Skipizm super research set 3

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 caregivers to determine which intervention methods most effectively manage aggression.

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, 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.

Under HIPAA, a "disclosure accounting" is required:

For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.

According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of:

Justice

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

Obtains, uses, studies, analyzes, or generates identifiable private information.

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

Officials of the institution may overrule an IRB approval.

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?

PHS Tuskegee Study

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that

Persons with diminished autonomy are entitled to protection

A medical record is an example of:

Private information

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:

Provide parents certain rights over their children's educational records.

A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of:

Public behavior

The Final Rule added a definition for three new terms, including: clinical trial, written or in writing, and:

Public health authority

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.

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.

Identify the example of when situation and time are key to assessing risk of harm in a research study:

A study on the efficacy of a behavioral intervention for smoking cessation that involves both adults and teenagers in the United States

Additional protections researchers can include in their practice to protect subject privacy and data confidentiality include:

All of the above

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.

In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:

FERPA, PPRA, and Subpart D of the federal regulations

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.

Research approved on 1 September 2019 conducted by a regulated entity would be subject to:

Final Rule (2018 Requirements)

The Final Rule made revisions to the following definition:

Human subject

A Researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?

If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

What are some considerations for a U.S researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

Broad consent for storage, maintenance, and secondary research use may be obtained:

In lieu of a full informed consent

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.

An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle?

Justice

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.

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

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.

When would an IRB consider the risks of a study to be controlled?

When there is an appropriate risk mitigation and management plan in place.

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

The compliance date for cooperative review is:

Three years from publishing the 2017 Final Rule in the Federal Register

The HIPAA "minimum necessary" standard applies...

To all human subjects research that uses PHI without an authorization from the data subject.

The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research.

True

The researcher's failure to protect research subjects from deductive disclosure of identity (that is, the re-identification of subjects by other researchers) is the primary ethical violation in which of the following studies?

"Tastes, Ties, and Time (T3)" study

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.

What existing federal regulations define technology-based risk assessment?

None of the above

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level.

HIPAA's protections for health information used for research purposes...

Supplement those of the Common Rule and FDA.

The following category of research was added to the "Exempt Research" section at 46.104:

Benign behavioral interventions

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

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.

Why are institutionally provisioned technology systems (in other words, systems provided through a university, hospital, or clinic) generally more secure than consumer products?

Because information technology professionals have vetted them with the vendor.

Why do custom-built, homegrown, and/or investigational technologies pose the greatest risk to research participants?

Because researchers cannot know all the potential risks until participants have used the technology in practice.

Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems because wardens of juvenile prisoners (unlike those for adult prisoners) act in loco parentis for juvenile offenders. This statement is false because:

Both subparts apply, as these individuals are under the legal age of consent and are incarcerated

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

Both the magnitude (or severity) and the probability (or likelihood) of harm.

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.

What is passive mobile data collection?

Data collection that occurs on the device that the researcher and participant are unaware of

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.

Instead of "data will be stored on the researcher's computer," what should a strong data security plan state?

Data will be stored on an encrypted computer with a strong password that only the researcher knows.

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.

HIPAA includes in its definition of "research," activities related to:

Development of generalizable knowledge.

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.

Which 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

A researcher submits a study to the IRB that proposes to evaluate a new after-school on-line tutoring program for middle-school students in a local school district examining the effect on student grades. She proposes to perform this assessment at the school that her children attend, because she is familiar with the school district. Students may use either their personal smartphone or computer to participate in the program. This study might be determined to be violating which principle of the Belmont Report?

Justice (requires that the benefits and burdens of research are equitably distributed and subject populations are not chosen because of convenience.)

The age of majority in international research is determined by the

Laws, customs, and norms in the area in which the research will be conducted.

The definition of "research" was expanded to:

List activities that are specifically deemed not to be research

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.

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availably of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?

No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.

A 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.

You learn that one of the subjects from your study will be admitted to prison next week. You assert that it is in the best interest of the subject to remain in the study while incarcerated. However, the study was not approved by the IRB in accordance with the requirements for research involving prisoners under Subpart C. What is the best course of action?

Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.

A census is a regularly-occurring and official count of a particular population. Census data available at the United States Census Bureau website are an example of:

Public information

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

Which of the following statements about prison research is true?

Researchers may study the effects of privilege upgrades awarded by the prison.

Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice

A study was submitted to the IRB designed to evaluate the effect of background noise on an individual's ability to concentrate and answer questions. The IRB approved the study and consent form. The consent form includes all the required information. The use of a consent form is an example of the Belmont principle of:

Respect for persons (subjects understand that participation is voluntary and that they are provided detailed information about the study before giving consent to participate)

What statement about risks in social and behavioral sciences research is most accurate:

Risks are specific to time, situation, and culture.

The two exempt research categories that always require limited IRB review as a condition of exemption are: Storage or maintenance for secondary research for which broad consent is required (Category 7) and which of the following?

Secondary research for which broad consent is required (Category 8)

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

The Final Rule revised the definition of "written or in writing" to clarify:

That these terms include electronic formats

Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?

The Family Educational Rights and Privacy Act.

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.

Data lifecycle management refers to what?

The ongoing oversight of research data by the researchers for the study's duration

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.

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.

How can a Bring Your Own Device (BYOD) study approach reduce or mitigate technology-related risks?

The participant may already know the risks of using the device if they are familiar with it for personal use. This decision indicates a level of pre-research risk acceptance.

According to the federal regulations, research is eligible for exemption, if:

The research falls into one of eight categories of research activity described in the regulations.

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

The research involves the use of educational tests

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.

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.

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?

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.

A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:

not be approved because prison population is a convenience sample

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.