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Changes to UMB IRB Policies

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Title: Changes to UMB IRB Policies


1
Changes to UMB IRB Policies ProceduresThe
Impact Upon the University of MD Research
Community
  • Leslie I. Katzel, MD, Ph.D.
  • Tiffany Smolinski, M.S., Program Manager
  • Ileane L. Platt, M.S., Quality Improvement
    Specialist
  • UMB HRPO and UM GCRC

2
Overview
  • Purpose of this presentation is to update the
    research community on changes and enhancements to
    the Human Research Protection Office and research
    oversight at UMB and VAMHCS, and how these
    changes will impact on the research community

3
Topics to be covered
  • Update on AAHRPP accreditation
  • Enhancements to Human Research Protections Office
  • Updates to the IRB standard operating procedure
    for protocol review
  • Updates to the Human Research Protection Program
    (HRPP) policies and procedures manual

4
Topics to be covered
  • Update on AAHRPP accreditation

5
Association for the Accreditation of Human
Research Protection Programs (AAHRPP)
  • AAHRPP is a nonprofit organization founded in
    2001 under the auspices of PRIMR, the
    Association of American Medical Colleges (AAMC),
    FASEB, and several other national organizations.
  • AAHRPP seeks not only to ensure compliance, but
    to raise the bar in human research protection by
    helping institutions reach performance standards
    that surpass the threshold of state and federal
    requirements (from AAHRPP website www.aahrpp.org
    )

6
Accreditation
  • The voluntary accreditation process is based on
    self assessment, peer review (site visit), and
    education
  • To date, 35 institutions have been accredited
  • Our program received Full Accreditation

7
Why become accredited?
  • Protect research participants
  • Improve research quality
  • Achieve compliance
  • Restore public trust
  • Instill confidence in sponsors (in the future it
    may be an economic/competitive advantage)
  • Prevent government intervention

8
How does accreditation work?
9
Maryland AAHRPP site visit
  • Occurred in September 2005
  • Based on the site visits extensive and detailed
    evaluation of our program, the institution has
    implemented changes to our policies and
    procedures to ensure compliance, improve
    efficiency, and enhance the safety protection
    of research participants

10
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11
Examples of Deficiencies Noted at the Site Visit
  • It was noted that the IRB was not always provided
    with sufficient information for them to make a
    determination on all the regulatory elements (for
    example information on protection of research
    subject privacy)
  • Consent forms were evaluated found to be
    missing necessary regulatory elements

12
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13
HRPO Agenda
  • Enhancements to Human Research Protections Office
    (HRPO)
  • Updates to the IRB standard operating procedure
    for protocol review

14
Enhancements to Human Research Protections Office
  • Increased Resources
  • Deferral Prevention Program
  • Quality Improvement Program

15
Enhancements to HRPO
  • Strong institutional support and commitment from
    the UMSOM Deans Office has led to a major
    expansion of the Human Research Protections
    Program (HRPP)

16
Financial Resources
17
HRPO Personnel Resources
  • FY04 Total 8
  • IRB Coordinators 4
  • Education Support Specialist 1
  • Research Compliance Specialist 2
  • Office Clerk 1
  • FY05FY06 Total 23
  • Executive Director
  • Program Managers 3 FTE
  • IRB Analysts 6 FTE
  • Quality Improvement Specialists 10 FTE
  • Information Systems Engineer 1 FTE
  • Office Clerk II 2 FTE

18
HRPO Organization
19
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20
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21
Deferral Prevention Program
  • Efforts are made prior to and during IRB
    Committee Meetings to prevent deferrals
  • Deferral Prevention Program 04/05
  • Contact PI Prior to Review
  • Real-Time Communication at IRB Meeting
  • Notification of Department Chair and/or Signatory
    Authority

22
Deferral Prevention Program
23
Quality Improvement Program
  • Goals
  • Strengthen safeguards for research participants
    through
  • Auditing
  • Monitoring
  • Ongoing education

24
HRPO QI Activity
25
Protocol Review Process Change
  • Implemented February 11, 2006
  • Five Member Teams (Analyst/QIS)
  • New process implemented for triaging and
    reviewing all incoming business
  • Immediate Triage (Expedited/Full Board)
  • Tighter timeframes for administrative review
  • Designated Staff Signature Authority

