Trial by Fire: CRISPR takes the next step

CRISPR-Cas9 has drawn applause for being one of the biggest technological advancements in recent history, but it also raises important ethical issues. This technology, an efficient genome editing tool, is now taking its next big step: CRISPR might be going in for human trials for its potential use in fighting cancer (namely, by altering T-cells to treat cancer cells as “foreign bodies”). Trials have been proposed to be conducted at three sites over a period of two years. The Recombinant DNA Advisory Committee (RAC) at the NIH gave its unanimous approval for these trials earlier this week. Now permissions from FDA and Institutional Review Boards remain before this becomes a reality.

Whether or not the studies will get that approval is uncertain. The RAC already expressed concerns about conflict of interest, and the ghosts of the trial involving Jesse Gelsinger 17 years ago at UPenn have resurfaced.  There are also important questions about risks, uncertainty, and informed consent from the research participants.

The scientific community and regulators have been wary of the gravity of the implications of genome editing. When a Chinese study involving gene editing in human embryos was submitted for publication, there was a hue and cry over whether journals should accept it, given ethical concerns. Currently, there is a moratorium on altering DNA that will subsequently pass on to new generations. Even when the CRISPR technology was approved for editing human embryos in the UK, it was mandated that embryos be destroyed within fourteen days.

Some argue that overly cautious regulatory approaches will slow down the progress in genome editing. Indeed, Steven Pinker went so far as to call on bioethicists to “get out of the way” of progress, given that even after two decades of Dolly the Sheep, we haven’t yet created a “Brave New World” or “designer babies”.  Indeed, there is no doubt that CRISPR has a huge potential to revolutionize healthcare by eliminating genetic diseases.

However, it will be essential to make sure that regulatory approaches balance progress with protection. For developing countries, in particular, regulatory capacity may be a concern, especially if trials are eventually to be conducted there.  Thus, it is time to start thinking through key research ethics questions, including whether the benefits of research will be appropriately shared with research populations themselves, where trials are most appropriately conducted, and the like.   As the first trials get off the ground, we have a lot of work to do.

This entry was posted in Bioethics, Biotechnology, Clinical Research, FDA, Genetics, Human Subjects Research by kellydhru. Bookmark the permalink.

About kellydhru

Kelly is an incoming LLM student at the Harvard Law School, and a 2016-17 Fulbright-Nehru Master’s Fellow in Public Health Law and Bioethics from India. Previously, Kelly has completed her BCL (Distinction) and MPhil in Law from University College, University of Oxford. Kelly holds a law degree from Gujarat National Law University, and has been the Research Director at Research Foundation for Governance in India, where she has been involved in drafting laws relating to public health, bioethics and human rights.