State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect (...) patients from egregious wrongdoing by physicians. (shrink)

Despite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems (...) account for the gap between what is known about pain management and what is practiced. Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing.State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny. (shrink)

Despite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems (...) account for the gap between what is known about pain management and what is practiced. Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing.State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny. (shrink)

State medical boards are beginning to take a more balanced approach to monitoring and disciplining for prescribing of pain medications, according to this survey of state medical boards across the country. Overall, respondents indicated that they are becoming more educated and more sophisticated in their approach to complaints of opioid overprescribing. In addition, their responses reflect a heightened awareness of the appropriateness of treating chronic pain with controlled substances.Yet, despite these inroads, boards generally (...) demonstrate a continued tolerance of pain undertreatment, the survey found. There is a discrepancy in the weight given to violation of standard of care, patient harm, and gross negligence for opioid overprescribing versus undertreatment of pain. Boards appear to have a higher threshold for patient harm in cases involving pain undertreatment — particularly for chronic nonmalignant pain. (shrink)

Uncertainty regarding potential disciplinary action may give physicians pause when considering whether to accept a chronic pain patient or how to treat a patient who may require long-term or high doses of opioids. Surveys have shown that physicians fear potential disciplinary acrion for prescribing controlled substances and that physicians will, in some cases, inadequately prescribe opioids due to fear of regulatory scrutiny. Prescribing opioids for long-term pain management, particularly noncancer pain management, has been controversial; and boards have investigated and, (...) in some cases, disciplined physicians for such prescribing. While in virtually all of these cases the disciplinary actions were successfully appealed, news of the success was not often as well-publicized as news of the disciplinary actions, leaving some physicians confused about their potential liability when prescribing opioids for pain. The confusion has perhaps increased as a result of two relatively recent cases, one where a physician was successfully disciplined by a state medical board for undertreatment of his patients’ pain, and another where the physician was successfully sued for inadequate pain treatment. (shrink)

A decade ago, conventional wisdom in the medical establishment was that physicians treating chronic pain with opioid analgesics were at a substantial risk of being sanctioned for overprescribing by state medical regulatory boards. Dozens of articles written since have alluded to this risk as an obstacle to effective pain re1ief. In the early 1990s, a number of high profile cases in which physicians were disciplined by regulatory boards for overprescribing to patients with chronic pain were (...) reported in the press. Although the board actions in many of these cases were eventually overturned by state judiciaries, the publicity heightened practitioners’. sensitivity to the regulatory risks associated with prescribing opioids.A review of the available data on state medical board actions nationwide for the period from 1990 to 1996 reveals that the perception of regulatory risk far exceeds the reality. Indeed, relatively few of the disciplinary actions taken for overprescribing by state medical boards in any given year directly concern the treatment of chronic pain—malignant or nonmalignant—in patients. (shrink)

A decade ago, conventional wisdom in the medical establishment was that physicians treating chronic pain with opioid analgesics were at a substantial risk of being sanctioned for overprescribing by state medical regulatory boards. Dozens of articles written since have alluded to this risk as an obstacle to effective pain re1ief. In the early 1990s, a number of high profile cases in which physicians were disciplined by regulatory boards for overprescribing to patients with chronic pain were (...) reported in the press. Although the board actions in many of these cases were eventually overturned by state judiciaries, the publicity heightened practitioners’. sensitivity to the regulatory risks associated with prescribing opioids.A review of the available data on state medical board actions nationwide for the period from 1990 to 1996 reveals that the perception of regulatory risk far exceeds the reality. Indeed, relatively few of the disciplinary actions taken for overprescribing by state medical boards in any given year directly concern the treatment of chronic pain—malignant or nonmalignant—in patients. (shrink)

The current debate about physician-assisted suicide and the question of whether patients would ask for such help if their pain were adequately controlled place in sharp focus the issue of undertreated pain. Studies have repeatedly documented the scope of the problem. A 1993 study of 897 physicians caring for cancer patients found that 86 percent of the physicians reported that most patients with cancer are undermedicated for their pain. A 1994 study found that noncancer patients receive even less adequate pain (...) treatment than patients with cancer-related pain, and that minority patients, the elderly, and women were more likely than others to receive inadequate pain treatment. Although the problem of undertreatment of pain is multifaceted, I only address how state medical boards contribute to the problem and suggest possible remedies.The literature on palliative care describes the numerous barriers that impede effective pain management and that result in the inadequate prescribing of pain-relieving drugs for terminally and chronically ill patients. (shrink)

The current debate about physician-assisted suicide and the question of whether patients would ask for such help if their pain were adequately controlled place in sharp focus the issue of undertreated pain. Studies have repeatedly documented the scope of the problem. A 1993 study of 897 physicians caring for cancer patients found that 86 percent of the physicians reported that most patients with cancer are undermedicated for their pain. A 1994 study found that noncancer patients receive even less adequate pain (...) treatment than patients with cancer-related pain, and that minority patients, the elderly, and women were more likely than others to receive inadequate pain treatment. Although the problem of undertreatment of pain is multifaceted, I only address how state medical boards contribute to the problem and suggest possible remedies.The literature on palliative care describes the numerous barriers that impede effective pain management and that result in the inadequate prescribing of pain-relieving drugs for terminally and chronically ill patients. (shrink)

