Why the tolerance of potential harms? Research ethics in Alzheimer disease

This article summarizes the history of presentations to the National Bioethics Advisory Commission (NBAC) by representatives of the Alzheimer's Disease and Related Disorders Association, Inc., on the topic of human subjects research ethics. The interactions between these two bodies presents a useful profile of a public commission and a voluntary association working to clarify issues of great importance to the association's constituency. The context of epidemiology and ongoing research is also briefly presented. The author is a member of the Alzheimer's Disease and Related Disorders Association, Inc., National Ethics Advisory Panel, and in that role presented the Association position before NBAC and at the Friends Research Institute conference.     

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.     

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.     

Deaths of people with serious mental disorder: An exploration of deaths in custody and fatal police contacts

People with serious mental disorders (PSMDs) are overrepresented both in prison deaths and during fatal encounters with the police in the community (deaths after police contact, DAPC). To identify common factors present across cases of who died during contact with the criminal justice system in Queensland, publicly available coroners reports were analysed (N = 38). The findings of the study indicated psychosis and mood disorders were the most common diagnosis in incarcerated PSMD deaths, and suicide was the most common cause of death for incarcerated PSMDs. Within incarcerated settings, access to healthcare records, medication compliance, risk assessment and monitoring, and safe housing of at‐risk prisoners may be potential areas to explore with regard to prevention. Similarly, PSMD DAPCs were more likely to be experiencing mood or psychosis disorders than other forms of mental disorder, and suicide and police shootings were the most common causes of death. In PSMD DAPC, inadequate mental health access, treatment noncompliance and comorbid substance use were included as potential areas that could direct research efforts toward prevention.     

A choice of one's own research advance directives: Anticipatory planning for research subjects with fluctuating or prospective decisionmaking impairments

Mental disorders that may affect decisionmaking capacity, like schizophrenia, have a deleterious effect not only on persons who are afflicted with the disorders but also on their families, their friends, and their communities. Realizing research to develop generalizable knowledge that may benefit this heterogeneous population is crucial. The moral challenge is to fashion processes that both respect research subjects’ autonomy and protect their wellbeing. Research advance directives may provide a mechanism that authorizes potential research subjects to make choices of their own regarding whether they wish to participate in a research protocol, to choose and appoint a surrogate decision maker, and to secure an array of protections for themselves should they lose their decisionmaking capacity during the period of the research protocol. Such research advance directives may be used by persons with fluctuating, limited or prospective decisionmaking impairments.     

Correlates of Treatment Retention Among Persons with Serious Mental Illness Receiving Integrated Care in a Community Mental Health Setting

ABSTRACT

Knowledge about methods to retain community mental health (CMH) clients in integrated primary and behavioral health care (PBHC) programs is needed to address longstanding health disparities. A preexisting data set that contained the clinical records of 446 PBHC program participants was used to examine whether baseline sociodemographic, health, and psychosocial characteristics predicted retention in care at 6 months post-enrollment. Results indicated that less than half of PBHC participants (43.7%) were retained in care, and approximately 17% of the variance in retention was explained by the inclusion of seven predictors in the model (overall health, medications, laboratory data, primary care provider, disorder type, transportation, and living arrangement). Clients with thought disorders were almost twice as likely as those with mood disorders to be retained in care, and greater frequency of prescribed medications also increased the likelihood of treatment continuation (ORs = 1.99 and 1.20, respectively). Future research should identify factors that improve retention in integrated PBHC programs overall, and among persons with mood disorders, in particular.     

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.     

Differences by Race in Social Work Students’ Social Distancing,Treatment Options,and Perceptions of Causes of Mental Illness

ABSTRACT

Research has shown that racial and cultural differences are related to the degree of social distancing associated with mental illness, beliefs about what causes mental illness, and what treatment options are best; however, there is little information on how this may manifest in social workers’ perceptions of these issues. This cross-sectional survey analyzed the differences in perceptions by race of 835 students enrolled in social work classes in the United States. Results indicated that individuals who self-identify as African American/Black expressed the greatest social distance concerning mental illness. Whites were most likely to endorse the use of medication and were least likely to normalize mental illness. The most frequently endorsed mental health provider varied according to racial/ethnic groups. Our findings show that future research may be needed to further investigate the conceptualization of the role of social work among different groups. The need for self-reflection and keeping biases in check are discussed as implications for social work practice and education. Suggestions for working with diverse clients, including religious diversity, are offered as well.     

Development of the Hassles of Environmental Poverty Instrument

Abstract

Contemporary research has shown that chronic hassles can be as debilitating as acute stress and may be more of a determinant in the development of mental and physical disorders. In fact, frequency and intensity of hassles can be better predictors of stress responses than major life events. Although daily hassles have been shown to be population specific, existing measures of hassles do not distinguish between the hassles that impact men and those that impact women, nor have they been normed on populations that are poor. The Hassles of Environmental Poverty (HOEP) Scale is a 74-item instrument designed to assess the stresses of daily mothering within the context of poverty. Items on the scale address mothering stressors with a level of detail not currently available in existing stress scales. In the paper, the authors report out the results of statistical analysis that were done on the field test respondents. The results indicated that the HOEP Scale can legitimately be used for practice and research purposes.     

