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ACRP - MDP Subspeciality > Declaration Of Helsinki (DOH) > Flashcards

Declaration Of Helsinki (DOH) Flashcards

1
Q

When (date) and by Whom was the Declaration of Helsinki (DOH) adopted by?

A

Adopted by the 18th World Medical Association (WMA) General Assembly, Helsinki, Finland 1964.

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2
Q

How often is the DOH revised

A

~4 years

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3
Q

Why was the DOH developed?

A

as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

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4
Q

Who is the DOH primarily addressed to?

A

Physicians, but encouraged to anyone in medical research involving human subjects adopt the principles.

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5
Q

T/F-Medical progress is based on research that ultimately must include studies involving human subjects.

A

True

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6
Q

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.

A

B. is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures, treatments).

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7
Q

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.

A

C. Safety, Effectiveness, Efficiency, Accessibility and Quality.

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8
Q

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.

A

FALSE.

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9
Q

The responsibility for the protection of research subjects must always rest with the ______ or _______ and never with the________, even though they have given consent.

A

PHYSICIAN
OTHER HEALTH CARE PROFESSIONALS
RESEARCH SUBJECTS

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10
Q

Can National or international ethical, legal or regulatory requirements set the standard for protections?

A

No-No, National or international ethical, legal or regulatory requirements can reduce or eliminate the protections in the DOH.

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11
Q

Medical Research should be conducted in a manner that minimizes possible harm to the:

A. Environment
B. Sponsor
C. Animal Subjects
D. Physician

A

A. Envrionment

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12
Q

Appropriate_____ and ______ who are harmed as a result of participating in research must be ensure.

A

Compensation and Treatment

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13
Q

T/F: In medical practice and medical research, most interventions don’t involve risks and burden.

A

False. They do :)

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14
Q

Medical research involving human subjects may only be conducted if: ______________?

A

The importance of the objectives outweighs the risks and burdens to the research subjects.

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15
Q

T/F Risks do not have to be continuously monitored, assessed and documented by the researched

A

False. They do.

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16
Q

What is a physician to do when risks are found to outweigh the potential benefits or conclusive proof of definitive outcomes?

A

Physician must assess whether to continue, modify or immediately stop the study.

17
Q

T/F: Vulnerable groups should receive specifically considered protections?

A

True

18
Q

3 Reasons when research with a Vulnerable group is justified:

A
  1. If the research is responsive to the health needs or priorities of group.
  2. Research cannot be carried out on non-vulnerable group.
  3. This group should stand to benefit from the knowledge, practices and interventions that result from the research.
19
Q

Which one isn’t true—-Medical research involving human subjects must conform to:

  1. Generally accepted scientific principles
  2. based on thorough knowledge of scientific literature
  3. other relevant sources of information
  4. Information in the Investigator Brochure
  5. adequate laboratory
  6. . Animal testing, if appropriate
A
  1. isn’t true, the rest apply.
20
Q

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.

A

F-The protocol SHOULD contain a statement of ethical considerations involved. (not legal). and how principles of DOH have been addressed.

21
Q 
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

A-F

22
Q

T/F: The protocol does not have to describe the appropriate arrangements for post-trial provisions.

A

False.

23
Q

Does the ethics committee have to be independent from the researcher?

A

Yes

24
Q

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
A

C and D

25
Q

What is submitted to the ethics committee at the end of a study?

A

Final Report summarizing study findings and conclusions.

26
Q

T/F: If an individual is capable of giving informed consent, it must be voluntary?

A

True

27
Q

When giving Informed Consent, what 10 things must the potential subject be informed of?

A
  1. Aims
  2. Methods
  3. Sources of funding
  4. any possible conflicts of interests
  5. institutional affiliations of the researcher
  6. Anticipated benefits
  7. Potential risks and discomfort it may entail
  8. Post-study provisions
  9. Any other relevant aspects of study
  10. Right to refuse or withdrawal from study at anytime.
28
Q

Can a subject just withdrawal from a study at anytime without proper notice?

A

Yes

29
Q

T/F: It is possible to get non-written informed consent?

A

True-must be formally documented and witnessed.

30
Q

If a subject can’t give informed consent, the physician must seek it from:

A

Legally Authorized Representative (LAR).

31
Q

A subject who can’t give informed consent can be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subjects.

A

False

32
Q

If a subject is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, what must the physician do?

A

Physician must seek that assent in addition to consent of the Legally Authorized Representative. The subjects dissent should be respected.

33
Q

Under what conditions can you obtain consent, If a potential research subject is physically or mentally unable to give consent?

A

It may be done only if the phsucail or mental condition that prevents giving informed consent is a necessary characteristic of the research group. Must obtain from LAR.

34
Q

If a LAR is not available for consent for a person who is mentally or physically unable to give consent, can you proceed with research?

A

Yes-only if research cannot be delayed and that the reasons for involving research subjects with a condition that renders them unable to give consent has been stated in the research protocol and the study is approved by the ethics committee.

35
Q

Why would consent to remain in a study be needed?

A

For a subject mentally and physically unable to give consent, and a LAR was not available. Consent to remain in study must be obtained from LAR or subject as soon as possible.

36
Q

T/F: Physicians must seek informed consent for medical research using identifiable human material or data?

A

True- unless it would be impossible or impracticable to obtain for such research. Approval by EC if that is the case.

ACRP - MDP Subspeciality (13 decks)

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