Chapter 9: Public Health Research

A common way to define research is on the basis of its goal to develop generalizable knowledge. For example, the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2002) defines research as “… a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principle s or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference.” Similarly, in the United States, research is defined as “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge ” (U.S. Department of Health and Human Services 2009).

In jurisdictions with legal requirements governing research activities, such as the United States, determining what is and is not research becomes critical. Sometimes, however, the line between research and practice-related activities is blurry. One way to identify if an activity is research is to look at intent. The primary intent of public health research is to yield generalizable knowledge. Key characteristics of public health research include (1) benefits beyond the needs of the study participants, (2) collection of data exceeding what is needed to care for study participants, and (3) generation of knowledge with relevance outside the population from which data were collected. In contrast, the primary intent of activities that constitute public health practice are to “… prevent or control disease or injury and improve health, or to improve a public health program or service …” (Centers for Disease Control and Prevention [CDC] 1999, 2010). Key characteristics of public health practice include (1) benefits that focus on activity participants, (2) collection of data needed to improve the activity or the health of the participants, and (3) generation of knowledge that does not go beyond the scope of the activity (CDC 1999, 2010).

Some researchers suggest that the difficulty in distinguishing public health research from public health practice emerges from a deeper conceptual issue relating to the impossibility of satisfactorily defining “research” and related categories (Fairchild and Bayer 2004). For example, public health surveillance might involve identical interventions and risks for public health research as for practice. This has led many public health professional s to call for reorienting ethical review around an activity’s level of risk, which applies to activities in both public health research and practice (Willison et al. 2014). Jurisdictions that do not yet have legal structures or have more flexibility to govern research activities than the United States might have an advantage. Whereas other jurisdictions might need to modify their approach to correlate ethical review with risk instead of on whether something falls under a slippery concept such as research.

Some potential research participants will always lack capacity to look after their own interests (e.g., children , people with dementia, the unconscious) and thus cannot provide consent. To protect people with diminished autonomy , informed consent is usually obtained from a parent , guardian, or legal representative. While it is clear that research participants with diminished capacity need extra protection, empirical evidence shows that even research participants with full cognitive capacity may not understand information presented as part of the consent process (Dawson 2009). For this reason, informed consent cannot be the only mechanism for protecting research participants. For instance, a research ethics committee can protect participants by assessing risks and benefits. Requiring approval by a research ethics com mittee might be considered a paternalistic judgment, but not an obviously wrong one (Garrard and Dawson 2005; Miller and Wertheimer 2007). Research ethics committees routinely consider waiving informed consent. This is true in public health research where the risk can be less than in biomedical research . Reliance on the judgments of research ethics committees presupposes that members have a high level of profession al trustworthiness and have the skills for ethical deliberation and analysis.

Cultural or social influences can challenge the ideal model of informed consent when conducting public health research. Marshall (2007) provides an excellent overview of challenges with obtaining informed consent, especially in resource-poor settings. These challenges include cultural and social factors that affect comprehension, communication of risks, and decisional authority for consent to do research. Language barriers and low literacy, mistaken beliefs about the benefits of participation , especially when access to health care is limited, and the need to communicate complex scientific information may reduce comprehension of study procedures, benefits, and risks. Marshall (2007) emphasizes the importance of engaging community leaders and soliciting and considering the opinions of community residents when identifying project goals and procedures and establishing consent processes. She notes that in many communities, relying solely on individual consent may not be culturally appropriate. In these situations, adding family or community consent is fitting.

Some research cannot be conducted if the standards of autonomous informed consent are always applied. A good example is emergency research when unconscious victims of head trauma may be randomized to different promising treatments, but the relative effectiveness of each treatment option is unknown. Some countries allow such research via waivers of informed consent if relevant conditions are met (e.g., minimal risk , and the research could not otherwise be carried out) (U.S. Department of Health and Human Services 2009). A public health research method for which it sometimes may be appropriate not to seek informed consent is the cluster randomized trial . By design, a cluster randomized trial compares interventions that target a group (i.e., social entity such as village or town, or a population). Various characteristics of these clusters are matched to ensure a robust comparison of interventions (including no intervention). In some cluster trials, obtaining individual informed consent can seem prohibitively expensive, damaging to a chieving study goals, or even impossible to attain (Sim and Dawson 2012; McRae et al. 2011b). Where consent is impossible to attain, is it right to require it at the expense of not doing the research? Attempts have been made to justify research without first attaining individual consent by appealing to an ethics committee for review, soliciting viewpoints from the community about whether the research is acceptable, or even seeking some form of community consent.

