Unit 7 Flashcards
The potential recipient of services or participant in a research study gives his or her explicit permission before any assessment or treatment is provided.
informed consent
requires more than obtaining permission – permission must come after full disclosure and information is provided to the participant
informed consent
Three tests must be met before informed consent can be considered valid
- capacity - information - voluntariness
requires that the person (including the guardian) giving consent has reached the age of majority (usually 18 years) and is competent to make such decisions.
Capacity (elements of informed consent)
- has reached age of majority - has NOT been adjudicated as incompetent
Legal Competence
requires that the person giving consent be informed - that he or she has the right to refuse to give consent without penalty - that he or she may withdraw consent at any time without penalty
information (elements of informed consent)
Must be informed of - the exact nature of the procedures - the expected benefits or the procedures - the potential risks of the procedures - the risks/benefits of alternative approaches
information (elements of informed consent)
requires that there be no coercion or duress in obtaining consent
voluntariness
for individuals incapable of giving informed consent, the bx analyst shall:
- provide an appropriate explanation - discontinue research if the person gives clear signs of unwillingness to continue participation - obtain appropriate permission from a legally authorized person, if such substitute consent is required by law
when there is no one from whom consent can be obtained:
- the consumer’s bx must be judged to present imminent danger to self or others and that, within reasonable certainty, harm will result if services are not provided. - there must be a reasonable probability that the proposed bx analysis services will produce beneficial effects for the consumer without harmful effects. - procedural safeguards should be in place to protect the rights of the consumer and service provider.
- the consumer has the right to revoke his or her consent at any time - consent should be time-limited and reviewed on a regular basis
Limits of Consent
obtaining/reviewing consent must reflect:
- risk - intrusiveness - irreversibility
general principle of informed consent
the riskier, more intrusive or more irreversible the activity; the more formal the consent process should be
relatively informal vs. more formal examples of consent…
- implied (no objection) - oral - written or recorded
Level of formality will determine who consents…
general principle – the less “mentally capable” the person, the more likely the consent of another will be required