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SOCRA 2025 > Regulations > Flashcards

Regulations Flashcards

1
Q

1st U.S. Regulation

A

Kefauver-Harris Drug amendments to the Federal Food, Drug, & Cosmetics Act of 1962, gave the FDA authority

Requires safety & effectiveness evidence for drugs from well-controlled studies & an ICF

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2
Q

2 important goals of ICFH E6 Standards

A

-assure trial data are credible
-assure the rights, well-being, and confidentiality of trial subject are protected

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3
Q

3 Principles of the Belmont Report and their purpose

A

Beneficence
Justice
Respect for Persons
Provide basic ethical principals, and boundaries between practice and research

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4
Q

4 Categories of ICH Guidelines

A

Quality Guidelines
Safety Guidelines
Efficacy Guidelines
Multidisciplinary Guidelines

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5
Q

6 Founding Members of ICH (regulatory & industry)
Current Additonal ICH Members
Observers Regulatory Members

A

EU, Japan, US, EPPIA (EU), JPMA (Japan), PHRMA (US)
Canada and Swissmedic
Brazil, China, South Korea, WHO

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6
Q

Belmont Report came out of:

A

National Research Act of 1974 which crated the National Commission for Protection of Human Subjects of Biomedical & Behavioral Research

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7
Q

Beneficence

A
  • Do no harm
  • helping or benefiting the patients according to best judgement
  • assessment of risks and benefits
  • when is it justifiable to seek certain benefits given the risks
  • Minimize possible harms, maximize possible benefits
  • Risks of distress and embarrassment included
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8
Q

Foundation of Current Ethics

Code of Research Ethics in 1979 from The Belmont Report

Born of Tuskegee

A

The National Commission for the Protection of Human Subjects of Biomedical and Behavior Research

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9
Q

Commission for the Belmont Report

A

Identify basic ethical principles that underlie the conduct of human subject research & develop guidelines to assure research is conduct in accordant with those principles

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10
Q

Differences between ICH GCP & DOH

A

ICH Does not Address:
-Use of placebo vs standard therapy
-Post study access to treatment and other benefits for subjects
-Public disclosure of study design
-Publication of study results
-Disclosure of COIs

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11
Q

For an ICH Protocol-what should be included?

A
  • Title
  • Identifiying #
  • Date of Trial Design
  • Name of sponsor
  • Overall investigator
  • Labs involved
  • Investigational Product-stopping rules, eligibility criteria, monitoring
  • Findings from non-clinical studies-efficacy, safety assessments
  • Known risks & benefits
  • # of subjects
  • Administration, dose, route, time of treatment
  • Statement of Compliance
  • Statistics
  • Population
  • Literature Background
  • Regulatory authority access/ethics
  • Objectives & Purpose
  • Financing
  • Supplements
  • Publication
  • Endpoints
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12
Q

Formation of ICH
1st Name Change
Revised E6

A

-Let to creation of standardized guidelines for clinical research of investigational drugs in the early 1990s
October 2015
2016-R1 & R2
2025-R3

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13
Q

GCP

A
  • Good Clinical Practice for ICH
  • Sets the Standard for the design, conduct, monitoring & reporting of clinical research
  • How human subjects are protected & data is accurate & credible
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14
Q

Henry Beecher
Willowbrook
Jewish Chronic Disease Hospital

A

1966-22 studies with risks without subjects kowledge
1956-1970-children with intellectual disbilities infected with hepatitis
163-live cancer cells injected into 22 cognitively impaired patients

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15
Q

ICH

A
  • International Council for Harmonisation (2015)
  • Previously the International Conference on Harmonisation (90s)
  • Standarized guidelines for clinical research of investigational drugs
  • Safety, quality, efficacy, and reducation of redundant testing
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16
Q

ICH Progress Reports

A

written to sponsor & IRB for signifcant changes to the study or increased risks to subjects
-written summary to IRB at least annual unless IRB says sooner

17
Q

ICH in regards to FDA

A

ICH is only guidance, not law or regulations in the U.S.

