Citi 13
Parental notification, in lieu of active parental permission, is allowed when: The researcher anticipates a low response rate. An IRB has approved a waiver of the requirement for parental permission. The researcher has conducted a similar study at another institution. The superintendent of schools and the principals have approved the study.
An IRB has approved a waiver of the requirement for parental permission
An example of a COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
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.
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.
Which of the following is the LEAST important activity when protecting human subjects in international research? Determining if the research might present unique risks to subjects given local socio-economic conditions. Considering local customs, norms, and laws. Assessing transportation conditions Consulting with members of the community from which subjects will be recruited.
Assessing transportation conditions
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.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold: Any equity interest in a publicly held company that exceeds $5,000 Any equity interest in a publicly held company that exceeds $30,000 Any equity interest in a publicly held company that exceeds $50,000 Any equity interest in a publicly held company that exceeds $15,000
Any equity interest in a publicly held company that exceeds $50,000
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.
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: Pregnant Women Prisoners Children Workers
Workers
A conflict of interest implies: The elimination of bias. The actual involvement of bias. An awareness of bias. The potential for bias.
The potential for bias.
According to Subpart D, research with children may be eligible for exemption when: The research involves the use of educational tests The children will be interviewed by the researcher. The research with children will involve participant observation with researcher interaction. The children will be asked to complete a survey
The research involves the use of educational tests
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? Parents must be notified that the study is taking place. The students must be offered an optional classroom activity. An independent consultant must approve the waiver. The research must pose no more than minimal risk.
The research must pose no more than minimal risk.
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 False
True
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?
Faculty Advisor/Research Mentor IRB Office
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Parents must approve written documentation. To protect minors documentation is always required. Documentation is required unless waived by an IRB. Federal regulations do not require the documentation of minors' assent.
Federal regulations do not 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.
According to the DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is: Greater than $5,000 of ownership in any single public entity/company. $25,000 and 5% of ownership in any single entity/company. Greater than $2,000 or 2% of ownership in any single entity/company. Greater than $10,000 or 5% of ownership in any single entity/company.
Greater than $5,000 of ownership in any single public entity/company.
Security measures are sometimes described as a combination of physical, technical, and administrative (PTA) safeguards. Which of these would be considered a technical safeguard?
Measures including device data encryption, anti-malware software, and communications encryption.
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
An investigator 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: -Educational. -Not an excessive incentive. -Of high quality. -Age appropriate.
Not an excessive incentive.
Which of the following constitutes both a breach of a 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 researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study. -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. -A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants. -In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
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 linguist copies portions of postings on a political blog to document the use of expletives, abbreviations, and the use of irony in the postings. A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her. A researcher observes the communications in an open support group without announcing her presence. She is interested in observing how long members participate and how the membership shifts over time. 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.
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
Which of the following elements must be included in an informed consent?
All foreseeable risks and discomforts.
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: 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. If the study results, if any, will be included in the employee's personnel records. All of the above
All of the above
When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: Unions may encourage employees to participate with the expectation that "entitlements" may follow from study results. The research study's finding could affect an employee's pay, benefits or promotion potential. The employer may encourage or deny participation of workers. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization. All of the above
All of the above
Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects? Downloading a publically available dataset that includes high school students' academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states. Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual's social network. 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. Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted.
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
An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that: The survey instrument is standardized. Confidentiality of the prisoners' health status is maintained. All prisoners receive HIV testing. A medical doctor serves as co-investigator.
Confidentiality of the prisoners' health status is maintained.
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of: Conflict of Interest Fraud Research Misconduct Malfeasance
Conflict of Interest
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 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: Use of decedents' information, with certain representations by the researcher. Data that does not cross state lines when disclosed by the covered entity. Activities preparatory to research, with certain representations by the researcher. Limited data set with an approved data use agreement.
Data that does not cross state lines when disclosed by the covered entity.
To minimize potential risks of harm, a researcher conducting an on-line survey can: Specify that all respondents must be legal adults. Suggest that subjects print a copy of the informed consent form for their records. Comply with the survey software's Terms of Service agreement. Design the survey so that no direct or indirect identifiers are collected.
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. Giving examples in the consent process of the kinds of questions that will be asked. Including the institution's privacy policy on the survey site. Providing a thorough debriefing at the end of the study.
Designing the survey so that subjects are not forced to answer one question before going to the next
Data are made anonymous by -Destroying all identifiers connected to the data. -Requiring all members of the research team to sign confidentiality agreements. -Keeping the key linking names to responses in a secure location. -Reporting data in aggregate form in publications resulting from the research.
Destroying all identifiers connected to the data.
What 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.
HIPAA includes in its definition of "research," activities related to ...
Development of generalizable knowledge.
HIPAA includes in its definition of "research," activities related to:
Development of generalizable knowledge.
