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SOCRA Exam 2024 > All Exam Contents > Flashcards

All Exam Contents Flashcards

1
Q

Nuremberg Code (1947)

A
  1. Informed Consents
  2. Sound research based on animal experiments and knowledge of disease
  3. Beneficence towards subjects
  4. Freedom to withdraw
  5. Risk < Human Importance
  6. Plans and facilities to prevent injury, disability and death
  7. Termination of participation at any stage
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2
Q

Declaration of Helsinki (1964)

A
  1. Informed consent by subject or LAR
  2. Protocol reviewed by independent committee
  3. Human research based on lab and animal experiments
  4. Research conducted by qualified medical personnel
  5. Risk &laquo_space;Benefits
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3
Q

Belmont Report (1979) Fundamental Principles (3)

A

Respect for Persons
Beneficence
Justice

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4
Q

Belmont Report: Respect for Persons

A
  1. Individual Autonomy
  2. Protection for individual with reduced autonomy
  3. Voluntary participation with adequate info
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5
Q

Belmont Report: Beneficence

A
  1. Max benefits and min harm
  2. Respect decisions
  3. Securing well being
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6
Q

Belmont Report: Justice

A
  1. Equitable distribution of research costs and benefits
  2. Participants should be treated equally
  3. Selection based on reason related to study
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7
Q

What did the Belmont Report create?

A

Office of Human Research Protections & Institutional Review Boards

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8
Q

General ICF Requirements

A
  1. No study activities until consent is signed
  2. Time to consider participation
  3. No coercion
  4. Language is understandable by subject
  5. Participation does not waive legal rights for subject and liabilities from sponsor/site
  6. All subjects receive a signed copy of consent
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9
Q

8 Basic Elements of Consent

A
  1. Statement of research, purpose, duration, procedures, experimental aspects
  2. Description of risk
  3. Disclosure of benefits
  4. Disclosure of alternative advantageous treatments/procedures
  5. State of how confidentiality will be protected for subjects
  6. For >min risk studies, compensation or treatment if I jury occurs
  7. Contact information for Qs related to research & research related injury
  8. Statement that research is voluntary and will not impact care
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10
Q

Additional Elements of Consent (6)

A
  1. Statement of risk to pregnant women or fetus if pregnancy occurs. Risk are unforeseeable currently
  2. Termination of participation by anticipated circumstance without subject consent
  3. Additional costs related to participation
  4. Consequences if subject withdraws (ie. cannot used IP) and procedures to complete termination
  5. Significant findings that affect willingness to participate
  6. # of study subjects
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11
Q

ICF Documentation

A
  1. IRB approved ICF must be signed and a copy must be given to subject
  2. FDA language that allows FDA inspection
  3. ICH language that allows regulating authorities (sponsor/sponsor rep/IRB) to inspect
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12
Q

Short Form Consent

A
  1. Form states the elements of consents and that it was discussed with subject.
  2. Subject only signs the short form
  3. Witness is required
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13
Q

Waiver of Consent : HHS vs FDA

A

HHS allows for waiver but FDA does not

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14
Q

Requirements for IRB to waive ICF

A
  1. Only record linking subject to research is the consent & only harm is breach of confidentiality
  2. Research is <min risk and involves no procedures which written consent is normally required outside of research context
  3. Waiver or alteration does not adversely affect welfare of subjects
  4. Research cannot be carried out without waiver
  5. Subject/LAR be provided with additional pertinent info after participation.
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15
Q

What might the IRB require study team to present is there is a waiver to ICF?

A

Study Fact Sheet (Info only, no signatures)

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16
Q

Consent Waiver: Emergency Research

A
  1. Subject in life threatening condition and unable to consent but research offers more benefits
  2. IRB must approve research and waiver
  3. Research cannot be conducted without waiver
  4. Community must be assembled and is favorable to research and benefits
  5. Investigator should still try to consent subject or LAR within certain timeframe and document prior to study participation
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17
Q

CA Only: BOR

A

Subjects must be given BOR in native language

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18
Q

Obtaining Informed Consent Process + Re-Consent

A

Informed consent is a multistep process.
1. Investigator must meet with patient.
2. Investigator must verbally explain the 8 elements to the subject + have sample ICF.
3. Allow time for subject to consider and ask questions
4. Prior to signing the consent, investigator must ascertain that patient is eligible, appropriately consented and subject understands study requirements
5. Subject must sign before investigator
6. If new significant findings arise that affect participation, investigator must inform subject and re-consent

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19
Q

Who can conduct consent sessions?

