What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
An example of an individual financial COI is:
A researcher’s wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study.
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
There may be bias by the peer reviewer as to the area of research
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
The COI management plan aims to:
Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
An example of an individual financial COI is:
A researcher’s wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
No later than the time of proposal submission
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
A researcher’s membership on an advisory board with an organization sponsoring research can create a COI because:
It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research’s success
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
Respect for persons.
Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
The researcher’s failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?
Harvard “Tastes, Ties, and Time (T3)” study (2006-2009)” study
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in relationship to anticipated benefits.
According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:
Identifiable private information.
A medical record is an example of:
Private information.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
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.
According to federal regulations, the expedited review process may be used when the study procedures pose:
No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
According to the federal regulations, research is eligible for exemption, if
The research falls into one of six categories of research activity described in the regulations.
Continuing review of an approved and ongoing protocol
Must occur within 12 months of the approval date.
Which of the following statements about the relationship between an institution and the institution’s IRB(s) is correct?
Officials of the institution may overrule an IRB approval.
In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?
Prisoners.
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
Additional safeguards that may be included in a social and behavioral study may include:
Remove all direct identifiers from the data as soon as possible.
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:
Obtain a waiver of documentation of informed consent.
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
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
A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?
The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children.
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.
A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
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.
A waiver of the requirement for documentation of informed consent may be granted when:
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
Privacy and Confidentiality – SBE Quiz
Privacy and Confidentiality – SBE Quiz
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.
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
The researcher cannot control what participants repeat about others outside the group.
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?
Securing a Certificate of Confidentiality.
Data are made anonymous by
Destroying all identifiers connected to the data.
Research with Prisoners – SBE Quiz
Research with Prisoners – SBE Quiz
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.
One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should NOT be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher?
The researcher should contact prison authorities of the medical issue , and report the events to the IRB of record.
A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:
Confidentiality of the prisoners’ health status is maintained.
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
A sociologist wants to study a culture that occurs in some women’s prisons: “state families,” in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:
Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.
Research with Children – SBE Quiz
Research with Children – SBE Quiz
A researcher’s study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision:
Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.
A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review?
This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
All research funded by HHS
According to Subpart D, research with children may be eligible for exemption when:
The research involves the use of educational tests
The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as:
Subpart D: Additional Protections for Children Involved as Subjects in Research
Research in Public Elementary and Secondary Schools – SBE Quiz
Research in Public Elementary and Secondary Schools – SBE Quiz
According to federal regulations, “children” are defined as:
Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.
Parental notification, in lieu of active parental permission, is allowed when:
An IRB has approved a waiver of the requirement for parental permission.
According to Subpart D, which of the following research activities with children would qualify for an exemption?
Research about educational testing
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:
Provide parents certain rights over their children’s educational records.
If research in a private school is directly funded by the Department of Education, then:
PPRA applies.
International Research – SBE Quiz
International Research – SBE Quiz
A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee as well as the Big State University IRB?
Will the researcher have collaborators at the research site abroad?
PPRA gives parents some level of control over their child’s:
Participation in third-party survey research or exposure to instructional materials developed by researchers
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted.
What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?
In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
What procedures must be described in an agreement called an “assurance of compliance” with OHRP?
Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
International Studies Quiz
International Studies Quiz
Which of the following is a commonly used resource for international ethical guidelines for human subjects research?
CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
Researchers designing studies to be conducted in host countries outside the U.S. should:
Remember that in some populations an individual cannot make a decision about medical care without the full engagement of relatives, friends and those in authority in the community
Internet-Based Research – SBE Quiz
Internet-Based Research – SBE Quiz
In most cases, a U.S. researcher affiliated with an academic institution, proposing to conducted funded research outside of the U.S., must have the approval of which of the following entities:
An IRB from both the researcher’s U.S. institution and an equivalent entity within the host country
The Internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the Internet as a research tool?
An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.
Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?
Designing the survey so that subjects are not forced to answer one question before going to the next.
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is:
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
Which of the following methods could be considered a “best practice” in terms of informing respondents how their answers to an on-line survey about personal information will be protected?
The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed.
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?
Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects’ significant others to be a part of the focus group.
Research and HIPAA Privacy Protections Quiz
Research and HIPAA Privacy Protections Quiz
A HIPAA authorization has which of the following characteristics:
Uses “plain language” that the data subject can understand, similar to the requirement for an informed consent document.
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 officer (“Privacy Officer”), or privacy official (“Privacy Official”), depending on the issue.
Vulnerable Subjects – Research Involving Workers/Employees Quiz
Vulnerable Subjects – Research Involving Workers/Employees Quiz
The HIPAA “minimum necessary” standard applies…
To all human subjects research that uses PHI without an authorization from the data subject.
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.
Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, except:
Workers
HIPAA’s protections for health information used for research purposes…
Supplement those of the Common Rule and FDA.
When workers are asked to participate in a research study, vulnerabilities related to the subject’s employment may include:
All of the above
Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker’s retention of a job, insurance or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:
All of the above
When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.
True
x

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