Changing Seasons .Changing Times Welcome Thank You For

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Changing Seasons .Changing Times

• Welcome
• Thank You For Celebrating
• With Us Today

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Office for Human Research Administration
(OHRA) Delia Wolf, MD, JD, MSCI Director
Quality Improvement Program Leslie Howes, MPH,
CIP Director Compliance Education Human
Research Support Alyssa Speier, MS, CIP QA/QI
Education Specialist
IRB Operations Andrea Saltzman, RN
Administrative Chair Paul Hryvniak Review
Specialist Andrea Landers, CIP Review
Specialist IRB Ichiro Kawachi, MD,
PhD Chair Michelle Mello, PhD, JD Chair
Special Projects Julie Kaberry, MHP, CIP Director
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We Are Very Proud !

• HSPH Received Full Accreditation status from the
  Association for Accreditation of Human Research
  Protection Program (AAHRPP) in June 2010

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We Are Very Proud !

• But We Could Not Have Done It Without You!

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Thank You

• To HSPH Principal Investigators who were
  interviewed by AAHRPP site visitors

• Jeffrey Anderson
• Myron Essex
• Stephen Gilman
• Murray Mittleman
• Karestan Koenen
• Megan Murray
• Phyllis Kanki
• Susan Korrick
• Jennifer Leaning
• Wafaie Fawzi

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And a Round of Applause for

• Our research staff super stars, who were
  interviewed by AAHRPP site visitors and whose
  contributions are invaluable to the success of
  HSPH research endeavors
• Anne Marie Borchelt
• Dept. of Nutrition
• Molly Pretorius Holme
• Dept. of Immunology and Infectious Disease
• ANova Ettien
• Dept. of Global Health Population

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We are Thankful

• For the participation of Department Chairs, who
  were interviewed by AAHRPP site visitors
• Victor DeGruttola
• Department of Biostatistics
• Walter Willett
• Department of Nutrition
• Arnold Epstein
• Department of Health Policy and Management
• Hans-Olov Adami
• Department of Epidemiology
• Douglas Dockery
• Department of Environmental Health

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Were Tremendously Grateful to

• Connie Galanis Sponsored Programs
  Administration
• Heather Quay Office of General Counsel
• Mark Barnes IRB Institutional Official
• For your time and effort in participating in the
  AAHRPP interview

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For Their Many Contributions

• Thanks to the HSPH IRB Members who were
  interviewed by AAHRPP site visitors

• Sophia Gruskin
• Miguel Hernan
• Daniel Milner
• Thomas Smith
• Sally Stoddard
• Arnold Messing
• Bruce Smith

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Two Thumbs Up for Our Terrific Two!

• Thanks to HSPH Leadership for their unconditional
  support and guidance
• Karen Emmons
• Associate Dean for Research
• David Hunter
• Dean for Academic Affairs

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We Couldnt Do Our Work, Without Your Work!

• Thanks to the Office of Human Resources, which
  provided counsel, support and significant
  contributions to our successful reorganization
• Trina Weekes
• Raina Gaurishankar
• Weber Torres

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We Couldnt Do Our Work, Without Your Work!

• Special thanks to our HR Partner
• for helping us build a qualified, enthusiastic,
  winning team!
• ?Diane Stacey-Wood

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Cant Beat a Visit to the SPA!

• Thanks to the Office of Sponsored Programs
  Administration (SPA) for their support and
  continued efforts towards collaboration and
  efficiency in Research Administration
• Frank Urso
• Constance Galanis
• Jamie Goldberg

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Making a Difference,One Protocol at a Time!

• Thanks to our IRB Members we
• applaud your knowledge and dedication!

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Welcome!

• To our newest IRB Members we extend our warmest
  welcome and thank you for coming aboard to
  contribute to our human research protection
  efforts.
• We look forward to working with you!
• Shaun Baran Dimock Community Health Ctr.
• Myechia Minter Jordan Dimock Community Health
  Ctr.
• David Christiani HSPH Faculty
• Dan Jorgenson AMAG Pharmaceutical

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Thank You

• To our IRB Chairs for their dedication, time,
  knowledge and valuable contributions throughout
  the year.
• Ichiro Kawachi, MD, PhD
• Professor of Social Epidemiology
• Chair, Dept. of Society, Human Development, and
  Health
• Michelle Mello, PhD, JD
• Professor of Law and Public Health
• Department of Health Policy and Management

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IRB Operations

• Meet the team responsible for
• Managing and supporting the IRB
• Determining whether an activity is Human
  Research
• Determining whether Human Research can be exempt
• And so much more.stop by their table today !
• Andrea Saltzman, RN
• Administrative Chair
• Paul Hryvniak
• Review Specialist
• Andrea Landers, CIP
• Review Specialist

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Department Assigned IRB Review SpecialistsPaul
Hryvniak

• Center for Biostatistics in AIDS Research
• Epidemiology
• Global Health and Population
• Society, Human Development, and Health

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Department Assigned IRB Review Specialists
Andrea Landers

• Environmental Health
• Genetics and Complex Diseases
• Health Policy and Management
• Immunology and Infectious Diseases
• Nutrition

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• Stop by the IRB Operations table and introduce
  yourself to our new
• IRB Administrative Chair
• Andrea Saltzman, RN
• Andrea joined OHRA in August 2010

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Thank you for participating in our Investigator
Manual Scavenger Hunt The answers are provided
on the next few slides - how did you do? Raffle
winners will be announced today!
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Investigator Manual Scavenger Hunt Multiple
Choice Questions
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1. What will happen if a Continuing Review
application is not received by the IRB prior to
the study's submission deadline?

