While medical ethics has a long history, and research ethics guidance emerged more formally in th... more While medical ethics has a long history, and research ethics guidance emerged more formally in the 1960s and 1970s, frameworks for public health ethics began to appear in the 1990s. The author's thinking about public health ethics evolved from consideration of some of the ethics and policy questions surfacing regularly in the HIV/AIDS epidemic. This essay discusses some of the shared commitments of public health and ethics, as well as how one might apply an ethics lens to public health programs, both generally and in the contexts of public health preparedness and obesity prevention. L ike others with many interests, I found picking a major in college a bit stressful. It was a relief to discover that Stanford, where I attended, had recently developed an interdisciplinary major called Human Biology, allowing me to study many things at once. "HumBio" had four main requirements: a year of coursework in biology, integrated with a year of social science core courses; a self-designed "area of concentration"; an internship; and a public policy course on either health or the environment. In the years since I graduated, options for areas of concentration have become more structured, but we had significant flexibility. My self-designed concentration was "A Feminist Approach to Public Health,"
Background: Distance learning may be useful for building health research capacity. However, evide... more Background: Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses. Methods: Subjects: Volunteer Indian scientists were randomly assigned to one of two arms. Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical. Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion, compared to baseline. Results: Baseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63% (p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14). Conclusion: On-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.
There is increased interest in transitioning to a "learning health care system" (LHCS).... more There is increased interest in transitioning to a "learning health care system" (LHCS). While this transition brings the potential for significant benefits, it also presents several ethical considerations. Identifying the ethical issues faced by institutions in this transition is critical for realizing the goals of learning health care so that these issues can be anticipated and, where possible, resolved. 29 semi-structured telephone interviews were conducted with leaders within 25 health care institutions. Respondents were recruiting using purposive sampling, targeting institutions considered as LHCS leaders. All interviews were audiorecorded and transcribed. NVIVO10 software was used to support qualitative analysis. Respondents described seven ethical challenges: (1) ethical oversight of learning activities; (2) transparency of learning activities to patients; (3) potential tensions between improving quality and reducing costs; (4) data sharing and data management; (5) l...
Questions have been raised about whether and how health care quality improvement (QI) initiatives... more Questions have been raised about whether and how health care quality improvement (QI) initiatives ought to be reviewed to address possible ethical issues associated with them. These questions have focused primarily on whether some QI initiatives meet the regulatory criteria for human subject research and should therefore be regulated and reviewed as such. Based on surveys of health care system professionals conducting QI initiatives and hospital CEOs, this issue brief finds that QI initiatives are routinely reviewed by a variety of internal mechanisms prior to implementation, although rarely through an institutional review board or another independent body charged specifically with ethical oversight of QI initiatives. Further research, the authors say, is needed to achieve a better understanding of how review mechanisms for QI initiatives are structured, including information on who reviews these activities, how they are reviewed, and whether such processes include an ethical assess...
As many as 1 in 10 patients is harmed while receiving hospital care in wealthy countries. The ris... more As many as 1 in 10 patients is harmed while receiving hospital care in wealthy countries. The risk of health careYassociated infection in some developing countries is as much as 20 times higher. In response, in many global regions, increased attention has turned to the implementation of a broad program of safety research, encompassing a variety of methods. Although important international ethical guidelines for research exist, literature has been emerging in the last 20 years that begins to apply such guidelines to patient safety research specifically. This paper provides a review of the literature related to ethics, oversight, and patient safety research; identifies issues highlighted in articles as being of ethical relevance; describes areas of consensus regarding how to respond to these ethical issues; and highlights areas where additional ethical analysis and discussion are needed to provide guidance to those in the field.
In many settings, and perhaps especially in low-middle income countries, training institutions do... more In many settings, and perhaps especially in low-middle income countries, training institutions do not adequately prepare their students for the ethical challenges that confront them in professional life. We conducted a survey to assess the training needs in research ethics among the faculty at the University of Zambia, School of Medicine (UNZASoM) using a structured questionnaire distributed to faculty members in January 2015. The study was approved by the University of Zambia Biomedical Research Ethics Committee. Seventy-five faculty members of various ranks completed the questionnaire. It was found that 31% of the faculty had not received any research ethics training. Of those who had received training, most of them had received it through short workshops of five days or less (57.4%, n = 31), while only 27.7% received ethics training as a component of an academic degree and 22.2% obtained it through electronic web-based courses. While most faculty (70.7%) reported being well-prepa...
Our primary aim was to evaluate the impact of US National Institutes of Health (NIH)-funded bioet... more Our primary aim was to evaluate the impact of US National Institutes of Health (NIH)-funded bioethics training programmes (Fogarty bioethics training programmes, FBTPs) that trained individuals from Africa over the programme's first 10 years to examine changes between pretraining and post-training in individual achievement and to document any associations between individual, training programme and post-training accomplishments. We surveyed trainees from the 10 bioethics programmes funded by NIH Fogarty International Center from 2000 to 2011 that included African trainees. McNemar's and Wilcoxon signed rank-sum tests were used to analyse pre-post levels of general and bioethics-related professional achievement. Likelihood of specific post-training achievement outcomes was measured using logistic regression including demographic, pretraining and intratraining variables. 10 different FBTPs that trained individuals from Africa from 2000 to 2011. Of 253 eligible respondents, 171 ...
The Yale Journal of Biology and Medicine, Oct 1, 2005
Part 2 applies the general public health ethics framework to avian influenza pandemic preparednes... more Part 2 applies the general public health ethics framework to avian influenza pandemic preparedness programs.
Background: In 2005, the NIH announced a funding mechanism, the Clinical and Translational Scienc... more Background: In 2005, the NIH announced a funding mechanism, the Clinical and Translational Science Award Program (CTSA), which focuses on facilitating the transfer of research-generated knowledge from the bench to the bedside to the community. Among other things, grant funding is dependent on an institution's plans for community engagement (CE). This strategy of institution-wide engagement, rather than project-specific CE, represents a shift in paradigm and may offer innovative models for CE. Methods: This project draws themes across all funded CTSA grant submissions' from 2005 and 2010 renewals from community engagement sections. Using qualitative content analysis, applications were coded according to: partner communities; structures, processes and strategies for engagement; and goals for CE. We compare each institution's 2005 and 2010 applications and review the corresponding NIH Requests For Applications to understand the relationship between the language of the RFAs ...
Journal of empirical research on human research ethics : JERHRE, 2015
Recently, there have been increasing numbers of activities labeled as either quality improvement ... more Recently, there have been increasing numbers of activities labeled as either quality improvement (QI) or comparative effectiveness research (CER), both of which are designed to learn what works and what does not in routine clinical care settings. These activities can create confusion for researchers, Institutional Review Board members, and other stakeholders as they try to determine which activities or components of activities constitute clinical practices and which constitute clinical research requiring ethical oversight and informed consent. We conducted a series of semi-structured focus groups with QI and CER professionals to understand their experiences and views of the ethical and regulatory challenges that exist as well as the formal or informal practices and criteria they and their institutions use to address these issues. We found that most participants have experienced challenges related to the ethical oversight of QI and CER activities, and many believe that current regula...
