INFORMED CONSENT STUDY GUIDE EXAM 2026/2027
QUESTIONS AND SOLUTIONS RATED A+
✔✔What is broad consent? - ✔✔Broad consent is an alternative to informed consent.
Broad consent is unlikely to be used by researchers in the social and behavioral
sciences but is an available option as an alternative to informed consent for each
individual study using the collected information or biospecimen.
✔✔3 ways researchers ensure that subjects understand consent information (the 3 P's)
- ✔✔1. Provide sufficient detail about the research
2. Present information in a way that is not just a list of facts
3. Prepare material in the subject's language at the appropriate reading level (8th gr)
✔✔What principle requires that participation in research be truly voluntary and free from
coercion or undue influence? - ✔✔Respect for persons
✔✔3 ways to ensure that subjects have free choice in consent process? (BEE) - ✔✔1.
Be mindful of time and setting
Time - give adequate time to consider whether they wish to take part in a study.
Setting - might include elements of undue influence (ex: Adolescents whose parents are
in the room or Employees asked to take part by their employer)
2. Ensure incentives are not so high they override other considerations for potential
subjects (undue influence)
3. Employ safeguards for vulnerable subjects (can include assessing the cognitive
capacity of potential subjects and ensuring that incentives are not coercive
✔✔Do the ethical principles in the Belmont Report still apply for research that is exempt
from federal regulations (still with human subjects)? Who decides who to handle
informed consent in these cases? - ✔✔Yes the principles still apply and each institution
or IRB decides how to handle informed consent in research that is eligible for exemption
from the regulations.
✔✔The waiver or alteration of any (or all) of the elements of consent can be authorized
by the IRB only if these 5 criteria are met: - ✔✔1. Research involves no more than
minimal risk to the subjects.
2. Research could not practicably be carried out without the requested waiver or
alteration.(Disclosing the purpose of the research may influence how subjects respond.)
3. If the research involves using identifiable private info, research could not practicably
be carried out without using such information in an identifiable format.
4. The waiver or alteration will not adversely affect the rights and welfare of the
subjects.
5. When appropriate, the subjects or LAR will be given additional pertinent information
after participation. (AKA debriefing; not required if subject selection was based on an
undesirable trait)
, ✔✔1 of 2 conditions to meet in order to get a waiver for obtaining info for screening,
recruiting, or determining eligibility without the informed consent of the prospective
subject - ✔✔1. The investigator will obtain information through oral or written
communication with the prospective subject or LAR
OR
2. The investigator will obtain identifiable private information by accessing records or
stored identifiable biospecimens.
✔✔In social and behavioral research, deception and complete non-disclosure of
information to subjects may be necessary to... - ✔✔avoid subject response bias in the
research
✔✔The IRB must review the research plan for deception or complete non-disclosure of
information to ensure... - ✔✔there is adequate justification for the technique as well as
an adequate debriefing plan for after the research.
✔✔______ _______ can sometimes be justified as essential for investigating a
particular phenomenon - ✔✔outright deception
✔✔______ _______ requires a waiver of all of elements of consent if the research
takes place in a setting in which subjects could reasonably expect that their behavior
was not being observed and recorded. - ✔✔Covert observation (under non-disclosure;
ppl may change behavior if they know they are observed)
✔✔1st method when documentation of informed consent is required - ✔✔1. The subject
or (LAR) signs a form (by hand or electronically) containing all the required elements of
consent and any additional info necessary to provide complete disclosure. The person
who signed the consent form is given a copy as a reference and reminder of the info..
✔✔2nd method when documentation of informed consent is required - ✔✔The consent
is done orally in the subject's language & is documented by an impartial witness. This
process uses two documents:
(1) a short form written consent document stating that the required elements of consent
have been presented orally to the subject or LAR
AND
(2) a written, IRB-approved summary of what will be said to the subject or LAR. The
subject signs the short form. The witness signs both forms. The person actually
obtaining consent signs the summary. Copies of the short form and the summary are
given to the subject.
