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Adverse Events and Unanticipated Problems

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Adverse Events and Unanticipated Problems Presented by: Karen Jeans, PhD, CCRN, CIP COACH Program Analyst * * HRPP 101 - April 28-29, 2008 - Washington DC Adverse ... – PowerPoint PPT presentation

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Title: Adverse Events and Unanticipated Problems


1
Adverse Events and Unanticipated Problems
  • Presented by
  • Karen Jeans, PhD, CCRN, CIP
  • COACH Program Analyst

2
Objectives
  • Define adverse event
  • Describe unanticipated problems involving risks
    to subjects to others
  • Identify examples of adverse events and
    unanticipated problems involving risks to
    subjects to others

3
Why Report Adverse Events and Unanticipated
Problems?
  • Because it helps ensure the safety of
    participants in human subject research, by
    providing information to the IRB and cognizant
    oversight agencies, and
  • Because it is required

4
Regulatory Background
  • Common Rule
  • Adverse Events do not exist
  • Unanticipated problems involving risks to
    subjects or others (38 CFR 16.103(a))

5
Regulatory Background
  • FDA Regulations
  • Adverse Event (21 CFR 312.30)
  • Adverse Experience (21 CFR 312.32)
  • Adverse Effect (21 CFR 312.64)
  • Unanticipated Adverse Device Effect
  • (21 CFR 812.46)
  • Unanticipated Problems involving risks to
    subjects or
  • others (21 CFR 56.108(b))

6
The Common Rule Requires
  • written procedures for ensuring prompt
    reporting to the IRB, appropriate institutional
    officials, and the Department or Agency head of
    (i) any unanticipated problems involving risks to
    subjects or others or any serious or continuing
    noncompliance and (ii) any suspension or
    termination of IRB approval.
  • Source 38 CFR 16.103(b)(5)

7
Criteria for IRB Approval (.111)
  • Required determinations
  • Risks to subjects are minimized
  • By using procedures consistent with sound
    research design
  • When appropriate, using procedures already being
    performed
  • Risks are reasonable in relation to benefits
  • Selection of subjects is equitable
  • Informed consent will be sought prospectively
  • Informed consent is appropriately documented
  • Research plan makes adequate provisions for
    safety monitoring
  • There are adequate provisions to protect privacy
    and confidentiality
  • B. When appropriate, additional protections for
    Vulnerable Subjects

8
What Is An Adverse Event (AE)?
  • An AE is any untoward occurrence (physical,
    psychological, economic, social, or legal) which
    affects a study subject
  • Includes any abnormal sign, symptom, or disease
    temporally associated with the subjects
    participation in the research
  • An AE does not require (or imply) a causal
    relationship with the research.
  • Source Modified from definition of Adverse
    Events in the 1996 International Conference on
    Harmonization E-6 Guidelines for Good Clinical
    Practice in OHRP Guidance on Reviewing and
    Reporting Unanticipated Problems Involving Risks
    to Subjects or Others and Adverse Events
    January 15, 2007

9
What Is An Adverse Event (AE) according to VHA
requirements?
  • An AE is any untoward physical or psychological
    occurrence in a human subject participating in
    research.
  • Can be unfavorable and unintended event
  • Includes any abnormal laboratory finding,
    symptom, or disease associated with the research
    or the use of a medical investigational test
    article.
  • Does not necessarily have to have a causal
    relationship with the research.
  • Source VHA Handbook 1058.01, Paragraph
    4(b)

10
Adverse Event Definitions VHA
OHRP Guidance
  • An AE is any untoward physical or psychological
    occurrence in a human subject participating in
    research.
  • Can be unfavorable and unintended event
  • Includes any abnormal laboratory finding,
    symptom, or disease associated with the research
    or the use of a medical investigational test
    article.
  • Does not necessarily have to have a causal
    relationship with the research.
  • An AE is any untoward occurrence (physical,
    psychological, economic, social, or legal) which
    affects a study subject
  • Includes any abnormal sign, symptom, or disease
    temporally associated with the subjects
    participation in the research
  • An AE does not require (or imply) a causal
    relationship with the research.

11
Types of Adverse Events
  • Unanticipated (unexpected)
  • Local (internal)
  • Non-local (external)
  • Related
  • Not related
  • Serious
  • Not Serious

12
Types of Adverse Events Unanticipated
  • Unanticipated (unexpected)
  • Event or problem that is new or greater than
    previously known in terms of nature, severity, or
    frequency, given the population described in
    protocol-related documents and the
    characteristics of the study population.
  • Source VHA Handbook 1058.01, Paragraph 4(bb)

13
Types of Adverse Events Local and Non-Local
  • Local (internal)
  • Adverse event occurring at the reporting
    individuals own facility
  • Source VHA Handbook 1058.01,
    Paragraph 7(c)
  • Non-local (external)
  • Adverse events occurring by subjects enrolled by
    investigators at other institutions

14
Types of Adverse Events Related
  • Related
  • There is a reasonable possibility based upon the
    available information that the event or outcome
    may have been caused by or resulted from
    participation in the research by the subject.

