question

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

answer

Respect for Persons, Beneficence, Justice

question

The history of ethical regulations in human subjects research began with the

answer

Nuremberg Code

question

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?

answer

Faculty advisor and IRB office

question

Which of the following elements must be included in an informed consent?

answer

all foreseeable risks and discomforts

question

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

answer

exempt

question

How can faculty researchers avoid coercion of student subjects?

answer

avoid using their own students in their research

question

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?

answer

exempt review

question

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?

answer

full board review

question

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?

answer

not human subjects

question

Which of the following studies need IRB approval?

answer

studies with living individuals

question

What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.)

answer

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.

question

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

answer

Ensuring that risks are reasonable in relationship to anticipated benefits.

question

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

answer

justice

question

The Belmont principle of beneficence requires that:

answer

Potential benefits justify the risks of harm.

question

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

answer

Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study

question

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:

answer

respect for persons

question

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

answer

A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.

question

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?

answer

The IRB will not review this study because it is not research as defined by the federal regulations.

question

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

answer

An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information

question

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:

answer

Identifiable private information.

question

A medical record is an example of

answer

private information

question

The primary purpose of a Certificate of Confidentiality is to

answer

allow law enforcement to investigate abuse cases

question

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

answer

asking women if they've had an abortion

question

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

answer

risks are specific to time, place, and culture

question

Additional safeguards that may be included in a social and behavioral study may include:

answer

Remove all direct identifiers from the data as soon as possible.

question

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

answer

Invasion of privacy, breach of confidentiality, and study procedures

question

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

answer

Officials of the institution may overrule IRB approval

question

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

answer

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

question

Continuing review of an approved and ongoing protocol

answer

must occur within 12 months. of the approval date

question

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

answer

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

question

In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations?

answer

prisoners

question

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?

answer

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.

question

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?

answer

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.

question

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:

answer

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

question

A waiver of the requirement for documentation of informed consent may be granted when:

answer

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality

question

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

answer

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

question

A financial conflict of interest could involve

answer

Receiving stock in a company funding your research.

question

A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:

answer

conflict of interest

question

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:

answer

designated institutional officials

question

Significant financial interest, as defined by the 2011 final rule that amended Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):

answer

- Equity/stock interests (regardless of value) in a non-publicly traded company. - Intellectual property rights upon receipt of income related to such rights. - Consulting payments in excess of $5,000.

question

The most important ethical concerns related to conflicts of interest in research are:

answer

Ensuring the objectivity of research and the protection of human subjects

question

Data are made anonymous by

answer

destroying all identifiers to the data

question

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)?

answer

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

question

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?

answer

There was neither a violation of privacy nor a breach of confidentiality.

question

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

answer

The researcher cannot control what participants repeat about others outside the group.

question

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?

answer

securing a certificate of confidentiality

question

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:

answer

Not approve this project because the prisoners are merely a population of convenience for the student.

question

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:

answer

not an excessive incentive

question

Which of the following statements about prison research is true?

answer

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

question

Which example of research with prisoners would be allowable under the regulations?

answer

Examining age at first arrest as a predictor of adult criminal history.

question

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:

answer

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

question

When required, the information provided to the data subject in a HIPAA disclosure accounting...

answer

must be more detailed for disclosures that involve fewer than 50 subject records.

question

If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:

answer

An organizational IRB or Privacy Board, privacy officer ("Privacy Officer"), or privacy official ("Privacy Official"), depending on the issue.

question

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...

answer

is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

question

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

answer

supplement those of the Common Rule and FDA.

question

A HIPAA authorization has which of the following characteristics:

answer

Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.

question

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:

answer

workers

question

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.

answer

true

question

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

answer

research uses educational tests

question

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?

answer

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.

question

The specific Department of Health and Human Services (DHHS) Regulations that apply to research with children are known as:

answer

Subpart D: Additional Protections for Children Involved as Subjects in Research

question

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?

answer

research must pose no more than minimal risk

question

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:

answer

FERPA, PPRA, and Subpart D of the federal regulations

question

Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?

answer

directory information

question

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

answer

The Family Educational Rights and Privacy Act.

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