount of reimbursement for one’s time and energy could also be high enough, depending on the socioeconomic background of the potential subject, to trigger a profit motive for the volunteer, especially if participants are in urgent demand. Similarly, the amount and type of payment to be given under the appreciation model could also serve as an incentive to participate if payment is mentioned upfront to volunteers in the interest of transparency.

When considering payment models, it is useful to ensure that they are not based on fluid and vague concepts such as compensation for one’s time, energy, and inconvenience caused, which may allow too much room for contentious interpretation. Such concepts are difficult to quantify. Ambiguity in the interpretation of concepts could be exploited to introduce undue inducement and negate the positive value of insights gained from the comparison of differing approaches.

One challenge to using the wage-payment model lies in the ability to concretely identify comparable wage-labor models across industries or research studies. This is essential in determining a basis for computation of applicable wage scales. However, this model can still be criticized for imbedded undue inducement, especially when the socioeconomic profiles of volunteers are taken into account. Reimbursement models avoid this problem if the levels of reimbursement track actual expenditure or the loss of wages, as opposed to fixed amounts that may be given out pegged to, for example, average salaries of a population in order to minimize administrative inconveniences.

1.22.5.3 Competence and Consent in Research

Informed consent is not only important in clinical care, but in a subject's competence to make a decision about research participation. Berg and Appelbaum101 have outlined four main standards for determining decision-making competence based on a framework developed by Appelbaum and Grisso.102 The first standard, most widely used by courts and legislatures, is the ability to communicate a choice. Many potential subjects fail to reach this standard because they are unable to coherently communicate, whether due to chronic schizophrenia, various levels of consciousness due to psychotic episodes, or other disorders. The ability to communicate choice does not necessarily translate into the capacity to make a choice autonomously. Comatose, mute, catatonic, or severely depressed persons, individuals with manic or catatonic excitements, and persons with severe psychotic thought disorders or severe dementia will fall under this category.

A second standard used is the ability to understand relevant information. This understanding means that the potential subjects have the ability to comprehend the concepts involved in the informed consent disclosure. Understanding itself is not enough; if a person understands the information, but is not able to retain the information long enough to make a decision, they are not competent enough to consent. Impairments of intelligence, attention, and memory can all affect this ability. A third standard is the ability to appreciate the nature of the situation and its likely consequences. The subject must be able to apply the information to his or her own situation. Denial, delusions, and psychotic levels of distortion can all impair this ability. The final standard is the ability to manipulate information rationally. It is necessary that a potential subject possess reasoning capacity and the ability to employ logic to compare the risks and benefits of the treatment options.

Recently, psychiatric research has been scrutinized out of fear that individuals with mental disorders are at a higher risk of being exploited due to the effect of mental illness on decision-making ability. Patients with schizophrenia, for example, experience delusions, apathy, lack of insight, and impaired memory and mental flexibility, which can impede informed consent to research.103 Subjects with psychiatric disorders have often failed to appreciate the nature of research and its possible impact on their treatment. Two multinational studies found that a diminished ability to appreciate that one is ill is prevalent among those with schizophrenia. Patients with schizophrenia or severe depression also had an impaired ability to appreciate the potential value of treatment.101 The MacArthur Treatment Competence Study104 found that subjects with schizophrenia were more likely to completely deny the presence of illness than were depressed patients (35% versus 4%). Most dementia patients lack the ability to recognize that they have a memory problem. This lack of ability to recognize their mental state could indicate an impaired ability to relate the research to their own situation.

