Research subject advocate: a new protector of research participants

In 2001, the National Center for Research Resources (NCRR) directed the 78 General Clinical Research Centers (GCRC) to develop a Research Subject Advocate (RSA) position. The RSA would report directly to the Principal Investigator (PI) of each GCRC and assure compliance of studies conducted on the GCRC with federal regulations and policies. Seven RSAs agreed to be interviewed about their new role. Website documents, electronic correspondence, and presentations at the first annual national meeting of RSAs were scrutinized using discursive analysis to shed light on this new organizational form and its potential for increased protection of human research participants. The RSA role actualizes the ethical principles of respect for persons, justice, and beneficence that are the foundation of the protection of research participants. The results also reveal the regulatory, institutional, collegial, and personal resources and barriers that assist the RSA in the successful implementation of the RSA role. In addition, issues important to the RSAs are described.     

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.     

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.     

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.     

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.     

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.     

Research misconduct,NSF v NIH: Its nature and prevalence and the impact of their respective methods of investigation and adjudication

ABSTRACT

The National Science Foundation (NSF) and the National Institutes of Health (NIH) have established separate administrative mechanisms for investigation and adjudication of alleged research misconduct.

This report compares research misconduct at NSF and NIH and the possible effects of their respective methods of investigation and adjudication.

Notable and paradoxical findings were identified: NIH supported four times the number of grants as NSF, yet NSF reviewed 2.5 times the number of research misconduct reports. NSF faculty were two-times more likely to be found guilty (88%) than faculty at NIH (42%). 83.6% of NSF offenders were guilty of plagiarism, vs. 4.8% at NIH. NSF trainees made up 6% of the guilty, vs. 42% at NIH. These findings are most likely related to the nature of their respective sciences, scientists, and the nature of their publications.

Investigative policies and procedures are quite similar at these two agencies with the exception of the subpoena power available to the NSF’s Office of the Inspector General (OIG) where it would be infrequently utilized in investigations of its predominant offense, plagiarism. However, it could prove useful if made available to the NIH Office of Research Integrity (ORI) for investigations of fabrication/falsification, its most common offense. Federal criteria for prosecution should be modified to increase the likelihood of prosecution of serious offenders referred by ORI.     

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.     

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.     

Perceptions of research integrity and the Chinese situation: In-depth interviews with Chinese biomedical researchers in Europe

ABSTRACT

Research misconduct has been a threat to Chinese biomedical research. Despite many publications dealing with research integrity in China, little empirical data is available concerning Chinese biomedical researchers’ perceptions of research integrity and misconduct. To learn more about this issue, we interviewed Chinese biomedical researchers in Europe to investigate their perceptions of this issue. Semi-structured interviews were conducted with 25 participants until data saturation was reached. The findings indicate that certain aspects of research integrity need elaboration among Chinese biomedical researchers. Participants had a vague understanding of general concepts related to research integrity. Data fabrication, data falsification and plagiarism were perceived as the most severe deviance. Inappropriate authorship (especially gift authorship) and ghost writing were regarded as the most prevalent types of research misconduct in Chinese biomedical research. The harms of certain practices, such as inappropriate authorship, salami publication and multiple submission, were not well recognized. Attitudes toward research misconduct were divided. The current scientific evaluation system, pressures of promotion, motives for fame and other factors were perceived as the main reasons for research misconduct. Participants suggested various measures in addition to existing safeguards to improve research integrity in Chinese biomedical research.     

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.     

National Scientific Misconduct Policies in Argentina: Two Definitions of Research Misconduct

ABSTRACT

In “An International Study of Research Misconduct Policies”, Resnik et al. count Argentina in the list of countries without national research misconduct policies. In this paper, we clarify that Argentina has national policies of research misconduct and present the research misconduct definitions of two official science organisms: the National Scientific and Technical Research Council (CONICET) and the Ethics Committee of the Argentine Ministry of Science (MINCyT).     

