children with down syndrome smiling

Many Families with Down syndrome Children Would Consider Gene Modification, but with Serious Concerns

By Marsha Michie, PhD and Megan Allyse, PhD

Scientists and bioethicists have been talking a lot recently about CRISPR/Cas9 and related technologies to alter genomes. But the voices of patients and families, especially those with genetic conditions, haven’t been nearly as audible in these conversations about so-called “gene editing”—despite calls for these voices from the National Academies and others.

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Now published: Consensus-based guidelines for the ethical oversight of Patient-Centered Outcomes Research

By Avni Gupta

Patient-Centered Outcomes Research (PCOR) is characterized by patients participating in various research roles other than merely the subjects. The Patient-Centered Outcomes Research Institute (PCORI), a major funder of PCOR research, defines patient engagement as including patients in all stages of research, “from topic selection through design and conduct of research to dissemination of results.”

However, while the concept of patient engagement in research and its potential for benefitting science are increasingly recognized by funders and investigators, IRBs’ comfort with patients in non-traditional roles in research protocols lags behind.

IRBs’ familiarity with patients in research has traditionally been with patients who are study participants or subjects, and are considered “vulnerable.” Therefore, many IRBs’ review process focuses on ensuring that adequate protective measures are in place to “protect” the patients, including measures such as a detailed written informed consent, continuing review, confidentiality measures, and so on.

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Why we need to “care” about healthcare

By Robert G. Urban

Humans often proclaim that “intelligence” is what sets our species apart – the ability to analyze, to imagine, to organize, to then cooperate and execute. A unique gift that enables us to be remarkable.

Monuments to humanity’s capability are sprinkled all across the world — early works are colossal demonstrations of ingenuity coupled to brute strength. Consider the statues of Easter Island, Rome’s colosseum, Egyptian and early American pyramids, or the Great Wall of China as examples, each demonstrating a singularly human ability (and need) to reshape our world and leave evidence of our presence.

And as time and talent has unfolded, the complexities of our contributions have advanced as well.

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‘Dignity’ and Biotechnology: Switzerland’s Sanctification of Nature

Many countries are skeptical of biotechnology. Restrictions on cloning, in vitro fertilization, surrogacy, and genetic modification in agriculture are common. But perhaps no country goes quite as far as Switzerland.

In the early 1990s, Switzerland added to its constitution by popular referendum two articles that restrict the use of biological technologies in its Confederation. Article 119 bans the traditional bugaboos of human bio-conservatives (cloning, surrogacy, human genetic intervention, etc.), and further stipulates that legislation on any new technologies must “ensure[] the protection of human dignity.” Article 120 mandates that legislation related to biological technologies in other organisms must “take into account . . . the dignity of living beings . . .” What?

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Don’t miss today’s Health Law Workshop with Zack Buck

September 24, 2018 5:00 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “The Price of Universality: Sustainable Access and the Twilight of the ACA”

Zack Buck specializes in health law, and his scholarship examines governmental enforcement of laws affecting health and health care in the United States. Most recently, his writing has sought to evaluate how the enforcement of health care fraud and abuse laws impacts American quality of care, with a particular focus on the legal regulation of overtreatment. Over the last five years, his work has been published in the California Law Review, Boston College Law Review, Ohio State Law Journal, Maryland Law Review, Florida State Law Review, and U.C. Davis Law Review, among others.

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In a Shift, Healthcare Dominates Midterm Election Campaign Ads

As the November midterm elections approach, healthcare is a top focus in campaign advertising.

According to a study by the Wesleyan Media Project, which tracks television advertisements for House and Senate races by state and topic, references to healthcare increased in August. The study found that 37 percent of all ads in August for federal races mentioned healthcare,  including references to both “ACA/health reform” and the more general “healthcare,” compared to 32 percent in the period between January 1, 2017 and July 31, 2018.

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Call for Abstracts now Open for 2019 Petrie-Flom Center Annual Conference

Breakthroughs in genetics have often raised complex ethical and legal questions. Many regard their genetic testing and sequencing as revealing something intensely personal and private. The questions raised by these technologies loom even larger as genetic testing is becoming more commonplace, affordable, and comprehensive. At the same time, advances in CRISPR and other related technologies raise anxieties about the implications of editing our own DNA. One can imagine a future when gene editing may become as widespread as genetic testing is today. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing. This conference will examine some of these issues.

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