PHREB POLICIES AND REQUIREMENTS FOR RESEARCH ETHICS TRAINING PROGRAMS

Date Effective: 11 June 2015

  

I.                    INTRODUCTION

 

Research ethics can be traced to the 1947 Nuremberg Code that came as an aftermath of the Nuremberg Trials in Germany. Research ethics was further articulated in the Declaration of Helsinki documents, the Universal Declaration of Human Rights, the 1974 Belmont Report, the CIOMS-WHO International Guidelines in Biomedical Research, and the 1996 ICH-GCP Guidelines in the conduct of clinical trials. All of these guidelines and standards were established in order to protect the dignity, welfare, and rights of human participants.

 

To comply with these guidelines, research protocols involving human participants must undergo review and be approved by an independent ethics committee before the commencement of recruitment of participants. For ethics review committees to do good and competent review, its members must be knowledgeable in the application of the international and national guidelines and standards and develop sensitivity in the recognition of ethical issues embedded in the protocols.

 

The Philippine Health Research Ethics Board (PHREB) aims to help establish and maintain functional Independent Ethics Review Committees with these competences. For this purpose, PHREB has identified the Committee on Information Dissemination, Training, and Advocacy (CIDTA).

 

 

II.                  GENERAL POLICY

 

Research ethics training programs must meet the standards set and be approved by PHREB-CIDTA in order to fulfill accreditation requirements of PHREB Committee on Standards and Accreditation (CSA).

 

1.       All Chairs of Research Ethics Committees (RECs) should have basic ethics training.

2.       All RECs must have training programs for members on basic research ethics and continuing ethics review.

3.       Special Training for specific needs may be required by PHREB in its Accreditation Policies. For example, RECs that review clinical trials for FDA registration need their reviewers/members to be trained in Good Clinical Practice (GCP). On the other hand, RECs that review mostly social research may need training on social research ethics.

 

 

III.                RESEARCH ETHICS TRAINING PROGRAMS

 

Research ethics training programs may be conducted by:

1.          PHREB-CIDTA

2.          Others

 

 PHREB-CIDTA RESEARCH ETHICS TRAINING PROGRAMS

 

TYPES OF PHREB-SIDTA RESEARCH ETHICS TRAINING PROGRAMS

Basic Research Ethics

  I.   Target participants:

a.    Researchers (including students)

b.   Members of Ethics Review Committees (ERCs)

c.    Research Advisers

d.   Reviewers

 

II.   Content:

a.    Definition of Terms

b.   Scientific Soundness

c.    Research Ethics Principles (Beneficence, Non-Maleficence, Autonomy, Justice)

d.   Declaration of Helsinki

e.   Research Ethics Review

f.     Informed Consent

g.    Authorship

h.   Review of the Research Proposal

i.      Ethics Review Systems

j.     Ethics Review Committees

k.    Ethical Researcher

Good Research Practice

  I.   Target Participants:

a.    ERC Members (ERC applying for level 3 accreditation)

b.   Clinical Researchers

 

II.   Content:

a.   Definition of Terms

b.  Review of different methodologies (e.g. social research)

c.   Research Ethics Principles (Beneficence, Non-Maleficence, Autonomy, Justice)

d.  Review of the  Research Proposal

e.  Nuremberg Code

f.    National Ethical Guidelines (ERC composition)

g.   ICH GCP

h.  ERC – organization, function, and responsibilities

i.     Vulnerable Population in Research

j.    Standard Operating Procedures (SOPs)

Advanced/Focused Workshop (topics depend on need; one to 1½ days training )

Common Topics:

a.    SOPs

b.   Conflicts of Interest (COIs)

c.    Informed Consent

d.   ERCs

e.   Training of Trainers

f.     Training for Evaluators

 

 

1.       Request Requirements of Research Ethics Training:

 

a.       Submit completed Training Request Form (Form 2015-01) to the PHREB Secretariat

                                                                           i.      Name of requesting party

                                                                         ii.      Type of training program requested

                                                                        iii.      General profile of participants (minimum of 15 and maximum of 30 participants)

                                                                       iv.      Preferred Dates (minimum of one month from date of application)

Note: Postponements by requesting party will be considered as a new application

                                                                         v.      Training Venue

                                                                       vi.      Contact person and number

 

b.      Four (4) complete research proposals (two weeks prior to approved schedule)

 

2.       Responsibilities of requesting party

a.       Training logistics (training venue, handouts, audio-visual equipment, food and drinks)

b.      Transportation

c.       Accommodation for resource persons and staff (if outside Metro Manila)

d.      Honoraria of resource persons

 

RESEARCH ETHICS TRAINING PROGRAMS BY NON-PHREB-CIDTA

 

Recognition of the training program will depend on an evaluation of the submitted requirements and actual conduct of the training by a PHREB CIDTA representative

 

Procedure

1.       Submission by requesting party at least one month before actual conduct of training.

a.       Completed Recognition Request Form (Form 2015-02)

                                                                           i.      Name of requesting individual/institution

                                                                         ii.      Type of training program

                                                                        iii.      General profile of participants

                                                                       iv.      Date(s)

                                                                         v.      Training Venue

                                                                       vi.      Contact person and number

 

b.      Description of the training program containing the following:

                                                                           i.      Objective: clearly stated and related to ethics in research

                                                                         ii.      Training Method: use of varied teaching-learning strategies that include didactics, workshops, small group discussions, etc.

                                                                        iii.      Policy statement on participant certification (policies on attendance, performance, participation, pre and post-tests)

                                                                       iv.      Content – program and copy of handouts

                                                                         v.      Post-training evaluation by participants

 

c.       CV of facilitators evidencing credibility to run program

 

2.       PHREB CIDTA may designate a representative to attend and observe implementation of the program

 

3.       If found satisfactory, the Certificate of Participation/Attendance/Completion shall be co-signed by the Chair of the PHREB-CIDTA. 

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