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2011 Conference Celebrates A Decade of Accreditation

2010 Conference Agendas: Quality Human Research Protection Programs Advancing Your HRPP to the Next Level
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One Set of Standards, Worldwide

One Set of Standards, Worldwide

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AAHRPP President & CEO Clarifies Coast Accreditation Status

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How AAHRPP Works with Your Partners to Earn Accreditation

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What Is Research?

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Documents

Title

AAHRPP Accreditation Standards

PDF  02/26/2010

AAHRPP Advance, Summer 2010, Vol. 7, No. 3
With articles on:

  • New Data Support Benchmarking
  • Sponsors, CROs Looking for Accreditation
  • HRPP Performance: Figures and Charts
  • Accreditation: 214 Organizations
PDF  06/23/2010

AAHRPP Advance, Spring 2010, Vol. 7, No. 2
With articles on:

  • Compliance: Accredited organizations again fare better with FDA
  • Competition: Pharma urged to use accredited sites
  • Collaboration: Harvard streamlines research review
  • Accreditation: 206 organizations
PDF  04/01/2010

AAHRPP Advance, Winter 2010, Vol. 7, No. 1
With articles on fewer burdens, more protections:

  • In the Final Revised Accreditation Standards
  • With a Longer Accreditation Period
  • By Working with Accreditation Directors before You Apply
  • In Deciding Whether to Check or Uncheck th
    PDF  01/13/2010

AAHRPP Advance, Fall 2009, Vol. 6, No. 4
With articles on HRPP Innovations: Quality Research IS Ethical Research at

  • The University of Colorado Denver
  • The University of Texas Health Science Center at Houston
PDF  10/01/2009

AAHRPP Advance, Summer 2009, Vol. 6, No. 3
With articles on:

  • Comment on Proposed Revised Accreditation Standards
  • Increasing Focus on COI
  • AAHRPP Seeks New Data
  • Doing The Right Thing Leads to The Smart Thing
PDF  07/06/2009

AAHRPP Advance, Spring 2009, Vol. 6, No. 2
With the upper chart on page 7 corrected
With articles on:

  • Pfizer Is First Drug Company Accredited
  • Improving the Accreditation Process
  • As Funding Increases, Put Some Aside to Earn Trust
  • Fewer Problems for the Accredited
    PDF  05/01/2009

AAHRPP Advance, Winter 2009, Vol. 6, No. 1
With articles on:

  • Maintaining Research Protections During an Economic Downturn
  • Online COI Disclosure at Cleveland Clinic
  • New OHRP Director Outlines Priorities
  • 2009 AAHRPP Conference Registration
PDF  01/14/2009

AAHRPP Advance, Fall 2008, Vol. 5, No.4
With articles on:

  • AAHRPP Accredits First Private Research Site
  • Looking Ahead: Your Input on Standards
  • Accreditation Reshapes Research Enterprise
  • Reviewing Prisoner Research at UC Irvine
PDF  11/06/2008

AAHRPP Advance, Summer 2008, Vol. 5, No. 3
With articles on:

  • Managing COI in Human Research: Organizations Call for More Progress
  • AAHRPP Standards for Financial COI
  • UAB and Children’s Hospital: Two Different, Effective Approaches to Managing COI
PDF  07/14/2008

AAHRPP Advance, Spring 2008, Vol. 5, No. 2
With articles on:

  • Quality Improvement: Research or Non-Research? AAHRPP’s Perspective
  • More than 100 Organizations Now Accredited
  • Conference Showcases Challenges, Solutions
PDF  04/15/2008

AAHRPP Advance, Winter 2008, Vol. 5, No. 1
With articles on:

  • IRBs and Behavioral and Social Science Research: Finding the Middle Ground
  • Revised Application Process for Accreditation: Site Visits Focus More on Practice
  • Accreditation Fosters Networking, Collaboration
PDF  01/14/2008

AAHRPP Advance, Fall 2007, Vol. 4, No. 3
With articles on:

  • The Role of the Organizational Official: Unparalleled Influence and Responsibility
  • AAHRPP Accreditation Results in Tangible Benefits
  • Officials Cite Improved Protections, Compliance, Respect and Other Benefits
PDF  10/22/2007

AAHRPP Advance, Summer 2007, Vol. 4, No. 2
Special Accreditation Edition,
With articles on:

  • Improving the Accreditation Process: Streamlined Approach Maintains Standards
  • Reaccreditation Starts Now
  • A Guide to the Self-Assessment
  • Preparing for Your Site Visit
PDF  06/15/2007