Research,Macro Practice and Aging in the Social Work Education Curriculum

Summary

This paper presents a model that used a macro emphasis for teaching research using older adults. Faculty developed the teaching model to address three key areas of concern in the education of Bachelor of Social Work (BSW) students for generalist practice: (1) research, (2) macro-level practice, and (3) aging. The paper explores the nature of these concerns and draws upon previous literature to delineate a teaching model designed to strengthen these areas of generalist practice by integrating content on macro-level concerns and aging into the curriculum of a research course. The development and evaluation of the research course within the context of a community and college project are described, as are the benefits for students, the social work program and the community. Preliminary findings indicate some support for the use of such a model.     

Trends in Domestic and International Social Work Research: A 10-Year Review of American Research Journals

ABSTRACT

This article presents a typology of international social work research and analyzes trends over a 10-year period (1995–2004) based on reviews of 707 articles from three major American social work research journals: Social Work Research, Journal of Social Service Research, and Research on Social Work Practice. The analysis revealed there was a considerable increase (3.5%) in the total amount of research articles, particularly a higher increase in international social work research (2.8%) than national social work research (0.8%). A small decline was detected in transnational comparative research (?0.4%).     

Observational Research in Intergenerational Programming

Summary

Research in the field of intergenerational programming is rapidly growing in both quantity and quality. Both those who plan and work directly with intergenerational program participants in the human services and those who hold positions as researchers and evaluators need to be encouraged to research and evaluate their programs. We argue that observational research, though not without its shortcomings, should be more widely used to study and evaluate intergenerational program effectiveness and the relationships among people within them. We also provide some examples of observational strategies useful in practice-based research. We conclude that by recording details of the actual program interactions and relationships and examining them carefully or preserving them for later scrutiny, intergenerational program planners can learn to make relationship-based interventions successful and rewarding for their clients and themselves.     

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.     

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.     

Statistics,ethics, and research: An agenda for education and reform

This essay argues that the research community needs to pay more attention to the appropriate use of statistical methods in discussions of research ethics, and proposes some strategies for enhancing discussions of the ethical uses of statistics within investigational, educational, and organizational settings. The essay supports its position by 1) explaining why statistics plays such a key role in research integrity, 2) describing how some common misuses of statistics in research violate ethical standards pertaining to honesty and error avoidance, and 3) reviewing evidence which suggests that the misuse of statistics is more prevalent (and perhaps more significant) than research misconduct (narrowly defined as “fabrication, falsification, or plagiarism").     

Today's Studies,Tomorrow's Meta-Analyses: Implications for Evidence Informed Decision–Making in Social Work

ABSTRACT

Meta-analyses play an important role in understanding aspects of human functioning and program effectiveness. Meta-analyses also inform practice and policy decision making in areas of interest to social work. This study examined the degree to which recent quantitative reports in top social work journals are eligible for inclusion in future meta-analytic studies based on method rigor. The results suggest a mixed picture. Articles in top social work journals typically present sufficient information on participant characteristics, p values, and Mean values, yet they often fail to present sufficient information on variance indicators or the precise numbers of participants, which limits the ability to calculate effect sizes. Furthermore, less than 10% of the reports utilized randomized experimental designs or tested for group equivalence. To enhance social work's ability to make evidence-based decisions by producing more meta-analyses, researchers should provide more detail in study reports and use stronger research designs.     

Preparing Whistleblowers for Reporting Research Misconduct

Making an allegation of research misconduct can be stressful for a whistleblower. The Research Integrity Officer (RIO) can play an important role in helping reduce the stress by thoroughly discussing what whistleblowers can expect if they make an allegation. Through interviews with 77 RIOs who had recently handled a research misconduct case, we found that RIOs who addressed more topics as well as specific aspects of the topics were more likely to have used some type of memory aide in their initial contact with whistleblowers, talked with ORI staff or other RIOs about “hypothetical” research misconduct cases, or attended a RIO boot camp training. We believe that RIOs who more fully inform whistleblowers are providing timely preparation and building whistleblowers' confidence so they can make a more informed decision about reporting and experience less stress.