Research Ethics Roundup:, gene drives, deidentification, and more

This edition of Research Ethics Roundup covers reporting, the ethics of gene drive technology, varied responses to germline editing, and the insufficiency of deidentification in the protection of subjects in environmental research.

FDA and NIH let clinical trial sponsors keep results secret and break the law
Twenty years after the launch of—and two years after a “final rule” that purported to increase incentive for trial sponsors to report results to the database—there are still major gaps in reporting, and zero instances of NIH or FDA penalizing sponsors for failing to do so. Some critics claim that this lack of reporting represents NIH’s failure to prioritize the publication of results to the website.

“Although the 2017 rule, and officials’ statements at the time, promised aggressive enforcement and stiff penalties, neither NIH nor FDA has cracked down. FDA now says it won’t brandish its big stick—penalties of up to $12,103 a day for failing to report a trial’s results—until after the agency issues further “guidance” on how it will exercise that power. It has not set a date.”

The Gene Drive Dilemma: We Can Alter Entire Species, but Should We?
In a wide-ranging feature for the New York Times, journalist Jennifer Kahn describes how understanding, addressing, and communicating the bioethical challenges of the future will require cross-disciplinary efforts. Kahn spoke with specialists from bioethics to linguistics to screenwriting to examine gene drive technology and how it would shape the future—including, crucially, how we will collectively process that future.

“’There are big philosophical questions that have been raised at various points but never answered… Like, ‘What does a good future look like, and who gets to decide?’”

Scientists Disagree About the Ethics and Governance of Human Germline Editing
The scientific community, despite generally consistent condemnation of He Jiankui’s “CRISPR baby” experiments, is actually split in two camps on the issue, argue bioethicists Françoise Baylis and Marcy Darnovsky. On one side of the divide are those who are insistent that human germline editing be done well; on the other, those skeptical that it should be done at all.

“Truly democratic public discussion requires stepping back from the downstream and derivative question, ‘How can we proceed ethically with human germline genome editing?’ to squarely confront the logically and ethically prior question, ‘Is it socially and ethically acceptable to alter the genomes of our children and future generations?’”

Participants in environmental health studies vulnerable to re-identification
A recent study by the Silent Spring Institute analyzed a dozen recent environmental studies for five types of participant data that are relatively straightforward to re-identify. In the analysis, it was demonstrated that deidentification of data is likely insufficient for adequate protection of research subjects.

“The implications of privacy risks are not trivial. Loss of privacy could result in stigma for individuals and communities. It could affect property values, insurance, or a person’s chances of employment. It could also damage trust in research.”