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Socra > 21 CFR 56 > Flashcards

21 CFR 56 Flashcards

1
Q

What is the FDA’s intention of having IRB comply with the regulations of 21 CFR 56?

A

The intention is to protect the rights and welfare of
human subjects involved in investigations regulated by
the FDA.

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2
Q

The FDA’s IRB regulations apply to research used in marketing applications for which types of products?

A
  1. Drugs, including over the counter drugs.
  2. Biologics
  3. Devices
  4. Color additives
  5. Addictive substances affecting the characteristics of or becoming a component of food.
  6. Electronic products.
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3
Q

T/F: In the FDA’s IRB regulations, the term research, clinical research, clinical study and clinical investigation are deemed to be synonymous.

A

true

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4
Q

In the FDA’s IRB regulations, what does the term emergency use mean?

A

Emergency use means the use of a test article on human subject in life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval.

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5
Q

T/F: IRB approval is required for any drug, device or biologic research product subject to FDA regulation
unless the research meets an exemption criteria.

A

true

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6
Q

T/F: The FDA may disallow consideration of data in support of an NDA if the data is from a study which was not approved by an IRB and waiver of approval was not issued by FDA.

A

true

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7
Q

Emergency use of a test article may occur prior to IRB approval, provided that such use is reported to the IRB
within how many working days?

A

5 working days

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8
Q

Upon application from a sponsor ,or sponsor investigator, the FDA may waive the requirement for
IRB review for either a specific research activity or for a
classes of research activities. TRUE OR FALSE?

A

true

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9
Q

What is the minimum number of members for an IRB?

A

5

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10
Q

An IRB must be qualified through its experience, expertise and diversity to promote respect for its advise and counsel in safeguarding the rights and
welfare of human subjects. TRUE OR FALSE?

A

true

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11
Q

Diversity with respect to race, gender, cultural background and sensitivity to community attitudes are not criteria for IRB membership. TRUE OR FALSE?

A

false

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12
Q

IRBs shall be able to ascertain the acceptability of proposed research in terms of institutional commitments, but not for regulations, applicable law or standard of professional conduct or practice. TRUE OR FALSE?

A

False. IRBs shall be able to ascertain the acceptability of research for all of these criteria.

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13
Q

What are the IRB membership requirements when the IRB regularly reviews research involving a vulnerable category of subjects such as children, prisoners, or mentally disabled persons?

A

IRB must consider including one or more individuals who are knowledgeable about, and have experience in, working with the vulnerable group of subjects.

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14
Q

Non-discriminatory efforts should be made to ensure
that no IRB consists entirely of men or entirely of women, so long as what standard applies?

A

That no selection is made to the IRB based solely on
gender.

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15
Q

What are the IRB membership requirements with respect to differing professions?

A

No IRB may consist entirely of member of one
profession.

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16
Q

What IRB requirements exist regarding members with scientific and non-scientific areas of concern?

A

At least one member must have a primary concern in a scientific area, and one member must have a primary
concern in a non-scientific area.

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17
Q

IRB membership shall include at least one person who is not otherwise affiliated with the institution. This
member must meet what additional criteria?

A

This member may not be a part of the immediate family of a person who is affiliated with the institution.

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18
Q

No IRB member may participate in the initial or conducting review process for any projects in which they have a conflicting interest except to provide what?

A

Information requested by the IRB.

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19
Q

An IRB is not allowed to obtain consulting information from anyone other than member of the IRB with full voting privileges. TRUE OR FALSE?

A

false

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20
Q

Name at least three areas for which an IRB must have written operating procedures that govern their actions
and responsibilities.

A
  1. Conducting initial and continuing reviews of research and reporting its actions and findings to investigators and affiliated institutions.
  2. Identifying projects requiring more than annual reviews & those which require information from sources other than the investigator.
  3. Establishing requirements for promptly reporting changes in research
  4. Ensuring changes in research are not initiated without IRB approval except when it may be necessary to eliminate hazard to study subjects.
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21
Q

Name at least two areas in which IRBs must have
written procedures which ensure prompt reporting to
the IRB, officials to the Institution, and the FDA.

