Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards

National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of “knowledge production” is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more suitable for CBPR, and we propose alternative questions and procedures that may be utilized when assessing the ethical appropriateness of CBPR. Flicker is with the Faculty of Environmental Studies, York University, Toronto, Canada; Travers is with the Ontario HIV Treatment Network, Toronto, Canada; Guta is with the University of Toronto, Toronto, Canada; McDonald is with the Community Based Research Resource Centre, Wellesley Institute, Toronto, Canada; Meagher is with the Mental Health Community Advisory Panel, St. Michael’s Hospital. Toronto, Canada.     

Understanding the barriers to cervical cancer screening among older women

Despite the fact that 90% of cervical cancers can be prevented by regular Pap screening, many women are not screened regularly, particularly older women. To understand better the barriers to screening, the authors held five focus groups during April 2000 in Prince Edward Island (PEI), Canada. Of the 32% of women aged 45 to 70 who had not been screened over a 5-year period (1995-2000), 60 randomly selected women participated in this research. The authors analyzed discussions for themes using an inductive approach, with interpretation guided by the population health model. Women who have avoided a Pap test are falling between the cracks created by a complex interaction between personal experiences and the health system's approach to Pap screening.     

What determines health? To where should we shift resources? : Attitudes towards the determinants of health among multiple stakeholder groups in Prince Edward Island, Canada

The population health perspective has become significant in academic and policy discourse. The purpose of this paper is to assess its significance among health care practitioners and administrators as well as the general public. Respondents in Prince Edward Island, Canada were asked to rank the broad determinants of health and comment on to where resources should be shifted to improve the health of the population. Important variations are noted between the groups with family physicians and front-line staff being similar in perceptions to the general public on most determinants than other groups. The paper concludes with discussion on the relevance of the findings for population health research and health policy.     

A minimal prevalence study of diagnosed diabetes in Newfoundland and Labrador

A two-stage random probability sampling survey of the medical charts of family physicians in Newfoundland and Labrador was done; the first stage sampled physicians randomly, in proportion to the 5 health districts of the province; the second stage took a quota sample of the physicians' charts. The survey revealed a total population minimal prevalence rate of diagnosed diabetics of 3.55% (95% confidence limits 2.55, 4.55). This rate is higher than that found in the only other provincial survey done in Canada (the Prince Edward Island survey). Of diagnosed diabetics, 40% were found to be using insulin. This proportion is higher than other rates in North America. The prevalence rate was slightly higher in males (3.7%) than in females (3.4%).     

Nutritional concerns in aboriginal children are similar to those in non-aboriginal children in Prince Edward Island, Canada

OBJECTIVE: To assess food consumption among aboriginal children living on Mi'kmaq reserves in Prince Edward Island, Canada. DESIGN: Data were collected as part of a larger study of health perceptions and behaviors in Mi'kmaq children and youth ages 1 to 18 years. Food consumption was assessed using a self-administered food frequency questionnaire during an in-home interview. SUBJECTS/SETTING: Fifty-five children living on a reserve (53% of total population) ages 9 to 18 years. STATISTICAL ANALYSES PERFORMED: The number of servings of milk products, vegetables and fruit, and snack foods/beverages was calculated by adding the responses to the frequency of consumption of foods assessed in each group. chi(2) analysis was used to assess differences in food consumption according to sex and age. RESULTS: Only one child reported consuming the recommended minimum of five vegetables and fruit daily (Canada's Food Guide to Healthy Eating, 1992) (mean [+/-standard deviation]=2.8+/-1.1 servings). Twenty-five (49%) of the children consumed three or more servings of milk products daily (mean=2.6+/-1.3 servings). Approximately half of the children had three or more snack foods/beverages daily (mean=3.1+/-2.2 servings). Younger children (grades 4 to 6) consumed more cereal, peanut butter, and yogurt than older children. There were no significant differences in food consumption between boys and girls. CONCLUSIONS: Our findings are consistent with past reports in aboriginal children. However, except for higher consumption of french fries, results are similar to recent surveys of other Prince Edward Island school children, suggesting a province-wide rather than cultural health issue.     

