CITI training responsible conduct
Issued in 1974, 45 CFR 46 raised to regulatory status:
45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".
Under HIPAA, a "disclosure accounting" is required:
For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA include
Identifiable health information that is created or held by covered entities and their business associates.
If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful:
If the only identifier collected in the course of a study would be the signature on the consent document and the principal source of harm would be a breach of confidentiality disclosing one's participation in the study, a waiver of documentation of informed consent should be sought. With such a waiver, the informed consent process could be conducted verbally with no written evidence of the subject's participation in the research.
IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
Occur at least annually.
The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that:
Persons with diminished autonomy are entitled to protection.
Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.
Which of the following is true regarding research misconduct?
Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct.
Which of the following brought increased public attention to the problems with the IRB system?
Although all of these are related to the problems with the IRB system, the death of a research subject (Jesse Gelsinger) was what received public attention.
In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
Although data encryption, using pseudonyms, and waiving documentation of consent, provide data protection, the researcher can link individuals to their responses. Therefore, the data are vulnerable to subpoena in civil, criminal, and administrative court proceedings. Unless the researcher has a Certificate of Confidentiality, he or she may be compelled to release individually identifiable information about research subjects. The Certificate provides the highest level of protection.
Which of the following is the most effective strategy for preventing research misconduct?
Among the options mentioned, good mentoring is the most effective strategy for preventing research misconduct.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue.
Identify the example of when situation and time are key to assessing risk of harm in a research study:
Asking women if they have had an abortion
According to the U.S. Federal Research Misconduct Policy, falsification involves:
Falsification involves purposefully manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
Recruiting into research ...
Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity. Comment It is still permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate. This common practice is considered to fall within the definition of treatment, at least when the conversation is undertaken by one of the patient's healthcare providers. If the contact will be made by someone other than the patient's healthcare provider, permission will be required.
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
For a minimum of three years after completion of the study
A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
Data that does not cross state lines when disclosed by the covered entity.
A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of:
Economic vulnerability
According to the U.S. Federal Research Misconduct Policy, fabrication involves:
Fabrication involves making up data or results, recording the data in a permanent record, sharing fake data informally or in a written report.
Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion?
Falsification
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...
Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:
Is there a power differential between researchers and subjects?
Which of the following most accurately describes the practice of ghost authorship?
It is a situation where the individual who wrote the manuscript is not listed as an author.
Which of the following is true about the management of conflicts of interest?
Management plans are often created to reduce the impact of conflicts of interest. Organizations often create management plans to reduce the impact of conflicts of interest rather than completely eliminating them. However, in some cases, it will be necessary to eliminate a conflict of interest.
According to the authors, there are four common abuses that historically are described as giving rise to vulnerability. Which response below contains the correct four?
Physical control, coercion, undue influence, and manipulation Comment There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation. These exist along a continuum of severity with physical control being the most severe and undue influence and manipulation being the least (Nelson and Merz 2002, V69-80). The other abuses- prejudice, neglect, and disrespect - should still be avoided in research.
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Report 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. Comment The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution.
According to the federal regulations, research is eligible for exemption, if:
Research is only eligible for exemption if all the activities associated with the research fall into one of eight categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the researcher are not criteria for determining eligibility for exemption.
Informed consent is considered an application of which Belmont principle?
Respect for Persons
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
In considering NBAC's analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
Situational cognitive vulnerability
HIPAA's protections for health information used for research purposes...
Supplement those of the Common Rule and FDA.
A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?
Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries
The National Research Act of 1974
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The identification of guidelines, ethical principles and regulations came as a result of the deliberations of the National Commission.
Which of the following is included in the Nuremberg Code:
The Nuremberg Code included the requirement of the voluntary consent of subjects. While all of the choices are valid ethical concerns, none of the other choices were included in the Nuremberg Code.
According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:
The two main criteria used by NSF to evaluate a grant proposal are the intellectual merit and broader impacts of the proposal.
A researcher leaves a research file in her car while she attends a 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. Which of the following statements best characterizes what occurred?
There was neither a violation of privacy nor a breach of confidentiality
The HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject.
Which of the following is true regarding the U.S. Federal Research Misconduct Policy?
To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
When required, the information provided to the data subject in a HIPAA disclosure accounting ...
must be more detailed for disclosures that involve fewer than 50 subject records.
Census data (the final report as published by the Census Bureau) is an example of:
public information
