Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)

As concerns about the negative health effects of unhealthy eating, overweight and obesity have increased, so too have policy efforts to promote healthy eating. Federal, state, and local governments have proposed and implemented a variety of healthy eating policies. Many of these policies are controversial, facing objections that range from the practical (e.g., the policy won’t succeed at improving people’s diets) to the ethical (e.g., the policy is paternalistic or inequitable). Especially controversial have been policies limiting the options offered in (...) the marketplace, limiting access to certain options, or providing disincentives for the purchase of certain options. Examples of such policies include proposed .. (shrink)

In Nigeria, as in other developing countries, access to training in research ethics is limited, due to weak social, economic, and health infrastructure. The project described in this article was designed to develop the capacity of academic staff of the College of Medicine, University of Ibadan, Nigeria to conduct ethically acceptable research involving human participants.

Public health ethics in the future will be distinguished from public health ethics in the past by this new subfield being labeled as such, acknowledged, and called upon for service. Ethical dilemmas have been present throughout the history of public health. The question of whether to force Henning Jacobson to be immunized in 1905 in accordance with the 1902 Massachusetts smallpox vaccination law was one of ethics as well as law. How Thomas Parran, Surgeon General in 1936, chose to respond (...) to a raging syphilis epidemic in the United States in the early part of the 2W century raised considerable moral debate in determining the appropriate public health response for a government? More recently, questions have arisen concerning the appropriate reach of government in controlling HIV banning smoking, or promoting healthy lifestyles. Debates over government infringement, morality, and justice recur throughout the history of public health. (shrink)

The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this approach in the form (...) of a case study from an institution in Africa. (shrink)

Public health raises critical ethics issues and concerns, making public heath ethics an essential topic for students and public health professionals. The 73 chapters in this volume examine public health ethics across a broad range of public health topics both in the U.S. and globally. It is the first ever comprehensive collection devoted to public health ethics.

During the past decade, screening tests using computed tomography have disseminated into practice and been marketed to patients despite neither conclusive evidence nor professional agreement about their efficacy and cost-effectiveness at the population level. This phenomenon raises questions about physicians' professional roles and responsibilities within the setting of medical innovation, as well as the appropriate scope of patient autonomy and access to unproven screening technology. This article explores how physicians ought to respond when new screening examinations that lack conclusive evidence (...) of overall population benefit emerge in the marketplace and are requested by individual patients. To this end, the article considers the nature of evidence and how it influences decision-making for screening at both the public policy and individual patient levels. We distinguish medical and ethical differences between screening recommended for a population and screening considered on an individual patient basis. Finally, we discuss specific cases to explore how evidence, patient risk factors and preferences, and physician judgment ought to balance when making individual patient screening decisions. (shrink)

Introduction The goal of this project was to develop and validate a new tool to evaluate learners' knowledge and skills related to research ethics. Methods A core set of 50 questions from existing computer-based online teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions were pilot-tested and item discrimination was calculated for each question. Poorly performing items were eliminated or refined. Two comparable assessment tools were created. These assessment (...) tools were administered as a pre-test and post-test to a cohort of 58 Indian junior health research investigators before and after exposure to a new course on research ethics. Half of the investigators were exposed to the course online, the other half in person. Item discrimination was calculated for each question and Cronbach's α for each assessment tool. A final version of the assessment tool that incorporated the best questions from the pre-/post-test phase was used to assess retention of research ethics knowledge and skills 3 months after course delivery. Results The final version of the REKASA includes 41 items and had a Cronbach's α of 0.837. Conclusion The results illustrate, in one sample of learners, the successful, systematic development and use of a knowledge and skills assessment tool in research ethics capable of not only measuring basic knowledge in research ethics and oversight but also assessing learners' ability to apply ethics knowledge to the analytical task of reasoning through research ethics cases, without reliance on essay or discussion-based examination. These promising preliminary findings should be confirmed with additional groups of learners. (shrink)

Research participants may not adequately understand the research in which they agree to enroll. This could be due to a myriad of factors. Such a missing link in the informed consent process contravenes the requirement for an.