A

Only Principal and Sub-Is unless other approved by IRB (if less than minimal risk)

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20
Q

Subject Declines Participation

A

Investigator must make notes in patient’s charts of refusal and do not further contact patient unless they reach out first

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21
Q

Federal Registration Act (1935)

A

Daily record of proposed rules, final rules and meetings

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22
Q

Code of Federal Regulations (1937)

A

Established the HHS and FDA

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23
Q

Food Drug and Cosmetic Act (1938)

A

Food = pure, wholesome, safe to eat and made under sanitary conditions
Drug + Device = safe and effective for intended use
Cosmetic = safe and made form appropriate ingredients
All labeling & packaging is truthful, informative & non-deceptive

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24
Q

Medical Device Amendments to FD&C Act (1976)

A

First major amendment specifically for devices

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25
Q

1987 Treatment Use of IND

A
26
Q

International Conference on Harmonization (ICH) 1989

A

Guidelines based on Dec. of Helsinki
International Regulating Body

27
Q

Food and Drug Modernization Act (1997)

A
28
Q

Federal Regulators

A

HHS & FDA

29
Q

FDA Guidance Documents

A

Does not establish legal enforcements, only includes suggestions/recommendations based on current thinking

30
Q

HHS Common Rule + Subparts

A

Common Rule (45CFR Part 46) is the federal policy for protection of human subjects
1. Subpart A: Basic HHS policy
2. Subpart B: Pregnant women, fetus, neonates
3. Subpart C: Prisoners
4. Subpart D: Minors

31
Q

Who enforced HHS policies?

A

Office of Human Research Protections (OHRP)

32
Q

FDA Oversights

A
  1. INDs: New drugs and biological
  2. IDE: new devices
  3. Emergency Use of test article
33
Q

Who enforces FDA policies?

A

FDA

34
Q

HHS vs FDA Differences

A

HHS allows for ICF waivers while FDA does not
HHS has defined specific guidelines to qualify as research while FDA deems all clinical investigators as research
HHS has oversight on all research funded by federal government or all research per FWA while FDA is responsible for food, drug, devices

35
Q

Good Clinical Practice (GCP)

A

International, ethical, scientific quality of standard for design, conduct, record & report of trials involving humans. Compliance provides public assurance that rights, safety & well being of subjects are protected consistently w/principles of Dec. of Helsinki & trial is credible.

36
Q

Role of Office of GCP in FDA Regulated Research

A
  1. Carries out FDA policies
  2. leadership + administration of HSP/GCP SC
  3. Coordinates FDA’s Biorsearch Monitoring policy for trials & works with FDA’s Office of Reg Affairs
  4. Contribute to international GCP harmonization efforts
  5. plans & conducts trainings and outreach programs
  6. liaison to HHS, ORHP and other agencies
37
Q

CA Specific Regulations

A

Protection of Human subjects in Medical Experimentation Act
Subjects must be given BOR
Surrogate Consent for Research
Assent for those less than or equal to 7 YO but under 18 YO
Obtain IRB approval prior to using death records

38
Q

ICH Principles for GCP (13)

A
  1. Trial conduct in accordance to Dec. of Helsinki & consistent with GCP & other reg authorities
  2. Trial should be initiated & continued only if anticipated benefit > risk
  3. Rights, safety & well being of subject above all interests to science and society
  4. Available non-clin & clin data on IP to support trial design
  5. Trial must be scientifically sound & detailed in protocol
  6. Trial conducted in compliance w/IRB (IEC) approved/favorable protocol
  7. Medical care/decisions are made by physician in best interest of subject
  8. Investigators are qualified by education, training and experience to carry out assigned tasks
  9. Freely obtained informed consent by subject
  10. All clinical trial info should be recorded, handled and stored in a a way that allows accurate reporting, interpretation & verification
  11. Confidentiality of records that could ID subjects should be produced, respecting the privacy and confidentiality rules per reg agency rules
  12. IP should be manufactured, handled and stored in accordance with GMP & approved protocol.
  13. Systems with procedures that assure the quality of every aspect of the trial should be implemented
39
Q

45 CFR 46: Subpart B (Pregnant Women & Fetuses)

A

Applies to all research involving pregnant women or human fetuses (including IVF)
Allowable research if:
1. previous research (pre-clin, animal, non-preg) has assessed risks for pregnant women & fetuses
2. Min risk to fetus or if >min risk there is direct benefit to woman or fetus
3. Risk is the least possible for achieving objectives of research
4. woman’s consent has been obtained with usual provisions
5. woman is fully informed of reasonably foreseeable impact of the research on the fetus
6. no inducements are offered to terminate the pregnancy
7. researchers will have no involvement in termination of pregnancy
8. researchers will have no involvement in determination of viability of the fetus

40
Q

When is both mother and father’s consent required for Subpart B?

