The participation in health-related research projects: compensated, reimbursed or gratuitous.

نویسنده

  • José Roberto Goldim
چکیده

Health research always poses new challenges. Nursing staff constantly deal with such activities, either as researchers or research team members. The interaction between healthcare and research activities creates situations that are not found in other fields. Research always stems from a researcher's idea, which materializes in a project. Once the project is approved by a Research Ethics Committee (REC), it is presented to potential participants. Such possibility is offered to participants in the form of an invitation, which may be accepted or not. This informed consent process is based on sharing essential information for people to understand what will be taking place in the course of research, ensuring their voluntary participation, and recognizing each person's self-determination. On the other hand, healthcare primarily stems from patients' needs as they seek a health professional or institution to see them. The relationship is established in order to offer help to those asking for it. The professional evaluates the different therapeutic alternatives available and their respective outcomes, whether they are risks or benefits, and shares the decision with the patient. As a result of such need, which may be an illness, for instance, the patient has a vulnerability that must also be taken into account during the decision-making process. By combining healthcare and research, clinical research couples possibilities and needs, the role of participant and that of a patient, a researcher's activity and that of a healthcare professional. Such combination creates very special research situations that must be seen as healthcare also by all those involved. Therefore, nursing staff may interact with research participants even though they are not research team members. The new proposal to amend Resolution 196/96, approved in December 2012 by the Brazilian Health Council (CNS), carries a few issues that should have been further discussed and thought through. One such issue is the possibility to compensate research project participants. Item II.10 of the new resolution 196/96, 2012 version, brings the possibility to pay participants in phase I or bioequivalence clinical research. That regulatory change is quite worrisome as it opens up a possibility not previously provided for or discussed. The version approved by the National Conference of Research Ethics Committees (ENCEP) held in 2012 to evaluate this new document did not contain such possibility. That version, which is still available on the National Research Ethics Committee (CONEP) website, is the one meant to be discussed by the CNS. The 1996 …

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عنوان ژورنال:
  • Revista gaucha de enfermagem

دوره 34 2  شماره 

صفحات  -

تاریخ انتشار 2013