CRP 113 Lecture 1

Question 1

why do we need ethics? (4)

Answer 1

-provide standard
-identify complex issues and guide decision making
-protect participants
-assess and balance benefit/risk ratio

Question 2

Beaumont Report 1833 (5)

Answer 2

-oldest american document of research ethics
-experimentation is needed
-invesigtor must be conscientious and resonsible
-investigator musthave good methodological approach, no random studies
-voluntary consent necessary
-discontinue experiment when participant distressed, objects, or dissatisfied

Question 3

Nuremburg Code 1947 10 elements

Answer 3

-first codification of research guidelines
-voluntary consent
-anticipate scientific benefits
-benefits outweigh risks
-animal experiments first
-avoid suffering
-no intentional death or disability
-protection from harm
-subject free to stop
-qualifies investigators
-investigator stop if harm occurs

Question 4

Hippocratic Oath

Answer 4

could not protect human rights and welfare in the context of research, was designed only for the scope of the doctor-patient relationship

Question 5

World Health Organization WHO 1948

Answer 5

-UN health authority
-leadership in global health
-shape research agenda
-norms and standards
-evidence-based policy
-assess health trends

Question 6

Clinical Trial Registery

Answer 6

-WHO
-publication of internationally agreedset of info on the design, conduct and administration of CTs

Question 7

Kefauver Amendments 1962

Answer 7

-required drug manufacturers to provide proof of effeciveness and safety of drugs before approval

Question 8

Declaration of Helsinki 1964

Answer 8

-Ethical principal for medical research involving human subjects
-18th world medical assembly
-forms the basis of modern GCP
-well-being over interests of science and society
-consent in writing
-caution for participants in dependent relationship with researcher
-limit use of placebo
-participants must benefit
-ethical review comittee approval required

Question 9

Belmont Report 1979

Answer 9

-National Comission for the protection of human subjects of biomedial and behavioral research
-distinctin between research and practice
-respect for persons, beneficence, justice

Question 10

respect for persons

Answer 10

-autonomy: mental capacity to understand info
-individuals as autonomous
-vulnerability: people choose for themselves, extra protection for those without autonomy
-must obtain informed consent
-respect privacy of participants

Question 11

Beneficence

Answer 11

-best possible research design to maximize benefits and minimize harm
-researchers able to perform procedures and handle risks
-cannot conduct research without favorable benefit risk ratio

Question 12

Justice

Answer 12

-select patients fairly and equitably
-do not exploid vulnerable populations or populations of convenience