Happy DNA Day! Every April 25, we commemorate the discovery of DNA’s double helix structure in 1953 and the completion of the Human Genome Project in 2003, two key milestones in genetics. A variety of DNA Day events are taking place worldwide and online, including the debut of our ’15 for 15′ infographics on recent advances in human genetics – check them out!
ASHG marks this date each year by announcing the winners of our Annual DNA Day Essay Contest. Open to high school students worldwide, this year’s contest asked students to share their views on whether medical professionals, such as medical geneticists or genetic counselors, should be required for all genetic testing, or if consumers should have direct access to predictive genetic testing.
We received over 1000 entries from 43 U.S. states and 23 countries. Essays went through three rounds of scoring by ASHG members, who selected a first, second, and third place winner as well as 10 honorable mentions. (Want to participate next year? Read Dennis Drayna’s blog post on the judging experience.)
The winning essays were thoughtful and nuanced, reflecting a variety of views and a sophisticated consideration of the issues, and we were excited to see high-quality entries from several countries around the world. We awarded first place to Diane Zhang, a junior at Fox Lane High School in Bedford, N.Y.; second place to Ilan Bocia, a senior at YULA-Boys in Los Angeles, Calif.; and third place to Nadia O’Hara, a freshman at Pechersk School International in Kyiv, Ukraine.
For a full list of winners, honorable mentions, and teachers, and to read the winning essays, check out the DNA Day 2018 Winners. Through this contest and our other K-12 initiatives, we hope to encourage young people to explore genetics and inspire the next generation of ASHG members and leaders.
Jannine Cody, PhD, Professor of Pediatrics at the University of Texas Health Science Center at San Antonio, is Chair of ASHG’s Information & Education Committee. Learn more about ASHG’s K-12 education programs.
Posted By: Jennifer Zeitzer, FASEB Director of Legislative Relations
The Federation of American Societies for Experimental Biology (FASEB) is the nation’s largest coalition of biomedical researchers, representing 30 scientific societies and more than 130,000 researchers from around the world. As a member of FASEB, ASHG works closely with FASEB and the other member societies to advance research and education in biological and biomedical sciences and advocate for increased funding for biomedical research. Through FASEB, ASHG also monitors and regularly speaks out on science policy issues impacting the scientific community.
For example, ASHG recently joined FASEB in celebrating the historic $3 billion dollar increase for the National Institutes of Health (NIH) approved by Congress in late March. Securing the increase was a collaborative effort between many organizations. ASHG urged its members to email and call their elected officials and sent two Board members to FASEB’s Capitol Hill Day to make the case for NIH funding with their members of Congress.
This month, Congress began consideration of the fiscal year (FY) 2019 budget, and ASHG and FASEB are again working together to advocate for increased NIH funding. There is a good chance NIH will receive another significant funding increase in FY 2019, thanks to legislation passed in February to raise strict spending caps that were enacted in 2011. The appropriations committees will determine how that additional funding is divided among federal agencies.
Making sure NIH gets another increase will require additional coordinated advocacy between ASHG and FASEB over the next few months. More information is forthcoming, but ASHG members should expect to receive e-alerts from FASEB as well as reminders to check out the resources and tools in the ASHG Advocacy Center.
ASHG members also have access to FASEB’s Advocacy Toolbox, which includes instructions for requesting a meeting with a member of Congress at home and tips for communicating with elected officials through social media. The Washington Update newsletter provides the latest news on science policy and advocacy inside the Beltway and from federal agencies (click here to subscribe).
The recent $3 billion increase for NIH and other advocacy successes would not have been possible without the joint effort between FASEB and its member societies. As Congress makes decisions about the 2019 budget, FASEB is proud to have a strong partnership with ASHG to ensure that the voices of scientists are heard on Capitol Hill and in congressional districts across the country.
Jennifer Zeitzer has been the Director of Legislative Relations at FASEB since 2008. She coordinates advocacy efforts with FASEB member societies and others in the biomedical research community, including organizing FASEB’s annual Capitol Hill Day.
FASEB offers free webinars on advocacy and policy issues. Sign up to receive notifications about future FASEB webinars here.
Posted by: Neil Hanchard, MD, PhD, ASHG Board Member
I don’t consider myself to be particularly ‘political’; however, the last two Presidential budgets have included closing the U.S. Department of Agriculture-funded building that houses my lab and office. This has made me keenly aware that the science we do doesn’t occur in a vacuum. I thus consider myself particularly fortunate to have had the opportunity to participate in FASEB’s Capitol Hill Day (March 8) as a representative of ASHG. This now annual event brings scientists from across FASEB’s 31 experimental biology societies – including ASHG – to the Capitol to lobby for their own science. It’s timed to coincide with annual budget making season and, since it’s been going on longer than any of the more than 50 fellow scientists in the room knew for sure, it’s a central piece of FASEB’s public policy engagement.
