Test 4 Informed Consent Flashcards
What are elements of the informed consent process?
Providing specific information about the study to subjects in a way that is understandable to them.
Answering questions to better ensure subjects understand the research and their role in it.
Giving subjects adequate time to consider their decisions.
Obtaining the voluntary agreement of subjects to take part in the study. The agreement is only to enter the study, as subjects may withdraw at any time, or decline to answer specific questions or complete specific tasks at any time during the research.
What is exculpatory language?
Subjects may not be asked to waive or even appear to waive any of their legal rights. They may not be asked to release a researcher, sponsor, or institution from liability for negligence. Institutions may provide information about how liabilities will be covered.
What are the 4 criteria for a waiver of informed consent?
no more than minimal risk
not adversely affect rights or welfare
could not practicably be carred out without the waiver or alteration
whenever appropriate, subjects will be provided with additional pertinent info after
What is deception?
not informing subjects about purpose
How does one ensure comprehension of consent information?
eliciting questions from subjects and asking questions, for example, “Could you describe in your own words what the study is about and what you will be asked to do?” or “Tell me what bad things might happen if you take part in this study.”
How does the principle of respect impact informed consent?
requires that participation in research be truly voluntary, free from coercion or undue influence.
What are the major issues when using incentives?
may become unduly influential if it is so high that it overrides other considerations for potential subjects. Subjects may misrepresent themselves
What are 2 methods for documentation of informed consent?
sign form
done orally and documented by impartial witness
What is a waiver of documentation of informed consent?
waivers to explain why informed consent didnt need to be documented (but it still occured.
