Background: Biomedical research is influenced by many factors, including the involvement of stakeholder groups invested in research outcomes. Stakeholder involvement in research efforts raises questions of justice as stakeholders’ specific interests and motivations play a role in directing research resources that ultimately produce knowledge, shaping how different conditions (and affected individuals) are understood and treated by society. This issue is highly relevant to child psychiatry research where diagnostic criteria and treatment strategies are often controversial. Biological similarities and stakeholder differences between attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) provide an opportunity to explore this issue by comparing research foci and stakeholder involvement in these conditions. Methods: A subset of ADHD and ASD research articles published between 1970 and 2010 were randomly selected from the PubMed database and coded for research focus, funding source(s), and author-reported conflicts of interest (COIs). Chi-squared analyses were performed to identify differences between and within ADHD and ASD research across time. Results: The proportion of ADHD research dedicated to basic, description, and treatment research was roughly similar and remained stable over time, while ASD research showed a significant increase in basic research over the past decade. Government was the primary research funder for both conditions, but for-profit funders were a notable presence in ADHD research, while joint funding efforts between nonprofit and government funders were a notable presence in ASD research. Lastly, COIs were noted more frequently in ADHD than in ASD research. Conclusions: Our study shows significant differences in research foci and funding sources between the conditions, and identifies the specific involvement of for-profit and nonprofit groups in ADHD and ASD, respectively. Our findings highlight the relationship between stakeholders outside the research community and research trajectories and suggest that examinations of these relationships must be included in broader considerations of biomedical research ethics.
BACKGROUND:Certificates of Confidentiality are intended to facilitate participation in critical public health research by protecting against forced disclosure of identifying data in legal proceedings, but little is known about the effect of Certificate descriptions in consent forms.METHODS:To gain preliminary insights, we conducted qualitative interviews with 50 HIV-positive individuals in Durham, North Carolina to explore their subjective understanding of Certificate descriptions and whether their reactions differed based on receiving a standard versus simplified description.RESULTS:Most interviewees were neither reassured nor alarmed by Certificate information, and most said it would not influence their willingness to participate or provide truthful information. However, compared with those receiving the simplified description, more who read the standard description said it raised new concerns, that their likelihood of participating would be lower, and that they might be less forthcoming. Most interviewees said they found the Certificate description clear, but standard-group participants often found particular words and phrases confusing, while simplified-group participants more often questioned the information's substance.CONCLUSIONS:Valid informed consent requires comprehension and voluntariness. Our findings highlight the importance of developing consent descriptions of Certificates and other confidentiality protections that are simple and accurate. These qualitative results provide rich detail to inform a larger, quantitative study that would permit further rigorous comparisons.
Background: This article focuses on the goals of our medical ethics education program and our formative assessments of students’ competency at various points during this education. Methods: Because of the critical relationship between a program's goals and the design of an assessment strategy, we provide an overview of the theoretical basis of our curriculum, our program's objectives, and teaching methods. In order to verify that our students had achieved minimum competency in the objectives of our ethics curriculum, we developed assessments that evaluated their ability to identify and apply ethical principles to clinical cases and to use moral reasoning to resolve dilemmas. We verified the reliability of these assessment instruments by correlating two different Mount Sinai raters’ scores of the same assessments with each other and the validity of these assessments with external reviewers. Results: For interrater reliability, paired raters scored the same student written exercise within 5 points of each other on 119 of the exercises (87% rater consensus). Therefore, we found our assessment tools to be reliable. Regarding validity, all three expert external reviewers agreed that our instruments were well suited for evaluating medical student competency in medical ethics and that they measured what we intended to measure. Conclusions: Our efforts in medical ethics education and competency assessment have produced an integrated model of goals, methodology, curriculum, and competency assessment. The entire model is directed at providing students with the ethical knowledge, skills, and attitudes required of an exemplary physician. We have developed reliable and valid assessment tools that allow us to evaluate the competency of students in medical ethics and to identify students who require remediation, and that are useful for other ethics programs. Keywords:: medical schoolethics educationmedical ethics curriculumcompetency assessmentclinical moral reasoning Acknowledgments A. Favia and L. Frank are equal first authors; E. Friedman and R. Rhodes are equal last authors.
