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.
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 methods could be considered a “best practice” in terms of informing respondents how their answers to an online 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.
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.
To minimize potential risks of harm, a researcher conducting an online survey can:
Design the survey so that no direct or indirect identifiers are collected.
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.
The federal regulations define both a human subject and research separately, but both definitions must be met to qualify as human subjects research. Thus, research with human subjects is defined as a systematic investigation (intent to contribute to generalizable knowledge) involving living individuals about whom a researcher conducting research obtains information through intervention or interaction with the individual, and uses, studies, or analyzes the information or obtains, uses, studies, analyzes or generates identifiable private information (Protection of Human Subjects 2018). Conducting an online focus group with live human beings to research familial support systems would therefore meet the definition of research with human subjects.
Analyzing the number of visits to a website provides information about the website itself not about the people who visit it and does not meet the federal definition of research with human subjects. Neither does gathering information about deceased individuals. Using data that is publically available and de-identified is no longer private or personally identifiable, and would also not meet the federal definition of research with human subjects.
Voluntary participation in research includes the right to withdraw from a study at any time and the right to choose not to answer questions. Online surveys that force subjects to answer one question before going to the next violate the requirement that all participation in research is voluntary.
Providing contact information for the researcher, privacy policies, and a description of the survey are important, but they do not address the requirement.
Which of the following online 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.
The study in which the researcher pretends to be a cancer survivor involves deception and research without any informed consent process. Therefore, the study raises concerns about the ethical principle of respect for persons. Any compromise of the principle should be justified by any scientific benefit to be derived from the study.
When a support group or a blog is open to any and all readers, it can be argued that the communications posted are not intended to be private and can therefore be observed and recorded without informed consent. The researcher studying interracial adoptees used the internet in a manner comparable to posting a flyer on a bulletin board.
Which of the following methods could be considered a “best practice” in terms of informing respondents how their answers to an online 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.
Although there are no guaranteed methods to assure absolute confidentiality of research data collected online, some internet-based research experts have identified “best practices” for describing commonly accepted confidentiality protections, such as including explanations about how data are transmitted from the subject to the investigator, how the investigator will maintain and secure the data.
Consent processes should also include a discussion to emphasize that there is no way to guarantee absolute confidentiality if data are of a personal or sensitive nature.
Investigators use the internet as a research tool when they actively engage, or interact, with their participants online. This can include distributing an instrument via email or hosting a web-based survey on an online survey provider, recruiting subjects from online panels, conducting interviews on-line, facilitating focus groups in private chat rooms, and posting on-line experiments or interventions on web-based service providers.
Researchers endeavouring to conduct an online 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.
The information posted online could, conceivably, be accessible to anyone with an internet connection. However, people may post their private identifiable information online without the intention of this information being public.
Private identifiable information that can be accessible to anyone can create the potential for several different risks of harm to subjects who may not be aware that their information is public. Assuming a pseudonymous online identity does not pose any risks of harm to subjects. Though it is true that researchers can recruit, consent and debrief subjects online with little to no interaction, this in of itself, would also not pose any risks of harm to subjects. Similarly, waiving the documentation of consent does not pose any potential risks of harm to subjects, and is not unique to internet-based research.
To minimize potential risks of harm, a researcher conducting an online survey can:
Design the survey so that no direct or indirect identifiers are collected.
In most internet-based research, the primary risk of harm is a breach of confidentiality. A simple way to help maintain the confidentiality of a subjects’ identity is not to collect direct or indirect identifiers.
Suggesting to subjects that they should print a copy of the informed consent form does not protect them from an inadvertent breach of identifiable responses. Similarly, complying with the Terms of Service does not protect against a breach. Specifying that all subjects be of legal adult age does not ensure compliance.
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
Researchers designing online studies should consider the following with respect to participant protections.
Researchers designing online studies should consider the risk factor that Participants might post private identifiable information about themselves online without intending it to be public and available to researchers.
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 COI management plan aims to:
Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
What is the term for management controls that are build in to a research study (for example, independent data analysis)?
Inherent controls
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 example of a COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.
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
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.
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.
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.
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.
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.
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.
HHS has reiterated in its guidance that use or disclosure of PHI for retrospective research studies may be done only with patient authorization — or with a waiver, alteration, or exception determination from an IRB or Privacy Board. However, remember that you generally cannot proceed on your own without some approval from an IRB, Privacy Board, or other designated governing 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:
Data that does not cross state lines when disclosed by the covered entity.
