Acreditação em saúde: revisão sistemática para avaliação da acreditação Association for the Accreditation of Human Research Protection Programs (AAHRPP) em centros de pesquisa clínica

Abstract

Clinical Research is defined as any scientific investigation conducted on humans through experiments of high methodological rigor, aiming to discover new treatments for diseases and assess the safety and efficacy of new drugs. This approach answers various questions related to therapeutic practices and the quality of healthcare services. In the context of clinical research, and beyond, Patient Safety is becoming an increasingly debated topic due to the new services offered in healthcare. For this reason, ANVISA established in RDC No. 36 of 2013 the mandatory creation of Patient Safety Units in healthcare services and the reporting of Adverse Events (AEs) associated with patient care. In Clinical Research Centers, all clinical study protocols must be conducted with the highest quality standards required by pharmaceutical companies and regulatory agencies, ensuring compliance with guaranteed quality, reporting AEs or errors in the study protocol processes, and fostering a culture of continuous improvement. The methodology of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), through quality procedures and policies, proposes a quality certification when it comes to Patient Safety in Clinical Research. In this scenario, the central objective of this dissertation was to investigate the contribution of the AAHRPP certification to promoting patient safety in Clinical Research Centers. The secondary objectives included: (a) Reviewing the legislation governing clinical research and patient safety in Brazil; (b) Mapping the bibliographic production on the subject in the scientific databases Scielo, PubMed, NEJM, Scopus, and Web of Science; (c) Mapping the research centers in Brazil integrated into the Brazilian Association of Representative Organizations of Clinical Research (ABRACRO); and (d) Analyzing the implementation of AAHRPP certification in clinical research centers in Brazil. Through documentary and bibliographic research, it was possible to understand the importance of AAHRPP accreditation in ensuring high safety and quality standards in clinical research centers. The AAHRPP methodology, by imposing strict ethical and operational criteria, provides greater reliability and excellence in the conduct of clinical trials, especially concerning patient protection. Furthermore, the research revealed that although Brazil has a significant number of research centers, few are internationally accredited, indicating the need to increase efforts to implement global standards. The adoption of this accreditation could position Brazilian research centers more competitively on the global stage, attracting more investments and promoting the advancement of medical and therapeutic sciences in the country.