A
  1. Unanticipated problems involving risk to human
    subjects or others.
  2. Serious or continuing noncompliance with federal
    regulations or IRB requirements.
  3. Any suspension or termination of IRB approval.
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22
Q

For routine, full review, how many IRB members must
be present in order for research to be approved?

A

A majority of members must be present at a convened
meeting.

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23
Q

As long s a majority of IRB members are present at a
review meeting, research may be approved without
regard to areas of primary concern represented by
those present. TRUE OR FALSE?

A

false

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24
Q

In order for research to be approved, a majority of
members present at a meeting must vote for approval.
TRUE OR FALSE?

A

true

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25
Q

Name the three actions that an IRB has authority to
take.

A
  1. Approve research.
  2. Disapprove research.
  3. Require modifications to secure approval of
    research.
26
Q

An IRB must require that informed consent documents
comply with the required elements of ICF(21 CFR
50.25), but cannot require additional criteria. TRUE OR
FALSE?

A

false

27
Q

Under what circumstances may an IRB waive the requirements for documentation of informed consent?

A

If the IRB finds that the research involves no more that
minimal risk or harm to the subjects and involves no
procedures for which ICF is normally required outside
of the research context, or if some or all of the subjects
meet the exception from ICF for emergency research in
21 CFR 50.24.

28
Q

If an IRB waives the need for documented ICF ,the IRB
may not require an investigator to provide subjects
with a written statement regarding the research. TRUE
OR FALSE?

A

false

29
Q

To whom must an IRB provide a written statement of
its actions when making a decision regarding approval
of a research project?

A

The Institution and the Investigator.

30
Q

In addition to providing written notification of its disapproval of research, an IRB must allow what additional activity to occur?

A

The IRB must allow the investigator to respond in
writing or in person.

31
Q

If an IRB finds that proposed research involving an
exception to ICF for emergency research does not meet
the requirements of 21CFR 50.24, or is determined to
be not ethical, whom must the IRB notify?

A

The IRB must promptly notify the investigator and the
sponsor of the research in writing, and include the
reasons for its finding.

32
Q

What is the required interval for an IRB to conduct
continuing review of previously approved research?

A

At intervals appropriate to the degree of risk, but not
less than once per year.

33
Q

The IRB has the right to require that a third party
observe the consent process and the research. TRUE
OR FALSE?

A

true

34
Q

If an IRB is required to publicly disclose information (in 21 CFR 50.24) based on its findings in the review of
emergency research, whom must the IRB notify?

A

The sponsor, promptly. The sponsor shall then promptly notify the FDA.

35
Q

Where and how often is a list of research categories
that may be reviewed by an IRB through an expedited
review process published?

A

In the Federal Register by the FDA. The list is updated
through periodic republication, when deemed necessary
by the FDA.

36
Q

For what reason, other than research found to involve
no more than minimal risk, may the IRB use an
expedited review process?

A

For minor changes in research which was previously
approved by the IRB during the period for which
approval was authorized (1 year or less).

37
Q

An IRB may use the expedited review process to
approve or disapprove research if the research involves only a minor change. TRUE OR FALSE?

A

false

38
Q

The full IRB committee does not need to be informed of
an expedited decision. TRUE OR FALSE?

A

false

39
Q

The FDA may restrict, suspend or terminate an IRB’s
use of the expedited review procedure under what
circumstances?

A

When deemed necessary to protect the rights or welfare of human subjects.

40
Q

The IRB must determine that the risks for procedures to be used in proposed research are minimized. Name the two criteria by which this is assured.

A

By using:
1. Procedures consistent with sound research design
& which do not unnecessarily expose subjects to
risk.
2. Procedures already being performed on the
subject for diagnostic or treatment purposes.

41
Q

In evaluating risks and benefits, the IRB should only consider those benefits that may result from the possible long range effects of applying knowledge
which may be gained from the research. TRUE OR
FALSE?

A

true

42
Q

The IRB is responsible for ensuring equitable selection
of subjects. Name at least four vulnerable populations
to which the IRB should pay special attention, relative
to equitable subject selection, and ensure these
subjects receive additional safeguards.