Knowledge translation case study: a rural community collaborates with researchers to investigate health issues

INTRODUCTION: Knowledge translation implies the exchange and synthesis of knowledge between researchers and research users, employing a high level of communication and participation, not only to share the knowledge found through research, but also to implement subsequent strategies. Prince Edward Island, a rural province in Canada, provided the setting to exchange knowledge between researchers and a rural community on the health issues affecting children. METHODS: A case study reports census data, demographic trends, and information about health issues immediate to the community. These focus groups were held to plan solutions to the community's health priorities. The process was participatory, characterized by community involvement. RESULTS: Those participating in the focus groups were interested in research findings and literature to solve local problems. Parenting and mental health were determined to be priority issues requiring broader community engagement. The process of translating knowledge into action after the focus groups met lacked widespread involvement of the community. DISCUSSION: Although encouraged to do so, the larger rural community did not participate in examining research findings or in planning interventions. The parents in this community may not have perceived themselves as having influence in the process or goals of the project.     

Information disclosure in population-based research involving genetics: a framework for the practice of ethics in epidemiology

PURPOSE: The completion of the Human Genome Project has resulted in increased epidemiological research to identify genes and their products as risk factors for adverse health events. A parallel increase in ethical issues associated with genetic research is noted. One such issue is whether or not epidemiologists should disclose individual genetic results to research participants. Existing ethical guidelines and frameworks are not helpful for determining whether disclosure is the moral choice. The purpose of this paper was to develop a framework for use by epidemiologists, research ethics boards, and institutional review boards during the protocol development stage to ethically address the dilemma regarding disclosure of individual genetic information. METHODS: The core principles of research ethics were introduced and applied to the issues surrounding disclosure of genetic information. A principle-based framework was developed through analysis of the current ethical arguments for and against disclosure. Finally, examples demonstrating the use of the framework were provided. CONCLUSION: The proposed framework will not solve all ethical dilemmas related to individual disclosure of genetic information. It is, however, a useful starting point to facilitate the consideration process.     

Toward an ethic of empowerment for health promotion

This paper lays out a conceptual framework for articulatingsome main ethical issues raised by health promotion and illnessprevention. Building from the concept of ‘enabling’in the Ottawa Charter, the paper articulates and advocates an‘ethic of empowerment’ for health promotion. If health promotion is understood in terms of enabling, thetired ethical debates between freedom and responsibility, orindividual and community, are recast in a new and more productivelight. Health promotion should resist the temptations of eithera coercive, paternalistic ethic or an individualistic, laissez-faireethic in favour of an ethic of enabling or empowerment.     

Ethical considerations for effective health human resources planning and management

This paper maps out some of the ethical issues associated with effective Health Human Resources (HHR) planning and management. The key HHR topics of ethical recruitment and retention are highlighted drawing upon an ethics framework that emphasizes the principle of transnational justice. The key take-home messages are as follows: (1) ethical recruitment of health workers from other jurisdictions needs to acknowledge the effect their recruitment has on the region, province, or country they leave behind and (2) an ethical approach to HHR management requires more attention be paid to deploying existing domestic HHR to their full scope. This would include but not be limited to non-practising internationally educated health professionals already in Canada.     

Canadian-trained nurses in North Carolina

Little is known about nurses who leave Canada to work in the US. The main purpose of this study is to gain some insight into the emigration component of nursing supply and demand by comparing characteristics of nurses who left Canada to nurses who stayed. Specifically, Canadian-trained RNs who work in the state of North Carolina are compared to RNs who work in Canada. Results show that there are 40% more Canadian-trained RNs in North Carolina than there are in Prince Edward Island. A higher percentage of Canadian-trained RNs in North Carolina are male, under 40 years of age, have baccalaureate training and graduated less than 10 years ago. Canadian-trained nurses in both countries have very low rates of unemployment. The loss of Canadian-trained RNs to the US is a significant problem, and there is an urgent need to obtain a better understanding of why nurses leave the country.     

The ethics of health systems research in low- and middle-income countries: A call to action

The increasing conduct of health systems research (HSR) in low- and middle-income countries (LMICs) has not been matched by concurrent work to clarify the field's ethical dimensions. To begin to address this gap, a two-day workshop on the ethics of HSR in LMICs was convened at Johns Hopkins University in June 2013. Participants included health systems researchers, philosophers, lawyers, bioethicists and institutional review board members from Botswana, Uganda, the UK, USA and Zambia. Based on discussions from the workshop, the paper affirms that, while HSR in LMICs raises ethical issues in relation to constructs (i.e. consent, risk, equipoise) common to international clinical research, the nature of the issues that arise often differ between the two fields. Three salient features of HSR and the ethical considerations associated with each of them in LMICs are described to demonstrate this point. Recommendations for institutional review boards’ oversight of HSR in LMICs are presented. Finally, a call is made for further action to develop thinking and guidance around the ethics of HSR in resource-poor settings.     

