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SOCRA_2015 > 45 CFR Part 46 > Flashcards

45 CFR Part 46 Flashcards

1
Q

research

A

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

46.102

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2
Q

human subject

A

a living individual about whom an investigator conducting research obtains data or private information

46.102

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3
Q

intervention

A

both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes

46.102

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4
Q

certification

A

official notification by the institution to the supporting Department or Agency that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance

46.102

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5
Q

minimal risk

A

the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily live or during the performance of routine physical or psychological examinations or tests

46.102

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6
Q

interaction

A

communication or interpersonal contact between investigator and subject

46.102

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7
Q

private information

A

information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public

46.102

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8
Q

research subject to regulation

A

research activities for which a federal department or agency has specific responsibility for regulating as a research activity

46.102

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9
Q

Each IRB shall have at least ___ members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.

a) 3
b) 5
c) 7
d) 10

A

b) 5

46. 107

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10
Q

assent

A

a child’s affirmative agreement to participate in research

46.402

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11
Q

The legally effective informed consent of both parents of a neonate must be obtained before a neonate may be involved in research.

true
false

A

false

…of either parent…

46.205

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12
Q

In research involving prisoners, at least one member of the IRB must be a prisoner.

true
false

A

false

At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity…

46.304(b)

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13
Q

Obtaining assent of children is not a necessary condition for proceeding with research if:

a) the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably consulted
b) the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research
c) assent must always be obtained from children
d) a and b

A

d) a and b

46. 408

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14
Q

An IRB must be registered with DHHS before it can be designated under an assurance approved for federalwide use by OHRP.

true
false

A

true

46.501

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15
Q

Basic elements of informed consent include which of the following:

a) description of risks and benefits
b) disclosure of appropriate alternative procedures or courses of treatment
c) statement that the study involves research
d) all of the above

A

d) all of the above

46. 116

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16
Q

45 CFR Part 46 Subpart A is titled:

a) Public Welfare in Research
b) Basic HHS Policy for Protection of Human Research Subjects
c) IRB Membership
d) Inspection of Investigator Records

A

b) Basic HHS Policy for Protection of Human Research Subjects

  • also known as the Common Rule*
    http: //www.hhs.gov/ohrp/humansubjects/commonrule/
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17
Q

IRB reviewers may disapprove a research activity under the expedited review procedures.

true
false

A

false

46.110
A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in 46.108.

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18
Q

At least two nonscientific IRB members must be present when reviewing proposed research at a convened meeting.

true
false

A

false

46.108
…a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

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19
Q

Department or Agency Head

A

The head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.

46.102

20
Q

What is the correct IRB composition?

a) at least 5 members, at least one member who is not affiliated with the institution, at least one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are in nonscientific areas
b) at least 5 members, at least one member not affiliated with the institution, either all men or all women, no members with a conflicting interest
c) at least 3 members, at least one member who is not affiliated with the institution, at least one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are in nonscientific areas
d) at least 3 members, at least one member not affiliated with the institution, either all men or all women, at least one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are in nonscientific areas, and no members with a conflicting interest

A

a) at least 5 members, at least one member who is not affiliated with the institution, at least one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are in nonscientific areas
46. 107

21
Q

In order for research to be approved by an IRB, it shall receive the approval of all of those members present at the meeting.

true
false

A

false

46.108
…approval of a majority of those members present…

22
Q

According to 45 CFR Part 46, how long should records be retained?

a) 1 year
b) 2 years
c) 3 years
d) 5 years

A

c) 3 years

46. 115

23
Q

The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

true
false

A

true

http://www.hhs.gov/ohrp/humansubjects/commonrule/

24
Q

Department or agency heads retain final judgment as to whether a particular activity is covered by 45 CFR Part 46.

true
false

A

true

46.101(c)

25
Q

Institutions without an approved assurance covering the research shall certify within ______ after receipt of a request for such a certification from the department or agency, that the application or proposal has been approved by the IRB.

a) 10 days
b) 15 days
c) 30 days
d) 3 months
e) 6 months

A

c) 30 days

46. 103(f)

26
Q

An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may vote with the IRB.

true
false

A

false
..may not vote with…

46.107(f)

27
Q

An IRB shall have authority to observe or have a third party observe the consent process and the research.

true
false

A

true

46.109(e)

28
Q

Under an expedited review, the review may be carried out by _______________.

a) by one or more experienced reviewers
b) the FDA
c) individual with competence in special areas
d) the IRB chairperson
e) the majority of IRB members
f) at least one IRB member whose primary concern is in scientific areas

A

a or d

46.110

29
Q

Criteria for IRB approval of research:

n=7

A

1) risks to subjects are minimized
2) risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be reasonably be expected to result
3) selection of subjects is equitable
4) informed consent will be sought from each prospective subject or the subject’s legally authorized representative
5) informed consent will be appropriately documented
6) when appropriate, research plan makes adequate provision for monitoring the data collected to ensure safety of subjects
7) when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

46.111

30
Q

Nothing in 45 CFR Part 46 is intended to limit the authority of a physician to provide emergency medical care.

true
false

A

true

416.116(f)

31
Q

An IRB may waive the requirement for a signed consent if the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.

true
false

A

true

46.117(c)

32
Q

If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions.

true
false

A

true

…except that the father’s consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.