Since their public launch, a little over a year ago, large language models (LLMs) have inspired a flurry of analysis about what their implications might be for medical ethics, and for society more broadly. 1 Much of the recent debate has moved beyond categorical evaluations of the permissibility or impermissibility of LLM use in different general contexts (eg, at work or school), to more fine-grained discussions of the criteria that should govern their appropriate use in specific domains or towards (...) certain ends. 2 With each passing week, it seems more and more inevitable that LLMs will be a pervasive feature of many, if not most, of our lives. It would not be possible—and would not be desirable—to prohibit them across the board. We need to learn how to live with LLMs; to identify and mitigate the risks they pose to us, to our fellow creatures, and the... (shrink)

Introduction: Variation across research ethics boards in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around (...) a case study with open-ended responses. Interviews were recorded, transcribed and coded manually.Results: Fourteen sites required individual patient consent for the study to proceed as proposed. Three indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites did not require consent. Two suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites required full committee review. Sixteen allowed an external research assistant to abstract information from the health record.Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions. (shrink)

BackgroundThe underrepresentation of scholarly works from low- and middle-income countries (LMICs) in academic literature is a documented concern, attributed partly to editorial biases. This trend, prevalent across various disciplines, has been less explored in the context of medical ethics journals. This study aimed to examine the composition of editorial board members (EBM) in high-impact medical ethics journals and to evaluate the extent of international diversity within these editorial teams.MethodsThis study incorporated an analysis of 16 high-impact medical ethics (...) journals. Information regarding the EBM of these journals was systematically gathered and categorized based on the World Bank’s country income classifications. An in-depth examination of the editorial board compositions was then conducted.ResultsThe study identified 669 EBM across the selected journals. A predominant 89.84% (601) of these members were from high-income countries (HICs), with upper-middle-income countries contributing 7.47% (50) and lower-middle-income countries 2.69% (18). No EBM were associated with low-income countries. A regional breakdown indicated that North America was the most represented area, accounting for 48.88% (327), followed by Europe & Central Asia (27.50%, 184), East Asia & Pacific (13.45%, 90), Latin America & Caribbean (4.63%, 31), Sub-Saharan Africa (4.19%, 28), Middle East & North Africa (0.75%, 5), and South Asia (0.60%, 4). In total, these EBMs hailed from 46 different countries, with the United States representing the largest proportion (43.80%, 293), followed by the United Kingdom (13.15%, 88), Australia (7.92%, 53), Germany (6.73%, 45), and Canada (5.08%, 34).ConclusionsThere is a significant lack of international representation within the EBM of high-impact medical ethics journals. The majority of editors in this field are affiliated with HICs, leading to a severe underrepresentation of LMICs within the editorial boards. (shrink)

Background: The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.Objective: To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.Design: Retrospective, observational study.Setting: Online (...) review of five major medical journals.Population: All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine.Measurements: Statement of REB approval and informed consent.Results: Of 1780 articles reviewed, 1133 met inclusion criteria , 36 articles lacked a statement of REB approval, 62 lacked disclosure of informed consent and 15 articles lacked both. Articles that did not state REB approval were associated with not stating informed consent . There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.Conclusions: Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency. (shrink)

Physician concern about regulatory scrutiny as a barrier to appropriate prescribing for pain management has been identified and studied. A 1991 Pain Research Group survey demonstrated a need to provide updated information about opioids and pain management to state medical board members. Indeed, a national survey even showed a need to provide more education about pain management to oncology Physicians. Two approaches for responding to these concerns have been undertaken in several states by the state medical (...) boards and the pain management community: the development and adoption of administrative policies designed to bring disciplinary standards in line with clinical practice; and the creation of education programs for state medical board members and staffs. Each can have a substantial impact on removing real and perceived regulatory barriers to effective pain relief. (shrink)

Physician concern about regulatory scrutiny as a barrier to appropriate prescribing for pain management has been identified and studied. A 1991 Pain Research Group survey demonstrated a need to provide updated information about opioids and pain management to state medical board members. Indeed, a national survey even showed a need to provide more education about pain management to oncology Physicians. Two approaches for responding to these concerns have been undertaken in several states by the state medical (...) boards and the pain management community: the development and adoption of administrative policies designed to bring disciplinary standards in line with clinical practice; and the creation of education programs for state medical board members and staffs. Each can have a substantial impact on removing real and perceived regulatory barriers to effective pain relief. (shrink)

Although more women continue to enter the medical profession, disparities between the sexes in academic medicine persist. This “gender gap” has implications for academic advancement. In 2006, Jagsi and colleagues reported that, although the proportion of women among first and last authors in the United States had significantly increased since 1970, women still represented a minority of the authors of original research and guest editorials in six prominent medical journals.1 In a related 2008 study, Jagsi and colleagues found (...) a substantial increase in women’s representation on editorial boards and as editors-in-chief of several prominent journals.2 We collected more recent data about the gender distribution of authors, members of editorial boards, and peer reviewers for prominent medical journals. Using data from 2010-2011, we determined the proportion of women who were authors of original research or guest editorials, members of editorial boards, or reviewers at six major general medical journals: the Annals of Internal Medicine (Ann Intern Med), the British Medical Journal (BMJ), JAMA, JAMA Internal Medicine, the Lancet, and the New England Journal of Medicine (NEJM). (shrink)