AAHRPP Advance, Spring 2007, Vol. 4, No. 1
With articles on:

  • Research Enterprise Feeling Positive Impact of AAHRPP, Accredited Organizations
  • BRANY: A Unique Model for Oversight, Protection
  • Trends Point to Increased Demand for Accreditation
PDF  03/06/2007

AAHRPP Advance, Winter 2006, Vol. 3, No. 4
With typographical errors corrected on page 7
With articles on:

  • Five Years of Advancing Human Protections and Ethical Research
  • UI and WIRB Set Example for Accreditation
PDF  12/11/2006

AAHRPP Advance, Fall 2006, Vol. 3, No. 3
With articles on:

  • AAHRPP Accredits First International Center
  • The Global Research Enterprise: A Growing Market Brings Growing Concerns
PDF  10/04/2006

AAHRPP Advance, Summer 2006, Vol. 3, No. 2
With articles on:

  • 2006 Conference: A Roadmap to Quality HRPPs
  • ― Ask Legal Counsel: Understanding and Making the Most of the IRB-Counsel Relationship
  • ― Regulations and Guidance: A Discussion with FDA And OHRP
PDF  07/13/2006

AAHRPP Advance, Spring 2006, Vol. 3, No. 1
With articles on:

  • AAHRPP Awarded $4.9 Million Contract to Accredit VA Facilities
  • Accreditation an Asset to Community Hospitals
PDF  07/13/2006

AAHRPP Advance, Winter 2005, Vol. 2, No. 4
With articles on:

  • AAHRPP Accreditation: Gold Standard and Standard Practice
  • AAHRPP Welcomes First Supporting Members
PDF  12/29/2005

AAHRPP Advance, Fall 2005, Vol. 2, No. 3
With articles on:

  • The Need for Accreditation in An Increasingly Complex Research Enterprise
  • Who Should Consider Accreditation?
PDF  09/21/2005

AAHRPP Advance, Summer 2005, Vol. 2, No. 2
With articles on:

  • Understanding―and Acknowledging―the Public’s Perspective
  • NHC: Serving Our Constituencies As a Founding Member
  • OHRP Thoughts on Accreditation
PDF  06/14/2005

AAHRPP Advance, Spring 2005, Vol. 2, No. 1
With articles on:

  • Strengthening the Clinical Research Enterprise:
  • Accredited Teaching Hospitals Respond
PDF  03/17/2005

AAHRPP Advance, Winter 2004, Vol. 1, No. 2
With articles on:

  • Accreditation’s Role in the Behavioral Sciences
  • Clinical Research Safety and Accreditation of Human Research Protection Programs— A View from PhRMA
PDF  12/13/2004

AAHRPP Advance, Fall 2004, Vol. 1, No. 1
With articles on:

  • Accreditation Spotlight: Cedars-Sinai Medical Center
  • American Council on Education Supports AAHRPP Accreditation
PDF  08/01/2004

Making the Business Case for Accreditation

PDF  01/15/2009

2009 Metrics on HRPP Performance

PDF  06/28/2010

AAHRPP Accreditation Procedures
Gives an overview of the procedures AAHRPP uses to provide accreditation services.

PDF  01/01/2010

AAHRPP Accreditation Standards

PDF  02/26/2010

AAHRPP Proposes Changes to Standards, Conflict-of-Interest Provisions

PDF  06/03/2009

Annual Report Form

RTF  01/04/2010

Checking or Unchecking the Boxes on the FWA, 4/22/10
Learn what checking or unchecking means to your organization.

DOC  03/24/2010

Checking or Unchecking the Boxes on the FWA, 4/29/10
Learn what checking or unchecking means to your organization.

Evaluation Instrument for Accreditation
Use to evaluate a Human Research Protection Program. Organizations should use this document to conduct a self-assessment for their Step 1 application.

PDF  02/26/2010

Finding Flexibility in the Regulations

Getting Started Registration
Learn how to conduct your self-assessment by registering for your own Getting Started Webinar.

DOC  03/15/2010

Guidance on Completing the Tables in the Application and Annual Report Forms

PDF  05/18/2009

If You Needed an Outside IRB, Could You Find One?

PDF  04/28/2009

Industry Summit
Report: Multi-Regional Clinical Trials Project

PDF  03/29/2010

Instructions to Apply for Initial Accreditation and Reaccreditation
Detailed instructions about the application process, including how to conduct a self-assessment and prepare your application package.

