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Section XI of the 2016 PHREB Policies and Requirements for Accreditation of Research Ethics Committees (version date: 07 September 2016)

Introduction:

The level of accreditation of specialty clinics needs special attention because of concerns in providing appropriate care to research participants who may need medical care that is not covered by the specialty offered in the facility, and in the management of conflict of interest when the pool of consultants where both researchers/ investigators and REC members are derived, is small. The following policies have been formulated to address the aforementioned issues.

Scope:

These policies cover specialty clinics defined as stand-alone health care facilities that offer specific medical specialty services only (e.g., dermatology, ophthalmology, hematology, dialysis, etc.). These policies do not cover health care facilities that offer stem cell therapy/research.

Policies:

1. Application for all levels shall require accomplishment of the PHREB Application Form 1.1a that is specific for Specialty Clinics. The application form shall provide information on :

  • Type of specialty services
  • Involvement in the production of health products including food preparations or supplements
  • Number of active consultant staff (full time or part-time) with reference to practice privileges
  • Nature of studies conducted
  • Description of the Research Ethics Committee (number of members with at least one non-affiliated medical member in the same specialty, officers, specialty, affiliation, scientist/non-scientist, gender, age representation and record of research ethics training)
  • Affiliation with / geographic access to a health facility with general medical services.

2. Application for Level 1 shall be processed according to the 2016 PHREB ACCREDITATION POLICIES AND REQUIREMENTS.

3. Processing and approval of an application for Levels 2 and 3 Accreditation shall take into consideration among others: an acceptable ratio (at least 10:1) of active consultant members of the research ethics committee to potential researchers and the accessibility of a health facility that offers general medical services to research participants, if needed.

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The Philippine Health Research Ethics Board (PHREB) will conduct a Trainers’ Forum on University Research Ethics on September 13, 2016 at the University of Santo Tomas Hospital, Sampaloc, Manila. The trainer’s forum aims to facilitate knowledge gain in addressing ethical issues arising in student researches, particularly in the field of social science.

According to the PHREB-Committee on Information Dissemination, Training, and Advocacy (PHREB-CIDTA), empowering Research Ethics Committees (RECs) through capacitating its current PHREB trainers, members, as well as university lecturers and facilitators, is essential in ensuring the safety and general well-being of the research participants. The trainer’s forum will enable RECs to identify common ethical issues in student researches and come up with a consensus on how to address the issues with the research subjects in mind.

Prof. Peter A. Sy, Associate Professor of the Department of Philosophy – University of the Philippines Diliman (UP Diliman), and Dr. Liane P. Alampay, University Research Ethics Office Director of the  Ateneo De Manila University, will lead the forum to discuss basic research ethics principles, ethics in publication, regulations in university research ethics review, and emerging issues in the social science dimension of research.  Moreover, Atty. Marcia Ruth Gabriela P. Fernandez, Associate Professor of the Department of Sociology – UP Diliman will talk about the implications of the research data management as manifested in the Data Privacy Act of 2012.

The Trainers’ Forum on University Research Ethics will address the demand for more research ethics training program for health and health-related researches.   Thirty-five (35) participants, composed of PHREB members and university faculty-researchers, are expected to engage in the said forum.

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PHREB Chair Dr. Leonardo D. De Castro moderates the workshop.

The Philippine Health Research Ethics Board (PHREB) and the National Ethics Committee (NEC) conducted the Workshop on emerging ethical issues in health and health-related researches at the National Institute of Health, at the University of the Philippines – Manila last July 18, 2016 to facilitate knowledge gain on stem-cell therapies/research, data privacy, and social science aspect of research.

Dr. Michelle De Vera, Director of the Institute of Personalized Molecular Medicine – The Medical City and Dr. Mark Pierre Dimamay, Center for Stem-Cell Research Scientist of St. Luke’s Medical Center, talked about the implications of the ethical issues in stem-cell therapies and researches in the country. “Improvements in objective measure of disease-related function are needed to determine whether there is evidence to change prevailing medical practice, as well as justify the imposition of the risks on research subjects,” Dr. De Vera stated. Dr. Dimamay, on the other hand, pushed for the formalization of the national guidelines on stem cell techniques to ensure safety and efficacy of commercially-introduced stem-cell procedures e.g. stem cell procedures in malls.

 

Dr. Amaryllis Torres, Executive Director of the Philippine Social Science Council, addressed the importance of the social science aspect of health-related researches, says that norms, values, and wellbeing should be considered before, during, and after the research.

Various conditions, exemptions, and applications of the Data Privacy Act vis-à-vis research purpose were introduced by Atty. Francis Euston Acero of the National Privacy Commission. During his talk, he detailed the rights of a data subject in qualitative and quantitative research. “…such rights include to be informed on how his or her personal information will be processed” he added.

A total of 40 PHREB and NEC members took part in the workshop. Participants are expected to formulate ethics guidelines in their respective research ethics committees and policy-making bodies using the new knowledge obtained from the activity.

 

 

   
                  

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