The role of litigation in human research accountability

This essay examines and analyzes the recent and dramatic series of personal injury lawsuits instituted against those individuals and institutions that conduct and monitor human research. It discusses the social engineering functions of tort litigation, outlines the legal elements and viability of lawsuits against those who conduct and monitor human research, and evaluates and predicts what role tort litigation will play in fulfilling the goals of accountability in the context of human research and human research regulation. In general, tort law engenders two forms of accountability: retrospective and prospective. Retrospective accountability is backward looking, focusing on harms that have already occurred, their culprits, and the reimbursement of individuals for their injuries. Prospective accountability is forward looking in that it encourages actors and institutions to fulfill responsibilities toward individuals in order that harm does not occur, or at least that the risk of harm is decreased. This article argues that research litigation is not, and will probably never become, an effective means of ensuring retrospective accountability in regard to research injuries and ethical violations. Paradoxically though, the current wave of research litigation may serve an important and even key role in encouraging and ensuring prospective accountability.     

Canadian policy on reporting breaches of research integrity: When should Research Ethics Boards be informed?

ABSTRACT

In Canada, institutions that receive research funding from the three federal granting agencies must establish research ethics boards (REBs) to review the ethical acceptability of research involving humans. Institutions are also expected to promote the responsible conduct of research, fostering researchers’ abilities to act with integrity in the conduct of their research. Where a researcher fails to act with integrity in research with humans, institutional policies and procedures of the U15, Canada’s most research-intensive universities, vary in the extent to which they involve their REBs in response to such breaches. Some make no mention of the REB, whereas others state that their REB should be provided with information relating to upheld allegations. In this paper, we argue that when allegations of research integrity breaches are corroborated, the institution’s REB should be identified as a party required to receive that information. Only then can REBs ensure compliance with research ethics standards, which is essential to maintain the public’s trust.     

Central Ethical Dilemmas in Research Involving Children

We are obligated to protect individual child subjects of research, yet it is also necessary to investigate the safety and efficacy of medical treatments that benefit children as a class. The federal regulations on research with children have provided ethical guidance since 1983, but divergent interpretations persist. Since varying interpretations can lead to confusion and abuses, efforts are underway to clarify the criteria. Clarity is needed to protect individual child subjects from harm while enabling ethical research to proceed. The "pediatric rule" and the "pediatric exclusivity" incentive are important policy initiatives for promoting sound research on the medical treatment of children.     

Clarifying the concept of the “Social” in risk assessments for human subjects research

International guidelines for the conduct of research with human participants, such as those put forth by the Council for International Organizations of Medical Sciences (CIOMS, 2002), recommend that research review committees account for social risk and benefits to society in their review of proposed research. What do the concepts of the “social” and “society” mean in the context of the review of human participants research? Here we analyze concepts of social and society to define the terms: social harm, social risk, social benefit, and benefits to society. We argue that use of these terms invite more questions than answers and beg for difficult empirical research to determine the nature, likelihood, and magnitude of this category of risk and benefit. Until more research is done and these questions are answered, we advise reviewers to adopt an attitude of provisionalism and caution in their review of specifically “social” risks and benefits and “benefits to society.”     

Validating a Behavioral Health Instrument for Adults: Exploratory Factor Analysis

ABSTRACT

Increasingly, social workers and behavioral health practitioners use assessment instruments to support service planning and to monitor progress. Following statewide implementation of the Adult Needs and Strengths Assessment (ANSA) to identify behavioral health symptoms, related functional challenges, risks, and strengths, this validation study explored the underlying structure of the instrument. An exploratory factor analysis used routinely collected information for Midwestern adults with diagnosed behavioral health disorders who participated in community-based services (N = 46,013). Five factors with adequate to good internal consistency (α = 0.733?0.880) emerged: personal recovery, trauma and stress related problems, substance use risks, self-sufficiency, and cultural-linguistic considerations. Validation of the ANSA supports use of the instrument to engage individuals and families, to plan services, to monitor progress, and to conduct research. Implications for social work education, supervision, and practice include the importance of understanding culture, holistic assessment, and services supporting personal recovery for individuals living with mental illness or substance use disorders. Confirmation of findings requires additional research.     

Articulating a Role for Program Evaluation in Responsible Conduct of Research Programs

Since Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct was released in 2001, there has been increased interest in evaluating programs designed to foster the responsible conduct of research (RCR). The field of program evaluation is designed to determine the worth or value of programs and can serve as a resource for institutions interested in evaluating their RCR programs. This article provides a very brief overview of program evaluation, demonstrates how it can be applied to RCR, and provides key reference information. Evaluating RCR programs can promote institutional accountability for the resources that are used in supporting those programs.     

Wealth, Power, and the Internal Revenue Service: Changing IRS Audit Policy through Litigation

Objectives . Although scholars have recognized that the wealth and power of litigants has substantial influence on litigation outcomes, there has been less recognition of the ability of the wealthy to sway agency policy through litigation. I argue that the wealthy, through lawsuits and the outcomes from the litigation, influence Internal Revenue Service (IRS) audits of the wealthy and the less affluent. Methods . I examine IRS state audit rates and use ordinary least squares regression with panel corrected standard errors. Results . I show that wealthy litigants can influence the IRS to decrease audits of the wealthy and increase audits of the less affluent. Conclusions . The wealthy appear to have the ability to influence IRS policy through lawsuits. Litigation can influence agency policy.     

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.     

