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A Malawi guideline for research study participant remuneration.

ABSTRACT: Background: Research participant remuneration has been variable and inconsistent world-wide for many years owing to uncertainty regarding best practice and a lack of written guidelines for investigators and research ethics committees. Recent recommendations are that researchers and regulators should develop regionally appropriate written guidelines to define reasonable remuneration based on expense reimbursement, compensation for time and burden associated with participation. Incentives to motivate participation are acceptable in specific circumstances. Methods: We wished to develop regionally informed, precise and applicable guidelines in Malawi that might also be generally useful for African researchers and review committees. We therefore reviewed the current literature and developed widely applicable and specific remuneration tables using acceptable and evidence-based payment rationales. Results: There were good international guidelines and limited published regional guidelines. There were published examples of best practice and sufficient material to suggest a structured remuneration table. The rationale and method for the table were discussed at an inter-disciplinary workshop resulting in a reimbursement and compensation model with fixed rates. Payment is recommended pro rata and equally across a study. Conclusions: Transparent, fair remuneration of research participants is recommended by researchers and regulators in Malawi. The means to achieve this are now presented in the Malawi research participant remuneration table.

SUBMITTER: Gordon SB

PROVIDER: S-EPMC6329041 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesParticipant-led research (PLR) is a rapidly developing form of citizen science in which individuals can create personal and generalisable knowledge. Although PLR lacks a formal framework for ethical review, participants should not be excused from considering the ethical implications of their work. Therefore, a PLR cohort consisting of 24 self-trackers aimed to: (1) substitute research ethics board procedures with engagement in ethical reflection before and throughout the study and (2) draft principles to encourage further development of the governance and ethical review of PLR.MethodsA qualitative case study method was used to analyse the ethical reflection process. Participants discussed study risks, risk management strategies and benefits pre-project, during a series of weekly webinars, via individual meetings with the participant-organisers, and during semi-structured interviews at project completion. Themes arising from discussions and interviews were used to draft prospective principles to guide PLR.ResultsData control, aggregation and identifiability were the most common risks identified. These were addressed by a commitment to transparency among all participants and by establishing participant control via self-collection and self-management of data. Group discussions and resources (eg, assistance with experimental design and data analysis) were the most commonly referenced benefits of participation. Additional benefits included greater understanding of one's physiology and greater ability to structure an experiment. Nine principles were constructed to encourage further development of ethical PLR practices. All participants expressed interest in participating in future PLR.ConclusionsProjects involving a small number of participants can sustain engagement in ethical reflection among participants and participant-organisers. PLR that prioritises transparency, participant control of data and ongoing risk-to-benefit evaluation is compatible with the principles that underlie traditional ethical review of health research, while being appropriate for a context in which citizen scientists play the central role.

Project description:The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants' experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomesTwenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption) and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach.The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants' relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes.These participants described no dramatic impacts attributable to taking part in this study. This study demonstrates the likely value of well conducted qualitative studies of subtle research participation effects, which may be particularly important to explore for alcohol. Separating unintended influences in trial participation from the effects of behaviour change interventions being evaluated therein is necessary for valid estimates of intervention effects.

Project description:The Pulmonary Hypertension Association (PHA) is a patient advocacy organization seeking to find ways to prevent, improve treatment for, and cure pulmonary hypertension (PH) and to provide hope for the PH community through support, education, research, advocacy, and awareness. Many patients involved with PHA are also involved in various PH-specific research studies; however, the patient expectations and priorities for PH-specific research are currently unknown or not well examined. Our objective was to identify the current modes of study entry, priorities within research, and expectations over the course of study involvement for patient constituents of PHA. A 29-question online survey was designed by PHA and disseminated to the PHA patient constituency on its Facebook page through a post on November 29, 2012. Responses were collected on SurveyMonkey through December 10, 2012. Respondents were divided into parallel survey tracks, depending on whether the respondent indicated previous participation in research studies. These two cohorts of individuals were analyzed and, where appropriate, compared with tests of association. A total of 234 respondents were included in the final data analysis, with 95 (40.6%) reporting previous participation in research studies. These respondents reported an overall positive experience in their research studies (64.9% very good, 21.3% good, 12.8% neutral, 1.1% bad). Of the respondents with previous research study participation, 91.1% indicated that receipt of the study outcome after participation would positively influence their decision to participate in future research; despite this, only 41.17% reported receiving information of this sort after their participation. Research participation is a strong interest of PHA patient constituents; clear and consistent communication from the research team is an expectation of many participants. Despite this expectation, 58.83% of respondents indicated they did not receive communication from the research team after participation. This offers an opportunity not only to improve participants' experiences but also to increase the likelihood of future study participation.

