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SOCRA 2023 > 45 CFR Part 46 > Flashcards

45 CFR Part 46 Flashcards

1
Q

What does 45 CFR Part 46 cover?

A

Protection of Human Subjects

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2
Q

dead fetus

A

a fetus that exhibits neither a heartbeat, spontaneous respiratory activity, movement of voluntary muscles, nor pulsation of the umbilical cord.

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3
Q

fetus

A

the product of conception from implantation until delivery

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4
Q

neonate

A

newborn

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5
Q

nonviable neonate

A

neonate after delivery that, although living, is not viable.

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6
Q

viable

A

as it pertains to a neonate: means being able, after delivery, to survive to the point of independently maintaining heartbeat and respiration.

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7
Q

pregnancy

A

period of time from implantation until delivery

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8
Q

DHHS

A

Department of Health and Human Services

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9
Q

children

A

persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

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10
Q

assent

A

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

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11
Q

permission

A

the agreement of parent(s) or guardian to the participation of their child or ward in research.

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12
Q

Parent

A

a child’s biological or adoptive parent.

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13
Q

guardian

A

an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care.

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14
Q

how often must an IRB renew its registration?

A

Every 3 years.

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15
Q

How often should Registration info for an IRB be updated when a contact or chair person’s information changes?

A

Within 90 days after changes occur regarding the contact person who provided the IRB registration information or the IRB chairperson.

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16
Q

How long after an update is accepted by the OHRP does an IRB renew its registration?

A

Any renewal or update that is submitted to, and accepted by, OHRP begins a new 3 year effective period.

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17
Q

How soon should an IRB report to OHRP that it intends to disband?

A

An institution’s decision to disband a registered IRB which it is operating also must be reported to OHRP in writing within 30 days after permanent cessation of the IRB’s review of HHS conducted or supported research.

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18
Q

According to 45 CFR part 46, is the following IRB exempt:

Research conducted in established or commonly accepted educational settings, involving normal educational practices.

A

Yes.

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19
Q

According to 45 CFR part 46, is the following IRB exempt:
Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior.

A

Yes UNLESS human subjects provide personally identifiable information or providing such info puts the subjects at criminal or civil liability or damages their reputation.

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20
Q

According to 45 CFR part 46, is the following IRB exempt:
Research involving educational tests, surveys, interview procedures, or observation of public behavior of public officials or candidates for public office.

A

Yes.

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21
Q

According to 45 CFR part 46, is the following IRB exempt:
Research involving the collection/study of existing data, documents, records, specimens, etc. where subjects can be identified.

A

No, only if the subjects can NOT be identified is it exempt.

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22
Q

According to 45 CFR part 46, is the following IRB exempt:

Research of public benefit or service programs.

A

Yes.

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23
Q

According to 45 CFR part 46, is the following IRB exempt:

Research on taste and food quality evaluation and consumer acceptance studies.

A

Yes.

24
Q

According to 45 CFR part 46, who has the final say as to whether an activity falls under OHRP regulation?

A

The Department or Agency heads.

25
Q

True or False. OHRP guidelines can be followed instead of state or local laws or regulations which may be applicable.

A

False.

26
Q

What is the minimum number of members required for an IRB to exist according to 45 CFR part 46.

A

Five members with emphasis on diversity of expertise, gender, race, etc. This includes at least one scientific member and one non-scientific member.

27
Q

It is OK for members of an IRB to consist of all one gender.

A

Every nondiscriminatory effort should be made to ensure this doesn’t happen.

28
Q

It is OK for members of an IRB to consist of all one profession.

A

No

29
Q

An IRB consists of all institution professionals and the daughter of one of the institution’s deans as its non-institution member. Is this appropriate?

A

No. All IRBs must have a non-institutional member who can not be an immediate family member of a person affiliated with the university.

30
Q

Who is required at IRB meeting for research approval?

A

A majority of members, including at least one non-scientific member.

31
Q

True or False: An IRB has the authority to approve, require modifications in, or disapprove of research activities.

A

True

32
Q

True or False. If an IRB gives a decision of disapproval, the investigator has an opportunity to respond in person or in writing?

A

True (Within 15 days)

33
Q

How often does IRB continuing review occur?

A

No less than once a year.

34
Q

What are the general characteristics of IRB submissions that qualify for expedited review?

A

They are no more than minimal risk or contain minor changes in previously approved research (of one year or less)

35
Q

Under expedited review, how many IRB members are required in order to approve the research? What about disapprove the research?

A

Only one member is required to approve the research. However, if the member disapproves it must go through full IRB review in order to be disapproved or require changes.

36
Q

What are the criteria for IRB approval of research?

A

Risk to subjects is minimized
Risk are reasonable in relation to anticipated benefits
Selection of subjects is equitable
Informed consent is gathered from each subject or LAR and properly documented
Monitoring plan is in place for subject data
Privacy of subject data

37
Q

If an IRB terminates or suspends the approval of research, who is notified?

A

Investigator, institutional officials and department/agency head.

38
Q

In the IRB meeting minutes, if a vote was taken what must be recorded?

A

Action taken,
number of members voting for, against and abstaining,
the basis for requiring changes or disapproving research,
and a written summary of the discussion.

39
Q

Do copies of all correspondence between the IRB and investigators need to be recorded by the IRB?

A

Yes.

40
Q

Do the IRB procedures written in detail need be recorded by the IRB?

A

Yes.

41
Q

Do statements of significant new findings provided to trial subjects need to be recorded by the IRB?

A

Yes.

42
Q

How long should IRB records be retained?

A

3 years.

43
Q

According to ICH GCP, an IRB/IEC should safeguard the ____, ____ and ____ of all trial subjects.

