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Year 2007 marked a significant milestone in the field of health research as the former President Gloria Macapagal-Arroyo declared every second week of August as the Philippine National Health Research System (PNHRS) Week by virtue of Proclamation No. 1309.

Following the proclamation, PNHRS yearly conducts the PNHRS Week Celebration in different regions of the country, designed to hold parallel and plenary sessions, regular forums, and focus group discussions to promote a smoother exchange of health research and related information among concerned stakeholders.

The Philippine Health Research Ethics Board, as one of the more explicit provision of the PNHRS, and in partnership with the Philippine Council for Health Research and Development (PCHRD), shall hold a Pre-conference session, focusing on the "Ethical Issues in Health and Health-related Research", during the 10th PNHRS Week Celebration at Citystate Asturias Hotel, Puerto Princesa City, Palawan, on 10 August 2016, 8:00 AM to 3:00 PM.

Below is the programme of the event, for reference. Attendance to the Pre-conference session is free of charge.

Participating in this pre-conference session presents an excellent opportunity for Ethics Committee members, researchers, students and stakeholders for professional development as well as engage other partners to make research and innovation benefit health, equity and development.

Should there be any concerns, contact the PHREB Secretariat at telephone number (02) 837 7537 or email at This email address is being protected from spambots. You need JavaScript enabled to view it..

The policies promote standards in the establishment of procedures and mechanisms that enable ethics review committees to conduct quality scientific and ethical review of research protocols and thereby ensure the safety and protection of the rights and welfare of the participants in research.

Section III of the 2016 PHREB Accreditation Policies states that "All health-related research protocols/proposals involving human participants shall be reviewed by a Research Ethics Committee (REC). As defined in the National Ethical Guidelines for Health Research 2011 p.143, Health research is generation of data that may contribute to new knowledge to  identify  and  deal  with  health  problems,  health  systems  and policies as well as those that impact on health such as socioeconomic, environment,  energy and agricultural policies. The World Health Organization (WHO) Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011 Preface, states on its preface that Health-related research includes biomedical, behavioral, social science, and epidemiological research."

Requirements for Accreditation

Level 1

The REC must demonstrate sufficient competency and efficiency in ethical review, adhere to a set of appropriate standard operating procedures, and have adequate administrative support as shown by an assigned office with standard equipment, a budget that supports honoraria for and training of REC members.

REC applicants for Level 1 accreditation shall submit the following documents:

• 1.1 Cover Letter
• 1.2 Copy of the institutional issuance on the constitution and terms of reference (TOR) of REC
• 1.3 Manual of Standard Operating Procedures for REC activities (refer to Section IV. Item No. 3)
• 1.4 Accomplished PHREB Form No. 1.1: Application for Accreditation
• 1.5 Accomplished PHREB Form No. 1.3: Protocol Summary, in the past year (if available)
• 1.6 Accomplished PHREB Form No. 1.4: Self-Assessment

Level 2

The REC must demonstrate sufficient competency and efficiency in ethical review, adhere to a set of appropriate standard operating procedures, have systematic filing, have adequate administrative support as shown by an assigned office with standard equipment, at least a part time dedicated support staff, a budget that supports honoraria for and training of the REC members, and a functional database.

1. REC applicants for Level 2 accreditation shall submit the following documents:

• 1.1 Cover Letter
• 1.2 Copy of the institutional issuance on the constitution and terms of reference (TOR) of REC
• 1.3 Manual of Standard Operating Procedures (refer to Section IV: Item No. 3)
• 1.4 Accomplished PHREB Form No. 1.1: Application for Accreditation
• 1.5 Accomplished PHREB Form No. 1.3: Protocol Summary, for the past two years, including the current year
• 1.6 Accomplished PHREB Form No. 1.5: Self-Assessment
• 1.7 Files of three (3) research protocols (1 full review - completed; 1 full review - ongoing; and 1 expedited - full review) that have been reviewed and approved by the REC. The protocol file should include: 
  • 1.7.1 Copy of the initial and revised protocols, initial and revised informed consent forms, accomplished assessment forms (technical/scientific and informed consent review);
  • 1.7.2 Minutes of the meeting when the research protocol was discussed (initial and subsequent continuing reviews);
  • 1.7.3 Letters/communications with the researchers (decision and approval letters); and
  • 1.7.4 Progress/final reports and corresponding assessments. 

• 1.8 Copies of the agenda and minutes of the most recent three (3) REC meetings.
• 1.9 Photograph of the office showing the equipment and storage system

2. The REC applicant shall comply with the following: 

• 2.1 Inclusion of a member who is a health or allied health practitioner and a social scientist, familiar with the types of research protocols being reviewed by the REC.
• 2.2 Review of at least ten (10) protocols, five (5) of which should have undergone full review, within the past year.
• 2.3 A dedicated office space, with basic equipment (computer with internet connection and printer, telephone, filing cabinets with locks), contents of the active and inactive cabinets or filing system, poster of the general flow chart of REC procedures, and a designated staff secretary.

Level 3

The REC must demonstrate sufficient competency and efficiency in ethical review, adhere to a set of appropriate standard operating procedures, have systematic filing, have adequate administrative support as shown by, but not limited to, an assigned office with standard equipment, a full time dedicated support staff, a budget that supports honoraria for and training of the REC members, and a functional database.