BackgroundInstitutional Review Boards (IRBs) play a vital role in safeguarding the rights and interests of both research participants and researchers. However, China initiated the establishment of its own IRB system relatively late in comparison to international standards. Despite commendable progress, there is a pressing need to strengthen the organizational capacity building of Chinese IRBs. Hence, this study aims to analyze the key factors driving the enhancement of organizational capacity within these committees.MethodThe cross-sectional survey for this research was conducted from (...) July 2020 to January 2022. Following the statistical grouping based on the "2020 China Health Statistical Yearbook", a systematic investigation of IRBs in various provinces of China was carried out. In-depth interviews and questionnaire surveys were conducted with the chairpersons and administrative executives (or secretaries) of highly cooperative IRBs. Subsequently, data were collected from 107 IRBs. Qualitative Comparative Analysis (QCA) was employed as the method to analyze the factors influencing the organizational capacity of medical ethics committees and explore the diverse combinations of these factors.ResultsThrough a singular necessary condition analysis, the variable "protection of rights and interests" emerges as a critical factor contributing to the robust construction of Institutional Review Boards Institutional Review Boards (IRBs). Conversely, the variables of "lack of member ability, absence of review process, and deficiency in the supervision mechanism" collectively constitute a sufficient condition leading to weaker IRB construction. The state analysis uncovers three interpretation modes: member ability-oriented (M1), system process-oriented mode (M2), and resource system-oriented mode (M3).ConclusionsThe results of this study are effectively explicable using the "Triangular Force" model proposed for the hypothesis of IRBs' organizational capacity, which provides a solid foundation for the development of organizational capabilities in IRBs. To enhance the organizational capacity of IRBs in China, it is imperative to elevate the competence of committee members and strengthen team development. This can be achieved by establishing a comprehensive regulatory framework and refining procedural protocols. Moreover, clarifying the organizational structure and optimizing resource allocation are essential steps in bolstering the overall organizational capabilities of these committees. (shrink)

Ethics boards have become obligatory passage points in today's medical science, and we forget how novel they really are. The use of humans in experiments is an age-old practice that records show goes back to at least the third century BC and, since the early modern period, as a practice it has become increasingly popular. Yet, in most countries around the world, hardly any formal checks and balances existed to govern the communal oversight of experiments involving human subjects (...) until at least the 1960s. Ethics by Committee traces the rise of ethics boards for human experimentation in the second half of the twentieth century. Using the Netherlands as a case-study, Noortje Jacobs shows how the authority of physicians to make decisions about clinical research gave way in most developed nations to formal mechanisms of communal decision-making that served to regiment the behavior of individual researchers. This historically unprecedented change in scientific governance came out of a growing international wariness of medical research in the decades after World War II. Research ethics committees were originally intended not only to make human experimentation more ethical but also to raise its epistemic quality. By examining complex negotiations over the appropriate governance of human subjects research, Ethics by Committee advances our understanding not only of the history of research ethics and the randomized controlled trial but also, more broadly, of how liberal democracies in the late twentieth century have sought to resolve public concerns over charged issues in medicine and science. (shrink)

The Medical School for International Health was created in 1996 by the Faculty of Health Sciences at Ben-Gurion University of the Negev in affiliation with Columbia University’s Health Sciences division. It is accredited by the New York State Board of Education. Students complete the first three years of the program on the Ben-Gurion University campus in Be’er-Sheva, Israel, while fourth-year electives are completed mainly in the United States along with a two-month global health elective at one of numerous (...) sites located around the world . The unique four-year, American-style curriculum is designed not only to prepare physicians who will be able to work at both an individual and community level but also at both of these levels anywhere in the world. In this way, it combines elements of medical and public health curricula not limited to an American perspective. (shrink)

Aim: Explore nurses’ values and perceptions regarding the practice of medical aid in dying. Background: Medical aid in dying is becoming increasing legal in the United States. The laws and American Nurses Association documents limit nursing involvement in this practice. Nurses’ values regarding this controversial topic are poorly understood. Methodology: Cross-sectional electronic survey design sent to nurse members of the American Nurses Association. Inductive thematic content analysis was applied to open-ended comments. Ethical Considerations: Approved by the institutional review (...) board (#191046). Participants: 1213 nurses provided 3639 open-ended comments. More than 80% of participants self-identified as white 58% held a graduate degree; and half were of Christian faith. Results: Values ranged on a continuum expressed through four themes: “Honoring Patient Autonomy without Judgment,” “Honoring with Limitations,” “Not until...,” and “Adamantly against.” Some felt it was a duty to honor the patients’ wishes, set aside own beliefs, and respect patients’ choices often with a spiritual connotation. Nurses held concerns about the process, policy, potential psychological harm, legal risk, and the need to learn more about MAID. Nurse who were adamantly against MAID associated the practice with murder/suicide and against religious beliefs. Disparate values were expressed about changing the MAID legislation to allow patient support with taking MAID medications and allowing MAID via advance directive. Conclusions: Nurses desire more education on MAID. There is not one universally held position on the nurse’s role during MAID. Healthcare policy/standards need to accommodate the wide variation in nurses’ values. Implications: Nurses desire education regarding their role in MAID. Nurses are encouraged to participate in policy discussions as the practice becomes increasingly legal. Managers need to expect that nurses, patients, and families will need psychological support to participate in MAID. Careful construction of policy/standards is needed to minimize conflict, moral distress, and psychological harm amongst nurses. Further research is needed. (shrink)