A

Rights, safety and well-being.

44
Q

According to ICH GCP, what documents do IRB/IEC’s need to obtain prior to the study beginning?

A

Trial protocol(s) / amendment(s)
Written informed consent form(s)
Subject recruitment procedures (e.g., advertisements)
Written information provided to subjects
Investigator’s Brochure
Available safety and compensation information
Investigator’s current CV

45
Q

What categories of research qualify for expedited IRB review?

A

No more than minimal risk or minor changes to approved research
IND/IDE used for its labeling purposes
Minimal blood sampling research
Collection of biological samples that is not invasive
Collection of routine data from clinical practice (heart rate, bp, etc.)
Research done on data collected for non-research purposes (e.g. - routine vitals)
Data from voice, video or digital
Research on individual or group characteristics
Previously approved research (continuing review)

46
Q

What is required for research to be approved using non-viable neonates?

A

Study must be scientifically appropriate and backed by science
The participants are fully informed of what might happen to the neonate
Study team has no say in determining the viability of the fetus
Vital functions will not be artificially maintained
Research doesn’t terminate heartbeat/respiration
No added risk to neonate
Objective of the research can’t be obtained another way
Provides important knowledge which can’t be provided another way
If no LAR, either parent can consent

47
Q

What is required for research to be approved using neonates with uncertain viability?

A

Study must be scientifically appropriate and backed by science
The participants are fully informed of what might happen to the neonate
Study team has no say in determining the viability of the fetus
Research holds out possibility of improving survival
Research provides important knowledge and couldn’t be provided any other way
Either parent or, if not available, LAR can be used for consent

48
Q

What is an assurance? Is it required by FDA?

A

Assurance is a document that confirms that the performance-site institution will comply with 45 CFR part 46. Used when research is conducted by HHS or is in someway supported by HHS. An assurance is not required by FDA.

49
Q

Can IRB members be paid for their services?

A

Yes.

50
Q

What are the essential components of an informed consent form?

A

1) Purpose of the study
2) Known and foreseeable risks
3) Compensation and contact for injury
4) Participation is voluntary and you can withdraw anytime
5) Benefits to the subject
6) Alternative treatment, therapy, etc. to the investigational product
7) Confidentiality / HIPPA and how subjects data will be maintained
8) Contact info for the investigator

51
Q

What are the additional components (nonmandatory) of an informed consent form?

A

1) Number of patients
2) Unforeseeable risks to subject
3) Additional costs to subject
4) You can be withdrawn from study by Investigator if they choose
5) What happens when the subject withdraws
6) Statement of new findings will be provided to subject that may affect their decision to stay in study

52
Q

The written informed consent form should be signed AND personally dated by the ______ (or ________ if applicable) and the ________.

A

Subject (or LAR if applicable) and the person who conducted the informed consent discussion.

53
Q

What happens during the informed consent process if a subject or LAR is unable to read?

A

An impartial witness needs to be present during the entire informed consent discussion. When the subject/LAR are orally consented, they sign and personally date the consent form and the witness signs and personally dates the consent form to attest that the information was accurately explained.

54
Q

According to ICH GCP, how many of the following are included in the informed consent form/discussion?
A) That the trial involves research
B) Probability for random assignment to each treatment
C) Trial procedures to be followed, including invasive procedures
D) The sponsor of the trial
E) The subject’s responsibilities
F) The investigators CV

A

A) That the trial involves research
B) Probability for random assignment to each treatment
C) Trial procedures to be followed, including invasive procedures
E) The subject’s responsibilities

55
Q

According to ICH GCP, how many of the following are included in the informed consent form/discussion?
A) Any foreseeable risks or inconveniences to the subject
B) Any expected benefits to the patient
C) The name of the IRB/IEC used for approval
D) Any alternative procedures / courses of treatment that are available and their benefits/risks
E) The demographics of patients the drug has been tested in previously
F) Any compensation or treatment for patients who experience a trial-related injury

A

A) Any foreseeable risks or inconveniences to the subject
B) Any expected benefits to the patient
D) Any alternative procedures / courses of treatment that are available and their benefits/risks
F) Any compensation or treatment for patients who experience a trial-related injury

56
Q

According to ICH GCP, how many of the following are included in the informed consent form/discussion?
A) Other interventions that the sponsor is developing
B) Anticipated expenses the subject may incur for participating in the trial
C) That the monitor, auditor, IRB/IEC and regulatory authority will be granted access to the subjects medical records without violating their confidentiality
D) That the subject’s records will be kept confidential
E) Someone to contact for further information about he trial
F) That the subject will be informed as soon as any new information becomes available that is relevant to the subjects participation in the trial

A

B) Anticipated expenses the subject may incur for participating in the trial
C) That the monitor, auditor, IRB/IEC and regulatory authority will be granted access to the subjects medical records without violating their confidentiality
D) That the subject’s records will be kept confidential
E) Someone to contact for further information about he trial
F) That the subject will be informed as soon as any new information becomes available that is relevant to the subjects participation in the trial

57
Q

According to ICH GCP, how many of the following are included in the informed consent form/discussion?
A) Any foreseeable circumstances/reasons the subject’s participation may be terminated
B) Expected duration of the subjects participation in the trial
C) Approximate number of subjects involved in the trial
D) Software used to analyze the subject’s trial data
E) Anticipated prorated payment to the subject participating in the trial
F) Contacts for the relevant regulatory authorities

A

The following should be included:
A) Any foreseeable circumstances/reasons the subject’s participation may be terminated
B) Expected duration of the subjects participation in the trial
C) Approximate number of subjects involved in the trial
E) Anticipated prorated payment to the subject participating in the trial

SOCRA 2023 (16 decks)

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