Background: African patients often prefer to relinquish their consent powers to their physicians. Physicians may not seek informed consent before medical procedures. This study was conducted to determine whether patients considered their informed consent necessary before medical procedures. Methods: Using a descriptive cross-sectional design, hospitalized adult patients in a Nigerian community were interviewed about their opinions on the necessity of their informed consent. Results: Overall, 92.5% (185/200) believed that their informed consent was necessary prior to a medical procedure. The percentage of participants holding this view ranged from 90 to 100% across most of the demographic and clinical categories. However, most of the participants reported not being adequately informed prior to at least one clinical procedure in the course of their current hospitalization. Conclusions: Most patients want physicians to seek their informed consent prior to clinical procedures. This position does not conflict with the possibility of patients’ eventual choice to authorize their physicians to determine what they consider best for their care. Physicians need retraining and reorientation to ensure that they obtain patients’ informed consent prior to performing medical procedures.
Background: Ethics education is an established part of the medical school curriculum and typically involves preclinical instruction that includes formal ethical terminology. However, it is not clear whether the language of ethics taught in preclinical settings is applied by students during the clinical years of training. Methods: We used a survey and a content analysis of written reflections to determine whether third-year (clinical) medical students were able to recall and apply ethical principles and other sources of ethical value they were taught as second-year (preclinical) students. Results: The majority of clinical students were able to recall the four ethical principles, appreciated the relevance of preclinical ethics education, and had positive self-assessments of their clinical-ethical reasoning abilities. However, they were less able to recall other (nonprinciple) sources of ethical value and infrequently used ethical terms spontaneously in written reflections about ethically or professionally challenging issues. Conclusions: Ethics educators should consider the extent to which preclinical ethics education depends on a formal language of ethics and should develop ways to reinforce that language meaningfully through experience-based learning opportunities during the clinical years of training, with special emphasis on the way clear ethical reasoning and communication demonstrate respect for other persons.
Background: To improve ethics quality in health care, health care organizations need a way to characterize whether ethical practices throughout the organization are consistent with accepted ethics standards, norms, and expectations for the organization and its staff. We developed the IntegratedEthics™ Staff Survey (IESS) to fill this need. Methods: The IESS was developed and validated through a rigorous multiyear process. This process included reviews of the bioethics and health care literature to develop conceptual maps of common ethical issues in health care; focus groups and interviews with institutional stakeholders to identify key ethical concerns; cognitive testing, pilot testing, and field testing to ensure that questions were understandable and useful; and item reduction and modification to reduce respondent burden. Results: The IESS addresses staff perceptions of ethical practices in nine domains: everyday workplace, business and management, government service, patient privacy and confidentiality, resource allocation, shared decision making with patients, professionalism in patient care, end-of-life care, and research. The 2010 version of the survey consisted of 76 questions (excluding 8 demographic questions), including questions about the degree to which facility staff demonstrate behavior consistent with specific ethical practices, systems-level or organizational factors that support or interfere with ethical practices, and the ethical environment and culture. The IESS has served as a catalyst for multiple quality improvement and educational activities. Conclusions: The IESS represents an across-the-board approach to measuring ethics quality in multiple areas encompassing clinical, organizational, and research ethics. In addition to its use in quality improvement efforts, the IESS may be used to assess whether there are systematic differences across different disciplines, services, and supervisory levels; to evaluate the effectiveness of ethics programs; and to identify trends in ethical practices over time.
Background: There has been a recent growth in empirical research on assent with pediatric populations, due in part to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent. Methods: The authors review a subsection of the empirical literature on adolescent assent focusing primarily on asthma and cancer therapeutic research; adolescent competencies to assent to these studies; perceptions of protocol risk and benefit; the effects of various social context variables on adolescent research participation decision making; and the interrelatedness of these psychological and social factors. Results: Contemporary studies of assent, using multivariate methods and updated approaches to statistical modeling, have revealed the importance of studying the intercorrelation between adolescents’ psychological capacities and their ability to employ these capacities in family and medical decision-making contexts. Understanding these dynamic relationships will enable researchers and ethicists to develop assent procedures that respect the authority of parents, while at the same time according adolescents appropriate decision-making autonomy. Conclusions: Reviews of empirical literature on the assent process reveal that adolescents possess varying capacities for biomedical research participation decision making depending on their maturity and the social context in which the decision is made. The relationship between adolescents and physician-investigators can be used to attenuate concerns about research protocols and clarify risk and benefit information so adolescents, in concert with their families, can make the most informed and ethical decisions. Future assent researchers will be better able to navigate the complicated interplay of contextual and developmental factors and develop the empirical bases for research enrollment protocols that will support increased involvement of adolescents in biomedical research.