The Physician Payment Sunshine Act (PPSA) intends to bring greater transparency to physicianindus... more The Physician Payment Sunshine Act (PPSA) intends to bring greater transparency to physicianindustry relationships. A reference to Justice Brandeis' observation that sunlight is said to be the best of disinfectants, the PPSA aims to shed light on financial relationships that may compromise patient care and research integrity. Public reporting of financial relationships is already required in 4 states plus the District of Columbia, and at least 13 pharmaceutical companies now disclose information through quasi-voluntary agreements reached through settlements with the U.S. Department of Justice (1). Nevertheless, the PPSA dramatically expanded transparency, extending the scope of disclosure and the degree of public accessibility. Under the new program, now known as Open Payments, manufacturers of drugs, devices, biologics, and medical supplies must report nearly all transfers of value made to physicians or teaching hospitals (2). This information will be posted to a public Web site, scheduled to launch 30 September 2014 (3). Among the PPSA's most notable disclosure expansions are for payments for research, including clinical trials (4). Unlike earlier disclosure requirements, which generally focused on marketing, speakers' fees, and gifts, the PPSA creates a separate disclosure stream for research. These payments will be distinguished from general payments, including speaking or consulting fees, gifts, royalties, and investment interests. Establishing 2 tracks to differentiate research payments from other activities reflects recognition of the special status of research, including its social value in advancing health. Nevertheless, 1 part of the PPSA's requirements for disclosing research payments risks conveying a distorted image of certain physicianindustry relationships. Specifically, the Centers for Medicare & Medicaid Services (CMS), which issued the final regulations for the PPSA's implementation, requires not only that investigators report industry funding of research projects but also, importantly, that manufacturers report the value of pharmaceuticals provided for research, including those donated for federally funded clinical trials. Consequently, for physicians doing research involving donated drugsa common practice in large networks funded by the National Institutes of Health (NIH), such as the cooperative oncology groups and the AIDS Clinical Trials Groupthe monetary value of those drugs will be listed as research payments in public databases. Reports will include the recipient physician's name, total payment amount, study name, and study drug (5). For research involving multiple investigators, the donation will be reported as a payment to the principal investigator or, for multicenter trials, to each site's investigator of record. For some studies, the reported value of these donations will be staggering. The NIH recently initiated a trial of sofosbuvir, a once-daily agent for hepatitis C virus infection whose retail value is approximately $1000 per dose, with a 12-week course of curative treatment, or 84 doses (6). An investigator enrolling just 10 patients would be reported as receiving $840000 from Gilead Sciences, sofosbuvir's manufacturer. Similar reports will probably ensue for research involving donated oncology drugs, for which the single-patient annual cost can easily exceed $100000 (7). Attributing such large payments to individual physician-investigators seems inconsistent with the PPSA's intent. Donated drugs are intended for use by patients and do not provide direct monetary value to physician-investigators. The PPSA rules cloud this critical distinction. The NIH encourages the use of donated drugs, and an investigator committed to doing federally funded research may have little choice but to inappropriately seem to have received industry payments. Of note, although CMS requires manufacturers to report drugs donated for clinical trials, they are not required to report transfers intended for patient use in nonresearch settings, including product samples, educational materials, and in-kind items to be used for charity care (5). How patients or the general public will interpret disclosures of donated drugs is unclear, particularly when their value seems poised to dwarf that of reimbursements for speaking or consulting activities. One may presume that the public may have difficulty distinguishing between donated drugs for research and transfers of financial value to physicians. Such confusion frustrates the purpose of the PPSA, casting shadows where bright light had been promised. Confusion over reporting for donated study drugs may also have a chilling effect on physicians' willingness to participate in research, should they choose to avoid the appearance of financial relationships that raise the potential for misinterpretation. What should be done given such possible confusion? One response would be to exclude drugs used in research from reportable research payments, as is done for…
Unhealthy eating can have value for individuals and groups, even while it has disvalue in virtue ... more Unhealthy eating can have value for individuals and groups, even while it has disvalue in virtue of being unhealthy. In this paper, we discuss some ways in which unhealthy eating has value and draw out implications for the ethics of policies limiting access to unhealthy food. Discussing the value and disvalue of unhealthy eating helps identify opportunities for reducing unhealthy eating that has little value, and helps identify opportunities for eliminating trade-offs between health and other values by making unhealthy food experiences healthier without eliminating their value. It also helps us think through when it is ethically acceptable, and when it might be ethically unacceptable, to limit valuable experience in order to promote health. Our discussion of the value and disvalue of eating is offered here as a necessary supplement to the familiar discussion of paternalism, autonomous choice, and public policy.
Background-While there is much discussion regarding ethical payment to healthy volunteers partici... more Background-While there is much discussion regarding ethical payment to healthy volunteers participating in clinical research, little data exist regarding how volunteers determine fair payment. Objective-To determine healthy volunteers' estimates of payment for participating in hypothetical clinical trials, to explore reasons for their estimates, and to examine associations of volunteer demographics with payment estimates. Methods-Sixty participants with previous healthy volunteer research experience were presented with four hypothetical studies and interviewed about their impressions of the studies. Results-For each study, the range of payment estimates varied greatly. However, individuals tended to be consistent in estimate placement within this range. No demographic factor was significantly associated with the estimated study payment. Subjects frequently mentioned risk and logistical burden as factors which should determine payment levels. Conclusions-Healthy volunteer subjects have an individualized yet consistent method of determining study payment based on perception of study burden and risk.
