INFORMED CONSENT 2026/2027 QUESTIONS AND
SOLUTIONS RATED A+
✔✔Documentation of the consent process is not always required (waivers of
documentation are not waivers of the consent process itself). An IRB may waive
documentation under 3 circumstances. What is the 1st circumstance? - ✔✔1. The
principal risks are those associated with a breach of confidentiality concerning the
subject's participation in the research, and the consent document is the only record
linking the subject with the research.
ex: women who left abusive partners
✔✔Documentation of the consent process is not always required (waivers of
documentation are not waivers of the consent process itself). An IRB may waive
documentation under 3 circumstances. What is the 2nd circumstance? - ✔✔2. Study
participation presents minimal risk of harm to the subject and the research involves no
procedures requiring consent outside the context of participation in a research study.
Ex: a telephone survey.
✔✔Documentation of the consent process is not always required (waivers of
documentation are not waivers of the consent process itself). An IRB may waive
documentation under 3 circumstances. What is the 3rd circumstance? - ✔✔3. Subjects
or LARs are members of a distinct cultural group/community where signing forms is not
the norm, the research presents no more than minimal risk of harm to subjects, and
provided there is an appropriate alternative for documenting that informed consent was
obtained.
✔✔ What are the 2 parts of informed consent? - ✔✔1. Provide information to
prospective subjects
2. Documentation that the process took place and record of the subject's agreement to
take part in the study
✔✔The emphasis is on presenting information that a _________ would want to have in
order to make an informed decision to participate, providing an opportunity to discuss,
and ensuring subject (or LAR) comprehension. - ✔✔"reasonable person"
✔✔In practice, informed consent forms often are used as a means to provide
information about a study, and, when signed.... - ✔✔serve as documentation of
consent.
✔✔Can oral consent be given without documentation? If so, who must approve it? -
✔✔Yes and the IRB
SOLUTIONS RATED A+
✔✔Documentation of the consent process is not always required (waivers of
documentation are not waivers of the consent process itself). An IRB may waive
documentation under 3 circumstances. What is the 1st circumstance? - ✔✔1. The
principal risks are those associated with a breach of confidentiality concerning the
subject's participation in the research, and the consent document is the only record
linking the subject with the research.
ex: women who left abusive partners
✔✔Documentation of the consent process is not always required (waivers of
documentation are not waivers of the consent process itself). An IRB may waive
documentation under 3 circumstances. What is the 2nd circumstance? - ✔✔2. Study
participation presents minimal risk of harm to the subject and the research involves no
procedures requiring consent outside the context of participation in a research study.
Ex: a telephone survey.
✔✔Documentation of the consent process is not always required (waivers of
documentation are not waivers of the consent process itself). An IRB may waive
documentation under 3 circumstances. What is the 3rd circumstance? - ✔✔3. Subjects
or LARs are members of a distinct cultural group/community where signing forms is not
the norm, the research presents no more than minimal risk of harm to subjects, and
provided there is an appropriate alternative for documenting that informed consent was
obtained.
✔✔ What are the 2 parts of informed consent? - ✔✔1. Provide information to
prospective subjects
2. Documentation that the process took place and record of the subject's agreement to
take part in the study
✔✔The emphasis is on presenting information that a _________ would want to have in
order to make an informed decision to participate, providing an opportunity to discuss,
and ensuring subject (or LAR) comprehension. - ✔✔"reasonable person"
✔✔In practice, informed consent forms often are used as a means to provide
information about a study, and, when signed.... - ✔✔serve as documentation of
consent.
✔✔Can oral consent be given without documentation? If so, who must approve it? -
✔✔Yes and the IRB
