CIP ACTUAL STUDY GUIDE QUESTIONS AND
ANSWERS SET A+
✔✔Stateville Prison Malaria Study - ✔✔1940s Prisoner-subjects were infected with
malaria for the purpose of testing the safety and efficacy of novel anti-malaria drugs.
Over time, commentators have shifted from viewing the malaria research at Stateville as
a model of ethical clinical research to seeing the experiments as paradigmatic of
abusive human experimentation.
✔✔The Radioactive Drug Research Committee (RDRC) program - ✔✔1975 The FDA
published a Federal Register notice classifying all radioactive drugs as either new drugs
requiring an Investigational New Drug Application (IND) for investigational use (21 CFR
312) or as generally recognized as safe and effective when administered under the
conditions specified in the RDRC regulations (21 CFR 361.1). The RDRC program
under 21 CFR 361.1 permits basic research using radioactive drugs in humans without
an IND when the drug is administered under the following conditions:
1. The research is considered basic science research and is done for the purpose of
advancing scientific knowledge. Under § 361.1(a), this type of research is:
*intended to obtain basic information regarding the metabolism (including kinetics,
distribution, dosimetry, and localization) of a radioactive drug or regarding human
physiology, pathophysiology, or biochemistry,
*not intended for immediate therapeutic, diagnostic or similar purposes (e.g. preventive
benefit to the study subject from the research), and
not intended to determine the safety and effectiveness of a radioactive drug in humans.
2. The research study is approved by an FDA-approved RDRC based on the following
requirements [§ 361.1(b)(1)(iv)]:
*qualified study investigators
*properly licensed medical facility to possess and handle radioactive materials
*appropriate selection and consent of research subjects
*appropriate quality assurance of radioactive drug administered
*sound research protocol design
*reporting of adverse events by the investigator to the RDRC
*approval by an appropriate Institutional Review Board (IRB)
, 3. The pharmacologic dose of the radioactive drug to be administered is known not to
cause any clinically detectable pharmacologic effect in humans [§ 361.1(b)(2)].
4. The radiation dose to be administered is justified by the quality of the s
✔✔ Minimal Risk - ✔✔The probability of harm or discomfort...not greater...than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations.
✔✔The Belmont Principles - ✔✔Respect for persons, beneficence, and justice
✔✔IRB - ✔✔An administrative body composed of scientists and nonscientists
established to protect the rights and welfare of human research subjects recruited to
participate in research activities conducted under the auspices of the institution with
which it is affiliated.
✔✔Institutional Official (IO) - ✔✔The person who signs the OHRP Federalwide
Assurance and has the legal authority to act and speak for the institution, and should be
somone who can ensure that the institution will effectively fulfill its research oversight
function.
✔✔OHRP - ✔✔Charged with monitoring and promoting compliance with DHHS
regulations that relate to the ethical standards of human-subject resarch. They have the
final word on when an institution is not complying with DHHS regulations and what the
institution must do to correct the problem.
✔✔Minutes - ✔✔45 CFR 46.115 (2) Require sufficiently detailed documentation to
include attendance at the meeting; actions taken by the IRB; the vote on these actions,
including the number of members voting for, against, or abstaining; the basis for
requiring changes in or disapproving research; and a written summary of the discussion
of controverted issues and their resolution.
✔✔Research Audit Program - ✔✔Proactive, non-punitive, and focused on educating
investigators about their ethical and regulatory responsibilities in the conduct of
research.
✔✔IRB Director/Administrator - ✔✔Primary person responsible for managing the IRB
office and many of the administrative aspects of IRB meetings.
✔✔IRB Membership - ✔✔Must consist of at least five members and include at least one
scientist, one nonscientist and one person not affiliated with the institution.
✔✔IRB Membership Roster - ✔✔Refers to the number of voting member positions on
the IRB.
ANSWERS SET A+
✔✔Stateville Prison Malaria Study - ✔✔1940s Prisoner-subjects were infected with
malaria for the purpose of testing the safety and efficacy of novel anti-malaria drugs.
Over time, commentators have shifted from viewing the malaria research at Stateville as
a model of ethical clinical research to seeing the experiments as paradigmatic of
abusive human experimentation.
✔✔The Radioactive Drug Research Committee (RDRC) program - ✔✔1975 The FDA
published a Federal Register notice classifying all radioactive drugs as either new drugs
requiring an Investigational New Drug Application (IND) for investigational use (21 CFR
312) or as generally recognized as safe and effective when administered under the
conditions specified in the RDRC regulations (21 CFR 361.1). The RDRC program
under 21 CFR 361.1 permits basic research using radioactive drugs in humans without
an IND when the drug is administered under the following conditions:
1. The research is considered basic science research and is done for the purpose of
advancing scientific knowledge. Under § 361.1(a), this type of research is:
*intended to obtain basic information regarding the metabolism (including kinetics,
distribution, dosimetry, and localization) of a radioactive drug or regarding human
physiology, pathophysiology, or biochemistry,
*not intended for immediate therapeutic, diagnostic or similar purposes (e.g. preventive
benefit to the study subject from the research), and
not intended to determine the safety and effectiveness of a radioactive drug in humans.
2. The research study is approved by an FDA-approved RDRC based on the following
requirements [§ 361.1(b)(1)(iv)]:
*qualified study investigators
*properly licensed medical facility to possess and handle radioactive materials
*appropriate selection and consent of research subjects
*appropriate quality assurance of radioactive drug administered
*sound research protocol design
*reporting of adverse events by the investigator to the RDRC
*approval by an appropriate Institutional Review Board (IRB)
, 3. The pharmacologic dose of the radioactive drug to be administered is known not to
cause any clinically detectable pharmacologic effect in humans [§ 361.1(b)(2)].
4. The radiation dose to be administered is justified by the quality of the s
✔✔ Minimal Risk - ✔✔The probability of harm or discomfort...not greater...than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations.
✔✔The Belmont Principles - ✔✔Respect for persons, beneficence, and justice
✔✔IRB - ✔✔An administrative body composed of scientists and nonscientists
established to protect the rights and welfare of human research subjects recruited to
participate in research activities conducted under the auspices of the institution with
which it is affiliated.
✔✔Institutional Official (IO) - ✔✔The person who signs the OHRP Federalwide
Assurance and has the legal authority to act and speak for the institution, and should be
somone who can ensure that the institution will effectively fulfill its research oversight
function.
✔✔OHRP - ✔✔Charged with monitoring and promoting compliance with DHHS
regulations that relate to the ethical standards of human-subject resarch. They have the
final word on when an institution is not complying with DHHS regulations and what the
institution must do to correct the problem.
✔✔Minutes - ✔✔45 CFR 46.115 (2) Require sufficiently detailed documentation to
include attendance at the meeting; actions taken by the IRB; the vote on these actions,
including the number of members voting for, against, or abstaining; the basis for
requiring changes in or disapproving research; and a written summary of the discussion
of controverted issues and their resolution.
✔✔Research Audit Program - ✔✔Proactive, non-punitive, and focused on educating
investigators about their ethical and regulatory responsibilities in the conduct of
research.
✔✔IRB Director/Administrator - ✔✔Primary person responsible for managing the IRB
office and many of the administrative aspects of IRB meetings.
✔✔IRB Membership - ✔✔Must consist of at least five members and include at least one
scientist, one nonscientist and one person not affiliated with the institution.
✔✔IRB Membership Roster - ✔✔Refers to the number of voting member positions on
the IRB.
