Preventing sexual harassment is “number one on my list,” said Carrie D. Wolinetz, associate director of science policy for NIH, in an interview with Bloomberg Law about the coming year.
Gene editing and data sharing are other top issues.
The NIH Advisory Committee to the Director formed a new working group to assess how well NIH-funded organizations handle sexual harassment allegations and to recommend systemwide changes. The group plans to unveil preliminary recommendations in June and issue a final report December 2019, which is when the committee typically meets.
The committee’s recommendations are not binding, but they often drive NIH policy decisions.
It is a major initiative with long-term policy implications, Wolinetz said. “I am very excited and enthusiastic about this effort we’re launching today on changing the culture to impact sexual harassment and this climate of gender harassment,” she said.
Common in Academia
Sexual harassment is common in academic science, engineering, and medicine, with more than 40 percent of female medical students experiencing it. The National Academies of Sciences, Engineering, and Medicine called for system-wide changes in its June report.
More than 80 percent of NIH’s $39 billion budget goes to grants at research institutions, which means the agency exerts enormous influence by tying conditions to its grants. But its jurisdiction is over the institution it funds, not individual scientists.
There is a collective responsibility in the research community, Wolinetz said. “Obviously through the power of the purse, NIH is a huge driver of culture and incentives. And I think we need to be very cognizant of that. But we can’t do this alone,” she said.
NIH is working with the National Science Foundation to ensure consistency in their anti-harassment policies. That will mean universities will not have to try to comply with different federal requirements.
Gene Editing
A perennial top issue for Wolinetz, gene editing is a group of technologies that gives scientists the ability to change an organism’s DNA. The issue has been at the forefront of public conversation recently because of excitement about the possibility of gene editing to cure sickle cell disease.
But it also is the subject of controversy. He Jiankui, a scientist in China, claimed to edit the genes of embryos that resulted in the birth of twin girls—a global first decried as a major breach of research ethics.
“This was clearly a rogue scientist and a massive failure all around,” said Wolinetz, who attended the summit in Hong Kong where He presented his work. “We need to move towards a scientific consensus in a way that drives the culture of people, and a universal understanding of where those boundaries are.”
For example, she said there is widespread understanding why plagiarism is wrong. “We need to reach that place when it comes to these sorts of experiments,” she said.
It is also important that NIH clearly communicate all the potential applications of gene editing, she said.
“We don’t want concerns about germline and embryo editing to derail the really exciting science in the sort of somatic gene editing space,” she said. Germ cells are the egg and sperm cells that join to form an embryo.
The new role of the Recombinant DNA Advisory Committee (RAC) could play a critical role in that effort, she said.
The committee, which formed in the 1970s, used to scrutinize every gene therapy study. But now those studies are more common, and gene therapies like Spark Therapeutics’ Luxturna have come onto the market.
The committee’s role will evolve to examine high-level ethical issues instead of duplicating the work of local ethics boards. That revised RAC role will happen over the next year. “That will be a really good space to watch in terms of some of these conversations,” Wolinetz said.
Data Sharing
Wolinetz also expects a draft policy on data sharing to come out in 2019.
Once finalized, it would mark NIH’s first blanket requirement to have data-sharing plans, instead of on a project-by-project basis. It is part of an effort to increase transparency of taxpayer-funded work while propelling science by making it easier for other researchers to use that data.
“Arguably, everything we do is about generating data,” she said. “This has a really potential huge impact on the way we do business. But I think there’s also a lot of exciting opportunities.”
In October, the agency released a first look of what a forthcoming data-sharing policy might look like. It essentially would require anyone who gets NIH research dollars to develop a plan for sharing the results of their studies.
“We’re trying to achieve responsible data sharing in a way that ultimately facilitates the science,” she said. “You don’t want to do data sharing badly. That helps no one, and could be expensive and it could be a disaster.”
Learn more in the update on NIH sexual harassment policies and the Draft NIH Data Management and Sharing Policy.
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.