If the data in question meet the definition of PHI and are being used for purposes that fall within HIPAA’s definition of research, HIPAA generally requires explicit written authorization (consent) from the data subject for research uses. However, HIPAA provides several alternatives that can bypass such authorizations: The research involves only minimal risk. The research is used solely for activities preparatory to research. Only deceased persons’ information is used. Only de-identified data is used. Only a “limited data set” is used, under an approved “data use agreement.” It is “grandfathered” research where all legal permissions were in place before HIPAA took effect.
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.
If you are unsure about the particulars, consult with your organization’s IRB, Privacy Board, or privacy official. For data security issues, consult with your organization’s security official. Consulting with an experienced colleague can always be helpful, but their advice is not authoritative. Do not assume that a representative of the funder will know all the rules, or that the generic advice of a professional association will be applicable to your organization’s particular rules.
HIPAA’s protections for health information used for research purposes…
Supplement those of the Common Rule and FDA.
Under HIPAA, a “disclosure accounting” is required:
For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
HIPAA’s relatively new data-focused protections, which took effect starting in 2003, supplement Common Rule and FDA protections; they are not a replacement. Institutional Review Board (IRB) protocol reviews using Common Rule and FDA criteria remain as before, including aspects related to data protection. IRBs may have the responsibility for addressing HIPAA’s additional requirements in their reviews when those apply; or some responsibilities may be given to another kind of body that HIPAA permits (a Privacy Board) or to an institutional official that HIPAA requires (a privacy officer). These federal standards complement states’ and accreditation bodies’ requirements.
In addition to being limited to external disclosures, disclosure accounting is not required for disclosures made under authority of a consent/authorization, on the theory that the data subjects are aware of what they have expressly permitted for that research. Neither is an accounting required for disclosures to the data subject directly about him/herself. Nor is it required for limited data set disclosures subject to a data use agreement. Nor, finally, is any accounting required for de-identified information that no longer qualifies as PHI.
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.
Authorizations are required unless the proposed use meets one of the exceptions listed in the HIPAA regulation. It is never at the researcher’s discretion. When they are required, authorizations must be: In “plain language” so that individuals can understand the information contained in the form, and thus able to make an informed decision. Executed in writing, and signed by the research subject (or an authorized personal representative). Authorizations must include a specific description of the PHI to be used or disclosed, the name(s) or other identification of persons involved in the research, and description of each purpose of the requested use or disclosure. Authorizations can be combined with other documents and can always be revoked by the data subject.
HIPAA includes in its definition of “research,” activities related to:
Development of generalizable knowledge.
Like the Common Rule, HIPAA defines research as a “systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge” (Protection of Human Subjects 2018; Security and Privacy 2013).
The HIPAA “minimum necessary” standard applies…
To all human subjects research that uses PHI without an authorization from the data subject.
Uses and disclosures of data for research that are allowed to bypass the authorization requirement are still subject to the “minimum necessary” standard – that is, the uses/disclosures must be no more than the minimum required for the described research purpose. A covered entity may rely on a researcher’s documentation – or the assessment of an IRB or Privacy Board – that the information requested is the minimum necessary for the research purpose. By contrast, research information obtained using an authorization is not bound by the minimum necessary standard – on the theory that the data subject has given explicit permission in accordance with the signed authorization. However, be aware that while HIPAA may not require a minimum necessary justification at all times, an IRB’s evaluation of risks and burdens on human subjects arguably does.
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.
It is still permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate. This common practice is considered to fall within the definition of treatment, at least when the conversation is undertaken by one of the patient’s healthcare providers. If the contact will be made by someone other than the patient’s healthcare provider, permission will be required.
Where fewer than 50 subjects’ records are involved, the listing must be more specific and detailed, commensurate with the requirements for other kinds of PHI disclosure accounting, including: specific date(s) of disclosures; names of entities to which PHI was disclosed; description of the PHI involved in the disclosure; and purpose of the disclosure.
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.
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’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.
HIPAA includes in its definition of “research,” activities related to …
Development of generalizable knowledge.
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.
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.
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.
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.
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.
Researchers should take into account a Debriefing sessions as well as giving clear and informative explanation to participants when designing an online study that presents participants with misleading information.
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.
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.
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.
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.
HIPAA’s protections for health information used for research purposes…
Supplement those of the Common Rule and FDA.
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.
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 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.
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.
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?
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?
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.
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.
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.
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.
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
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
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
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.
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.
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.
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.
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
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.
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.
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.
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
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
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.
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
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
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.
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.
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.
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
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.
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.
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.
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.
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
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
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 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
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
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
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.
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
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.