Although the informed consent process is crucial to protecting human research subjects, there are... more Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor's name on the consent form may allow the form to serve as a surrogate for subjects' HIV status. There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.
Electronic clinical data (ECD) will increasingly serve as an important source of information for ... more Electronic clinical data (ECD) will increasingly serve as an important source of information for comparative effectiveness research (CER). Although many retrospective studies have relied on ECD, new study designs propose using ECD for prospective CER. These designs have great potential but they also raise important ethics questions. Drawing on an ethics framework for learning health care systems, we identify morally relevant features of prospective CER-ECD studies by examining 1 case of an observational study and a second of a pragmatic, randomized trial. We focus only on questions of consent and assume research has been subject to appropriate ethics review and oversight. We conclude that a CER-ECD observational study that imposes no or minimal additional risk to or burden on patients may proceed ethically without express informed consent from participants in settings where: (a) patients are regularly informed of the health care institution&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s commitment to learning through the integration of research and practice; and (b) there are appropriate protections for patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; rights and interests. In addition, where (a) and (b) apply, some pragmatic, randomized trials that similarly impose no or minimal additional risk to or burden on patients may also proceed ethically without express consent, when certain additional conditions are satisfied, including: (c) the trial does not negatively affect patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; prospects for good clinical outcomes; (d) physicians have the option of using an intervention other than the one assigned if they believe doing so is important for a particular patient; and (e) the trial does not engage preferences or values that are meaningful to patients.
Progress in Community Health Partnerships: Research, Education, and Action, 2007
The Environmental Justice Partnership (EJP) was formed in 2003 to bring together researchers from... more The Environmental Justice Partnership (EJP) was formed in 2003 to bring together researchers from Johns Hopkins and members of the surrounding urban community for increased, equitable partnerships and sustained dialogue, particularly in relation to research conducted in the local community. The EJP includes a Community Board of East Baltimore leaders and community based organizations, Johns Hopkins faculty and staff, and graphic art designers from the Maryland Institute of Art. In an effort to know how best to apply the principles of community-based participatory research (CBPR) to future research partnerships between Johns Hopkins and the local East Baltimore community, The EJP stressed the importance of learning community stakeholders experiences and views on research. Through this project, and in close partnership between the community and Johns Hopkins researchers, the EJP conducted focus groups with East Baltimore residents and interviews with other community leaders and representatives of community-based organizations. The goal of these focus groups and interviews was to learn experiences, attitudes, and recommendations about research in their community.
Pregnant women, imagining they were HIV-positive, were asked whether they would have an abortion ... more Pregnant women, imagining they were HIV-positive, were asked whether they would have an abortion or avoid pregnancy under shifting probabilities of vertical transmission. I nfants and children are among the fastest-growing categories of persons infected with the human immunodeficiency virus (HIV). With the virtual elimination of contaminated blood products as a source of infection, perinatal transmission now accounts for most cases of HIV infection in children. Thus, the ethnic background of infants and children with AIDS mirrors that among women with the infection and is highly concentrated in African-Americans and Hispanics. ~ Because we currently lack the means to prevent maternal-to-infant transmission, one obvious response to the pediatric AIDS epidemic has been a call for HIV-positive women to reduce or cease childbearing. Concern also has focused on the uninfected children of HIV-positive women who are likely to lose at least one parent early in life, sometimes entire families. In addition, childbearing may not be in the best interests of HIV-positive women themselves, because the demands of infant care may make it difficult for some women to take proper care of themselves. Thus, although there may be good reasons for HIV-positive women to eschew childbearing, any attempt on the part of health professionals to influence their reproductive decisions raises profound moral, legal, and policy issues. Reproductive choice is among the most elemental and most cherished components of rights to autonomy and privacy. Given the legacy of racism in the United States, it also is not surprising that some members of the minority community view HIV-related reproductive restraints as a genocidal attack by whites. 2'3 Coerced abortions among HIV-infected women have been reported. 4 Although several scholarly analyses of the moral and social issues raised
