Help Secure $2 Billion More for NIH!

Posted By: Derek Scholes, ASHG Director of Science Policy, and Jillian Galloway, Science Policy Analyst

Take Action Now

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.

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U.S. Capitol (Credit: National Park Service)

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.

For more information on ASHG programs in policy and advocacy, visit the Policy & Advocacy page.

Reflections on My Experience as a Genetics & Public Policy Fellow

Posted by: Christa Wagner, PhD, 2016-17 ASHG/NHGRI Genetics & Public Policy Fellow

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.

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Making a trip to Capitol Hill with Genetics & Education Fellow Teresa Ramirez (credit: NHGRI)

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!

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Senators do care about science! (credit: Sherrod Brown via Twitter)

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.

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Meeting Canadian Senator James Cowan, ASHG Advocacy Award recipient, at the ASHG 2016 Annual Meeting (credit: ASHG)

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!

 

ASHG Policy and Advocacy: 2017 Highlights

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.

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ASHG, along with representatives from other FASEB societies, participated in FASEB’s Hill Day this spring. (Credit: Dr. Scholes)

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.

Also, this year the Society released a position statement on germline genome editing. This statement is the latest in a series that the Society issues periodically on a range of genetics policy issues and uses of genetic information. Written by a workgroup led by Kelly Ormond and Doug Mortlock, and including perspectives and feedback from members, the statement gives the Society’s perspective on the use of CRISPR/Cas9 or similar tools to alter the genome of an embryo or germ cell.

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 policy@ashg.org.

Social Issues Committee Initiates New Duty to Recontact Statement

Posted By: Jillian Galloway, MS, Science Policy Analyst at ASHG

The ASHG Social Issues Committee (SIC) is taking the lead on an important issue affecting genetics and genomics researchers, namely the duty to recontact research participants. At ASHG 2017 in Orlando, the Board of Directors asked the SIC to draft a Society statement offering greater guidance on this topic.

Over the past few years, advances in next-generation sequencing technologies and the volume of genomic information produced have raised thought-provoking questions regarding the ethical, operational, and regulatory considerations of recontacting research participants about new genomic information that is clinically significant (such as a new interpretation of the pathogenicity of a variant harbored by participants). For individual researchers and their associated institutions, questions of whom, when, and how to recontact are daunting. What’s more, for many, the preliminary question of whether researchers have an ethical duty and/or professional obligation to recontact participants is not easily answered.

To involve the ASHG community early in planning the scope and key points of the statement, Yvonne Bombard (SIC chair) and Howard Levy (SIC member) presented this topic at a CoLab session during the Annual Meeting. They described how new IT advances make greater data sharing possible and could facilitate the dissemination of information from researcher to participant. They also outlined emerging questions when considering the duty to recontact, such as 1) What kind of information is relevant and useful for participants? and 2) How does one appropriately and responsibly inform participants and use technology to facilitate contacting and recontacting?

CoLab attendees provided many insightful comments useful for informing the ASHG statement. For example, they noted that research is not an open-ended commitment: funding ends and teams disband, raising questions about researchers’ duty to contact participants with new or updated information after the study ends. Attendees also discussed operational difficulties in recontacting participants or revisiting results. Furthermore, questions were raised about the appropriate method for contacting participants. Such comments highlighted the complexities of the issues and the challenges faced by researchers today.

As the SIC begins drafting the Society statement on this issue, we welcome you to submit your thoughts on the topic to policy@ashg.org. All comments submitted will be shared with the SIC.

Jillian E. Galloway, MS, is a Science Policy Analyst at ASHG. Learn more about ASHG’s activities in Policy & Advocacy.  

What You Need to Know About FDA Oversight of Genomics Research

Posted By: Christa Wagner, PhD, 2016-17 ASHG/NHGRI Genetics & Public Policy Fellow

With rapid DNA sequencing now routine, genetics researchers are increasingly testing the clinical utility of its application in various healthcare settings and the barriers to using genomic information in healthcare decision-making. In doing so, some are discovering that their research might be subject to a Food and Drug Administration (FDA) regulation known as the investigational device exemption (IDE) regulation. However, many in the genetics community are unfamiliar with this regulation.

To raise awareness of the IDE regulation, ASHG hosted a policy luncheon at ASHG 2017 that included representatives from the FDA, the research community, and the National Human Genome Research Institute (NHGRI). Presenters explained the relevance of the regulation for genomics research, described an experience of applying for an IDE, and made attendees aware of helpful resources available to the genomics community.

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(L-R) Policy Luncheon presenters Kate Donigan, Jonathan Berg, Cristina Kapustij, and Derek Scholes.