A
  1. Children.
  2. Prisoners.
  3. Pregnant Women.
  4. Handicapped persons.
  5. Mentally disabled persons.
  6. Economically or educationally disadvantaged
    persons.
43
Q

Prior to approving research, an IRB must ensure that
procedures for obtaining and documenting IC are
consistent with FDA requirements. TRUE OR FALSE?

A

true

44
Q

An Institution may require reviews of research in
addition to an IRB’s review, but may not approve research not already approved by an IRB. TRUE OR
FALSE?

A

true

45
Q

An IRB may not approve research if it finds that the
safety of subjects is not being adequately monitored
through review of collected data, or subject privacy or
confidentiality of data is not adequately protected.
TRUE OR FALSE?

A

true

46
Q

Under what conditions may an IRB suspend or terminate approval of research?

A
  1. The research is not being conducted in accordance
    with the IRB’s requirements.
  2. The research has been associated with unexpected
    serious harm to subjects.
47
Q

When an IRB terminates research approval, whom
must it notify of the decision?

A
  1. The investigator.
  2. The FDA
  3. appropriate institutional officials.
48
Q

Name two options institutions involved in multi institutional
studies may use to avoid duplication of
efforts.

A
  1. Joint review with other Institutions
  2. Reliance upon the review of another qualified IRB.
49
Q

Name at least four records (items) which an IRB must
maintain for each research project that it approves.

A
  1. The research proposal (protocol).
  2. Approved sample consent form.
  3. Investigator progress reports.
  4. Reports of injuries to subjects.
  5. All correspondence with investigators.
  6. Statements of new findings provided to subjects.
  7. Detailed minutes of the IRB meetings.
  8. Records of continuous reviews.
50
Q

Name the membership information that must be
maintained by an IRB.

A
  1. Certifications & licenses, sufficient to describe the
    primary anticipated contribution of the member.
  2. Relationship between the institution and the IRB
    member.
51
Q

How long must an IRB retain its records for each research projects?

A

Three years after completion of the research.

52
Q

The FDA may inspect IRB records at reasonable times,
and in a reasonable manner, but may not take copies
of IRB records. TRUE OR FALSE?

A

FALSE. The FDA may also copy the records.

53
Q

If an IRB refuses to allow the FDA to inspect its
records, the FDA may disallow data from clinical
investigation reviewed by the IRB in support of an NDA. TRUE OR FALSE?

A

true

54
Q

Upon finding non-compliance during an initial or follow up
IRB inspection, the FDA may impose restrictions on
an IRB, while awaiting corrections to address the noncompliance.
Name two of these restrictions

A
  1. Withhold approval of new studies subject to the
    requirements.
  2. Direct that no new subject be added to ongoing
    studies.
  3. Terminate ongoing studies when doing so would
    not endanger the safety of subjects.
  4. Notify relevant state & federal authorities when
    the IRB’s apparent non-compliance poses a
    significant threat to the rights & welfare of the
    subjects.
55
Q

Generally, the FDA will ordinarily direct any
administrative actions related to an IRB against the
parent institution, because it presumes the institution
responsible for the operation of an IRB. TRUE OR
FALSE?

A

true

56
Q

In addition to disqualifying an IRB, the FDA may disqualify the IRB’s parent institution. TRUE OR FALSE?

A

true

57
Q

If the rights or welfare of the subjects are adversely
affected by an IRB’s non-compliance, the IRB may be
disqualified. TRUE OR FALSE?

A

true

58
Q

If an IRB or its parent institution is disqualified, the
FDA may send a notice to other interested parties such
as sponsors or investigators. Additionally, the FDA may
publish a notice of its action in the Federal Register.
TRUE OR FALSE?

A

true

59
Q

If an IRB has been disqualified by the FDA, what must
it do to be considered for reinstatement by the FDA?

A

Provide a written statement from the IRB or Institution explaining the corrective action that will be taken and
that the IRB or institution will operate in compliance
with the FDA’s IRB requirements.

60
Q

The only legal action that the FDA can take against an
IRB is disqualification. TRUE OR FALSE?

A

false

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