What are the 3 principles discussed in the Belmont Report?
Respect for Persons Beneficence Justice
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.
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.
The history of ethical regulations in human subjects research began with the
Nuremberg Code
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 elements must be included in an informed consent?
All foreseeable risks and discomforts.
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?
Exempt
How can faculty researchers avoid coercion of student subjects?
Avoid using their own students in their research
A student is conducting a research project that involves using a survey. The survey asks participants about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?
Exempt Review
A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review?
Full Board Review
A master’s degree candidate needs to conduct a research project for her master’s thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stock and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?
Not Human Subjects
Which of the following studies need IRB approval?
Studies collecting data about living individuals.
What is the Institutional Review Board (IRB) charged with?
– Protecting the rights and welfare of human subjects. – Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed. – Reviewing subject recruitment materials and strategies.
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?
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. B. Stanford Prison Experiment (Zimbardo). C. Tearoom Trade Study (Humphreys). D. The Harvard T3 study.
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
The Belmont principle of beneficence requires that:
A. The study makes a significant contribution to generalizable knowledge.
B. Subjects derive individual benefit from study participation.
C. Risks are managed so that they are no more than minimal.
D. Potential benefits justify the risks of harm.
D. Potential benefits justify the risks of harm.
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:
A. Justice.
B. Beneficence.
C. Respect for persons.
C. Respect for persons
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.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
A. Beneficence.
B. Justice.
C. Respect for persons.
B. Justice
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
a. Providing detailed information about the study to potential subjects.
b. Ensuring that risks are reasonable in relationship to anticipated benefits.
c. Ensuring that the selection of subjects is fair.
d. Ensuring that subjects understand that participation is voluntary
b. Ensuring that risks are reasonable in relationship to anticipated benefits.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
a. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS.
b. A researcher conducts a linguistic study of comments posted on a local public blog.
c. A researcher uses the Customs Office’s passenger lists for ships bringing immigrants to the US between1820-1845 to track the numbers of immigrants from certain ethnic groups.
d. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
d. 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. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership.
b. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
c. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department.
d. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.
b. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
a. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches.
b. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.
c. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger’s comments on a similar topic in a weekly magazine.
d. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
d. 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. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.
b. The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided.
c. 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.
d. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.
c. 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 the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:
a. Identifiable public information.
b. De-identified private information.
c. Identifiable private information.
d. Observations of public behavior.
c. Identifiable private information.
According to the federal regulations, research is eligible for exemption, if
a. All the subjects are adults and the risk is minimal.
b. The investigator is experienced in the field of inquiry.
c. The research falls into one of six categories of research activity described in the regulations.
d. Participation in the research will involve 10 minutes or less of the subjects’ time.
c. The research falls into one of six categories of research activity described in the regulations.
In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations?
a. College students.
b. Adults with decisional impairments.
c. The elderly.
d. Prisoners.
d. Prisoners.
According to federal regulations, the expedited review process may be used when the study procedures pose:
a. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.
b. More than minimal risk, but the study replicates previously approved research.
c. Any level of risk, but all the subjects are adults.
d. No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
d. No more than minimal risk and the research activities fall within regulatory categories identified as eligible.
Continuing review of an approved and ongoing protocol
a. Is limited to review of unanticipated problems.
b. Must be conducted by a convened IRB.
c. Is not required unless additional risks have been identified.
d. Must occur within 12 months of the approval date.
d. 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?
a. Institutional priorities take precedence over all IRB determinations.
b. Department chairs can overturn an IRB disapproval.
c. Officials of the institution may overrule an IRB approval.
d. Officials of the institution may overturn an IRB disapproval.
c. Officials of the institution may overrule an IRB approval.
An investigator 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:
a. Experience emotional or psychological distress.
b. Lose their legal status.
c. Lose their employment.
d. Feel that their privacy has been invaded.
a. Experience emotional or psychological distress
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:
a. Have the subject sign the consent form under an assumed name.
b. Obtain a Certificate of Confidentiality.
c. Code the subjects’ responses.
d. Obtain a waiver of documentation of informed consent.
d. Obtain a waiver of documentation of informed consent.
The primary purpose of a Certificate of Confidentiality is to:
a. Prevent subjects from knowing the purpose of a study.
b. Allow law enforcement to investigate abuse cases.
c. Protect researchers from disclosing conflicts of interest.
d. Protect identifiable research information from compelled disclosure.
d. Protect identifiable research information from compelled disclosure.
Risk should be evaluated solely by the magnitude or severity of expected harm, not probability.