While medical ethics has a long history, and research ethics guidance emerged more formally in th... more While medical ethics has a long history, and research ethics guidance emerged more formally in the 1960s and 1970s, frameworks for public health ethics began to appear in the 1990s. The author's thinking about public health ethics evolved from consideration of some of the ethics and policy questions surfacing regularly in the HIV/AIDS epidemic. This essay discusses some of the shared commitments of public health and ethics, as well as how one might apply an ethics lens to public health programs, both generally and in the contexts of public health preparedness and obesity prevention. L ike others with many interests, I found picking a major in college a bit stressful. It was a relief to discover that Stanford, where I attended, had recently developed an interdisciplinary major called Human Biology, allowing me to study many things at once. "HumBio" had four main requirements: a year of coursework in biology, integrated with a year of social science core courses; a self-designed "area of concentration"; an internship; and a public policy course on either health or the environment. In the years since I graduated, options for areas of concentration have become more structured, but we had significant flexibility. My self-designed concentration was "A Feminist Approach to Public Health,"
Background: Distance learning may be useful for building health research capacity. However, evide... more Background: Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses. Methods: Subjects: Volunteer Indian scientists were randomly assigned to one of two arms. Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical. Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion, compared to baseline. Results: Baseline characteristics were similar in both arms (n = 29 each). Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p < 0.001) 3 months after the on-site course, and from 48% to 63% (p = 0.009) after the on-line course. For the on-site Research Ethics course, median score increased from 69% to 83% (p = 0.005), and for the on-line Research Ethics course from 62% to 80% (p < 0.001). Three months after the course, median gains in knowledge scores remained similar for the on-site and on-line platforms for both Biostatistics (16% vs. 12%; p = 0.59) and Research Ethics (17% vs. 13%; p = 0.14). Conclusion: On-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.
There is increased interest in transitioning to a "learning health care system" (LHCS).... more There is increased interest in transitioning to a "learning health care system" (LHCS). While this transition brings the potential for significant benefits, it also presents several ethical considerations. Identifying the ethical issues faced by institutions in this transition is critical for realizing the goals of learning health care so that these issues can be anticipated and, where possible, resolved. 29 semi-structured telephone interviews were conducted with leaders within 25 health care institutions. Respondents were recruiting using purposive sampling, targeting institutions considered as LHCS leaders. All interviews were audiorecorded and transcribed. NVIVO10 software was used to support qualitative analysis. Respondents described seven ethical challenges: (1) ethical oversight of learning activities; (2) transparency of learning activities to patients; (3) potential tensions between improving quality and reducing costs; (4) data sharing and data management; (5) l...
Questions have been raised about whether and how health care quality improvement (QI) initiatives... more Questions have been raised about whether and how health care quality improvement (QI) initiatives ought to be reviewed to address possible ethical issues associated with them. These questions have focused primarily on whether some QI initiatives meet the regulatory criteria for human subject research and should therefore be regulated and reviewed as such. Based on surveys of health care system professionals conducting QI initiatives and hospital CEOs, this issue brief finds that QI initiatives are routinely reviewed by a variety of internal mechanisms prior to implementation, although rarely through an institutional review board or another independent body charged specifically with ethical oversight of QI initiatives. Further research, the authors say, is needed to achieve a better understanding of how review mechanisms for QI initiatives are structured, including information on who reviews these activities, how they are reviewed, and whether such processes include an ethical assess...
As many as 1 in 10 patients is harmed while receiving hospital care in wealthy countries. The ris... more As many as 1 in 10 patients is harmed while receiving hospital care in wealthy countries. The risk of health careYassociated infection in some developing countries is as much as 20 times higher. In response, in many global regions, increased attention has turned to the implementation of a broad program of safety research, encompassing a variety of methods. Although important international ethical guidelines for research exist, literature has been emerging in the last 20 years that begins to apply such guidelines to patient safety research specifically. This paper provides a review of the literature related to ethics, oversight, and patient safety research; identifies issues highlighted in articles as being of ethical relevance; describes areas of consensus regarding how to respond to these ethical issues; and highlights areas where additional ethical analysis and discussion are needed to provide guidance to those in the field.
