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Parallel Session on:

Strengthening Research Ethics Review


Marco Polo Hotel, Mindanao Room, Ground Floor
13 August 2009

Importance of Ethics in Research:


History of Research Ethics
International and National Guidelines

Marita V. T. Reyes, MD
Philippine Health Research Ethics Board
Topics
Definitions:
Research, Health Research
Ethics, Research Ethics
Good Clinical Practice
Historical Notes in the Development of Research
Ethics
Importance of Ethics in Research
Research Ethics in the Philippines
Definitions

Research- refers to a class of activity designed to


develop or contribute to generalizable knowledge
(e.g., theories, principles or relationships) or the
accumulation of information on which they are based,
that can be corroborated by accepted scientific
methods of observations and inference.

Health Research- medical and behavioral studies


pertaining to human health.

(CIOMS, 2002)
Definitions

Ethics- is doing the right thing (deals with the concept


of what is “good” as a goal and what is “right” as a
course of action or as the justified claim or entitlement).

Research Ethics- is setting good goals and defining


right processes in the conduct of health research.
Definitions

Good Clinical Practice- “a standard for the design,


conduct, performance, monitoring, auditing, recording,
analysis, and reporting of clinical trials that provides
assurance that the data and reported results are
credible and accurate and that the rights, integrity and
confidentiality of trial subjects are protected”.

(ICH-GCP, 1997)
Historical Notes
in the Development of Research Ethics
1. The Nazi Experiments and the Nuremberg Trials
> Nuremberg Code
> Helsinki Declaration
> The Universal Declaration of Human Rights
2. The Tuskegee Clinical Experiments
> The Belmont Report
3. Drug Trials in Developing Countries
> CIOMS-WHO International Ethical Guidelines for
Biomedical Research Involving Human Subjects
Historical notes in the development of Research
Ethics...

4. Inter-country Registration of Pharmaceutical Products


> ICH-GCP Guidelines
5. Increasing need for ERBs
> WHO Operational Guidelines for Ethics
Committees that Review Biomedical Research (Geneva
2000)
Nazi experiments exposed during the
Nuremberg Trials (1946)
23 German doctors committed crimes against humanity
for “performing medical experiments upon concentration
camp inmates and other human subjects without their
consent”.

The Experiments:
On limits of human endurance in high altitudes: (Subjects
placed in low-pressure chambers)
On the most effective means of resuscitating pilots who
have been severely chilled/ frozen after falling into the
sea: (Subjects forced to remain in ice water for 3 hours)
Nazi experiments, cont’d
For diseases troubling German occupation forces
- malaria: Healthy subjects infected using mosquitos
- infected wounds: Sulfanilamide clinical trial
Subjects deliberately wounded, infected with
bacteria, circulation interrupted, aggravated by
forcing wood shavings and ground glass.)
- feasibility of organ transplantation: Bone, muscle
and nerves removed from one group and
transplanted into the other group.

On methods of sterilizing men and women

On the most efficient means of mass execution of


“useless” people, ex: poisons
Nuremberg Code- 1947

- Focused on voluntary consent and human rights of


human participants.
- Avoidance of “unnecessary physical and mental
suffering and injury”
- Balancing risks and benefits
- Termination of research participation by the human
subject
- proper design and prior information
- Qualification of researcher
Code for Research and Experimentations
(WMA 1954)

- Proxy consent for human participants who cannot


give consent for themselves.

The Helsinki Declaration (WMA)


1964, 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008

- Proxy consent
- Standard of care
- Therapeutic/ Non-therapeutic research
- Placebo controls
Universal Declaration of Human
Rights 1966

(UN General Assembly) International Covenant on Civil


and Political Rights

Art. 7- No one shall be subjected to torture or to cruel,


inhuman or degrading treatment or punishment. In
particular, no one shall be subjected without his free
consent to medical or scientific experimentation.
Willowbrook Hepatitis Exp’t (1960’s)
Objective: To determine the mode of infection the
hepatitis virus and course of the disease and to test
effectiveness of gamma globulin.
Subjects: >700 mentally retarded children
Methodology: deliberate infection with hepatitis virus
*early subjects fed extracts of stools from infected
individuals
*later subjects received purified virus preparations
Defense: Majority of the children will acquire the
infection at Willowbrook so it’s better for them to be
infected under carefully controlled research conditions.
Tuskegee Clinical Trial (1932-1972)

NIH- sponsored, Alabama, USA


Objective: To determine the clinical course of untreated
syphilis.
Subjects: 600 men with syphilis
Methodology:
300 randomized to treatment
300 randomized to NO treatment
No clear endpoints, no info, no permission
Results: untreated patients fared poorly, many died

CNN, May 16, 1997: Public apology from US Pres.


