James M. DuBois

Instruction in the Responsible Conduct of Research: An Inventory of Programs and Materials within CTSAs

The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortiums Clinical Research Ethics Key Function Committee (CRE‐KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8‐item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.

Content Analysis of Major Textbooks and Online Resources Used in Responsible Conduct of Research Instruction

Instruction in the responsible conduct of research (RCR) is required for all trainees funded by the National Institues of Health (NIH) or National Science Foundation (NSF). A recent Delphi study identified 53 key topics in 7 core areas that RCR education experts felt should be included in this instruction, which is required of many trainees in clinical and translational research. We performed a content analysis of major textbooks and online resources used in RCR instruction to determine the extent to which the 53 key topics identified in the Delphi study are covered by these resources. Textbooks and online resources used in RCR education at Clinical and Translational Science Award institutions were identified via survey. These resources were subjected to a content analysis. The 53 key topics identified in the Delphi study formed the basis of these analyses. We identified 10 textbooks and 1 online resource currently in use. Of the 53 key topics, only 4 were included in all 11 resources, and another 12 were included in 10. Twenty-three topics were covered in fewer than 65% of the resources, and two topics were absent from nearly all. Educators in clinical and translational research should be aware of key topics that are not covered in the RCR textbooks and online resources they may use and should consider augmenting discussion of such topics with other materials.

BETWEEN A ROCK AND A HARD PLACE: CAN PHYSICIANS PRESCRIBE OPIOIDS TO TREAT PAIN ADEQUATELY WHILE AVOIDING LEGAL SANCTION?

Prescription opioids are an important tool for physicians in treating pain but also carry significant risks of harm when prescribed inappropriately or misused by patients or others. Recent increases in opioid-related morbidity and mortality has reignited scrutiny of prescribing practices by law enforcement, regulatory agencies, and state medical boards. At the same time, the predominant 4D model of misprescribers is outdated and insufficient; it groups physician misprescribers as dated, duped, disabled, or dishonest. The weaknesses and inaccuracies of the 4D model are explored, along with the serious consequences of its application. This Article calls for development of an evidence base in this area and suggests an alternate model of misprescribers, the 3C model, which more accurately characterizes misprescribers as careless, corrupt, or compromised by impairment.

Addressing risks to advance mental health research.

IMPORTANCE Risk communication and management are essential to the ethical conduct of research, yet addressing risks may be time consuming for investigators and institutional review boards may reject study designs that seem too risky. This can discourage needed research, particularly in higher-risk protocols or those enrolling potentially vulnerable individuals, such as those with some level of suicidality. Improved mechanisms for addressing research risks may facilitate much needed psychiatric research. OBJECTIVE To provide mental health researchers with practical approaches to (1) identify and define various intrinsic research risks, (2) communicate these risks to others (eg, potential participants, regulatory bodies, and society), (3) manage these risks during the course of a study, and (4) justify the risks. EVIDENCE REVIEW As part of a National Institute of Mental Health-funded scientific meeting series, a public conference and a closed-session expert panel meeting were held on managing and disclosing risks in mental health clinical trials. The expert panel reviewed the literature with a focus on empirical studies and developed recommendations for best practices and further research on managing and disclosing risks in mental health clinical trials. No institutional review board-review was required because there were no human subjects. FINDINGS Challenges, current data, practical strategies, and topics for future research are addressed for each of 4 key areas pertaining to management and disclosure of risks in clinical trials: identifying and defining risks, communicating risks, managing risks during studies, and justifying research risks. CONCLUSIONS AND RELEVANCE Empirical data on risk communication, managing risks, and the benefits of research can support the ethical conduct of mental health research and may help investigators better conceptualize and confront risks and to gain institutional review board-approval.

Aligning objectives and assessment in responsible conduct of research instruction.

Efforts to advance research integrity in light of concerns about misbehavior in research rely heavily on education in the responsible conduct of research (RCR). However, there is limited evidence for the effectiveness of RCR instruction as a remedy. Assessment is essential in RCR education if the research community wishes to expend the effort of instructors, students, and trainees wisely. This article presents key considerations that instructors and course directors must consider in aligning learning objectives with instructional methods and assessment measures, and it provides illustrative examples. Above all, in order for RCR educators to assess outcomes more effectively, they must align assessment to their learning objectives and attend to the validity of the measures used.