Background Community advisory boards have expanded beyond high-income countries and play an increasing role in low- and middle-income country research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. Methods We searched five databases for publications describing or evaluating CABs in LMICs. Two researchers independently (...) reviewed articles for inclusion. Data related to the following aspects of CABs were extracted from included publications: time, country, financial support, research focus, responsibilities, and challenges. Thematic analyses were used to summarize textual data describing challenges. Results Our search yielded 2005 citations, 83 of which were deemed eligible for inclusion. Most studies were published between 2010 and 2017. Upper-middle-income countries were more likely to have studies describing CABs, with South Africa, China, and Thailand having the greatest numbers. The United States National Institutes of Health was the main source of financial support for CABs. Many CABs focused on HIV research. Thirty-four studies reported how CABs influenced the informed consent process for clinical trials or other aspects of research ethics. CAB responsibilities were related to clinical trials, including reviewing study protocols, educating local communities about research activities, and promoting the ethical conduct of research. Challenges faced by CABs included the following: incomplete ethical regulations and guidance; limited knowledge of science among members of communities and CABs; unstable and unbalanced power relationships between researchers and local communities; poor CAB management, including lack of formal participation structures and absence of CAB leadership; competing demands for time that limited participation in CAB activities; and language barriers between research staff and community members. Several challenges reflected shortcomings within the research team. Conclusions Our findings examine the formation and implementation of CABs in LMICs and identify several ethical challenges. These findings suggest the need for further ethics training among CAB members and researchers in LMICs. (shrink)

During the 1970s and 1980s, legal precedent, governmental recommendations, and professional society guidelines drove the formation of hospital ethics committees (HECs). The Joint Commission on Accreditation of Health Care Organization’s requirements in the early 1990s solidified the role of HECs as the primary mechanism to address ethical issues in patient care. Because external factors drove the rapid growth of HECs on an institution-byinstitution basis, however, no initial consensus formed around the structure and function of these committees. There are now almost (...) 40 years of empirical studies on the composition, administration, and activities of HECs in the United States. We conducted a systematic review of the available empirical literature on HECs to describe their evolution. As HECs changed over time, they increased their total number of members and percentage of members from nursing and the community. Although physicians increasingly chaired these committees, their presence as a percentage of overall members declined. The percentage of administrative members remained steady, although committees became increasingly likely to have at least one administrative member. HECs were also increasingly likely to report to an administrative body or to the board of trustees or directors rather than to the medical staff. Finally, consultation volume increased steadily over time. There has not, however, been a national survey of the composition of ethics committees, their administration, or volume of consultation in more than 10 years, despite increasing calls for professional standards and quality improvement assessments among HECs. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:594 Feminist Studies 41, no. 3. © 2015 by Feminist Studies, Inc. Liberty Walther Barnes and Christin L. Munsch The Paradoxical Privilege of Men and Masculinity in Institutional Review Boards In the 1939 Hollywood classic The Wizard of Oz, the great wizard admonishes Dorothy and her friends to “pay no attention to that man behind the curtain.” Dorothy and company turn to see a man standing before a (...) large control panel operating the smoke, holographic image, and voice of the great wizard. Realizing he has been discovered, the man gives up manipulating the switches and the nebulous wizard vanishes.1 Hegemonic masculinity is analogous to the “all-powerful” wizard.2 In order to maintain its grandeur, power, and mystique, the mechanics of masculine ideology—as well as the social actors who participate in its reproduction —must be kept hidden.3 A crucial aim of feminist research is to 1. The Wizard of Oz, directed by Victor Fleming (Culver City, CA: Metro-Goldwyn -Mayer, 1939). 2. See R. W. Connell, Masculinities: Knowledge, Power and Social Change (Berkeley : University of California Press, 1995); R. W. Connell and James W. Messerschmidt, “Hegemonic Masculinity: Rethinking the Concept,” Gender & Society 19 (2005): 829–61; Michael Kaufman, “Me, Feminism, and Men’s Contradictory Experiences of Power,” in Theorizing Masculinities, ed. Harry Brod and Michael Kaufman (Thousand Oaks, CA: Sage Publications, 1994), 142– 63; and Michael S. Kimmel, “Masculinity as Homophobia: Fear, Shame, and Silence in the Construction of Gender Identity” in Brod and Kaufman, Theorizing Masculinities, 119–42. 3. Michael Flood and Bob Pease, “Undoing Men’s Privilege and Advancing Gender Equality in Public Sector Institutions,” Policy and Society 24, no. 4 (2005): 119–38; Allan G. Johnson, The Gender Knot: Unraveling Liberty Walther Barnes and Christin L. Munsch 595 pull back the curtain on men’s lives and masculine institutions in order to demystify socially constructed masculinities, particularly in their most powerful forms. As early feminist scholars note, male privilege renders women’s lives invisible.4 But male privilege renders aspects of men’s lives invisible, too. In this article we highlight how institutional review boards (IRBs) in universities and hospitals erect barriers to research that render particular aspects of men’s lives invisible. We draw on our experiences of submitting ten applications for a series of methodologically diverse studies of masculinity to eight IRBs. First, we argue that, despite their original function of protecting subordinated groups, IRBs are gendered institutions in which members base their decisions on culturally dominant, normative images of women and men. We show how this results in the stringent protection of male research participants, the safeguarding of participants’ personal masculinity, and the shielding of men’s lives from social inquiry. Second, we argue that IRBs are gendering institutions. Our experiences reveal how the privileging and protection of masculinity results in mandatory protocol modifications that idealize hegemonic masculinity. These modifications require researcher-participant interactions that socialize men to engage in gender “appropriate” behavior and reify gendered expectations. Third, our experiences reveal the ways in which IRBs protect the institution itself and privilege the universities, hospitals, and (predominantly male) medical doctors they represent. Consequently, the ways they reproduce social inequality remain impervious to academic inquiry. IRBS AS GENDERED AND GENDERING INSTITUTIONS Every university and hospital in the United States where human research is conducted houses a human research protections program, or IRB, to oversee academic research. Universities with hospitals typically our Patriarchal Legacy (Philadelphia, PA: Temple University Press, 1997); Michael Kimmel, Guyland: The Perilous World Where Boys Become Men (New York: Harper Collins, 2008). 4. Simone de Beauvoir, The Second Sex, trans. Howard M. Parshley (New York: Knopf, 1951); Sandra Harding, The Science Question in Feminism (Ithaca, NY: Cornell University Press, 1986); Dorothy E. Smith, “Women’s Perspective as a Radical Critique of Sociology,” in Feminist Perspectives on Social Research, ed. Sharlene N. Hesse-Biber and Michelle L. Yaiser (New York: Oxford University Press, 2004), 84–96. 596 Liberty Walther Barnes and Christin L. Munsch maintain two types of IRB committees: a social-behavioral committee that oversees studies in the social sciences, and a biomedical committee to supervise clinical drug trials, experimental medical treatments, and tissue and blood research. The duty of the... (shrink)