For me, getting up close and personal with the machinations that enable the science engine was a truly fascinating experience. The DC-based staff of FASEB and ASHG essentially do this all the time and, accordingly, were like a well-oiled sequencer. They did an amazing job of prepping first time scientists-come-lobbyists (like myself) – hosting prep sessions well before the event, as well the night before and morning of. Plus, they ensured that everyone was suitably armed with critical talking points for their State representatives and glossy summary pamphlets to go along with them. After a day running around (literally) meeting with State representatives’ aides in the halls and offices of the National’s Capitol, here are my top 5 takeaways:
There is strength (and comfort) in numbers. FASEB represents ~130,000 scientists in the U.S. and around the world – that’s not a trivial number and the powers-that-be know it.
The Capitol is very large. It’s a mind-boggling maze of offices and hallways, with a subway linking the two houses to boot. With multiple 10-15 minute meetings strewn across the “The Hill”, there’s no way we could have done it on our own – the FASEB facilitators, who included our own ASHG staff, knew not only where we were going, but each of the representatives’ voting and stances on science issues as well.
There is an art to the lobby. There’s an etiquette to lobbying, with polite, often unwritten rules of how to deal – the mandatory exchange of business cards (which I forgot – whoops!); the pitch, the pivot (when you’ve lost your audience); the parting promises and closing invitations – a well-rehearsed dance that, performed well, can be the difference between a “yea” and a “nay”.
Everyone wants their piece of the pie. The Lobby dance is performed by umpteen groups this time of year – if there’s a group you can think of, they were probably there. For scientists to get the funding they need to continue doing good science, they should remember that “the squeaky wheel gets the grease.”
Science is bipartisan. Somewhat surprisingly for me, the pitch for NIH, NSF, and USDA science was well-received at all of the Texas representatives’ offices we visited, irrespective of party affiliation. I also learned of several unheralded champions for science from both sides of the political aisle.
All in all, this was a truly enlightening and emboldening experience; honestly, if I can do it, pretty much anyone can, and there’s a strong argument that any and all scientists should – host a representative in your lab, visit your local representative’s office, make the phone call/sign the email – as jaded as I was about the process at the start, it was heartening to know that it can actually make a difference.
Neil Hanchard, MD, PhD, FACMG, serves as Early-Career Member of the ASHG Board of Directors. He is an Assistant Professor and Clinical Geneticist at Baylor College of Medicine and Texas Children’s Hospital, and has been a member of ASHG since 2010.
On Monday, the Office of Management and Budget rolled out the President’s budget request for Fiscal Year (FY) 2019. Although Congress ultimately determines federal spending, the President’s budget sets the tone for the nation’s domestic and international priorities. The proposed budget for the Department of Health and Human Services (see page 40) suggests $34.8 billion for the National Institutes of Health (NIH). While this represents an increase over the current funding for NIH, most institutes at the NIH funding genetics research would see their funding cut. In response, ASHG President David Nelson issued a statement expressing disappointment and the Society’s enthusiasm for working with congressional leaders to sustain ongoing investments in biomedical research.
With the FY 2019 announcement coming from the White House this week, you might assume that Congress has finished its work for funding FY 2018. But you’d be wrong! After several months of debate and delay, and a couple of brief government shutdowns, Congress is finally entering the home stretch. As you may have heard, last Friday Congress passed legislation allowing spending caps on federal programs to increase by $296 billion. The passage of this legislation also established a deadline of March 23 for Congress to determine how much funding to allocate to each federal agency in FY 2018, including for NIH. Therefore, now is the time to contact your members of Congress about why sustained federal funding for human genetics research is so important.
The FY 2018 funding story to date has been complicated, so let’s briefly recap what’s happened so far. Congress was unable to pass legislation to establish FY 2018 funding for federal agencies by the September 30, 2017 deadline established by law. Since then, Congress has been passing a series of Continuing Resolutions, or CRs, to allow the government to continue to function. These have been necessary because Congress has been unable to reach agreement on overall levels of funding in FY 2018 and what the funding of each agency should be. The passage of last week’s budget agreement between Republicans and Democrats marks a significant hurdle in overcoming this impasse.
For NIH specifically, there are two alternative proposals on the table for FY 2018. House appropriators have proposed $35.2 billion for the agency, an increase of $1.1 billion over the FY 2017 funding of $34.1 billion. A Senate proposal goes further, supporting a $2 billion increase to $36.1 billion. Over the past several months, ASHG and its partners within the Federation of American Societies for Experimental Biology (FASEB) have been working with the larger biomedical research community in making the case for a $2 billion increase. These numbers stand in stark contrast to the Administration’s proposal to cut funding for NIH by an unprecedented $7 billion cut to $26.9 billion.
