Transcript UTHSC Pursues Accreditation for Our Human Research

UTHSC Pursues Accreditation
for Our Human Research
Protection Program (HRPP)
Goals of Accreditation
• “Improve the systems that protect the rights and welfare of
individuals who participate in research”
• “Communicate to the public the strength of an Organization’s
commitment to the protection of human research participants”
From http://www.aahrpp.org/learn/accreditation/goals-principles-standards
Why should we pursue accreditation?
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To evaluate UTHSC’s research policies and procedures for accuracy, consistency, &
thoroughness in regards to federal regulations and guidance
To formalize interaction and communication across all UTHSC research boards,
committees, offices, units, and personnel
To reduce the risk of research non-compliance on campus
To look at more efficient ways of protecting human participants
To attract sponsors who want to conduct research with accredited organizations
The Association for the Accreditation of Human
Research Protection Programs, Inc. (AAHRPP)
• Nonprofit organization
• Founded in 2001
• Has accredited 198 organizations representing 600 entities*
• The only long-standing, reputable, and global accrediting organization
*from December 4, 2014 PRIM&R preconference workshop, AAHRPP PowerPoint presentation
Types of Organizations Accredited by AAHRPP
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Academic Institutions (over 65% of U.S. medical schools are accredited or in the process*)
Hospitals (such as St. Jude Children’s Hospital)
Independent IRBs (such as WIRB)
Sponsors (such as Pfizer)
Contract Research Organizations (CROs, such as Celerion, Inc.)
Government (such as National Institutes of Health NCI CIRB and some VA facilities)
Research Institutions (such as National Marrow Donor Program)
Dedicated Research Sites (such as Miami Research Associates, Inc.)
*from http://www.aahrpp.org/learn/news-releases
Where are AAHRPP accredited organizations?
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46 U.S. states
Canada
China
India
Mexico
Republic of Korea
Saudi Arabia
Singapore
Taiwan
From http://www.aahrpp.org/learn/news-releases
What is a Human Research Protection Program
(HRPP)?
• A Human Research Protection Program is made up of all boards,
committees, offices, units, and personnel at an organization who contribute
to the protection of human research participants.
• The IRB is not the entity pursuing accreditation.
• The HRPP of UTHSC is pursing accreditation, and this includes you!
UTHSC HRPP Components
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Research coordinators, nurses, & staff
Investigators (PIs, Co-Is, Sub-Is)
Institutional Review Board (IRB Chair, Board members, & staff)
Institutional Biosafety Committee (committee members & staff)
Radiation Safety Committee (committee members & staff)
Grants and Contracts
Finance and Operations
Office of Clinical Research
UT Research Foundation
Research Administration
Our client institutions (such as Methodist, Le Bonheur, & Regional One Health)
The Accreditation Process: Self-Evaluation
• We will conduct a self-evaluation using AAHRPP’s 130-page instrument.
• We must review all HRPP policies & procedures (not just IRB p & p) to ensure
that all 60 elements under the 15 AAHRPP standards are met.
• This will require review and revision of current p & p, creation of new p & p,
and putting revised and new policies and procedures into practice.
• This will take several months.
Example of AAHRPP standard
• Standard III-1: In addition to following applicable laws and regulations,
Researchers and Research Staff adhere to ethical principles and standards
appropriate for their discipline. In designing and conducting research
studies, Researchers and Research Staff have the protection of the rights
and welfare of research participants as a primary concern.
Example of AAHRPP Elements
under Standard III-1.
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III.1.A. Researchers & Research Staff know which of the activities they conduct are overseen
by the HRPP, and they seek guidance when appropriate.
III.1.B. Researchers & Research Staff identify and disclose financial interests according to
organizational policies and regulatory requirements and, with the Organization, manage,
minimize, or eliminate financial conflicts of interest.
III.1.C. Researchers employ sound study design in accordance with the standards of their
discipline. Researchers design studies in a manner that minimizes risks to participants.
III.1.D. Researchers determine that the resources necessary to protect participants are
present before conducting each research study.
Step 1 Application
• When the self-evaluation is complete, we must submit a Step 1 application
to AAHRPP.
• This application will include:
Application for Accreditation
Overview of our HRPP and explanation of each component’s
responsibility in protecting human subjects
Element-by-element index to supporting documents
Supporting documents from all components of our HRPP
IRB Rosters including requested details about members
Response to Step 1 Application
• We will receive AAHRPP’s response within 30 business days
• If they have questions, comments, or requested revisions, we can respond
only 1 element at a time.
• Once the element in question is satisfactory, we can begin to answer the 2nd
element in question.
• This process must be completed within one year of the date we submitted
the Step 1 application.
