Ethics and Regulation Flashcards
Moral problem in Clinical Research
- benefit to individuals is not the goal (it can occur)
- people are a means to develop useful knowledge
THE GOAL IS GAINING USEFUL KNOWLEDGE ABOUT HUMANS AND ILLNESS
dual responsibility physcicians
Clinical care (patient care oriented) 2) clinical reseach: produce generalizable findings for a whole population
Codes and guidelines (5)
Nuremberg Code
Belmont report, delcaration of Helsink, Council for Int Org of Medical Sciences (CIOMS), ICH GCP, E6.
Aims of ethical requirments
Ensure rights and welfare of subjects are respected and protected, minimize possibility of exploitation
Ethical Pilars of Research Codes (8)
Autonomy, Beneficience Non malfeasance (avoid harm), Fidelity-duty to care, Truthfullness, Confidentiality Justice Independent review
toelichting ethical pillars: Autonomy, Beneficence
Auto: recht op zelfbeschikking, bescherming kwetsbaren, vrijwillig informed consent, informed participants,
Bene: maximize benefit, acceptable risk/benefit.
vertaling malfeasance:
misdrijf!, dus non-malfeasance = avoid/minimize harm.
Toelichting: Fidelity-Duty to care
Toelichting truthfullnes:
(vert: trouw/ plicht tot zorg): 1) conform to accepted scientific principles/current literature. 2) qualified individuals
3) provisions for those who may be harmed
Truth: zowel naar participatns als wetenschappelijke community
Toelichting Ethical pilar JUSTICE (3)
Fair sharing of burdens and benefits of research, 2) those who bear the burden share in the benefit.
3) access to what is studied.
Herhaling 8 pilars ethical research
Autonomy, beneficience, fidelity/duty to care, non-malfeasance, truthfulness, confidentialiy, justice, independent review (IRB)
Investigator responsibilities ICH -E6 (13)
qualification adequacy of resources medical care study partci, communication IRB compliance protocol investigational product care randomization/blinding informed consent records/reports progress reports safety reporting stopping/susp a study reporting
WMA Decleration of Helsinki: physcician investigators
It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty.
GCP
- bron: Intern conf on Harmonization (ICH)
- gebasseerd op: decl of Helsinki
- bescherming human subjects
- uniforme design, uitvoering, reporting trials,
- public assurance
- resutls are accurtae, credible
Wat is het doel van een onderzoeksprotocol? (6)
allows medical/statistical/ethical review, adresses feasibility, demostrates qualifications and readiness, ris/benefit desciscion making IRB
Research plan: population ethical issue
justice: inviduals and groups that bear the burden should share in potential benefits
DaarnaasT: avoid overprotection in vullnerable or other populations (kinderen)
