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45 CFR 46 Flashcards

1
Q

What types of human drug research are required to
comply with DHHS regulations?

A

All studies that are conducted by, supported or are otherwise subject to regulations by any federal department or agency that defines this regulation as
applicable.

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2
Q

Direct or indirect identification of human subject in educational research settings is the only condition under which educational research is typically subject to the requirements of 45 CFR 46. TRUE OR FALSE?

A

false

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3
Q

Research involving the collection or study of existing data, documents, records, pathological specimens, or
diagnostic specimens is not subject to the requirement of 45 CFR 46 if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified.

TRUE OR FALSE?

A

true

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4
Q

The requirements of 45 CFR 46 do not affect any state, local or foreign laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. TRUE OR FALSE?

A

true

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5
Q

For U.S. funded studies conducted outside of the U.S., if a department or agency head determines that the
procedures prescribed by a local Institution afford protections that are at least equivalent to those in 45
CFR 46,he/she may approve the substitution of the foreign procedures provided what occurs?

A

true

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6
Q

Unless otherwise required by law, department or agency heads may waive the applicability of some or all
of the provisions of 45 CFR 46 to specific research activities otherwise covered by this policy, provided what is done with the waiver?

A

Provided advance notice is sent to the Office for Protection from Research Risks (renamed as Office of Human Research Protection) and published in the federal Register or as otherwise provided in department or agency procedures.

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7
Q

Institutions with DHHS-approved assurances on file are required to abide by provisions of title 45 CFR part 46 subparts A-D. TRUE OR FALSE?

A

true

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8
Q

What is the definition of “research” in the DHHS
regulation 45 CFR 46?

A

Research means a systematic investigation, including
research, development, testing and evaluation designed to develop or contribute to generalizable knowledge.

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9
Q

For federally supported research, “human subject” means a living individual about whom an investigator
conducting research obtains either of which two items?

A
  1. Data through intervention or interaction with the
    individual.
  2. Identifiable private information.
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10
Q

Regulations for federally-supported research define the term “private information “ to include two types of
information. Name them.

A
  1. Information about behavior that occurs in a context in which an individual can reasonably
    expect that no observation or recording is taking place
  2. Information which has been provided for specific purposes by an individual and which the individual
    can reasonably expect will not be made public (for example, a medical record).
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11
Q

For federally supported research, the term ‘intervention’ includes both the physical procedure by which data are gathered (e.g., Venipuncture) and
manipulations of the subject’s environment that are performed for research purposes. TRUE OR FALSE?

A

true

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12
Q

Private information must be individually identifiable
(i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the
information) in order to obtain the information to constitute research involving human subjects. TRUE OR
FALSE?

A

true

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13
Q

What does the term “certification” mean with respect to federally-supported research?

A

Certification is the official notification by an institute to the supporting department or agency, in accordance with the requirements of 45 CFR 46 that a research project or activity involving human subjects has been
reviewed and approved by an IRB in accordance with an approved assurance.

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14
Q

What information must each institution engaged in federally-supported research covered by 45 CFR 46 provide to the department or agency head?

A

Each Institution must either submit a written assurance ,or provide documentation of the existence
of a current federal wide assurance, that is appropriate for research in question that is on file with the Office of Human Research Protection (OHRP).

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15
Q

Federal departments and agencies will conduct or support research covered by 45 CFR 46,only if the institution has certified to the department or agency
head that the research has been reviewed and approved by an IRB, provided for in a valid assurance,
and will be subject to continuing review by the IRB.
TRUE OR FALSE?

A

true

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16
Q

Assurances applicable to federally-supported or conducted research are required to include a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the
research is subject to federal regulation. TRUE OR FALSE?

A

true

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17
Q

Assurances applicable to federally supported or conducted research are required to include designation
of one or more IRBs established n accordance with the requirements of 45 CFR 46, and for which provisions
are made for meeting space and sufficient staff to support the IRB’s review and record keeping duties.
TRUE OR FALSE?

A

true

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18
Q

Assurances applicable to federally supported or conducted research are required to include written procedures which an IRB will follow. TRUE OR FALSE?

A

true

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19
Q

For federally supported research, who is responsible for publishing a list of categories of research that may be reviewed by the IRB through an expedited review
procedure?

A

The Secretary, Health & Human Services, publishes the
list in the Federal Register. A copy of the list is
available from the office for Protection from Research
Risks (renamed the Office of Human Research
Protection).

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20
Q

A federal department or agency head may restrict,
suspend, terminate or choose not to authorize an
institution’s IRB’s use of the expedited review
procedure. TRUE OR FALSE?

A

true

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21
Q

When appropriate ,an IRB is required to determine
whether, the research plan makes adequate provision
for monitoring the data collected to ensure the safety
of subjects. TRUE OR FALSE?

