Intervention Research With Minority Older Adults

Abstract

Minority older adults are the fastest-growing segment of the older adult population, and a disproportionate number have the greatest psychosocial needs. It is the need to understand and bridge existing racial and ethnic disparities that makes research with minority older adults so necessary. However, these very vulnerabilities may lead to ethical dilemmas in undertaking research with this population, particularly because for many minority older adults, interventions offered through research may be the only treatment option available. This article discusses this and other ethical issues that may arise in the development and implementation of research protocols with minority older adults. By presenting specific examples of research challenges encountered the authors aim to encourage discussion about the clinically and ethically responsible ways of anticipating, preparing for, and addressing ethical research with minority older adults in ways that foster research integrity, best serve study participants, and contribute to greater knowledge and understanding for bridging disparities.

Keywords

ethical dilemmas clinical research Latinos African Americans

People of color (generally defined as American Indian/Native Alaskan, Asian, Black or African American, Latino or Hispanic, and Native Hawaiian/Pacific Islander) are the fastest growing segment of the older adult (65 and older) population. By 2050, nearly 40% of older Americans are projected to be people of color; 18% will be Latino, 12% African American, and 8% Asian (Federal Interagency Forum on Aging-Related Statistics [FIFAS], 2008). A disproportionate number of these older adults tend to have the greatest psychosocial needs. Older adults of color, particularly Blacks and Latinos, are more likely to live in poverty, have lower educational attainment, and report worse health outcomes than White older adults (Bulatso & Anderson, 2004; Dannefer, 2003; LaVeist, 2003; Nazroo, 2003). It is the need to understand and bridge these existing racial and ethnic health disparities that makes research with minority older adults such an imperative. However, it is these very vulnerabilities that may create special ethical considerations in undertaking intervention research with this population. Given unequal access to resources, many of these minority older adults rely on intervention research as the only viable treatment option.

There is a vast literature on ethics in intervention research, with two opposing viewpoints as to what ethical guidelines should govern the research. The “similarity position” argues that intervention research should be governed by the same ethics undergirding therapeutic treatment. According to this position, the ethics of the therapist–client relationship must govern the clinical trials, therapists who conduct these trials have a therapeutic obligation to the individual subjects enrolled in the study, and randomized controlled trials must be done only when there is genuine uncertainty over whether the new intervention tested will be beneficial. This latter guideline is called clinical equipoise and is seen as the bridge between therapeutic care and scientific experimentation. Proponents of this position view clinical trials through a therapeutic lens. The trials are conducted by therapists who retain fidelity to the principles of therapeutic beneficence and therapeutic nonmalfeasance—the ethics governing therapeutic interventions. Therapeutic beneficence ensures that clinicians practice with primary fidelity to promote the health and well-being of particular clients. Therapeutic nonmalfeasance ensures that the risks of the therapeutic intervention the client is exposed to are justified by the prospect of the potential benefits for that client. Any placebo-controlled trials are ruled out whenever there is a proven effective intervention strategy available for the problem under investigation.

The “difference position” argues that though the goal of clinical treatment is to offer optimal care tailored to individual clients, intervention research has a very different aim, that of producing generalizable knowledge. As such, there will always be “an inherent tension between pursuing rigorous science and protecting research participants from harm” (Miller & Brody, 2003, p. 21). Investigators will and should be focused on conducting the investigation in such a way that valid and reliable data on the intervention’s impact on a group is the focus. This position views intervention research as dedicated primarily to the promotion of the therapeutic good of future clients by means of scientific knowledge gained from experimentation with current research participants. In other words, intervention research is guided by a utilitarian purpose with the focus of achieving the greatest benefit for the greatest number of future clients. The difference position underscores the fact that intervention research has an inherent potential for exploiting research participants. Participants in intervention research run the risk of having their individual well-being compromised in the course of scientific investigation. For this reason, reviews and approvals of the protocols by independent scientific review boards are important to ensure there is a balance between the interest of producing generalizable knowledge and the interests of the research participants.

