Declaration of Helsinki

Question 1

What is the primary purpose of medical research involving human subjects?

Answer 1

To understand the causes, development, and effects of disease and improve preventive, diagnostic, and therapeutic interventions (methods, procedures, and treatments)

Question 2

Even the best proven interventions must be evaluated continually through research for their…….

Answer 2

safety, effectiveness, efficacy, accountability, and quality

Question 3

Appropriate _______________________ for subjects who are harmed as a result of participating in research must be ensured.

Answer 3

compensation and treatment

Question 4

Medical research with a ___________________ is only justified if 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.

Answer 4

vulnerable group

Question 5

Required elements of protocols from Declaration of Helsinki

Answer 5

• statement of the ethical considerations involved and indicate how the principle of the Declaration of Helsinki have been addressed - information regarding funding, sponsors, institutional affiliations, potential conflicts of interested - incentives for subjects - information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study - arrangements for post-trial provisions

Question 6

Informed Consent Requirements - Declaration of Helsinki

Answer 6

• aims - methods - sources of funding - any possible conflicts of interest - institutional affiliations of the researcher - anticipated benefits and potential risks of the study and the discomfort it may entail - post-study provisions - informed of right to refuse or to withdraw at any time

Question 7

Every research study involving human subjects must be registered in a publicly accessible database before _________________.

Answer 7

recruitment of the first subject

Question 8

How often is the Declaration of Helsinki reviewed and updates?

Answer 8

Every 4 years