Dickert and Sugarman (2005) make a distinction between community consent and community consultation. Consent means seeking approval, whereas consultation means seeking ideas and opinions. They note, however, that this distinction gets blurred in practice, and that community consultation should not be approached as a box to check off without scrutinizing the input. They identify four ethical goals for any community consultation: enhanced protection, enhanced benefits, legitimacy, and shared responsibility. Adherence to these goals may ensure that risks are identified and protections put into place; that the research benefits not only the researchers, but also the participants and communities being studied; and that the legitimacy of the findings is increased. However, this does not constitute a direct parallel to the individual model of informed consent described previously. Community consent involves meeting with legitimate community representatives empowered to permit researchers to conduct studies involving community members (Weijer and Emanuel 2000; Dickert and Sugarman 2005). The involvement of community representatives in public health research is most clearly seen in community-based participatory research (CBPR) . In CBPR, authorities are involved at all levels of research—from initiation of ideas and projects through data collection, analysis and interpretation, and use of research findings to prompt community change (Flicker et al. 2007).

Research participants may encounter several types of risks. One obvious risk is physical harm, which may include discomfort, pain, or injury from interventions such as drug regimens or medical procedures. Another risk is psychological harm. Research participants may experience stress, anxiety , embarrassment, depression, or other negative emotions. These emotions, which can occur during or after participation in the research, are common in research involving sensitive topics such as sexual preferences or behavior. Social and economic harms are another type of risk. Participants in research that focuses on mental illness, illegal activities, and even certain diseases such as HIV may risk being labeled or stigmatized if precautions are not taken to provide adequate privacy and confidentially. A person’s economic status may be affected if cost s are incurred for participating (e.g., transportation expenses to and from the study site) or by loss of employment (present or future) if a breach of confidentiality occurs (e.g., an employer discovers an employee is being treated for substance abuse ).

One common problem—about which ethics guidelines are typically silent—is how we should conceptualize study participants (McRae et al. 2011a). Consider, for example, that cluster randomized designs and cohort studies commonly compare a group receiving active intervention with a parallel group receiving no intervention. Does the term “participant” apply to those receiving no intervention? This question has far-reaching consequences. If people who do not receive intervention count as participants, researchers may have obligations to them that otherwise would not exist. Another way to think about this is to identify who might be at increased risk, rather than who is a participant. For example, the U.S. National Bioethics Advisory Commission (NBAC) recommends that whenever researchers anticipate that risks will extend beyond study participants, researchers should try to minimize risks to nonpartic ipants (NBAC 2001).

The benefits of health research are any favorable or positive outcome received as a direct result of the research. Put simply, without the research, the outcome would not exist. Sometimes the benefits of health research extend beyond study participants to society; other times, however, research participants do not benefit. And in other instances, only a few participants might benefit. Researchers should thoroughly consider what to do in all these scenarios and how benefits could be provided to those in need. Sometimes research involves reimbursement, incentives, or other tangible goods. Although such items may be provided when someone agrees to participate in research, these items should not be considered benefits arising from the research procedures. In some contexts, such as prisons, offering anything in return for participation in research may be viewed as pressure to participate and therefore should be carefully considered.

The risks of research must be reasonable when compared to the anticipated benefits. This can be difficult to assess because risks will vary depending on the study population . For example, research procedures considered safe for healthy adults may be risky for adults with compromised health or for vulnerable populations such as children , pregnant woman, or seniors. Even if the potential benefits are the same, if the risks differ, the risk/benefit balance is affected. Another consideration for evaluating risks and benefits is the expected result of the research. A higher level of risk may be acceptable if the research can reasonably be expected to benefit the participants. If there is no expectation that the research participants will benefit, the same level of risk may be unacceptable.

