Presentation Importance and History of Research Ethics

8/8/2019 Presentation Importance and History of Research Ethics

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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 EthicsInternational and National Guidelines

Marita V. T. Reyes, MDPhilippine Health Research Ethics Board


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Topics

Definitions:

Research, Health Research

Ethics, Research Ethics

Good Clinical Practice

Historical Notes in the Development of ResearchEthics

Importance of Ethics in ResearchResearch Ethics in the Philippines


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Definitions

Research- refers to a class of activity designed todevelop or contribute to generalizable knowledge(e.g., theories, principles or relationships) or theaccumulation of information on which they are based,

that can be corroborated by accepted scientificmethods of observations and inference.

Health Research- medical and behavioral studiespertaining to human health.

(CIOMS, 2002)


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Definitions

Ethics- is doing the right thing (deals with the conceptof 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 definingright processes in the conduct of health research.


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Definitions

Good Clinical Practice- a standard for the design,

conduct, performance, monitoring, auditing, recording,

analysis, and reporting of clinical trials that providesassurance that the data and reported results arecredible and accurate and that the rights, integrity andconfidentiality of trial subjects are protected.

(ICH-GCP, 1997)


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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-WHOInternational Ethical Guidelines forBiomedical Research Involving Human Subjects


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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 (Geneva2000)


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Nazi experiments exposed during the

Nuremberg Trials (1946)

23 German doctors committed crimes against humanityfor 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 whohave been severely chilled/ frozen after falling into the

sea: (Subjects forced to remain in ice water for 3 hours)


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Nazi experiments, contd

For diseases troubling German occupation forces

- malaria: Healthy subjects infected using mosquitos- infected wounds: Sulfanilamide clinical trial

Subjects deliberately wounded, infected withbacteria, circulation interrupted, aggravated byforcing wood shavings and ground glass.)

- feasibility of organ transplantation: Bone, muscleand 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 ofuseless people, ex: poisons


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Nuremberg Code- 1947

- Focused on voluntary consent and human rights ofhuman participants.

- Avoidance of unnecessary physical and mentalsuffering and injury

- Balancing risks and benefits

- Termination of research participation by the humansubject

- proper design and prior information

- Qualification of researcher


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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


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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 freeconsent to medical or scientific experimentation.


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Willowbrook Hepatitis Expt (1960s)

Objective: To determine the mode of infection thehepatitis virus and course of the disease and to testeffectiveness 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 theinfection at Willowbrook so its better for them to beinfected under carefully controlled research conditions.


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Tuskegee Clinical Trial (1932-1972)

NIH- sponsored, Alabama, USA

Objective: To determine the clinical course of untreatedsyphilis.

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.


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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.


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CIOMS-WHO

International Ethical Guidelines forBiomedical Research involving Human

Subjects1982, 1993, 2002

(Council for International Organizations of Medical Sciences- foundedunder the auspices of WHO and UNESCO in 1949)

Application of ethical standards in local circumstances,and establishing or improving ethical reviewmechanisms.

Aims to reflect the conditions and the needs of low-resource countries, and the implications for multinationalor transnational research in which they may be partnersespecially those involving vulnerable groups.


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ICH Guidelines for Good ClinicalPractice (1996)

International Conference on Harmonization of Technical Requirementsfor Registration of Pharmaceuticals for Human Use

Objective: To provide a unified standard for the EU,Japan and the United Sates to facilitate the mutualacceptance of clinical data by the regulatoryauthorities in these jurisdictions

A standard for the design, conduct, performance,monitoring, auditing, recording, analyses, andreporting of clinical trials that provides assurance-

(1) that the data and reported results are credibleand accurate, and

(2) that the rights, integrity and confidentiality oftrial subjects are protected.


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WHO Operational Guidelines for EthicsCommittees that Review Biomedical

Research (Geneva 2000)

Intended to facilitate and support ethical review in allcountries around the world.

Objective: To contribute to the development of qualityand consistency in the ethical review of biomedicalresearch.

- To be used by national and local bodies in developing,evaluating and progressively refining SOPs for ethicalreview of biomedical research.


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Worst Examples of Research

Research driven by curiosity or ambition that treatsthe patient as a means to an end.

Research that needlessly prolongs distress because ofthe protocol design.

Research where researchers lose interest after the lastday of the study.

(Research that an investigator would not recommend

to his or her own loved ones if they were similarlyaffected by the illness)


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Importance of Ethics in Research

1. Human subjects can be harmed or wronged asparticipants in health research.

2. Good guys can sometimes be bad.

3. Scientific/economic interest may trump individualperson's interest.

4. Promote public credibility of research.

5. Sustain public support.


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National Policies for Health Research

RA 3573: Reporting of communicable diseases

RA 3720: Food, Drugs and Devices and Cosmetics ActRA 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 LocalManufacturers 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 departmentDOH 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 toensure that all health research and development proposals conformwith ethical standards


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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


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The National Ethical Guidelines

for Health Research

1984 PCHRD SO No. 84-053: Organization of the NationalEthics Committee

1985 National Guidelines for Biomedical Research

1996 National Guidelines for Biomedical /Behavioral

Research (2ndedition)

2000 (3rdedition)

2003 PNHRS MOU

2004 PNHRS-TWG on Ethics

2005 Ad Hoc Committee on Revision of Guidelines2006 Organization of the Philippine Research Ethics Board

2006 National Ethical Guidelines for Health Research


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How to use the GuidelinesAbbreviations

Ethics Review Authorities

Ethics Review Committees

The Review Process

General Guidelines

Special Guidelines

Guidelines on Authorship and Publications

Glossary

Index

Contents


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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)


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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.


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Presentation Importance and History of Research Ethics

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