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Return of Individual Research Results: A Guide for Biomedical Researchers Utilizing Human Biospecimens
Mark E Sobel1, Jennifer C Dreyfus2, Kelsey Dillehay McKillip3
1American Society for Investigative Pathology, Rockville, Maryland.
The American Journal of Pathology
|March 24, 2020
Summary
Returning individual research results from human biospecimen studies presents ethical and legal challenges. This article explores the rationale, risks, and US legal framework, offering recommendations for balancing subject interests and research integrity.
Area of Science:
- Bioethics
- Laboratory Medicine
- Genomic Research
Background:
- Returning individual research results (IRR) from human biospecimen research poses ethical and legal complexities.
- Participant interest in knowing test results conflicts with potential risks and existing medical laboratory regulations.
Purpose of the Study:
- To discuss the rationale and potential risks of returning IRR to study participants.
- To examine the US legal framework governing the testing of identifiable human biospecimens.
- To provide recommendations for investigators conducting human biospecimen research.
Main Methods:
- Literature review and legal analysis of existing US laws and regulations.
- Discussion of ethical considerations regarding participant autonomy and potential harms.
- Synthesis of findings to develop practical recommendations for researchers.
Main Results:
- The drive to return IRR is increasing, creating tension with established practices.
- Potential risks include psychological distress, misuse of information, and challenges to the research process.
- The current US legal landscape for laboratory testing is complex and may not fully address IRR from research.
Conclusions:
- A careful balance is needed between participants' right to know and the protection of individuals and research integrity.
- Investigators must proactively address ethical and legal issues when planning research involving human biospecimens.
- Recommendations focus on informed consent, risk mitigation, and compliance with evolving regulations for returning individual research results.
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