Foreseeing the benefits and harms in a study can be challenging. Striking a balance between the two can be difficult and, at times, controversial. A good example of this is the discussion generated by a series of studies conducted in Baltimore that assessed different methods for reducing the exposure of children to lead paint in older rented properties (Mastroianni and Kahn 2002). In this case, the fact was already known that exposure of children to lead is dangerous. However, due to the high cost of removing lead-based paint (the known, best solution), the researchers assessed the effectiveness of cheaper, partial methods of abatement for reducing or even removing the risk of exposure. If found to be effective, these alternative methods would allow treatment of more homes at the same cost, potentially benefiting more children. Monitoring during the study found that some children in the alternative abatement options had elevated blood lead levels. Some health officials believe that the research should not have gone ahead because of this likelihood. Others think that the research was justified because the children were not exposed to any greater level of lead, and in most cases, significantly less than if the research had not been conducted. In other words, no child was put at greater risk through participation , and all children be nefited from blood monitoring. This study demonstrates the complexities of evaluating risks and benefits in public health research.

Despite such worries about protecting vulnerable populations, a strong To exclude vulnerable populations violates the spirit of the principle of justice , which requires fair distribution of risks and benefits of research. Inclusion of vulnerable populations may require accommodations to address the specific nature of the vulnerability; however, once these accommodations are in place, vulnerable people with the cognitive capacity to provide informed consent should exercise autonomous choice about their participation . For example, it seems arbitrary to exclude pregnant women from research as a matter of course rather than making a decision based on an assessment of risk levels, the ability to control risks , and the likelihood of direct benefit to the participant .

When and how should individual-level data, including incidental and secondary findings , be communicated to research participants? The primary argument for an ethical imperative to offer participants research findings, both summary and individual results, rests on the principle of respect for persons ; however, the principles of beneficence and justice are also frequently cited (Presidential Commission for the Study of Bioethical Issues 2013; Miller et al. 2008; Fernandez et al. 2003). The word “offer” is important because giving people the right to decline results is also an expression of respect for persons. The ethical justification for a “duty to disclose research results,” especially individual-level data, has been challenged due to the potential harms of disclosure (Miller et al. 2008). Miller and colleagues argue that the lack of consistent policy guidance for disclosures and the ambiguity about what to disclose undermines any generalized ethical duty to disclose. Clearly, before making a decision to return results, especially individual-level data, the potential benefits and harms from disclosure must be carefully assessed.

The research consent process should describe plans for returning results or provide an option for not receiving results. The consent process should explain the potential harms and benefits associated with receiving research results, the possible strengths and limitations of the results, and the options for follow-up and support if unanticipated consequences occur. If a decision is made to return results, careful considerations must be given to how the results will be returned (e.g., in person, over the telephone, through a letter), whether opt-in or opt-out procedures will be used, and when the results should be returned. Fernandez and colleagues (2003) argue that “research results should, in general, be delayed until the results are published or until they have undergone peer review and been accepted for publication.” This recommendation is based on the need to ensure the integrity of the interpretation of the data and to prevent disclosure of inaccurate information .

To illustrate the diversity of opinion about sharing research data, some researchers have taken the obligation for disclosure further by advocating that research participants be granted access to their raw data via a data repository before these data are analyzed (Lunshof et al. 2014). Lunshof and colleagues suggest that access to raw personal data would increase transparency, personal choice, and reciprocity. Further, such access could equalize the relationship between those who donate data and those who use data for research. However, this rather utopian view raises issues with potential breaches of confidentiality, so more discussion is needed. More discussion is also needed about participants increasingly sharing information about research studies through social media, which can result in breaches of confidentiality and further challenge the integrity of research (Lipset 2014).

