In line with the implementation of new regulations for the Philippine Health Research Ethics Board (PHREB), a Regulatory Update Training was conducted for lecturers, accreditors, and other members of the PHREB last 29 to 30 April 2019 at the Consunji Room, Bahay ng Alumni, University of the Philippines (UP) Diliman, Quezon City. The training aims to provide information on data privacy, guidance documents of the US Food and Drug Administration (FDA) in comparison with that of the Philippine FDA, safe data management and reporting for conflicts of interest, serious adverse events, deviations and amendments for a more effective clinical research.
The two-day training was facilitated by Balik Scientist Dr. Fidela Ll. Moreno who is also a Strategic Operations Consultant at the Intermountain Heart Institute, Salt Lake City, Utah, USA. Aside from this, Dr. Moreno is also a Visiting Professor at the University of Santo Tomas (UST), Faculty of Medicine and Surgery; Professional Chair of Medicine and Allied Health Sciences at the University of Perpetual Help; Consultant at Research Institute for Tropical Medicine and Consultant of the FDA Philippines.
Focusing on the regulations for Data Protection, the discussions centered on the compliance of the country with international standards, specifically with the Data Privacy Act of 2012 (Republic Act 10173) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The US FDA Guidance documents were also presented to share the best practices which protect the patient’s rights, safety, and welfare in producing clinical research. An example of this is the Institutional Review Board (IRB) Responsibilities for the review of the qualification of investigators, the adequacy of research sites for the protection of human subjects, and the reduction of regulatory burden.
Regulations governing the informed consent was also discussed, along with its benefits and risks. Dr. Moreno further elucidated this with the privacy laws and its application to digital communication by elaborating the guidelines for the use of electronic informed consent.
Safety management and reporting was also presented as a review for the importance of monitoring and the identification and handling adverse events. This covers the role of the IRB or the Research Ethics Committee (REC) in the management of data safety, in order to safeguard the dignity, rights, and well-being of all actual or potential research participants. The lecture also covered other ethical practices for protocol violations and research practices in line with the guidelines provided by the IRB, REC, FDA and the CFR.
To conclude the event, participants were given sample cases on breach of data privacy as examples for discussion in line with the Data Privacy Act of the Philippines.
