Tag: Biosafety

Next week marks the one-year anniversary of NIH shifting to maximum telework in response to the COVID-19 pandemic. Like employers and employees across the country, overnight we needed to adapt our entire enterprise and reinvent our jobs in the virtual workplace. Coincidentally, next week is also when with a deep breath and a big hug, I send my six year old back to school in person, masked up and excited to meet his 1^st grade teacher in person for the first time. So it seems like a good time to reflect on what the past year has been like, juggling the demands of serving in the leadership of a government agency square in the middle of COVID response with the needs of two young children during this nationwide experiment in virtual schooling.

Over the past year, I have gotten expert at the hand-over-the-mouth side conversations with my kids while muted on videoconference. There are good days and there are bad days. Like when my already prone-to-anxiety fifth grader gets hysterical because there are technology glitches and is panicked he’s missed something. Or when my first grader breaks down into tears because he’s had to sit in front of a computer for hours and is confused by something being asked of him. Inevitably, these moments occur when I’m in the middle of a critical meeting. I’ve accidentally come off mute while in the middle of alternately yelling at and bribing my children to behave so I can just pay attention to this conversation. I long for five minutes to just pay sole attention to the work I am doing and not have to think about snack time or lunch options or whether trombone is starting to whether a Chromebook is charged. I struggle to feel smart and competent as either a mother or as a professional when the unrelenting demands of one are constantly competing with the other.

Much to the entertainment of my colleagues, I have found my six year old does best when I am working nearby, which means he is constantly in the background of my WebEx or Zoom – fidgeting, coloring, doing jumping jacks – as I try to provide intelligent advice on agency policy with a song about counting frogs in one ear. I have been caught frozen in moments of indecision, as my children come running up in hysterical tears for help with one thing or another, but I have an upcoming item on the agenda to speak to. And that’s the curated account – not delving into the darker moments when I break down in tears or lose my temper because I reached the limits of my emotional wherewithal and snap at my kids in a voice I barely recognize as my own. Or those days when I have trouble caring about what’s going on at work or just turn my children over to electronic devices for a moment of peace. I worry all the time that having my children continually visible in my workspace, demonstrating my constant state of distraction, will cause my (primarily older and male) colleagues to take me less seriously.

The media has offered extensive coverage of how truly difficult this balancing act has been, the disproportionate effect it is having on women or individuals whose jobs do not support telework, such as healthcare workers or front-line service providers, and the agonizing choice faced by many parents struggling with impossible dilemmas of keeping themselves or their loved ones safe from a deadly disease while trying to do what’s best for their child’s well-being and education. The wrench the pandemic has thrown into the everyday tension of work-life balance just doesn’t affect women, of course. In my own household, my husband has taken on more childcare responsibilities than ever, as the pandemic has increased my workload, and a recent Pew study seems to indicate this is happening all over the country¹. But evidence has long shown that women bear a disproportionate burden of household and dependent care responsibilities², and the early data on the negative impact of the pandemic on the productivity of women in science is truly alarming³. There is recognition across the biomedical enterprise that the long-term impact of the pandemic could entail a devastating setback for women and others with dependent care responsibilities, and there are a lot of discussions of strategies to minimize that risk.

In a world currently experiencing staggering loss of life and economic misfortune due to COVID-19, my challenges pale by comparison. My family has been able to stay safe, we are healthy, we are employed… and yet still it is a struggle. Even as it feels like hope is on the horizon, in the form of vaccine and falling hospitalization rates and opening of schools, we must recognize not just the toll the past year has taken on working women and parents, but also not lose sight of the bright light the pandemic has cast on this balancing act. The challenge of balancing work and caregiving doesn’t go away just because it isn’t visible on Zoom. We need to create an environment that feels safe for caregivers, particularly women, to talk about their real-world dilemmas and ask for help or just feel empathy from their peers, without feeling like revealing this diminishes us as professionals. I thought long and hard about writing such a personal blog post, but I worry that by not talking candidly and honestly about how difficult juggling this all is, I am serving as a bad role model. The working mom dilemma exists in the best of time, as author Amy Westfield describes it “We expect women to work like they don’t have children, and raise children as if they don’t work.”

I am not going to end this blog post with a pithy solution that diminishes the complexity of the problem or suggests I personally have this all figured out. The next few years will undoubtedly be dominated by a “lessons learned” conversation about COVID 19, and I plan to use my seat at the table of scientific leadership to make sure we haven’t squandered a crisis for women in science.  I hope other leaders, both men and women, will do the same.

