Beruflich Dokumente
Kultur Dokumente
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
(CIOMS, 2002)
Definitions
(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...
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.
- Proxy consent
- Standard of care
- Therapeutic/ Non-therapeutic research
- Placebo controls
Universal Declaration of Human
Rights 1966