26
More comprehensive pre-review
  • Increased and more comprehensive administrative
    pre-review of protocols by IRB staff prior to
    the protocols going to convened committee
  • Main goal is to correct clerical errors, missing
    information, ensure regulatory requirements are
    met and address issues that would result in the
    protocol being tabled or deferred

27
Implementation of new checklists
  • Enhanced and updated checklists will be employed
    by the IRB to help ensure compliance with federal
    regulations
  • A new consent form checklist has been e-mailed to
    investigators
  • Beta-versions of checklists posted on HRPO
    website

28
Implementation of new checklists
  • The expectation is that the investigator will use
    these lists for new submissions, and re-examine
    their protocols and consent forms using these new
    checklists
  • The IRB will use these new checklists at time of
    initial review, continuing review, and review of
    amendments

29
Full Board Review Process
30
Full Board Review Process (contd)
31
February 2006Average Approval Times
32
March 2006 Average Approval Times
33
Education/Outreach
  • Program Manager
  • Education Strategic Plan
  • Khristy Bozylinski, M.S.
  • Quality Improvement Specialists
  • Protocol Review
  • Monitoring Investigator Sponsored Studies

34
How Do These Changes Effect You?
  • Improve Efficiency
  • Protocol Turnaround Times
  • Protocol Review
  • Administrative Modifications
  • If all admin. mods are adequately addressed prior
    to the meeting, the board mods will focus on more
    scientific issues instead of administrative
    issues.

35

36
HRPO FY06 Goals
  • Continuous Quality Improvement (CQI)
  • Utilize data to assess efficiency improve
    process
  • Increase outreach/education
  • Expand auditing/monitoring activities

37
Topics to be covered
  • Updates to the Human Research Protection Program
    (HRPP) policies and procedures manual

38
Updates to policies and procedures
  • A thorough review of our polices and procedures
    has led to updates, revisions, and clarifications
    for internal consistency and achieving and
    maintaining regulatory compliance

39
Definitions Have Been Revised and Their Use
Clarified
  • Child/Children
  • Conflict of Interest
  • Continuing Non-compliance
  • Date of Expiration
  • Emancipated Minor
  • Guardian
  • Human Participant
  • Legally Authorized Representative
  • Major Amendment
  • Minor/LAC
  • Minor Amendment
  • Non-Human Subjects Research
  • Principal Investigator
  • Research
  • Serious Non-compliance
  • Surrogate
  • Unanticipated Problem Involving Risks to
    Participants or Others

40
Moving Forward
  • The direct impact of these changes on your
    research will be highly dependent upon the type
    of research that you do
  • For example, a number of the changes deal with
    informed consent in vulnerable populations. If
    your research does not involve vulnerable
    populations these changes will have minimal
    impact on your work

41
Additional information requested by IRB
  • IRB is not always provided with sufficient
    information in the BRAAN protocol to make a
    determination on all the regulatory elements

42
Information to Be Attached in Section S (1)
  • Documentation from other pertinent organizational
    committees (i.e., pharmacy, radiation safety
    committee and/or institutional biosafety
    committee, conflict of interest committee, and
    others) as applicable. (SOPs 3C Procedure II.C
    3E Procedure II.D.11)
  • A signed and dated copy of the 1572 (where
    applicable). (SOP 11A Procedure I.D)

43
Information to Be Attached in Section S (2)
  • These materials, when applicable, are now
    required with submissions for initial review,
    modifications/amendments, and continuing review
    regardless of whether the review will be
    processed by expedited procedures or by the Full
    IRB Committee.
  • DHHS-approved sample informed consent document
    (when one existed)
  • DHHS-approved protocol (when one existed)
  • Federal grant application (when applicable)
  • Investigators brochure (when one existed)

44
Information to Be Attached in Section S (3)
  • The investigator must justify in writing
    deletions or substantive modifications of
    information concerning risks or alternative
    procedures contained in the DHHS-approved sample
    informed consent document and to provide details
    of the anticipated age ranges, health status,
    gender and racial/ethnic composition of the
    participant population.
  • (SOP 3D Policy II.D.1-3)

