We conduct research on confidentiality risks and harms in large-scale genomic, translational, and other biomedical research; the scope and limits of applicable protections, including Certificates of Confidentiality; and how these are and should be described to prospective participants.
Funding for this research was provided by the National Human Genome Research Institute.
Confidentiality Risks and Protections in Precision Medicine Research
What are the risks in precision medicine research?
- Beskow LM, Hammack CM, Brelsford KM, McKenna KC. Thought leader perspectives on risks in precision medicine research. In: IG Cohen, HF Lynch, E Vayena, Gasser U (eds), Big Data, Health Law, and Bioethics. Cambridge, UK: Cambridge University Press (2018)
What are the potential benefits and harms in precision medicine research?
- Beskow LM, Hammack CM, Brelsford KM. Thought leader perspectives on benefits and harms in precision medicine research. PLoS One (2018)
What are the strengths and limitations of confidentiality protections available for precision medicine research?
- Hammack CM, Brelsford KM, Beskow LM. Thought leader perspectives on participant protections in precision medicine research. Journal of Law, Medicine & Ethics (2019)
- Wolf LE, Brown ECF, Kerr R, et al. The web of legal protections for participants in genomic research. Health Matrix: Journal of Law-Medicine (2019)
- Wolf, LE. Risks and legal protections in the world of big-data. Asia Pacific Journal of Health Law & Ethics (2018)
- Wolf LE, Hammack-Aviran CM, Brown EF, Brelsford KM, Beskow LM. Protecting participants in genomic research: understanding the “web of protections” afforded by federal and state law. Journal of Law, Medicine & Ethics (2020)
What consent language captures this precision medicine research landscape and helps people think about their own values relative to participation?
Beskow LM, Hammack-Aviran CM, Brelsford KM. Developing model biobanking consent language: what matters to prospective participants? BMC Medical Research Methodology (2020)
Certificates of Confidentiality
How do IRBs and institutional legal counsel view and use Certificates?
- Beskow LM, Check DK, Namey EE, et al. Institutional review boards’ use and understanding of Certificates of Confidentiality. PLoS One (2012)
- Wolf LE, Dame LA, Patel M, et al. Certificates of Confidentiality: Legal counsels’ experiences with and perspectives on legal demands for research data. Journal of Empirical Research on Human Research Ethics (2012)
What do legislation, regulations, and case law tell us about Certificates’ effectiveness?
- For lawyers: Wolf LE, Patel MJ, Williams BA, et al. Certificates of Confidentiality: Protecting human subject research data in law and practice. Minnesota Journal of Law, Science & Technology (2013)
- For non-lawyers: Wolf LE, Patel MJ, Williams BA, et al. Certificates of Confidentiality: Protecting human subject research data in law and practice. Journal of Law, Medicine & Ethics (2015)
How should Certificates be described in informed consent forms and processes?
- Check DK, Wolf LE, Dame LA, Beskow LM. Certificates of confidentiality and informed consent: perspectives of IRB chairs and institutional legal counsel. IRB: Ethics & Human Research (2014)
- Beskow LM, Check DK, Ammarell N. Research participants’ understanding of and reactions to Certificates of Confidentiality. AJOB Empirical Bioethics (2014)
Foundational Publications on Certificates of Confidentiality
- Beskow LM, Dame L, Costello EJ. Certificates of Confidentiality and compelled disclosure of data. Science (2008)
- Williams BA, Wolf LE. Biobanking, consent, and Certificates of Confidentiality: Does the ANPRM muddy the water? Journal of Law, Medicine & Ethics (2013)
- Wolf LE, Beskow LM. New and improved? 21st Century Cures Act revisions to Certificates of Confidentiality. American Journal of Law & Medicine (2018)
- Wolf LE, Beskow LM. Genomic databases, subpoenas, and Certificates of Confidentiality. Genetics in Medicine. (2019)
Download Confidentiality Consent Materials
Simplified Consent Language Describing Certificates of Confidentiality
Model Consent Language For Precision Medicine Research
We are currently collaborating with Drs. Ellen Clayton and Brad Malin on privacy and identifiability issues in ancestry and kinship testing
- Visit the GetPreCiSe web site