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.