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees.Our data (...) show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues (...) to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies. (shrink)

In the past ten years, there has been growing interest in and concern about protecting the privacy of personal medical information. Insofar as medical records increasingly are stored electronically, and electronic information can be shared easily and widely, there have been legislative efforts as well as scholarly analyses calling for greater privacy protections to ensure that patients can feel safe disclosing personal information to their health-care providers. At the same time, the volume of biomedical research conducted in this country continues (...) to grow. The budget of the National Institutes of Health, for example, was $20,298 million in 2001, having more than doubled from a budget of $9,218 million 10 years before. This growing body of research includes increased efforts to use stored medical records as a source of data for health services, epidemiologic, and clinical studies. (shrink)

We describe and evaluate FABTP and the efforts of its trainees. Our data show that since 2001, the 28 former FABTP trainees have auth.

Meat is a multi-billion-dollar industry that relies on people performing risky physical work inside meat-processing facilities over long shifts in close proximity. These workers are socially disempowered, and many are members of groups beset by historic and ongoing structural discrimination. The combination of working conditions and worker characteristics facilitate the spread of SARS-CoV-2, the virus that causes COVID-19. Workers have been expected to put their health and lives at risk during the pandemic because of government and industry pressures to keep (...) this “essential industry” producing. Numerous interventions can significantly reduce the risks to workers and their communities; however, the industry’s implementation has been sporadic and inconsistent. With a focus on the U.S. context, this paper offers an ethical framework for infection prevention and control recommendations grounded in public health values of health and safety, interdependence and solidarity, and health equity and justice, with particular attention to considerations of reciprocity, equitable burden sharing, harm reduction, and health promotion. Meat-processing workers are owed an approach that protects their health relative to the risks of harms to them, their families, and their communities. Sacrifices from businesses benefitting financially from essential industry status are ethically warranted and should acknowledge the risks assumed by workers in the context of existing structural inequities. (shrink)

Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with participants who have joined non-therapeutic research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the potential benefits of enrollment.Methods: In-depth (...) interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis.Results: Participants perceived that research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that research was risky whilst others thought that the benefits outweighed the risks.Conclusion: Participants perceived research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals. (shrink)

Participants in clinical research sometimes view participation as therapy or exaggerate potential benefits, especially in phase I or phase II trials. We conducted this study to discover what methods might improve cancer patients’ understanding of early-phase clinical trials. We randomly assigned 130 cancer patients from three U.S. medical centers who were considering enrollment in a phase I or phase II cancer trial to receive either a multimedia intervention or a National Cancer Institute pamphlet explaining the trial and its purpose. Intervention (...) participants were 32 times more likely to believe that the trial’s purpose was to examine safety and 60 % less likely to believe they would experience long-term benefit or cure. There was no difference in enrollment decision. However, while patients’ understanding of the trial’s purpose improved and expectations of long-term benefit diminished, half the respondents still believed they would experience long-term benefit or cure from participation. Therefore, we conclude that multimedia interventions such as this one may help oncologists to explain the risks and benefits of early-phase cancer trials in a way that patients can more easily understand, helping them to make more informed decisions about participation. But further research into other factors that influence patients’ beliefs about the outcome of enrollment is needed, both to modify the interventions and to determine how malleable patient beliefs are. (shrink)

Response to Emily A. Largent, Franklin G. Miller and Steven Joffe, A Prescription for Ethical Learning, Hastings Center Report, 43, s1, (S28-S29), (2013).