Step 2 Application
• Within 10 business days of AAHRPP’s approval of our Step 1 application, we
must submit our Step 2 application.
• This application will include:
All parts of the Step 1 application, revised to incorporate any and all
changes we have made since its submission
Meeting minutes, any government correspondence, and an internal audit
summary for the last year
Complete list of active protocols for the last year, including requested
details about them
List of key personnel involved in HRPP including role
Site Visit
• Will occur no less than 50-55 business days before the Council meeting date
• Site visit will include several days of:
Review of iMedRIS for consistency with policies and procedures submitted in Step 2
application
Interviews of key personnel in HRPP (this includes you!) regarding knowledge of your
role in HRPP, your practices according to HRPP polices and procedures, and how you
communicate with the other components of the HRPP
Evaluation of how our HRPP components work together to protect research
participants
End-of-day meetings with Lead Contact at UTHSC with questions and possible revision
requests
Response to Site Visit
• AAHRPP will send us a draft site visit report within 20 business days.
• We must respond to this draft site visit report within another 20 business
days.
• Our final site visit report is reviewed at the next quarterly Council meeting,
and a determination is made regarding accreditation.
What does all this mean for me?
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Research coordinators, nurses, & staff
Investigators (PIs, Co-Is, Sub-Is)
Institutional Review Board (IRB Chair, Board members, & staff)
Institutional Biosafety Committee (committee members & staff)
Radiation Safety Committee (committee members & staff)
Grants and Contracts
Finance and Operations
Office of Clinical Research
UT Research Foundation
Research Administration
Our client institutions (such as Methodist, Le Bonheur, & Regional One Health)
What do I need to do?
• If you are on a committee or in an office or unit in our HRPP, send me your
policies and procedures (or a link to them if they are current on the website)
We may be requesting revisions of those policies in order to meet one or
more AAHRPP elements/standards; please revise them promptly and/or
call us to discuss
• All personnel involved in our HRPP must become familiar with the HRPP
policies and procedures that apply to their role in the HRPP
IRB Standard Operating Procedures
http://www.uthsc.edu/research/research_compliance/IRB/policies.php
Accreditation- An Ongoing Process
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Once we receive full accreditation status, we will display the AAHRPP seal on the
IRB website
In order to maintain accreditation, we must do the following:
Maintain adherence to our HRPP’s accredited policies and procedures (and by
doing so, adhere to the federal regulations for the protection of research
participants)
Maintain metrics for the AAHRPP-required annual report
Maintain programs begun specifically for accreditation (and not required by
federal regulations)
Provide prompt status reports when requested by AAHRPP
Accreditation- An Ongoing Process
• In order to maintain accreditation, we must do the following (cont’d):
Provide prompt annual reports
Inform AAHRPP of any major changes to our HRPP and/or our p & p
Inform AAHRPP within 24 hours of any sanctions by government offices
or any lawsuits related to human research protection
Allow site visits if we have had any major changes, sanctions, or lawsuits
Maintain accreditation records for 10 years from date of accreditation
Pay annual fees
Reaccreditation
• The first accreditation period granted is only 3 years; however, every
reaccreditation period thereafter will last 5 years.
• The process is essentially the same as that required for accreditation.
• We must submit our Step 1 Application 12 months before the Council
meeting to which we are assigned for reaccreditation review.
AAHRPP Element under Standard III-1.
• III.1.B. Researchers & Research Staff identify and disclose financial interests
according to organizational policies and regulatory requirements and, with
the Organization, manage, minimize, or eliminate financial conflicts of
interest.
Pop Quiz
• Where in iMedRIS do you disclose financial
interests?
Section (3300)
Pop Quiz
• What does the IRB’s Conflicts of Interest
policy say?
Significant Financial Interest
Means anything of monetary value, including but not limited to:
• The value of any remuneration received from a publicly traded entity in the previous 12
months preceding the disclosure and the value of any equity interest in the entity as of the
date of disclosure, when aggregated, exceeds $5,000; or
• The value of any remuneration received from a non-publicly traded entity in the 12 months
preceding the disclosure, when aggregated, exceeds $5,000, or when any individual among
the key study personnel holds any equity interest in that entity; or
• Intellectual property rights and interests (patents, trademarks or copyrights) are held in the
drug, device or other article being tested, and income related to such rights and interest
has been received.
Applies to key research personnel and their spouses, parents, and children
IRB Conflict of Interest Policy cont’d
• If a conflict is reported, the IRB will not approve the study until the conflict
of interest is reviewed by the UTHSC Finance and Operations Office and a
plan for managing those interests has been formulated and approved by
that office under the provisions of Fl0125 Conflicts of Interest.
• Plans for managing financial conflicts of interest of investigators and other
key research personnel must be reviewed and approved by the full Board.