Shrinking budgets for public health activities have led many health departments, even those in resource-rich countries, to explore alternative approaches to financing public health research, leading to questions about what constitutes an appropriate partnership and to concerns about real or perceived conflicts of interest. For example, should government s collaborate with vaccine manufacturers to research potential adverse effects of a vaccine? Should researchers collaborate with soda manufactures to study the association between sugar-sweetened beverages and obesity? The U.S. Institute of Medicine (IOM) Committee on Conflicts of Interest in Medical Research, Education, and Practice defines conflict of interest as “a relationship that may place primary interests (e.g., public well-being or research integrity) at risk of being improperly influenced by the secondary, personal interests of the relationship (e.g., financial, professional, or intellectual gains)” (IOM 2009). When Bes-Rastrollo and colleagues (2013) studied systematic reviews of the association between sugar-sweetened beverages and weight gain, they found instances where conflicts of interest influenced scientific findings. The systematic reviews that identified sponsorship or conflicts of interest with food or beverage companies were five times more likely to report “no positive association” between consumption of sugar-sweetened beverages and weight gain or obesity than the reviews that reported having no industry sponsorship or conflicts of interest. These findings point to the need for guidance on how to identify and avoid conflicts of interest with potential to influence outcomes of public health research, especially when the research shapes public policy (IOM 2014).

If the decision is made to conduct research during a public health emergency, some unique ethical concerns must be considered: the research should not detract resources and personnel from emergency response activities; research activities should be prioritized by highest social and scientific value; and, as people in an emergency are often affected physically and psychologically, and sometimes traumatized, they should be considered a vulnerable population (Jennings and Arras 2008; WHO 2015). At the very least during an emergency, keep in mind that some people may not be able to make reasoned, informed decisions to participate in the research. Consequently, adequate means of protection for participants must be in place. The procedures for an ethics committee review may need to be modified for disaster research projects (Lurie et al. 2013). Possible approaches for ensuring appropriate review include developing just-in-case protocols and establishing centralized or specialized ethics review committees that can approve disaster research protocols quickly (Médecins Sans Frontières 2013).

Collaborative international public health research offers the opportunity to build local capacity (Mayhew et al. 2008). However, such research raises a number of issues about researchers’ obligations and responsibilities . First is the responsibility to protect research participants from harm, an obligation recognized by all research ethics guidelines. This duty of protection is heightened when the research participants are from vulnerable populations (Hurst 2008), especially when they are recruited from extremely impoverished populations. Researchers’ responsibilities toward research participants also include ensuring that they benefit from the results of the research whenever possible. For example, the International Ethical Guidelines for Biomedical Research Involving Human Subjects directs that “any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community” (Council for International Organizations of Medical Sciences 2002, guideline 10). A second researcher responsibility is to support students and staff hired as part of the research project and to protect them from harm (Wilson 1992). This responsibility can be thought of both as the duty of an employer and the fiduciary duty of an academic supervisor and must extend to situations of whistleblowing. Third, researchers involved in collaborative research have a responsibility to colleagues and collaborators, especially given that research may play a crucial role in capacity building (Garcia and Curioso 2008). Although partnerships with local researchers have been touted as highly valuable (Costello and Zumla 2000), these ties may also result in unexpected ethical dilemmas for local researchers if conflicts arise between their research activities and their established local obligations and responsibilities (Richman et al. 2012). A fourth responsibility of researchers is dedication to the research enterprise. The conduct of public health research can have significant implications for the well-being of large segments of the population, but it requires the trust of the public and of relevant authorities. Endangering the relationship of trust in the context of one specific public health study may jeopardize or ruin other research initiatives (Corbie-Smith et al. 1999). Finally, a fifth responsibility of publicly funded researchers is their duty to the public in whose name they conduct research. Good stewardship requires that researchers strive to maximize the relevance and usefulness of their efforts and that they disseminate their findings (Arzberger et al. 2004). Researchers conducting collaborative international public health research may encounter ethically challenging conflicts among these five lines of responsibilit ies.