In many settings, and perhaps especially in low-middle income countries, training institutions do... more In many settings, and perhaps especially in low-middle income countries, training institutions do not adequately prepare their students for the ethical challenges that confront them in professional life. We conducted a survey to assess the training needs in research ethics among the faculty at the University of Zambia, School of Medicine (UNZASoM) using a structured questionnaire distributed to faculty members in January 2015. The study was approved by the University of Zambia Biomedical Research Ethics Committee. Seventy-five faculty members of various ranks completed the questionnaire. It was found that 31% of the faculty had not received any research ethics training. Of those who had received training, most of them had received it through short workshops of five days or less (57.4%, n = 31), while only 27.7% received ethics training as a component of an academic degree and 22.2% obtained it through electronic web-based courses. While most faculty (70.7%) reported being well-prepa...
Our primary aim was to evaluate the impact of US National Institutes of Health (NIH)-funded bioet... more Our primary aim was to evaluate the impact of US National Institutes of Health (NIH)-funded bioethics training programmes (Fogarty bioethics training programmes, FBTPs) that trained individuals from Africa over the programme's first 10 years to examine changes between pretraining and post-training in individual achievement and to document any associations between individual, training programme and post-training accomplishments. We surveyed trainees from the 10 bioethics programmes funded by NIH Fogarty International Center from 2000 to 2011 that included African trainees. McNemar's and Wilcoxon signed rank-sum tests were used to analyse pre-post levels of general and bioethics-related professional achievement. Likelihood of specific post-training achievement outcomes was measured using logistic regression including demographic, pretraining and intratraining variables. 10 different FBTPs that trained individuals from Africa from 2000 to 2011. Of 253 eligible respondents, 171 ...
The Yale Journal of Biology and Medicine, Oct 1, 2005
Part 2 applies the general public health ethics framework to avian influenza pandemic preparednes... more Part 2 applies the general public health ethics framework to avian influenza pandemic preparedness programs.
Background: In 2005, the NIH announced a funding mechanism, the Clinical and Translational Scienc... more Background: In 2005, the NIH announced a funding mechanism, the Clinical and Translational Science Award Program (CTSA), which focuses on facilitating the transfer of research-generated knowledge from the bench to the bedside to the community. Among other things, grant funding is dependent on an institution's plans for community engagement (CE). This strategy of institution-wide engagement, rather than project-specific CE, represents a shift in paradigm and may offer innovative models for CE. Methods: This project draws themes across all funded CTSA grant submissions' from 2005 and 2010 renewals from community engagement sections. Using qualitative content analysis, applications were coded according to: partner communities; structures, processes and strategies for engagement; and goals for CE. We compare each institution's 2005 and 2010 applications and review the corresponding NIH Requests For Applications to understand the relationship between the language of the RFAs ...
Journal of empirical research on human research ethics : JERHRE, 2015
Recently, there have been increasing numbers of activities labeled as either quality improvement ... more Recently, there have been increasing numbers of activities labeled as either quality improvement (QI) or comparative effectiveness research (CER), both of which are designed to learn what works and what does not in routine clinical care settings. These activities can create confusion for researchers, Institutional Review Board members, and other stakeholders as they try to determine which activities or components of activities constitute clinical practices and which constitute clinical research requiring ethical oversight and informed consent. We conducted a series of semi-structured focus groups with QI and CER professionals to understand their experiences and views of the ethical and regulatory challenges that exist as well as the formal or informal practices and criteria they and their institutions use to address these issues. We found that most participants have experienced challenges related to the ethical oversight of QI and CER activities, and many believe that current regula...