BACKGROUND:Research has generally examined institutional review boards (IRBs) in isolation, but critical questions arise of how these entities fit into the larger institutional contexts in which they operate and what the implications may be. METHODS:Semi-structured interviews were conducted with leaders of IRBs from among the top 240 institutions receiving funding from the National Institutes of Health. RESULTS:Interviewees felt that institutions may affect IRBs through both broad, indirect features (e.g., size, type of research, and culture of the institution), and more direct, IRB-related factors (e.g., amount of leadership and resource support for the IRB). Interviewees thought that institutional support of IRBs ranged from financial to non-financial, direct and indirect, and that these institutional factors can mold amounts of IRB staff and education, audits, and education of principal investigators (PIs), and tensions IRBs had to address. Respondents felt that these factors can in turn potentially affect IRB reviews of protocols and interactions with principle investigators (PIs). Within the complex systems of an institution, IRBs felt that PIs' experiences and complaints about the IRB to institutional leaders may also shape how the institution related to the IRB. CONCLUSIONS:These data are the first to show how IRBs perceive themselves as working within the contexts of dynamic local institutional relationships and systems that pose challenges and tensions that can potentially affect critical aspects of IRB functioning. The findings have implications for practice, future research, and policy.
BACKGROUND:In 2003, Havasupai tribe members in Arizona discovered that their DNA samples, collected for genetic studies on Type II diabetes, had been used for studies on schizophrenia, migration, and inbreeding without their approval. The resulting lawsuit brought by the Havasupai reached a settlement in April 2010 in which tribe members received monetary compensation and the return of DNA samples. In this study, we examine the perceptions of Institutional Review Board (IRB) chairpersons and human genetic researchers about the case and its impact on the practice of research.METHODS:Twenty-minute semi-structured interviews were conducted with 26 Institutional Review Board (IRB) chairs and researchers at six top NIH-funded institutions. Participants were questioned about their knowledge and perceived impact of the Havasupai case and their perceptions of informed consent in genetic research studies.RESULTS:We found that most study participants did not perceive that the Havasupai case had a large impact. However, we identified key concerns and opinions of the case, in particular, increased awareness of culturally sensitive issues with informed consent and secondary uses of samples.CONCLUSIONS:The results provide a deeper understanding of how informed consent issues are understood by IRB members and human genetic researchers and the implications for research ethics education.
BACKGROUND:Strict criteria for manuscript authorship exist to guide decisions on who should be considered an author. Less is known about how authorship for scientific meetings is determined. Our goal was to explore factors that influence decisions about authorship of conference abstracts. METHODS:In 2010, we conducted qualitative focus groups with a stratified sample of 36 trainees, 19 junior faculty, and 11 senior faculty. Focus group transcripts were coded using a coding scheme derived from an initial review of the transcripts and a preliminary theoretical framework, which was based on the literature, anecdotes, and personal experience. RESULTS:We identified 6 themes related to abstract authorship: comparisons with manuscripts; collaboration dynamics; time; experience and professional development; standards for authorship; and funding. We found that: views of abstracts as a lesser form of publication lead to diminished integrity of authorship; trainee inexperience and the dynamics of collaboration adversely influence the integrity of authorship independently of the perceived difference between an abstract and an article; and early communication about authorship appears to increase the integrity of authorship decisions. CONCLUSIONS:Authors do not hold abstracts to the same standard as manuscripts. As such, authorship decisions are frequently inconsistent with authorship criteria pertaining to manuscripts. Such inconsistencies might be improved with stricter institutional rules, clear and consistent authorship guidelines for abstracts submitted to conferences, a requirement that all authors verify their contributions to the abstract, and additional training in the responsible conduct of research.
Background: In an earlier study, we described the impact of formal misconduct determinations on established scientists' careers, showing that many retained scientific careers, and more than half (51%) continued to publish at least one paper per year after their cases were decided. Here, we extend our study to examine the ramifications of final misconduct findings by the Office of Research Integrity (ORI) on the careers of postdoctoral fellows. Methods: We tracked publication histories and attempted to track down all postdoctoral trainees found by ORI to have committed misconduct, and attempted to interview them about their experiences. Results: Trainees found to have committed misconduct between 1993 and 2007 whom we could trace were less likely to continue to publish than more established scientists, with only 11% publishing more than one paper per year after their misconduct determinations. Our assessment is constrained by our inability to reliably trace postdoctoral fellows, reflecting the fact that a majority of U.S. postdocs are from other countries. Conclusions: Because of concern about the fairness of severe punishment of trainees, the U.S. Office of Research Integrity appears to be shifting from funding debarments toward requiring education, mentorship, and oversight for trainees, which may enhance the likelihood of rehabilitation. Whether this policy succeeds remains to be seen.