PDF  01/01/2010

Organizational Conflict of Interest, 6/23/10
Learn how organizations implement policies and procedures for organizational conflict of interest.

Pfizer First Pharma Company to Receive Accreditation for Study Subject Protections

PDF  04/21/2009

Pfizer Presentation at 2009 Annual Conference

Pfizer Presentation at 2009 Annual Conference

Principles of Accreditation

PDF  11/17/2005

Providing Equivalent Protections to Participants
When Conducting Research outside the U.S.

DOC  03/01/2010

Reviewing Clinical Trials: A Guide for the Ethics Committee
By Johan P.E. Karlberg, M.D., Ph.D., and Marjorie A. Speers, Ph.D.

PDF  03/29/2010

Sites Need Strict Rules on Conflict of Interest

PDF  06/11/2009

Standards Comparison
Compare the previous AAHRPP Accreditation Standards (in effect until February 28, 2010) and the AHRPP Accreditation Standards (in effect beginning March 1, 2010).

PDF  03/29/2010

Step 1 Application Form for Accreditation
Document to be completed, signed, and included with Step 1 application package when applying for initial accreditation

RTF  01/01/2010

Step 1 Application Form for Reaccreditation
Document to be completed, signed, and included with Step 1 application package when applying for reaccreditation

RTF  01/01/2010

Step 2 Application Form for Accreditation
Document to be completed, signed, and included with Step 2 application package when applying for initial accreditation.

RTF  01/01/2010

Step 2 Application Form for Reaccreditation
Document to be completed, signed, and included with Step 2 application package when apply for reaccreditation.

RTF  01/01/2010

Template for Application Section C
Use this form as a template to create the index of supporting documents (Section C) for your application.

RTF  02/26/2010

Template for Application Section F (Protocol List)
Use this spreadsheet as a template to create your protocol list (Section F) for your application.

XLS  06/01/2007

Template for IRB Rosters
Use this spreadsheet as a template to create your IRB roster (Section D) for your application.

XLS  06/01/2007

Tip Sheet: Criteria for Approval of Research

PDF  10/01/2009

Tip Sheet: Determining Whether an Activity is Research Involving Human Participants

PDF  10/01/2009

Tip Sheet: Documenting Discussions and Decisions on Research Studies

PDF  10/01/2009

Tip Sheet: Evaluating Maintenance of Confidentiality of Data in Proposed Research

PDF  10/01/2009

Tip Sheet: Evaluating Protections of Privacy Interests of Participants in Proposed Research

PDF  10/01/2009

Tip Sheet: Evaluating Provisions for Monitoring Data and Safety in Proposed Research

PDF  10/01/2009

Tip Sheet: Evaluation of IRB Chairs, Vice-Chairs, IRB Members and IRB Staff

PDF  08/06/2010

Tip Sheet: Exemptions: Criteria for Making Determinations

PDF  10/01/2009

Tip Sheet: Exemptions: Determinations and Review

PDF  10/01/2009

Tip Sheet: Financial Conflict of Interest for Researchers and Research Staff

PDF  10/01/2009

Tip Sheet: Following the Guidelines of the ICH-GCP

PDF  07/09/2010

Tip Sheet: Human Research Protection Program Plan

PDF  05/24/2007

Tip Sheet: IRB or EC Authority and Independence

PDF  10/01/2009

Tip Sheet: IRB or EC Member and Consultant Conflict of Interest

PDF  10/01/2009

Tip Sheet: Non-compliance

PDF  10/01/2009

Tip Sheet: Regulatory Requirements for Investigators Who Hold INDs or IDEs

PDF  05/24/2007

Tip Sheet: Reporting of Unanticipated Problems, Terminations, Suspensions, and Non-compliance

PDF  10/01/2009

Tip Sheet: Review of Research by the Convened IRB or EC

PDF  10/01/2009

Tip Sheet: Review of Research by the Expedited Procedure

PDF  10/01/2009

Tip Sheet: State and Local Law

PDF  05/24/2007

Tip Sheet: Sufficient Information to Determine Whether the Regulatory Criteria for Approval are Met

PDF  10/01/2009

Tip Sheet: Suspensions and Terminations of IRB or EC Approval

PDF  10/01/2009

Tip Sheet: The IRB or EC Member Roster

PDF  10/01/2009

Tip Sheet: Unanticipated Problems Involving Risks to Participants or Others

PDF  10/01/2009

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