Proponents of the difference position argue that it is the failure to explicitly acknowledge the difference between clinical treatment and intervention research that leads to problems. These problems include therapeutic misconception, which refers to potential research participants not distinguishing between the aims of intervention research and clinical treatment (Appelbaum, Roth, & Lidz, 1982; Lidz & Appelbaum, 2002), and role conflict, the tensions a clinician doing research might encounter in performing these two roles, which can at times have opposing obligations (Locher, Bronstein, Robinson, Williams, & Ritchie, 2006). These ethical tensions can be particularly salient in intervention research with minority older adults, who are likely to experience the multiple jeopardy (Stoller & Gibson, 1994) of compounded effects of institutional racism, social inequities, lack of access to health care, health disparities, and ageism, and thus may be particularly vulnerable in research situations (Groger, 1998). Without the careful consideration of ethical dilemmas that might arise in including minority older adults in intervention research, researchers run the risk of inadvertent exploitation. If the scientific reason for intervention research – the generation of generalizable knowledge—is not explained, therapeutic misconception becomes a problem. Many minority older adults, lacking access to health services, may see intervention research as an opportunity and perhaps as the only avenue for getting much-needed care. When strict protocols have to be followed to adhere to the scientific intent of the research, and these protocols cannot be tailored to fit the participant, the latter may not be receiving optimal care as an individual. Role conflict can also become a factor for the researcher in situations like this, particularly if the researcher is aware of the lack of access to services for this group of clients (Appelbaum, Lidz, & Grisso, 2004).

This article explores some of the ethical issues that can arise in the planning, development, and implementation of intervention research protocols with minority older adults. As an alternative ethical framework seeking to bridge some of the harsh dichotomies of the similarity/difference position, we use Emanuel, Wendler, and Grady’s (2000) influential proposed requirements for ethical intervention research. This framework acknowledges a difference between research and treatment and emphasizes the protection of research participants. However, our examples of challenges encountered in intervention research with Latino and African -American older adults suggest further refinement of this framework appears necessary. We hope to stimulate a discussion about ways of anticipating, preparing for, and addressing ethical issues in research with minority older adults in ways that foster research integrity, best serve study participants, and contribute to greater knowledge and understanding for bridging existing disparities.

Ethical Framework

Emanuel et al. developed a “systematic and coherent framework” (p. 2701) for evaluating the ethical nature of clinical studies by distilling the underlying philosophical assumptions of the major codes and declarations governing research with human subjects, including the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, and 10 others. Based on their examination they propose seven requirements for what they call clinical research, and which includes intervention research such as that we present, to be ethical. The first is that the latter must be socially, clinically, or scientifically valuable; some knowledge that can potentially enhance health and well-being must derive from the research. Second, the research must be methodologically rigorous and sound so that results are valid and reliable. Third, participant selection must be fair. That is, participants must be recruited because they meet the scientific objectives of the study, and not for reasons of either vulnerability or privilege. Fourth, the study must have a favorable risk–benefit ratio: Potential risks are minimized, potential benefits are enhanced, and benefits are proportionate or outweigh risks. Fifth, ethical clinical research is independently reviewed, for example, through an IRB, in order to minimize conflicts of interest and increase social accountability. Sixth, in ethical clinical research a thorough informed consent procedure ensures that potential participants fully control whether or not they enroll. They “must be accurately informed of the purpose, methods, risks, benefits, and alternatives to the research; understand this information and its bearing on their own clinical situation; and make a voluntary and uncoerced decision whether to participate” (Emanuel et al., 2000, p. 2706). Finally, ethical clinical research respects participants by protecting their privacy, monitoring their welfare, offering them new information learned as a result of the research, and allowing them to withdraw from the research. Emanuel and colleagues argue that fulfillment of all seven requirements is necessary and sufficient for clinical research to be ethical. However, as our examples demonstrate, in undertaking intervention research with minority older adults, because of multiple vulnerabilities, ethical dilemmas can arise even when these seven requirements are met.

Examples of Intervention Research With Minority Older Adults

Two intervention research studies conducted by the authors in different parts of the country were selected to guide the discussion because they generated ethical dilemmas and raised important questions about the vulnerability of minority older adults participating in this type of research. By dint of being just two, these studies are by no means representative of intervention research with minority populations. They merely serve as examples of how ethical dilemmas can present in this type of intervention research even when ethical guidelines are followed.

Study 1: Evaluating the New York University Caregiver Intervention (NYUCI) With Latinos

The first study illustrating potential ethical dilemmas encountered in intervention research with minority older adults involved the implementation and evaluation of a supportive intervention for Latino caregivers of relatives with Alzheimer’s disease (AD). The New York University Caregiver Intervention (NYUCI) has demonstrated improved caregiver and care recipient outcomes, including postponed placement of patients in nursing homes (Mittelman, Haley, Clay, & Roth, 2006) and increased emotional well-being for caregivers (Drentea, Clay, Roth, & Mittelman, 2006; Mittelman, Roth, Coon, & Haley, 2004). However, the NYUCI has been evaluated and used primarily with non-Hispanic White spousal caregivers. Because other ethnic groups experience different caregiving stressors and have different coping resources, coping styles, and appraisals of caregiving burden (Adams, Aranda, Kemp, & Takagi, 2002; Mausbach et al., 2004), the NYUCI’s potential efﬁcacy specifically for Latinos was being evaluated. Study inclusion criteria were self-identification as a Latino and primary caregiver for a relative with AD still residing in the community. We employed a recruitment strategy focusing on outreach to community service agencies and other important neighborhood institutions such as churches and beauty parlors (Gallagher-Thompson, Solano, Coon, & Arean, 2003). We also adopted barrier-reducing approaches such as having a bilingual, bicultural, principal investigator and research assistant. Ten caregivers participated in the study.

The NYUCI has three components: (1) 6 individual and/or family counseling sessions over 4 months, (2) referral to existing support group (e.g., one run by the Alzheimer’s Association), and (3) ongoing consultation or case management as needed (for the purposes of this research that meant study duration). Participants completed pre- and post-intervention assessments including measures of depression, stress, social isolation, and caregiver burden, in order to evaluate the impact of the intervention. They were paid US$25 in consideration of their time for each assessment, which was administered by a research assistant, and not the researcher-clinician administering the intervention. Contact with caregivers ranged from 6 to 106 hr, with an average of 24 hr of contact per participant.

Study 2: Geriatric Evaluation and Self-Management Services (GEMS) Project

The second project illustrating ethical dilemmas in intervention research with minority older adults investigated the impact of interdisciplinary home-based assessment and self-management services for community-dwelling older adults with one or more chronic conditions. The study was informed by the self-efficacy perspective of social cognitive theory (Bandura 1986, 1997) and designed to (a) identify evidence-based geriatric assessment and brief, prevention-oriented intervention practices; (b) teach these practices and related skills to interdisciplinary teams of students and professionals in social work and physical therapy; (c) use those so trained to provide these services to community-dwelling older adults to complement traditional care from primary physicians; and (d) evaluate the effectiveness of both these training and service components (Faul et al., 2009).

The study used a quasi-experimental, pre- and post-test group design with random assignment to two intervention protocols. The first protocol—the Assessment and Brief Intervention Group (ABIG)—included comprehensive, interdisciplinary, home-based geriatric assessment services, with a recommended self-management care plan negotiated with each participant in their home by a team consisting of a physical therapist, a physical therapy student, and a social work student. Clients spent 12 weeks implementing their plan without assistance. The second protocol – the Assessment and Telehealth Intervention Group (ATIG) – included comprehensive, interdisciplinary geriatric assessment services, with a self-management plan similar to the ABIG protocol, plus 8 additional phone calls over a 12-week period to provide additional support, based on research suggesting the added value of additional telephone support (Glueckauf & Ketterson, 2004; Kinsella, 2003; Pariser, O’Hanlon, & Espinoza, 2006).

