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.

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