Image of binary and dna

Assessing genetic relationships between academia and industry

By Kayte Spector-Bagdady JD, MBioethics
Department of Obstetrics & Gynecology; Research Ethics Service, Center for Bioethics & Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, MI

With recent reports of Google’s data deals with Ascension health and the University of Chicago, there has been a lot of attention paid recently to the sharing and use of health data by unexpected entities.

But we know that patients are uncomfortable when hospitals “commercialize” or sell their health data or biospecimens to industry. In fact, the recent revisions to the human subjects research regulations included a specific biospecimen commercialization disclosure requirement.

Read More

close up of DNA fingerprints

DNA databases, cracking crimes, and confidentiality

By: Leslie E. Wolf, JD, MPH, Georgia State University College of Law, Interim Dean and Distinguished University Professor and Laura M. Beskow, MPH, PhD, Ann Geddes Stahlman Chair in Medical Ethics, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center

In our article, Genomic databases, subpoenas, and Certificates of Confidentiality, published in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), we considered the protections available to research genomic databases in light of law enforcement’s use of ancestry databases to help solve crimes.

Read More

Scientist analyzes DNA gel used in genetics, forensics, drug discovery, biology and medicine

Time to Ban Heritable Genome Editing

By Jeffrey R. Botkin, MD, MPH, Professor of Pediatrics and Medical Ethics at University of Utah

We are at a critical crossroad in reproductive medicine.  How should science and society more broadly manage the powerful new technologies that can alter the genes of human embryos?  In a recent paper published in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), I argue that banning the use of this technology editing human embryo is the right direction.

Concerns over theoretical capabilities of “designer babies” have been with us for generations.  The ability screen and test for embryos and fetuses with undesirable characteristics and forestall their birth is well-developed and familiar. But the actual ability to add, subtract or alter genes in the embryo is quite new.  The CRISPR-Cas9 technology and related technologies burst on the scene in the last decade and the ability to relatively easily and cheaply to alter human embryos is no longer science fiction.

Read More

Considering stakeholders in policy around secondary findings in genomics

By Michael Mackley

It took nearly thirteen years and an army of scientists to generate the first sequence of the human genome. Now, patients around the world are having their genomes sequenced every day. Since the first sequence was unveiled in 2003, the cost of whole-genome sequencing (WGS) has dropped from almost $1 billion to less than $1,000—allowing WGS to enter routine clinical care, potentially transforming the way we diagnose and treat disease. Large national initiatives to read individuals’ genomes are helping to drive this transition; the UK’s NHS England is currently sequencing 100,000 genomes, and the USA has plans to sequence 1 million genomes in the near future. A 2015 study predicts that up to 2 billion people worldwide could have their genomes sequenced within the next decade—comparable to the current reach of the Internet. With so many genomes to be sequenced, it is imperative that laws and policy ensure that individuals, and society, are protected from harm. While larger pieces of legislation—such as those protecting against discrimination—are needed internationally, guidance and policies around routine management are also required.

One area of particular concern is that of ‘secondary’ (or ‘incidental’) findings. While WGS provides a valuable opportunity to learn about genetic contributions to disease (‘primary’ findings), it can also reveal genetic information that may not be relevant to the health condition affecting the patient or their family. This includes genetic changes associated with other health conditions—ranging from medically actionable findings, such as genetic predispositions to breast cancer where treatment is available, to non-actionable findings, such as genetic changes associated with an increased risk of Alzheimer’s. The American College of Medical Genetics and Genomics published recommendations suggesting a moral obligation to seek and return actionable secondary findings, fueling significant debate (1,2). Medical Genetics organizations from other countries (including Canada and Europe) have published more conservative guidelines restricting generation of secondary findings, at least until more evidence is available to support (or refute) clinical utility and assess wider impacts. Read More