Clinton, Support for lasting bioethics reforms.
The Belmont Report (1974)
National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research

- mandated by Congress to provide an ethical


foundation for a system of protections for human
subjects.

- identified 3 basic ethical principles relevant to


research involving human subjects: a) respect for
persons (personal autonomy); b) beneficence; and c)
justice.
CIOMS-WHO
International Ethical Guidelines for
Biomedical Research involving Human
Subjects
1982, 1993, 2002
(Council for International Organizations of Medical Sciences- founded
under the auspices of WHO and UNESCO in 1949)

Application of ethical standards in local circumstances,


and establishing or improving ethical review
mechanisms.

“Aims to reflect the conditions and the needs of low-


resource countries, and the implications for multinational
or transnational research in which they may be partners”
especially those involving vulnerable groups.
ICH Guidelines for Good Clinical
Practice (1996)
International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use

Objective: To provide a unified standard for the EU,


Japan and the United Sates to facilitate the mutual
acceptance of clinical data by the regulatory
authorities in these jurisdictions

“A standard for the design, conduct, performance,


monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides assurance-
(1) that the data and reported results are credible
and accurate, and
(2) that the rights, integrity and confidentiality of
trial subjects are protected.”
WHO Operational Guidelines for Ethics
Committees that Review Biomedical
Research (Geneva 2000)

Intended to facilitate and support ethical review in all


countries around the world.

Objective: To contribute to the development of quality


and consistency in the ethical review of biomedical
research.

- To be used by national and local bodies in developing,


evaluating and progressively refining SOPs for ethical
review of biomedical research.
Worst Examples of Research
Research driven by curiosity or ambition that treats
the patient as a means to an end.
Research that needlessly prolongs distress because of
the protocol design.
Research where researchers lose interest after the last
day of the study.

(Research that an investigator would not recommend


to his or her own loved ones if they were similarly
affected by the illness)
Importance of Ethics in Research

1. Human subjects can be harmed or wronged as


participants in health research.
2. “Good guys can sometimes be bad.”
3. Scientific/economic interest may trump individual
person's interest.
4. Promote public credibility of research.
5. Sustain public support.
National Policies for Health Research
RA 3573: Reporting of communicable diseases
RA 3720: Food, Drugs and Devices and Cosmetics Act
RA 8230: Prohibition of Counterfeit Drugs
RA 8423: Traditional and Alternative Medicine Act
RA 8504: Philippine AIDS Prevention and Control Act

DOH AO-22-A s1982: Research Policies and Guidelines in the MOH


DOH AO 27 s2001: Rules and Regulations for Licensing Local
Manufacturers of Vaccines and Biologic Products
DOH AO 47-A s2001: Rules and Regulations on the Registration,
including approval and Conduct of Clinical Trials…
DOH DO 255-1s2002: To establish a functional institutional ethics
review system for researches in the department
DOH AO 46-A s2003: Implementing Guidelines for Establishment of
Research Review System in the DOH
DOST PCHRD SO 84-053: Creation of a National Ethics Committee to
ensure that all health research and development proposals conform
with ethical standards
Philippine Guidelines for Biomedical
and Behavioral Research

National Guidelines for Biomedical/Behavioral


Research (PCHRD-NEC) 1985, 1996, 2000, 2006
Ethical Guidelines in AIDS Investigation in the
Philippines, 1998
Ethics of Social Science Research in Health, 2004
Institutional Guidelines
The National Ethical Guidelines
for Health Research
1984 PCHRD SO No. 84-053: Organization of the National
Ethics Committee
1985 National Guidelines for Biomedical Research
1996 National Guidelines for Biomedical /Behavioral
Research (2nd edition)
2000 (3rd edition)
2003 PNHRS MOU
2004 PNHRS-TWG on Ethics
2005 Ad Hoc Committee on Revision of Guidelines
2006 Organization of the Philippine Research Ethics Board
2006 National Ethical Guidelines for Health Research
Contents
How to use the Guidelines
Abbreviations
Ethics Review Authorities
Ethics Review Committees
The Review Process
General Guidelines
Special Guidelines
Guidelines on Authorship and Publications
Glossary
Index
Rationale: A need for-

A reference that integrates the common issues


addressed by international ethical guidelines.
Contextualization of international guidelines in the
local research environment.
A reference for ethical concerns unique to the country
(structural and substantive)
Research ethics is a way of thinking. It is about
our responsibilities to one another in a
research environment/context. It is about
respect, truthfulness, caring and collaboration.