The Physician Payment Sunshine Act (PPSA) intends to bring greater transparency to physicianindus... more The Physician Payment Sunshine Act (PPSA) intends to bring greater transparency to physicianindustry relationships. A reference to Justice Brandeis' observation that sunlight is said to be the best of disinfectants, the PPSA aims to shed light on financial relationships that may compromise patient care and research integrity. Public reporting of financial relationships is already required in 4 states plus the District of Columbia, and at least 13 pharmaceutical companies now disclose information through quasi-voluntary agreements reached through settlements with the U.S. Department of Justice (1). Nevertheless, the PPSA dramatically expanded transparency, extending the scope of disclosure and the degree of public accessibility. Under the new program, now known as Open Payments, manufacturers of drugs, devices, biologics, and medical supplies must report nearly all transfers of value made to physicians or teaching hospitals (2). This information will be posted to a public Web site, scheduled to launch 30 September 2014 (3). Among the PPSA's most notable disclosure expansions are for payments for research, including clinical trials (4). Unlike earlier disclosure requirements, which generally focused on marketing, speakers' fees, and gifts, the PPSA creates a separate disclosure stream for research. These payments will be distinguished from general payments, including speaking or consulting fees, gifts, royalties, and investment interests. Establishing 2 tracks to differentiate research payments from other activities reflects recognition of the special status of research, including its social value in advancing health. Nevertheless, 1 part of the PPSA's requirements for disclosing research payments risks conveying a distorted image of certain physicianindustry relationships. Specifically, the Centers for Medicare & Medicaid Services (CMS), which issued the final regulations for the PPSA's implementation, requires not only that investigators report industry funding of research projects but also, importantly, that manufacturers report the value of pharmaceuticals provided for research, including those donated for federally funded clinical trials. Consequently, for physicians doing research involving donated drugsa common practice in large networks funded by the National Institutes of Health (NIH), such as the cooperative oncology groups and the AIDS Clinical Trials Groupthe monetary value of those drugs will be listed as research payments in public databases. Reports will include the recipient physician's name, total payment amount, study name, and study drug (5). For research involving multiple investigators, the donation will be reported as a payment to the principal investigator or, for multicenter trials, to each site's investigator of record. For some studies, the reported value of these donations will be staggering. The NIH recently initiated a trial of sofosbuvir, a once-daily agent for hepatitis C virus infection whose retail value is approximately $1000 per dose, with a 12-week course of curative treatment, or 84 doses (6). An investigator enrolling just 10 patients would be reported as receiving $840000 from Gilead Sciences, sofosbuvir's manufacturer. Similar reports will probably ensue for research involving donated oncology drugs, for which the single-patient annual cost can easily exceed $100000 (7). Attributing such large payments to individual physician-investigators seems inconsistent with the PPSA's intent. Donated drugs are intended for use by patients and do not provide direct monetary value to physician-investigators. The PPSA rules cloud this critical distinction. The NIH encourages the use of donated drugs, and an investigator committed to doing federally funded research may have little choice but to inappropriately seem to have received industry payments. Of note, although CMS requires manufacturers to report drugs donated for clinical trials, they are not required to report transfers intended for patient use in nonresearch settings, including product samples, educational materials, and in-kind items to be used for charity care (5). How patients or the general public will interpret disclosures of donated drugs is unclear, particularly when their value seems poised to dwarf that of reimbursements for speaking or consulting activities. One may presume that the public may have difficulty distinguishing between donated drugs for research and transfers of financial value to physicians. Such confusion frustrates the purpose of the PPSA, casting shadows where bright light had been promised. Confusion over reporting for donated study drugs may also have a chilling effect on physicians' willingness to participate in research, should they choose to avoid the appearance of financial relationships that raise the potential for misinterpretation. What should be done given such possible confusion? One response would be to exclude drugs used in research from reportable research payments, as is done for…
Unhealthy eating can have value for individuals and groups, even while it has disvalue in virtue ... more Unhealthy eating can have value for individuals and groups, even while it has disvalue in virtue of being unhealthy. In this paper, we discuss some ways in which unhealthy eating has value and draw out implications for the ethics of policies limiting access to unhealthy food. Discussing the value and disvalue of unhealthy eating helps identify opportunities for reducing unhealthy eating that has little value, and helps identify opportunities for eliminating trade-offs between health and other values by making unhealthy food experiences healthier without eliminating their value. It also helps us think through when it is ethically acceptable, and when it might be ethically unacceptable, to limit valuable experience in order to promote health. Our discussion of the value and disvalue of eating is offered here as a necessary supplement to the familiar discussion of paternalism, autonomous choice, and public policy.
Background-While there is much discussion regarding ethical payment to healthy volunteers partici... more Background-While there is much discussion regarding ethical payment to healthy volunteers participating in clinical research, little data exist regarding how volunteers determine fair payment. Objective-To determine healthy volunteers' estimates of payment for participating in hypothetical clinical trials, to explore reasons for their estimates, and to examine associations of volunteer demographics with payment estimates. Methods-Sixty participants with previous healthy volunteer research experience were presented with four hypothetical studies and interviewed about their impressions of the studies. Results-For each study, the range of payment estimates varied greatly. However, individuals tended to be consistent in estimate placement within this range. No demographic factor was significantly associated with the estimated study payment. Subjects frequently mentioned risk and logistical burden as factors which should determine payment levels. Conclusions-Healthy volunteer subjects have an individualized yet consistent method of determining study payment based on perception of study burden and risk.