Motivations and decision-making styles that influence participation in biomedical research vary across study types, cultures, and countries. While there is a small amount of literature on informed consent in non-western cultures, few studies have examined how participants make the decision to join research. This study was designed to identify the factors motivating people to participate in biomedical research in a traditional Nigerian community, assess the degree to which participants involve others in the decision-making process, and examine issues of autonomy in (...) decision-making for research. A descriptive cross-sectional study was conducted with 100 adults (50 men, 50 women) in an urban Nigerian community who had participated in a biomedical research study. Subjects were interviewed using a survey instrument.Two-thirds of the respondents reported participating in the biomedical study to learn more about their illness, while 30% hoped to get some medical care. Over three-quarters (78%) of participants discussed the enrolment decision with someone else and 39% reported obtaining permission from a spouse or family member to participate in the study. Women were more than twice as likely as men to report obtaining permission from someone else before participating. More specifically, half of the female participants reported seeking permission from a spouse before enrolling. The findings suggest that informed consent in this community is understood and practised as a relational activity that involves others in the decision making process. Further studies are needed in non-Western countries concerning autonomy, decision-making, and motivation to participate in research studies. (shrink)

As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of widely-used (...) therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt-out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low-risk pragmatic comparative effectiveness trials of widely-used therapies as long as a sufficient amount of choice is preserved. (shrink)

: In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from the past, yet some (...) problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

Access to treatment, in HIV vaccine trials (HVTs), remains ethically controversial. In most prevention trials, including in South Africa, participants who seroconvert are referred to publicly funded programmes for treatment. This strategy is problematic when there is inadequate and uneven access to public sector antiretroviral therapy (ART) and support resources. The responsibilities, if any, of researchers, sponsors and public health authorities involved in HVTs has been hotly debated among academics, scholars, representatives of international organizations and sponsors. However, there is little (...) published on community perceptions. Recent guidance asserts that communities should make inputs into treatment and care decisions. This qualitative study explored a South African community's perceptions of who should provide what to HVT participants as well as how and why this should be done. Twenty-nine adults working at or attending five primary health care clinics in two rural areas in KwaZulu-Natal participated in in-depth interviews. Respondents expressed that researchers should ‘help participants to access’ treatment and care ‘because they are in a position to do so’ and ‘are in a relationship with’ trial participants. Respondents suggested that researchers could help by ‘facilitating referral’ until such time that participants can access care and treatment on their own. We highlight a series of implications for researchers in HVTs, including their need to be aware of prospective participants' considerable trust in and respect for researchers, the responsibility that this places on them, and the need for clear communication with communities so as not to erode community trust. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

A large body of literature supports the notion that the language used in informed consent forms is not comprehensible to most research participants. Creating comprehensible informed consent forms for international research presents a further challenge because they are generally written first in English and then translated into the local language. The Kenya Medical Research National Ethical Review Committee determines readability of English consent forms before translation; however, it is neither their policy nor practice to determine whether the forms, once translated (...) into Kiswahili, are of comparable readability to the English forms. Thus, the aim of this study is to measure and compare the text difficulty in 10 pairs of English informed consent forms and their translated Kiswahili forms. The results show that a readable English-language consent form does not necessarily result in a readable form once translated into Kiswahili. (shrink)

We conducted a retrospective review of research protocols from four IRBs at one large academic medical institution. The project examined whether having the Principal Investigator attend the initial IRB review of his or her study improves the efficiency of the review. We measured efficiency by the number of days from protocol submission to approval, volume of correspondence exchanged between investigator and IRB prior to approval, and the number of convened IRB meetings required prior to approval. We assessed two samples of (...) research records. The first cross-sectional sample was drawn concurrently from four IRBs—two that routinely invite PIs to be present when their protocols are reviewed, and two that do not. No statistical differences in review efficiency were found between these groups. The second sample was a historical comparison in which protocols from an IRB that initially did not invite PIs to attend review were compared to protocols from the same IRB after it had changed its policy to encourage PI attendance. This sample revealed that the protocols for which the PI attended were reviewed in fewer days and with fewer meetings. Further research is needed to explore whether PI attendance and other strategies may increase the efficiency of IRB review, and whether PI attendance may have other benefits besides efficiency that would make the investigator’s presence at review desirable. (shrink)

