GCP Research Misconduct
Researchers are not required to account for disclosures of protected health information (PHI) when: A) The participant authorizes disclosure. B) The information is provided as a complete data set. C) The information contains particpant identifiers.
A) The participant authorizes disclosure.
Medical records, paper based and electronic, are subject to disclosure and confidentiality requirements. A) True B) False
A) True
Which of the following constitutes research misconduct according to federal regulations? A. Fabrication of data. B. Falsification of data. C. Failure to protect human research subjects. D. Plagiarism. E. A, B, and D
A, B, and D
The U.S. Congress passed the Health Insurance Portability and Accountability Act.HIPAA in 1996, and the HIPAA Privacy Rule applies to which of the following entities? A) IRB B) A health plan. C) A health care clearinghouse. D) Scientific advisory committees. E) A and D F) B and C
F) B and C
Each research site taking part in a study is always responsible for obtaining its own certificate of confidentiality. A. True B. False
False
Which one is NOT a goal Of the regulations for dealing with research misconduct. ( 42 CFR 50 Subpart A). A. To define research misconduct. B. To define penalties for research misconduct. C. To establish procedures for reporting and investigating research misconduct. D. To protect both those who report alleged research misconduct. E. To protect those accused of research misconduct.
To establish procedures for reporting and investigating research misconduct.
Research and research institutions have the primary responsibility for reporting and investigating allegations of research misconduct. True or False
True
Regarding response to allegations of research misconduct, which of the following is CORRECT: A) The accused researcher is entitled to know who the informant is. B) The informant privacy must be protected to the extent possible and may remain anonymous c) The information may be penalized if the allegations are not sustained even if made in good faith. d) Anyone with appropriate expertise may be selected to investigate an allegation of research misconduct e) All cases of alleged misconduct in a clinical trial must be immediately reported to the trial principal investigator, the federal agency sponsoring the trial and the office of research integrity (ORI).
d) Anyone with appropriate expertise may be selected to investigate an allegation of research misconduct
The term fraud describes: a) Illegal and deceptive practices b) Fabrication c) Falsification d) plagiarism e) none of the above
a) Illegal and deceptive practices
The document that provides protection for the privacy of study participants in alcohol and drug abuse research studies is called? a) Affidavit. b) Certificate of confidentiality. c) Disclosure certificate d) Confidentiality agreement forms.
b) Certificate of confidentiality.
Which of the following events is considered research misconduct? a) Unintentional errors in data entry b) Differences of opinion c) Failure to protect human research subjects. d) Authorship dispute not involving plagiarism
c) Failure to protect human research subjects.
Which element or elements are required for a finding of research misconduct? a) the misconduct must have resulted in harm to human research subjects b) research misconduct must be committed "intentionally, or knowingly, or recklessly c) An allegation of research misconduct must be proven by a" preponderance of the evidence" (that is by most of the evidence) d) significant departure from accepted practices of the relevant research community e) B, C, and D
e) B, C, and D
Define fabrication of data
making up data or results and recording or reporting them
Define plagiarism
using another person's ideas, processes, results or works without giving appropriate credit
Falsification of data is:
manipulating research material, equipment, or credit processes or changing or omitting data or results such that the research is not accurately represented in the research record
