rendering of luminous DNA with gene being removed with forceps.

Designer Babies? The Ethical and Regulatory Implications of Polygenic Embryo Screening

By Hannah Rahim

New technologies are increasing the accessibility of polygenic embryo screening, which can assess the likelihood of an embryo developing polygenic diseases (e.g., diabetes, schizophrenia) or provide insight into certain polygenic traits (e.g., height, intelligence). This procedure has many complex clinical, social, and ethical implications, but is currently unregulated in the U.S.

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Person hands keys into another person's outstretched hand.

We May Not ‘Own’ Our Bodies. Should We?

By Adithi Iyer

As the provision of human tissue leaves the research realm and becomes a bona fide consumer transaction, our legal responses to these developments will be most effective when we know what we want to protect, and how.

Perhaps the most famous discussion around tissue “donation” comes from the story of Henrietta Lacks and her family. Ms. Lacks is the namesake and unknowing donor of HeLa cells, and subject of the Rebecca Skloot bestseller, The Immortal Life of Henrietta Lacks. In a settlement obtained just this past summer with manufacturing giant ThermoFisher, the Lacks estate (Ms. Lacks herself died of an aggressive cervical cancer in 1951) obtained a confidential payment for the unconsented taking of her cells for research. The settled case was built on an unjust enrichment claim, and while this wasn’t decided on the merits, it raises the question of whether a provision of tissue is a transfer of value. If so, what are our ownership stakes in that value? Read More

Operating room Doctor or Surgeon anatomy on Advanced robotic surgery machine.

Protecting Consumer Privacy in DTC Tissue Testing

By Adithi Iyer

In my last piece, I discussed the hypothetical successor of 23andme — a tissue-based direct-to-consumer testing service I’ve called yourtissueandyou — and the promise and perils that it might bring in consumer health information and privacy. Now, as promised, a closer look at the “who” and “how” of protecting the consumer at the heart of direct-to-consumer precision medicine. While several potential consumer interests are at stake with these services, at top of mind is data privacy — especially when the data is medically relevant and incredibly difficult to truly de-anonymize.

As we’ve established, the data collected by a tissue-based service will be vaster and more varied than we’ve seen before, magnifying existing issues with traditional data privacy. Consumer protections for this type of information are, in a word, complicated. A singular “authority” for data privacy does not exist in the United States, instead being spread among individual state data privacy statutes and regulatory backstops (with overlapping sections of some federal statutes in the background). In the context of health, let alone highly sophisticated cell signaling and microenvironment data, the web gets even more tangled.

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sample tube in female hands with pipette.

Why We Should Care About the Move from Saliva to Living Cells in Precision Medicine

By Adithi Iyer

The cultural, informational, and medical phenomenon that is 23andMe has placed a spotlight on precision medicine, which seeks to personalize medical care to each patient’s unique makeup. Thus far, advances in direct-to-consumer genetic testing have made saliva-sample sequencing services all the rage in this space, but regenerative medicine, which relies on cells and tissues, rather than saliva, now brings us to a new, increasingly complex inflection point.

While collecting and isolating DNA samples from saliva may offer a wealth of information regarding heredity, disease risk, and other outflows of the “instruction manual” for patients, analyzing cells captures the minutiae of patients that goes “beyond the book” and most closely informs pathology. Disease isn’t always “written in the stars” for patients. Epigenetic changes from environmental exposures, cell-to-cell signaling behaviors, and the mutations present in diseased cells all profoundly inform how cells behave in whether and how they code the instructions that DNA offers. These factors are critical to understanding how disease materializes, progresses, and ultimately responds to treatment. This information is highly personal to each patient, and reflects behavioral factors as well as genetics.

Regenerative medical technologies use cell- and tissue-based methods to recapitulate, bioengineer, and reprogram human tissue, making a whole suite of sci-fi-sounding technologies an ever-closer reality. With cell-based and other regenerative therapies entering the market (making up an entire FDA subgroup), it well worth considering how cell-based medicine can advance the world of personalized consumer testing. In other words, could a corporate, direct-to-consumer cell-based testing service be the next 23andMe? And what would that mean for patients?

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DNA helix on colored background.

