Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I (...) assess critically the role of this categorization of pregnant women involved in research as “vulnerable,” both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not “vulnerable” according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as “vulnerable” and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research. (shrink)
Background Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members’ roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs.Methods We distributed a self-administered REDCap survey of members of the Association for the Accreditation (...) of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members.Results 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials.Conclusions Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members. (shrink)
Introduction to healthcare ethics committees / D. Micah Hester and Toby Schonfeld -- Brief introduction to ethics and ethical theory / D. Micah Hester and Toby Schonfeld -- Ethics committees and the law / Stephen Latham -- Cultural and ...
As web instruction becomes more and more prevalent at universities across the country, instructors of ethics are being encouraged to develop online courses to meet the needs of a diverse array of students. Web instruction is often viewed as a cost-saving technique, where large numbers of students can be reached by distance education in an effort to conserve classroom and instructor resources. In practice, however, the reverse is often true: online courses require more of faculty time and effort than do (...) many traditional classes. Based on personal experience teaching an online course in health care ethics for students in the Allied Health Professions, it is evident that there are both benefits and challenges in teaching online courses, particularly in ethics. Examples of benefits are (1) the asynchronous nature of web instruction allows students to progress through the course at their own pace and at times that are convenient given their clinical responsibilities; (2) web courses allow for a standardization of content and quality of instruction over a diversity of programs; and (3) examples can be tailored to the differing experiences of students in the course. Some challenges to teaching online ethics courses include (1) the fact that online instruction benefits visual learners and disadvantages those lacking good reading comprehension or strong writing skills; (2) developing meaningful student-student and student-instructor interaction; and (3) teaching ethics involves teaching a process rather than a product. Allowing students to apply their knowledge to real-world cases in their disciplines and encouraging them to share experiences from clinical practice is an effective way to meet several of these challenges. Building an online community is another good way to increase the interaction of students and their engagement with the material. (shrink)
Assessing mastery of bioethics in a graduate program requires careful attention not simply to the content knowledge and skill development of students but also to the principles of sound assessment processes. In this article, we describe the rationale, development process, and features of the comprehensive exam we created as a culminating experience of a master’s program in bioethics. The exam became the students’ opportunity to demonstrate the way they were able to integrate course, textual, and practical knowledge gained throughout the (...) experience of the program. Additionally, the exam assessed students’ proficiency in the field of bioethics and their ability to critically and constructively analyze bioethical issues. In this article, we offer tips to other exam creators regarding our experiences with question and answer development, scoring of the exam, and relationships between coursework and exam preparation and completion. We also include a sample rubric for others to see how we determined which student answers were satisfactory. (shrink)
The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing concerns over research (...) carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)
This commentary was submitted to the World Medical Association on behalf of the International Network on Feminist Approaches to Bioethics. Our submission included a description of feminist research ethics, suggestions for specific revisions to the Declaration, and elements found in other international research ethics codes that are important from a feminist perspective. Our goals were to encourage the WMA to craft a declaration that: conceptualizes issues of vulnerability in richer and more nuanced ways, resists the influence of profit motives, and (...) extends the scope of responsibility for ethical research more broadly. (shrink)
A hub and spoke model offers an effective and efficient approach to providing informed guidance to those who need it. The National Center for Ethics in Health Care (NCEHC) at the Veterans Health Administration, Department of Veterans Affairs, is the largest known hub and spoke healthcare ethics delivery model. In this article, we describe ways NCEHC’s hub and spoke configuration succeeded during the COVID- 19 pandemic, as well as limitations of the model and possible improvements to inform adoption at other (...) healthcare systems. (shrink)
Although online education is becoming increasingly commonplace in health professional education, methods to evaluate student progress and knowledge base adequately remain uncertain. This paper describes a project that attempted to assess whether or not an online course was an effective way to teach applied ethics to students preparing for the health professions by qualitatively analyzing responses to a pre-test and post-test administered to students in the course. While previous studies have reported various findings regarding the success of online ethics courses, (...) our study failed to demonstrate that students gained a greater understanding of key concepts in ethics—respect for autonomy, decisional capacity, informed consent, and role of the provider. Our findings demonstrate the need for better subjective methods of evaluation and raise questions regarding the efficacy of current models of online ethics courses for health professional students. (shrink)
Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These principles require us to (...) look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research. (shrink)
In their article in the September-October 2010 issue of IRB: Ethics & Human Research, Chris Kaposy and Françoise Baylis argue that the contraception policy of the University of Nebraska Medical Center’s institutional review board fails to meet an ethically ideal standard in establishing the criteria investigators should follow when including women of childbearing potential in clinical research. In this response, we argue that the UNMC IRB’s policy is evidence-based and pragmatically oriented and that it therefore better safeguards women’s autonomy than (...) an ideal policy could. We also offer some of our experiences with the policy since it was implemented six years ago. (shrink)
While tens of thousands of people across the United States serve on hospital and other healthcare ethics committees , almost no carefully prepared educational material exists for HEC members. Ethics by Committee is a one volume collection of chapters developed exclusively for this educational purpose. Experts in bioethics, clinical consultation, health law, and social psychology from across the country contribute chapters on ethics consultation, education, and policy development.
Following the widespread occurrence of birth defects from the use of thalidomide to treat nausea during pregnancy in the 1960s and 1970s, the Food and Drug Administration became particularly vigilant about the use of therapeutic agents during pregnancy and in women of childbearing potential. The FDA developed a list that categorizes an agent according to the known risks to a fetus. The drug thalidomide falls into Category X: agents that have demonstrated clear risk of fetal abnormalities and whose risks outweigh (...) the benefits of use during pregnancy.Another Category X drug is isotretinoin, commonly known by its trade name Accutane. Isotretinoin is an oral medication prescribed for severe recalcitrant, nodular acne in patients who are unresponsive to conventional therapy. Isotretinoin has been available since 1982, and it remains the only effective treatment for this condition. (shrink)
The reference to the vagina as “it” or “down there” is symptomatic of two larger cultural problems: not naming the vagina when speaking about the vagina, and conflating the vagina with the external female genitalia. The euphemisms and obfuscating language have implications both for lay understandings of female bodies and for the practice of health care. Granting and using a name gives both the named and the namer power and legitimacy.