Maria W. Merritt

Ancillary Care for Public Health Research in Developing Countries

Belsky and Richardson1 defined ancillary care as care needed by research participants but not necessary to ensure scientific validity, prevent study-related harms, or address study-related injuries and introduced a framework for evaluating ancillary care based on 2 questions.2 Does a participant’s need for care fall within the scope of the investigator’s responsibility for the participant’s health, as defined by aspects of health implicitly entrusted to the investigator through the participant’s consent to comply with research procedures? If so, what is the strength of the participant’s moral claim on the investigator to address that need? The strength of the claim is modulated by attributes of the participant-investigator relationship, such as depth of involvement, degree of participant’s vulnerability, and degree of participant’s dependence, together with limits on available resources.2 Dickert et al3 questioned the narrow limits of Belsky and Richardson’s definition of the investigator’s scope of responsibility and exposed the tensions between vulnerability, dependency, cost, and scientific objectives in assessing the strength of a potential ancillary care claim. Participants at a workshop also high-lighted the need for additional ethical guidelines to address ancillary care.4 They proposed 4 “guidance points” to help researchers and sponsors act on their ancillary care obligations—identifying a positive duty, planning for ancillary care, building partnerships, and making practical provisions.4 Although the contributions reviewed above move the discussion of ancillary care forward, they are constrained by 3 issues. First, by focusing on the ethics of researchers’ relationship to the individual participant, the discussion to date has yet to consider studies in which the primary unit of research interest is a group. Second, separate analyses of research-specific and context-specific factors might help stakeholders assess the strength of ancillary care claims more systematically. Third, an operational process is needed to help researchers and sponsors implement the proposed guidance points. The goal of this Commentary is to advance the discussion of ancillary care in developing countries addressing these 3 issues.

Community engagement and the human infrastructure of global health research

BackgroundBiomedical research is increasingly globalized with ever more research conducted in low and middle-income countries. This trend raises a host of ethical concerns and critiques. While community engagement (CE) has been proposed as an ethically important practice for global biomedical research, there is no agreement about what these practices contribute to the ethics of research, or when they are needed.DiscussionIn this paper, we propose an ethical framework for CE. The framework is grounded in the insight that relationships between the researcher and the community extend beyond the normal bounds of the researcher-research participant encounter and are the foundation of meaningful engagement. These relationships create an essential “human infrastructure” – a web of relationships between researchers and the stakeholder community—i.e., the diverse stakeholders who have interests in the conduct and/or outcomes of the research. Through these relationships, researchers are able to address three core ethical responsibilities: (1) identifying and managing non-obvious risks and benefits; (2) expanding respect beyond the individual to the stakeholder community; and (3) building legitimacy for the research project.SummaryBy recognizing the social and political context of biomedical research, CE offers a promising solution to many seemingly intractable challenges in global health research; however there are increasing concerns about what makes engagement meaningful. We have responded to those concerns by presenting an ethical framework for CE. This framework reflects our belief that the value of CE is realized through relationships between researchers and stakeholders, thereby advancing three distinct ethical goals. Clarity about the aims of researcher-stakeholder relationships helps to make engagement programs more meaningful, and contributes to greater clarity about when CE should be recommended or required.

Integrating ethics, health policy and health systems in low- and middle-income countries: case studies from Malaysia and Pakistan

Scientific progress is a significant basis for change in public-health policy and practice, but the field also invests in value-laden concepts and responds daily to sociopolitical, cultural and evaluative concerns. The concepts that drive much of public-health practice are shaped by the collective and individual mores that define social systems. This paper seeks to describe the ethics processes in play when public-health mechanisms are established in low- and middle-income countries, by focusing on two cases where ethics played a crucial role in producing positive institutional change in public-health policy. First, we introduce an overview of the relationship between ethics and public health; second, we provide a conceptual framework for the ethical analysis of health system events, noting how this approach might enhance the power of existing frameworks; and third, we demonstrate the interplay of these frameworks through the analysis of a programme to enhance road safety in Malaysia and an initiative to establish a national ethics committee in Pakistan. We conclude that, while ethics are gradually being integrated into public-health policy decisions in many developing health systems, ethical analysis is often implicit and undervalued. This paper highlights the need to analyse public-health decision-making from an ethical perspective.

Ethical Issues in mHealth Research Involving Persons Living with HIV/AIDS and Substance Abuse

We aim to raise awareness and stimulate dialogue among investigators and research ethics committees regarding ethical issues that arise specifically in the design and conduct of mHealth research involving persons living with HIV/AIDS and substance abuse. Following a brief background discussion of mHealth research in general, we offer a case example to illustrate the characteristics of mHealth research involving people living with HIV/AIDS and substance abuse. With reference to a well-established systematic general ethical framework for biomedical research with human participants, we identify a range of ethical issues that have particular salience for the protection of participants in mHealth research on HIV/AIDS and substance abuse.

A Field Training Guide for Human Subjects Research Ethics

Maria Merritt and colleagues report on a Field Training Guide for Human Subjects Research Ethics that they have developed to help train field workers in ethics for research.

