Protecting Participants and Facilitating Social and Behavioral Sciences Research 1st Edition by Surveys, Social Science Research Panel on Institutional Review Boards, National Research Council ISBN 9780309511360 0309511364

Protecting Participants and Facilitating Social and Behavioral Sciences Research 1st Edition by  Surveys, and Social Science Research Panel on Institutional Review Boards, National Research Council  – Ebook PDF Instant Download/Delivery:  9780309511360, 0309511364
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Product details: 

ISBN 10:   0309511364

ISBN 13: 9780309511360

Author:  Surveys, and Social Science Research Panel on Institutional Review Boards, National Research Council

Institutional review boards (IRBs) are the linchpins of the protection systems that govern human participation in research. In recent years, high-profile cases have focused attention on the weaknesses of the procedures for protecting participants in medical research. The issues surrounding participants protection in the social, behavioral, and economic sciences may be less visible to the public eye, but they are no less important in ensuring ethical and responsible research.

This report examines three key issues related to human participation in social, behavioral, and economic sciences research: (1) obtaining informed, voluntary consent from prospective participants: (2) guaranteeing the confidentiality of information collected from participants, which is a particularly challenging problem in social sciences research; and (3) using appropriate review procedures for “minimal-risk” research.

Protecting Participants and Facilitating Social and Behavioral Sciences Research will be important to policy makers, research administrators, research sponsors, IRB members, and investigators. More generally, it contains important information for all who want to ensure the best protection—for participants and researchers alike—in the social, behavioral, and economic sciences.

Table of contents: 

1 Introduction

The Issues

Panel Charge and Scope

Activities

Organization of Report

2 Basic Concepts

Principles and Practices for Ethical Research

Harms, Risks, and Benefits

Minimal Risk

Role of IRBS

SBES Research

Conclusion

3 Regulatory History

From 1945 to 1966 From 1966 to 1974 From 1974 to 1981 From 1981 to 1991 Developments Since 1991

Conclusion

4 Enhancing Informed Consent

IRB Focus on Informed Consent Research to Improve Consent Procedures

Informed Consent for Special Populations

Third-Party Consent

Waiving Written Consent

Omitting Elements of Informed Consent

Conclusion

5 Enhancing Confidentiality Protection

History of Confidentiality Protection in the Participant

Protection System

Confidentiality Protection in the Federal Statistical System

Protecting Confidentiality Today

The Role of Researchers, IRBs, OHRP, and Funding Agencies in Protecting Confidentiality

A Confidentiality Protection System for Public-Use Microdata

Concluding Note: Minimal Disclosure Risk is Not Zero Risk

6 Enhancing the Effectiveness of Review: Minimal-Risk Research

Guidance on the Review Process

Guidance for Initial Review

Continuing Review

Documenting Risks and Harms

Ongoing Data System

In-Depth Studies

7 System Issues

Guidance and Support for IRBS

Qualifications and Performance Standards

Communication Among IRBs and Researchers

Organization of and Among IRBs

Developing National Policy for Human Research Participant Protection

Continuing System Evolution

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Tags: Surveys, Social Science Research Panel on Institutional Review Boards, National Research Council, Protecting Participants, Facilitating Social