(forthcoming) Journal of Medical Licensure and Discipline. Rapid advances in human genetics raise the prospect that one day we may be able to develop genetic enhancements to promote a diverse range of phenotypes (e.g. health, intelligence, behaviour, etc.). Perhaps the biggest challenge that genetic enhancements pose for medical practitioners is that they will compel us to re-think a good deal of the conventional wisdom of the status quo. Radical enhancements are likely to have this affect for a variety (...) of reasons. Firstly, the status quo is premised (at least in large part) on a sharp distinction between treatment and enhancement; a distinction that at least some genetic enhancements will call into question. Secondly, the prospect of radical enhancements requires us to keep an open mind concerning how we conceive of the harm of non-intervention (i.e. the harm of the status quo). And thirdly, some enhancements might compromise the preservation of personal identity. All of these issues may have important consequences for State Medical Boards, ranging from the way we view the aspiration to prevent harm and ensure reasonable standards of care, to malpractice, continuing competency and medical specialization. (shrink)

BackgroundInstitutional review boards (IRBs) have been criticised for delays in approvals for research proposals due to inadequate or inexperienced IRB staff. Artificial intelligence (AI), particularly large language models (LLMs), has significant potential to assist IRB members in a prompt and efficient reviewing process.MethodsFour LLMs were evaluated on whether they could identify potential ethical issues in seven validated case studies. The LLMs were prompted with queries related to the proposed eligibility criteria of the study participants, vulnerability issues, information to be (...) disclosed in the informed consent document (ICD), risk–benefit assessment and justification of the use of a placebo. Another query was issued to the LLMs to generate ICDs for these case scenarios.ResultsAll four LLMs were able to provide answers to the queries related to all seven cases. In general, the responses were homogeneous with respect to most elements. LLMs performed suboptimally in identifying the suitability of the placebo arm, risk mitigation strategies and potential risks to study participants in certain case studies with a single prompt. However, multiple prompts led to better outputs in all of these domains. Each of the LLMs included all of the fundamental elements of the ICD for all case scenarios. Use of jargon, understatement of benefits and failure to state potential risks were the key observations in the AI-generated ICD.ConclusionIt is likely that LLMs can enhance the identification of potential ethical issues in clinical research, and they can be used as an adjunct tool to prescreen research proposals and enhance the efficiency of an IRB. (shrink)