Timothy’s research consists of an examination of the impact of his country’s recent abolishment of health care user fees for children younger than 5 years. User fees had been implemented uniformly in the 1990s without special consideration for poorer families with young children. Initial indicators suggest that health care services continue to be underused in some districts, especially by poor children, despite the recent removal of user fees. Despite the limited uptake, the ministry of health touts the polic y abolishing user fees for children younger than 5 years as an important success. Timothy is conducting his study at several urban health centers, including the hospital from which he is currently on leave. The research project has received ethics approval from Milena’s institution and from the relevant local review boards.

Recently, Timothy r equested a meeting with Milena saying that he needed advice. He reports that he has identified a system of informal fees that undermines the ministry of health’s official policy by making health care once again too expensive for many families with young children. From what Timothy understands, the fees are levied primarily to fund better obstetric care locally, but some indicators point toward senior administrators keeping a small share for themselves. Timothy worries that making his findings public is too risky for him, especially since his involvement in this fieldwork is well-known. He does not think it possible to share his findings without identifying himself as the source of the information . His hospital is one of the sites where he has identified the system of informal payments. He also has good reasons to believe that some members of the ministry of health are already aware of the situation but have not taken action to address it. Disseminating his results will jeopardize his employment at the hospital, his relationships with government officials, and, potentially, the plans to improve obstetric care.

Milena is also conflicted. She recognizes that she has multiple roles, responsibilities, and interests, and that individual and communal goods are at stake. Identifying and seeking to address informal payment structures could improve accessibility of health care services for children, which is the primary goal of her research program. However, the team has responsibilities to Timothy as their student and colleague. Demanding that he upend his career, either for their benefit or for the improvement of health care accessibility , might fail to respect him as an individual. In addition, bringing the situation to light could embarrass the ministry of health. Because the research program depends on the ministry of health’s authorization, tensions in relationships could lead to premature termination of the research. Such an event would have unpredictable outcomes on the careers of everyone on the research team and on the future of health care acces sibility locally.

Family structures in the camp vary, ranging from matriarchal families, extended families, and traditional patriarchal families to even modern families where parent s jointly make decisions. These family structures also include complex formations where, for example, a remarried father lives with his new wife and stepchildren. In such complex families, children often have several guardians or authority figures. Sociocultural conceptions shared by parents and social workers stress the reliance of children on parental decisions—parents know what is best for children, while children know they must obey parental decisions.

In resource-poor settings like the camps, many nongovernmental organizations (NGOs) supplement UNRWA services, thereby gaining influence. The perceived power that the local Palestinian NGOs hold in the community derives from years of providing supplemental economic and social services to residents. Not surprisingly, if an NGO is politicized, it also will hold political power. In this context, if an NGO agrees to participate in a project, residents may agree to participate without paying close attention to the details or the scope of work. They participate either because they trust the NGO to decide on their behalf or because they want to avoid being perceived as opposing an organization that provides them with needed services. Similarly, international NGOs hold perceived power by providing essential services and distributing needed supplies, especially during emergencies. Universities can acquire such power, even unintentionally, not only from the prestige and status that educational institutions generally enjoy, but also from the potential benefits that research projects bring to the camps. Intentional or not, exercising such power can raise unanticipated problems for the research enterprise.

To p rotect research participants, some national and international commissions have published guidance documents about equitable distribution of benefits and respect for autonomy , beneficence , and social justice . These documents include the Nuremberg Code (1947), the Declaration of Helsinki (World Medical Association 1964), The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979), and the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Science 2002). Even though these international guidelines acknowledge the need to consider culture and community, they lack adequate guidance for community-based public health research (Racher 2007; Bledsoe and Hopson 2009). In addition, these guidelines are difficult to apply in nonbiomedical research contexts in community settings. This difficulty could be attributed to applying guideline s without first considering local contexts (Dawson and Kass 2005; Benatar 2002; Chilisa 2009). Many community-oriented practitioners find the principle s too limiting to guide public health research ethics in community settings and recommend incorporating broader conceptions of respect, trust , inclusion , diversity , participation , empowerment , and advocacy (Racher 2007; Bledsoe and Hopson 2009).

