Declaration of Helsinki

Question 1

Declaration of Helsinki was first document that (x2)

Answer 1

-guided the conduct of research
- set guidelines for ethical principles

Question 2

Declaration of Helsinki created what 4 things?

Answer 2

-ICF
-IRB
-Knowledge and guidance of special protections of vulnerable populations
-Recommendation that trials are registered on public databases

Question 3

When do research studies have to be registered on public database?

Answer 3

Before first subject is enrolled in study

Question 4

Name some vulnerable populations

Answer 4

Children, minors, pregnant women, fetuses, human in vitro fertilization, prisoners, employees, military persons and students in hierarchical organizations, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized, elderly

Question 5

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 5

vulnerable group

Question 6

Required elements of protocols from Declaration of Helsinki

Answer 6

• 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 7

Informed Consent Requirements - Declaration of Helsinki

Answer 7

• 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 8

What are vulnerable populations?

Answer 8

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate