Declaration of Helsinki

Question 1

The Declaration of Helsinki was formulated by the?

a) National commission for the protection of human subject
b) Council for the international organization of medical sciences
c) The War Crimes Tribunal
d) World Medical Association

Answer 1

d) World Medical Association

Question 2

Which of the following ethical frameworks has been revised on several occasions?

a) The Belmont report
b) The Nuremberg Code
c) ICH-GCP
d) The Declaration of Helsinki

Answer 2

d) The Declaration of Helsinki

Question 3

The Declaration of Helsinki contains which of the following items:

a) In medical research most procedures involve risks and burdens
b) The welfare of animals must be respected
c) Medical research is justified only if there is likelihood that the research populations stand to benefit from the results of the research
d) Medical research should only be carried out if the importance of the objective outweighs the inherent risks to the subjects
e) Negative as well as positive results should be published or made publicly available.
f) Post-trial provision of a beneficial treatment should be provided with the relevant information to study participants
g) All of the above

Answer 3

g) All of the above

a) In medical research most procedures involve risks and burdens
b) The welfare of animals must be respected
c) Medical research is justified only if there is likelihood that the research populations stand to benefit from the results of the research
d) Medical research should only be carried out if the importance of the objective outweighs the inherent risks to the subjects
e) Negative as well as positive results should be published or made publicly available.
f) Post-trial provision of a beneficial treatment should be provided with the relevant information to study participants

Question 4

Regarding the informed consent process the Declaration of Helsinki does not include which of the following:
(Select all that apply)

a) Participation by individuals giving consent must be voluntary
b) It may be appropriate to consult with family members or community leaders regarding the informed consent process
c) The informed consent must include sources of funding and conflicts of interest and institutional affiliations of the researcher.
d) The dependent relationship with a physician should be avoided in a consent situation
e) The refusal of consent should not affect the patient physician relationship.
f) Payment information must be included.
g) The ability of external regulatory bodies to audit the study must be included in the consent.
h) For medical research on data or material to be contained in biobanks or similar repositories informed consent must be obtained regarding collection, storage, use and reuse.

Answer 4

b) It may be appropriate to consult with family members or community leaders regarding the informed consent process

Question 5

Regarding the reporting of serious adverse events, which of the following statements is included in the Declaration of Helsinki;

a) Serious adverse events need to be reported only if they are unanticipated and possibly related to the research.
b) The data and safety monitoring board should send reports directly to the research ethics committee
c) The researcher must provide monitoring information to the committee especially information about any serious adverse events
d) The research ethics committee should review all adverse events from all participating sites in a clinical trial.

Answer 5

c) The researcher must provide monitoring information to the committee especially information about any serious adverse events

Question 6

Regarding the use of placebos in clinical trials, the Declaration of Helsinki states that:

a) The benefits risks and burdens of a new intervention must be tested against the best proven intervention.
b) Placebo may be used when for sound methodological reasons it is important to determine safety and efficacy of the intervention
c) The use of placebo will not result in additional risks of serious or irreversible harm to the subject relative to not receiving the best possible intervention
d) All of the above

Answer 6

d) All of the above

a) The benefits risks and burdens of a new intervention must be tested against the best proven intervention.
b) Placebo may be used when for sound methodological reasons it is important to determine safety and efficacy of the intervention
c) The use of placebo will not result in additional risks of serious or irreversible harm to the subject relative to not receiving the best possible intervention

Question 7

With regard to the role of medical care in medical research the Declaration of Helsinki notes:

a) Consent for the medical care is not separately required
b) Medical care and medical research should be kept separable as much as possible
c) Procedures for medical research but not medical care should be described in the informed consent
d) When medical research is combined with medical care, additional standards apply to protect the research subjects.

Answer 7

d) When medical research is combined with medical care, additional standards apply to protect the research subjects.