True
False
False
What statement about risks in social and behavioral sciences research is most accurate:
a. If a study offers potential benefits, it is not necessary to minimize risks.
b. Anonymizing data effectively manages the risk of creating emotional distress.
c. There are never any risks.
d. Risks are specific to time, situation, and culture.
d. Risks are specific to time, situation, and culture.
a. The therapist creates her clients’ records; therefore, she does not need parents’ permission to use the information for research purposes.
b. If it is the best interests of the community that the children participate in the study, parental permission is optional.
c. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn’t have to ask the parents for permission.
d. 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.
d. 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?
a. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.
b. 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.
c. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.
d. In the event of any distress you may have related to this research, you will be given access to appropriate resources.
b. 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. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects’ attention on the material.
b. 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.
c. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.
d. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.
b. 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:
a. The subjects are literate in their own language; however, they do not read, write, or speak English
b. Potential subjects might find some of the research questions embarrassing, personal, or intrusive
c. The investigator has no convenient place to store signed consent forms separate from the research data
d. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
d. 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:
a. Describe penalties that may be imposed for non-participation.
b. Recommend that potential subjects discuss their decision to participate with family members.
c. Provide a list of the IRB members who reviewed the protocol.
d. Provide potential subjects with information at the appropriate reading comprehension level.
. d. Provide potential subjects with information at the appropriate reading comprehension level.
Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?
Citizenship. Directory information. Religious affiliation. SAT scores.
Directory information.
PPRA gives parents some level of control over their child’s:
Medical records Educational records Participation in third-party survey research or exposure to instructional materials developed by researchers Ability to opt out of health education (specifically, sexual health education)
Participation in third-party survey research or exposure to instructional materials developed by researchers
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. The Family Educational Rights and Privacy Act. Subpart D of 45 CFR 46. The Protection of Pupil Rights Amendment.
The Family Educational Rights and Privacy Act.
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.
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)?
Observation of public behavior when the researcher participates in the activities being observed Survey procedures Research about aptitude testing Interviews
Research about aptitude testing
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 provisions of Subpart D must be applied to all research funded by the HHS (which includes NIH). However, not all federal agencies that have adopted the Common Rule have also adopted Subpart D. In addition to HHS, only the U.S. Food and Drug Administration and the Department of Education have adopted it. Institutions may elect to apply the subpart to all research, regardless of the source of funding.
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.
Research involving children may be expedited if the level of risk is no more than minimal and if the research falls into a category of research identified as eligible for expedited review. Therefore, unless the nature of the topic would raise the level to more than minimal risk to the adolescent subjects, the study previously approved for adults through expedited review procedures would also be eligible for expedited review. It is not necessary for adolescents to have obtained some adult rights through emancipation procedures, nor must the reading level of the subjects be predetermined in order for a study involving minors to be eligible for expedited review. Consent forms, including the readability of the information, must always be tailored to the particular subject population of a study.
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.
The exemption categories that may be used with children include observations of children in public settings, as long as the researcher does not participate in the activities being observed or record information in such a manner that the identity of the subjects can be readily ascertained. Research does not require full committee review when it involves children, unless it does not fall into an exempt or expedited category.
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
The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research are the specific Department of Health and Human Services (HHS) regulations that apply to research with children. Subpart B specifies Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research, Subpart C specifies Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects and Subpart A is the Basic HHS Policy for Protection of Human Research Subjects (generally referred to as the Common Rule).
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.
According to the federal regulations, children are 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. Generally, though not always, the age of consent is the age at which minors reach the age of majority and are considered adults. In the United States, state law dictates the age of majority. In most states, the age of majority is 18. This means that a 17-year-old may be considered a child when applying the federal regulations for protecting research subjects.
According to Subpart D, research with children may be eligible for exemption under Category 2 when:
The research involves the use of educational tests
Subpart D restricts the use of exemptions when children are research subjects. Research that involves interviews, surveys, or participant observation when the researcher interacts with the children is not eligible for exemption under Category 2.
Which of the following statements most accurately describes the requirement for the documentation of minors’ assent to participate in research?
Federal regulations do not require the documentation of minors’ assent.
The federal regulations do not require that child assent be documented. Therefore it is not necessary to request a waiver of a requirement to document assent. An IRB will determine whether and how documentation is required for a particular study. The document does not require parental input or parental review.
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
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.
According to Subpart D, research with children may be eligible for exemption when:
The research involves the use of educational tests
Which of the following statements most accurately describes the requirement for the documentation of minors’ assent to participate in research?
Federal regulations do not require the documentation of minors’ assent.
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.
