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SOCRA 2022 notes > Regulation > Flashcards

Regulation Flashcards

1
Q

45CFR Part 46?

A

Federal Policy for the Protection of Human
Subjects (HHS)

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2
Q

45CRF Part 46 subparts?

A

Subpart A: Basic HHS policy
Subpart B: Pregnant women, Fetuses and Neonates
Subpart C: Prisoners
Subpart D: Minors

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3
Q

Who enforces 45CRF part 46 regulation?

A

OHRP – Office for Human Research Protections

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4
Q

21 CFR 312?

A

INDs- New Drugs/ Biologics

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5
Q

21 CFR 812

A

INVESTIGATIONAL DEVICE EXEMPTIONS (IDE)- New Devices

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6
Q

21CFR 56.102 (d)

A

Emergency Use of Test Article

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7
Q

21CFR Parts 50 and 56, include?

A

1) INDs- New Drugs/ Biologics (21CFR 312)
2) IDEs- New Devices (21CFR 812) 3) Emergency Use of Test Article

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8
Q

Who enforces 21CFR Parts 50 and 56 regulation?

A

FDA does their own enforcement

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9
Q

Do we have to abide by both OHRP and FDA requirements?If so, when?

A

Yes. An NIH-funded study that involves the research use of an FDA-regulated drug
may need to comply with both sets of regulations – the FDA regulations because the
drug is an FDA-regulated product, and the Common Rule and its subparts because the
research is funded by NIH, which is part of HHS.

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10
Q

FDA Regulations on Human Subject Research?

A

Through CFR title 21

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11
Q

What is Title 21 of the CFR?

A

Is reserved for rules of the Food and Drug Administration.

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12
Q

What are 21 CFR parts?

A

Part 50 (protection of human subjects): Subpart A (definitions), Subpart B (informed consent), Subpart D (children)

Note: No subparts for prisoners or pregnant women/fetus/neonates for 21 CFR, only for 45 CFR (HHS)

Part 54 (financial disclosure by clinical investigators)

Part 56 (Institutional Review Boards)

Part 11 (Electronic Records, signatures)

Part 312 (Investigational New Drug Application)

Part 809 (In Vitro Diagnostic products for human use)

Part 812 (Investigational Device Exemption)

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13
Q

HHS AND FDA REGULATORY DIFFERENCES?

A
  • HHS and FDA do not have complete harmony between their regulations.
  • Some examples:
  • HHS allows for waiver of written consent in minimal risk research; FDA does not recognize waiver of consent
  • FDA clinical investigation = research; HHS definition of research is very detailed and specific
  • Scope of responsibility
  • FDA – all food, drug, biologic and device research
  • HHS – research funded by Federal govt, or all research as per FWA
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14
Q

ICH?

A
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) – first met in 1991
  • Joins efforts of Western Europe, U.S., Japan
  • Primary purpose is to coordinate the drug regulatory process to prevent redundancy in research
  • GCP Guidelines issued, based on Declaration of Helsinki, attempt to provide a unified standard for the protection of human subjects
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15
Q

DEFINITION OF GCP

A

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

Compliance with this standard provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible (ICH, 1996).

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16
Q

ICH PRINCIPLES FOR GCP?

A

1) Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

2) Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

3)The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

4) The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

5) A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.

6) Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

7) The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

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17
Q

Research may involve prisoners when:

A
  • Study of the possible causes, effects, and processes
    of incarceration, and of criminal behavior, or
  • Study of prisons as institutional structures or of prisoners as incarcerated persons,
  • provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.
  • Other types of research involving prisoners must have approval of the Secretary, DHHS
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18
Q

45 CFR 46: SUBPART D?

A

Children

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19
Q

What is 45 CFR 46: SUBPART D: CHILDREN apply for?

A

Applies to children (have not attained the legal age for consent to treatments or procedures) as subjects

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20
Q

Categories for 45 CFR 46: SUBPART D: CHILDREN?

A
  • No greater than minimal risk (category I)
  • > minimal risk; prospect of direct benefit (category II)
  • > minimal risk; no prospect of direct benefit, but likely to yield generalizable knowledge about subject’s disorder or condition (category III)
    -Research not otherwise approvable which presents an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children (category IV)
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21
Q

Permission from Parents or Guardians for children:

A
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22
Q

PERMISSION OF BOTH PARENTS:

A

Under certain conditions, permission is required from both parents, except when:
1. One parent is deceased, unknown, incompetent, or not reasonably available, or
2. One parent has legal responsibility for the care and custody of the child

23
Q

RISK CATEGORY I FOR CHILDREN

A
  • Minimal risk
    IRB Duties:
    1. Confirm provisions for child assent
    2. Confirm provisions for parental consent
24
Q

RISK CATEGORY II FOR CHILDREN

A

> Minimal risk, but direct benefit
- IRB Duties
1. Determine that risk is justified by benefit
2. Benefit/risk relationship is at least as favorable as alternative approaches
3. Confirm adequate provisions for child’s assent and parental consent (one or both parents)

25
Q

RISK CATEGORY III FOR CHILDREN

A

> Minimal risk, no direct benefit, but likely to yield generalizable knowledge about the subject’s disorder or condition
- IRB Duties:
1. Determination of minor increase over minimal risk; project will yield knowledge of vital importance to the subject’s disorder
2. Determination that intervention presents experiences relatively commensurate with alternative medical, dental, psychological, or educational interventions
3. Confirm provisions for child assent and parental consent (both parents)

26
Q

RISK category IV FOR children

A

Research not otherwise approvable which presents an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children (category IV)

  • Can be approved by DHHS after:
    1. IRB review
    2. DHHS Consultation with an expert panel, and opportunity for public review and comment
    3. Local IRB cannot approve this research
27
Q

Assent of children?

