CITI Training
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.
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.
According to the 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.
Which of the following statements about the relationship between an institution and the institutions IRBs is correct?
Officials of the institution may overrule an IRB approval.
If research in a private school is directly funded by the Department of Education, then:
PPRA applies
What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?
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.
According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?
Promptly
Data are made anonymous by
Destroying all identifiers connected to the data.
Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?
Directory information
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
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
If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?
Research about aptitude testing
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
Which of the following about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that the risks are reasonable in relationship to anticipated benefits.
A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to the federal regulations, is review required at the foreign site?
If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
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.
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 toddler and their caregivers to determine which intervention methods most effectively manage aggression.
Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, count 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-identifiable.
HIPAA protects a category of information known as protected health information (PHI). PHI under HIPPA includes:
Identifiable health information that is created or held by covered entities and their business associates.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
The Belmont Principle Requires that
Risks to subjects are reasonable in relation to anticipated benefits.
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
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.
Which of the following statements most accurately describes the requirement for the documentation of minors; assent to participate in research?
Federal regulations do no require the documentation of minors' assent
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.
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?
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 online without intending it to be public and available to researchers.
What is the term for management controls that are built in to a research study?
Inherent controls
Researchers must report potential unanticipated problems that involve risks to others directly to the:
Institutional Review Board (IRB)
The specific U.S. 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
True
Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems since Wardens of Juvenile prisoners - unlike those for adult prisoners - act in loco parentis for juvenile offenders. This statement is false because:
Both subparts apply, as these individuals are under the legal age of consent and are incarcerated.
In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:
FERPA, PPRA, and Subpart D of the federal regulations
The researcher's failure to protect research subjects from deductive disclosure of identity (that is, re-identification of subjects by other researchers) is the primary ethical violation of which of the following studies?
"Tastes, Ties, and Time (T3) study
Which of the following IRB members must be present during the IRB's discussion and vote on a proposal?
The non-scientist member
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.
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent.
A researcher proposes to join a moderated support group for cancer survivors posing as a surviver. She plans to insert comments to see how the members respond.
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.
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
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 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.
Which of the following examples of using the internet to conduct research meets the federal definition of research with human subjects?
Conducting an online 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
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.
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.
A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effects on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont report?
Justice
A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?
No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures or receiving or sharing any private, identifiable information.
A graduate student wants to examine the effect of print media versus televised media on individual's position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:
Not approve this project because the prisoners are merely a population of convenience for the student.
A full IRB committee meeting is convened and one agenda item is a new research proposal to evaluate how mothers interact with their learning-disabled child. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. The committee determined that the mother's required task may upset the child. The IRB approved the study with appropriate language in the parental permission form regarding the possibility that children might become upset. After the start of the study, the Principal Investigator reports to the IRB that, as expected, one of the children became upset. The incident was handled according to the protocol and the child is fine. What should the IRB do with regard to this report?
Nothing
You learn that one of the subjects from your study will be admitted to prison next week. You assert that it is in the best interest of the subject to remain in the study while incarcerated. However, the study was not approved by the IRB in accordance with the requirements for research involving prisoners under Subpart C. What is the best course of action?
Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.
The purpose of the family educational rights and privacy act (FERPA) is to:
Provide parents certain rights over their children's educational records
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension levels.
A census is a regularly occuring and official count of a particular population. Census data available at the United States Census Bureau website are an example of:
Public Information
A full IRB committee meeting is convened and one agenda item is a new research proposal to evaluate how mothers interact with their children with learning disabilities. The inclusion criteria require the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. The committee considers that the risks to the children could be more than minimal, but the proposal does not include adequate information to make a final determination regarding the risks. Which of the following best describes how the IRB should proceed?
Table the protocol and ask the investigator to provide
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 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 injury.
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.
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?
The new research would need full review by a convened IRB because children are a protected population
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 documentation and the principal risk.
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?
The research must pose no more than minimal risk.
A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements in true?
The research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting
The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
There may be a bias by the peer reviewer as to the area of research.
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 the component. Which of the following statements best characterizes what occured?
There was neither a violation of privacy nor a breach of confidentiality.
A HIPPA 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.
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 as grandparents etc. 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 research. The use of this staff is:
Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
A full IRB committee meeting is convened. The IRB committee roster consists of 15 members. However, only 8 members are in attendance for today's meeting. One of the IRB members is Principal Investigator for one of the studies being reviewed and receives a portion of her salary from the supporting grant. The IRB member who is the Principal Investigator, must recuse herself from the room during both the final deliberations and the vote on the study. Which of the following best describes the committee's action after the member leaves the IRB meeting?
Defer the proposal to the next meeting because of a loss if quorum
To minimize potential risks of harm, a researcher conducting an on-line survey can:
Design the survey so that no direct or indirect identifiers are collected.
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.
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:
Determined by the institution in its written policies and procedures.
Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects?
Determining that the study has a maximization of benefits and a minimization of risks.
A researcher wants to contact three former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:
Do nothing in regards to the Subpart C because the research does not meet the criteria for prison research-individuals on parole are not considered prisoners. The definition applies to both minors and adults.
A researcher's study uses an identifiable 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 they study is exempt from IRB review. This decision:
Is wrong because 46.104 states research conducted in prisons is not exempt if the subject population is only prisoners.
An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?
Justice
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.
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB.
Must occur within 12 months of the approval date.
A researcher conducts a focus group. One of the subjects has a heart attack and is hospitalized. Based on HHS regulations, should the researcher report this event to the IRB?
No, this does not need to be reported because it is unrelated to participation in the study.
A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting the the IRB?
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
Which of the following constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
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 protocol?
PHS Tuskegee Study
A professor at a Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?
The IRB will not review this study because it is not research as defined by the federal regulation.
During the course of a study, the researcher reports to the IRB that the consent form needs to be changed to reflect her new contact information. Who can approve this change?
The chair of the IRB
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.
According to the federal regulations, research is eligible for exemption, if
The research falls into one of the eight categories of research activity described in regulations.
According to Subpart D, research with children may be eligible for exemption when:
The research involves the use of educational tests
A convened IRB approved protocol with more than minimal risk on February 15, 2019. Which of the following best describes the IRB continuation review requirements for this study?
The research must be re-reviewed by the convened IRB on or before February 14, 2020
A professor at a 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?
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
The HIPAA "minimum necessary" standard applies...
To all human subjects research that uses PHI without an authorization from the data subject.