46.204(e)

33
Q

Individuals engaged in the research will have no part in any decisions to terminate a pregnancy or in determining the viability of a neonate.

true
false

A

true

46.204(i & j)

34
Q

The legally effective informed consent of both parents of the neonate must be obtained before a nonviable neonate may be involved in research.

true
false

A

true

46.205(c))5)

35
Q

The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will suffice to meet the requirements of 46.205(c)(5).

true
false

A

false

…will not suffice…

46.205(c)(5)

36
Q

The definition of prisoner includes:

a) a parolee held in a treatment facility as part of their sentence
b) a parolee living in society
c) a person involuntarily confined in a mental institution
d) an individual involuntarily confined or detained in a penal institution

A

a and d

  1. 303 and
    https: //www.youtube.com/watch?v=SqRw6FevuXg&feature=player_embedded
37
Q

Control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.

true
false

A

true

46.305(a)(4)

Unless the principal investigator provides to the Board justification in writing for following some other procedures…

38
Q

Permitted research involving prisoners includes:

a) study of possible causes, effects and processes of incarceration
b) study of possible causes, effects and processes of criminal behavior
c) research on conditions particularly affecting prisoners as a class
d) research on practices which have the intent and reasonable probability of improving the health or well-being of the subject

A

a, b, c, d

46.306(a)(2)

39
Q

Do parental permission and child assent for research involving children have to occur at the same time or in any particular order?

yes
no

A

The HHS regulations do not specify the order in which parental or guardian permission and child assent should be sought. Therefore, Institutional Review Boards (IRB) have the discretion to determine the appropriate order given the research and the context in which it will be conducted.

In general, parental or guardian permission should be sought before seeking the assent of a child, particularly in more than minimal risk research, unless the requirement for obtaining parental or guardian permission can be waived. There might be some cases, however, involving minimal risk research, where it would be reasonable to seek child assent prior to seeking parental permission.

For example, a school-based study of minimal risk (e.g., investigating children’s responses to music), could be posed to children in the school setting. Children could be asked if they wanted to participate and if so, sent home with a request for parental or guardian permission. In all cases, except when the requirement for obtaining parental or guardian permission can be waived, parental or guardian permission, even if sought after child assent is provided, is required before the child can be enrolled in the study.

http://www.hhs.gov/ohrp/policy/faq/children-research/order-of-permission-assent.html

40
Q

For each of the following, indicate whether permission of one (1) parent is sufficient or whether permission is to be obtained from both (2) parents.

a) research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children
b) research not involving greater than minimal risk
c) research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subject
d) research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition

A

a) both 46.407
b) one 46.404
c) one 46.405
d) both 46.406

46.408(b)

41
Q

When the IRB determines that assent is required, it shall also determine _________ assent must be documented.

a) whether
b) how
c) when
d) whether and how
e) when and how

A

d) whether and how

46. 408(e)

42
Q

One individual may server as advocate for more than one child.

true
false

A

true

46.409

43
Q

What information must be provided when registering an IRB?

a) name, mailing/street address of institution or organization operating the IRB
b) name, mailing address, phone number, facsimile number, and electronic mail address of senior officer or head official of institution overseeing IRB
c) name, mailing address, phone number, facsimile number, and electronic mail address of contact person providing registration information
d) IRBs name, mailing/street address, phone number, facsimile number, and electronic mail address
e) name, phone number, and electronic mail address of the IRB chairperson
f) approximate numbers of active protocols, active protocols conducted or supported by HHS, and number of full-time equivalent positions devoted to the IRBs administrative activities

A

all

46.502

44
Q

IRB registration become effective when ____________ by OHRP.

a) received
b) reviewed
c) accepted
d) b and c
e) a and b

A

d) b and c

46. 503

45
Q

Each IRB must renew its registration every ______.

a) year
b) 2 years
c) 3 years

A

c) 3 years

46. 505

46
Q

The registration information for an IRB must be updated within _______ after changes occur regarding the contact person who provided the IRB registration information or the IRB chairperson.

a) 30 days
b) 90 days
c) 6 months
d) 1 year

A

b) 90 days

46. 505

47
Q

An institution’s or organization’s decision to disband a registered IRB which it is operating also must be reported to OHRP in writing within ________ after permanent cessation of the IRB’s review of HHS-conducted or -supported research.

a) 30 days
b) 90 days
c) 6 months
d) 1 year

A

a) 30 days

46. 505

SOCRA_2015 (15 decks)

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