Although the informed consent process is crucial to protecting human research subjects, there are... more Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor's name on the consent form may allow the form to serve as a surrogate for subjects' HIV status. There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.
Electronic clinical data (ECD) will increasingly serve as an important source of information for ... more Electronic clinical data (ECD) will increasingly serve as an important source of information for comparative effectiveness research (CER). Although many retrospective studies have relied on ECD, new study designs propose using ECD for prospective CER. These designs have great potential but they also raise important ethics questions. Drawing on an ethics framework for learning health care systems, we identify morally relevant features of prospective CER-ECD studies by examining 1 case of an observational study and a second of a pragmatic, randomized trial. We focus only on questions of consent and assume research has been subject to appropriate ethics review and oversight. We conclude that a CER-ECD observational study that imposes no or minimal additional risk to or burden on patients may proceed ethically without express informed consent from participants in settings where: (a) patients are regularly informed of the health care institution&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s commitment to learning through the integration of research and practice; and (b) there are appropriate protections for patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; rights and interests. In addition, where (a) and (b) apply, some pragmatic, randomized trials that similarly impose no or minimal additional risk to or burden on patients may also proceed ethically without express consent, when certain additional conditions are satisfied, including: (c) the trial does not negatively affect patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; prospects for good clinical outcomes; (d) physicians have the option of using an intervention other than the one assigned if they believe doing so is important for a particular patient; and (e) the trial does not engage preferences or values that are meaningful to patients.
Progress in Community Health Partnerships: Research, Education, and Action, 2007
The Environmental Justice Partnership (EJP) was formed in 2003 to bring together researchers from... more The Environmental Justice Partnership (EJP) was formed in 2003 to bring together researchers from Johns Hopkins and members of the surrounding urban community for increased, equitable partnerships and sustained dialogue, particularly in relation to research conducted in the local community. The EJP includes a Community Board of East Baltimore leaders and community based organizations, Johns Hopkins faculty and staff, and graphic art designers from the Maryland Institute of Art. In an effort to know how best to apply the principles of community-based participatory research (CBPR) to future research partnerships between Johns Hopkins and the local East Baltimore community, The EJP stressed the importance of learning community stakeholders experiences and views on research. Through this project, and in close partnership between the community and Johns Hopkins researchers, the EJP conducted focus groups with East Baltimore residents and interviews with other community leaders and representatives of community-based organizations. The goal of these focus groups and interviews was to learn experiences, attitudes, and recommendations about research in their community.
Pregnant women, imagining they were HIV-positive, were asked whether they would have an abortion ... more Pregnant women, imagining they were HIV-positive, were asked whether they would have an abortion or avoid pregnancy under shifting probabilities of vertical transmission. I nfants and children are among the fastest-growing categories of persons infected with the human immunodeficiency virus (HIV). With the virtual elimination of contaminated blood products as a source of infection, perinatal transmission now accounts for most cases of HIV infection in children. Thus, the ethnic background of infants and children with AIDS mirrors that among women with the infection and is highly concentrated in African-Americans and Hispanics. ~ Because we currently lack the means to prevent maternal-to-infant transmission, one obvious response to the pediatric AIDS epidemic has been a call for HIV-positive women to reduce or cease childbearing. Concern also has focused on the uninfected children of HIV-positive women who are likely to lose at least one parent early in life, sometimes entire families. In addition, childbearing may not be in the best interests of HIV-positive women themselves, because the demands of infant care may make it difficult for some women to take proper care of themselves. Thus, although there may be good reasons for HIV-positive women to eschew childbearing, any attempt on the part of health professionals to influence their reproductive decisions raises profound moral, legal, and policy issues. Reproductive choice is among the most elemental and most cherished components of rights to autonomy and privacy. Given the legacy of racism in the United States, it also is not surprising that some members of the minority community view HIV-related reproductive restraints as a genocidal attack by whites. 2'3 Coerced abortions among HIV-infected women have been reported. 4 Although several scholarly analyses of the moral and social issues raised
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Papers by Nancy Kass