 1. REC applicants for Level 3 accreditation shall submit the following documents:

• 1.1 Cover letter
• 1.2 Accomplished PHREB Form No. 1.1: Application for Accreditation
• 1.3 Accomplished PHREB Form No. 1.3: Protocol Summary, in the last two years, including the current year
• 1.4 Accomplished PHREB Form No. 1.6: Self-Assessment
• 1.5 REC Manual of Standard Operating Procedures (refer to Section IV: Item No. 3)

2. The REC applicant shall comply with the following:

• 2.1 All members should have basic research ethics training.
• 2.2 Majority of the members, including the Chair, should have GCP training within the past three (3) years.
• 2.3 At least one (1) member should have training in SOP writing.
• 2.4 All members should provide evidence of training in the use of the REC SOPs.
• 2.5 A dedicated office space, basic office equipment (computer with internet connection and printer, telephone, filing cabinets with locks, poster of the general flow chart of REC procedures and a full-time staff secretary).

 3. The REC shall undergo an Accreditation Visit that will involve the following:

• 3.1 Preliminary coordination between PHREB and host REC regarding schedule of visit and logistics;
• 3.2 The accreditation visit shall include: opening and closing meetings, interview of REC members and staff, inspection of the REC office, including the archives, an observation of an REC meeting and review of documents (e.g. standard operating procedures, membership files, selected protocol files, SAE files, file of agenda and minutes of meetings, communications file, log book and databases)

The PHREB Accreditation forms can be downloaded through the link below:

http://www.ethics.healthresearch.ph/index.php/forms

Process:

1. Accomplish PHREB Accreditation forms (Arial or Times New Roman; font 12)

2. Submit soft copy of accomplished forms and documentary requirements thru email <This email address is being protected from spambots. You need JavaScript enabled to view it.>

3. Upon initial assessment of completeness, PHREB advise to send three (3) sets of hard copy thru its office, Room 306, c/o PCHRD, DOST Main Building, Gen. Santos Ave., Bicutan, Taguig 

4. Mode of payment of accreditation processing fee shall only be by means of cash or cheque (if cheque, payable to PCHRD)

The whole document (2016 PHREB Accreditation Policies and Requirements) can be downloaded through the link below:

http://www.ethics.healthresearch.ph/index.php/phoca-downloads/category/6-phreb-r-a-documents?download=82:phreb-policies-and-requirements-for-accreditation-07sept2016

For more information about PHREB Accreditation and its process, contact PHREB Secretariat at telephone numbers (02) 837 75 37 or (02) 837 20 71 local 2112; fax (02) 837 29 24; or email This email address is being protected from spambots. You need JavaScript enabled to view it.

Standard Operating Procedures (SOPs) are the step-by-step description of the different procedures done to accomplish the objectives of an identified activity. They guide Research Ethics Committees (RECs) in ensuring consistency, transparency, and quality assurance in ethical review. They should be simple and easy to follow instructions. Operationally, the question is “How does the REC do this particular activity efficiently?”

This Workbook is intended for RECs who are planning to develop their SOPs. It was developed from the materials used by the Philippine Health Research Ethics Board (PHREB) in its conduct of SOP seminar-workshops.

The Workbook begins with an outline of SOP groupings. The different SOPs are presented in a template format which is suggested for easy reference.

In this workbook, there are 21 SOPs which are organized into ten major groupings. This system of organizing SOPs need not be used by all RECs. For example, in RECs with limited activities, a straightforward listing of SOPs may suffice and be simpler to use.

Please click on the link below to access/download the PHREB SOP Workbook:

DOWNLOAD PHREB SOP WORKBOOK HERE

For more information regarding the use of the SOP Workbook, you may contact PHREB via email at This email address is being protected from spambots. You need JavaScript enabled to view it. or landline at (02) 837-7537.

NOTE: If your REC used the SOP Workbook for your REC SOP manual, please do not forget to acknowledge PHREB as reference.

*NOTE: As requested by Drs. Marcelo and Umali, please visit http://telehealth.ph or email: This email address is being protected from spambots. You need JavaScript enabled to view it.

PHREB is inviting Biomedical researchers, policy makers and members of ethics committees, to attend the Ethics Pre-Forum on 24 August 2015, 1:00 – 5:00 PM, at Summit Hall C and D, Philippine International Convention Center (PICC), Pasay City. Please confirm attendance by returning the reply slip on or before August 07, 2015. Below is the programme of the event, for reference. Attendance to the Pre-forum is free of charge.

Participating in this pre-forum presents an excellent opportunity for you and your Society for professional development as well as engage other partners to make research and innovation benefit health, equity and development.

Should there be any concerns, contact the PHREB Secretariat at telephone number (02) 837 7537 or email at This email address is being protected from spambots. You need JavaScript enabled to view it..

Presented by PHREB Subcommittee on Standards and Accreditation Chair, Dr. Cecilia V. Tomas, during the Philippine Clinical Research Professionals' General Assembly last 4 March 2015 at UST Hospital Benavides Cancer Institute Auditorium, Manila

You may view or download the presentation by clicking the slide below