Declaration of Helsinki Flashcards
Who developed the Declaration of Helsinki?
World Medical Association (WMA)
What is the purpose of medical research?
The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments)
According to the Declaration of Helsinki, subjects who are harmed as a result of participating in research must be ensured of what?
Appropriate compensation + treatment
According to the Declaration of Helsinki, what should the protocol contain? (4)
The protocol should contain
- a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed.
- information regarding funding, sponsors, institutional affiliations, potential conflicts of interest
- incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.
- appropriate arrangements for post-trial provisions.
T/F Only high risk research studies involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
False, Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
Who has ethical obligations with regard to the publication and dissemination of the results of research?
Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research.
According to the Declaration of Helsinki, who has the right to monitoring ongoing studies?
The IRB committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events.
What do subjects need to be informed of in the ICF? (7)
Each potential subject must be adequately informed of the
- study aims,
- methods,
- sources of funding,
- any possible conflicts of interest,
- institutional affiliations of the researcher,
- the anticipated benefits and potential risks of the study and the discomfort it may entail,
- post-study provisions and any other relevant aspects of the study.
- right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.
Who must the physician must seek informed consent of for a potential research subject who is incapable of giving informed consent?
LAR
The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in what circumstances?
- Where no proven intervention exists, the use of placebo, or no intervention, is acceptable
- 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
Define Post Trial Provisions
A research participants’ right to continue to access the potentially beneficial interventions after the completion of the clinical trial.
This information must also be disclosed to participants during the informed consent process
When can unproven interventions in clinical practice be used?
In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgment it offers hope of saving life, re-establishing health or alleviating suffering.
This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy.
What audience/group was the Declaration of Helsinki intended to be written for?
Physicians
According to the Declaration of Helsinki, who can conduct medical research involving human subjects?
Only by individuals with the appropriate ethics and scientific education, training and qualifications; requires supervision of a competent and appropriately qualified physician or other health care professional
According to the Declaration of Helsinki, should groups that are underrepresented in medical research be able to participate?
Yes, they should be provided appropriate access to participate in research