The GEMS study targeted community-dwelling older adults. Eligible participants had to be aged 65 years or older, literate, and have a permanent address (excluding nursing homes), a primary care physician, no acute medical or mental health needs, nor recent (past 6 months) major medical event, and no ongoing home health care. Despite a multipronged recruitment plan including presentations, brochures, and newspaper articles aimed at recruiting a sample that reflects the racial breakdown in the urban area where the study took place (Whites = 63%, African Americans = 33%, and Other = 4%), the sample of 86 participants were predominantly White, with only 11% (n = 9) of the sample African American. Participants received a written report about their health together with a self-management plan as incentive for participation.

Application of Ethical Framework to Research Examples

We apply Emanuel and colleagues’ framework to the two research exemplars to highlight the ethical dilemmas that can arise with minority older adult populations despite adherence to high ethical standards. In terms of the first of seven requirements for the research to be ethical, the NYUCI pilot study sought to evaluate the impact on Latino caregivers of an intervention that had already been demonstrated to improve caregiver and care recipient outcomes. The GEMS study sought to provide evidence-based assessment and self-management services to older adults living in the community. Thus, both studies had social, clinical, and scientific value.

In terms of the second requirement, scientific validity, in both the NYUCI pilot study and GEMS study, participants received the intervention, completed pre- and post-intervention instruments, and also participated in qualitative interviews about their experiences of the intervention. The methodology was consistent with the purposes of the studies, and every effort was made for it to be rigorously and systematically followed.

The third requirement, participant selection based on the scientific goals of study, was also met for both studies. There was a strong rationale for selecting Latino caregivers for the NYUCI study, despite their potential vulnerability. Latinos constitute the fastest-growing subpopulation among the aged in the United States, with an accompanying increase in the number of older Latinos suffering from AD—from approximately 200,000 to as many as 1.3 million by 2050 (Alzheimer’s Association, 2004). Caring for someone with AD can create a tremendous burden for families (Pinquart & Sörensen, 2003), and research indicates that Latino family caregivers face special challenges and may be particularly affected by caregiving (Janevic & Connell, 2001). Thus, Latino family caregivers may have an especially strong need for interventions that support them in their caregiving role.

In the GEMS study the goal was to develop home-based assessment and intervention strategies for community-dwelling older adults in an effort to maintain independence, functioning, and quality of life. In a study like this it is of particular importance to properly sample a heterogeneous population to ensure sample representativeness. Important scientific questions such as racial and ethnic differences in the management of chronic conditions by community-dwelling older adults can only be explored if there is sufficient representation of the different racial and ethnic groups in the sample (Ford, Havstad, & Tilley, 2003). Furthermore, numerous disparities are documented in the health care received by African Americans as compared with Caucasian non-Hispanics, and such disparities disproportionately affect older African Americans (Smedley, Stith, & Nelson, 2003). It was, therefore, justified to focus recruitment efforts toward a representative sample of minority older adults, precisely because of the vulnerability of these populations and the need to learn more about their experience in order to address the disparities.

Examining the fourth requirement, a favorable risk–benefit ratio, the potential benefits of providing supportive interventions already found to be effective in other populations strongly outweighed potential risks in either of the studies.

The criterion of independent review was also met. Both studies were reviewed by the IRBs of the two universities involved to ensure protection of human subjects, social accountability, and lack of conflict of interest. In the GEMS study, there was additional oversight from the funding agency.