45
Privacy and Confidentiality
  • Investigators must address privacy and
    confidentiality separately. If this information
    is not included with submissions, administrative
    modifications will be sent requesting it.
  • (SOP 3B, Procedure II.A.1.g)

46
Informed consent process
  • The Investigator will provide a detailed
    description of the intended method for obtaining
    informed consent, including the timing of the
    process, in the initial BRAAN Application in
    Section J1 and elaborate on additional
    protections for vulnerable populations in Section
    E2, if applicable.
  • (SOP 4A Procedure I.A)

47
Waiver of Informed Consent or Consent
Documentation
  • In cases in which the documentation requirement
    is waived, the IRB will require the Principal
    Investigator to ask each participant whether the
    participant wants documentation linking him/her
    with the research, and the participant's wishes
    will govern. (SOP 4B, Policy IV.B)
  • For waiver of informed consent The investigator
    will attach in Section S a written summary and
    the information to be provided to the
    participant. (SOP 4C, Procedure I.A.2.a)

48
Subjects rights
  • Revisions to the Subjects Rights section of the
    Informed Consent document in order to avoid the
    use of exculpatory language.
  • Changes have been implemented to the boiler
    plate University language in the consent form
  • If you need additional information, call your
    Analyst

49
Foreign language consent
  • When an investigator plans to use a translated
    consent document, the application must include
    details regarding who (i.e., PI, PIs staff,
    translator) will conduct the consent
    procedures/discussion, communicate other
    information, and be available to answer questions
    in a language understandable to the participants.
  • (SOP 4A, Procedure I.A.2)

50
Other Changes to Note (1)
  • Clarification of Finders Fees Bonuses
  • (SOP 10G, Policy XIV XV)
  • Specifications for participant payment in VAMHCS
    research have been clarified.
  • (SOP 10F, Policy I).

51
Other Changes to Note (2)
  • Chart and consultation requirements before taking
    consent from a legally authorized representative
    (SOP 9D, Procedure I.D)
  • The role and responsibilities of the
    Sponsor-Investigator have been clarified. (SOP
    6B, I.K)
  • Additional requirements for the use of an
    investigational device are outlined (SOP 11C,
    Procedure I.M Procedure IV.I).
  • Clarification regarding the Investigators
    responsibilities for an Emergency Use of an
    Investigational Drug, Agent, Biologic, or Device
    (SOP 11E, Procedure I.B.1.b Procedure I.D.1.b)

52
Expedited Exempt Research
  • Revisions have been made to clarify which
    activities are subject to IRB jurisdiction. Some
    types of research that were previously considered
    Exempt may now be considered Non-human
    Subjects Research. (SOP 1B)

53
Renewals
  • More specific details will be required at the
    time of renewal submission and should be included
    in the General Summary section of the renewal
    report. If they are not included, the Analyst
    will request this information with administrative
    modifications. (Section 3J, Procedures I.B
    III.B)

54
Renewals Additional Information Required (1)
  • Total number of participants who have completed
    the study.
  • Total number of participants enrolled.
  • Total number withdrawn since the previous IRB
    continuing review approval.
  • Summary status for participants still actively
    taking part in the study.
  • A description of difficulties regarding
    recruitment.
  • Information regarding other sites if the
    Investigator is responsible for activities at
    other sites.

55
Renewals Additional Information Required (2)
  • A summary of all unanticipated problems involving
    risk to participants or others.
  • More specific details regarding recent relevant
    literature, interim findings and relevant
    multi-center trial reports.
  • Summary of participant benefits and a current
    risk-benefit assessment.

56
Renewal of Greater Than Minimal Risk Protocols
Limited to Data Analysis
  • Research proposals that are limited to data
    analysis with de-identified data sets may request
    for closure. Per UMB policy, research proposals
    that are limited to data analysis with identified
    data sets must remain open but may be reviewed
    via the expedited procedures.
  • If data analysis reveals any information that
    places participants at risk or yields information
    that they would need to know, notification to the
    IRB and subsequent notification of participants
    is required.
  • (SOP 3J, Policy IV.B)

57
Adverse event reporting
  • Policies and Procedures have been completely
    revised regarding the Investigators reporting of
    unanticipated problems.
  • SOP 2C Reporting Requirements for Unanticipated
    Events, Serious and Continuing Noncompliance,
    and/or Termination of IRB Approval
  • SOP 2F Unanticipated Problems Involving Risks to
    Participants or Others.