To secure the $2 billion increase for NIH, your Senators and Representatives need to hear from you now! Please go to our Advocacy Center to send a personal appeal to your elected representatives about the impact of federal appropriations on your research and/or institution, urging them to support a $2 billion increase for NIH. Your story matters: Emphasizing the important role federal funding makes to your genetics work is imperative for making the case, more generally, for scientific discovery as a national priority. Take action today and make sure your voice is heard on Capitol Hill.
If you had asked me when I started my PhD if I could envision myself working in public policy, including as a staffer in the U.S. Senate, I would have said no way! But this reality is the beauty and excitement of the ASHG/NHGRI Genetics & Public Policy Fellowship, which has exposed me to policymaking in the executive and legislative branches of the U.S. Government, as well as with the Science Policy Department at ASHG.
As a graduate student at the Johns Hopkins University School of Medicine, my research on a complex genetic disorder that often results in immune deficiencies opened my eyes to issues in bioethics and policymaking. I wondered how non-scientists in state and federal law-making bodies were informed about the scientific and health implications of their policies. I stepped out of the box and took a short leave of absence from graduate school to work with the Policy Director at the Ovarian Cancer National Alliance in Washington, D.C., and was hooked.
Breaking the Ice
The Genetics & Public Policy Fellowship has been essential and a life-changing experience in my transition from an academic research environment into policy and advocacy. I began my fellowship in the Policy and Program Analysis Branch (PPAB) at the National Human Genome Research Institute (NHGRI). I helped the team keep up with new legislation in Congress and with regulations in other agencies that would affect NHGRI researchers and grantees. I helped assemble the FY2018 Congressional Budget Justification, which each agency compiles yearly to outline financial needs and highlight program successes and goals. Since 2016 was an election year, I also helped to draft the presidential transition team documents, again outlining the important work being conducted by intramural and extramural researchers at NHGRI.
Lessons in Drinking from a Fire Hose
My second rotation was a primer in hitting the ground running, as I joined the office of Senator Sherrod Brown just before Inauguration Day in January 2017. I worked on a broad range of issues in healthcare and biomedical research, including Medicare and Medicaid, infant mortality, the opioid addiction crisis, antibiotic resistance, drug pricing, and rare diseases.
My daily activities varied, but generally involved meeting with Ohio constituents (including graduate students!) to discuss their legislative concerns, as well as drafting bills, letters, and memos, and preparing the Senator for Senate committee hearings. I also managed Senator Brown’s health-related appropriations requests for FY2018, and represented the office in communicating with stakeholders after a blood lead level testing kit was recalled by the FDA and CDC over the summer. Additionally, I found ways to stick to my genetics roots, and in April combined DNA Day with Take Your Children to Work Day by encouraging my colleagues and their kids to celebrate by extracting strawberry DNA in our office conference room!
Coming Full Circle
I am wrapping up my fellowship by working with the science policy team at ASHG this fall. I think ASHG members would be surprised to see all that happens behind the scenes here, and I’ve enjoyed bringing the experience I’ve gained through my government rotations back to a scientific society.
At ASHG, I’ve been able to fulfill my primary goal of the fellowship: to use my knowledge and skills in bridging the gap between legislators in Washington D.C. and ASHG members. I used my scientific background to educate Society and Congressional staff about advances in gene editing technology in preparation for a Senate hearing. I also authored blog posts about changes to the NIH definition of clinical trials and FDA oversight of genomics research, and worked with ASHG members to develop a comment letter to the National Academies Committee on return of individual-specific research results.
Looking to the Future
Overall, the fellowship has been a wonderful and successful experience in solidifying my interests and informing my career trajectory. It has shown me the translatability of my research skills and allowed me to cultivate a distinct and highly valuable analytical skillset. This fellowship has opened my eyes to the incredibly diverse health and science policy worlds, teaching me how to take creative approaches to policy changes and build effective collaborations.
I am further thrilled to be joining the ranks of a wonderful fellowship alumni community. Previous fellows have been instrumental in helping me during this entire experience, from offering suggestions on Capitol Hill rotations to career advice and networking. I look forward to carrying along these relationships and experiences to my next role working in policy and advocacy on the Government Relations team at the Association of American Medical Colleges beginning in 2018.
And finally, thank you to ASHG and NHGRI for continuing to support this fellowship. I look forward to remaining a member of this community and to welcoming future classes of fellows!
Posted By: Derek Scholes, ASHG Director of Science Policy, and Jillian Galloway, Science Policy Analyst
As the year comes to an end, we thought it timely to reflect upon the Society’s many policy and advocacy accomplishments in 2017.
First, with the help of members and approval by the Board, we established a new policy platform. It will provide direction for ASHG’s policy and advocacy activities for the next several years. This is essential for communicating our perspectives to lawmakers and other stakeholders.