During an Institutional Review Board (IRB) meeting, an 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
The most important ethical concerns related to conflicts of interest in research are: Maintaining a supply of volunteers for research studies and their active involvement in research Ensuring the objectivity of research and the protection of human subjects Protecting proprietary information and fidelity to contracts with sponsors Establishing open dialog with sponsors and security of study records
Ensuring the objectivity of research and the protection of human subjects
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?
Exempt
HIPAA protects a category of information known as protected health information (PHI). PHI includes:
Identifiable health information that is created or held by covered entities and their business associates.
A Researcher proposes to conduct a study at a foreign site that 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.
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: People assume pseudonymous on-line identities, such as an avatar in an MMORPG. Online studies do not require the documentation of informed consent. Recruiting, consenting and debriefing subjects takes place on-line, and may require little to no interaction with the subjects. Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
What is the term for management controls that are build in to a research study (for example, independent data analysis)?
Inherent controls
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.
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
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.
The age of majority in international research is determined by the Legal drinking age where the research will take place. Laws in the state where the researchers' institution resides. Laws, customs, and norms in the area in which the research will be conducted. The research sponsor.
Laws, customs, and norms in the area in which the research will be conducted.
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 availably 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 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: Approve this project but submit it for federal review. Approve this project since the risk appears to be no more than minimal. Not approve this project because the prisoners are merely a population of convenience for the student. Approve this project since the superintendent is the ultimate authority on what happens in his facility.
Not approve this project because the prisoners are merely a population of convenience for the student
The history of ethical regulations in human subjects research began with the
Nuremberg Code
Which of the following activities constitutes engagement in research? Providing potential subjects with written information about a study. Obtaining informed consent and conducting research interviews. Informing prospective subjects about the availability of research. Obtaining subjects' permission for researchers to contact them.
Obtaining informed consent and conducting research interviews.
The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: Ensure that surveys do not ask school children to provide sensitive information about their parents. Provide parents certain rights over their children's educational records. Give school principals the right to discuss students' behavioral problems with their parents. Allow school counselors to access students' grades.
Provide parents certain rights over their children's educational records.
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
According to Subpart D, which of the following research activities with children would qualify for an exemption? Survey procedures Observation of public behavior when the researcher participates in the activities being observed. Interviews Research about educational testing
Research about educational testing
Which of the following statements about prison research is true? Participation in research can be considered during parole hearings. Researchers may study the effects of privilege upgrades awarded by the prison. It is permissible for risks to be higher than those that would be accepted by non-prisoners. The regulations prohibit compensating prisoners.
Researchers may study the effects of privilege upgrades awarded by the prison.
What are the 3 principles discussed in the Belmont Report?
Respect for Persons Beneficence Justice
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? -Using data encryption for stored files. -Securing a Certificate of Confidentiality. -Waiving documentation of consent. -Using pseudonyms in research reports.
Securing a Certificate of Confidentiality
Which of these is not generally a good practice for fax machine use?
Sensitive faxes -- inbound or outbound -- are left sitting in or around the machine.
HIPAA's protections for health information used for research purposes...
Supplement those of the Common Rule and FDA.
All of the following are true regarding the Belmont Report, EXCEPT:
The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.
Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? The No Child Left Behind Act. Subpart D of 45 CFR 46. The Protection of Pupil Rights Amendment. The Family Educational Rights and Privacy Act.
The Family Educational Rights and Privacy Act
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? -If group members know each other confidentiality is not an issue. -Using pseudonyms in reports removes the concern about any confidences shared in the group. -The researcher cannot control what participants repeat about others outside the group. -If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
The researcher cannot control what participants repeat about others outside the group
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 -The subjects' privacy has been violated. -Confidentiality of the data has been breached -There was both a violation of privacy and a breach of confidentiality.
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 these is not a good practice for physical security?
To preserve good customer relations, visitors are generally allowed access to all areas of a facility unless it appears they are doing something suspicious.
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? The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population. The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors. 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. The new research would need full review by a convened IRB because children are a protected population.
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.
Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities?
Use of full names in public areas or on intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid misidentification.
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.
Which of these is not generally a good practice for telephone use?
Using voicemail systems and answering machines that do not require a password or PIN for access.
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?
HIPAA includes in its definition of "research," activities related to ... anything a researcher does in a federally-supported laboratory. development of generalizable knowledge. quality assessment and improvement. population health.
development of generalizable knowledge.
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. for all research where the data crosses state lines, otherwise state law applies. for all human subjects research that uses PHI. solely at the principle investigator's discretion.
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 includes: identifiable health information that is created or held by covered entities, provided the data subject is a US citizen. identifiable health information that is created or held by covered entities. any identifiable health information. Identifiable health information that is created or held by covered entities that operate across state lines.
identifiable health information that is created or held by covered entities.
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.
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. is always the same, regardless of the number of records involved. is limited to the information elements the data subject specifically requests. is at the discretion of the organization, given its accounting policies.
must be more detailed for disclosures that involve fewer than 50 subject records.
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.