Alzheimer's disease can also affect decision-making.105 While many cognitive functions account for impaired decision-making abilities in Alzheimer's disease, neuropsychological measures of executive dysfunction were the best indicators of impaired decisional ability in Alzheimer's patients.106 The issue of competence in elderly patients suffering from dementia has become increasingly significant as the clinical research on Alzheimer's disease is rapidly accelerating and aiming to develop methods of early detection and prevention. Dr Scott Kim and his colleagues write in the American Journal of Psychiatry that more subjects with relatively mild illness will begin to be invited to participate in therapeutic and nontherapeutic Alzheimer's research. Thus, there will likely be a large range in the ability of individuals to give consent, with some “not capable even while they maintain their ‘social graces’ and their expressive abilities.”107 In assessing the competency of patients with Alzheimer's disease under various legal standards, researchers have found that even mild to moderate Alzheimer's disease has a significant impact on treatment consent capacity.108 Researchers do, however, reinforce the ethical principle that diagnosis of dementia does not necessarily imply incapacity.109 Therefore, distinguishing capable from incapable Alzheimer's patients remains a considerable challenge.

Unlike research involving other populations considered vulnerable, such as children, prisoners, and fetuses, no additional federal regulations specifically govern research involving potential subjects who are cognitively impaired. The recommendations of the National Commission for the Protection of Human Subjects are similar to those made with respect to children.110 Many psychiatric researchers, and a number of patient advocacy groups, have argued that many patients with mental disorders still possess substantial decision-making capacity. They believe that providing additional regulations for the mentally ill is paternalistic and that it would reinforce a social stigma about the disease and further impede research.

Institutional Review Board (IRB)

The IRB is an administrative body that is designed to protect the rights and welfare of individuals who are approached for research participation, as well as individuals who are participating in research. The IRB has the authority to approve, disapprove, and regulate all research within an institution based on the federal guidelines mentioned previously. An IRB may exist within one institution (e.g., university, hospital, medical center) and serve only that institution, or it may exist within the private sector and serve many institutions. Different interpretation and application of the federal regulations across IRBs result in different allowable research practices across institutions. For example, some institutions never allow waiver of parental consent despite federal regulations allowing it in certain circumstances.

1.2 The role of cancer centers and community health assessments to identify and address the need

Among many accountability measures, cancer centers are expected to identify and assess the needs in their communities, increase clinical research participation, and ensure patients do not fall through the gaps in care (Paskett & Hiatt, 2018; Tai & Hiatt, 2017). However, barriers that prohibit access and utilization of cancer services and research vary by community, requiring cancer centers to develop and implement strategic plans to assess and respond effectively to disparities within their catchment area. One strategy to assess and describe the cancer burden and respond to the need, is by conducting community health assessments and employing key methodologies of community engagement and partnerships (Barrett et al., 2016; Wilkins Consuelo & Alberti Philip, 2019).

The opportunity to identify and develop partnered strategies to advance health equity research are critical and timely. In 2017 the NCI heightened focus on the importance of community engagement and outreach to address cancer disparities across NCI-designated Cancer Centers and their catchment areas. This priority has encouraged a renewed focus on stakeholder engagement and the importance of authentic and impactful collaborations in improving cancer outcomes through community and population health assessments, health equity research, and interventions across the cancer spectrum (Hiatt et al., 2018).

B Ethical Considerations

In developing ways to recruit participants, set up participant pools, and carry out experiments, researchers have confronted two main ethical concerns: (1) how to avoid coercive practices; and (2) how to ensure that research participation has educational value.

Research as a Benefit

Events in the late 1980s and 1990s altered some public perspectives on clinical research. Certain articulate and vocal activists asserted that research participation can offer an advantage that individuals want access to, rather than simply harm to be protected from.13 According to this perspective, as espoused by human immunodeficiency virus (HIV) and breast cancer activists and others, participation in research is a benefit, protectionism is discrimination, and exclusion from research can be unjust. Empirical studies have demonstrated that oncology patients, for example, who participate in clinical trials benefit through improved survival.14,15 Activism and changes in public attitudes about research led to substantive changes in the way research is done and drugs are approved.