Biomedical guidelines often clash with community interactions, especially in the nonindustrialized world (Bledsoe and Hopson 2009; Matsumoto and Jones 2009; Chilisa 2009). One such clash occurs between individual-oriented societies and more collectivist societies that view personhood and individual decision making through the lens of a person’s relation to society (Marshall and Baten 2003). Another clash occurs between the artificially impersonal character of research environments and the centrality of relationships and partnerships in communities. Randomized clinical trials (RCTs), for example, require control of all possible confounders, a nearly impossible standard to achieve in close-knit and dense community settings (Makhoul et al. 2013). Implementing ethical guidelines in the context of power dynamics (Marshall and Baten 2004), like the pronounced power that males wield over females in patriarchal societies , can instigate numerous clashes. In communities like refugee camps that offer few economic or career opportunities, the perceived power that NGO s and, even more so, academic institutions wield is a force that must be taken into account. In such restricted settings, the power dynamics between researchers and research subjects can take on a subtle coercive character.

These same tensions, challenges, and dynamics will emerge in any efforts to obtain informed consent to participate in research. The emergence may stem from failure to appreciate the unique complexity of local familial, cultural, and political structures, or it may represent limitations in the principles being applied.

The goal of the intervention is to enhance positive mental health by increasing the social and life skills of young adolescents, who will be recruited through the schools. The six elementary schools have comparable resources and student profiles. Each school has been randomly assigned either to the intervention or to the control arm of the study, and only fifth and sixth graders will participate. Participating students in the intervention group will receive 45 extracurricular sessions of 1½ h each over 9 months and gain skills in solving problems, making decisions, building self-esteem, and enhancing relationships with peers, parent s, and teachers. Parents of the students in the intervention group will receive 15 1-h group sessions, and teachers in the intervention schools will be offered six workshops addressing the same topics. Students randomized to the control group will receive 10 sessions over the course of 9 months, but their parents will not participate in the program. However, because teachers often work in more than one camp school, some teachers at the control schools may participate in the intervention workshops. All participants in either the intervention or control condition must complete pre- and post-assessment questionnaires that measure mental health and social and life skills before and after the intervention and at 6 months follow-up.

Recruitment into the research project will unfold in phases. Toward the end of the school year preceding the intervention, parents will be invited to an informational session about the project that will take place in one of the camp schools. After the informational session, meetings will take place with individual families in their homes to recruit students entering grades 5 and 6. Some youth (ages 17–23 years) who live in the camp will receive training to become part of the recruitment team. These youth will visit the homes of all potential intervention and control participants to explain the study and to obtain parental consent . If the parents consent, students will be invited to the school for further discussion (to ensure confidentiality and autonomy of decision making). Once the study has been explained to them, they’ll be asked individually to give their assent .

You are a member of the university research team leading the effort to obtain informed consent. You would like to obtain consent and assent in accordance with standard international procedures, but you realize their application may need to be adjusted to the context of the camp. In particular, you have considered what role principle s such as trust , inclusion , diversity , and broad community participation should play in the research project. That is why you chose to have older youth from the camp obtain both parental consent and student’s assent, but you are concerned about potential problems that this approach may encounter. Also, given the power dynamics and conditions in the camp, you would like the research team to consider how this project can be used to spearhead a discussion with the community coalition about larger issues of empowerment and advocacy . With this in mind, you plan to address the followin g questions with your research team.

In TB-endemic areas of Africa, the volume and complexity of research have increased without a corresponding strengthening in the capacity of local RECs (WHO 2011). At least 190 RECs operate throughout Africa, but the quality and capacity of each vary widely (IJssemuiden et al. 2012). Although some RECs still lac k adequate research regulatory frameworks, the major challenge to strengthening capacity is lack of funding (Kass et al. 2007). This means, for example, that few, if any, African RECs have tools like electronic information management systems to coordinate submissions efficiently. It also means that few have trained REC administrators, a gap rightly identified as the missing link to improved quality and throughput of ethical review (IJsselmuiden et al. 2012). These factors can delay ethical reviews and create problems with quality and consistency (Milford et al. 2006; Kass et al. 2007). Whenever significant research funds are wasted on managing inefficient RECs, fewer funds are available to study ways to improve public health care services (Tully et al. 2000). This waste of resources on inefficient ethical review affects the timeliness of health services, which, in turn, affects subsequent health care polic y and decision making. Ironically, such wastefulness poses an unethical barrier to potentially beneficial public health research activities. Worse, these inefficiencies can cost research institutions a chance to compete for grants that require prior ethical review of research proposals by the country’s internal REC.