A

TRUE.

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22
Q

Determination of the adequacy of provisions to protect
the privacy of subjects and to maintain the
confidentiality of data, are not IRB responsibilities and
therefore do not impact approval or research. TRUE OR
FALSE?

A

false

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23
Q

The IRB must pay particular attention to ensure
additional safeguards to have been taken for vulnerable
subjects in federally supported research. List at least
three groups of vulnerable subjects of concern.

A
  1. Children.
  2. Prisoners
  3. Pregnant Women.
  4. Mentally disabled persons.
  5. Economically or educationally disadvantaged
    persons
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24
Q

Institutions may require approvals in addition to the
IRB approval, but may not approve the research if it
has not been approved by an IRB. TRUE OR FALSE?

A

true

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25
Q

An IRB shall have authority to suspend or terminate
approval of research that is not being conducted in
accordance with IRB’s requirements or that has been
associated with unexpected serious harm to subjects.
TRUE OR FALSE?

A

true

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26
Q

The IRB is responsible for ensuring that legal ICF will
be obtained for all clinical trials subjects. TRUE OR
FALSE?

A

true

27
Q

An institution participating in a cooperative project may
enter into a joint review of another qualified IRB, or
make similar arrangements for avoiding duplication of
effort. TRUE OR FALSE?

A

false

28
Q

An Institutional, or when appropriate, an IRB, is
required to prepare and maintain copies of all research
proposals reviewed, approved sample sample consent
documents, progress reports submitted by
investigators and reports of injuries to subjects. TRUE OR FALSE?

A

true

29
Q

For federally funded research, minutes of IRB meetings
are required to include sufficient detail to define which
items?

A
  1. Attendance at the meetings.
  2. Actions taken by the IRB, including the vote with
    the number of members voting for, against &
    abstaining.
  3. The basis for requiring changes in or disapproving
    research.
  4. A written summary of the discussion of
    controverted issues & their resolution.
30
Q

IRB’s reviewing federally supported research are
required to maintain records of continuing review
activities, only if the research is approved to continue.
TRUE OR FALSE?

A

false

31
Q

Maintaining copies of all correspondence b/w the IRB
and the investigators and a detailed list of IRB
members that complies with federal regulations is
required for all IRBs. TRUE OR FALSE?

A

true

32
Q

IRBs are required to maintain written operating
procedures. TRUE OR FALSE?

A

true

33
Q

What information is an IRB required to maintain in its
records that it receives from investigators regarding
new information for study subjects?

A

Statements of significant new findings provided to
subjects.

34
Q

How long must an IRB retain its records, and to whom
must the IRB provide access to the records?

A

The records shall be retained for at least 3 years, and
records relating to research which is conducted should
be retained for at least 3 years after completion of the
research. All records shall be accessible for inspection and copying by authorized representatives of the
department or agency at reasonable times and in
reasonable manner.

35
Q

Unless a federal policy permits otherwise, no investigator may involve human being as a subject in research covered by 45 CFR 46, unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized
representative.

A

true

36
Q

When obtaining ICF from prospective research
subjects, investigators are required to ensure certain
circumstances or conditions are present. Name these
circumstances or conditions.

A
  1. The subjects has sufficient opportunity to consider
    whether to participate.
  2. The possibility that coercion or undue influence is
    minimized.
37
Q

Name general requirements for ICF regarding
language.

A

The language must be understandable to the subject or the representative and may not include any exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appear to
release the investigator ,the sponsor or the institution or its agent from liability for negligence.

38
Q

A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be
maintained must be included in all ICF documents.
TRUE OR FALSE?

A

true

39
Q

ICF should always include a statement that participation is voluntary and refusal to participate involves what?

A

No penalty or loss of benefits to which the subject is
otherwise entitled and the subject may discontinue
participation at any time without penalty or loss
benefits to which the subject is otherwise entitled.

40
Q

An IRB may approve a modified consent procedure or
form, or waive the requirement to obtain ICF for certain types of federally-supported research, provided what criteria are met?

A

Provided that the IRB finds and document that the
research meets the exemptions defined in 45 CFR 46.

41
Q

Nothing in 45 CFR 46 is intended to limit the authority
of a physician to provide emergency medical care, to
the extent the physician is permitted to do so under
applicable federal, state or local law. TRUE OR FALSE?

A

true

42
Q

An IRB may waive the requirement for the investigator to obtain a signed ICF for some or all subjects if it finds one or two conditions are present. Name these
conditions.

