National,independent oversight: Reinforcing the safety net for human subjects research*

National, independent oversight is vital to resolve the problems and inconsistencies in oversight of human subjects research. Three key functions that must be considered in any proposal for such a mechanism are (1) issue spotting, (2) guidance on identified issues, and (3) sampling and follow‐up. The 1998 report and recommendations of the National Bioethics Advisory Commission concerning research involving persons with mental disorders that may affect decisionmaking capacity address these functions in part, but application is limited to a small segment of the research population. Incorporation of these three key functions in a formal, national, independent oversight process is necessary in order to ensure accountability and maintain public trust in research.     

Patients’ competence to consent to neurobiological research

Progress has been made defining the standards for determining subjects’ competence to consent to research: abilities to communicate a choice, understand relevant information, appreciate the nature of the situation and its consequences, and manipulate information rationally. Available data show clearly that persons with mental illness display a spectrum of decisionmaking abilities, with many performing well, but some doing quite poorly. More attention now is required to identifying the degree of capacity required for competent consent to projects with varying risk/benefit characteristics. Practical means are also required for screening for subjects with impaired capacities, attempting to improve their performance, and providing substituted consent when their deficiencies are intractable.     

Competence and consent to research: A critique of the recommendations of the national bioethics advisory commission*

Concern about the participation of incompetent subjects in psychiatric research has grown in the last several years. In response, the National Bioethics Advisory Commission (NBAC) recommended in its recent report that all investigations involving persons with mental disorders that may be associated with cognitive impairment that may pose greater than minimal risk to subjects utilize independent assessors to verify the capacities of subjects prior to entry into the study. This recommendation poses several problems for the conduct of research and the protection of research subjects. First, it fails to target that group of subjects most likely to be at risk for incapacity. Second, it focuses on too broad a range of research projects, many of which pose little risk to participants. The substantial costs of this approach are therefore not likely to be outweighed by concomitant benefits. In place of the NBAC recommendation, the author proposes a more flexible system of capacity assessment, designed to balance the costs with a greater likelihood of achieving meaningful protection for research subjects with mental disorders.     

Long-Term Planning and Decision-Making Among Midlife and Older Gay Men and Lesbians

Abstract

This article examines the issues of long-term planning and decision-making among midlife and older gay men and lesbian caregivers. Using a qualitative methodology, in-depth interviews were conducted with 19 gay men and lesbians over 50. Participants reported on their long-term planning and decision-making processes. All but four persons reported that their partners had advance directives, but the majority of caregivers did not have advance directives for themselves. Concerns about informal family dynamics and interactions with formal systems were expressed, along with financial and ownership issues. It is important for social workers to intervene across individual, organizational, and community levels in advocacy for the needs of older gay men and lesbian clients.     

The Influence of Sociodemographic and Psychosocial Factors on Advance Care Planning

This study investigated sociodemographic and psychosocial factors that enhance or impede the completion of advance care planning, analyzing data from the Health and Retirement Study. The analytic subsample included the panel participants who died between 2006 and 2010 and who had answered the psychosocial and lifestyle questionnaire when they were alive. Multinomial logistic regression was executed to answer the research question (N = 1,056). The study found that persons who were older, who were women, who identified themselves as White, and who had higher levels of income and education were more likely to be motivated to complete advance care planning. Having greater sense of control was found to weaken the adverse relationship between being African American and the completion of advance directives. Having cancer, suffering from the illnesses for longer periods of time, and having experience of nursing home institutionalization also predicted the completion of advance care planning. Implications include incorporating a culturally tailored approach for racial/ethnic minorities and using advance directives that are clear and easily understood. In addition, future research needs to include a larger minority population and examine the extent to which variations between racial/ethnic groups exist in relation to advance care planning.     