Project description:BackgroundWearables provide opportunities for frequent health data collection and symptom monitoring. The feasibility of using consumer cellular smartwatches to provide information both on symptoms and contemporary sensor data has not yet been investigated.ObjectiveThis study aimed to investigate the feasibility and acceptability of using cellular smartwatches to capture multiple patient-reported outcomes per day alongside continuous physical activity data over a 3-month period in people living with knee osteoarthritis (OA).MethodsFor the KOALAP (Knee OsteoArthritis: Linking Activity and Pain) study, a novel cellular smartwatch app for health data collection was developed. Participants (age ?50 years; self-diagnosed knee OA) received a smartwatch (Huawei Watch 2) with the KOALAP app. When worn, the watch collected sensor data and prompted participants to self-report outcomes multiple times per day. Participants were invited for a baseline and follow-up interview to discuss their motivations and experiences. Engagement with the watch was measured using daily watch wear time and the percentage completion of watch questions. Interview transcripts were analyzed using grounded thematic analysis.ResultsA total of 26 people participated in the study. Good use and engagement were observed over 3 months: most participants wore the watch on 75% (68/90) of days or more, for a median of 11 hours. The number of active participants declined over the study duration, especially in the final week. Among participants who remained active, neither watch time nor question completion percentage declined over time. Participants were mainly motivated to learn about their symptoms and enjoyed the self-tracking aspects of the watch. Barriers to full engagement were battery life limitations, technical problems, and unfulfilled expectations of the watch. Participants reported that they would have liked to report symptoms more than 4 or 5 times per day.ConclusionsThis study shows that capture of patient-reported outcomes multiple times per day with linked sensor data from a smartwatch is feasible over at least a 3-month period.International registered report identifier (irrid)RR2-10.2196/10238.

Project description:Background:By participating in priority-setting activities in research, patients and members of the public help ensure that important questions are incorporated into future research agendas. Surveys, focus groups, and online crowdsourcing are increasingly used to obtain input, yet little is known about how they compare for prioritizing research topics. To address this gap, the Study of Methods for Assessing Research Topic Elicitation and pRioritization (SMARTER) evaluated participant satisfaction with the engagement experience across three prioritization activities. Methods:Respondents from Back pain Outcomes using Longitudinal Data (BOLD), a registry of patients 65?years and older with low back pain (LBP), were randomly assigned to one of three interactive prioritization activities: online crowd-voting, in-person focus groups using nominal group technique, and two rounds of a mailed survey (Delphi). To assess quality of experience, participants completed a brief survey; a subset were subsequently interviewed. We used descriptive statistics to characterize participants, and we analyzed responses to the evaluation using a mixed-methods approach, tabulating responses to Likert-scale questions and using thematic analysis of interviews to explore participant understanding of the activity and perceptions of experience. Results:The crowd-voting activity had 38 participants, focus groups 39, and the Delphi survey 74. Women outnumbered men in the focus groups and Delphi survey; otherwise, demographics among groups were similar, with participants being predominantly white, non-Hispanic, and college educated. Activities generated similar lists of research priorities, including causes of LBP, improving physician-patient communication, and self-care strategies. The evaluation survey was completed by 123 participants. Of these, 31 across all activities were interviewed about motivations to participate, understanding of activity goals, logistics, clarity of instructions, and the role of patients in research. Focus group participants rated their experience highest, in both the evaluation and interviews. Conclusion:Common methods for research prioritization yielded similar priorities but differing perceptions of experience. Such comparative studies are rare but important in understanding methods to involve patients and the public in research. Preferences for different methods may vary across stakeholder groups; this warrants future study. Trial registration:NICHSR, HSRP20152274. Registered 19 February 2015.

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A Malawi guideline for research study participant remuneration.

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