✔✔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
QUESTIONS AND SOLUTIONS RATED A+
✔✔What is broad consent? - ✔✔Broad consent is an alternative to informed consent.
Broad consent is unlikely to be used by researchers in the social and behavioral
sciences but is an available option as an alternative to informed consent for each
individual study using the collected information or biospecimen.
✔✔3 ways researchers ensure that subjects understand consent information (the 3 P's)
- ✔✔1. Provide sufficient detail about the research
2. Present information in a way that is not just a list of facts
3. Prepare material in the subject's language at the appropriate reading level (8th gr)
✔✔What principle requires that participation in research be truly voluntary and free from
coercion or undue influence? - ✔✔Respect for persons
✔✔3 ways to ensure that subjects have free choice in consent process? (BEE) - ✔✔1.
Be mindful of time and setting
Time - give adequate time to consider whether they wish to take part in a study.
Setting - might include elements of undue influence (ex: Adolescents whose parents are
in the room or Employees asked to take part by their employer)
2. Ensure incentives are not so high they override other considerations for potential
subjects (undue influence)
3. Employ safeguards for vulnerable subjects (can include assessing the cognitive
capacity of potential subjects and ensuring that incentives are not coercive
✔✔Do the ethical principles in the Belmont Report still apply for research that is exempt
from federal regulations (still with human subjects)? Who decides who to handle
informed consent in these cases? - ✔✔Yes the principles still apply and each institution
or IRB decides how to handle informed consent in research that is eligible for exemption
from the regulations.
✔✔The waiver or alteration of any (or all) of the elements of consent can be authorized
by the IRB only if these 5 criteria are met: - ✔✔1. Research involves no more than
minimal risk to the subjects.
2. Research could not practicably be carried out without the requested waiver or
alteration.(Disclosing the purpose of the research may influence how subjects respond.)
3. If the research involves using identifiable private info, research could not practicably
be carried out without using such information in an identifiable format.
4. The waiver or alteration will not adversely affect the rights and welfare of the
subjects.
5. When appropriate, the subjects or LAR will be given additional pertinent information
after participation. (AKA debriefing; not required if subject selection was based on an
undesirable trait)
, ✔✔1 of 2 conditions to meet in order to get a waiver for obtaining info for screening,
recruiting, or determining eligibility without the informed consent of the prospective
subject - ✔✔1. The investigator will obtain information through oral or written
communication with the prospective subject or LAR
OR
2. The investigator will obtain identifiable private information by accessing records or
stored identifiable biospecimens.
✔✔In social and behavioral research, deception and complete non-disclosure of
information to subjects may be necessary to... - ✔✔avoid subject response bias in the
research
✔✔The IRB must review the research plan for deception or complete non-disclosure of
information to ensure... - ✔✔there is adequate justification for the technique as well as
an adequate debriefing plan for after the research.
✔✔______ _______ can sometimes be justified as essential for investigating a
particular phenomenon - ✔✔outright deception
✔✔______ _______ requires a waiver of all of elements of consent if the research
takes place in a setting in which subjects could reasonably expect that their behavior
was not being observed and recorded. - ✔✔Covert observation (under non-disclosure;
ppl may change behavior if they know they are observed)
✔✔1st method when documentation of informed consent is required - ✔✔1. The subject
or (LAR) signs a form (by hand or electronically) containing all the required elements of
consent and any additional info necessary to provide complete disclosure. The person
who signed the consent form is given a copy as a reference and reminder of the info..
✔✔2nd method when documentation of informed consent is required - ✔✔The consent
is done orally in the subject's language & is documented by an impartial witness. This
process uses two documents:
(1) a short form written consent document stating that the required elements of consent
have been presented orally to the subject or LAR
AND
(2) a written, IRB-approved summary of what will be said to the subject or LAR. The
subject signs the short form. The witness signs both forms. The person actually
obtaining consent signs the summary. Copies of the short form and the summary are
given to the subject.
✔✔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
