The actual involvement of bias.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?

Designing the survey so that subjects are not forced to answer one question before going to the next.

Giving examples in the consent process of the kinds of questions that will be asked.

Including the institution’s privacy policy on the survey site.

Providing a thorough debriefing at the end of the study.

To minimize potential risks of harm, a researcher conducting an on-line survey can:

Specify that all respondents must be legal adults.

Suggest that subjects print a copy of the informed consent form for their records.

Comply with the survey software’s Terms of Service agreement.

Design the survey so that no direct or indirect identifiers are collected.

Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?

Downloading a publically available dataset that includes high school students’ academic achievement rates. The data are in aggregate and were derived from multiple school districts from different states.

Gathering data to supplement an oral history project about a local civil rights activist. The activist passed away while the researcher was in the process of conducting in-person interviews with the individual’s social network.

Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects’ significant others to be a part of the focus group.

Analyzing a website visitor report from several pro-anorexia blogs to determine the popularity of each blog. Access to the blogs is not restricted.

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.

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.

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.

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.

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.

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

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

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

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

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

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

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.

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

A conflict of interest implies:

The elimination of bias.

The actual involvement of bias.

An awareness of bias.

The potential for bias.