Differences in preferences for models of consent for biobanks between Black and White women

Biobanks are essential resources, and participation by individuals from diverse groups is needed. Various models of consent have been proposed for secondary research use of biospecimens, differing in level of donor control and information received. Data are needed regarding participant preferences for models of consent, particularly among minorities. We conducted qualitative semi-structured interviews with 60 women to examine their attitudes about different models of consent. Recruitment was stratified by race (Black/White) and prior biobank participation (yes/no). Two coders independently coded interview transcripts. Qualitative thematic analysis was conducted using NVivo 10. The majority of Black and White participants preferred “broad” consent (i.e., blanket permission for secondary research use of biospecimens), and the second most preferred model for both groups was “study-specific” consent (i.e., consent for each future research study). The qualitative analysis showed that participants selected their most preferred model for 3 major reasons: having enough information, having control over their sample, and being asked for permission. Least preferred was notice model (i.e., participants notified that biospecimens may be used in future research). Attitudes toward models of consent differed somewhat by race and prior biobank participation. Participants preferred models of consent for secondary research use of biospecimens that provided them with both specific and general information, control over their biospecimens, and asked them to give permission for use. Our findings suggest that it will be important for researchers to provide information about future uses of biospecimens to the extent possible and have an explicit permission step for secondary research use.

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities

ABSTRACT Due to issues related to informed research consent, older adults with cognitive impairments are often excluded from high-quality studies that are not directly related to cognitive impairment, which has led to a dearth of evidence for this population. The challenges to including cognitively impaired older adults in research and the implications of their exclusion are a transdisciplinary issue. The ethical challenges and logistical barriers to conducting research with cognitively impaired older adults are addressed from the perspectives of three different fields—social work, emergency medicine, and orthopaedic surgery. Issues related to funding, study design, intervention components, and outcomes are discussed through the unique experiences of three different providers. A fourth perspective—medical research ethics—provides alternatives to exclusion when conducting research with cognitively impaired older adults such as timing, corrective feedback and plain language, and capacity assessment and proxy appointments. Given the increasing aging population and the lack of evidence on cognitively impaired older adults, it is critical that researchers, funders, and institutional review boards not be dissuaded from including this population in research studies.

Establishing the need and identifying goals for a curriculum in medical business ethics: a survey of students and residents at two medical centers in Missouri.

BackgroundIn recent years, issues in medical business ethics (MBE), such as conflicts of interest (COI), Medicare fraud and abuse, and the structure and functioning of reimbursement systems, have received significant attention from the media and professional associations in the United States. As a result of highly publicized instances of financial interests altering physician decision-making, major professional organizations and government bodies have produced reports and guidelines to encourage self-regulation and impose rules to limit physician relationships with for-profit entities. Nevertheless, no published curricula exist in the area of MBE. This study aimed to establish a baseline level of knowledge and the educational goals medical students and residents prioritize in the area of MBE.Methods732 medical students and 380 residents at two academic medical centers in the state of Missouri, USA, completed a brief survey indicating their awareness of major MBE guidance documents, knowledge of key MBE research, beliefs about the goals of an education in MBE, and the areas of MBE they were most interested in learning more about.ResultsMedical students and residents had little awareness of recent and major reports on MBE topics, and had minimal knowledge of basic MBE facts. Residents scored statistically better than medical students in both of these areas. Medical students and residents were in close agreement regarding the goals of an MBE curriculum. Both groups showed significant interest in learning more about MBE topics with an emphasis on background topics such as “the business aspects of medicine” and “health care delivery systems”.ConclusionsThe content of major reports by professional associations and expert bodies has not trickled down to medical students and residents, yet both groups are interested in learning more about MBE topics. Our survey suggests potentially beneficial ways to frame and embed MBE topics into the larger framework of medical education.

Communication in pediatric oncology: State of the field and research agenda

From the time of diagnosis through either survivorship or end of life, communication between healthcare providers and patients or parents can serve several core functions, including fostering healing relationships, exchanging information, responding to emotions, managing uncertainty, making decisions, and enabling patient/family self‐management. We systematically reviewed all studies that focused on communication between clinicians and patients or parents in pediatric oncology, categorizing studies based on which core functions of communication they addressed. After identifying gaps in the literature, we propose a research agenda to further the field.

A Mixed-Method Analysis of Reports on 100 Cases of Improper Prescribing of Controlled Substances

Improper prescribing of controlled substances (IPCS) contributes to opioid addictions and deaths by overdose. Studies conducted to date have largely lacked a theoretical framework and ignored the interaction of individual with environmental factors. We conducted a mixed-method analysis of published reports on 100 cases that occurred in the United States. An average of 17 reports (e.g., from medical boards) per case were coded for 38 dichotomous variables describing the physician, setting, patients, and investigation. A theory on how the case occurred was developed for each case. Explanatory typologies were developed and then validated through hierarchical cluster analysis. Most cases involved physicians who were male (88%), >40 years old (90%), non-board certified (63%), and in small private practices (97%); 54% of cases reported facts about the physician indicative of self-centered personality traits. Three explanatory typologies were validated. Increasing oversight provided by peers and trainees may help prevent improper prescribing of controlled substances.