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The potential exploitation of research participants in high income countries who lack access to health care.

ABSTRACT: There are millions of individuals living in North America and the European Union who lack access to healthcare services. When these individuals participate in research, they are at increased risk of being exposed to the risks and burdens of clinical trials without realizing the benefits that result from them. The mechanisms that have been proposed to ensure that research participants in low- and middle-income countries are not exploited are unlikely to protect participants in high-income countries. The present manuscript argues that one way to address concerns about exploitation in high-income countries would be to require sponsors to provide targeted benefits such as medical treatment during the trial, or the study drug after the trial. The latter could be achieved through extension studies, expanded access programs, or named-patient programs. Sponsors also might provide non-medical benefits, such as education or social support. Ethical and regulatory guidance should be revised to ensure that research participants in high-income countries who lack access to healthcare services receive sufficient benefits.

SUBMITTER: Dal-Re R

PROVIDER: S-EPMC4834591 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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The potential exploitation of research participants in high income countries who lack access to health care.

Dal-Ré Rafael R Rid Annette A Emanuel Ezekiel E Wendler David D

British journal of clinical pharmacology 20160229 5

There are millions of individuals living in North America and the European Union who lack access to healthcare services. When these individuals participate in research, they are at increased risk of being exposed to the risks and burdens of clinical trials without realizing the benefits that result from them. The mechanisms that have been proposed to ensure that research participants in low- and middle-income countries are not exploited are unlikely to protect participants in high-income countri ...[more]

PMID: 26743927

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Project description:Background Universal access to family planning services is a well-recognized human right and several countries and organizations are committed to this goal. Our objective was to identify countries who improved family planning coverage in the last 40 years and investigate which contexts enabled those advances. Methods Analyses were based on data from publicly available national health surveys carried out since 1986 in Egypt, Ethiopia, Rwanda, Afghanistan, Brazil, and Ecuador, selected based on previous evidence. We estimated demand for family planning satisfied with modern methods (mDFPS) for each country and explored inequalities in terms of wealth, women's education, and women's age. We also explored contextual differences in terms of women's empowerment, percentage of population living in extreme poverty, and share of each type of contraceptive. To better understand political and sociocultural contexts, country case studies were included, based on literature review. Results Patterns of mDFPS increase were distinct in the selected countries. Current level of mDFPS coverage ranged between 94% in Brazil and 38% in Afghanistan. All countries experienced an important reduction in both gender inequality and extreme poverty. According to the share of each type of contraceptive, most countries presented higher use of short-acting reversible methods. Exceptions were Ecuador, where the most used method is sterilization, and Egypt, which presented higher use of long-acting reversible methods. In the first years analyzed, all countries presented huge gaps in coverage according to wealth, women's education and women's age. All countries managed to increase coverage over recent years, especially among women from the more disadvantaged groups. Conclusions Family planning coverage increased along with reductions in poverty and gender inequality, with substantial increases in coverage among the most disadvantaged in recent years. Policies involving primary health care services, provision of various methods, and high quality training of health providers are crucial to increase coverage.

Project description:BackgroundGaps continue to exist between research-based evidence and clinical practice. We surveyed health care providers in 10 low- and middle-income countries about their use of research-based evidence and examined factors that may facilitate or impede such use.MethodsWe surveyed 1499 health care providers practising in one of four areas relevant to the Millennium Development Goals (prevention of malaria, care of women seeking contraception, care of children with diarrhea and care of patients with tuberculosis) in each of China, Ghana, India, Iran, Kazakhstan, Laos, Mexico, Pakistan, Senegal and Tanzania.ResultsThe proportion of respondents who reported that research was likely to change their clinical practice if performed and published in their own country (84.6% and 86.0% respectively) was higher than the proportion who reported the same about research and publications from their region (66.4% and 63.1%) or from high-income countries (55.8% and 55.5%). Respondents who were most likely to report that the use of research-based evidence led to changes in their practice included those who reported using clinical practice guidelines in paper format (odds ratio [OR] 1.54, 95% confidence interval [CI] 1.03-2.28), using scientific journals from their own country in paper format (OR 1.70, 95% CI 1.26-2.28), viewing the quality of research performed in their country as above average or excellent (OR 1.93, 95% CI 1.16-3.22); trusting systematic reviews of randomized controlled trials (OR 1.59, 95% CI 1.08-2.35); and having easy access to the Internet (OR 1.90, 95% CI 1.19-3.02).InterpretationLocally conducted or published research has played an important role in changing the professional practice of health care providers surveyed in low- and middle-income countries. Increased investments in local research, or at least in locally adapted publications of research-based evidence from other settings, are therefore needed. Although access to the Internet was viewed as a significant factor in whether research-based evidence led to concrete changes in practice, few respondents reported having easy access to the Internet. Therefore, efforts to improve Internet access in clinical settings need to be accelerated.