18
Q

ICH:
Monitoring
Audit
Inspection

A
  • Overseeing progress of trial & ensuring it was conducted, reported, & recorded with the protocol and regulations, ongoing process
  • Systematic & independent examination of trial-related activities & documents & data, to ensure tiral followed teh reugaltions, quality assurance, SOPS, and monitoring
  • Regulatory authorities official review of documents, facilities, and records related to the tiral, protection of subjects & verify the marketing of data
19
Q

Justice

A
  • No individual population is exposed to risks while others receive the benefits
  • Who should receive the benefits and who should bear the burdens of reserach?
  • Can’t choose a population because of convienence
  • Benefits and burdens need to be equitably distributed
  • No prejudice of creation against a group
  • Group chosen should be relevant to the problem being studied
20
Q

National Research Act

A

1974, estabilished the National Commission for the protection of human subjects of biomedica & behavioral research, which included the Belmont report, informed consent, requirements for children, establish IRBs

Published in 1977

21
Q

Nuremberg Code Year

22
Q

OHRP

A

Office of Human Research Protections (only federally-funded research)
-oversees IRBs

23
Q

OHRP created the

A

International Compilation of Human Research Standards

24
Q

Principles of Bioethics-Beauchamp & Childress

A

autonomy, non-maleficence (do no harm), beneficience, & justice

25
Purpose of Declaration of Helsinki
Provide ethical principles for the World Medical Association -Ethical principles for medical research involving human subjects (including research on identifiable human material & data)
26
Purpose of the Nuremborg Code
Protect Human Subjects following the Nuremberg trials in which WWII Nazis were tired for human experimentation -10 ethical prinicples for human experimentation as a result of the Nuremberg trials -voluntary consent, scientific merit, benefits outweigh risks, participant can withdraw at any time
27
Respect for Persons
* Autonomy to make decisions * Give subjects information, risks, so they understand and are informed * Minimum consent components- information, comprehension, **voluntariness** * Protect for Deductive Disclosure * Protect subjects with diminished autonomy
28
Respect for Persons> Beneficience> Justice>
informed consent>privacy systematic assessment of risks & benefits> minimization of risks selection of subjects> who received benefits/burdens of reserach
29
The Belmont Report and the Common Rule: criteria for IRB approval
* Informed consent will be sought from each prospective subject or the subject's legally authorized representative, Informed consent will be appropriately documented, * When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data * When some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects * Risks to subjects are minimized: By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects * Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. * When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. * Selection of subjects is equitable
30
What ethical standards is the ICH document based on?
Declaration of Helsinki
31
Year of Belmont Report
1978
32
Year of Declaration of Helsinki
1964 (June)
33
What association created the Declaration of Helsinki in 1964?
The World Medical Association (WMA)
34
Declaration of Helsinki
* Serves to protect the rights of subjects * A physician should act in the patient’s best interest * Subject’s life, health, dignity, privacy/confidentiality, right of self-determination must be protected * Trial should be conducted in accordance with an already-IRB/IEC-approved protocol * Freely-given informed consent should be obtained by every patient
35
What does ALCOA-C stand for?
Attributable, Legible, Contemporaneous, Original, Accurate, Complete
36
Differences between FDA & ICH
ICH: * says informed consent form must state that monitor(s), auditor(s), IRB/IEC, and reg authority will be granted direct access to the subjects original medical records for verifying clinical trial procedures and/or data * requires sponsor to obtain from investigator/institution… a statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations * says "the sponsor should verify that each subject has consented, in writing, to direct access to his/her original medical records for trial-related monitoring, audit, IRB/IEC review, and regulatory inspection FDA: * requires the informed consent form only to have a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
37
Differences between ICH & FDA Essential Documents
ICH: * Needed docs: Protocol, amds, ICF, any subject recruitment, anything written that’s provided to subjects (pill diaries), IBs, any safety info, info about payments/compensation for subjects, investigator’s current CV/qualifications proof * Investigator/institution should have control of all essential docs before, during, and after trial * When copy is used to replace original doc, it should be a certified copy * Sponsor shouldn’t have exclusive control of CRF data * Sponsor should ensure investigator has control of & continuous access to CRF data reported to sponsor * Sponsor & investigator to maintain record of the location(s) of their essential docs, including source docs * Individual trials may require additional documents not mentioned in essential list, and these should be included in trial master file (TMF)
38
What are the 10 points of the Nuremberg Code?
* Required voluntary, informed consent * Experiment aims at positive results for society * Based on previous knowledge that justifies the experiment * Study design avoids unnecessary physical and mental suffering and injuries * Not conducted if there is any reason to believe it implies at risk of death or disabling injury * Risks

SOCRA 2025 (14 decks)

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