Background: The role of front-line researchers, those whose responsibilities include face-to-face contact with participants, is critical to ensuring the responsible conduct of community-based drug use research. To date, there has been little empirical examination of how front-line researchers perceive the effectiveness of ethical procedures in their real-world application and the moral stress they may experience when adherence to scientific procedures appears to conflict with participant protections. Methods: This study represents a first step in applying psychological science to examine the work-related attitudes, ethics climate, and moral dilemmas experienced by a national sample of 275 front-line staff members whose responsibilities include face-to-face interaction with participants in community-based drug-use research. Using an anonymous Web-based survey we psychometrically evaluated and examined relationships among six new scales tapping moral stress (frustration in response to perceived barriers to conducting research in a morally appropriate manner); organizational ethics climate; staff support; moral practice dilemmas (perceived conflicts between scientific integrity and participant welfare); research commitment; and research mistrust. Results: As predicted, front-line researchers who evidence a strong commitment to their role in the research process and who perceive their organizations as committed to research ethics and staff support experienced lower levels of moral stress. Front-line researchers who were distrustful of the research enterprise and frequently grappled with moral practice dilemmas reported higher levels of moral stress. Conclusion: Applying psychometrically reliable scales to empirically examine research ethics challenges can illuminate specific threats to scientific integrity and human subjects protections encountered by front-line staff and suggest organizational strategies for reducing moral stress and enhancing the responsible conduct of research.
Background: In pediatrics, the “best interest” standard has become the prevailing standard in decision making even though it proves difficult to apply in practice. Differences in values can lead to different views by families and physicians of what is in the interest of a child. Our aim was to gain insight into the views of parents, children, and physicians in a pediatric oncology setting. Methods: We conducted a qualitative multicenter study, using in-depth semistructured interviews, with 21 children aged 8–18 years undergoing cancer treatment, 26 parents, and 15 pediatric oncologists. Results: At the onset of treatment, parents, children, and physicians had the same views on what is in the interest of the child: survival by following the treatment protocol. In the course of treatment, however, a transition takes place. For families, what constitutes the best interests expands beyond medical considerations, to include the wish to lead a normal life, having control over certain aspects of treatment, and maintaining one's identity (e.g., through religion). These aspects sometimes collide with medical aspects, leading to different professional and familial views about what course of action is appropriate. Conclusions: In order to recognize personal views and avoid conflicts, physicians should explicitly discuss parent and family concerns and opinions in the course of treatment. We present a model of “communicative ethics” to make these issues a subject of discussion. The role of the family in determining what is in the best interest of the child should only be limited when it implies a substantial medical risk of (irreversible) harm to the child.
Background: This study aimed at assessing knowledge of research ethics in a Nigerian health research community based on criteria for ethical research in the national code. It also sought to test the hypothesis that prior research ethics training, higher academic rank, and self-judged adequate knowledge of research ethics were not associated with knowledge of research ethics. Methods: As part of a descriptive, cross-sectional study, lecturers in university medical schools in two Nigerian states completed a structured questionnaire. Results: Of 133 study participants, 100 (75.2%) were trained in research ethics, mostly through workshops (72%). Fifty (37.6%) correctly identified all 10 criteria for ethical research listed. Prior research ethics training, rank, and self-judged adequate knowledge of research ethics were not associated with aggregate scores of research ethics knowledge. Conclusions: The majority of the respondents were trained in research ethics, but knowledge gaps were identified. Health researchers in this setting need to be trained more effectively in research ethics.
Background: IntegratedEthicsTM (IE) establishes a new model for ethics programs, with the goal of continuously improving "ethics quality" in health care. This article describes the IntegratedEthics Facility Workbook (IEFW), an evaluation tool developed by the National Center for Ethics in Health Care (NCEHC) to help health care facilities improve ethics quality in their organization. The workbook helps facilities to evaluate their local ethics programs relative to specific quality standards established for the IE model. This article describes the origins of the quality standards established for the IE model, explains IEFW conceptual underpinnings and tool development, illustrates how ethics programs use the tool to drive local program quality improvement, and provides longitudinal IEFW national results (2008–2011) for Department of Veterans Affairs (VA) IE programs. Methods: The project uses descriptive analysis of IEFW data submitted by VA facilities from 2008 through 2011. Results: In VA, longitudinal IEFW data demonstrate that facilities have made great strides in improving their ethics programs relative to quality standards defined for IntegratedEthics. Improvements in ethics consultation and preventive ethics practices—particularly related to accountability structures, consistent use of standardized processes, and evaluation of program quality—have been impressive and generally consistent over time. In the area of ethical leadership, facilities have had some success in improving structures and processes (e.g., the top corporate decision making body includes a member with recognized expertise in ethics), but less success in improving behaviors by individual leaders (e.g., involving clinical staff members in major organizational decisions that have ethical implications). Conclusions: The IEFW is a useful tool for monitoring progress in building a high-quality ethics program.