Project description:BackgroundInjuries represent a vast and relatively neglected burden of disease affecting low- and middle-income countries (LMICs). While many health systems underperform in treating injured patients, most assessments have not considered the whole system. We integrated findings from 9 methods using a 3 delays approach (delays in seeking, reaching, or receiving care) to prioritise important trauma care health system barriers in Karonga, Northern Malawi, and exemplify a holistic health system assessment approach applicable in comparable settings.Methods and findingsTo provide multiple perspectives on each conceptual delay and include data from community-based and facility-based sources, we used 9 methods to examine the injury care health system. The methods were (1) household survey; (2) verbal autopsy analysis; (3) community focus group discussions (FGDs); (4) community photovoice; (5) facility care-pathway process mapping and elucidation of barriers following injury; (6) facility healthcare worker survey; (7) facility assessment survey; (8) clinical vignettes for care process quality assessment of facility-based healthcare workers; and (9) geographic information system (GIS) analysis. Empirical data collection took place in Karonga, Northern Malawi, between July 2019 and February 2020. We used a convergent parallel study design concurrently conducting all data collection before subsequently integrating results for interpretation. For each delay, a matrix was created to juxtapose method-specific data relevant to each barrier identified as driving delays to injury care. Using a consensus approach, we graded the evidence from each method as to whether an identified barrier was important within the health system. We identified 26 barriers to access timely quality injury care evidenced by at least 3 of the 9 study methods. There were 10 barriers at delay 1, 6 at delay 2, and 10 at delay 3. We found that the barriers "cost," "transport," and "physical resources" had the most methods providing strong evidence they were important health system barriers within delays 1 (seeking care), 2 (reaching care), and 3 (receiving care), respectively. Facility process mapping provided evidence for the greatest number of barriers-25 of 26 within the integrated analysis. There were some barriers with notable divergent findings between the community- and facility-based methods, as well as among different community- and facility-based methods, which are discussed. The main limitation of our study is that the framework for grading evidence strength for important health system barriers across the 9 studies was done by author-derived consensus; other researchers might have created a different framework.ConclusionsBy integrating 9 different methods, including qualitative, quantitative, community-, patient-, and healthcare worker-derived data sources, we gained a rich insight into the functioning of this health system's ability to provide injury care. This approach allowed more holistic appraisal of this health system's issues by establishing convergence of evidence across the diverse methods used that the barriers of cost, transport, and physical resources were the most important health system barriers driving delays to seeking, reaching, and receiving injury care, respectively. This offers direction and confidence, over and above that derived from single methodology studies, for prioritising barriers to address through health service development and policy.

Project description:Strengthening research capacity in low- and middle-income countries is one of the most effective ways of advancing their health and development but the complexity and heterogeneity of health research capacity strengthening (RCS) initiatives means it is difficult to evaluate their effectiveness. Our study aimed to enhance understanding about these difficulties and to make recommendations about how to make health RCS evaluations more effective. Through discussions and surveys of health RCS funders, including the ESSENCE on Health Research initiative, we identified themes that were important to health RCS funders and used these to guide a systematic analysis of their evaluation reports. Eighteen reports, produced between 2000 and 2013, representing 12 evaluations, were purposefully selected from 54 reports provided by the funders to provide maximum variety. Text from the reports was extracted independently by two authors against a pre-designed framework. Information about the health RCS approaches, tensions and suggested solutions was re-constructed into a narrative. Throughout the process contacts in the health RCS funder agencies were involved in helping us to validate and interpret our results. The focus of the health RCS evaluations ranged from individuals and institutions to national, regional and global levels. Our analysis identified tensions around how much stakeholders should participate in an evaluation, the appropriate balance between measuring and learning and between a focus on short-term processes vs longer-term impact and sustainability. Suggested solutions to these tensions included early and ongoing stakeholder engagement in planning and evaluating health RCS, modelling of impact pathways and rapid assimilation of lessons learned for continuous improvement of decision making and programming. The use of developmental approaches could improve health RCS evaluations by addressing common tensions and promoting sustainability. Sharing learning about how to do robust and useful health RCS evaluations should happen alongside, not after, health RCS efforts.