To meet the sixth criterion, informed consent forms were developed and presented to potential participants prior to their enrollment in the studies. The informed consent provided the purpose, methods, risks, and benefits of research, in order for the participant to make a voluntary and uncoerced decision about whether to participate,

The final criterion, respect for participants, was embedded in the research protocol followed by the two studies. Participants could withdraw at any time, resulting in 11 dropouts in the GEMS study for reasons such as emergency hospitalization, busy schedules, mental health problems, and lack of motivation to continue with the study. None of the participants recruited in the NYUCI pilot study dropped out. Participant privacy was protected throughout both studies by use of codes and secure filing. Nevertheless, despite hewing to these principles, ethical dilemmas arose in the conduct of both studies in large part because of the very vulnerabilities of the populations involved.

Ethical Dilemmas Encountered

Compromised Autonomy

The first ethical dilemma both research teams were confronted with was the question of participants’ potentially compromised autonomy addressed in Emanuel and colleagues’ sixth and seventh criteria for ethical research: informed consent and respect for participants. Both studies dealt with vulnerable populations who did not have full access to health care services. For such populations, despite conscientious provision of information to potential participants that the intervention they are being offered is part of a research study, given reduced opportunities for treatment, the decision to participate in the research may be predicated on the need or desire to get some treatment, even in the form of research, rather than none at all. Thus, the decision to participate is not truly an autonomous one, but compromised by the need for services.

In the NYUCI pilot study, 9 out of the 10 participants experienced multiple obstacles to accessing services due to geographic, language, financial, and immigration-status barriers. Expectably, these barriers were greatest for families with the lowest income, level of education, and least facility in English: the most vulnerable research participants (Cook, Moore-Cox, Xavier, Lauzier, & Roberts, 2008). The intervention offered through this research was, as four participants explicitly reported, the only option for receiving any treatment as caregivers, as they did not speak English, lived in remote areas, or because of their undocumented status were afraid of accessing agency services. Although potential participants were provided with informed consent about the nature of the study and the fact that it was research, it is impossible to say how many of the respondents enrolled because they perceived no other way of receiving services, rather than from a position of true autonomy.

In the GEMS study, recruitment efforts focused on potential participants of lower socioeconomic and minority status, due to goals of targeting those with the greatest need for services. These participants lived in an area with marked health disparities and a lack of access to basic health care services. At the time of the study the metropolitan area had an age-adjusted death rate that was 39% higher for African Americans than for Whites, mainly from chronic diseases of the heart and lungs. Furthermore, the percentage of the African American population with health care coverage decreased during the time of the study, in contrast to that of the White population, which showed an increase. Nearly 22% of the population in the area lived below the poverty line, with two thirds of this group being African American (Office of Policy Planning and Evaluation, 2009; U.S. Census Bureau 2009). The study provided for many of the African American participants the only access to an interdisciplinary team who could do a thorough geriatric assessment, provide an individualized exercise program, and offer recommendations to reduce home-fall hazards.

Thus, the question arises as to how truly voluntary and uncoerced the decision to participate in intervention research can be under circumstances where the services offered through the research are realistically the only services potential participants have access to because of their low socioeconomic and minority status.

Aspects of this question have been discussed in the literature. If intervention research offers very attractive services or goods, the concern raised is that it may impair decision making, causing potential participants to disregard any research risks (Denny & Grady, 2006). Wertheimer and Miller (2008) pose the question of whether, if there aren’t viable options for treatment elsewhere, the opportunity to participate in research and receive an intervention, not to mention the financial compensation offered for completing assessments, might constitute undue inducement. Even if a study offers a fair level of benefit, but participants enroll only because of limited options, is the study exploitative? Denny and Grady contend that if research offers a fair level of benefit, then researchers are not taking unfair advantage, and that concern about unjust socioeconomic circumstances is being confused with concern about the potentially unjust nature of the research itself. Two studies using hypothetical research scenarios indicate that economically disadvantaged research participants are not more likely to discount research risks when offered greater compensation (Bentley & Thacker, 2004; Halpern, Karlawish, & Casarett, 2004). However, there is no consensus in the literature providing clear guidance regarding the potential for compromised autonomy for minority older adults participating in intervention studies who might be doing so primarily because clinical services are otherwise unavailable (Nelson & Merz, 2002). Thus, researchers must remain particularly attuned to this possibility when engaging in this type of research with vulnerable populations. Furthermore, this issue must be addressed at a macro level; research protocols should not be the only way that minority, poor, uninsured, undocumented people have access to interventions.

