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      Compensating control participants when the intervention is of significant value: experience in Guatemala, India, Peru and Rwanda

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          Abstract

          The Household Air Pollution Intervention Network (HAPIN) trial is a randomised controlled trial in Guatemala, India, Peru and Rwanda to assess the health impact of a clean cooking intervention in households using solid biomass for cooking. The HAPIN intervention—a liquefied petroleum gas (LPG) stove and 18-month supply of LPG—has significant value in these communities, irrespective of potential health benefits. For control households, it was necessary to develop a compensation strategy that would be comparable across four settings and would address concerns about differential loss to follow-up, fairness and potential effects on household economics. Each site developed slightly different, contextually appropriate compensation packages by combining a set of uniform principles with local community input. In Guatemala, control compensation consists of coupons equivalent to the LPG stove’s value that can be redeemed for the participant’s choice of household items, which could include an LPG stove. In Peru, control households receive several small items during the trial, plus the intervention stove and 1 month of fuel at the trial’s conclusion. Rwandan participants are given small items during the trial and a choice of a solar kit, LPG stove and four fuel refills, or cash equivalent at the end. India is the only setting in which control participants receive the intervention (LPG stove and 18 months of fuel) at the trial’s end while also being compensated for their time during the trial, in accordance with local ethics committee requirements. The approaches presented here could inform compensation strategy development in future multi-country trials.

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          India's Janani Suraksha Yojana, a conditional cash transfer programme to increase births in health facilities: an impact evaluation.

          In 2005, with the goal of reducing the numbers of maternal and neonatal deaths, the Government of India launched Janani Suraksha Yojana (JSY), a conditional cash transfer scheme, to incentivise women to give birth in a health facility. We independently assessed the effect of JSY on intervention coverage and health outcomes. We used data from the nationwide district-level household surveys done in 2002-04 and 2007-09 to assess receipt of financial assistance from JSY as a function of socioeconomic and demographic characteristics; and used three analytical approaches (matching, with-versus-without comparison, and differences in differences) to assess the effect of JSY on antenatal care, in-facility births, and perinatal, neonatal, and maternal deaths. Implementation of JSY in 2007-08 was highly variable by state-from less than 5% to 44% of women giving birth receiving cash payments from JSY. The poorest and least educated women did not always have the highest odds of receiving JSY payments. JSY had a significant effect on increasing antenatal care and in-facility births. In the matching analysis, JSY payment was associated with a reduction of 3.7 (95% CI 2.2-5.2) perinatal deaths per 1000 pregnancies and 2.3 (0.9-3.7) neonatal deaths per 1000 livebirths. In the with-versus-without comparison, the reductions were 4.1 (2.5-5.7) perinatal deaths per 1000 pregnancies and 2.4 (0.7-4.1) neonatal deaths per 1000 livebirths. The findings of this assessment are encouraging, but they also emphasise the need for improved targeting of the poorest women and attention to quality of obstetric care in health facilities. Continued independent monitoring and evaluations are important to measure the effect of JSY as financial and political commitment to the programme intensifies. Bill & Melinda Gates Foundation. Copyright 2010 Elsevier Ltd. All rights reserved.
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            Payment of clinical research subjects.

            Offering payment to clinical research subjects, in an effort to enhance recruitment by providing an incentive to take part or enabling subjects to participate without financial sacrifice, is a common yet uneven and contentious practice in the US. Concern exists regarding the potential for payment to unduly influence participation and thus obscure risks, impair judgment, or encourage misrepresentation. Heightening these concerns is the participation not only of adults but also of children in pediatric research trials. Thorough assessment of risks, careful eligibility screening, and attention to a participant's freedom to refuse all serve to reduce the possibility of compensation adversely affecting the individual and/or the study. Institutional review boards currently evaluate payment proposals with minimal guidance from federal regulations. Here, reasons for providing payment, payment models, ethical concerns, and areas for further research are examined.
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              Benefits and payments for research participants: Experiences and views from a research centre on the Kenyan coast

              Background There is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies conducted by the KEMRI-Wellcome Trust programme in Kilifi, Kenya. Methods Following an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these ‘benefits’ were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist. Findings The most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits. Conclusions Research staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability.
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                Author and article information

                Journal
                BMJ Glob Health
                BMJ Glob Health
                bmjgh
                bmjgh
                BMJ Global Health
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2059-7908
                2019
                21 August 2019
                : 4
                : 4
                : e001567
                Affiliations
                [1 ] departmentFogarty International Center , National Institutes of Health , Bethesda, Maryland, USA
                [2 ] departmentDivision of Pulmonary and Critical Care Medicine , Johns Hopkins University School of Medicine , Baltimore, Maryland, USA
                [3 ] departmentNell Hodgson Woodruff School of Nursing , Emory University , Atlanta, Georgia, USA
                [4 ] departmentDepartment of Disease Control, Faculty of Infectious and Tropical Diseases , London School of Hygiene and Tropical Medicine , London, UK
                [5 ] departmentCentro de Estudios en Salud , Universidad del Valle de Guatemala , Guatemala City, Guatemala
                [6 ] departmentDepartment of Environmental Health Engineering , Sri Ramachandra Insitute of Higher Education and Research , Chennai, Tamil Nadu, India
                [7 ] departmentCRONICAS Center of Excellence in Chronic Diseases and Department of Medicine, School of Medicine , Universidad Peruana Cayetano Heredia , Lima, Peru
                [8 ] departmentDepartment of Environmental Health, Rollins School of Public Health , Emory University , Atlanta, Georgia, USA
                [9 ] departmentDepartment of International Health, Johns Hopkins Bloomberg School of Public Health , Johns Hopkins University , Baltimore, Maryland, USA
                Author notes
                [Correspondence to ] Dr Ashlinn K Quinn; ashlinn.quinn@ 123456nih.gov
                Author information
                http://orcid.org/0000-0002-0050-2647
                http://orcid.org/0000-0002-4738-5468
                Article
                bmjgh-2019-001567
                10.1136/bmjgh-2019-001567
                6730613
                56acca87-0697-4cfb-81d9-a8f484aad539
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 18 March 2019
                : 03 July 2019
                : 05 July 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000865, Bill and Melinda Gates Foundation;
                Award ID: OPP1131279
                Funded by: FundRef http://dx.doi.org/10.13039/100000050, National Heart, Lung, and Blood Institute;
                Award ID: 1UM1HL134590
                Categories
                Practice
                1506
                Custom metadata
                unlocked

                randomised controlled trial,compensation,ethics,multi-country trial

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