58
Investigational Drugs
  • All investigational drugs must utilize the IDS
    Pharmacy. The IDS Pharmacy must either
  • Handle the drug AND/OR
  • Approve the plan for handling.
  • (SOP 11A, Policy I.A)

59
VAMHCS Research
  • For VAMHCS research where the investigator will
    include participants other than veterans, there
    must be a description in Section E2 indicating
    the rationale as to why there are insufficient
    veterans available to complete the research.
  • (SOP 3D, Procedure I.D.1)
  • (Renewals) The number of participants considered
    as members of specific vulnerable populations and
    an assurance that all serious adverse events and
    unanticipated adverse events had been reported as
    required.
  • (SOP 3E Procedure I.D.1)

60
VAMHCS ResearchLapses in Renewal
  • For VAMHCS research that lapsed approval due to
    failure to gain continuing approval the
    investigator is required to immediately submit to
    the IRB Chair a list of participants for whom
    suspension of the research would cause harm, and
    for the IRB Chair, with appropriate consultation
    with the VA Chief of Staff, to determine which
    participants could continue in the research
    because it was in their best interest.
  • (SOPs 1F.2 Procedure I.H I, 2C Policy
    statement, and 3J Policy IV.E and Procedure I.J
    K)

61
VAMHCS ResearchLapses in Renewal
  • Lapses in gaining continuing approval must be
    reported to the sponsoring agency, private
    sponsor, ORD, ORO, and other federal agencies as
    appropriate.
  • (SOPs 1F.2 Procedure I.H I, 2C Policy
    statement, and 3J Policy IV.E and Procedure I.J
    K)

62
VAMHCS Research Consent
  • For VAMHCS research, if someone other than the
    investigator will conduct the interview and
    obtain informed consent, the investigator must
    formally delegate this responsibility and the
    person so delegated must receive appropriate
    training to perform this activity.
  • (SOPs 4A Procedure I.A.1 6B Policy II.B.1)

63
VAMHCS Research Consent
  • Policies and procedures require the person
    obtaining the informed consent to sign and date
    the consent document. Policies and procedures
    require a copy of the signed informed consent to
    be provided to the participant or the
    participants representative. (SOP 4B, Policy
    VII)

64
Summary
  • Changes are being made to keep us in regulatory
    compliance and to enhance the protection and
    safety of research participants.
  • Changes in HRPOs operation have lead to a more
    comprehensive administrative review, quicker
    turn-around for minimal risk research and
    expedited transactions, fewer deferrals and
    system closures/expirations, and ultimately to
    quicker approval of protocols.

65
Providing Feedback to the HRPO
  • Complete our web-based survey.
  • Contact a member of the HRPO staff directly.
  • Dr. Jarrell, Acting Senior Associate Dean for
    Research Graduate Studies, hosts quarterly
    luncheons for investigators and faculty to elicit
    feedback about the program.

66
Providing Feedback to the HRPO
  • Coming soon. Look for our upcoming Needs
    Assessment survey and tell us how we can help you
    -- Our Education Program is expanding but we need
    to hear from you!

67
Topics for Upcoming Brown Bag Lunch Training
Sessions
  • Informed Consent
  • Changes Impacting VAMHCS Research
  • Unanticipated Problems Involving Risk to
    Participants or Others
  • Privacy and Confidentiality
  • Specific dates are still to be determined.
    Please check the web site for updates.

68
Resources
  • Contact the HRPO at 410-706-5037 or
    HRPO_at_som.umaryland.edu
  • Contact your Analyst
  • Visit the HRPO web site regularly at
    http//medschool.umaryland.edu/orags/hrpo/
  • Contact Khristy Bozylinski, Program Manager for
    Education, regarding upcoming educational
    sessions or specific departmental needs for
    training. (6-4514 or kbozylinski_at_som.umaryland.edu
    )
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