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Human Research Protections: Historical, Ethical

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Human Research Protections: Historical, Ethical & Regulatory Perspectives for Good Clinical Practices Susan C. Buskirk, RN, BSN, CCRC Executive Director Human ... – PowerPoint PPT presentation

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Title: Human Research Protections: Historical, Ethical


1
Human Research Protections Historical, Ethical
Regulatory Perspectives for Good Clinical
Practices
  • Susan C. Buskirk, RN, BSN, CCRC
  • Executive Director
  • Human Research Protections Program

2
Outline
  • Definition of Good Clinical Practice
  • Historical Background
  • Ethical Milestones
  • Basic Protections for Human Subjects
  • Regulatory Oversight
  • Institutional Requirements

3
Good Clinical Practices (GCPs)
  • International ethical and scientific quality
    standards for designing, conducting, recording,
    and reporting trials that involve the
    participation of human subjects.
  • Purpose
  • Protect human subjects during clinical studies
  • Protect patients who might receive approved
    products in the future
  • Not just one document
  • Several different components which vary by
    country and research setting

4
Good Clinical (Research) Practices
  • Why GCPs are important
  • -Insure that one can validate the human subject
    protections decided upon by the IRB and PI were
    carried out
  • -Insure that data reported by research results
    can be validated
  • This is an introduction and summary

5
Human Subjects Research
  • DEFINITION
  • A human subject is a living individual about who
    an investigator obtains either
  • data through interaction or intervention with the
    individual
  • bodily materials (cells, blood, urine, organs,
    nail clippings, hair) even if the investigator
    did not collect these
  • Private, identifiable information (Medical info)

6
History
  • 1948 Nuremburg Code
  • Voluntary Informed Consent
  • Favorable Risk/Benefit Analysis
  • Right to withdraw without penalty

7
History (2)
  • 1964 Declaration of Helsinki
  • Builds on Nuremburg Code
  • Interests of subjects be given higher priority
    than those of society
  • Every research subject should receive the best
    known treatment

8
History (3)
  • 1974 National Research Act
  • Established modern IRB system
  • National Commission for the Protection of Human
    Subjects of Biomedical and Behavioral Research
  • Belmont Report

9
Belmont Report
  • Ethical Principle 1 Respect for Persons
  • Treat individuals as autonomous agents
  • Protect persons with reduced autonomy
  • IRB Requirements
  • Participants voluntary consent
  • Privacy and confidentiality are protected

10
Belmont Report (2)
  • Ethical Principle 2 Beneficence
  • Do unto others as you would have them do unto you
  • IRB Requirements
  • Risks of research are justified by potential
    benefits
  • Study is designed to minimized risks
  • Adequate data and safety monitoring
  • Conflicts of Interest are managed adequately

11
Belmont Report (3)
  • Ethical Principle 3 Justice
  • Distribute the risks and potential benefits of
    research equally among those who may benefit from
    the research.
  • IRB Requirements
  • Vulnerable subjects are not targeted for
    convenience
  • Subject selection is equitable
  • Population exclusion is justified

12
Basic Protections for Human Subjects
  • Ethics
  • Regulations (ethics operationalized)
  • Oversight (Culture of conscience)
  • Science
  • Design/Important question
  • Conduct/Validity

13
Three Levels of Protection
  • Assurances/ Regulatory Oversight
  • Institutional Review Board (IRB)
  • Informed Consent

14
Oversight Agencies
  • Office of Human Research Protections
  • 45 CFR 46
  • Subparts A, B, C
  • Food and Drug Administration
  • 21 CFR 50, 56
  • Office of Good Clinical Practice
  • Office of Research Oversight (VA)
  • DHHS Agencies (DOD)
  • ICH Good Clinical Practices

15
GCP Standards
FDA OHRP ICH
21 CFR (IND, IDE studies) 45 CFR 46 (Federal funding) International E6 (Industry standard and often basis of NIH and other SOPs)
Electronic docs (11) Informed Consent (50) Financial Disclosure (54) IND Regs. (312) More re devices and biologics IRBs (A) Informed Consent (A) Women (B) Prisoners (C) Children (D) Glossary (1) Principles (2) IRBs (3) Investigator (4) Sponsor (5) Essential Documents (8)
16
Institutional Assurances
  • The Assurance formalizes the institutions
    commitment to protect human subjects. The
    requirement to file an Assurance includes both
    awardee and collaborating performance site
    institutions.

17
University of Maryland Baltimore
  • regardless of whether the research is subject
    to Federal regulation or with whom conducted or
    source of support (i.e., sponsorship).

18
IRB/IEC
  • Purpose
  • To protect the rights and welfare of human
    subjects

19
IRB REVIEW
  • Appropriate Informed Consent
  • Acceptable Risk/Benefit ratio
  • Privacy and Confidentiality Protection
  • Data and Safety Monitoring
  • Scientific Validity
  • Equitable Subject Selection

20
Initial Protocol Review
  • Risk/Benefit
  • What are the risks?
  • Is the potential knowledge important enough to
    justify the risks?
  • Is subject selection equitable?