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 since these individuals are under the legal age of consent and are incarcerated
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.
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 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 contact former prisoners who are now on parole. She wants to study the difficulty of getting employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:
Do nothing in regards the Subpart C since 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.
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.
The 1974 National Research Act
US Public Health Service Policy
Informed consent is considered an application of which Belmont principle?
Respect for Persons
Which of the following brought increased public attention to the problems with the IRB system?
Death of Jesse Gelsinger
Which of the following is included in the Nuremberg Code:
Voluntary consent
The National Research Act of 1974
Established the National Commission.
Which of the following was the result of the Beecher article?
Realization that ethical abuses are not limited to the Nazi regime
The use of prisoners in research is a concern under the Belmont principle of Justice because:
Prisoners may be used to conduct research that only benefits the larger society
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Report the adverse drug experience in a timely manner, in keeping with the IRB’s policies and procedures, using the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
For a minimum of three years after completion of the study
According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
The changes must be immediately implemented for the health and well being of the subject.
IRB continuing review of an approved protocol must:
Occur at least annually.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
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
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.
The primary purpose of a Certificate of Confidentiality is to:
Protect identifiable research information from compelled disclosure.
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
Destroying all identifiers connected to the data.
Destroying all identifiers connected to the data.
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.
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.
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.
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.
An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
A breach of confidentiality.
A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects.
Which of the following considerations was relevant to the IRB’s determination that this activity does not constitute research with human subjects?
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient’s information; however, the “key” to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?
The study is human subject research which is eligible for expedited review.
The HIPAA “minimum necessary” standard applies… Your answer : To all human subjects research that uses PHI.
To all human subjects research that uses PHI without an authorization from the data subject.
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.
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.
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.
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.
According to the HHS 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/public company.
A financial conflict of interest could involve:
Receiving stock in a company funding your research.
A conflict of interest implies:
The potential for bias.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
Any equity interest in a publicly held company that exceeds $50,000
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
Designated institutional officials
The Data Manager should review the study protocol:
to understand primary and secondary endpoints
When designing a database and data collection instruments for a study, the Data Manager should:
Use standards to reduce the time required to set up the database and to increase the consistency of the data
Every member of a study team must define quality the same way in order to produce a high quality database.
False
Which member of a study team is ultimately responsible for the conduct of the study at a site?
The Investigator
Which member of a study team acts as the liaison between a sponsor and site, ensuring that reported data are verifiable to source documentation?
The Clinical Research Associate
In order for a quality process to work, study team members must understand all of the following EXCEPT:
how to perform the other team members’ jobs
Typical study conduct activities performed by the data manager include all of the following EXCEPT:
defining edit checks
t what point should a Data Manager get involved with the database development?
At study startup
Prior to locking a database, a data manager should ensure all data have been entered and all queries are resolved.
True
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.
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.
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.
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
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.
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
The Belmont Report’s principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that:
persons with diminished autonomy are entitled to protection
Which of the following 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.
Which of the following are the three principles discussed in the Belmont Report?
Respect for Persons, Beneficence, 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.
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
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 Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
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.
Continuing review of an approved and ongoing protocol
Must occur within 12 months of the approval date.
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.
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.
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.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture.
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 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 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.
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.
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.
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.
Data are made anonymous by
Destroying all identifiers connected to the data.
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 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.
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.
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
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 Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
Justice.
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.
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.
Census data (the final report as published by the Census Bureau) is an example of:
Public information.
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.
A medical record is an example of:
Private information.
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.
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.
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.
A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
Report the adverse drug experience in a timely manner, in keeping with the IRB’s policies and procedures, using the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
For a minimum of three years after completion of the study
According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
The changes must be immediately implemented for the health and well being of the subject.
IRB continuing review of an approved protocol must:
Occur at least annually.
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.
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.
Data are made anonymous by
Destroying all identifiers connected to the data.
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.
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 conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects.
Which of the following considerations was relevant to the IRB’s determination that this activity does not constitute research with human subjects?
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient’s information; however, the “key” to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true?
The study is human subject research which is eligible for expedited review.
An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes:
A breach of confidentiality.
NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability?
High potential for individual benefit from participating in research
n considering NBAC’s analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:
Situational cognitive vulnerability
According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four?
Physical control, coercion, undue influence, and manipulation
Identify the following groups that are protected in the federal regulations (45 CFR 46), specifically in Subparts B, C and D with additional protections:
Pregnant women, prisoners, children
Which is true of inducements in research?
Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
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 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?
An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
Census data is an example of:
Public information.
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 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.
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