CITI Training Review: Human Subjects
Research
"The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male"
Study - ANS - The study most directly linked to the establishment of the "National
Research Act" (1974) and ultimately the "Belmont Report and Federal Regulations for
Human Subject Protection"
A criterion for waiving informed consent: - ANS - When appropriate, subjects are
provided additional pertinent information after the study
A researcher leaves a research file in her car while she attends concert and her car is
stolen. The file contains charts of aggregated numerical data from a research study with
human subjects, but no other documents. The consent form said that no identifying
information would be retained, and the researcher adhered to that component. - ANS -
Neither a Breach of Confidentiality or a Violation of Subject's Privacy
A subject in a clinical trial experiences a serious, unanticipated adverse drug
experience. The investigator should proceed, with respect to the IRB, after the
discovery of the adverse event occurrence by: - ANS - Reporting the adverse drug
experience in a timely manner, in keeping with the IRB's policies and procedures, using
the forms or the mechanism provided by the IRB
A Violation of Subjects' Privacy - ANS - The right of the individuals to be protected
against intrusion into their personal lives or affairs
A waiver of the requirement for documentation of informed consent may be granted
when: - ANS - - The only record linking the subject and the research is the consent
document
- AND the principal risk is a breach of confidentiality
Amendments involving changes to IRB approved protocols do NOT need prior IRB
approval if: - ANS - The changes must be immediately implemented for the health and
well-being of the subject
, An investigator is required to keep consent documents, IRB correspondence, and
research records for: - ANS - A minimum of 3 years after completion of the study
Anonymity - ANS - Implies that the researcher or readers of the final research report or
paper cannot identify a given response with a specific respondent
As a part of the consent process, researchers are required (by the Federal regulations)
to provide subjects with information: - ANS - At the appropriate reading comprehension
level
Breach of Confidentiality - ANS - The research data have been disclosed, counter to
the agreement between researcher and subjects
Careers & Scores - ANS - GRE: 310-330 (competitive)
Internship/shadow: 2000 hours
GPA: 3.5+
Community Service
Research
Confidentiality - ANS - The researcher can identify a person's responses, but promises
not to divulge that person's identity in any report, paper, or public forum
Data are made anonymous by: - ANS - Destroying all identifiers connected to the data
Disclosure - ANS - Usually, researchers have an obligation to provide some
information about their study to potential subjects before data collection to help them
decide whether or not they wish to participate in the study
Ethics - ANS - - Conformance to the standards of conduct of a given profession or
group
- the moral distinction between right and wrong
Example of a study in which it would NOT be appropriate to provide subjects with
information about missing elements of consent: - ANS - A study in which subjects were
assigned to study activities based on an undesirable or unflattering physical
characteristic as assessed by members of the research team.
Example of a study that constitutes both a Breach of Confidentiality AND a Violation of
Subjects' Privacy - ANS - A faculty member makes identifiable data about sexual
Research
"The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male"
Study - ANS - The study most directly linked to the establishment of the "National
Research Act" (1974) and ultimately the "Belmont Report and Federal Regulations for
Human Subject Protection"
A criterion for waiving informed consent: - ANS - When appropriate, subjects are
provided additional pertinent information after the study
A researcher leaves a research file in her car while she attends concert and her car is
stolen. The file contains charts of aggregated numerical data from a research study with
human subjects, but no other documents. The consent form said that no identifying
information would be retained, and the researcher adhered to that component. - ANS -
Neither a Breach of Confidentiality or a Violation of Subject's Privacy
A subject in a clinical trial experiences a serious, unanticipated adverse drug
experience. The investigator should proceed, with respect to the IRB, after the
discovery of the adverse event occurrence by: - ANS - Reporting the adverse drug
experience in a timely manner, in keeping with the IRB's policies and procedures, using
the forms or the mechanism provided by the IRB
A Violation of Subjects' Privacy - ANS - The right of the individuals to be protected
against intrusion into their personal lives or affairs
A waiver of the requirement for documentation of informed consent may be granted
when: - ANS - - The only record linking the subject and the research is the consent
document
- AND the principal risk is a breach of confidentiality
Amendments involving changes to IRB approved protocols do NOT need prior IRB
approval if: - ANS - The changes must be immediately implemented for the health and
well-being of the subject
, An investigator is required to keep consent documents, IRB correspondence, and
research records for: - ANS - A minimum of 3 years after completion of the study
Anonymity - ANS - Implies that the researcher or readers of the final research report or
paper cannot identify a given response with a specific respondent
As a part of the consent process, researchers are required (by the Federal regulations)
to provide subjects with information: - ANS - At the appropriate reading comprehension
level
Breach of Confidentiality - ANS - The research data have been disclosed, counter to
the agreement between researcher and subjects
Careers & Scores - ANS - GRE: 310-330 (competitive)
Internship/shadow: 2000 hours
GPA: 3.5+
Community Service
Research
Confidentiality - ANS - The researcher can identify a person's responses, but promises
not to divulge that person's identity in any report, paper, or public forum
Data are made anonymous by: - ANS - Destroying all identifiers connected to the data
Disclosure - ANS - Usually, researchers have an obligation to provide some
information about their study to potential subjects before data collection to help them
decide whether or not they wish to participate in the study
Ethics - ANS - - Conformance to the standards of conduct of a given profession or
group
- the moral distinction between right and wrong
Example of a study in which it would NOT be appropriate to provide subjects with
information about missing elements of consent: - ANS - A study in which subjects were
assigned to study activities based on an undesirable or unflattering physical
characteristic as assessed by members of the research team.
Example of a study that constitutes both a Breach of Confidentiality AND a Violation of
Subjects' Privacy - ANS - A faculty member makes identifiable data about sexual