Ethical Challenges in International HIV Prevention Research

Members of an HIV-prevention research network were asked to describe ethical challenges faced in their work. Major themes included acceptable standards of care for participants, defining research of relevance to host countries, reducing risks related to stigma, designing research that meets local needs without contributing to an inadequate status quo, and ensuring informed consent for complex research with potentially vulnerable participants. The challenges are interrelated and highlight the need for innovative, practical strategies to be incorporated into the planning, design, and conduct of HIV prevention trials. Research in applied ethics to support decision-making about HIV prevention research is needed, along with ethics training, mechanisms to support community-wide benefit from research, and expanded dialog on the ethics surrounding HIV prevention and public health research.     

国家行政赔偿救济额度的立法完善

对国家行政赔偿救济额度 ,我国的国家赔偿立法采用了“半免责”的法律机制设置 ,而明显低于民事侵权赔偿救济 ,在某种程度上已限制了我国行政诉讼的发展并形成掣肘。文章认为 ,行政侵权赔偿 ,不仅应赔偿直接损害 ,而且对间接损害也应救济 ;不仅应赔偿客观的物质损害 ,对精神损害也应赔偿 ,考虑到行政侵权客观的表现形式 ,对于因限制人身自由的间接受害者的精神损害如已造成严重后果的 ,应考虑予以赔偿     

Rhetoric and Reality in European Co-operation with Third Countries: A Case Study

This case study illustrates the reality of trying to achieve the European Commission objective of fruitful international research co-operation with Third Countries. The process of responding to an EC research call, preparing a proposal and negotiating a contract are explored with areas of general applicability being highlighted. The case study is drawn from the Avicenne Initiative in the area of health systems research. The difficulties and inequality of access to information, administrative research support and resourcing are explored as both issues for individuals and institutions and also as part of the difficulties of developing south-north or east-west research partnerships. The backstage of research is explored in order to highlight issues of discourse, practice and procedure which, if tackled, could provide a more level playing field for researchers from a wide range of institutions and countries.     

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.     

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.     

Developing a clinical trial governance framework for pharmaceutical industry-funded clinical trials

ABSTRACT

Rising concerns relating to pharmaceutical sponsor bias in the conduct of clinical trials have compelled the need to develop a clinical trial governance framework. This article describes the development of the Conflict of Interest in Research (COIR), a clinical trial governance framework. The COIR, consisting of three process phases (initiation, concurrent, and ongoing), developed following a needs assessment, using a four-stage methodology, and evaluated against the International Conference on Harmonization--Good Clinical Practice (ICH-GCP) guidelines. The Conflict of Interest Resolution algorithm, the backbone of COIR, enables constant surveillance to detect/resolve conflicts at all stages of the clinical trial life-cycle. COIR promotes interaction between the regulatory system and the sponsors, independent of individuals. COIR enables rapid detection of scientific and financial conflicts, to prevent subject harm and, to assure optimal funds utilization, the latter feature helped to reduce a significant burden for the ethics committee, as it lacks financial expertise. COIR is a semi-automated Oracle system, requires manpower, and is affected by human expertise and subjectivity. Complete automation to overcome this limitation will still need human expertise to scale changing trial regulations. Nevertheless, the COIR has won the distinction of the “most favored site” from pharmaceutical sponsors and is anticipated to be adopted by other clinical trial sites.     

Parents’ verbal communications with schizophrenic offspring∗

Abstract

Current research findings as well as both public protests and lawsuits by parent groups demonstrate the increasing dissatisfaction with prevailing approaches to the diagnosis and treatment of the syndrome termed “childhood hyperactivity.” First, this study summarizes a comprehensive review of research about the syndrome, and elaborates the research and practice issues that give rise to the contemporary controversy. Then, a promising, comprehensive new theory of child development, psychopathology, and treatment — intrapsychic humanism — is applied to the psychosocial treatment of children labelled hyperactive and their families in mental health, educational, and child welfare settings.     

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.     

The Canadian Agency for the Oversight of Research Involving Humans: A Reform Proposal

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada’s current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of “frequently asked questions” about the proposed agency design such as “What about ‘local context’?” and “Why not have a system of accreditation of institutional REBs instead?” In sum, radical reform is needed and, in this paper, I present a proposal for such reform.     

Ethical Beliefs of Social Work Researchers

Abstract

The purpose of this study is to examine the beliefs of social work researchers about ethical practices. Surveys were mailed to a random sample of 240 members of the Society for Social Work and Research (SSWR) to elicit their views about ethical practices in social work research. Responses from 160 members (67% response rate) yielded information regarding the appropriateness of dual relationships, authorship practices, informed consent procedures, and other conduct in social work research. Age, gender, educational level, years of social work research experience, and current teaching of social work research were related to respondents' ethical views about practices with students and sexual relationships with research subjects. The need for additional resources on ethics in social work research is highlighted.     

Stewardship of research resources

Most accounts of research ethics focus on the importance of a handful of ethical and epistemological norms for the conduct of science, such as honesty, integrity, transparency, accountability, objectivity, collegiality, fairness, social responsibility, but have little to say about another, less well-known norm that also deserves attention: stewardship of research resources. Many of the behaviors and practices that are widely regarded as unethical or ethically questionable involve wasting or misusing money, time, and other resources. While good stewardship of resources may not be as crucial to the ethics of science as other norms, it is an important consideration that scientists should keep in mind when managing their own resources or mentoring students and trainees in the responsible conduct of research. Additional investigation into the ethics of stewardship may help us better understand how this norm interacts with other research norms and guides scientific conduct.