Fair Participant Selection

A second ethical dilemma, faced specifically by the GEMS research team, dealt with Emanuel and colleagues’ principle of fair participant selection. Although a fair representation of participants was sought, African Americans were significantly underrepresented and thus as a group had less access to the potentially beneficial intervention being evaluated. The challenges of recruiting minority participants to research studies have consistently been remarked on in the literature (see, for example, UyBico, Pavel, & Gross, 2007; Yancey, Ortega, & Kumanyika, 2006). Aware of the challenges, the GEMS research team attempted to institute recommended strategies, such as community outreach and advertisement in local media. However, the team was under pressure from funders to meet enrollment goals, and the time necessary to establish the types of contacts and connections in the community that would allow for increased minority participation was not available.

Participation and, thus, fair subject selection, was further compromised by compliance with Emanuel and colleagues’ fifth and sixth criteria for ethical research, which require an independent review by an institutional review board (IRB) and thorough informed consent procedures. The GEMS study IRB review resulted in a complex 6-page informed consent form and 3-page HIPAA research authorization form to be completed in duplicate. The concept of random assignment into one of two different intervention groups was explained therein. Many potential participants found such complex information off-putting and declined to participate. As Grady (2007) notes, scientific information is often complex, research methods are unfamiliar, and participants have varying levels of education, understanding of science, and knowledge about their chronic conditions. The metropolitan area in which GEMS participants were recruited showed low educational attainment for African American adults, with only 25% holding a high school diploma and only 11% holding a college degree (U.S. Census Bureau, 2009). The research team reported during its monthly meetings that potential African American participants expressed their discomfort with the lengthy IRB forms and did not trust the random assignment to different service protocols. Many thought the study discriminatory, since one group would receive more services than the other, and expressed these misgivings to the research team.

Research has shown that a lack of knowledge about research designs among African American older adults results in refusals to participate in studies (Sinclair et al., 2000). Student members of the GEMS research team had originally been assigned the duty of obtaining informed consent. It became clear that because of their inexperience, the complexity of the forms, and expressed participant mistrust, they were not successful in getting informed consent from African American older adults. The protocol was, therefore, changed and an experienced researcher was given the role of obtaining informed consent. Although this resulted in improved recruitment, African Americans still remained underrepresented.

What can be done to increase trust and, therefore, participation and retention of minorities in research studies to ensure fair subject selection? In disability research the slogan has emerged: “Nothing about us without us” (Charlton, 2000), referring to the ethical obligation of researchers to become part of the community in which they do research and to meaningfully involve the community in the research. There is general consensus that building trust and establishing credibility is much easier when at least part of the research team, preferably the principal investigator, is of the same ethnicity as the research participants (Levkoff & Sanchez, 2003). In the NYUCI study, the researcher was Latina, facilitating trust and engagement with research participants. In the GEMS study the research team consisted mainly of young and inexperienced students from the dominant White group in the community, with the principal investigators being White faculty. However, this does not mean that noncommunity members cannot properly understand and represent a particular group’s experience or that being an outsider equates to exploitation and disrespect. Respectful ethical researchers, focusing on sensitive and reflexive understanding of the experiences of others, can empower minority communities (Bridges, 2001). In addition, a community-based participatory research approach in which the communities of interest are engaged equitably in the assessment of needs, the process of addressing them, and the analysis of the data may be the best way of ensuring their full participation and the resulting validity and applicability of the research and findings (Corbie-Smith, Moody-Ayers, & Thrasher, 2004; Delgado, 1997; Israel et al., 2005).