Research ethics and clinical trials: Fostering collaboration with research participants

Accountability in research is a concept that applies to researchers and study participants alike. Human subjects play an active part in the success or failure of a clinical trial by virtue of their understanding of a study's goals expectations of personal gain, and adherence to study design. Trials must be designed to address patient concerns, offer an improved consent process, and move beyond our narrow conception of “patient rights.”; Problems with protocol adherence may be reduced by conceptualizing clinical research as an endeavor with mutual accountability within a relational ethic.     

Neurobiological research involving human subjects: Perspectives from the office for protection from research risks

Department of Health and Human Services (HHS) regulations at 45 CFR 46 require that all human subjects research supported by HHS be reviewed and approved by a local Institutional Review Board (IRB). Investigators may not involve human subjects in research without their informed consent, and additional safeguards are required when subjects are likely to be vulnerable to coercion or undue influence. Application of the regulations to neurobiological research is discussed.     

Social Workers' Personal Death Attitudes,Experiences, and Advance Directive Communication Behavior

Abstract

This research surveyed 29 social workers to examine their personal death attitudes and experiences in relation to their advance directives communication practice behavior. The study measured death attitudes on 5 dimensions: fear, avoidance, neutral, approach, or escape acceptance of death. Participants' personal experiences with terminal illness and death were also assessed. Advance directive communication practices were operationalized as 7 phases: initiation of the topic, disclosure of information, identification of a surrogate decision-maker, discussion of treatment options, elicitation of patient values, interaction with family members, and collaboration with other health care professionals. Findings suggest that social workers' advance directive communication behavior differs by practitioners' death attitudes and experiences. Implications for social work education and professional development are discussed.     

The issue of consent in research that administers drugs of addiction to addicted persons

In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain free and informed consent.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Resolving Beecher's Paradox: Getting beyond IRB reform

Protection of persons participating as research subjects is an essential element of ethical research conduct. There is growing concern that the existing system of institutional review boards (IRBs) and informed consent may not be adequate and is in need of reform. When science and medicine are “merged”; in clinical research, confusion of roles and conflicts of interests arise in relationships between patient‐subjects and physician‐investigators. IRBs have always had a primary role in protection of research participants. Their efforts to protect research subjects may make it more difficult for investigators to conduct research. This tension has lead to the development of an adversarial relationship between IRBs and investigators. Investigators and IRBs are also subject to external pressures that could impact efforts to protect research subjects. Efforts are underway to address these concerns. IRB reform, while needed, is not likely to be sufficient. Adoption of a new paradigm in which IRBs, investigators and research sponsors collectively accept protection of research subjects as their primary and shared responsibility may provide a more effective and efficient model that will be better able to deal with difficult ethical and social issues in clinical research.     

Guinea Pigs on the payroll: The ethics of paying research subjects

Regulatory bodies and scholars have traditionally conceptualized biomedical research on healthy subjects in the same way as research on patients. Guidelines and regulations have portrayed payment to a healthy subject as a potential constraint, or “undue influence,”; on the subject's free consent. In this essay we suggest an alternative way of conceptualizing research on healthy subjects, which sees the basic issue not as one of undue influence but as one of justice. Healthy subjects generally enroll in research protocols not for humanitarian reasons but for the money they will receive. Many of these protocols are conducted by profit‐driven corporations. Yet current guidelines and regulations prohibit subjects from negotiating for fair payment for the risks, discomforts and inconveniences they undergo, and IRBs are not staffed adequately to monitor the subject's safety. We propose to remedy the situation by regulating payment to healthy subjects as a labor relation.     

Planning for future research participation: Ethical and practical considerations

This paper addresses the concept of advance planning for future research participation during episodic or permanent decisional incapacity. First, the concept and its historical origins are described. Second, the concept's ethical justifications are presented. Third, commentary raising ethical and practical concerns about advance research planning is discussed. The paper concludes with the author's views on advance research planning and on the relevant recommendations of the National Bioethics Advisory Commission.     