In addition to the possible benefits of participation for individuals, it was claimed that certain traditionally underrepresented groups were being denied the benefits of the application of knowledge gained through research.16 Since 1994, the US National Institutes of Health (NIH) has required that those who receive research funding must include previously underrepresented women and ethnic minorities.17 Since 1998, NIH guidelines have required the inclusion of children in research or justification for their exclusion.18

7 Recruitment and retention of women, minorities, and other vulnerable and/or potentially vulnerable populations

During the second half of the 20th century the traditional perspective that vulnerable individuals must be protected from the harms and burdens of research participation shifted to one in which all individuals, particularly women and those from minority populations, should have access to the potential benefits of research. This philosophical turn-about was given practical shape by the NIH Revitalization Act of 1993, which required establishing guidelines for inclusion of women and minorities in clinical research. The guidelines call for all NIH-funded clinical trials, especially at the phase III level, to collect sufficient data to elicit information about participants of both genders and diverse racial and ethnic groups. The influence this guidance has had on changes in clinical research populations is immeasurable (e.g., Nielsen and Berthelsen, 2019; Myles et al., 2018; Kurt et al., 2016, 2017; Neelotpol et al., 2016). Prior to 1993, it was common for women to be excluded from clinical trials, even of medical interventions that, if approved, would be taken by women as well as men. There was a general lack of appreciation of the possibility that differences in female and male chemistry and physiology might result in substantial differences in the ways therapeutic interventions affected each gender. Couple this lack of attention to differences in treatment impact with the variability in women’s bodies resulting from menstrual cycles—it was just considered easier to study men. As data mounted that significant differences in drug metabolism and outcome existed between the sexes, however, data also accumulated pointing to differences in health patterns across racial and ethnic groups. These scientific awakenings were taking place within a social context of attention to injustices towards women and minority populations in other sectors of society. The resulting 1993 act literally changed the face of clinical research, regardless of funding source. Progress has been swift in some ways and in other ways it has been slower. Today, women, even women of reproductive potential, are regularly included in clinical trials. The shift from excluding women completely to only excluding women of childbearing potential to including all but pregnant women (see discussion in Chapter 5 and in the next section of this chapter) has been accomplished quite completely. Of note here is that pregnant women are no longer included in the RCR as an example of a population that is potentially vulnerable (like the removal of “handicapped” or physically disabled individuals) to coercion or undue influence.

For studies in which a fetus would need to be protected from an experimental agent, protocols and consent documents include clear and explicit language on requirements for birth control. Also, an increased equalitarianism has surfaced when scientifically appropriate. When relevant, birth control is required for both female and male study participants. This attention to gender issues in reproduction can be seen in other ways as well, such as discussions of egg and sperm banking in relevant protocols.

The swift shift to a reasonable and fair balance of the benefits and burdens of research participation that can be seen between males and females, however, has not been achieved as successfully concerning inclusion and retention of minority populations. Recruitment and retention of minority populations in research continues to exist at lower levels than would be hoped for on the basis of fair access and percentage representation in the general population. There appear to be multiple reasons for the reduced numbers of minority participants. Fear and mistrust on the part of minority communities of the majority-dominated research community account for much of the problem. Few discussions of problems in recruiting minorities escape reference to the lingering effects of the Tuskegee Syphilis Study on lower numbers of African-American research participants (see Chapter 15). It is unlikely, however, that mistrust is the only cause of low minority recruitment. Researchers are working to learn better techniques for community outreach. The 1993 act specifically requires the creation of outreach programs to recruit the populations covered by the act. As researchers gain knowledge of which outreach strategies work best (Wong et al., 2019; Lunn et al., 2019; Winter et al., 2018; Wallington et al., 2016; Friedman et al., 2015; Brown et al., 2014; Arean et al., 2003; Meinert et al., 2003; Swanson and Ward, 1995) it can be anticipated that the numbers of minority participants will increase.

3.03.4.1 Ethical Requirements

Certain ethical conditions regarding the subjects and the treatments or interventions must be met (Department of Health and Human Services, 1994). Research participation requires informed consent from the participant or from an appropriately authorized surrogate, for example, a parent for a minor child. Even in cases where consent is obtained from a surrogate, the research participant (e.g., the child) must provide “assent.” Assent is the term used for agreement to participate by individuals who are judged to lack the capacity to provide fully informed consent. Currently in the USA regulations are promulgated by the Department of Health and Human Services that define 12 elements of informed consent. They are:

An explanation of the procedures to be followed, including specification of those that are experimental.

