Changes to UMB IRB Policies

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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

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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

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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

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Topics to be covered

• Update on AAHRPP accreditation

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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
  )

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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

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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

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How does accreditation work?
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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

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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

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HRPO Agenda

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

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Enhancements to Human Research Protections Office

• Increased Resources
• Deferral Prevention Program
• Quality Improvement Program

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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)

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Financial Resources
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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

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HRPO Organization
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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

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Deferral Prevention Program
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Quality Improvement Program

• Goals
• Strengthen safeguards for research participants
  through
• Auditing
• Monitoring
• Ongoing education

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HRPO QI Activity
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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

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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

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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

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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

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Full Board Review Process
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Full Board Review Process (contd)
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February 2006Average Approval Times
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March 2006 Average Approval Times
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Education/Outreach

• Program Manager
• Education Strategic Plan
• Khristy Bozylinski, M.S.
• Quality Improvement Specialists
• Protocol Review
• Monitoring Investigator Sponsored Studies

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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.

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HRPO FY06 Goals

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

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Topics to be covered

• Updates to the Human Research Protection Program
  (HRPP) policies and procedures manual

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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

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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

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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

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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

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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)

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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)

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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)

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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)

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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)

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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)

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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

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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)

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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).

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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)

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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)

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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)

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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.

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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.

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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)

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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.

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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)

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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)

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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)

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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)

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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)

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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)

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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.

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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.

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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!

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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.

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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
  )