Another intervention for increasing recruitment and retention of minorities in research is the enhancement of informed-consent procedures. There is a growing literature addressing this issue, given findings that participants, particularly those of older age and less education, often do not fully understand the risks and benefits of research involvement (Lidz, Appelbaum, Grisso, & Renaud, 2004; Sugarman, McCrory, & Hubal, 1998) and also may be put off by complex and confusing forms (Sinclair et al., 2000). Experts in this area recommend that the informed-consent process be designed to ensure both initial and continued comprehension of research participation through the use of various techniques such as simplified forms, multiple disclosure sessions, and quizzing of subjects to ensure comprehension (Sudore et al., 2006; Woodsong & Karim, 2005).

Scientific Validity Versus Respect for Participants

A third dilemma, encountered by both research teams, arose from tensions between issues of scientific validity and what Emanuel and colleagues subsume under the category of respect for participants. In their view, this includes carefully monitoring participants’ welfare such that if “changes in clinical status [occur], they [participants] should be provided with appropriate treatment . . .” (Emanuel et al., 2000, p. 2707). During the course of the NYUCI study, some families needed support and treatment beyond what the protocol was offering, because in addition to the already significant burden of the Alzheimer’s disease, they were grappling with multiple biopsychosocial problems. For example, 7 caregivers reported annual incomes of less than US$25,000; 4 of the care recipients had a serious physical illness, such as cancer or diabetes, in addition to the AD; and 4 caregivers were concurrently dealing with their own serious medical illness, including crippling arthritis and a possible recurrence of breast cancer. Six caregivers scored as stressed in the Perceived Stress Scale (Cohen, Kamarck, & Marmelstein, 1983), with three as mildly and two as severely depressed in the Mood Assessment Scale (Yesavage, Brink, Rose, & Adey, 1983). In Emanuel et al.’s framework, the obligation of observing study protocol conflicted with the clinical assessment that some participants required further intervention and “should be provided with appropriate treatment” (Emanuel et al., 2000, p. 2707). In a parallel manner, at the conclusion of the treatment protocol, two of the caregivers experiencing particular burden wanted to continue receiving counseling sessions from the researcher. This was particularly challenging because as undocumented immigrants and monolingual Spanish speakers, there were no alternative services to refer them to. Under such circumstances should the intervention be extended? If so, how does this affect the validity of the research? In other words, which ethical requirement should be privileged? It is also true that in some cases researchers will be unable to attend to all of participants’ needs, not out of concern for protecting the scientific validity of their protocol, but for reasons of limited staffing and funding.

In the GEMS study many of the minority participants were less interested in the research aspects of the study than in receiving free assessment services and recommendations for the self-management of their chronic conditions. Special effort had to be made to remind participants that this was a research project and not clinical services. In addition, the research team had to randomly assign participants to two service protocols, with one being less intense. They struggled with the perception that they were depriving needy participants of the more intensive protocol if the random assignment put them in the less intense protocol. In such instances, responding to minority participants’ restricted access to services, student members of the research team wanted to provide counseling or other health care services that were outside the prescribed protocol.

In the framework of the similarity/difference position, proponents of the former would argue that research participants be treated with the same duty of beneficence as patients. Proponents of the difference position would argue that the situation described above is a problem only because participants and researchers have failed to recognize the distinction between research and treatment. However, our example demonstrates that in intervention research with some minority older adults, because of lack of alternative clinical services, the distinction cannot be so clearly made. Resnik (2009) offers a contextual approach to addressing the extent of an investigator’s scientific and clinical obligations vis-à-vis a participant. Resnik argues that these will vary depending on multiple factors, including the research’s design; level of risk and benefit; participants’ reasonable expectations; their medical, psychological, or economic vulnerabilities; their motivations for participation; the investigator’s ability to benefit participants, which is dependent on resources; expertise and knowledge of participants’ needs; and the prior relationship between investigator and participant. Thus, under certain circumstances, investigators will have extensive clinical obligations, whereas in other research contexts these will be minimal. This flexible model seems to us to offer a useful framework for navigating some of the challenges that can arise in intervention research with minority older adults.