Project description:BackgroundIdentifying determinants of health and understanding their role in health production constitutes an important research theme. We aimed to document the state of recent multi-country research on this theme in the literature.MethodsWe followed the PRISMA-ScR guidelines to systematically identify, triage and review literature (January 2013-July 2019). We searched for studies that performed cross-national statistical analyses aiming to evaluate the impact of one or more aggregate level determinants on one or more general population health outcomes in high-income countries. To assess in which combinations and to what extent individual (or thematically linked) determinants had been studied together, we performed multidimensional scaling and cluster analysis.ResultsSixty studies were selected, out of an original yield of 3686. Life-expectancy and overall mortality were the most widely used population health indicators, while determinants came from the areas of healthcare, culture, politics, socio-economics, environment, labor, fertility, demographics, life-style, and psychology. The family of regression models was the predominant statistical approach. Results from our multidimensional scaling showed that a relatively tight core of determinants have received much attention, as main covariates of interest or controls, whereas the majority of other determinants were studied in very limited contexts. We consider findings from these studies regarding the importance of any given health determinant inconclusive at present. Across a multitude of model specifications, different country samples, and varying time periods, effects fluctuated between statistically significant and not significant, and between beneficial and detrimental to health.ConclusionsWe conclude that efforts to understand the underlying mechanisms of population health are far from settled, and the present state of research on the topic leaves much to be desired. It is essential that future research considers multiple factors simultaneously and takes advantage of more sophisticated methodology with regards to quantifying health as well as analyzing determinants' influence.

Project description:IntroductionLow levels of household access to basic environmental health assets (EHAs)-including technologies such as clean cookstoves and bed nets or infrastructure such as piped water and electricity-in low- and middle-income countries (LMICs) are known to contribute significantly to the global burden of disease. This low access persists despite decades of promotion of many low-cost, life-saving technologies, and is particularly pronounced among poor households. This study aims to characterize variation in access to EHAs among LMIC households as a function of wealth, as defined by ownership of various assets.MethodsDemographic and Health Survey (DHS) data from 41 low- and middle-income countries were used to assess household-level access to the following EHAs: 1) improved water supply; 2) piped water supply; 3) improved sanitation; 4) modern cooking fuels; 5) electricity; and 6) bed nets. For comparison, we included access to mobile phones, which is considered a highly successful technology in terms of its penetration into poor households within LMICs. Ownership levels were compared across country-specific wealth quintiles constructed from household assets using bivariate analysis and multivariable linear regression models.ResultsAccess to EHAs was low among the households in the bottom three quintiles of wealth. Access to piped water, modern cooking fuels, electricity and improved sanitation, for example, were all below 50% for households in the bottom three wealth quintiles. Access to certain EHAs such as improved water supply and bed nets increased only slowly with concomitant increases in wealth, while gaps in access to other EHAs varied to a greater degree by wealth quintile. For example, disparities in access between the richest and poorest quintiles were greatest for electricity and improved sanitation. Rural households in all wealth quintiles had much lower levels of access to EHAs, except for bed nets, relative to urban households.ConclusionsThe findings of this study provide a basis for understanding how EHAs are distributed among poor households in LMICs, elucidate where inequalities in access are particularly pronounced, and point to a need for strategies that better reach the poor, if the global environmental burden of disease is to be reduced.

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The potential exploitation of research participants in high income countries who lack access to health care.

Publications

The potential exploitation of research participants in high income countries who lack access to health care.

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