Engaging the public in policy development: The national bioethics advisory commission report on research involving persons with mental disorders that may affect decisionmaking capacity

U.S. bioethics commissions have used a variety of methods to involve the public. All share a common requirement: as federal advisory committees they are required to comply with the Federal Advisory Committee Act, the federal law established during the Nixon administration which provides the public with an assurance that groups established by the government to advise the government should be publicly accountable. This paper will describe some of the ways the National Bioethics Advisory Commission (NBAC) sought to involve the public in its report on Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity.     

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.     

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.     

A 12-Month Follow-Up Evaluation of Integrated Treatment for Homeless Individuals With Co-Occurring Disorders

ABSTRACT

This study examined the effectiveness of the Comprehensive, Continuous, Integrated System of Care (CCISC) model in addressing co-occurring mental health and substance use disorders. Clients were eligible for participation if they had co-occurring disorders and were homeless or at risk of homelessness. Forty-eight clients received a comprehensive array of services consistent with the CCISC model. Measures assessing housing, employment, mental health, and substance use were completed at baseline, 6-month, and 12-month follow-up. Results demonstrated significant improvements in housing, employment, mental health, and substance use at 12-month follow-up. These results underscore the effectiveness of implementing evidence-based care.     

Scientific evidence and the judicial system

Research involving the vulnerable sick raises difficult challenges for investigators and Institutional Review Boards. Exactly who among the ill counts as vulnerable is a matter of judgement, and involves consideration of susceptibility to harm and capacity to provide free and informed consent. A balanced approach is required when protections are considered, and the benefits as well as the risks of research participation must be carefully weighed. A variety of protections for the vulnerable sick in research are available, including enrolling subjects in a study only with a strong justification, ensuring that consent is free and comprehending, and setting limits on the risk to which they may be asked to endure. Discussion of three contemporary controversies, placebo‐controlled trials in the psychiatric setting, phase I clinical trials and oncology patients, and emergency room research involving patients incapable of giving consent, highlights the little recognized prominence of risk‐benefit issues in the clinical studies in the vulnerable sick.     

The market for (Ir)reproducible econometrics

Context: As the volume and complexity of research have increased, the amount of time spent on Institutional Review Board (IRB) review has decreased. The complexity of research has expanded, requiring increasingly specialized knowledge to review it. Dilemma: Under the current system, increasing numbers of research studies requiring expertise in ethics, new technologies or diverse study designs place a substantial burden upon local IRBs and often result in substantial variability among their reviews. This lack of uniformity in the review process creates uneven human subjects’ protection thus undermining the intent of the Common Rule. Objectives: To outline a scenario for expert centralized IRB review via implementation of a national virtual IRB review system overseen by the Office for Human Research Protections (OHRP). Conclusions: The complicated ethical issues and science involved in much of current research warrant an expert review panel. Centralized review would enable expert review specific to the research at hand, ensure consistency in human subjects protection, reduce the burden on local IRBs, and may reduce time spent obtaining approval. A centralized virtual system would allow IRB members to remain at their institutions while providing unprecedented expert review through currently available technology, and make information regarding monitoring and adverse event reporting available online in real-time.     

Anonymous Enrollment in AIDS Prevention Telephone Group Counseling

SUMMARY

Participants in an outcome study of a 14-week AIDS prevention counseling intervention, delivered entirely by telephone, were able to enroll either confidentially or anonymously. Anonymous enrollees (27%) were more likely to be bisexual, in a primary relationship with a female, and colseted. They were less self-accepting of their sexual orientation, less acculturated in the gay community, and less likely to have close social supports for safer sex. They were less likely to have been tested for HIV antibodies or to have perticipated in risk-reduction programs despite reporting risk behaviors comparable to that of confidential perticipants. By the program's conclusion, most anonymous enrollees had provided their phone numbers or other personally identifying information. Participants who retained their anonymity throughout (10%) were less likely to complete treatment or follow-up assessments. The findings support the effectiveness of anonymous enrollment in facilitating the participation of potential clients and research subjects who might otherwise have remained unreached.     

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.     

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.     

COVID-19 pandemic and the determinants of depressive symptoms among senior citizens of India: An empirical investigation

The COVID-19 pandemic inflicted multiple threats to individuals' physical, mental, and financial health conditions. The pandemic-related restrictive behaviors pose serious consequences for public health and increase the risk of mental illness among individuals, particularly among older citizens. The combination of their pre-existing illnesses, social isolation, COVID fear, and financial adversity frequently aggravates their condition and leads to depression and mental illness. Thus, the present study investigates the mental health status and the determinants of depressive symptoms among older adults of Bhubaneswar during the COVID pandemic context. The study used the Geriatric Depression Scale (GDS-15) to measure their depressive symptoms. The social isolation parameter is measured with the De Jong Gierveld Loneliness Scale. Financial self-efficacy, COVID-19-related psychological fear, and comorbidity health status are other determinants considered. A chi-square test and multinomial logistic regression (MLR) models are adopted to find the probable risk factors that may influence depressive symptoms among older people. The results indicate that comorbidity health conditions, a social isolation mindset, and financial efficacy issues are the significant determinants that drive an older person towards different depression categories. The improvement of these influential factors can lead senior citizens to avoid any health emergency like COVID pandemic. In the event of a public health emergency, such as COVID pandemic, the government could use the study's findings to devise methods for assisting the elderly. Society as a whole should be aware of these findings, which can lead to depressive symptoms, and offer support to the elderly. Future research may concentrate on identifying the causes of depressive symptoms in different age groups or in the presence of specific comorbidity health conditions. Future research may also investigate the factors influencing depressive symptoms in a specific occupation.     

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.