Agricultural contamination of groundwater as a possible risk factor for growth restriction or prematurity

Agricultural activity on Prince Edward Island poses a potential hazard to groundwater, which is the sole source of drinking water on the island. This study investigates the potential impact of groundwater nitrate exposure on prematurity and intrauterine growth restriction on Prince Edward Island. A total of 210 intrauterine growth restriction cases, 336 premature births, and 4098 controls were abstracted from a database of all Island births. An ecological measure of groundwater nitrate level was used to gauge potential exposure to agriculturally contaminated drinking water. The higher nitrate exposure categories were positively associated with intrauterine growth restriction and prematurity, and significant dose-response trends were seen, even after adjustment for several important covariates. Nevertheless, these risks must be interpreted cautiously because of the ecological nature of this exposure metric. An investigation using nitrate levels for individual study subjects is needed to confirm this association.     

Network of Ethical Relationships model for global North–South population health research

Although a substantial body of literature exists that details how to address ethical issues and provide oversight for traditional research study designs, there currently is very little guidance available to researchers on how to deal with the unique and novel challenges that arise when conducting research that goes outside of these well-defined boundaries. One such example is North–South (N-S) team-based global population health (GPH) research. This paper presents a Network of Ethical Relationships (NER) model which can allow GPH researchers better understand and resolve ethical issues that arise in N-S collaborative research efforts. The NER model elucidates some of the core relationships involved in GPH research and sheds light on the complex milieu of moral, institutional, societal and legal processes in which it is embedded. The utility of the NER model is examined by reviewing 14 GPH research teams, looking at two relationships in more detail – Researcher–Ethics Board, and Researcher–Funder relationships. The paper argues that improved dialogue and flexibility in the application of formal ethical rules and procedures can lead to research being conducted in a more ethical manner since it better accounts for the multitude of voices and perspectives influencing researchers’ choices and actions.     

Measured weights in PEI adults reveal higher than expected obesity rates

BACKGROUND: The increasing prevalence of obesity and overweight in Canada is a significant health concern. Unfortunately, we know very little about the actual weight status and associated health risks in our population since most surveys use only self-reported body weights and heights and typically do not include a measure of body fat distribution. This paper summarizes the findings of the Prince Edward Island Nutrition Survey. METHODS: A random sample of 1,995 adults aged 18-74 were interviewed in their homes and weights, heights and waist circumference measurements were obtained. Relative health risks, population proportions and their corresponding 95% confidence intervals were calculated. RESULTS: Overall, almost one third of PEI adults are obese (BMI > or = 30). This is almost double that reported in the 1995 National Population Health Survey using self-reported heights and weights. More women were classified as being very severely obese (Class III) than men, but for both men and women there appears to be a trend of increased mild obesity with age. Based on BMI and waist circumference, over one third of the population is considered to be at high to extremely high risk for health problems. CONCLUSION: Self-reported height and weight data appear to result in significant underestimation of the problem of obesity. Given the serious health consequences associated with this condition, it is critical that measured heights and weights be collected in future population-based surveys to ensure that public health interventions are based on accurate prevalence data.     

Supplementing the traditional institutional review board with an environmental health and community review board

BACKGROUND: Community-based research often involves additional ethical, legal, and social considerations beyond those of the specific individuals involved in the study. The traditional institutional review board (IRB) typically focuses on protecting the rights and ensuring the safety of the individuals involved. For projects involving community members, IRBs should be more sensitive to issues related to the broader community concerns. OBJECTIVES: The objective of this article is to discuss the concept of community-based participatory research and the shortcomings of the traditional IRBs in dealing with ethical issues associated with broader community concerns such as implications for family members, neighborhood groups, and local businesses. I examine the rationale and benefits for expanding the roles and responsibilities of review boards related to community-based issues. DISCUSSION: I propose the development of environmental health and community review boards (EHCRBs) that combine the fundamental responsibilities and ethical concept of the traditional review boards with an expanded ethical construct of dignity, veracity, sustainability, and justice, with an added emphasis on community. CONCLUSIONS: Only by acknowledging the needs of and working with the community can we ensure ethically based and socially responsible research. An EHCRB will allow researchers and community members to more fully address their mutual interest in conducting scientific, ethical, and socially responsible research.     