Vital Conversations with Family in the Nursing Home: Preparation for End-Stage Dementia Care

Family members of persons with advanced dementia may be asked to make complex treatment decisions without having adequate knowledge regarding the risks and benefits. This 6-month, prospective, randomized trial tested the effect of an intervention consisting of a face-to-face, structured conversation about end-of-life care options with family members of nursing home residents with advanced dementia. A comparison group received only social contact via telephone. Structured conversations between a palliative care team and intervention group family members included goals of care and how best to achieve those goals, and provision of psychosocial support. Psychosocial support was also provided via telephone at three 2-month intervals. Family members participated in three telephone interviews: baseline, 3, and 6 months. Specific advance directives for persons with dementia were extracted from medical records. Results showed that intervention families had higher satisfaction with care than comparison families at the 6-month time point, and they were more likely to have decided on medical options listed in residents' advance directives (Do Not Resuscitate, Intubate, Hospitalize) over time. Study findings reinforce the need for increased education and support for families around issues of end-of-life care decisions for advanced dementia.     

Long-term planning and decision-making among midlife and older gay men and lesbians

This article examines the issues of long-term planning and decision-making among midlife and older gay men and lesbian caregivers. Using a qualitative methodology, in-depth interviews were conducted with 19 gay men and lesbians over 50. Participants reported on their long-term planning and decision-making processes. All but four persons reported that their partners had advance directives, but the majority of caregivers did not have advance directives for themselves. Concerns about informal family dynamics and interactions with formal systems were expressed, along with financial and ownership issues. It is important for social workers to intervene across individual, organizational, and community levels in advocacy for the needs of older gay men and lesbian clients.     

A New Grandparenting

Summary

The author explores the social identity of older persons and their potential for taking leadership roles in their families and communities as mentors to young persons with disability. Dealt with is the powerlessness of both these groups within society and the way in which they may be able to empower each other. It is posited that serious and active grandparenting and mentoring have the potential of filling a large gap in the continuum of meaningful and productive activities for older adults and provide highly valuable support and human resource to young persons with disabilities.     

The therapeutic misconception,beneficence, and respect

In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of “informational manipulation”; that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disabused of the TM, the action they take in enrolling in a trial is not the one they intend nor is it autonomously chosen. Changes in consent procedures should be adopted to ensure that all subjects are aware inter alia that (a) the health interests of future patients (as well as the researchers’ and their sponsors’ financial interests) may be more important to researchers than the interest of a subject in his or her health, and (b) normal subjects neither understand nor believe this when told. Close attention to the response of prospective subjects to this information should allow for the exclusion of all but the truly altruistic. However, the result of conscientious implementation of such policies would likely be that human medical research could no longer be conducted on more than a minimal level.     

The Issue of Consent in Research that Administers Drugs of Addiction to Addicted Persons

In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain free and informed consent.     

Empirically supported ethical research practice: The costs and benefits of research from the participants’ view

Researchers and institutional review boards are routinely called upon to evaluate the cost‐benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.     

Further Evidence of Racial Disparities in Drug Court Outcomes: Enhancing Service-Delivery to Reduce Criminal Recidivism Rates for Non-White Participants

Abstract

The first drug court began in 1989, and since their inception, they have expanded to over 3,000 in the United States and United States territories. The long-term goal of drug courts is to reduce criminal recidivism rates for nonviolent offenders who have substance use disorders. This study adds to the literature by using secondary data to compare criminal recidivism rates between drug court participants (n?=?163) and probationers who had diagnosed substance use disorders and arrests that were eligible for drug court but they did probation instead (n?=?185). Criminal recidivism was measured up to 36?months post drug court/probation discharge, which provides a more accurate assessment of the long-term effectiveness of drug court. Furthermore, this study identified which drug court participants were most likely to recidivate. Drug court participants were less likely to recidivate than the probation group. However, differences between the two groups may have contributed to the difference in criminal recidivism rates and also suggest that screening criteria may exclude some non-White participants from drug court. Non-white participants were more likely to recidivate than their White counterparts. Implications for future research and drug court practice are discussed, focusing on enhancing the service-delivery of education and employment opportunities to non-White drug court participants.