Conflicts of interest are rampant in the American medical community. Today it is not uncommon for doctors to refer patients to clinics or labs in which they have a financial interest (40% of physicians in Florida invest in medical centers); for hospitals to offer incentives to physicians who refer patients (a practice that can lead to unnecessary hospitalization); or for drug companies to provide lucrative give-aways to entice doctors to use their "brand name" drugs (which are much more (...) expensive than generic drugs). In Medicine, Money and Morals, Marc A. Rodwin draws on his own experience as a health lawyer--and his research in health ethics, law, and policy--to reveal how financial conflicts of interest can and do negatively affect the quality of patient care. He shows that the problem has become worse over the last century and provides many actual examples of how doctors' decisions are influenced by financial considerations. We learn how two California physicians, for example, resumed referrals to Pasadena General Hospital only after the hospital started paying $70 per patient (their referrals grew from 14 in one month to 82 in the next). As Rodwin writes, incentives such as this can inhibit a doctor from taking action when a hospital fails to provide proper service, and may also lead to the unnecessary hospitalization of patients. We also learn of a Wyeth-Ayerst Labs promotion in which physicians who started patients on INDERAL (a drug for high blood pressure, angina, and migraines) received 1000 mileage points on American Airlines for each patient (studies show that promotions such as this have a direct effect on a doctor's choice of drug). Rodwin reveals why the medical community has failed to regulate conflicts of interest: peer review has little authority, state licensing boards are usually ignorant of abuses, and the AMA code of ethics has historically been recommended rather than required. He examines what can be learned from the way society has coped with the conflicts of interest of other professionals --lawyers, government officials, and businessmen--all of which are held to higher standards of accountability than doctors. And he recommends that efforts be made to prohibit and regulate certain kinds of activity (such as kickbacks and self-referrals), to monitor and regulate conduct, and to provide penalties for improper conduct. Our failure to face physicians' conflicts of interest has distorted the way medicine is practiced, compromised the loyalty of doctors to patients, and harmed society, the integrity of the medical profession, and patients. For those concerned with the quality of health care or medical ethics, Medicine, Money and Morals is a provocative look into the current health care crisis and a powerful prescription for change. (shrink)

Background Genomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond. Objective and methods To explore publicly accessible IRB websites for guidance in (...) this area, using summative content analysis. Findings Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of ‘significant new findings’ (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level. Conclusion IRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined. (shrink)

Pharmaceutical companies routinely engage physicians, particularly those with prestigious academic credentials, to deliver educational talks to groups of physicians in the community to help market the company's brand-name drugs. These speakers receive substantial compensation to lecture at events sponsored by pharmaceutical companies, a practice that has garnered attention, controversy, and scrutiny in recent years from legislators, professional associations, researchers, and ethicists on the issue of whether it is appropriate for academic physicians to serve in a promotional role. These relationships have (...) become so contentious that three years ago the pharmaceutical industry trade association, the Pharmaceutical Research and Manufacturers of America, adopted voluntary guidelines stating that drug companies should stop giving doctors free pens, calendars, sports bags, or tickets to entertainment events. Further, numerous medical associations, such as the Association of American Medical Colleges, the American Board of Internal Medicine and the Institute on Medicine as a Profession, and government bodies such as the Institute of Medicine have recommended that medical schools and teaching hospitals prohibit or strongly discourage faculty from participating in so-called industry Speakers Bureaus — promotional events designed solely to market pharmaceutical products. (shrink)

Background The European Union aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury, aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury. (...) Documents included detailed information on IRB procedures and the duration from IRB submission until approval. They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally or locally and primary IRB approval was obtained after one, two or three review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days and appeared to be shorter after submission to local IRBs compared to central IRBs. Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries. (shrink)

Background Medical boards and fitness-to-practice committees aim to ensure that medical students and physicians have “good moral character” and are not impaired in their practice of medicine. Method Presented here is an ethical analysis of stalking behavior by physicians and medical students, with focus on the case of Teleka Patrick, MD (a psychiatry resident practicing medicine while under a restraining order due to her alleged stalking behavior). Conclusions While a restraining order is not generally considered a (...) criminal conviction, stalking behavior is clearly unprofessional and a marker of inappropriate character and fitness, yet the reporting obligations for such matters are complex. Medical schools and training programs that fail to assess, record, and report matters of moral conduct such as this potentially allow impaired students to graduate and enter the work force (unless a robust licensing process identifies them). Patrick’s case should be a wake-up call for medical schools and medical boards to better integrate the professionalism domain into their operations. Further, the professionalism of students and doctors need to be integrated into the legal domain, so that those who are unfit to practice are, in fact, prevented from doing so. Guidance for integration is provided. (shrink)

The problem of inadequate pain management for both terminally ill patients and patients with chronic pain has recently been documented by a number of authors and studies. A 1997 report by the Institute of Medicine, for example, states that “a significant proportion of dying patients and patients with advanced disease experience serious pain, despite the availability of effective pharmacological and other options for relieving most pain.” There are particularly impressive data that pain associated with cancer is not adequately treated.The problem (...) has been attributed to inadequate education of physicians on approaches to pain management and an often misguided belief that prolonged therapy with certain pain medication will lead to addiction; legal obstacles, such as physicians’ fear of criminal prosecution and other disciplinary actions by state licensing boards for overprescribing narcotics; and inadequate insurance coverage as a result of narrow eligibility criteria for hospice care for Medicare beneficiaries, and inadequate reimbursement more generally for pain management and palliative care. (shrink)