Early in the year, we took action to preserve the genetic privacy protections outlined by the Genetic Information Nondiscrimination Act (GINA). As strong supporters of GINA, we opposed the Preserving Employee Wellness Programs Act (H.R. 1313), a bill allowing employers to ask employees invasive questions about their and their families’ health, including genetic tests they may have undergone. We also encouraged members to contact their legislators and sign on to the ASHG opposition letter. More than 1,000 of you did so and it had a real impact: Our opposition to H.R. 1313 was widely reported in the media and since then, the bill has not moved forward in Congress.
In addition, ASHG supported a $2 billion increase in funding for the National Institutes of Health (NIH). We have seen a $2 billion increase in the NIH budget for 2018 and we ask that Congress continue the progress we have made. As we all know, we need robust, predictable, and sustainable federal funding to fuel scientific advances. Currently, federal agencies are operating under a “continuing resolution” (CR) set to expire December 22. With the deadline fast approaching, Congress needs to pass another CR to keep the government running into the new year.
More recently, we opposed any changes to the tax-exempt status of tuition waivers within the U.S. Congress tax bill called The Tax Cuts and Jobs Act (HR 1), as proposed by the House (but not the Senate). The House provision changed the tax-exemption status of tuition waivers commonly granted to graduate students, and taxing them would create financial hardship for individuals with already modest incomes. Thanks to the efforts of concerned members and other scientists, the final version of the tax bill does not include such a provision.
To help you learn more, share current policy information, and contact legislators directly, we also launched a new Advocacy Center. This site makes it easy for members to take action by sending customizable messages to Congress on important science policy issues, as well as learn when ASHG is speaking out and how to get involved. It links to ASHG statements, blogs, and press releases on pending genetics policy issues.
ASHG is working hard to keep you informed and empower you to influence science policy. In the new year, it will take all of us becoming engaged to build on the Society’s advocacy progress in 2017.
Derek Scholes, PhD, is Director of Science Policy at ASHG, and Jillian E. Galloway, MS, is a Science Policy Analyst at ASHG. Learn more about ASHG’s activities in Policy & Advocacy. and share your thoughts on policy issues or ASHG’s efforts by emailing email@example.com.
Starting this month, the grant application process for NIH-funded research that includes human subjects will change for many investigators. This stems from modifications NIH has made to its definition of a clinical trial, and a number of new requirements the agency is establishing for investigators conducting NIH-funded clinical trials. It is important that researchers understand these changes and consider whether their research is now regarded as a clinical trial by NIH.
What is Defined as a Clinical Trial?
NIH’s new definition went into effect in January 2015 and states that a clinical trial is:
“A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
Many scientists think of clinical trials as investigations of the safety and effectiveness of potential clinical interventions. For instance, the National Heart, Lung, and Blood Institute has defined clinical trials as “research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans”. In contrast, the new NIH definition includes research projects that don’t take place in a clinical setting and those that do not test a new treatment – studies that some researchers regard as basic research. This is best demonstrated by case studies the NIH has issued to illustrate what types of research fall within its new definition.
New Requirements for Researchers Conducting Clinical Trials
Understanding whether NIH defines your research as a clinical trial is important because the agency is setting new requirements for clinical trial investigators. These changes affect the grant application process and grant review, as well as the awarding of funding; training of staff conducting clinical trials; management and oversight of a funded trial; public registration of the trial; and timely dissemination of results. Below is a list of relevant policy changes, their effective date, and how they could impact your research and funding.
Definition of clinical trial – January 1, 2015. The new definition (see above) expands the scope of what is considered a clinical trial, encompassing more research than the previous definition. For example, it may include many ELSI research projects, such as feasibility studies and studies comparing consent approaches. Read this blog post from the NIH, this decision guide, or the list of case studies if you are unsure of how to categorize any research you conduct with human subjects. Of particular interest to the ASHG community are case studies 4, 7, 10, 11, 13, and 20.
Good Clinical Practice (GCP) training – January 1, 2017. This policy requires PIs and staff involved in NIH-funded clinical trials to receive training in good clinical practice as a condition of the award.
Clinical trial protocol template – May 2, 2017. NIH and FDA collaborated on a new template for Phase 2 and 3 Investigational New Drug (IND)/Investigational Device Exemption (IDE) clinical trials.
Registering clinical trials and reporting results – January 18, 2017. Any clinical trial receiving NIH funding must register on ClinicalTrials.gov within 21 days of enrolling its first participant. Furthermore, results from a clinical trial must be submitted to the same website within one year of the trial’s completion. Failure to do so may result in the NIH withholding grant funding from the grantee institution. Read more about registering and reporting of research.
We encourage you to look into how these changes will affect your NIH-funded research with human subjects. Please feel free to let us know your questions, comments, or concerns by posting below or emailing firstname.lastname@example.org.
Additional Information from NIH Blogs and Publications