INFORMED CONSENT TEST PAPER 2026/2027
QUESTIONS AND SOLUTIONS RATED A+
✔✔The 9 items from the basic elements of informed consent (category 1) that must be
included. What are items 4 and 5? - ✔✔4. A disclosure of appropriate alternative
procedures or courses of treatment, if any, that might be advantageous to the subject.
(mainly in biomedical; but sometimes social and behavioral research if behavioral
interventions are proposed)
5. A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained. (must include full disclosure of state-mandated reporting
requirements, such as suspicion of child abuse or harm to others.)
✔✔The 9 items from the basic elements of informed consent (category 1) that must be
included. What are items 6 and 7? - ✔✔6. An explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist of, what
compensation will be provided, and where further information may be obtained. (For
research involving more than minimal risk)
7. An explanation of whom to contact for answers to pertinent questions about the
research and research subjects' rights, and whom to contact in the event of a research-
related injury to the subject. (Alternative means of communication must be established,
such as a local contact on the research team if call/email not available)
✔✔The 9 items from the basic elements of informed consent (category 1) that must be
included. What is item 8? - ✔✔8. A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the subject is otherwise
entitled, and the subject may discontinue participation at any time without penalty or
loss of benefits to which the subject is otherwise entitled.
*(Most researchers in the social/behavioral sciences aren't in a position to impose
penalties. However, study-related assurances that no negative consequences with
choosing not to take part might be appropriate. ex: kids in school won't have grades
affected)
✔✔The 9 items from the basic elements of informed consent (category 1) that must be
included. What is item 9? - ✔✔9. One of the following statements about any research
involving collection of identifiable private info must be included:
1. A statement that identifiers might be removed from the identifiable private info and
that, after removal, the info could be used for future studies or given to another
investigator without additional informed consent if this might be a possibility;
OR
2)A statement that the subject's info collected, even if identifiers are removed, will not
be used or distributed for future research studies.
(*only needed for research that involves the collection of identifiable info or
biospecimens)
, ✔✔What are incentives? Do they need to be described in the consent process? - ✔✔1.
Incentives are payments or gifts offered to subjects as reimbursement for their
participation.
2. They must be described during the consent process as well as the conditions under
which subjects will receive partial or no payment.
✔✔What role does recruitment play in the informed consent process? - ✔✔Recruitment
starts the process of providing information of the study
✔✔What are some examples of recruitment strategies? Do all recruitment strategies
have to be approved by the IRB? For those who need approval, when must they get it?
- ✔✔1. fliers, email messages, newspaper advertisements, phone scripts
2. Yes and approved before they are used
✔✔Exculpatory vs Non-exculpatory language - ✔✔Exculpatory: you waive any rights to
sue or any compensation for any injuries you may receive as a result for your
participation
Non-exculpatory: your participation is voluntary. Choosing not to participate or changing
your mind later will not affect your relationship with the researcher or your right to other
eligible services
✔✔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
QUESTIONS AND SOLUTIONS RATED A+
✔✔The 9 items from the basic elements of informed consent (category 1) that must be
included. What are items 4 and 5? - ✔✔4. A disclosure of appropriate alternative
procedures or courses of treatment, if any, that might be advantageous to the subject.
(mainly in biomedical; but sometimes social and behavioral research if behavioral
interventions are proposed)
5. A statement describing the extent, if any, to which confidentiality of records identifying
the subject will be maintained. (must include full disclosure of state-mandated reporting
requirements, such as suspicion of child abuse or harm to others.)
✔✔The 9 items from the basic elements of informed consent (category 1) that must be
included. What are items 6 and 7? - ✔✔6. An explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist of, what
compensation will be provided, and where further information may be obtained. (For
research involving more than minimal risk)
7. An explanation of whom to contact for answers to pertinent questions about the
research and research subjects' rights, and whom to contact in the event of a research-
related injury to the subject. (Alternative means of communication must be established,
such as a local contact on the research team if call/email not available)
✔✔The 9 items from the basic elements of informed consent (category 1) that must be
included. What is item 8? - ✔✔8. A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the subject is otherwise
entitled, and the subject may discontinue participation at any time without penalty or
loss of benefits to which the subject is otherwise entitled.
*(Most researchers in the social/behavioral sciences aren't in a position to impose
penalties. However, study-related assurances that no negative consequences with
choosing not to take part might be appropriate. ex: kids in school won't have grades
affected)
✔✔The 9 items from the basic elements of informed consent (category 1) that must be
included. What is item 9? - ✔✔9. One of the following statements about any research
involving collection of identifiable private info must be included:
1. A statement that identifiers might be removed from the identifiable private info and
that, after removal, the info could be used for future studies or given to another
investigator without additional informed consent if this might be a possibility;
OR
2)A statement that the subject's info collected, even if identifiers are removed, will not
be used or distributed for future research studies.
(*only needed for research that involves the collection of identifiable info or
biospecimens)
, ✔✔What are incentives? Do they need to be described in the consent process? - ✔✔1.
Incentives are payments or gifts offered to subjects as reimbursement for their
participation.
2. They must be described during the consent process as well as the conditions under
which subjects will receive partial or no payment.
✔✔What role does recruitment play in the informed consent process? - ✔✔Recruitment
starts the process of providing information of the study
✔✔What are some examples of recruitment strategies? Do all recruitment strategies
have to be approved by the IRB? For those who need approval, when must they get it?
- ✔✔1. fliers, email messages, newspaper advertisements, phone scripts
2. Yes and approved before they are used
✔✔Exculpatory vs Non-exculpatory language - ✔✔Exculpatory: you waive any rights to
sue or any compensation for any injuries you may receive as a result for your
participation
Non-exculpatory: your participation is voluntary. Choosing not to participate or changing
your mind later will not affect your relationship with the researcher or your right to other
eligible services
✔✔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