The problem of inadequate pain management for both terminally ill patients and patients with chronic pain has recently been documented by a number of authors and studies. A 1997 report by the Institute of Medicine, for example, states that “a significant proportion of dying patients and patients with advanced disease experience serious pain, despite the availability of effective pharmacological and other options for relieving most pain.” There are particularly impressive data that pain associated with cancer is not adequately treated.The problem (...) has been attributed to inadequate education of physicians on approaches to pain management and an often misguided belief that prolonged therapy with certain pain medication will lead to addiction; legal obstacles, such as physicians’ fear of criminal prosecution and other disciplinary actions by state licensing boards for overprescribing narcotics; and inadequate insurance coverage as a result of narrow eligibility criteria for hospice care for Medicare beneficiaries, and inadequate reimbursement more generally for pain management and palliative care. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical Bioethics at NIH:History and A New VisionJohn C. Fletcher (bio)On July 3, 1995, Dr. John I. Gallin, Director of the Magnuson Clinical Center of the National Institutes of Health (NIH), convened a one-day "Conference on the Future of Clinical Bioethics at the National Institutes of Health Intramural Program." Conferees included NIH officials and a panel of consultants from bioethics programs around the nation.1 The subject was the future (...) of NIH's intramural bioethics program and specifically a vision of a new multi-component program, presented by Dr. Gallin, the first speaker. Dr. Harold Varmus, Director of NIH, was there to assure his support for Dr. Gallin's vision. This author, honored to be second speaker, was invited to sketch a brief history of bioethics at NIH. The present article reviews some of this history and then reports on Dr. Gallin's proposal, points of consensus among speakers and conferees, and the search for a Chief of the Clinical Bioethics Program.History of Bioethics at NIHIt is often said that NIH is a well-kept secret as the nation's leading biomedical research facility. Also, few people know that NIH has a long history in bioethics. Some key events in that history are shown in Figure 1, beginning with two that occurred prior to the birth of bioethics. NIH made an early policy response to protect human subjects of research and to find acceptable limits for scientific freedom. The Clinical Center (CC), a 550-bed research hospital, opened in 1953. A subcommittee of the Medical Board, the Clinical Research Committee (CRC), was formed for prior group review of all studies with normal volunteers. The traditional practice was for researchers themselves to decide when studies would begin, which subjects to recruit, and whether informed consent would be sought. The CRC intervention bit into this tradition. In addition, patient studies that posed significant risks or departed widely from medical practice were reviewed by referral from the Clinical Directors of the various Institutes. Was this CRC an early institutional review [End Page 355] board (IRB)? As a guest researcher, I was permitted to observe the CRCs meetings between 1966 and 1969. It functioned much like an IRB but had no community or non-scientist members. Other IRB-like review groups undoubtedly existed prior to the CRC. Robert Levine (personal communication, September 7, 1995) recalls that Beth Israel Hospital in Boston had one in 1938. Historical research is clearly needed on the earliest forms of research review.Table 1. Bioethics at NIHEventYearClinical Research Committee1953Surgeon-General's PPO #1291966NIGMS funds Hastings Genetics Group1973OPRR's Mission1974NLM's grant to KennedyInstitute for Bibliography of Bioethics1974Recombinant DNA Advisory Committee1974STEP Series Bioethics Speakers1975Pre-IRBs at the CC1975-76Assistant for Bioethics to Director, CC1977RAC-Human Gene Therapy Subcommittee1983Lipsett Proposal (ICD)1983Liaison Group, CC1983Bioethics Program, CC1985Durable Power of Attorney for Researchwith Incapacitated Subjects1985-86NLM funds National Reference Centerfor Bioethics Literature1985National Institute for Nursing Research1986Bioethics Post-Doctoral Fellows Program1989ELSI Program1989Bioethicists on CC-IRBs1989CC-Ethics Committee1990Office of Human Subjects Research1992 [End Page 356]Between 1963 and 1967, the media exposed instances of ethically troubling research, and Beecher (1966) and Pappworth (1967) published sharp criticisms of the weak state of research ethics. In 1966, Surgeon-General William Stewart and NIH Director James Shannon issued a policy requiring local group review of all research involving human subjects before making an application for NIH peer review (Surgeon General 1966). The policy was the first in any nation to mandate ethics committees for clinical research. However, it did not apply to the NIH intramural program until Congress passed the National Research Act in 1974 (Public Law 93-348; 202, 88 Stat. 342, 1974). This lag permitted NIH intramural investigators the luxury of feeling above the norms imposed on ordinary mortals and guaranteed more resistance to the inevitable change to come. Resistance to change marked the intramural program from the mid-1960s to the mid-1970s... (shrink)

While cadaver dissection remains an unmatched learning tool for structural anatomy, recent shifts in medical culture and pedagogy indicate that developing humanistic practices and fostering empathic responses are crucial components of early medical education. The Donor Letter Project was designed to accompany a traditional dissection curriculum, and the pilot, described here, tested its quality and efficacy. In 2017, family members of recently deceased donors to the Colorado State Anatomical Board were invited to submit letters about their loved (...) ones, and forty-seven first-year medical students at the University of Colorado School of Medicine volunteered to read the letters after their human anatomy course. The students then completed a survey about their experience. Because student and donor family responses to the DLP were overwhelmingly positive, the DLP will be repeated with incoming medical school classes, and an addendum to the State Anatomical Board donation application will invite donors to submit letters along with their enrollment materials that may be read by students at the time of donation. (shrink)