A description of the reasonably foreseeable attendant discomforts and risks and a statement of the uncertainty of the anticipated risks due to the inherent nature of the research process.

A description of the benefits that may be expected.

A disclosure of appropriate and available alternate procedures that might be advantageous for the subject.

An offer to answer any inquiries concerning the procedures.

A statement that information may be withheld from the subject in certain cases when the investigator believes that full disclosure may be detrimental to the subject or fatal to the study design (provided, however, that the Institutional Review Board (IRB) has given proper approval to such withholding of information).

A disclosure of the probability that the subject may be given a placebo at some time during the course of the research study if placebo is to be utilized in the study.

An explanation in lay terms of the probability that the subject may be placed in one or another treatment group if randomization is a part of the study design.

An instruction that the subject may withdraw consent and may discontinue participation in the study at any time.

An explanation that there is no penalty for not participating in or withdrawng from the study once the project has been initiated.

A statement that the investigator will inform the subject of any significant new information arising from the experiment or other ongoing experiments which may bear on the subject's choice to remain in the study.

A statement that the investigator will provide a review of the nature and results of the study to subjects who request such information.

All these essential elements must be included in an Informed Consent Form to insure adequate consent to participate in any research.

In studies that involve randomization to treatment, some elements are of particular importance because they represent concepts that are sometimes difficult for potential subjects to appreciate. The first, of course, is that of randomization itself—that treatment will be decided “as if tossing a coin.” The second is that the clinician or treater will not choose “the best” treatment for the client. Other elements of informed consent that need to be emphasized for a truly informed process is that the subject is free to withdraw at any time and that those providing treatment may also discontinue the subject's participation if they believe it to be in the subject's best interest.

In most countries research involving human subjects must be reviewed by local Research Ethics Committees or IRBs that are mandated to insure that the research meets ethical standards, that all elements of informed consent are present, and that the interests of subjects are protected.

A number of issues regarding consent that go beyond the 12 critical items are currently a subject of debate. Participants in these deliberations include various regulatory bodies, independent commissions, and private individuals and groups that are self-declared protectors of those who may participate in experiments regarding treatments or interventions of interest to clinical psychology. Among these issues are the following: requiring that an independent person unaffiliated with a given research project oversee the consent process; expanding the definition of those who lack the capacity to provide informed consent to include populations such as all those diagnosed with schizophrenia and other illnesses; restricting the conduct of research that does not offer direct benefit to the participant subjects; elimination of the use of placebo treatment conditions in patient groups for whom there is any evidence of treatments that are effective. These potential changes may well alter the nature of experimental research regarding treatment and intervention.

In general, concerns about placebo treatment or no-treatment control conditions have been hotly debated in the arena of pharmacological treatment rather than psychological interventions. However, as evidence regarding the efficacy and effectiveness of psychological interventions becomes widely accepted, experimental strategies such as waiting list controls, “usual care,” and even nonspecified psychotherapies may require re-evaluation. One strategy that may receive increasing attention and popularity is that of treatment dosage. In other words, a comparison group may be defined as one that receives the intervention of interest but receives less of it.

Interventions and control conditions being compared should be potentially effective; there should be evidence regarding benefit. If this assertion is accepted, how can a “no-treatment” comparison group be included in an experiment? First, there should be provision for the subject to receive the potentially more effective intervention following study participation. In other words, the “no-treatment” group is really a delayed treatment or the time hallowed waiting list condition. This may be relatively easy to implement with short-term treatment interventions but more difficult for long-term interventions. Alternate solutions include the use of minimal treatment conditions. Later in the chapter, both of these conditions will be discussed in more detail from the substantive perspective. In the present context, both represent plausible solutions to the ethical dilemma of providing appropriate treatment for client populations for whom there exist a corpus of information regarding treatment effects. Obviously, these concerns are moot in specific patient or client populations where there are no data regarding treatment effects. The ethical dilemma is heightened when the intervention is long term or there may be substantial risk if treatment is deferred. For example, studies of treatment for depression generally exclude subjects who are suicidal.