21
Initial Protocol Review (2)
  • Consent Process
  • Are mechanisms for obtaining consent appropriate?
  • All risks/benefits documented appropriately?
  • Is a waiver of consent requested?
  • If yes, is the waiver justified?

22
Initial Protocol Review (3)
  • Vulnerable Populations
  • Prisoners
  • Children
  • Pregnant woman and Fetus
  • Cognitively impaired
  • Are the protections adequate? OR Why are they not?

23
Initial Protocol Review (4)
  • Privacy and Confidentiality
  • HIPAA Is PHI involved?
  • Plans to protect PHI
  • Authorization to collect PHI?
  • Who will have access to identifiers?
  • Will the data be coded?
  • Where will the data be stored?

24
Review Levels
  • EXEMPT
  • IRB Determination
  • EXPEDITED
  • Not Fast
  • Regulatory Definition
  • FULL BOARD
  • Anything greater than minimal risk

25
IRB Authority
  • Initial Continuing Review
  • Approve
  • Disapprove
  • Require modifications
  • Terminate

26
IRB Reporting Requirements
  • Unanticipated events involving risks to human
    subjects
  • Serious and Ongoing non-compliance

27
Continuing Review
  • The guideline for continuing IRB review of
    previously approved protocols are as follows
  • 1) Determine if the study is currently actively
    enrolling, treating, or following subject
  • Summary of progress to date

28
Continuing Review (2)
  • 2) Accrual
  • Equitable?
  • Over enrollment?
  • Unable to meet enrollment goals?

29
Continuing Review (3)
  • 3) Review any requested protocol revisions and
    any revisions that have been approved by the IRB
    since last continuing review.
  • BRAAN Amendments
  • How have these impacted the overall protocol?

30
Continuing Review (4)
  • 4) Determine if the study is progressing as
    planned.
  • Will the study objectives be met?
  • Under enrollment
  • Unexpected toxicity profile
  • Risk/Benefit ratio still favorable?

31
Continuing Review (5)
  • 5) Determine if unexpected events have occurred
    that may indicate a need for a change in the
    protocol or consent document.
  • Review DSM reports
  • SAE reports in BRAAN
  • Subject Complaints
  • Unexpected rate of withdrawals

32
Continuing Review (6)
  • 6) Determine if information has become available
    since the study that indicates a need to make
    modifications.
  • Interim Analyses
  • SAEs

33
Amendments
  • Federal Regulations require that all revisions be
    approved by the IRB prior to their implementation
  • Revisions that increase the risk of research
    participation must be approved by the full IRB
    committee.

34
Amendments (2)
  • Guidelines for the review of protocol amendments
  • Identify the part of the research proposal being
    revised.
  • Determine if the revision increases risk for
    currently enrolled subjects.

35
Amendments (3)
  • 3) Determine if the revision increases risk for
    future subjects.
  • 4) Determine if the consent form should be
    revised or if the proposed revision to the
    consent form is adequate.

36
Amendments (4)
  • 5) Determine if currently enrolled subjects
    should be re-consented.
  • 6) If the revision increases risk to current or
    future subjects, determine if the protocol still
    meets the criteria that are used to evaluate new
    studies.

37
Unanticipated Problems
  • Include Serious Adverse Events
  • Not necessarily adverse events
  • Expedited reporting
  • UMB policy
  • Sponsor policy

38
Deviations
  • Deviation Any difference in study conduct from
    the criteria or procedures prescribed in the
    approved protocol may constitute a deviation.
    Deviations may result from the action of the
    participant, investigator, or staff.
  • Expedited reporting vs. Continuing Review
  • Affect risk and/or study integrity
  • Do not affect risk and/or study integrity

39
Exception Request
  • An exception is an anticipated departure from
    approved protocol procedures
  • Requested by the investigator and are usually
    specific to an individual subject.
  • Exceptions are also approved by the sponsor.

40
Study Monitoring Oversight
  • Sponsor or Sponsor/PI is responsible for
    continued monitoring of the study
  • Auditing by IRB/Sponsor
  • Inspections by FDA and other oversight agencies

41
Investigator Responsibilities
  • Scientific validity
  • Research design
  • Ethical principles upheld
  • Quality of study conduct (GCPs)
  • Compliant with federal, state, institutional
    requirements

42
Conclusion
  • Know your responsibilities
  • Educate others
  • Be Accountable
  • PI, Coordinator, Nurse, IRB, Institution
  • Education and Training
  • CITI University of Miami
  • Utilize Resources

43
Human Research Protections Office
  • Emergency 410-963-1237 (Chair)
  • Direct Access to Analyst/Staff
  • Email
  • HRPO_at_som.umaryland.edu
  • Website (New July 1, 2005)
  • http//medschool1.somweb.som.umaryland.edu/orags/h
    rpo/default.asp
  • New Content, Navigation, Layout
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