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—such as results with unknown validity—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—investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants—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.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• COMMITTEE ON THE RETURN OF INDIVIDUAL-SPECIFIC RESEARCH RESULTS GENERATED IN RESEARCH LABORATORIES
• Reviewers
• Preface
• Acknowledgments
• Acronyms and Abbreviations
• Abstract
• Summary
  • SCOPE AND KEY TERMINOLOGY
  • BENEFITS AND RISKS OF RETURNING INDIVIDUAL RESEARCH RESULTS
  • GUIDING PRINCIPLES FOR RETURNING INDIVIDUAL RESEARCH RESULTS
  • QUALITY MANAGMEMENT SYSTEMS FOR LABORATORIES TESTING HUMAN BIOSPECIMENS
  • A DECISION-MAKING FRAMEWORK FOR THE RETURN OF INDIVIDUAL RESEARCH RESULTS
  • PLANNING FOR THE RETURN OF INDIVIDUAL RESEARCH RESULTS
  • EFFECTIVELY COMMUNICATING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS
  • RESHAPING THE REGULATORY ENVIRONMENT
  • FINAL THOUGHTS
• 1. Introduction
  • STUDY SCOPE AND KEY TERMINOLOGY
  • STUDY CONTEXT
  • STUDY APPROACH
  • ORGANIZATION OF THE REPORT
• 2. Principles for the Return of Individual Research Results: Ethical and Societal Considerations
  • ETHICAL CONSIDERATIONS FOR THE RETURN OF INDIVIDUAL RESULTS IN HUMAN PARTICIPANT RESEARCH
  • SOCIETAL CONSIDERATIONS FOR THE RETURN OF INDIVIDUAL RESULTS IN HUMAN PARTICIPANT RESEARCH
  • RECOMMENDATION AND GUIDING PRINCIPLES FOR THE RETURN OF INDIVIDUAL RESEARCH RESULTS
  • REFERENCES
• 3. Laboratory Quality Systems for Research Testing of Human Biospecimens
  • THE SPECTRUM OF TRANSLATIONAL RESEARCH
  • THE IMPORTANCE OF ANALYTIC AND CLINICAL VALIDITY OF RESEARCH RESULTS
  • LABORATORY QUALITY SYSTEMS TO INCREASE CONFIDENCE IN THE VALIDITY OF RESEARCH RESULTS
  • ADDRESSING RESOURCE AND INFRASTRUCTURE NEEDS IN RESEARCH LABORATORIES TO ENABLE RETURN OF HIGH-QUALITY INDIVIDUAL RESEARCH RESULTS
  • REFERENCES
• 4. Processes to Enable Appropriate Decision Making Regarding the Return of Individual Research Results
  • DIMENSIONS TO CONSIDER IN DECISIONS ON RETURNING INDIVIDUAL RESEARCH RESULTS
  • A DECISION-MAKING FRAMEWORK FOR THE RETURN OF INDIVIDUAL RESEARCH RESULTS
  • PLANNING FOR THE RETURN OF INDIVIDUAL RESEARCH RESULTS
  • CONCLUSION
  • REFERENCES
• 5. Advancing Practices for Returning Individual Research Results
  • OPPORTUNITIES TO IMPROVE THE RETURN OF RESEARCH RESULTS: LEARNING FROM CURRENT PRACTICES
  • SETTING PARTICIPANT EXPECTATIONS IN THE CONSENT PROCESS AND BEYOND
  • EFFECTIVELY COMMUNICATING INDIVIDUAL RESEARCH RESULTS TO PARTICIPANTS
  • DEVELOPING A LEARNING PROCESS TO IMPROVE THE RETURN OF RESEARCH RESULTS
  • REFERENCES
• 6. Reshaping the Legal and Regulatory Landscape to Support Return of Individual Research Results
  • LEGAL AND REGULATORY PROTECTIONS IN RELATION TO THE BENEFITS AND RISKS OF RETURNING INDIVIDUAL RESEARCH RESULTS
  • CREATING A REGULATORY ENVIRONMENT BETTER ALIGNED WITH THE BENEFITS AND RISKS OF THE RETURN OF INDIVIDUAL RESEARCH RESULTS
  • FINAL THOUGHTS
  • REFERENCES
• APPENDIXES
  • A. Study Approach and Methods
  • B. Public Agendas
  • C. Analysis of Legal and Regulatory Landscape Relevant to Return of Individual Results Generated from Biospecimens in Research
  • D. The Return of Individual-Specific Research Results from Laboratories: Perspectives and Ethical Underpinnings
  • E. Biographical Sketches of Committee Members, Consultants, and Staff

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2018. Returning individual research results to participants: Guidance for a new research paradigm. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25094.