Transcript Document

This module will provide an overview of the
accreditation process .
Please read the material carefully and take a few minutes
to answer some questions at the very end.
Working Towards
AAHRPP Accreditation
Dushyantha T. Jayaweera MD, MRCOG (UK), FACP, CIP
Associate Vice Provost for Human Subject Research
Kenia Viamonte, MA
Sr. Manager for Compliance/ IRB Affairs
Human Subject Research Office
Amanda Coltes-Rojas, MPH, CIP, CHRC
Director, Regulatory Affairs & Education
Objectives
At the conclusion of this module, you should be more familiar with:
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Accreditation Process
Your role
Where to go with questions
How to prepare
What to expect from the site visit
Human Research Protection Program (HRPP):
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An integrated process where all the various components of an organization involved in the conduct of human research work
together to protect the rights and welfare of participants
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It is not an office but rather the collective effort of all who participate in the conduct, review, approval and facilitation of
human subject research at the University of Miami.
Our HRPP
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The University of Miami’s HRPP strives to adhere to the highest ethical standards in its protection of human research
participants in addition to ensuring compliance with all relevant federal regulations and state law.
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To this end, we have applied for accreditation of our Human Research Protection Program (HRPP). We are seeking
accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc.® (www.aahrpp.org).
Some Important Components of our HRPP
Institution
Researcher/
Sponsor
Research Staff
Other Compliance
Units
Grants and Contracts
IRB
Ancillary Review
What is AAHRPP?
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Association for the Accreditation of Human Research Protection Programs (AAHRPP)
An independent, non-profit accrediting body
Voluntary, peer-driven, educational model
About AAHRPP
What AAHRPP does
Includes assessments, assistance, site visits and a set of rigorous performance standards and outcome measures. Applying
Institutions seeking accreditation complete a self-assessment that requires comprehensive information concerning the type
of research they conduct and their policies governing the protection of research participants. Surveyors will examine all of
the information provided and conduct site visits, upon satisfactory completion of Steps 1 and 2 of application and
corresponding documentation. At the site visit, the surveyors evaluate the HRPP’s performance using AAHRPP‘s evaluation
instruments and conduct one on one interviews with institutional officials, IRB members, IRB management, investigators
and research coordinators. Organizations that achieve accreditation must be re-evaluated every three years in order to
remain accredited.
What AAHRPP Doesn't Do
AAHRPP does not ‘audit’ the IRB, decisions made by the IRB or the Institution. AAHRPP is not a "second guessing" exercise
and does not critique researcher’s proposals. Finally AAHRPP does not report "findings" to regulatory agencies
Why seek accreditation?
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Visible indicator that our Human Research Protection Program (HRPP) follows rigorous standards for ethics, quality and
protections for human subjects
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As an Institution, we are committed to continuous improvement and best practices
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Although AAHRPP is not the sole HRPP accrediting body, it is the largest and is recognized as such nationally and
internationally
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Attaining Accreditation in this industry serves as a "gold seal" signifying adherence to a rigorous set of human protection
standards, and that our HRPP is consistent and uniform to other well recognized institutions conducting biomedical and
social behavioral research
Why seek AAHRPP accreditation cont’d
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Public trust and confidence
Government recognition-National Cancer Institute (NCI) is now accredited and will be looking to other ‘like’ Institutions
Pharmaceutical companies, such as Pfizer, are now accredited, and will only be looking to accredited Institutions
Industry is moving towards single IRB review model for multi-site research- IRB consortiums and Clinical and Translational
Science Institute (CTSI) hubs will look to include accredited institutions as the floor for program inclusion
Accreditation Process
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Conduct self-assessment (where we are vs. where we need to be prior to submittal)- COMPLETED 4th Quarter 2013
Step 1 Application (Application and supporting materials)- Approved 1st Quarter, 2014
Feedback from AAHRPP on items requiring further development/ Gap analysis- RECEIVED June 20, 2014
Response preparation- Submitted 3rd Quarter, 2014
Step 2 Application (active study list, additional materials) Approved 3 rd Quarter, 2014
On-site evaluation of HRPP’s performance (scheduled for April 1-3, 2015)
Site report provided for HRPP response
Response to site report submittal
Council review (EXPECTED FALL / WINTER 2015)
AAHRPP Accreditation Standards
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Domain I: The Organization
Domain II: Institutional Review Board or Ethics Committee
Domain III: Researcher and Research Staff
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http://www.aahrpp.org/apply/process-overview/standards
We are all in this together…
Although the HSRO/IRB will be spearheading this effort, it is important to recognize that:
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Accreditation is not just about the IRB, it is the entire human subject research protection program that becomes accredited
Institutional Information
The role of the institution in conducting human subject research is defined in the federal regulations: the institution bears the
responsibility for compliance with all federal regulations governing human subject research.
The institution is responsible for:
• The overall performance of all research activities involving human subjects under the direction of the institution’s employees or its
agents
• Establishing and overseeing a human research protection program
• Assuring safeguards are taken in research with vulnerable subjects
• Educating researcher on issues of research ethics and scientific integrity
• Having a COI policy and process in place
• Investigating alleged cases of scientific misconduct
Our Institutional Official :
John L. Bixby, Ph.D
Professor of Molecular & Cellular Pharmacology and Neurological Surgery
Vice Provost for Research
What you can do…
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We are counting on the commitment you make to conduct quality research and solicit your help in this endeavor. To
successfully obtain accreditation, all interviews must be successful.
