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EBP :/ > PHRP Quizzes > Flashcards

PHRP Quizzes Flashcards

1
Q

How do human subjects research benefit society?

A

It contributes to advances in technology and healthcare

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2
Q

“A living individual about whom an investigator conducting research obtains information through intervention or interaction with the individual” defines what?

A

human subject

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3
Q

If investigators collect identifiable private information about research subjects or their identifiable biospecimens, the research may be considered:

A

human subjects research

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4
Q

“A systematic investigation designed to develop or contribute to generalizable knowledge, including research development, testing, and evaluation” defines what?

A

research

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5
Q

Information or records used for criminal justice investigative purposes are generally considered:

A

not to be human subjects research

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6
Q

Tissue or data not obtained directly from the patient or their records is not considered human subjects research as long as:

A

the information is anonymous

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7
Q

If participants are used to provide information about a topic unrelated to themselves, such as evaluating a product, is the study considered human subjects research?

A

no

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8
Q

Federal policy dictates that human subjects research must include a variety of races, ethnicities, genders, ages and:

A

disability status

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9
Q

To contribute to advances in healthcare and social programs, the design of a research study should consider:

A

whether the treatment affects different subpopulations differently

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10
Q

Which of the following is considered human subjects research?

A
  1. Collecting blood from participants
  2. Conducting a survey over the phone
  3. Administering medicine to participants
  4. Conducting an in-person focus group
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11
Q

The purpose of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was to:

A

identify ethical principles for conducting research involving humans

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12
Q

The Belmont Report principle of “Respect for persons” states that individuals should be treated as:

A

autonomous agents

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13
Q

If a participant has diminished comprehension or is unable to make an informed decision, what should the study provide for that person?

A

additional protections

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14
Q

Beneficence involves treating people in an ethical manner by respecting their decisions, protecting them from harm, and making efforts to:

A

protect a person’s well-being

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15
Q

During the planning of a research study, researchers should design ways to:

A

maximize the benefits and reduce the risks of harm

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16
Q

What is never morally justified in human subjects research?

A

brutal or inhumane treatment

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17
Q

Debriefing participants after the research is over can help protect participants from which type of harm?

A

psychological harm

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18
Q

Vulnerable subjects are individuals who have difficulty providing voluntary consent, lack decision-making capacity, or:

A

are at risk for exploitation

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19
Q

When is it important to include vulnerable subjects in research?

A

when the research can provide advances in treatment for that population

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20
Q

Which of the following measures does NOT help researchers protect participants from physical harm?

A

Provide counseling after research sessions

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21
Q

The Common Rule, based on 45 CFR 46 provides as the regulatory foundation for which of the following federal agencies?

A

1Department of Education
2Central Intelligence Agency
3Department of Transportation
4Department of Health and Human Services

22
Q

Which of the following provides protections for children involved in research supported by or conducted by the Department of Health and Human Services?

A

Subpart D

23
Q

How often should each IRB renew its registration?

A

Every 3 years

24
Q

Which of the following is not a Common Rule federal agency or department?

A

Federal Bureau of Investigation

YES:
1Department of Transportation
2Department of Housing and Urban Development
3Department of Education

25
Q

What is an Institutional Authorization Agreement (IAA)?

A

A Method to Use for Single IRB Review

26
Q

The Common Rule outlines core provisions. Which one of the following is not a provision of the Common Rule?

A

The choice of clinical trial participants

27
Q

Which of the following provides protections for human fetuses?

A

Subpart B

28
Q

Which of the following is true as it relates to department heads of organizations operating under the Common Rule?

A

Department Heads retain final judgement as to whether a particular activity it conducts or supports is covered by the Common Rule

29
Q

What government agency issues Federal Wide Assurance?

A

OHRP

30
Q

Which of the following research is permitted when prisoners are involved?

A
  1. Research to determine the possible causes, effects, or processes of incarceration and criminal behavior.
  2. Research to determine to determine conditions affecting prisoners as a class.
  3. Research to study prisons as institutional structures.
31
Q

What institutions in the United States must abide by the Common Rule?

A

All institutions receiving U.S. Government funding for their research activities

32
Q

The term “Common Rule” refers to:

A

45 CFR 46 Subpart A

33
Q

The Common Rule can best be described by which phrase below?

A

1Respect for persons, beneficence, and justice
2Regulatory rules of ethics for human subjects protection
3Guidance for biomedical and behavioral research involving human subjects
4Baseline standard of ethics for government-funded research using human subjects

34
Q

True or False? The FWA is legally binding.

A

True

35
Q

Institutions that have signed an FWA and started a research study prior to Sept. 21, 2019:

A
  1. Can switch their study to follow the revised Rule
  2. Can continue their study with the original Rule
36
Q

True or False? For a research project that started after Sept. 21, 2019, you can choose to follow the original Rule.

A

False

37
Q

The purpose of the 2018 Common Rule revisions was to:

A

1Strengthen protections for study participants
2Decrease administrative workloads for researchers
3Add flexibility for the modern research environment

38
Q

True or False? Under the revised Rule, certain public health surveillance activities are NOT considered research.

A

True

39
Q

True or False? Under the revised Rule, all research must be reviewed by an IRB at least once per year.

A

False

40
Q

How many times has the Rule been revised?

A

One

41
Q

At a minimum, the IRB must be comprised of 5 members.

A

True

42
Q

Which of the following provides the regulatory language for the IRB?

A

Common Rule

43
Q

Which of the following is not an outcome associated with a full IRB review?

A

Referral

44
Q

What are the outcomes associated with a full IRB review?

A

1Tabled
2Approved
3Disapproved

CHECK

45
Q

The IRB ensures the research investigator(s) follow institutional policies and procedures related to research.

A

True

46
Q

Under an exempt review, which of the following would occur if the protection of the confidential information of the research subject is warranted?

A

1Self Determination
2Limited Review (correct?)
3Full Review (wrong)
4Private Review

47
Q

Which of the following might be present within an organization with an expansive research portfolio?

A

Human Research and Protection Program

48
Q

At a minimum, which of the following must be part of an IRB?

A

1A scientist
2A non-scientist
3An individual not associated with the organization

49
Q

Which of the following types of research could fall under HHS regulations exemptions?

A

1Educational Exemptions
2Public Benefit/Service Program Research
3Benign Behavioral Intervention

50
Q

Under the Common Rule, an IRB must ensure certain written procedures are in place. Which of the below choices is NOT correct?

A

Investigators must report how many researchers are involved

51
Q

Research studies that do not clearly show there is adequate protection of human research subjects will often lead to which of the following?

A

Disapproval

EBP :/ (11 decks)

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