Declaration Of Helsinki (DOH) Flashcards
When (date) and by Whom was the Declaration of Helsinki (DOH) adopted by?
Adopted by the 18th World Medical Association (WMA) General Assembly, Helsinki, Finland 1964.
How often is the DOH revised
~4 years
Why was the DOH developed?
as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
Who is the DOH primarily addressed to?
Physicians, but encouraged to anyone in medical research involving human subjects adopt the principles.
T/F-Medical progress is based on research that ultimately must include studies involving human subjects.
True
According to the DOH, what is the primary purpose of medical research involving human subjects?
A. is to understand the causes and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures, treatments).
B. is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures, treatments).
C. is to understand the effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures, treatments).
D. is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions.
B. is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures, treatments).
Even the best proven interventions must be evaluated continually through research for their:
A. Safety, Effectiveness, Accessibility and Quality.
B. Effectiveness, Efficiency, Accessibility, Quality and Popularity.
C. Safety, Effectiveness, Efficiency, Accessibility and Quality.
D. Safety, Effectiveness, Reliability, Accessibility and Quality.
C. Safety, Effectiveness, Efficiency, Accessibility and Quality.
T/F: While the primary purpose of medical research is to generate new knowledge, under certain circumstances this can take precedence over the rights and interest of individual research subjects.
FALSE.
The responsibility for the protection of research subjects must always rest with the ______ or _______ and never with the________, even though they have given consent.
PHYSICIAN
OTHER HEALTH CARE PROFESSIONALS
RESEARCH SUBJECTS
Can National or international ethical, legal or regulatory requirements set the standard for protections?
No-No, National or international ethical, legal or regulatory requirements can reduce or eliminate the protections in the DOH.
Medical Research should be conducted in a manner that minimizes possible harm to the:
A. Environment
B. Sponsor
C. Animal Subjects
D. Physician
A. Envrionment
Appropriate_____ and ______ who are harmed as a result of participating in research must be ensure.
Compensation and Treatment
T/F: In medical practice and medical research, most interventions don’t involve risks and burden.
False. They do :)
Medical research involving human subjects may only be conducted if: ______________?
The importance of the objectives outweighs the risks and burdens to the research subjects.
T/F Risks do not have to be continuously monitored, assessed and documented by the researched
False. They do.
What is a physician to do when risks are found to outweigh the potential benefits or conclusive proof of definitive outcomes?
Physician must assess whether to continue, modify or immediately stop the study.
T/F: Vulnerable groups should receive specifically considered protections?
True
3 Reasons when research with a Vulnerable group is justified:
- If the research is responsive to the health needs or priorities of group.
- Research cannot be carried out on non-vulnerable group.
- This group should stand to benefit from the knowledge, practices and interventions that result from the research.
Which one isn’t true—-Medical research involving human subjects must conform to:
- Generally accepted scientific principles
- based on thorough knowledge of scientific literature
- other relevant sources of information
- Information in the Investigator Brochure
- adequate laboratory
- . Animal testing, if appropriate
- isn’t true, the rest apply.
T/F: The protocol may contain a statement of the ethical and legal considerations involved and should indicate how the principles of the DOH have been addressed.
F-The protocol SHOULD contain a statement of ethical considerations involved. (not legal). and how principles of DOH have been addressed.
The protocol should contain the following information: A. Funding B. Sponsors C. Institutional affiliations D. Potential Conflicts of Interests E. Incentives for Subjects F. Information Regarding provisions for treating/compensating subjects who are harmed. G. Vulnerable populations included H. All of the Above.
A-F
T/F: The protocol does not have to describe the appropriate arrangements for post-trial provisions.
False.
Does the ethics committee have to be independent from the researcher?
Yes
What does the researcher have to provide the ethics committee for review?
A. Adverse Events B. Protocol Deviations C. Serious Adverse Events D. Protocol Revisions E. All of the Above
C and D
