Goals of Accreditation

Slides:



Advertisements
Similar presentations
The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
Advertisements

Managing Compliance Related to Human Subjects Research Review Joseph Sherwin, Ph.D. Office of Regulatory Affairs University of Pennsylvania Fourth Annual.
VCOM Conflict of Interest Policy Overview of Financial Conflict of Interest Related to Research December 4, 2013.
Financial Conflict of Interest July 2012 rev
Conflict of Interest, Conflict of Commitment, and Outside Activities UTSA HOP 1.33 Non-covered UTSA staff 1.
Conflict of Interest (COI) Objectives: Provide an overview of financial conflict of interest (FCOI) related to research activities at Gillette Describe.
THE UW HEALTH SCIENCES IRB S OVERVIEW PRACTICAL REGULATORY ISSUES IN HUMAN SUBJECTS RESEARCH.
SOP Melody Lin, Ph.D. Deputy Director, Office for Human Research Protections Director, International Activities Santiago, Chile August.
Financial Conflict of Interest (FCOI) Updates Office of Sponsored Programs April 2014.
University of Vermont Sponsored Project Administration New PHS Financial Conflict of Interest (FCOI) Regulations Effective August 24th, 2012 Ruth Farrell,
NIH FINANCIAL CONFLICT OF INTEREST REGULATIONS – 2012 Office of Sponsored Programs Research & Graduate Studies.
This tutorial reviews the main requirements of and the responsibilities for compliance with the 2011 revised Federal regulation on Financial Conflict of.
Sherry Davis, Manager Pacific Northwest National Laboratory Human Research Protection Program AAHRPP As A Self-Assessment Tool May, 2008.
Submission to Approval What happens to my protocol once I submit it to the HIC office.
The IRB Process Tony Medure, M.A., CIP, RAC Vanderbilt Human Research Protection Program.
IRB Determinations 1. AAHRPP Site Visit Results Site visitors observed a real commitment to human subject protections Investigator and research staff.
ANPRM Single IRB Review mandated for multi-site domestic research P. Pearl O’Rourke, M.D. Partners Health Care.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary’s Advisory Committee on Human Research Protections October.
POST APPROVAL MONITORING AND EDUCATION PROGRAM Jane Lehmbeck 1, Sarah Blackman 1, Karen Davenport 2, Karen Parks 1 Office of the Vice President for Research.
Copyright © 2013 AAHRPP ® All rights reserved Elyse I. Summers, J.D. President and CEO CAREB 2014 National Conference Montreal, Quebec April 23 – 26, 2014.
National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Research Studies UCSF HRPP Submission Process Overview Tuesday, December.
Conflict of Interest Faculty & Staff of Instruction or Research Human Resources 2011.
NIH Proposed Use of a Central IRB (C-IRB) for NIH-funded multi-site studies Committee on Clinical Research January 26,
Promoting Objectivity in Research by Managing, Reducing, or Eliminating Conflicts of Interest UT HOP UT HOP The University of Texas at Austin.
Institutional Review Board (IRB) Human Subject Research Office (HSRO) University of Miami and Affiliated Institutions.
Basic Research Administration Principles Presented by Ronald Kiguba Research Coordinator, Makerere Medical School.
Overview of Good Clinical Practices (GCPs)
Research Conflicts of Interest: Identifying and Minimizing COI from the Perspectives of Sponsors, Faculty and the IRB Research Conflicts of Interest: Identifying.
Copyright © 2013 AAHRPP ® All rights reserved Elyse I. Summers, J.D. President and CEO CAREB 2015 National Conference Vancouver, British Columbia May 1-2,
Human Research Protection Program Institutional Review Board Requirements and Expectations of Researchers and Research Staff Moira A Keane, MA, CIP Executive.
Responsible Conduct of Research (RCR) Farida Lada October 16, 2013
Elements of Clinical Trial Quality Assurance Regulatory Coordinator –SCTR SUCCESS Center QA Monitor – NIDA Clinical Trials Network Stephanie Gentilin,
ORO Reviews: Frequent Findings Related to IRBs Bob Brooks Associate Director Research Compliance Education and Policy VHA Office of Research Oversight.