• A member of OHRA will come to the Principal
  Investigators office to track down the required
  Continuing Review materials.
• ? The Principal Investigator will be restricted
  from submitting new Human Research until the
  completed application has been received.
• OHRAs Quality Improvement Program (QIP) will
  conduct a Directed (for-cause) Audit of the
  researchers study files.
• The study can continue as planned.

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2. If any study document (informed consent form,
recruitment materials) will be translated into
languages other than English, which of the
following are true?

• Both the Principal Investigator and the
  translator must sign a Translation Attestation
  Form
• A copy of the translated document must be
  submitted to the HSPH IRB when it becomes
  available
• Back-translation of foreign-language consent
  forms into English is not required
• ? All of the above

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3. If a submission to the IRB is incomplete, the
Principal Investigator will receive an email
requesting additional materials. The submission
will be withdrawn if the requested materials are
not received by the IRB within

• ? 45 calendar days
• 25 calendar days
• 30 calendar days
• 15 calendar days

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4. Which of the following must be reported,
within 5 days, to the IRB using a Report of New
Information Form?

• Information that indicates a change to the risks
  or potential benefits of the human research
• Local/internal adverse event which in the
  opinion of the investigator are unexpected and at
  least possibly related to the study procedures
• External adverse event which in the opinion of
  the sponsor or investigator requires changes to
  the protocol or informed consent form
• Audit, inspection, or inquiry by a federal
  agency
• Failure to follow the protocol due to the action
  or inaction of the investigator or study staff
• Finding of Non-Compliance or Allegation of
  Non-Compliance.
• ? All of the above

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5. According to OHRA policy, how many years
should signed and dated consent documents be
maintained after completion of the research?

• 1 year
• 3 years
• ? 6 years
• 8 years

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6. Which of the following criteria must be met in
order to close a study?

• The research is permanently closed to enrollment
  and all participants have completed all
  research-related interventions/interactions
• Collection of private identifiable information
  is completed
• Analyses of private identifiable information is
  completed
• ? All of the above
•  

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Investigator Manual Scavenger Hunt True /False
Questions
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7. To serve as Principal Investigator for a
non-exempt study, you must have a faculty
appointment at HSPH

 
? TRUE
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8. If the HSPH IRB has approved a protocol that
will be conducted internationally, the research
may commence before other organizational and/or
local approvals have been secured.

 
? FALSE
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9. If a PI offers a research participant 10 to
complete a survey, this should this be listed
under the 'Benefits' section of the Consent Form.

 
? FALSE
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10. At the request of the Principal Investigator,
the Quality Improvement Program can provide
assistance with drafting informed consent forms
and recruitment materials.

 
? TRUE
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11. Final copies of printed advertisements must
be approved by the IRB prior to their use in the
field.

 
? TRUE
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12. Copies of previously translated study
documents should be resubmitted with each
Continuing Review application.

 
? FALSE
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Congratulations to our Scavenger Hunt Winners !

• 100 Correct Job Well Done!

• Michael Roy
• Katie Herz
• Rio Holaday
• A'Nova Ettien
• Molly Pretorius Holme
• Sarah Meyers-Ohki

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Have you heard about our Quality Improvement
Program? QIP Learn More Today!
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Whos WHO of the Quality Improvement Program
(QIP)

• Leslie Howes, MPH, CIP
• Director

• Alyssa Speier, MS, CIP
• QA/QI Education Specialist

Come meet today us at QIPs table
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Sign Up for QIP Services Today!

• Available Services

• Temporary Research Coordinator Support
• Routine On-site Review
• Study Consultation
• In-Service/Education
• IRB Submission Assistance
• Study Staff Orientation

• Visit QIPs table to sign up

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WERE LOOKING FOR A FEW GOOD MENOR WOMEN!

• NOW HIRING
• QA/QI Specialist Position

• Working closely with Investigators
• and their staff study
• Facilitating the IRB review/
• approval process
• IRB Submission Assistance
• Study Consultation
• Temporary Research Coordinator Support
• Study Monitoring
• Conducting on-site reviews/audits

• INTERESTED?
• Visit ASPIRE to apply today (requisition 22370)
• Learn more at QIPs Table

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Get Organized!

• Pick up your
• protocol-specific
• Regulatory Binder
• Today!

• Visit QIPs table to get your binder(s)

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Meet OHRAs latest additions

• Maxwell Wyatt Speier
• Born April 23, 2010

• Penelope Bray Howes
• Born May 21, 2010