In Africa, external grants are often used to fund health research activities, whereas REC funding typically is either nonexistent or constrained by more pressing health care needs. Attempting to prioritize and allocate resources for activities with outcomes linked to funding puts policy makers in a dilemma . On the one hand, diverting funds from the immediate treatment of life-threatening diseases to a weak, inefficient REC can waste critical resources. On the other hand, not allocating funds to strengthen RECs can lead to the loss of external research funding, the very research that could reduce the burden of disease in the long run. Moreover, external funding, though filling a critical gap, often heightens the tensions at play in prioritizing between immediate needs for health care and long term needs for research and RECs.

In one country eligible for the grant, the ministry of health (MoH) encouraged its National Tuberculosis Research Centre to apply. The grant funding would have boosted the country’s long-term efforts to strengthen the capacity of its public health research by restructuring its TB treatment protocol. The Research Centre promptly submitted a proposal to the national REC, which levies 10 % of the grant as overhead to sustain the REC.

Despite the overhead funding, the country’s national REC l acks an administrator formally trained in research ethics and a robust ethics review structure. Although the REC receives more than 100 applications annually, it only meets every 3 months, often missing deadlines, because it cannot afford essential tools to coordinate submissions efficiently. To have a proposal reviewed; applicants have to submit 20 hard copies of the research application form and 10 copies of all other study materials. The review procedure typically forces the principal investigator of a clinical trial to submit nearly 20 kg of paper copies, a considerable sum in supplies and manpower. Despite its high profile, the TB Research Centre’s grant application does not prove to be an exception to the notoriously slow review process.

Professor Y, a highly capable public health specialist, directs the public health department in the local MoH. She also lectures at a local medical school, serves as Principal Investigator (PI) of an ongoing TB clinical trial in the country, and has extensive experience at all levels of REC activity and oversight. Unfortunately, Professor Y has never had formal training in research ethics, which is critical for anyone involved in managing REC activities. Because of her background, Professor Y became aware of the delays in reviewing the TB Research Centre’s application. Recognizing its importance to the country, Professor Y offered to serve as the primary reviewer for the proposal. Professor Y called an ad hoc REC meeting. At this meeting, the other members, who had only received copies of the grant application form to prepare for their review, unanimously agreed to outsource review of the protocol because they lacked the expertise to evaluate the application. Amid these delays, institutions in other countries competing for the same grant, having already received ethical clearance from their RECs, were awarded the grant. Not only did the delays cost the country a funding opportunity to enhance its public health research capacity, but preparing the application also wasted precious time and scarce resources.

In response to this bungled opportunity, the MoH set up a task force to analyse the situation and offer recommendations. In its report, the task force recommended allocating more resources to RECs to strengthen capacity. Due to budget constraints, the MoH had to divert the money allocated to RECs from the antiretroviral program. Meanwhile, the MoH recommended temporarily outsourcing all REC services to a U.S. based clinical research organization.

The challenge of reaching some populations has led many practitioners to consider innovative intervention methods that rely on technologies such as the Internet and mobile telephones. Public health profession als are using these technologies to deliver health education to vulnerable populations in big cities, small towns, and hard-to-reach rural areas. In particular, the past decade has seen more health communication efforts using the Internet to prevent HIV and sexually transmitted diseases (Bull et al. 2007, 2009; Rietmeijer and McFarlane 2009). Studies of interventions that use Internet chat rooms, online modules, and health intervention websites show promising results that bode well for the future of these technolo gies (Chiasson et al. 2009; Moskowitz et al. 2009).

