When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research results"e;such as results with unknown validity"e;and the associated burdens on the research enterprise are competing considerations.Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholders"e;investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants"e;and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
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Table of contents
- COVER PAGE
- TITLE PAGE
- COPYRIGHT PAGE
- TABLE OF CONTENTS
- ACRONYMS AND ABBREVIATIONS
- ABSTRACT
- SUMMARY
- 1 INTRODUCTION
- 2 PRINCIPLES FOR THE RETURN OF INDIVIDUAL RESEARCH RESULTS: ETHICAL AND SOCIETAL CONSIDERATIONS
- 3 LABORATORY QUALITY SYSTEMS FOR RESEARCH TESTING OF HUMAN BIOSPECIMENS
- 4 PROCESSES TO ENABLE APPROPRIATE DECISION MAKING REGARDING THE RETURN OF INDIVIDUAL RESEARCH RESULTS
- 5 ADVANCING PRACTICES FOR RETURNING INDIVIDUAL RESEARCH RESULTS
- 6 RESHAPING THE LEGAL AND REGULATORY LANDSCAPE TO SUPPORT RETURN OF INDIVIDUAL RESEARCH RESULTS
- APPENDIXES
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