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UPDATED PHREB Policies and Requirements for Accreditation of Research Ethics Committees (2016)
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:
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.