Studies conducted with marginalized and vulnerable populations such as black men who have sex with men (MSM) can pose difficulties. On the technology front, many difficulties reflect the Internet’s relative novelty for conducting studies and the consequent lack of clarity in dealing with the rules, language, and norms of a virtual community culture compared with a traditional community culture (Loue and Pike 2010). On the allocation front, having limited resources usually implies that tailoring interventions to a specific group will mean forgoing benefits to another group. Still, in promoting the health of populations, public health professionals must strive to distribute resources fairly while responding to the specific needs of racial, ethnic, and cultural groups. These concurrent goals require maintaining a delicate balance between targeted and population interventions. On the ethics front, because some projects straddle the line between research and practice, public health profession als can become unsure about whether the ethical guideline s of research or of community work should govern their actions. They must bear in mind that trust , which is essential for conducting community-based participatory research , becomes more crucial when working with vulnerable populations, which tend to show a high degree of mistrust (Loue and Pike 2010). Those who study vulnerable populations need to negotiate community entry either by developing trust or by working closely with local practitioners and building upon established trust.

In the United States , the HIV/AIDS epidemic has hit the African-American population hardest, with black men accounting for 70 % of new HIV infections . Between 2006 and 2009, new HIV infections increased 48 % among black 13- to 24-year-old MSM (Centers for Disease Control and Prevention 2015); by 2009, 37 % of new HIV cases among black men were from black MSM. Given this high prevalence, before the end of 2015, the U.S. national HIV/AIDS strategy calls for a 20 % increase in the proportion of African Americans diagnosed with HIV who have an undetectable viral load (Office of National AIDS Policy 2012). Already, information about HIV issues affecting young MSM (Mustanski et al. 2011) is widely available on the Internet, including messages about how to reduce risk (Hightow-Weidman et al. 2011) and interventions to prevent HIV risk behaviors among MSM (Rhodes et al. 2010) and blacks who inject drugs (Washington and Thomas 2010). Studies show that online delivery of HIV counseling and behavioral interventions for MSM at high risk for HIV are successful, suggesting that the future holds great promise for Internet-delivered interventions for this vulnerable population (Chiasson et al. 2009; Moskowitz et al. 2009).

Project participants will be recruited via the Internet in gay chat rooms and be verified electronically by using Internet Protocol and Microsoft Access usernames and passwords (Bull 2011). Participants will be surveyed before they begin the training modules and again at 1- and 6-week intervals after completing the modules. Participants will be randomly assigned to control and experimental arms. Those in the control arm will receive 6 h of online training about health and well-being (e.g., nutrition, physical activity, stress reduction). The experimental arm will receive a 6-h online program including two 1-h modules on each of the following topics: (a) HIV/AIDS-related knowledge; (b) development and improvement of safe sex skills, such as partner communication and monogamous sexual relationships; and (c) self-efficacy in using condoms. The modules will include automated reminders for HIV testing . The study will measure improved knowledge on HIV/AIDS , partner communication about safer sex, and condom usage self-efficacy. Data will be analyzed using statistical software.

Dr. Albert thinks the results could be generalized not only to black MSM in the community but also to black MSM overall. He plans to write an article describing the results for publication in a scientific journal. Although Dr. Baines knows the impact of education on health, especially in underprivileged communities, she wants to educate only a subset of the community they will reach. Besides, since their work is for a public health agency, she believes the intervention ought to reach as many community members possible. She claims the project’s goal is to provide a vulnerable and disadvantaged population with much needed education on health matters and health-promoting behavior and doubts their project constitutes research.

Dr. Albert worries that, because his colleague lacks academic rigor and underappreciates the role of evidence, she fails to appreciate the project’s rationale and design and, as a result, is indifferent to the challenges the Internet poses (e.g., technology-induced bias, protection of confidentiality). Conversely, Dr. Baines believes Dr. Albert has missed the boat and is wasting resources, spuriously introducing statistical analysis of experimental and control arms into what the agency clearly had intended as an education intervention.