Certificates of Confidentiality and Mandatory Reporting.

This Viewpoint discusses the importance of obtaining federal certificates of confidentiality to free researchers to perform important research into child sexual abuse.

Certificates of confidentiality: privileging research data.

With the Supreme Court's decision in Dobbs, reproductive research now joins other sensitive research topics that present legal risks to research participants, underscoring the role of Certificates in protecting them. Yet, stakeholders question whether Certificates will hold up in court. In this article, we describe the essential arguments supporting Congress's regulation of biomedical research and, thus, Certificates, under its authority to regulate interstate commerce. Our analysis should reassure researchers and Institutional review boards who rely on Certificates to protect the confidentiality of research participants' data. We conclude with recommendations for stakeholders based on our analysis.

Get law enforcement out of biospecimen authentication.

Use of D NA markers in research that are used in law enforcement risks undermining public trust and participation.

FAMILIAL SEARCHES, THE FOURTH AMENDMENT, AND GENOMIC CONTROL.

In recent years, police have increasingly made use of consumer genomic databases to solve a variety of crimes, from long-cold serial killings to assaults. They do so frequently without judicial oversight per the Fourth Amendment's warrant requirement by using consumer genomic platforms, which store hundreds of thousands or millions of user genomic profiles and enable law enforcement to infer the identity of distant genomic relatives who may be criminal suspects. This Essay puts this practice into context given recent legal and technological developments. As for the law, the Supreme Court in United States v. Carpenter has suggested that technologically driven and expansive datasets may be entitled to the full suite of Fourth Amendment protections. As for technology, we describe here the development of a novel technology that allows users to engage in genomic analysis in a secured environment without making such information available to a third party. Taken together, we present a possible technological solution to ensuring Fourth Amendment protections for direct-to-consumer genomic data.

Regulating forensic genetic genealogy.

Maryland 's new law provides a model for others.

Legal and ethical implications of wastewater monitoring of SARS-CoV-2 for COVID-19 surveillance.

Scientists have observed that molecular markers for COVID-19 can be detected in wastewater of infected communities both during an outbreak and, in some cases, before the first case is confirmed. The Centers for Disease Control and Prevention and other government entities are considering whether to add community surveillance through wastewater monitoring to assist in tracking disease prevalence and guiding public health responses to the COVID-19 pandemic. This scientific breakthrough may lead to many useful potential applications for tracking disease, intensifying testing, initiating social distancing or quarantines, and even lifting restrictions once a cessation of infection is detected and confirmed. Yet, new technologies developed in response to a public health crisis may raise difficult legal and ethical questions about how such technologies may impact both the public health and civil liberties of the population. This paper describes recent scientific evidence regarding COVID-19 detection in wastewater, identifying public health benefits that may result from this breakthrough, as well as the limitations of existing data. The paper then assesses the legal and ethical implications of implementing policy based on positive sewage signals. It concludes that the first step to implementing legal and ethical wastewater monitoring is to develop scientific understanding. Even if reliability and efficacy are established, limits on sample and data collection, use, and sharing must also be considered to prevent undermining privacy and autonomy in order to implement these public health strategies consistent with legal and ethical considerations.

Mass surveillance in the age of COVID-19.

Epidemiological surveillance programs such as digital contact tracing have been touted as a silver bullet that will free the American public from the strictures of social distancing, enabling a return to school, work, and socializing. This Article assesses whether and under what circumstances the United States ought to embrace such programs. Part I analyzes the constitutionality of programs like digital contact tracing, arguing that the Fourth Amendment's protection against unreasonable searches and seizures may well regulate the use of location data for epidemiological purposes, but that the legislative and executive branches have significant latitude to develop these programs within the broad constraints of the ``special needs'' doctrine elaborated by the courts in parallel circumstances. Part II cautions that the absence of a firm warrant requirement for digital contact tracing should not serve as a green light for unregulated and mass digital location tracking. In light of substantial risks to privacy, policy makers must ask hard questions about efficacy and the comparative advantages of location tracking versus more traditional means of controlling epidemic contagions, take seriously threats to privacy, tailor programs parsimoniously, establish clear metrics for determining success, and set clear plans for decommissioning surveillance programs.

Eligibility of cryopreserved human embryos for stem cell research in Canada.

OBJECTIVE: To determine whether cryopreserved embryos in Canadian in vitro fertilization (IVF) clinics available (in theory) for research use are actually eligible (in practice) for stem cell research in accordance with the Assisted Human Reproduction Act, the Canadian Institutes of Health Research's Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research, and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. METHODS: Copies of current and past patient information sheets and consent forms for embryo cryopreservation, the future disposition of cryopreserved embryos, and the donation of cryopreserved embryos for research were requested from Canadian IVF clinics. Fourteen of 24 clinics (response rate 58%) provided one or more of the requested documents. RESULTS: A review of the documents currently in use showed that, as of May 2005, all 14 responding clinics require an advance directive for the eventual disposition of cryopreserved embryos. Ten of these 14 clinics allow the donation of cryopreserved embryos for research. Only three of these 10 clinics, however, satisfy in writing the disclosure requirements for embryo research at the time of initial consent for the cryopreservation and future disposition of embryos. Only one clinic specifically identifies the option of embryonic stem cell research. CONCLUSION: Only three of the responding Canadian IVF clinics provide written details about future donation of cryopreserved embryos for research use and about the need for re-contact in accordance with relevant legislation and guidelines. Two of these three clinics, however, include disposition options that may not be legally available. In the event of death or loss of contact, it will not be possible to get project-specific research consent from the legitimate embryo providers as required by law. These same two clinics also fail to mention embryonic stem cell research as one of the research categories. It follows that we have identified only one Canadian IVF clinic with cryopreserved embryos unequivocally eligible for stem cell research, provided the forms we reviewed were used to obtain consent for the cryopreservation of those embryos.

Cryopreserved human embryos in Canada and their availability for research.

OBJECTIVE: To determine the number of cryopreserved human embryos at all Canadian in vitro fertilization (IVF) clinics, the number of these embryos that have been donated to research, and the consent processes regarding the disposition of embryos no longer required for reproductive purposes. METHODS: A questionnaire was mailed to 24 fertility clinics identified as conducting IVF and cryopreservation, inviting completion of the questionnaire by telephone. Thirteen clinics (response rate 54%) completed the survey. RESULTS: As of August 2003, all 13 clinics cryopreserve embryos not required for intrauterine transfer; in total, 15,615 embryos are currently in storage in these clinics. Nine clinics specifically offer patients the option of donating embryos to research; in total, 299 embryos have been allocated for research, about 2% of all embryos stored by these 13 clinics. All 9 clinics routinely seek consent for research use of embryos, with 7 clinics currently using such embryos for research to improve clinic practices. CONCLUSION: The results highlight the difficulties of gathering accurate data on assisted human reproduction and related research in a context where there is no legislation governing these practices. Nonetheless, the data suggest there are very few cryopreserved embryos in Canada available for research and that even fewer of these may be potentially eligible for research due to incomplete or inadequate consent processes.