ACRP CCRC Exam - CITI GCP Questions
With Correct Answers
Belmont /Report /(1979) /- /verified /answer(s)-✔✔Created /to /summarize /basic /ethical /principles
/for /research.
Pharmacodynamics /(PD) /- /verified /answer(s)-✔✔Describes /the /effects /of /the /agent /on /the
/body.
3 /basic /ethical /principles /of /Belmont /Report /- /verified /answer(s)-✔✔1. /Respect /for /Persons
2. /Beneficence
3. /Justice
Respect /for /Persons /- /verified /answer(s)-✔✔Treating /persons /as /autonomous /agents /and
/protecting /those /with /diminished /autonomy. /
Ex: /Providing /informed /consent /(accurate /information /about /the /study /and /its /procedures),
/ensuring /comprehension /and /that /patients' /participation /is /voluntary /in /research.
Beneficence /- /verified /answer(s)-✔✔Obligation /to /secure /persons' /wellbeing, /"do /good",
/maximize /possible /benefits /and /minimize /possible /harms.
Justice /- /verified /answer(s)-✔✔Fairness /in /distribution.
Distribution /of /benefits /and /burdens /to /each /person:
1. /an /equal /share
, 2. /according /to /individual /need
3. /according /to /individual /effort
4. /according /to /societal /contribution
5. /according /to /merit
Informed /Consent /- /verified /answer(s)-✔✔Document /voluntarily /signed /by /patient /that
/clearly /describes /purpose, /methods, /procedures, /anticipated /benefits, /and /risks /of /a
/diagnostic /or /treatment /procedure.
Incomplete /Disclosure /- /verified /answer(s)-✔✔Withholding /some /information /in /order /to
/conduct /an /unbiased /study /when /informing /patients /of /some /pertinent /aspect(s) /of /the
/study /is /likely /to /impair /the /validity /of /the /research.
Justifications /for /Incomplete /Disclosure /- /verified /answer(s)-✔✔Incomplete /Disclosure /is /only
/justified /when:
1. /it /is /truly /necessary /to /accomplish /goals /of /the /research
2. /there /are /no /undisclosed /risks /to /subjects /that /are /more /than /minimal /risk
3. /there /is /an /adequate /plan /for /debriefing /subjects /when /appropriate /and /for /dissemination
/of /research /results /to /them
Coercion /- /verified /answer(s)-✔✔An /overt /threat /or /harm /is /intentionally /presented /by /one
/person /to /another /to /obtain /compliance.
Undue /Influence /- /verified /answer(s)-✔✔Occurs /through /offer /of /an /excessive, /unwarranted,
/inappropriate, /or /improper /reward /in /order /to /obtain /compliance.
Risk /- /verified /answer(s)-✔✔Possibility /that /harm /may /occur, /includes /chance /(probability)
/and /severity /(magnitude) /of /envisioned /harm.
With Correct Answers
Belmont /Report /(1979) /- /verified /answer(s)-✔✔Created /to /summarize /basic /ethical /principles
/for /research.
Pharmacodynamics /(PD) /- /verified /answer(s)-✔✔Describes /the /effects /of /the /agent /on /the
/body.
3 /basic /ethical /principles /of /Belmont /Report /- /verified /answer(s)-✔✔1. /Respect /for /Persons
2. /Beneficence
3. /Justice
Respect /for /Persons /- /verified /answer(s)-✔✔Treating /persons /as /autonomous /agents /and
/protecting /those /with /diminished /autonomy. /
Ex: /Providing /informed /consent /(accurate /information /about /the /study /and /its /procedures),
/ensuring /comprehension /and /that /patients' /participation /is /voluntary /in /research.
Beneficence /- /verified /answer(s)-✔✔Obligation /to /secure /persons' /wellbeing, /"do /good",
/maximize /possible /benefits /and /minimize /possible /harms.
Justice /- /verified /answer(s)-✔✔Fairness /in /distribution.
Distribution /of /benefits /and /burdens /to /each /person:
1. /an /equal /share
, 2. /according /to /individual /need
3. /according /to /individual /effort
4. /according /to /societal /contribution
5. /according /to /merit
Informed /Consent /- /verified /answer(s)-✔✔Document /voluntarily /signed /by /patient /that
/clearly /describes /purpose, /methods, /procedures, /anticipated /benefits, /and /risks /of /a
/diagnostic /or /treatment /procedure.
Incomplete /Disclosure /- /verified /answer(s)-✔✔Withholding /some /information /in /order /to
/conduct /an /unbiased /study /when /informing /patients /of /some /pertinent /aspect(s) /of /the
/study /is /likely /to /impair /the /validity /of /the /research.
Justifications /for /Incomplete /Disclosure /- /verified /answer(s)-✔✔Incomplete /Disclosure /is /only
/justified /when:
1. /it /is /truly /necessary /to /accomplish /goals /of /the /research
2. /there /are /no /undisclosed /risks /to /subjects /that /are /more /than /minimal /risk
3. /there /is /an /adequate /plan /for /debriefing /subjects /when /appropriate /and /for /dissemination
/of /research /results /to /them
Coercion /- /verified /answer(s)-✔✔An /overt /threat /or /harm /is /intentionally /presented /by /one
/person /to /another /to /obtain /compliance.
Undue /Influence /- /verified /answer(s)-✔✔Occurs /through /offer /of /an /excessive, /unwarranted,
/inappropriate, /or /improper /reward /in /order /to /obtain /compliance.
Risk /- /verified /answer(s)-✔✔Possibility /that /harm /may /occur, /includes /chance /(probability)
/and /severity /(magnitude) /of /envisioned /harm.