15
Types of Adverse Events Serious
  • FDA Regulations
  • An Adverse Event that
  • Results in death, a life-threatening experience,
    inpatient hospitalization, a persistent or
    significant disability or incapacity, or a
    congenital anomaly or birth defect or
  • Requires, based on a reasonable medical judgment,
    a medical or surgical intervention to prevent an
    outcome described above.
  • Source Section 761(a)(2) of the Food Drug
    Cosmetic Act (21 U.S.C. 379aa-1(a)(2))

16
Types of Adverse Events Serious
  • VHA Requirements
  • An Adverse Event in Human Research that
  • Results in death, a life-threatening experience,
    inpatient hospitalization, prolongation of
    hospitalization, persistent or significant
    disability or incapacity, congenital anomaly or
    birth defect.
  • Also considered serious when medical, surgical,
    behavioral, social, or other intervention is
    needed to prevent such an outcome.
  • Source VHA Handbook 1058.01,
    Paragraph 4(w)

17
Serious Adverse Event Definitions VA
FDA
  • Results in death, a life-threatening experience,
    inpatient hospitalization, prolongation of
    hospitalization, persistent or significant
    disability or incapacity, congenital anomaly or
    birth defect.
  • Also considered serious when medical, surgical,
    behavioral, social, or other intervention is
    needed to prevent such an outcome.
  • Results in death, a life-threatening experience,
    inpatient hospitalization, a persistent or
    significant disability or incapacity, or a
    congenital anomaly or birth defect or
  • Requires, based on a reasonable medical judgment,
    a medical or surgical intervention to prevent an
    outcome described above.

18
What is the Difference Between Adverse Events and
Unanticipated Problems Involving Risks to
Subjects or Others?

AE/UPR
19
Definition Unanticipated Problem Involving
Risks to Subjects or Others
  • Common Rule
  • Undefined
  • FDA Regulations
  • Undefined

20
Unanticipated Problems Involving Risks to
Subjects or Others
  • Any incident, experience, or outcomes that meets
    all three criteria
  • Unexpected
  • Related or possibly related to participation in
    research
  • Suggests that the research places subjects or
    others at a greater risk of harm than was
    previously known or recognized
  • May be physical, psychological, economic, or
    social harm
  • Source OHRP Guidance on Reviewing and Reporting
    Unanticipated Problems Involving Risks to
  • Subjects or Others and Adverse Events January
    15, 2007

21
Unanticipated Problems Involving Risks to
Subjects or Others vs. Adverse Events
  • Most Adverse Events are not Unanticipated
    Problems Involving Risks to Subjects or Others
  • All Unanticipated Problems Involving Risks to
    Subjects or Others are not Adverse Events
  • All Unanticipated Problems Involving Risks to
    Subjects or Others Adverse are not Serious

22
Research-related Events or Problems Which Could
Be (Or Could Reveal) Unanticipated Problems
Involving Risks to Subjects or Others
  • PI-initiated changes in protocol
  • Study amendments, for example
  • revision of the Consent Form
  • revision of inclusion/exclusion criteria
  • addition/deletion of study procedures etc.
  • Suspension of enrollment
  • New Information (e.g., DSMB reports,
    publications, sponsor alerts, etc.)

23
Reporting Adverse Events and Unanticipated
Problems Involving Risks to Subjects or Others
  • Study sponsors (if multisite study) make reports
    to PIs, who, in turn, report them to the IRB.
  • Members of the VA research community are
    responsible for reporting to the IRB per local
    IRB Standard Operating Policies and Procedures
  • Local IRB Standard Operating Policies and
    Procedures can exceed but not be less stringent
    than federal requirements

24
Reporting Adverse Events and Unanticipated
Problems Involving Risks to Subjects or Others
  • The IRB determine when events, incidents, or
    outcomes are Unanticipated Problems Involving
    Risks to Subjects or Others and report to
    Institutional Officials

25
IRB Actions
  • Require study modification
  • Providing additional information to subjects
  • Modify informed consent process/document
  • Educational plan
  • Assignment of Mentor
  • Require additional monitoring
  • Suspension or termination of IRB approval
  • Other actions as determined by the IRB

26
Reporting By The IRB And Institutional Officials
  • When the IRB determines that a study-related
    event is an Unanticipated Problem involving Risk
    to subjects or others, it must be reported to
  • Institutional Official
  • Institutional Official reports to Oversight
    Agencies and entities as applicable
  • Office of Research Oversight
  • Office for Human Research Protections
  • U.S. Food and Drug Administration
  • Sponsors
  • Other entities

27
Summary
  • Adverse Events and Unanticipated Problems
    Involving Risks to Subjects or Others are not
    synonymous
  • Policies and procedures must describe when and
    how adverse events and possible unanticipated
    problems involving risks to subjects or others
    are reported to the IRB.
  • The IRB reviews reports and determines which are
    unanticipated problems involving risks to
    subjects or others

28
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