Katherine Donigan, PhD, from the Personalized Medicine Staff at FDA began the session by speaking about the IDE regulation itself and her office’s role in ensuring public health and safety while supporting innovative research and discovery. She explained that genomics research has made great advancements since the IDE regulation went into effect in 1976, and that research using next-generation sequencing where results are being returned to participants warrants consideration under the IDE regulation.

Studies can fall into one of three categories: IDE exempt, Nonsignificant Risk (NSR), and Significant Risk (SR). Only SR studies require FDA involvement, and Kate outlined the variables that her team uses to determine SR, such as the invasiveness of sample collection and the potential for false results. She advised researchers to reach out to FDA to talk through their proposed studies before applying for a grant, so that they know in advance if their research will likely be categorized as SR. This will facilitate a faster IDE application and approval process once grant funding has been awarded.

Jonathan Berg, MD, PhD, from the University of North Carolina then presented on his experience as a trailblazer in interacting with FDA regarding IDE regulations for genomic studies. Jonathan’s NC NEXUS project in the NSIGHT consortium explores the utility of exome sequencing for enhancing newborn screening by sequencing both healthy newborns and infants previously identified through newborn screening, and studying parental decision-making on the additional genomic testing. He detailed the multi-year long process his research group struggled through to become aware of, apply for, and eventually receive an IDE approval. Jonathan explained that he is supportive of FDA oversight but that the regulations need to be applied in a way that does not derail scientific research. He offered some words to the wise: get help! Discuss the risks involved in your research studies with your IRB or other institutional regulatory assistance staff, or consult with the FDA.

Cristina Kapustij, MS, from NHGRI rounded out the panel by outlining the support role her policy team offers to stakeholders and grantees embarking on human genetics research. She explained that NHGRI is working as a bridge to the FDA for researchers looking for guidance on the IDE process when they are designing studies or applying for grants. She described a workshop hosted by NHGRI in 2016 and drew attention to the NHGRI Points to Consider online resource.

The panel concluded with a Q&A session. Attendees asked great questions about diverse topics from funding to return results, retrospective research with biobank samples, streamlining the IDE submission process as technology continues to advance, and more! Check out the information below for more details on IDEs.

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Overview of IDE process and responsible parties (credit: NHGRI Points to Consider)

Resources

ASHG 2017 Policy Luncheon

NHGRI

FDA

Christa Wagner, PhD, is the 2016-17 ASHG/NHGRI Genetics & Public Policy Fellow. For more information on the fellowship and application details, please visit the Genetics & Public Policy Fellowship website.

 

 

 

 

NIH Redefines Clinical Trials and Sets New Requirements: Is Your Human Subjects Research Affected?

Posted by: Christa Wagner, 2016-17 ASHG/NHGRI Genetics & Public Policy Fellow

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.

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Clinical trial processes and relevant changes. (Credit: NIH; source)
  • 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.
  • Applying for NIH funding for clinical trials research – January 25, 2018. This month, all Funding Opportunity Announcements (FOAs) will be changed to accommodate the new definition of clinical trial. For grant applications due on or after January 25, 2018, research projects now deemed a clinical trial must be submitted to a new category of FOA specifically designated for clinical trials research.
  • Use of single Institutional Review Board (sIRB) – January 25, 2018. This policy applies to multi-site research proposals.

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 policy@ashg.org.

Additional Information from NIH Blogs and Publications

Just Launched: A New Advocacy Center for ASHG

Posted By: Jillian E. Galloway, Science Policy Analyst at ASHG

We are delighted to announce that ASHG has a new online Advocacy Center! Developed with members’ needs in mind and the Society’s desire to become more involved in policy and advocacy, the site provides tools and channels for members to learn more and share their views directly with legislators.20171013_advocacy-center

The Advocacy Center makes it easy for members to take action by sending customizable messages to Congress on important science policy issues. Members and others can also stay current with press releases and news clips related to ASHG advocacy activities, read recent letters and comments to policymakers, explore blog posts related to policy and advocacy, and check out helpful tools and resources.

ASHG advocates for policies consistent with its policy platform that support scientific discovery, the translation of scientific discoveries into health advances, and the appropriate application of genetics within society. We further support policies that advance the understanding of genetics by healthcare professionals and the public.

To reach these goals, we need your help! Visit our Advocacy Center to connect with Capitol Hill and get your voice heard on a number of significant issues, including supporting NIH funding and opposing genetic discrimination!

Jillian E. Galloway, MS, is a Science Policy Analyst at ASHG. Learn more about ASHG’s activities in Policy & Advocacy.