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.

 

 

 

 

Inside AJHG: A Chat with Diego Calderon, Audrey Fu, and Jonathan Pritchard

Posted by: Sara Cullinan, PhD, Deputy Editor, AJHG

Each month, the editors of The American Journal of Human Genetics interview an author(s) of a recently published paper. This month we check in with Diego Calderon (@diegoisworking), a Stanford University graduate student, along with senior authors Audrey Fu and Jonathan Pritchard (@jkpritch), to discuss their paper, “Inferring Relevant Cell Types for Complex Traits by Using Single-Cell Gene Expression.”

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Diego Calderon, PhD student, Stanford University (courtesy Mr. Calderon)

AJHG: What prompted you to start working on this project?

Diego: Single-cell RNA-seq is a hugely powerful tool for finding novel fine-scale cell types in complex tissues. But if we’re interested in human disease, how can we prioritize potentially trait-involved cells, out of all the newly identified cell types, for further characterization? Our idea was to focus on cell types that tend to specifically express genes near mutations associated with the trait of interest. Surprisingly, when we started thinking about this project, there hadn’t been work published attempting to connect GWAS data and such findings from single-cell assays.

AJHG: What about this paper/project most excites you?

Diego: The development of RolyPoly allowed us to find finer-scale trait-associated cell types from complex tissues; particularly, we focused on neuropsychiatric traits and single-cell data from human brains. There had been hints of immune involvement in Alzheimer’s disease, thus we were intrigued to see this association with microglia, which are the brain’s immune cells. Additionally, there has been wonderful work clustering single-cells into cell states, which we can also scan for links with complex traits. For example, we found that actively replicating cell types from early timepoints of fetal brain development were associated with schizophrenia. These findings are exciting because they can be used to inform the development of cell type or state models that more specifically capture human disease processes.

AJHG: Thinking about the bigger picture, what implications do you see from this work for the larger human genetics community?

Diego: When we began this project, there were only a limited number of human single-cell datasets publicly available. Earlier this year, plans for the human cell atlas were announced, which will result in large publicly accessible datasets of single-cell RNA-seq measurements. Our hope is that researchers can use our tool along with other single-cell methods to further our understanding of biology and complex traits.

AJHG: What advice do you have for trainees/young scientists?

Diego: As a young scientist, you should think deeply about your chosen scientific problem. However, it’s also worth considering how best to communicate your new ideas. The ability to make complex biological or computational concepts accessible is a skill that’s worth refining and will help advance your career regardless of your chosen field. As a result, it takes time and persistence to continue to refine your writing and ideas without becoming discouraged. It took us many months to finalize our manuscript.

AJHG: And for fun, tell us something about your life outside of the lab.

When not in the lab, Diego enjoys throwing clay coffee mugs at the ceramics studio and eating a hot meal after a long day of backpacking. Audrey appreciates listening to opera and singing karaoke. Jonathan is fond of spending time with his family, searching for the best veggie burrito at Stanford, and running through the foothills of Palo Alto.

Diego Calderon, BA, is a graduate student at Stanford and has been an ASHG member since 2014. Audrey Fu, PhD, is an assistant professor at the University of Idaho, and has been an ASHG member since 2014. Jonathan Pritchard, PhD, is a professor of biology and genetics at Stanford, and has been involved with ASHG since 2002.

Expanding Role for Genetic Counselors: Good for Our Profession, Great for Our Patients

Guest Post By: Erica Ramos, MS, CGC, President-Elect, National Society of Genetic Counselors

As we observe the first annual Genetic Counselor Awareness Day on Nov. 9, I can’t help but be astonished by the changes in our profession and how they are shaping, and being shaped by, the exciting advances in how we diagnose and treat genetically-influenced conditions. As President-Elect of the National Society of Genetic Counselors (NSGC), I have never been more proud or excited to declare “I am a genetic counselor!” and share how we bring the voice of patients and clinicians to all areas and applications of genomics.

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Erica Ramos, MS, CGC (courtesy NSGC)

When I completed my genetic counseling training in 2001, I couldn’t have predicted that I would find myself working on the leading edge of clinical genomics. When I began working at a genomics biotechnology company in 2012, I was only the second genetic counselor on staff. According to the 2012 NSGC Professional Status Survey (PSS), a mere 0.5% of our profession was employed by R&D or biotechnology companies.