A

Assent of children should be solicited when in the judgment of the IRB the children are capable of providing assent (based on age, maturity and psychological state)

  • State regulation (Health and Safety Code) mandates consent of child who is seven years of age or older
28
Q

FINANCIAL DISCLOSURE

A

FDA requires form 3454 and 3455

  • Submitted with IND or IDE applications/updates for:
  1. Form 3454 – certification of no financial interest
  2. Form 3455 – disclosure of interests and steps to minimize bias
29
Q

Form 3454

A

form for certification of no financial interest

30
Q

Form 3455

A

form for disclosure of interests and steps to minimize bias

31
Q

Definition of covered clinical trial

A

any study of a drug or device in humans submitted in a marketing application or reclassification petition that the applicant or FDA relies on to establish that the product is effective, or to demonstrate safety.

32
Q

Significant equity interest

A

Any ownership interest, stock options, or other financial interest whose value cannot be readily determined through reference to public prices (generally, interests in a nonpublicly traded corporation), or any equity interest in a publicly traded corporation that exceeds $50,000 during the time the clinical investigator is carrying out the study and for 1 year following completion of the study.

33
Q

Record maintenance of FD

A

Complete records of financial interests or payments made/received must be maintained for a minimum of 2 years following approval of the drug/device application.

34
Q

Codes / Guidelines vs. Regulations / Guidance

A
  • Nuremberg Code and Declaration of Helsinki are codes/guidelines
  • Belmont Report is an ethical guideline
  • 45CFR 46 and 21CFR 50, 56, 54, etc. are regulations
  • FDA issues guidance documents
35
Q

21 CFR part 56

A

IRB

36
Q

IRB Role?

A

The Institutional Review Board is a committee whose primary purpose is to protect the rights and welfare of human research participants

37
Q

IRB Members

A
38
Q

IRB Responsibility?

A

The basic charge of an IRB is to protect research participants and to evaluate whether a research project has met the regulatory and ethical requirements for the conduct of research

39
Q

21 CFR Sec. 312.60?

A

General responsibilities of investigators.

40
Q

21 CFR Sec. 312.60_General responsibilities of investigators.

A

An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator’s care; and for the control of drugs under investigation.

An investigator shall, in accordance with the provisions of part 50 of this chapter, obtain the informed consent of each human subject to whom the drug is administered, except as provided in 50.23 or 50.24 of this chapter. Additional specific responsibilities of clinical investigators are set forth in this part and in parts 50 and 56 of this chapter.

41
Q

21 CFR Sec. 312.61

A

Control of the investigational drug.

42
Q

21 CFR Sec. 312.61 Control of the investigational drug.

A

An investigator shall administer the drug only to subjects under the investigator’s personal supervision or under the supervision of a sub-investigator responsible to the investigator. The investigator shall not supply the investigational drug to any person not authorized under this part to receive it.

43
Q

21 CFR Sec. 312.62

A

Investigator record-keeping and record retention.

44
Q

21 CFR Sec. 312.62 Investigator recordkeeping and record retention.

A

(a) Disposition of drug.
(b) Case histories.
(c) Record retention.

45
Q

Record retention

A

An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.

46
Q

21 CFR Sec. 312.64

A

Investigator reports.

47
Q

21 CFR Sec. 312.64 Investigator reports.

A

(a) Progress reports.
(b) Safety reports.
(c) Final report
(d) Financial disclosure reports.

48
Q

(d) Financial disclosure reports.

A

The clinical investigator shall provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements as required under part 54 of this chapter. The clinical investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study

49
Q

21 CFR Sec. 312.66

A

Assurance of IRB review.

50
Q

21 CFR Sec. 312.66:Assurance of IRB review.

A

An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.

51
Q

21 CFR Sec. 312.68

A

Inspection of investigator’s records and reports.

52
Q

21 CFR Sec. 312.68 Inspection of investigator’s records and reports.

A

An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to 312.62. The investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.

53
Q

21 CFR Sec. 312.69

A

Handling of controlled substances.

54
Q

Devices may be exempt from IDE regulations

A

According to 21 CRF 812.2(c):

(1) A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time.

(2) A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.

(3) A diagnostic device, if the sponsor complies with applicable requirements in § 809.10(c) and if the testing:

(i) Is noninvasive,

(ii) Does not require an invasive sampling procedure that presents significant risk,

(iii) Does not by design or intention introduce energy into a subject, and

(iv) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.

(4) A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.

(5) A device intended solely for veterinary use.

(6) A device shipped solely for research on or with laboratory animals and labeled in accordance with § 812.5(c).

(7) A custom device as defined in § 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.

SOCRA 2022 notes (1 decks)

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