Copyright © 2009 AAHRPP ® All rights reserved Update on AAHRPP – Revised Standards and Procedures Marjorie A. Speers, Ph.D. President and CEO.
Sara Brand Associate Director Research Compliance Administration.
Michelle Groy Johnson Quality Improvement Officer Research Integrity Office Tough Love: Understanding the Purpose and Processes of Quality Assurance.
University of Miami Office of Research Compliance Assessment Lynn E. Smith, JD, CIM, CIP Johanna Stamates, RN, BA, CCRC With assistance from Elizabeth.
Questions: AAHRPP Evaluation Instrument for Use with Final Revised Accreditation Standards Presented by: C. Karen Jeans, MSN, CCRN, CIP COACH Program Analyst,
UC DAVIS OFFICE OF RESEARCH Overview of Good Clinical Practices (GCP) Investigator and Study Team Responsibilities Miles McFann IRB Administration Training.
Institutional Review Board Procedures and Implications After the applied dissertation committee has approved the proposal and the IRB package, the student.
The NCI Central IRB Initiative Third Annual Medical Research Summit Washington, D.C. March 2003.
New Federal Policy on Financial Conflicts of Interest Matt Richter, MA, JD anticipated 2012 COI Program Specialist Office of Research Policy
Partners Conflict of Interest Policy and Reporting October 11, 2012.
Welcome New IRB Members! Today we will discuss: Your Role in the IRB: What to Know The IRB Review Process Resources Human Research Protections.
AAHRPP ACCREDITATION (Association for the Accreditation of Human Protection Programs)
HRPP Policies & Forms Chapter Two Created/Revised for AAHRPP June 1, 2007.
Fully accredited since 2006 Tom Conquergood, CIP Working with Quorum October 13, 2015 Thomas Jefferson University.
Paul Kelly Facility Research Compliance Officer for the Ralph H. Johnson VA Medical Center.
Welcome New IRB Member! This brief presentation covers: Your Role in the IRB: What to Know The IRB Review Process Resources Human Research Protections.
1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.
Conducting Research at Lincoln IRB/HRPP Policies, Procedures & Good Clinical Practices B Kanna MD, MPH, FACP Associate Program Director of Internal Medicine.
The TJU Human Research Protection Program (HRPP): Part I – Which Entities/Offices are Involved ? J. Bruce Smith, MD, CIP.
Financial Conflict of Interest January  Financial Conflict of Interest regulation 42 CFR 50 Subpart F promotes objectivity in research by establishing.
VA Central IRB K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs September.
Marianne M. Elliott Office of Research Integrity and Ethics Bureau of Medicine and Surgery U. S Navy.
HRPP METRICS Cynthia Monahan, MBA, CIP IRB Director Boston University Charles River Campus IRB.
COCE Institutional Review Board Academic Spotlight
myGRANT Conflicts of Interest (COI) Module
Beverley Alberola, CIP Associate Director, Research Protections
UW Conflict of Interest Program Manager Office of Research Policy
Brown Bag Series First Tuesday of each month (except July)
HUMAN RESEARCH PROTECTION PROGRAM or
AAHRPP Accreditation Welcome to the University of Georgia’s presentation for accreditation of the human research protection program (HRPP). This presentation.
Conflict of Interest IRB Review of Management Plans
AAHRPP + IRB Update Michael Mahoney
Research Compliance at Dartmouth
myGRANT COI NEW User Interface Effective
Conflict of Interest Shilene Johnson- Research Compliance Specialist
Investigator of Record – Definition
Presentation transcript:

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? 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 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? 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 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. 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? 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

Accreditation- An Ongoing Process 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.