Ensure the rights of clinical research participants, the quality of the studies and the validity and replicability of results.
On May 19th and 20th, PRISMA promoted the course “Good Clinical Practices- GCP” sponsored by the NAtional Institute of HEalth of Peru (INS) and Cayetano Heredia University. The event took place at the auditórium of the Colegio Médico del Perú, with the objective of strengthening knowledge and capacity of clinical researchers and members of Ethics Committees in Perú.
During the event, workshops helped to understand and identify ethical aspects of clinical trials, focusing on the importance of implementing and monitoring good clinical practices as well as ensuring its compliance in all clinical investigations that require participation of voluntary human subjects.
The specialist in charge of the course was Mg. Shirley Roach, from Allied Technologies and Consulting – USA, a professional with over 30 years’ experience in the field of Good Clinical Practices and quality control of research. (cGCP and CAPA- Corrective action and preventive action) emphasizing on the ethical process in research and the importance of transparency in data handling to avoid fraud, data falsification, participant supplantation among other issues to be aware of.
The INS research director did a presentation of the new Reglamento de Ensayos Clínicos (regulation for clinical trials), where she highlighted the new regulations and criteria for accreditation of Ethics committees in our country. These new measures promote improved procedures among ethics committees that are actively reviewing clinical trial protocols before they are implemented in order to ensure protection of the rights and wellbeing of voluntary participants in research.
Prisma´s Ethics Committee´s president did a presentation about the importance of ethics not only as it is applied to the field of research but also in people’s everyday life. He also talked about a professional’s obligation to care for their patients and the need to increase and improve the ethics training in our universities.
Methodologies used included team work and debate of specific cases to allow participants to share their own experiences and to establish networks with specialists among institutions working on research in our country.
This event also featured participation of Dra. Lelis Solari, director of the Office of Research at INS, Dr. Salomón Zavala, president of PRISMA´s institutional Ethics committee, who presented their perspectives on GCP.
