Preserving public trust : accreditation and human research participant protection programs / Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy, Institute of Medicine.

Format:

Book

Author/Creator:

Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Subjects.

Language:

English

Subjects (All):

Human experimentation in medicine--Standards--United States.

Human experimentation in medicine.

Informed consent (Medical law)--United States.

Informed consent (Medical law).

Physical Description:

1 online resource (232 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. ; [Great Britain] : National Academy Press, c2001.

Language Note:

English

Summary:

This report was produced by the Institute of Medicine's Committee on Assessing the System for Protecting Human Research Subjects. The report explores a variety of issues related to the safety and rights of the participants in clinical research, including informed consent, the right of subjects to say no and the choice to change one's mind, the ability of institutional review boards to handle the complex responsibilities given to them, and the ability to organize and monitor this "nonsystem of evolutionarily unprecedented human behavior" in order to "maximize its glorious potential and control its dark risks." The report suggests ways in which accreditation might contribute to a new level of excellence. Annotation copyrighted by Book News Inc., Portland, OR.

Contents:

Preserving Public Trust: Accreditation and Human Research Participant Protection Programs

Copyright

Preface

REVIEWERS

Acronyms

Contents

Executive Summary

ABSTRACT

THE COMMITTEE'S TASK

MAJOR FINDINGS

RECOMMENDATIONS

CONCLUDING REMARKS

1 Introduction, Background, and Definitions

ORGANIZATION OF THE REPORT

A SHORT HISTORY OF HUMAN SUBJECTS PROTECTIONS IN THE UNITED STATES

MORE RECENT EVENTS

Advisory Committee on Human Radiation Experiments

The National Bioethics Advisory Commission

Reports from DHHS Office of the Inspector General

Shutdowns of Clinical Research at Academic and VA Medical Centers

The Death of Jesse Gelsinger

A CALL FOR ACCOUNTABILITY

STATEMENT OF TASK

DEFINITIONS

Subject or Participant?

What Is a Human Research Participant Protection Program?

The Centrality of Informed Consent

The Rise of Clinical Trials and Privately Funded Research

Nonbiomedical Research

Independent IRBs

Sponsors

The Role of the Research Participant

Research Monitoring

Accreditation Versus Certification

2 Models of Accreditation

MODELS OF ACCREDITATION

ELEMENTS OF AN ACCREDITATION PROCESS

Accreditation Bodies

PRIM&amp

R and the Formation of AAHRPP

The VA and NCQA Accreditation Process

Eligibility Criteria and an Application Process

Self-Evaluation

External Evaluation

Appeals Process

Repeat Accreditation

APPLYING THE MODELS TO HUMAN RESEARCH OVERSIGHT

SOME ISSUES THAT ACCREDITATION ALONE CANNOT ADDRESS

Identifying, Investigating, and Sanctioning Violations

Educating Investigators

Improving Research Monitoring

WILL ACCREDITATION ENHANCE PERFORMANCE?

3 Standards for Accreditation

STANDARDS FOR STANDARDS

DEVELOPING MEASURES TO ACCOMPANY STANDARDS.

NEED FOR STANDARDS TO ENCOMPASS MULTIPLE RESEARCH SETTINGS AND METHODS

RELATION OF THE STANDARDS TO THE EXISTING REGULATORY REQUIREMENTS

STANDARDS FOR QUALITY IMPROVEMENT AND SELF-STUDY

NEED FOR STANDARDS TO ENHANCE THE ROLE OF RESEARCH PARTICIPANTS

NEED FOR STANDARDS REGARDING ROLES AND RESPONSIBILITIES OF RESEARCH SPONSORS

REVIEW OF AVAILABLE DRAFT STANDARDS

Scope and Focus of the Standards

R Standards

NCQA Standards

Relation to Existing Regulatory Requirements

Extent to Which the Standards Can Be Implemented, Measured, and Enforced

What Is Missing

INTERNATIONAL CONFERENCE ON HARMONISATION GUIDELINE FOR GOOD CLINICAL PRACTICE

RECOMMENDATION FOR INITIAL STANDARDS TO BEGIN PILOT TESTING

4 Evaluating HRPPP Pilot Accreditation Programs

References

Appendixes

APPENDIX A Data Sources and Methods

PRESENTATIONS AND PUBLIC COMMENT

LITERATURE REVIEW

DRAFT STANDARDS FOR ACCREDITATION

APPENDIX B PRIM&amp

R Accreditation Standards

INTRODUCTION

GOALS

PRINCIPLES UNDERLYING THE PROTECTION OF HUMANS STUDIED IN RESEARCH

GLOSSARY

PROPOSED STANDARDS

Section 1-Organizational Responsibilities

Section 2-Institutional Review Boards (IRBs)

Section 3-Investigators and Other Research Personnel

PUBLICATIONS CITED IN ACCREDITATION STANDARDS

APPENDIX C VA Human Research Protection Accreditation Program Draft Accreditation Standards

BACKGROUND

SOURCE OF STANDARDS

ORGANIZATION OF THE STANDARDS

OPERATION OF ACCREDITATION PROGRAM

PROGRAM COMPONENTS UNDER DEVELOPMENT

APPENDIX D Committee, Expert Adviser, and Staff Biographies

EXPERT ADVISERS

LIAISONS

STUDY STAFF

IOM BOARD ON HEALTH SCIENCES POLICY STAFF

CONSULTANT

Index.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references and index.

ISBN:

9786610184842

9780309171090

0309171091

9781280184840

1280184841

9780309569910

0309569915

OCLC:

51820950