A

When research benefits only the fetus (both greater and less than min risk)

41
Q

45CFR 46: Subpart C Prisoners

A
  1. Applicable to all biomedical and behavioral research involving prisoners
  2. Additional safeguards are necessary since incarceration could affect their ability to make a truly voluntary & uncoerced decision re: participation
  3. Majority of members will have no association w/prisons involved
  4. At least 1 member of IRB will be a prisoner or prisoner rep w/appropriate background & experience to serve in that capacity
42
Q

Subpart C: IRB Duties

A

Research involving prisoners if:
1. Study of possible causes, effects & processes of incarceration & criminal behavior
2. Study of prisons as institutional structures or of prisoners as incarcerated persons (provided that study is min risk or lower and no inconvenience)
3. Have approval from DHHS
4. Risk < Benefit
5. Risks involved are commensurate w/risks accepted by non-prisoners
6. Fair selection
7. Parole boards will not take into account research participation in making parole decision
8. necessary follow up has been provided

43
Q

45CFR 46: Subpart D Children

A

Applies to children as subjects (<18 YO)

44
Q

Children (Category I)

A

Risk Category: Minimal
IRB Duties: confirm provisions of child assent & parental consent
Permission of parent/guardian is sought
Permission of one parent is adequate

45
Q

Children (Category II)

A

> min risk: prospect of direct benefit
Risk is justified by anticipated benefit
Anticipated benefit/risk is comparable to available alternatives
Assent is necessary
Permission of parent & guardian is sought
Permission of 1 parent is adequate

46
Q

Children (Category III)

A

Risk Category: >Min Risk, no direct benefit (can yield general knowledge)
IRB Duties:
1. Determination of Risk
2. Determination that exp. procedure is commensurate with SOC
3. Confirm provisions for child assent & parental consent (both parent signatures)

47
Q

45 CFR Subpart D (Category IV)

A

Research not otherwise approvable which presents an opportunity to understand. prevent or alleviate a serious prob affecting health/welfare of children
Can be approved by DHHS after:
1. IRB Review
2. DHHS consultation w/expert panel & public review
3. Local IRB cannot approve research
Assent of Children should be solicited when in judgment of IRB the children are capable of providing assent & state regulations

48
Q

FDA Form 3454

A

Submitted with IND/IDE
Certificate of no financial interest

49
Q

FDA Form 3455

A

Submitted with IND/IDE
Disclosure of interests and steps to minimize bias

50
Q

IRB Role

A

Committee to protect rights and welfare of human subjects

51
Q

IRB Members

A

At least 5 members (at least 1 scientific member, 1 non-scientist, 1 non affiliated member)
Sufficiently qualified, diverse and sensitive to community attitudes
Experts on vulnerable research participants
Those that have a COI will be recused from that project’s review
Non-voting consultant w/specific expertise may provide assistance

52
Q

IRB Responsibility

A

Protect research participants and to eval whether research has met the regulatory & ethical requirements for conduct of research

53
Q

Clinical Trials Phase 1

A
  1. First exposure in humans (small numbers exposed)
  2. Usually conducted on health individuals
  3. Safety & tolerability are key goals
  4. MTD
  5. Bioavailability, PK studies
54
Q

Clinical Trials Phase II

A
  1. Conducted in disease-targeted individuals
  2. Safety assessment remains key goal
  3. Initial probe of efficacy
  4. Number of participants-up to several hundred
55
Q

Clinical Trials Phase III

A
  1. Final confirmatory trial before FDA approval
  2. Larger sample size
  3. Randomized, double blind design
  4. Safety & efficacy of side effects
56
Q

Clinical Trials Phase IV

A
  1. Occurs after FDA approval
  2. Evaluates general use in population w/side effect
57
Q

What does a protocol contain?

A
  1. General Information: title, IND, date, version history, name and address of monitor & sponsor, medical monitor, investigators, clinical labs
  2. Background information
  3. Trial Objective and Purpose
  4. Trial Design
  5. Eligibility Criteria
  6. Treatment & Procedures
  7. Efficacy Assessments
  8. Safety Assessments
  9. Statistical Plans
  10. Source Documents - Data Review
  11. Ethical Considerations
  12. Amendments to Protocol
58
Q

FDA Form 1571

A

Agreement from sponsor or sponsor investigator to adhere to FDA requirements
Coversheet for all FDA submissions

59
Q

Investigator’s Roles & Responsibilities

A
  1. Conduct study according to IRB approved protocol
  2. Provided training documentation for all study personnel
  3. Maintain DOA
  4. Assume responsibility for initial & ongoing IRB review
  5. Report any/all protocol and/or subject enrollment changes to the IRB
  6. Report unanticipated risks (AE/SAE) to IRB & protocol sponsor
  7. Assess & document subject eligibility
  8. Inform subjects of investigational status of test article (risk & benefits)
  9. Ensure that research staff accurately follow up all procedures & timelines specified in the protocol
  10. Obtain and document ICF & HIPAA
  11. Maintain adequate audit ready research records
  12. Administer IP per protocol and only to subjects, maintain records on disposition
  13. Record retention for at least 2 years (approval to market) or 2 years after study is discontinued and FDA is notified
60
Q
A

SOCRA Exam 2024 (1 decks)

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