Ethics Committees

Pacifico Eric Eusebio Calderon, M.D.

Bioethics 3
San Beda College of Medicine

Ethics Consultants
Professionals offering services for helping

with emergent ethical dilemmas

Three models of ethics consultation:
Individual Consultation Approach
Team Approach
Small Team Approach

Models of Ethics Consultation

Individual consultation approach
Provides immediate response to ethical

issues
Fewer logistical considerations
Requires that the consultant has a wide
knowledge on medical and ethical issues
May have consultant bias

Models of Ethics Consultation

Team approach
Composed of 6-20 expert members
Provides multidisciplinary views on the issue
May take longer than individual consultation

Models of Ethics Consultation

Small team approach
Most practical

Ethics Committees
Liberal, Western, and pluralistic in origin
Process-oriented
Sometimes bureaucratic
Three main functions (broad)
Case review
Policy advice
Staff education

Types of Ethics Committees

Research Ethics Committees
Clinical Ethics Committees/Hospital Ethics

Committees
National Advisory Ethics Committees
Ethics Review Committee (ERC)
Ethics Review Board (ERB)
Independent Ethics Committee (IEC)
Institutional Review Board (IRB)

Ethics Review Committee

(ERC)

to help safeguard the dignity, rights,

safety, and well-being of all actual or

potential human participants
The ERC shall be independent of political,
institutional, professional, and market
influences (in reference to its composition,
procedures, and decision-making).

Functions of an ERC
Philippine institutions that engage in

biomedical and behavioral research shall

establish an institutional ethics review
committee which shall provide independent,
competent, and timely review of the ethics of
proposed studies.
The ERC should consider both the scientific

and ethical aspects of the proposed research

even when the ERC is distinct from the
technical review committee (Technical
Review)

Functions of an ERC
Responsible for acting in the full interest

of potential research participants and

affected communities, taking into account
the interests and needs of the researchers,
and having due regard for the requirements
of relevant regulatory agencies and
applicable laws

Functions of an ERC
To evaluate the conduct of research in their

institutions in accordance with international

and national guidelines, local laws,
standards of professional conduct and
practice, and community values, and needs
To promote research integrity by identifying
and resolving conflicts of interest

Functions of an ERC
To establish appropriate mechanisms in all

stages of the research in order to:

ensure the safety, protect the rights, and promote

the welfare and well-being of human participants

provide counsel to human participants, including
proponents and researchers
ensure prompt reporting of changes in the
protocol and unanticipated problems
ensure the proper documentation of and
adherence to the confidentiality rule and policy on
informed consent
monitor the progress of ongoing research

Functions of an ERC
To report to the institutional or national

authorities any matter that affects the

conduct and ethics of research which in its
view may affect the rights and safety of
research participants
To keep a systematic and organized record
of all proposals reviewed, including actions
taken and other pertinent information

Composition of an ERC
Multidisciplinary
Multisectoral
With relevant expertise, e.g., medicine and

research, theology, social or behavioral

science, law, philosophy, environmental
science, and public health

Composition of an ERC
Person without disciplinal constraints (lay

person)
At least one member should be
independent of the institution or research
site
At least five members and should consider
age and gender distribution

Composition of an ERC
Members of the ERC shall undergo

continuing training on the ethics and

science of biomedical research.
Initial training must be required of new
members.

Supporting Guidelines
Declaration of Helsinki
International Conference on Harmonisation

Guideline for Good Clinical Practice E6(R1)

National Ethical Guidelines for Health
Research

Supporting Guidelines
DOST Administrative Order 001 Series of

2007: Requirement for review of all health

researches involving human
subjects/participants
CHED Memorandum Order 034 Series of
2007 (endorsement of DOST AO 001 Series
2007)
DOST Administrative Order 001 Series of
2008: Registration of all Ethics Review
Committees at the PHREB

Reading
Enfield and Truwit. The Purpose,

Composition, and Function of an

Institutional Review Board: Balancing
Priorities. Respir Care. 2008; 53(10):1330
1336
A brief summary of the functions of an IRB

References
National Ethical Guidelines for Health

Research (PCHRD) 2006

International Conference On Harmonisation
Guideline For Good Clinical Practice E6(R1)
Declaration of Helsinki 2008
WHO Operational Guidelines for Ethics
Committees that Review Biomedical
Research, 2000

Ethics Committees
Pacifico Eric Eusebio Calderon, M.D.
Bioethics 3
San Beda College of Medicine