BackgroundCommunity engagement in research is valuable for instrumental and intrinsic reasons. Despite existing guidance on how to ensure meaningful CE, much of what it takes to achieve this goal differs across settings. Considering the emerging trend towards mandating CE in many research studies, this study aimed at documenting how CE is conceptualized and implemented, and then providing context-specific guidance on how researchers and research regulators in Uganda could think about and manage CE in research.MethodsWe conducted qualitative interviews and focus group (...) discussions involving forty-one respondents who were experienced in HIV/aids biomedical research involving CE. Thirty-eight of these were directly or indirectly associated with Uganda’s leading research institution in the field of HIV/aids. They included Principal Investigators, Community Liaisons Officers, Research Ethics Committee members and Community Advisory Board Members. Three respondents were from Uganda National Council for Science and Technology. Data were collected between August 2019 and August 2020, using audio-taped focus group discussions and key informant interviews, transcribed and analyzed manually to generate themes and subthemes.ResultsThree major themes emerged: goals or value of CE; the means of CE, and, the evaluation of CE. Goals or value of CE generated four subthemes representing the overarching goals of CE: Promote communities’ agency; Generate and sustain trust; Protect and promote communities’ rights and interests; and, Help studies optimize participation in the form of enrolment and retention of participants. What usually comes under the nomenclatures of methods, strategies, and approaches of CE, such as town-hall meetings, sports events, drama, and the like, should simply be understood as the means of CE, and it is not desirable to hold pre-conceived and fixed ideas about the best means to conduct CE in research since a lot depend on the context. Finally, the study found that despite CE’s critical importance, which suggests the need to track and evaluate it, CE is currently intermittently evaluated, and for inadequate motivations.ConclusionsExisting guidance on how to conduct robust CE in research is no substitute for creativity, flexibility, and reflexivity on the part of both researchers and research regulators. (shrink)

Post-abortion care research is increasingly being conducted in low- and middle-income countries to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma around abortion and (...) community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents’ right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance. (shrink)

Research ethics remains a cornerstone of the scientific enterprise as it defines the boundaries of responsible conduct of research. Our aim was to systematically identify, review and test online training courses in research ethics which could be considered most appropriate for future training at the University of Botswana. We used an evaluative tool that included both descriptive and evaluative criteria for assessing the strengths, weaknesses and appropriateness of 10 online research ethics courses which are publicly accessible. We then assembled Focus (...) Group Discussions to engage the UB community to select the best 2–3 online courses that are considered most suited for use in future training of research ethics at UB. Twenty respondents participated in three FGDs. Our findings show that there is limited research ethics training capacity in low resourced academic institutions like UB. Online training opportunities could be used to address this challenge. Our analysis reveal that out of the 10 online courses reviewed, CITI program, Family Health International, and Training and Resource in Research Ethics Evaluation have characteristics that would make them suitable for utilization in Botswana. We believe the findings from this case study will be of value to other similarly situated research institutions. (shrink)

ABSTRACT The amount of biomedical research being conducted around the world has greatly expanded over the past 15 years, with particularly large growth occurring in low- and middle-income countries. This increased focus on understanding and responding to disease burdens around the world has brought forth a desire to help LMIC institutions enhance their own capacity to conduct scientifically and ethically sound research. In support of these goals the Johns Hopkins-Fogarty African Bioethics Training Program has, for the past six years, partnered (...) with three research institutions in Africa to support research ethics capacity. Each partnership began with a baseline evaluation of institutional research ethics environments in order to properly tailor capacity strengthening activities and help direct limited institutional resources. Through the course of these partnerships we have learned several lessons regarding the evaluation process and the framework used to complete the assessments. We believe that these lessons are generalizable and will be useful for groups conducting such assessments in the future. (shrink)