Motives for participating in a clinical research trial: a pilot study in Brazil

Abstract

BackgroundIn the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil.MethodsMixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing.ResultsThe motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study.ConclusionsThe present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral understanding of the ICS is not clear.

Motivational Factors for Participation in Biomedical Research

“…These findings agree with findings of studies conducted in Brazil and India by Nappo et al (2013) as well as Doshi et al (2013). In situations of poor service delivery, medical care in a research setting is described in favorable terms.…”

The feasibility of determining the effectiveness and cost-effectiveness of medication organisation devices compared with usual care for older people in a community setting: systematic review, stakeholder focus groups and feasibility randomised controlled trial

“…16,34 The primary motivations for trial participation by older people are altruism, social engagement and anticipated personal benefits. [103][104][105] These mirror precisely the findings of the pre-study focus groups and post-study discussions with participants. Participants cited study involvement as an opportunity to payback the NHS, and with 57% of participants in the MOD RCT group remaining on MODs and 29% of the usual-care group being initiated into MODs post-study completion, there is a clear element of personal benefit.…”

“…Previous research has cited inconvenience/burden of trial involvement and risk of harm. [103][104][105] The nature of the intervention is such that potential participants are unlikely to have perceived it as a high risk of harm. It therefore follows that the trial processes were considered a burden that outweighed the potential benefits.…”

Conhecimento e voluntariedade para participação em pesquisas: um estudo descritivo com participantes de um ensaio clínico

“…Apesar de vários autores insistirem que esse fator é mais comum nos países em desenvolvimento 54 , estudos demonstram que ele é encontrado em sujeitos de estudos em todo o mundo 55,56 , inclusive no Brasil 57 . Como implicação ética dessa influência, destacase que a busca por tratamento médico pode ser um indício da precariedade de serviços de saúde disponíveis para a população, impelindo esses participantes a fazerem parte de pesquisas clínicas 13 .…”