Freedman and Stulberg's (2013) “Conflicts in Care for Obstetric Complications in Catholic Hospitals” raises several interesting, important, and complex clinical and organizational ethics issues wor...
Background: The validity of results from clinical trials depends on both clinical researchers and participants consistently and strictly following research protocols. However, clinical trial researchers are also expected to provide excellent medical care to the participants. These two commitments may conflict under some circumstances. Methods: A questionnaire previously used for a national Internet-based survey was adapted to conduct in-depth, semistructured interviews in order to further explore reported attitudes and/or behaviors that indicated that patient well-being sometimes took precedence over strict adherence to the study protocol. We conducted 96 interviews with researchers working on Phase II and/or Phase III clinical trials in a variety of medical fields at four major academic medical centers. Results: Due to concerns for the welfare of their patients, the researchers we interviewed described decisions that involved “individualized” rather than protocol-driven decisions about recruitment, protocol implementation, and termination. The individualized decisions could threaten the validity of the trials. Conclusions: Clinical researchers should be strongly encouraged to carefully document and report selective recruitment, implementation, and termination decisions so that it will be easier to evaluate to whom the results of research studies apply. Those who design clinical trials should be careful to construct them so that the clinicians who carry them out will not feel that implementing the protocol will violate their commitments to good clinical care.
Background: Understanding of informed consent forms (ICFs) for clinical research remains insufficient despite attempts to simplify them. Through linguistic discourse analysis, we sought to identify pitfalls within the text of ICFs that could hinder readers’ understanding of participation in research. Methods: We conducted a linguistic discourse analysis on a qualitative sample of 19 ICFs approved by research ethics committees (RECs) for oncology protocols and explored whether our findings also applied to standard U.S. documents available online. Results: We identified five major categories of language patterns that were problematic with respect to ensuring informed consent. We categorized them as follows: “bypassing consent,” “seeker–supplier inversion,” “interlocking Russian dolls,” “vanishing author,” and “one size fits all.” At least one instance of these findings existed in all analyzed forms (median 10 per ICF, range 1–18) and in national templates and U.S. documents. Conclusions: Linguistic discourse analysis identified recurrent pitfalls in the language of REC-approved ICFs and templates. This approach may provide new tools to improve ICFs.
Background: A recent national survey revealed that over half of obstetrician-gynecologists working in Catholic hospitals have conflicts with religious policies, but the survey did not elucidate the nature of the conflicts. Our qualitative study examines the nature of physician conflicts with religious policies governing obstetrician-gynecologist (ob-gyn) care. Results related to restrictions on the management of obstetric complications are reported here. Methods: In-depth interviews lasting about one hour were conducted with obstetrician-gynecologists throughout the United States. Questions focused on physicians’ general satisfaction with their hospital work settings and specific experiences with religious doctrine-based ob-gyn policies in the various hospitals where they have worked. Results: Conflicts reported here include cases in which Catholic hospital religious policy (Ethical and Religious Directives for Catholic Health Care Services) impacted physicians’ abilities to offer treatment to women experiencing certain obstetric emergencies, such as pregnancy-related health problems, molar pregnancy, miscarriage, or previable premature rupture of membranes (PPROM), because hospital authorities perceived treatment as equivalent to a prohibited abortion. Physicians were contractually obligated to follow doctrine-based policies while practicing in these Catholic hospitals. Conclusions: For some physicians, their hospital's prohibition on abortion initially seemed congruent with their own principles, but when applied to cases in which patients were already losing a desired pregnancy and/or the patient's health was at risk, some physicians found the institutional restrictions on care to be unacceptable. Keywords: obstetrical emergenciesobstetric complicationsabortionmiscarriageCatholic health careCatholic bioethicsphysiciansqualitativein-depth interviews Notes All initials are pseudonyms.
