Reimbursement of expenses or compensation for research subjects in Brazil: an exploratory study

• Grant number: 11/17870-2
• Support Opportunities: Regular Research Grants
• Start date: August 01, 2012
• End date: July 31, 2013
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Silvana Aparecida Ferreira Bento
• Grantee: Silvana Aparecida Ferreira Bento
• Host Institution: Centro de Pesquisas em Saúde Reprodutiva de Campinas (CEMICAMP). Campinas , SP, Brazil

Abstract

Resolution 196/96 which regulates research involving human subjects in Brazil provides, among other rules, the one that establishes the reimbursement of expenses for research participants. However, this compensation can not be taken as payment for the volunteer. The researcher should describe in the protocol if there will be reimbursement of expenses and specify it detailed. The Institutional Review Board (IRB) will be responsible for evaluating if the compensation is adequate and if it is clear that is only reimbursement of the expenses and not payment and/or motivation as the volunteer agrees to take part of the study. The objective is to understand the experience and opinion of teacher- researchers, coordinators and members of IRB in the State of São Paulo about the reimbursement or compensation given to research subjects. A qualitative study using the technique of semi-structured interviews by telephone will be carried out. The number of interviews is not defined because it will obey the saturation of information criteria. It is estimated that will be held approximately 80 to 10 interviews in each category of participant. Teacher-researchers of four Obstetrics and Gynecology post-graduation course (2 privates universities and 2 publics universities); coordinators and members of four IRB (2 from public institutions and 2 from private institutions) among the ones accredited in the CONEP in 2010, all of them in the São Paulo State, will be invited to take part of the research. All the teacher-researchers should have been involved in research activity in the area of obstetrics and gynecology in the last 24 months. The coordinators and members of ERC should be part of the ethical evaluation of research projects over the past 12 months. The criteria for exclusion of the subjects will be: teacher-researchers, coordinators and members of the IRB who will be on vacation and/or license leaving during the research. To perform the semi-structured interviews will be used two guides which will be elaborated from the study's objectives. The guides are acculturated in a similar population that will be studied. The semi-structured interviews will be transcribed, and the texts will be checked with the content recorded in a second reading. The text corresponding to the transcript of each interview will be inserted into the computer using the software NVivo. Content analysis will be conducted according to the Minayo´s guidelines. (AU)