State Genetic Privacy Statutes: Good Intentions, Unintended Consequences?

By Christi Guerrini, David Gurney, Steve Kramer, CeCe Moore, Margaret Press, and Amy McGuire

State legislators have enacted a flurry of genetic privacy bills that will strengthen the privacy and security practices of direct-to-consumer genetic testing companies and give customers more control over their data. What they might not realize is that these bills could be interpreted in ways that limit law enforcement’s ability to use a new technique that helps identify violent criminals and human remains and exonerate the wrongfully convicted.

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Photo of Susannah Baruch in front of book shelves.

Meet Susannah Baruch: Q&A with the Petrie-Flom Center’s New Executive Director

On June 20th, the Petrie-Flom Center welcomed Susannah Baruch on board as its new Executive Director.

Susannah comes to the Petrie-Flom Center with expertise in reproductive health law policy, genetics, and genomics, and a wealth of experience in nonprofits, academia, and government. We asked Susannah to share a bit about herself and her past work by way of introduction to Bill of Health’s readers.

The following interview has been edited and condensed.

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Society or population, social diversity. Flat cartoon vector illustration.

European Skew in Genetic Research Databases Won’t Abate Without More Concerted Effort

By Robert I. Field, Anthony W. Orlando and Arnold J. Rosoff

The “pangenome” project that is mapping the genetic sequences of 47 diverse human beings from around the world is a much-needed step forward for science and humanity. The lack of racial diversity in genetic databases used in research has been noted for some time, and it has raised growing concerns about the development of clinical applications based on research results. The pangenome does not eliminate these concerns, but it calls greater attention to the significant racial underrepresentation that remains in most databases currently used in research.

For genomic medicine to have widespread effectiveness, it is important that it be based on the study of a diverse pool of subjects. This is especially true in the development of “precision medicine,” in which therapies are tailored to a patient’s genetic characteristics. If a patient’s genetic traits are not represented in a database that was used for the research that led to a treatment, that treatment may be less effective or even risky for them.

Black Americans, as well as members of other racial and ethnic minorities, are most commonly underrepresented in medical research, yet they are the ones most vulnerable to the effects of such underrepresentation. This can create yet another instance of racial disadvantage in health care. However, a recent study of genetic researchers found that investigators tend to give only limited consideration to demographic diversity when selecting a database to use, with more attention paid to ease of access and other logistical considerations.

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rendering of luminous DNA with gene being removed with forceps.

Bioethics Experts vs Ordinary South Africans on the Governance of Human Genome Editing

By Donrich Thaldar

On the issue of human genome editing (HGE), attitudes between bioethics scholars and the general public diverge, as highlighted by my team’s findings from a recent deliberative public engagement study.

In the study, which assessed views on heritable HGE among South Africans, participants adopted a pragmatic risk-benefit approach to specific applications of heritable HGE. This rational pragmatism of the study participants was informed by values such as improving quality of life, equality and (universal) access to healthcare, moral autonomy, and innovation. By contrast, we might characterize bioethics experts as raising principled objections to heritable HGE as a technology, such as Jürgen Habermas’s articulation of the “right” of the prospective child to an “unaltered genome.” (Not one study participant relied on this objection during the more than 20 hours of deliberations.)

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Child holding paper family in LGBT rainbow colors.

Gamete Regulation and Family Protection in a Post-Dobbs World

By Courtney G. Joslin

Increasing numbers of people are forming families through assisted reproduction. Recently, there has been a push to impose new regulations on various aspects of this process. Some of these new laws open up participants to a range of possible penalties — civil, criminal, and/or professional discipline — for past “misconduct.” Other laws seek proactively to regulate the fertility care process. For example, some laws regulate the collection and dissemination of medical and identifying information about gamete providers — that is, sperm and egg donors. Other proposals seek to require gamete providers to agree to the release of their medical records.

It is surely important to assess and evaluate fertility care practices and to consider whether additional regulation is appropriate in this space. Particularly in the post-Dobbs era — an era marked by increasing attacks on reproductive health care (including access to IVF) and on LGBTQ people — it is also important to proceed cautiously and to consider how these proposals may adversely impact reproductive autonomy and family recognition.

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