A
  1. The only record linking the subject & the research
    would be the consent document & the principal
    risk would be potential harm resulting from a
    breach of confidentiality.
  2. The research presents no more than minimal risk
    of harm to subjects & involves no procedures for
    which written consent is normally required outside
    of the research context.
43
Q

In cases in which the ICF documentation requirement is
waived, an IRB may require the investigator to provide
subjects with a written statement regarding the
research. TRUE OR FALSE?

A

true

44
Q

Certain applications for federal funding may be submitted without prior IRB approval, if the proposal does not include definite plans for involvement of human subjects. For example, human subject research would be dependent upon prior research, such as
animal or laboratory research. However, prior to involving humans in research, what may occur?

A

IRB review approval must be obtained, and certification
such approval must be submitted by the grantee
institution to the department or agency funding
research.

45
Q

What actions must be taken by institutions or investigators supported by federally funded research that is undertaken without the intention to involve human subjects, that later proposes to involve human subjects?

A

The Research must first be reviewed and approved by
an IRB, a certification submitted by the institution to
the department or agency, and the final approval given
to the proposed change by the department or agency.

46
Q

All applications and proposals involving human subjects
submitted to a federal department or agency for
funding will be reviewed by appropriate persons. What
will the evaluation take into consideration?

A

The risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the
research subjects and others, and the importance of
the knowledge gained or to be gained.

47
Q

What decisions may a federal agency make regarding
an application submitted for funding that involves human subjects?

A

The department or agency head may approve or
disapprove the application or proposal, or enter into
negotiations to develop an approval one.

48
Q

Federal funds administered by a department or agency
may not expended for research involving human
subjects unless the requirements of 45 CFR 46 have been satisfied. TRUE OR FALSE?

A

true

49
Q

A federal agency reserves the right to suspend or
terminate any project if the agency head finds that the
institution has materially failed to comply with the
terms of 45 CFR 46. TRUE OR FALSE?

A

true

50
Q

Since it is IRB responsibility, federal agencies are not
permitted to impose additional conditions prior to or at
the time of approval of a research project, if the
department or agency determines that the additional
conditions are necessary for the protection of human
subjects. TRUE OR FALSE?

A

FALSE. Additional conditions may be imposed at the
discretion of the agency.

51
Q

Although there are exceptions for obtaining a father’s
consent, prior to enrolling a pregnant woman into a
federally-funded research project the researcher must
normally obtain both her consent and the consent of
the father. TRUE OR FALSE?

A

true

52
Q

No pregnant woman may be involved as a subject in a
research study unless what conditions are present?

A
  1. The purpose of the research is to meet the health
    needs of the mother while minimizing the health
    risks to the fetus.
  2. The risk to the fetus is minimal.
53
Q

Federally funded research activities directed towards an
in-utero fetus typically requires ICF of both the mother
and father, unless an exception applies. TRUE OR FALSE?

A

true

54
Q

Federal regulations generally prohibit research on a
viable ex-utero fetus, unless the research is intended
to enhance the possibility of survival. TRUE OR FALSE?

A

true

55
Q

What laws govern the conduct of federally funded research involving a dead fetus, fetal material or placenta?

A

State and/or local laws.

56
Q

Under what conditions may modifications related to the
requirements of additional protections of research
related to fetuses, pregnant women and in vitro
fertilization be made?

A

The Secretary of Health & Human Services may waive certain requirements, only after approval of an ethical
advisory board, IRB approval, an opportunity for public
comment and publication of the waiver in Federal
Register.

57
Q

What is the basic premise for providing additional
protection to prisoners who are research subjects?

A

It is believed that prisoners, due to their incarceration
are under constraints that may inhibit their ability to
make a truly voluntary decision to participate in
research.

58
Q

Name two of the four types of Federally funded
research that may be done using prisoners as subjects.

A

Research involving:
1. Possible causes, effects & processes of
incarceration & criminal behavior.
2. Prisons as institutional structures or prisoners as
incarcerated persons
3. Conditions particularly affecting prisoners.
4. Practices aimed at improving the health or wellbeing
of prisoners.

59
Q

State the DHHS definition of “assent” by a child.

A

A child’s affirmative agreement to participate in
research. Mere failure to object, absent of affirmative
agreement, should not be constitute as assent.

60
Q

What is the DHHS definition of “Children”?

A

Persons who have not attained the legal age of consent
to treatments or procedures involved in research under
the applicable law of the jurisdiction where the
research will be conducted

61
Q

Even though a child may assent, permission of each of
child’s parents pr guardian is required prior to enrolling
children into research studies, unless a special
exception applies. TRUE OR FALSE?

A

true

62
Q

Who is responsible for determining whether children
are capable of assenting to participate in research trial?

A

The IRB

63
Q

Children who are wards of the state or any other
agency may only participate in research if the research
is related to their status as wards, or include other
children, the majority of whom are not wards. TRUE OR
FALSE?

A

true

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