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 editions. This (...) update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

Over the past 20 years or so, a small but growing literature has emerged with the aim of modeling agents who are unaware of certain things. In this paper we compare two different approaches to modeling unawareness: the object-based approach of Board and Chung (Object-based unawareness: theory and applications. University of Minnesota, Mimeo, 2008) and the subjective-state-space approach of Heifetz et al. (J Econ Theory 130: 78-94,2006). In particular, we show that subjectivestate-space models (henceforth HMS structures) can be embedded (...) within object-based models (henceforth OBU structures), demonstrating that the latter are at least as expressive. As long as certain restrictions are imposed on the form of the OBU structure, the embedding can also go the other way. A generalization of HMS structures (relaxing the partitional properties of knowledge) gives us a full converse. (shrink)

Historical continuities and constraints in the professionalization of nursingThe support of medicine and the state may be crucial to nursing's current professional aspirations for legitimation and implementation of nursing reforms and for new roles for nurses in health care. As such, medicine and the state are in the invidious position of influencing nursing's occupational future. This situation is not new. An historical analysis of the establishment of nursing at Prince Alfred Hospital, Sydney, Australia, at the end of the (...) nineteenth century reveals that the State Government of NSW and the medical profession supported nursing's occupational development, yet set the framework within which this could occur. For instance, the state provided patronage to nursing through recommendations of the 1873 Royal Commission and because it financially backed Prince Alfred Hospital, while the medical profession defined nursing knowledge and practice through its control of the nursing curriculum. Membership of the hospital board provided both medicine and the state with powerful positions over hospital policies that affected nursing. While nursing became established as a distinct occupation for women with the aid of State and medical support, its subordinate position in health care was, and continues to be, constrained by these traditional supporters. This relationship between nursing, medicine and the state has implications for nursing's current professionalization strategies and aspirations. (shrink)

The doctrine of double effect is a principle of crucial importance in law and medicine. In medicine, the principle is generally accepted to apply in cases where the treatment necessary to relieve pain and physical suffering runs the risk of hastening the patient’s death. More controversially, it has also been used as a justification for withdrawal of treatment from living individuals and physician-assisted suicide. In this paper, I will critique the findings of the controversial Victorian Civil and Administrative Tribunal hearing (...) Syme vs the Medical Board of Australia. In that hearing, Dr Rodney Syme, a urologist and euthanasia advocate, was defending his practice of prescribing barbiturates to terminally ill patients. Syme claimed that he prescribed the drugs with the intention of relieving their existential suffering and not to assist in suicide; he argued that the DDE could be applied. Pace VCAT, I argue that this is an illegitimate application of DDE. I argue that a close scrutiny of Syme’s actions reveals that, at the very least, he intended to give patients the option of suicide. He furthermore used what on a traditional definition of DDE would be considered a ‘bad’ means—the prescription of Nembutal—to achieve a ‘good’ end—the relief of suffering. The case demonstrates the crucial importance of analysing an agent’s ‘intention’ and the ‘effects’ of their actions when applying DDE. Ethicists and, indeed, the judiciary need to attend to the ethical complexities of DDE when they assess the applicability of DDE to end of life care. If they fail to do this, the doctrine risks losing its legitimacy as an ethical principle. (shrink)

Institutional review boards are almost universally considered to be overworked and understaffed. They also require substantial commitments of time and resources from their members. Although some surveys report average IRB memberships of 15 people or more, federal regulations require only five. We present data on IRB meetings at eight of the top 25 academic medical centers in the United States funded by the National Institutes of Health. These data indicate substantial contributions from primary reviewers and chairs during protocol (...) discussions but little from other members, which implies that it may be possible for smaller IRBs to accomplish the same tasks with no reduction in the quality of review. (shrink)

In a seminal paper, Aumann (1987, Econometrica 55, 1–18) showed how the choices of rational players could be analyzed in a unified state space framework. His innovation was to include the choices of the players in the description of the states, thus abolishing Savage’s (1954, The Foundations of Statistics. Wiley, New York) distinction between acts and consequences. But this simplification comes at a price: Aumann’s notion of Bayes rationality does not allow players to evaluate what would happen were they (...) to deviate from their actual choices. We show how the addition of a causal structure to the framework enables us to analyze such counterfactual statements, and use it to introduce a notion of causal rationality. Under a plausible causal independence condition, the two notions are shown to be equivalent. If we are prepared to accept this condition we can dispense with the causal apparatus and retain Aumann’s original framework. (shrink)

This issue was published in the framework of a program that has been made possible by the generous support of the American people through the United States Department of State. The contents are the responsibility of the authors and do not necessarily reflect the views of the Department of State or the United States Government.

In this paper, I argue that medical school admissions should be limited to statistically relevant factors. My argument rests primarily on three assumptions. A state professional school should maximize production. If a state professional school should maximize production, then it should maximize production per student. If a state professional school should maximize production per student, then, within the optimum budget, a state medical school should maximize quality-adjusted medical services per graduate. I put forth (...) a tentative equation for ranking applicants as a way of maximizing quality-adjusted medical services per graduate. This way of ranking is cheaper than the way admissions is currently done. Hence, the proposal is practically as well as theoretically appealing. (shrink)