Declaration of Helsinki

Question 1

What is the World Medical Association Declaration of Helsinki?

Answer 1

It is a set of ethical principles for medical research involving human subjects. It has been amended a number of times since the original adoption; most recently by the WMA in October 2013

Question 2

Who is the WMA Declaration of Helsinki primarily addressed to?

Answer 2

Physicians – however the WMA encourages others who are involved in medical research with human subjects to adopt these principles.

Question 3

What topics does the Declaration of Helsinki address?

Answer 3

Risks, Burdens, & Benefits.
Vulnerable Groups and Individuals.
Scientific Requirements and Research Protocols.
Research Ethics Committees.
Privacy and Confidentiality.
Use of Placebo.
Post Trial Provisions
Research Registration and Publication and Dissemination of Results.
Unproven Interventions in Clinical Practice.
Informed Consent

Question 4

_____ developed the Declaration of Helsinki in 1964

Answer 4

“World Medical Association”

Question 5

It is the duty of ______ to promote and safeguard the health of patients including those in research

Answer 5

the physician

Question 6

What document (Nuremberg, Belmont, Helsinki) established the need for a legally authorized representative?

Answer 6

Declaration of Helsinki.

Question 7

“The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including”

Answer 7

“Research on identifiable
human material and data.”

Question 8

The Declaration of Geneva of the WMA binds the physician with the words, “

Answer 8

“The health of my
patient will be my first consideration”

Question 9

The primary purpose of medical research involving human subjects is to

Answer 9

To understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

Question 10

“Appropriate compensation and treatment for subjects who are harmed as a result of
participating in research must be ensured.”

Answer 10

TRUE

Question 11

Physicians may not be involved in a research study involving human subjects unless

Answer 11

they are confident that the risks have been adequately assessed and can be satisfactorily managed.

Question 12

Medical research with a vulnerable group is only justified if

Answer 12

The research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non‐vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Question 13

Post‐Trial Provisions

Answer 13

In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post‐trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Question 14

For a potential research subject who is incapable of giving informed consent,

Answer 14

MUST NOT 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 subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

Question 15

When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research,

Answer 15

the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.

Question 16

In research involving subjects who are physically or mentally incapable of giving consent (for example, unconscious patients)

Answer 16

The physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

Question 17

For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories,

Answer 17

The physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Question 18

The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Answer 18

“Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.”

Question 19

Since 1964, there have been…..revisions and …..clarifications

Answer 19

7; 2

Question 20

“In 1964, the Declaration of Helsinki was
developed by the World Medical Association, forming the basis for the ethical principles that underlie”

Answer 20

ICH-GCP guidelines

Question 21

For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, there may be exceptional situations where consent would be impossible or impracticable to obtain for such research.

Answer 21

In such situations the research may be done only after consideration and approval of a research ethics committee.