INFORMED CONSENT COMPREHENSIVE EXAM
2026/2027 QUESTIONS AND SOLUTIONS RATED A+
✔✔Consent - ✔✔Mutual agreement between researchers and subjects which both
parties affirm their intentions to behave in patiular ways
✔✔Therapeutic Misconception - ✔✔Believe that primary goal of study is to provide
treatment instead of gain scientific knowledge. Causes them to overemphasize benefits
and underestimate risks. Researchers should explain difference between research and
therapy
✔✔Elements of Consent - ✔✔Competence, Information, Voluntariness,
Comprehension, and Authorization
✔✔Competence element of Consent - ✔✔Refers to the legal capacity to make a
decision. If court declares someone incompetent parent or guardian make decisions for
that person. Children legally incompetent.
Decision making capacity
✔✔Decision making capacity - ✔✔If you have Decision making capacity, you are
capable of making a responsible choice. You might be legally competent but lack DMC.
Ex: Adult that is mentally ill legally competent but lacks Decision making capacity.
Ex 2: 17 year old smart as hell and has decision making capacity but not legally
competent
✔✔Legally Authorized Representative - ✔✔Individual who decides wether someone
who is legally competent, has the DMC to make the choice.
Ex Jacksons mom deciding if he can do the study or not
✔✔Information element of Consent - ✔✔Person providing consent must have enough
information to make a responsible choice. Regulations require that researchers disclose
information that a reasonable person would want to have to make a decision to
participation
✔✔Three Standards for Disclosing Information - ✔✔Professional Standard, Reasonable
Person Standard, and Subjective Standard
✔✔Subjective Standard - ✔✔Medical professional should disclose information patient
would want to know. Engage in a lot of dialogue to know what someone would want to
know. Just places a lot of stress on researcher because takes a lot of time.
2026/2027 QUESTIONS AND SOLUTIONS RATED A+
✔✔Consent - ✔✔Mutual agreement between researchers and subjects which both
parties affirm their intentions to behave in patiular ways
✔✔Therapeutic Misconception - ✔✔Believe that primary goal of study is to provide
treatment instead of gain scientific knowledge. Causes them to overemphasize benefits
and underestimate risks. Researchers should explain difference between research and
therapy
✔✔Elements of Consent - ✔✔Competence, Information, Voluntariness,
Comprehension, and Authorization
✔✔Competence element of Consent - ✔✔Refers to the legal capacity to make a
decision. If court declares someone incompetent parent or guardian make decisions for
that person. Children legally incompetent.
Decision making capacity
✔✔Decision making capacity - ✔✔If you have Decision making capacity, you are
capable of making a responsible choice. You might be legally competent but lack DMC.
Ex: Adult that is mentally ill legally competent but lacks Decision making capacity.
Ex 2: 17 year old smart as hell and has decision making capacity but not legally
competent
✔✔Legally Authorized Representative - ✔✔Individual who decides wether someone
who is legally competent, has the DMC to make the choice.
Ex Jacksons mom deciding if he can do the study or not
✔✔Information element of Consent - ✔✔Person providing consent must have enough
information to make a responsible choice. Regulations require that researchers disclose
information that a reasonable person would want to have to make a decision to
participation
✔✔Three Standards for Disclosing Information - ✔✔Professional Standard, Reasonable
Person Standard, and Subjective Standard
✔✔Subjective Standard - ✔✔Medical professional should disclose information patient
would want to know. Engage in a lot of dialogue to know what someone would want to
know. Just places a lot of stress on researcher because takes a lot of time.