As part of the HRPP, you must have:
– Basic understanding of the HRPP
– Clear understanding of your role in the HRPP
Site Visit
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Interviewees will be provided with materials and prep sessions to help them succeed.
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A team of AAHRPP professionals will be on site for 3 days reviewing UM’s HRPP. The site visit will include interviews,
selected by the agency, of IRB members, investigators, research coordinators, administrators , HSRO staff and other
individuals involved with the HRPP.
Know your resources!
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Prepare for the site visit (Scheduled for April 2015):
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AAHRPP interviewers will want to see that you are familiar with the information and services available to you, and that you
know where to find assistance if you have questions.
–http://hsro.med.miami.edu and https://eprost.med.miami.edu
–Note: Visit the IRB Library: to access library, you must have an eprost account established)
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Know how to access Policies and Procedures for other areas related to human subject research protection
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http://uresearch.miami.edu/
Learn more about the accreditation process
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http://www.aahrpp.org/apply/process-overview/standards
How to Prepare
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Reportable New Information: Know how to report trouble, non-compliance, adverse events, unanticipated events, etc.
Know where to go for advice/ guidance (which office and for what purpose)
Maintain compliant research records and documentation, and justification for decisions
Focus on philosophical aspects of your role first, then know the regulatory details (e.g. what you are reviewing/performing
is sound, purposeful, and has value, before the nuts and bolts of compliance assessment- elements of consent, how to
minimize risk etc)
Understand what constitutes a conflict of interest at all levels (e.g. staff, IRB, institution, administration)
Familiarize yourself with the terminology/jargon for human subject research protection
Difference between Privacy and Confidentiality
Describe the Human Subjects Education you’ve had and how you apply it in your research; What are the training
requirements at our Institution?
Know the ethics of recruitment and inclusion/exclusion criteria
Standard Operating Procedures
Provides all the information you need to know in regards to IRB operations and workflow. They are identified as HRP (and a
number). HRP stands for Human Research Protection.
For example:
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HRP-090 - SOP - Informed Consent Process
HRP-055 – SOP – Financial COI
HRP-063 - SOP - Expiration of IRB Approval
General (Comprised of 4 Sections)
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HRP-101 – Human Research Protection Program Plan for the U of Miami, which is the general outline of rules and
responsibilities
HRP-102 – Work Flowchart for IRB
HRP-103 –Investigator Manual- Study team responsibilities- Most complete resource
HRP-104 - Should I Take Part in Research? Information for study subjects
Worksheets
There are (24) documents that reference what the IRB is looking for in a study when conducting their review. For ex:
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HRP-306 – Drugs
HRP-307 - Devices
HRP-312 - Exemption Determination
HRP-313 - Eligibility for Review Using the Expedited Procedure
HRP-314 - Criteria for Approval and Additional Consider
HRP-324 - Contract Items Related to Human Subject Protections.doc(0.03)
HRP-330 - HIPAA Authorization
Checklists
There are (16) documents that reference what you need to know when the IRB is reviewing a study. For ex:
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HRP-402 - Non-Committee Review used to be called expedited review
HRP-410 - Waiver or Alteration of Consent Process
HRP-412 - Research Involving Pregnant Women
HRP-415 - Research Involving Prisoners
HRP-416 - Research Involving Children
Templates
Examples:
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HRP-502 – Consent document
HRP-503 – Template protocol > Minimal risk
HRP-503 - Template Protocol – no more than Minimal Risk
HRP-506 - Consent document – Emergency Use
HRP-507 - Consent Document Short Form
When in doubt…
If you don’t know the answer to the question the site visitor may be asking…A few words of advice:
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Acknowledge there is a policy, website, etc to which you refer to as needed
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Indicate you would call the IRB office
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Indicate you would review the regulations: DHHS, FDA
Business as Usual
Areas of standard requisite knowledge includes, but not limited to:
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subject accountability, informed consent, staff qualifications, protocol compliance, subject records, site regulatory
administration, data management, documentation practices, and adverse event reporting, vulnerable populations,
additional safeguards, confidentiality
Top Issues Identified at AAHRPP Site Visits
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ELEMENT: The Organization has written policies and procedures to identify and manage financial conflicts of interest of the
Organization that could influence the conduct of the research or the integrity of the Human Research Protection Program.
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ISSUE: 26.6% of Draft Site Visit Reports include concerns in this Element. LACK of senior level awareness or understanding.
HRPP components unaware of organizational policies
Top Issues Identified at AAHRPP Site Visits
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ELEMENT: The Organization has written policies and procedures to identify and manage financial conflicts of interest of the
Organization that could influence the conduct of the research or the integrity of the Human Research Protection Program.
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ISSUE: Over 20% of Draft Site Visit Reports include concerns in this Element. LACK of senior level awareness or
understanding. HRPP components unaware of organizational policies in regards to COI policy and process.
Be our partner in getting the ‘U’ AAHRPP Accredited!
Thank you!
Questions regarding the
University of Miami’s AAHRPP application?
Human Subject Research Office
305-243-3195