CITI Training
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.
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.
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.
During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:
Disclose their potential COI and may answer questions, but recuse themselves from voting
A researcher wants to contact 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 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.
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 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 effect 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
According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:
Justice
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.
According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:
Obtains, uses, studies, analyzes, or generates identifiable private information.
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.
Informed consent in research with homeless youth is:
Often carried out with waiver of documentation when risk is no greater than minimal
What does de-identifying data with a code mean?
Presenting data with a code that researchers can match to other data
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
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.
A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?
Promptly
As part of the consent process, the federal regulations require researchers to:
Provide potential subjects with information at the appropriate reading comprehension level.
A recognized retention strategy for research involving marginalized populations is:
"Collateral contacts" such as family and friends
What are student administrative data?
Student educational records in paper and electronic form
What are the three different ways to reduce the possibility of an unauthorized PII disclosure?
Suppressing, blurring, and masking
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 provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:
All research funded by HHS
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.
Content from online educational tools that FERPA does not protect includes:
Any metadata that an online tool produces (for example, data about a student's usage of a tool, or how much time it took them to take an assessment or look at a video) if they are not tied to any identifying information
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
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
Socially or economically disadvantaged research subjects are:
Best protected when an IRB with expertise in local conditions has reviewed the protocol
Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because 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
A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:
Both the magnitude (or severity) and the probability (or likelihood) of harm.
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:
The research study's finding could affect an employee's pay, benefits, or promotion potential. The employer may encourage or deny participation of workers. Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization.
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.
Which of the following is a risk associated with a small cell size?
The risk of disclosure of students' information reported in that cell
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
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.
Trust and transparency are critical to successful and culturally competent research. In the research setting, establishing trust in diverse communities does NOT require:
Limiting public transparency and accountability
Socially or economically disadvantaged subjects:
May be included in research protocols designed for their inclusion or in general studies
A graduate student wants to examine the effect of print media versus televised media on individuals' 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.
Overcoming challenges to cultural competence in research requires that: (Check ALL that apply)
- Investigators examine and understand historical contexts for study populations before initiating research study design.- Early-phase study design should take into account race, ethnicity and cultural factors.- IRB membership should include representatives of large communities and cultural groups as representatives.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
1. 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. 2. A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. 3. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.
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
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 is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:
Not an excessive incentive.
In 1979, the National Commission for the Protection of Humans Subjects of Biomedical and Behavioral Research developed ethical principles and guidelines for the protection of human subjects for research. The purpose of these guidelines was to:
Provide a framework for use in the resolution of ethical problems arising from research involving human subjects.
A researcher is conducting a study of four graduate students enrolled in a unique university program. The foundation supporting the study wants a report that provides summary information about the students' outcomes, including their grades and survey responses. What would be the least risky option?
Provide a summation of survey results, without the grades
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
A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of:
Public behavior
A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of:
Public information
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.
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 survivor. She plans to insert comments to see how the members respond.
An example of an individual financial COI is:
A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
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.
Federal regulations do not permit research that includes economically or educationally disadvantaged persons.
False
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 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.
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
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:
If the study results, if any, will be included in the employee's personnel records. Who will have access to the data. If personal identifiers will be retained and used in the data analysis. How the data will be collected and secured.
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 on-line without intending it to be public and available to researchers.
The following groups may be vulnerable in the context of "socially and economically disadvantaged" including: (Choose all that apply)
Individuals who are uneducated or undereducated Individuals who are food insecure Individuals who are homeless
The Belmont Report cautions that:
Inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
Researchers must report potential unanticipated problems that involve risks to others directly to the:
Institutional Review Board (IRB)
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
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
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.
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.
The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?
Researcher
Which of the following statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
The Belmont principle of beneficence requires that:
Risks to subjects are reasonable in relation to anticipated benefits.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, Justice
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
Payments to research subjects must be:
Reviewed and approved by the IRB
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
Which of the following statements is true?
The Higher Education Act of 2008 requires Title IV postsecondary institutions to report aggregate information on graduates
A professor at 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 regulations.
Cultural competence in research is defined as the ability of researchers to provide high quality research that takes into account:
The diversity of population's values, beliefs and behaviors when developing research ideas, conducting research and exploring applicability of their findings.
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 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.
According to the federal regulations, research is eligible for exemption, if:
The research falls into one of eight categories of research activity described in the regulations.
According to Subpart D, research with children may be eligible for exemption under Category 2 when:
The research involves the use of educational tests
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
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.
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 is true?
This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.
According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:
Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk
A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) 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?
Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.
NIH has set forth guidelines on the inclusion of women and members of minority groups and their subpopulations in biomedical and behavioral human subject research. This inclusion is to ensure that:
Valid analyses of differences in intervention effects can be accomplished.
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 researchers have collaborators at the research site abroad?
Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:
Workers
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.
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.
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.
Data are made anonymous by
Destroying all identifiers connected to the data.
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
When IRBs are applying the federal regulatory criteria for approval to protocols involving socially or economically disadvantaged persons:
Each criterion should be analyzed in relation to the special characteristics of the populations
A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:
Experience emotional or psychological distress.
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 the study is exempt from IRB review. This decision:
Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.
A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. 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 to the IRB?
No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.
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.
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
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.