Future Directions

In responding to the ethical imperative of understanding and reducing disparities in health of minority older adults by including them in intervention research, because of the multiple vulnerabilities this population can experience, ethical dilemmas can occur, despite close adherence to ethical principles. Our experience working with Latinos and African American older adults in intervention research underscores the importance of anticipating, preparing for, and actively addressing common issues that may arise. One fundamental step that can be taken to address not only potential ethical dilemmas but related problems of minority inclusion and retention in research is meaningful partnership with the communities being studied in all phases of the planning, development, and implementation of the protocol (Shatenstein, Kergoat, & Reid, 2008; Dowdy, 2006; Ellis et al., 2007). In addition to building trust and credibility with the population of interest, noncommunity team members become sensitive to the health beliefs and cultural considerations of the community. With this knowledge, and collaboratively with community partners, they are therefore better able to offer accessible and clear informed consent (which may mitigate issues of therapeutic misconception and compromised autonomy), and communicate potential benefits of participation as well as results of the work to benefit the community. Flexibility in executing research protocols, guided by a contextual approach to the investigator–participant relationship is also important (Resnik, 2009).

The gatekeeping role of independent institutional review boards (IRBs) cannot be overemphasized. The literature is clear in showing how research participants frequently overestimate the likely benefits of entry into research studies, how risks are underestimated, and how participants are confused about randomized assignment (Appelbaum et al., 2004). Independent reviews of protocols can help ensure that benefits and risks are presented clearly, so that there is a balance between the interests of the researcher and the research participant.

Maybe the most important future direction for us, as a society, is to fulfill our obligation to work toward better health care for all populations, so that research participants will have access to health services through programs other than research participation. Research demonstrates that minority adults are more likely to delay seeking care and are more likely to demonstrate poor adherence to treatment regimens as a result of mistrust of providers, poor interactions with the health care system, cultural mismatch between patient and provider, and health literacy issues. In addition, research shows that people of color, who are more likely to be employed in low-paying jobs, are less likely to have employee-sponsored health care and more likely to live in medically underserved areas (Smedley et al., 2003). The Agency for Health Care Research and Quality (2007) notes that people of color continue to receive worse quality of care for many conditions even after being admitted to a hospital. Unless we as a society work to overcome these barriers, intervention research will continue to pose ethical dilemmas because of the potential that some underserved populations perceive it as the only viable source of treatment. When health care is accessible to all, the vulnerability of underserved older adults will be greatly reduced, as less will participate in intervention studies in order to get the care they desperately need, without clearly understanding the risks they take.

Footnotes

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The NYU Caregiver Intervention Study by Caroline Gelman was supported by the New York University Alzheimer’s Disease Center Grant P30-AG08051, funded by the National Institutes of Aging (NIA). The GEMS study was funded by the DHHS, HRSA, Allied Health Special Projects, D37HP02904 to Anna Faul and Pamela Yankeelov.

Author Biographies

Caroline Gelman is an associate professor at the Silberman School of Social Work of Hunter College of the City University of New York. Her current research focuses on the experiences and needs of older adults and their caregivers.

Anna C. Faul is a professor and Associate Dean Academic Affairs at the Kent School of Social Work, University of Louisville. Her current research focuses on health disparities, chronic disease management and older adult caregiving.

Pamela A. Yankeelov is a professor at the Kent School of Social Work, University of Louisville. Her research interests include the individual, environmental and policy influences that play a role in older adults’ management of their chronic illnesses.

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