Investing in Justice: Ethics, Evidence, and the Eradication Investment Cases for Lymphatic Filariasis and Onchocerciasis

It has been suggested that initiatives to eradicate specific communicable diseases need to be informed by eradication investment cases to assess the feasibility, costs, and consequences of eradication compared with elimination or control. A methodological challenge of eradication investment cases is how to account for the ethical importance of the benefits, burdens, and distributions thereof that are salient in peoples experiences of the diseases and related interventions but are not assessed in traditional approaches to health and economic evaluation. We have offered a method of ethical analysis grounded in theories of social justice. We have described the method and its philosophical rationale and illustrated its use in application to eradication investment cases for lymphatic filariasis and onchocerciasis, 2 neglected tropical diseases that are candidates for eradication.

Why We Need Community Engagement in Medical Research

Background The medical research enterprise depends on public recognition of its societal value. In light of evidence indicating public mistrust, especially among minorities, inadequate enrollment as well as diversity of research participants, and poor uptake of findings, medical research seems to fall short of sufficient public regard. Community engagement in medical research, with special attention to minority communities, may help to remedy this shortfall by demonstrating respect for the communities in practical ways. Approach We provided 3 case examples that illustrate how specific approaches to community-engaged research can build trust between researchers and communities, encourage participation among underrepresented groups, and enhance the relevance as well as the uptake of research findings. Discussion A common attribute of the specific approaches discussed here is that they enable the researchers to demonstrate respect by recognizing community values and interests. The demonstration of respect for the communities has intrinsic ethical importance. Conclusions The 2 potential outgrowths of demonstrating respect specifically through community engagement are (1) the production of research that is more relevant to the community and (2) the mitigation of asymmetry in the researcher-community relationship. We summarized practical resources available to researchers who seek to incorporate community engagement in their research.

The Ethics of Testing a Test: Randomized Trials of the Health Impact of Diagnostic Tests for Infectious Diseases

In the last decade, many new rapid diagnostic tests for infectious diseases have been developed. In general, these new tests are developed with the intent to optimize feasibility and population health, not accuracy alone. However, unlike drugs or vaccines, diagnostic tests are evaluated and licensed on the basis of accuracy, not health impact (eg, reduced morbidity or mortality). Thus, these tests are sometimes recommended or scaled up for purposes of improving population health without randomized evidence that they do so. We highlight the importance of randomized trials to evaluate the health impact of novel diagnostics and note that such trials raise distinctive ethical challenges of equipoise, equity, and informed consent. We discuss the distinction between equipoise for patient-important outcomes versus diagnostic accuracy, the equity implications of evaluating health impact of diagnostics under routine conditions, and the importance of offering reasonable choices for informed consent in diagnostic trials.

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials

Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for “human research subjects” under conventional research ethics regulations. To stimulate such work, we propose to distinguish among categories of research participants in pragmatic clinical trials as follows: Direct participants: (1) individuals being directly intervened upon and/or (2) individuals from whom personal identifiable data are being collected for the purposes of the pragmatic clinical trial. Indirect participants: individuals who are (1) not identified as direct participants and (2) whose rights and welfare may be affected by the intervention through their routine exposure to the environment in which the intervention is being deployed. Collateral participants: patient groups and other stakeholder communities who may be otherwise affected by the occurrence and findings of the pragmatic clinical trial. We illustrate these distinctions with case examples and discuss the distinctive responsibilities of researchers and pragmatic clinical trial leadership toward each type of participant. We suggest that pragmatic clinical trial investigators, institutional review boards, health systems leaders, and others engaged in the research enterprise work together to identify these participants. For indirect participants, risks and benefits to which they are exposed should be weighed to ensure that their rights and welfare are protected accordingly, and communication strategies should be considered to help them make well-informed decisions. Collateral participants could provide input on the design, planning, and conduct of a pragmatic clinical trial and offer insights regarding the best way to communicate the trial’s results to their constituencies.

Supporting those who go to fight ebola.

The Ebola epidemic is testing virtually every aspect of the public health and health care systems in the United States, including health care institutions’ public service commitments. Although the number of cases in the US remains very small, an extraordinary amount of public and hospital resources have been devoted to preparing for new cases domestically [1–4]. In contrast, although US hospital and medical professional organizations have called for an “enhanced focus” on containing Ebola in West Africa [5], there is a striking absence of public commitments on the part of US health care institutions to contribute to the containment effort. By quickly mobilizing qualified health care professionals (HCPs) to work in Guinea, Liberia, and Sierra Leone, US hospitals could not only meet the needs of desperate patients, but could contain Ebola at its source, averting global risk [6]. Yet, US institutions’ response to the West African epidemic has been muted thus far. Reports indicate that many institutions—even those with a tradition of sending personnel to respond to other humanitarian crises—have asked their HCPs to stay home this time [7–9]. Although some academic medical centers (AMCs) in the US have invoked their usual policy that the university will support overseas work with services such as emergency travel assistance, others have specified that staff who serve in Ebola-affected regions do so in their personal capacity, not as employees. Still others have strongly cautioned against serving, prohibited official travel to affected regions, required staff to take vacation time or unpaid leave for 21 days following repatriation before returning to work, and made clear that the university will not assist if the HCP falls ill. The concerns that may motivate hospitals to discourage volunteers do not outweigh the countervailing considerations. At a minimum, institutions ought not to impede service; ideally, they would promote it.