National EMS Research Agenda Recommendation 8

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National EMS Research AgendaRecommendation 8

• The IRB Administrator Perspective
• Marti Benedict RN,BSN,CIP
• State University of New York
• Upstate Medical University
• Syracuse, New York

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The Institutional Review Board (IRB)
An administrative body established to protect the
rights and welfare of human research subjects
recruited to participate in research activities
conducted under the auspices of the institution.
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IRB Composition
Must have at least five members with varying
backgrounds to promote complete and adequate
review of research activities commonly conducted
by the institution.

• 1 member whose primary concerns are in scientific
  areas.
• 1 member whose primary concerns are in
  nonscientific. areas.?
• 1 member who is not otherwise affiliated with the
  institution.

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IRB Membership at Upstate

• 1 pediatric hematologist
• 1 Medicine/ID specialist
• 1 Medicine/GI specialist
• 1 Radiologist
• 1 Radiation/Oncologist
• 1 Adult Oncologist
• 1 OB/GYN Critical Care
• 1 Orthopedist
• 2 Psychologists (Adult Child)
• 1 Pathologist

• 1 anesthesiologist
• 1 Cell Biologist
• 1 community rep. ?
• 1 hospital administrator
• 1 Bio-Statistician
• 2 Geneticists (alternate)
• 1 Nurse Researcher
• 1 IRB Administrator
• 1 Internist Pharmacist
• 1 Neurosurgeon

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The Public Access Defibrillation Trial (PAD)

• This is an out-of-hospital trial to investigate
  whether defibrillation by non-medical volunteers
  will significantly increase survival in out of
  hospital cardiac arrest by reducing the time from
  collapse to defibrillation.
• 40 sites selected and volunteers recruited.
• Sites randomized to Control Group (volunteers
  trained to access 911 and perform CPR) or
  Intervention Group (volunteers trained to access
  911, perform CPR and use an automated external
  defibrillator (AED).

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IRB Decision Matrix
Subject selection Inclusion/exclusion Recruitment
Risk/Benefit Analysis Experimental
Design Qualifications of PI
J. Cooper, Albany Medical Center
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The Public Access Defibrillation Trial
(PAD)UPSTATE IRB FINDINGS

• Study design is appropriate
• Risk to subjects (including volunteers) is
  acceptable and minimized by volunteer
  training/testing procedures, establishment of a
  DSMB and adverse event reporting procedures
• Eligibility criteria appropriate
• Acceptable for children to participate (subpart
  D)
• Consent documents appropriate and clearly
  written
• Outline for community notification is
  appropriate.

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allows research on life-threatening conditions
for which available treatments are unproven or
unsatisfactory and where it is not possible to
obtain informed consent.? applies to research
involving children
Emergency Research Consent Waiver Effective
November 1,1996 Harmonization of DHHS and FDA
Regs. A single standard for emergency medicine
research?
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Emergency Research Consent Waiver (1)
Conditional upon documented findings by a duly
constituted Institutional Review Board (IRB)

• The Regulation (21 CFR 50.24) requires that a
  licensed physician not otherwise involved with
  the study, concur with the approval.
• The physician may be an IRB member or a
  consultant to the IRB.

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Emergency Research Consent Waiver (2)Required
IRB Findings

• The Research is Subject to FDA Regulations.
• If so, must be carried out under an
  investigational new drug application (IND) or an
  investigational device exemption (IDE). The IND
  or IDE application must clearly identify that the
  research study will include subjects unable to
  provide consent.
• OR
• The Research is Not Subject to FDA Regulations

AND
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The Public Access Defibrillation Trial
(PAD)UPSTATE IRB FINDINGS

• The Research is Subject to FDA Regulations.
• IDE issued by the FDA

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Emergency Research Consent Waiver (3)Required
IRB Findings

• The human subjects are in a life-threatening
  situation.
• Obtaining informed consent is not feasible.
• Participation in the research holds out the
  prospect of direct benefit to the subjects.
• The research could not practicably be carried out
  without the waiver.
• The proposed research protocol defines the length
  of the potential therapeutic window based on
  scientific evidence and the investigator has
  committed to attempting to contact a legally
  authorized representative for each subject within
  that window of time and, if feasible, obtain
  consent.
• IRB has reviewed and approved informed consent
  procedures and an informed consent document.
  These procedures and the informed consent
  document are to be used with subjects or their
  legally authorized representatives in situations
  where use of such procedures and documents is
  feasible.
• Additional protections of the rights and welfare
  of the subjects will be provided, including, at
  least
• Community consultation, public disclosure (before
  and after the study), establishment of a data
  monitoring committee, subject/representative
  notification and consent.

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The Public Access Defibrillation Trial
(PAD)UPSTATE IRB FINDINGS

• That all provisions (21 CFR 50.24) for the
  emergency research consent waiverhave been met.

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The Public Access Defibrillation Trial
(PAD)Community Notification Procedures

• Media
• TV
• Newspaper
• Information Sessions Public Information Posters
• At each of the 40 sites
• Community Committee
• Meets quarterly
• Includes representatives from the county health
  department, American Heart Assoc., Red Cross,
  local EMS agencies, and private citizens.

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How to make your life easier (1)
Establish a Working Relationship with your IRB

• The Chairperson
• The Administrator
• The IRB Staff

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How to make your life easier (2)
Know the Federal Regulations the Local
IRB-Institutional Policies

• Federal Guidelines are the Minimum
• Educate the IRB
• Volunteer to serve on the IRB (If you cant beat
  them, join them).

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CONSCIOUSNESS RAISING
Emergency Medicine Research Issues in the
National Arena

• Present concerns at the National Level
• PRIMR/ARENA Meeting
• OHRP/FDA Regional Workshops
• MCWIRB The Institutional Review Board -
  Discussion and News Forum (on-line)

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SUMMARY

• GET INVOLVED AT ALL LEVELS
• EDUCATE
• NETWORK TO AVOID DUPLICATION

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RESOURCES

• Public Responsibility in Medicine and Research
  (PRIMR)
• http//www.primr.org/
• Applied Research Ethics National Association
  (ARENA)
• http//www.arena.org/
• FDA Information Sheets
• http//www.fda.gov/oc/ohrt/irbs/default.htm
• Office for Human Research Protections(OHRP)
• http//ohrp.osophs.dhhs.gov/
• MCWIRB
• http//www.irbforum.org/