Breast cancer risk, fungicide exposure and CYP1A1*2A gene-environment interactions in a province-wide case control study in Prince Edward Island, Canada

Scientific certainty regarding environmental toxin-related etiologies of breast cancer, particularly among women with genetic polymorphisms in estrogen metabolizing enzymes, is lacking. Fungicides have been recognized for their carcinogenic potential, yet there is a paucity of epidemiological studies examining the health risks of these agents. The association between agricultural fungicide exposure and breast cancer risk was examined in a secondary analysis of a province-wide breast cancer case-control study in Prince Edward Island (PEI) Canada. Specific objectives were: (1) to derive and examine the level of association between estimated fungicide exposures, and breast cancer risk among women in PEI; and (2) to assess the potential for gene-environment interactions between fungicide exposure and a CYP1A1 polymorphism in cases versus controls. After 1:3 matching of 207 cases to 621 controls by age, family history of breast cancer and menopausal status, fungicide exposure was not significantly associated with an increased risk of breast cancer (OR = 0.74; 95% CI: 0.46-1.17). Moreover, no statistically significant interactions between fungicide exposure and CYP1A1*2A were observed. Gene-environment interactions were identified. Though interpretations of findings are challenged by uncertainty of exposure assignment and small sample sizes, this study does provide grounds for further research.     

Research as intervention in heart health promotion

BACKGROUND: Capacity building in health promotion has traditionally involved training interventions to support knowledge, skill and resource building for effective practice. However, there is a need to understand how research can be used to support capacity building and practice. METHODS: Findings are based on a parallel case study comprising qualitative analysis of 66 key informant interviews from five provincial heart health projects (Manitoba, Prince Edward Island, Ontario, Saskatchewan, and Newfoundland and Labrador) as part of the Canadian Heart Health Dissemination Project. FINDINGS: Results indicate research was used primarily to monitor and report results about health promotion capacity and dissemination to stakeholders, and contribute to participatory processes. Respondents noted that research as intervention had an influence on five areas of health promotion capacity and practice: increased heart health promotion knowledge/skills; improved programming, planning and prioritizing; increased motivation for (heart) health promotion initiatives; and cultivation of relationships as well as buy-in. INTERPRETATION: Research was a complementary capacity-building activity, although it did not directly increase program implementation. These findings contribute to linking researchers, practitioners and community decision-makers in the process of enhancing health promotion practice.     

The relationship between school-based smoking policies and prevention programs on smoking behavior among grade 12 students in Prince Edward Island: a multilevel analysis

PURPOSE: To examine how school-based smoking policies and prevention programs are associated with occasional and regular smoking among a cohort of grade 12 students in Prince Edward Island, Canada, between 1999 and 2001. METHODS: Data from the Tobacco Module of the School Health Action, Planning and Evaluation System (SHAPES) collected from 3,965 grade 12 students in 10 high schools were examined using multi-level regression analysis. RESULTS: Attending a school with smoking prevention programming was associated with a decreased risk of being an occasional smoker (OR 0.42, 95% CI: 0.18, 0.97). School-based policies banning smoking on school property were associated with a small increased risk of occasional smoking (OR 1.06, 95% CI: 0.67, 1.68) among some students. The combination of both policies and programs was not associated with either occasional or regular smoking. CONCLUSION: This preliminary evidence suggests that tailored school-based prevention programming may be effective at reducing smoking uptake; however, school smoking policies and the combination of programs and policies were relatively ineffective. These findings suggest that a new approach to school-based tobacco use prevention may be required.     

Advanced training in biomedical ethics: a curriculum in clinical specialty programmes

Summary. Medical ethics play an essential role in the practice of medicine, in the care of individual patients, in the allocation of health care resources, and in the formulation of health care policy. A specific body of knowledge, ‘biomedical ethics’, has developed which applies ethical theory to biomedical practice. This has provided doctors with tools systematically to integrate rational ethical analysis into clinical decision-making. Training in the discipline of biomedical ethics is now required for all doctors in Canada. The goals, content areas, learning objectives, and learning methods considered appropriate for advanced training in this field for medical specialists are provided in this paper. Six topic areas are discussed: introduction to ethical theory, clinical ethics, professional ethics, ethics of human experimentation, ethics of health policy, and independent study. Ways this curriculum could be organized and evaluated are also offered.