Ethical issues in a Brazilian hospital.
OBJECTIVE
The objective of this paper is to discuss ethical issues such as data protection, confidentiality, and patient freedom taking two ongoing studies as examples.


METHODS
The two studies are being carried out at a public hospital in southern Brazil. Study 1 evaluates inadequate use of drugs (mainly vancomycin) and aims at reviewing criteria for drug use control. It includes records of 100 patients whose prescriptions are dispensed at the hospital's pharmacy. A major ethical concern in this study was to ensure data confidentiality. Study 2 evaluates treatment adherence by hypertension patients with a focus on hydrochlorothiazide. Here, in addition to data protection, a major ethical concern was the ability of patients to understand the informed consent form and therefore freely enter or refuse to enter the study. Both projects were approved by the Institutional Review Board at Hospital de Clínicas de Porto Alegre.


RESULTS
In both studies, data confidentiality is ensured by the removal of all personal information from the forms used for data analysis. In Study 2, readability of the informed consent was considered adequate by the IRB for the population served by the clinic, and one-third of the patients who were contacted agreed to participate in the study.


CONCLUSIONS
To obtain reliable results, basic ethical principles must be observed throughout the planning and execution of research projects, whether data are obtained from medical records or from actual interaction with patients. Thus, monitoring by an Institutional Review Board or equivalent is of paramount importance.
de Castro
M S
MS
Department of Drug Production and Control, School of Pharmacy, Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Brazil. mascastro@hcpa.ufrgs.br
Goldim
J R
JR
Ferreira
M B
MB
D001675:Bioethics; D001938:Brazil / Q000453:epidemiology; D003219:Confidentiality; D003625:Data Collection; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent; D010349:Patient Compliance; D017891:Pharmacoepidemiology / Q000592:standards*