¹ https://www.pewresearch.org/fact-tank/2020/10/22/fewer-mothers-and-fathers-in-u-s-are-working-due-to-covid-19-downturn-those-at-work-have-cut-hours/

² https://www.forbes.com/sites/maggiegermano/2019/03/27/women-are-working-more-than-ever-but-they-still-take-on-most-household-responsibilities/?sh=71bbae5e52e9

³ https://www.scientificamerican.com/article/women-in-science-may-suffer-lasting-career-damage-from-covid-19/

Posted by Dr. Carrie D. Wolinetz, March 8, 2021

‘Twas the night before Christmas, in a very strange year,
OSP is so quiet, because there’s nobody here!
Teleworking from home, like the whole NIH,
But science policy has hardly slowed pace!
OSP staff are masterfully juggling,
Homeschool and glitches and cat laptop snuggling!
While COVID 19 has grabbed our attention,
OSP’s 2020 still had much to mention.
At long last, it’s final, the DMSP!
(Data sharing policy, to the cognoscenti…)
Please share your data and show us your plan!
It might affect if you get your next grant…
Doesn’t go into effect until 2023,
So, look for more guidance, tell us what you need.
Advisory Committees? Why, yes, there were three:
The NSABB, the NExTRAC, and the EAB.
sIRB exception for COVID is there,
COVID trial results, we hope that you’ll share!
Bioethics funding, we hope you’ll apply!
As a working group wrestles with using gene drives.
And when we look to the horizon, what should appear?
A glimpse at what continues into the next year
On CRISPR! On DURC! On biosafety!
On clinical trials diversity!
On digital health! On genomic data!
On privacy protections, based on risk or pro rata!
From primate research conducted with rigor,
De-identity challenges growing bigger and bigger,
Despite the pandemic, we see science advance,
And so, too, goes policy! (On Zoom! In sweat pants!)
As we come to the end of the year 2020,
From across OSP, there are wishes a-plenty,
To policy wonks, friends, and family,
To stakeholders and critics and the whole USG,
Stay healthy! Stay well! Wear a mask! Hang in tight!
Happy holidays to all, and to all a good night!

Last year, NIH unveiled the Novel and Exceptional Technology & Research Advisory Committee (NExTRAC), a forum for advice and transparent discussions about the scientific, safety, and social issues associated with emerging biotechnologies. Today and tomorrow, the NExTRAC will be meeting to address its first two charges: considering the safety and responsible use of gene drives in biomedical research and establishing a framework to guide NExTRAC in future deliberations of emerging biotechnologies. Amidst the continuing backdrop of the COVID-19 pandemic, the proactive consideration of science on the horizon may feel esoteric, but science continues unabated and so must our examination of the appropriate boundaries under which to continue to develop new biotechnologies to improve human health and quality of life.

Indeed the recent celebration of the Nobel Prize awarded to Drs. Jennifer Doudna and Emmanuelle Charpentier for development of the CRISPR gene editing technology and announcement of the World Health Organization (WHO) position on genetically modified mosquitoes, illustrate the timeliness of Monday and Tuesday’s NExTRAC workshop on biosafety guidance and considerations for field work for the use of gene drives. There are many questions to be considered in using this technology to control vector-borne diseases, like malaria or dengue fever, ranging from the practical – is current biosafety guidance adequate? – to the scientific – what is the current state of the science on risk mitigation strategies? – to policy implicating – what is the state of infrastructure for oversight and engagement? We hope that the convening of experts in the field and comments from the public will begin to bring some clarity to these questions.

Gene drives is, of course, only one of many emerging technologies on the horizon, and the Working Group to Establish a NExTRAC Framework is laying the groundwork for future considerations of these technologies by the Committee. They will be presenting a draft report describing their current thinking on identification of emerging technologies or areas of science and a deliberative process and prompts for discussing and evaluating such technologies. This framework, pending approval by the NExTRAC, will be incredibly useful for guiding the work of NExTRAC in the future.

In keeping with the commitment of the NExTRAC as a public and transparent forum for discourse, the virtual meeting can be watched live at: https://videocast.nih.gov and will be archived for future viewing. We hope you will have a chance to tune in and public input on NExTRAC activities is always welcome at [email protected].

Posted by Dr. Carrie D. Wolinetz, November 9, 2020