Four years later, the 2016 PSS showed this had doubled. Today, there are 17 genetic counselors at my company, working collaboratively with scientists, bioinformaticians, developers and executives, contributing our skills and expertise to areas such as medical affairs, market development, product marketing and strategic planning, and sharing the real-world impact that their work ultimately has on patients and their families.

Mine is just one example of genetic counselors’ expanding roles. We are leading patient-centered original research and are integral to Geisinger’s MyCode study, The Ohio State University’s Statewide Colon Cancer Initiative and All of Us, to name just a few. We are driving growth and change in clinic by branching into specialty areas including neurogenetics and psychiatric genetics. NSGC surveys tell the story: In the 10 years leading up to 2016, the number of specialty areas where genetic counselors work went from 14 to 33, a 135% increase.

Vast and exciting career opportunities are fantastic for the genetic counseling profession and ensure a bright future for those entering our field. But as good as this trend is for our profession and the 4,000 certified genetic counselors in the U.S., the benefits are even greater for other genomics professionals and, critically, to patients.

Genetic counselors have deep scientific and medical knowledge. Paired with our communications and counseling skills, we are a valuable resource in translating research advances in genetics and genomics to healthcare providers and patients. As media coverage of these advances expands, providers and patients often have questions about how these new discoveries impact their care. We unravel the complexities of research so that clinicians and patients receive clear, accurate and digestible information, regardless of their culture or background.

So, here’s to Genetic Counselor Awareness Day! Working together to improve appreciation and understanding of how we and our partners in genomics empower patients and their healthcare team and provide them with ever improving personalized attention and care.

Erica Ramos, MS, CGC, is President-Elect of the National Society of Genetic Counselors (NSGC). She has been a member of ASHG since 2014. 

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

#ASHG17 in the Shoes of a Trainee

Posted By: Monika Schmidt, Chair, ASHG Training & Development Committee

On any given day of the ASHG Annual Meeting, I find myself in a predicament: What’s next on the schedule? Should I attend the exhibitor talk in the CoLab theater, visit interesting posters, or seek advice at the Careers in Academia panel?

No matter how carefully I plan my schedule ahead of time, the meeting always has more to offer than I could possibly take advantage of: exciting talks, posters, trainee events, workshops, exhibitor presentations, and naturally, social events. This year’s meeting in sunny Orlando was no exception, and in my role as Chair of the Training and Development Committee (TDC), I hardly had a moment to sleep.

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TDC members Lauren Tindale, Monika Schmidt, and Julie Jurgens take a moment to enjoy Orlando’s non-genetics attractions. (courtesy Ms. Schmidt)

I kicked off my experience early on Tuesday, October 17, by presenting to ASHG’s Board of Directors all the fabulous work the TDC has done over the past year. Despite being a bit nerve-wracking, this was hugely rewarding – there is so much support for trainee professional development and mentorship from the ASHG community. These two themes reverberated over the rest of the meeting.

Professional Development and Networking at #ASHG17

Developing networking skills benefits from lessons and practice. Recognizing this, ASHG teamed up with The Jackson Laboratory to develop the multi-week Conference to Career Program, which included a dedicated section on networking skills for national meetings.

Following the Conference to Career in-person session, the TDC hosted Peer Networking Trivia – an ideal event to put networking lessons into practice. 2017 marked the third year the TDC hosted this event for trainees; it was rewarding to watch new friendships form as trainees commiserated over the challenging genetics trivia questions. Naturally, it’s much easier to get chatting when a topic is presented for discussion, and so the Tweetup, Opening Reception, and various evening exhibitor events presented new situations for trainees to practice their networking skills. I thoroughly enjoyed meeting trainees at these receptions, chatting about their vision for future initiatives, and of course, singing along with NIH Director Francis Collins on guitar.

Mentors at ASHG: Many Ways to Connect

Between scientific sessions in the mornings and afternoons, trainee mentorship became the focus of my lunch hours. The TDC hosted two panel discussions this year: Careers in Academia and Careers in Industry. The panelists’ responses to trainee questions were thoughtful and thorough, which meant that I and my TDC colleagues spent a lot of time live-tweeting the discussions using our newly-introduced hashtag: #ASHGtrainee. Panelists hung back after the sessions to answer questions one-on-one, providing another networking opportunity.

On Thursday, the TDC launched our inaugural myIDP (Individualized Development Plan) session, led by Philip Clifford. I was blown away by the incredible turnout and high level of engagement with the material presented. This session led trainees on an introspective journey aided by their peers, and asked them to examine their values, strengths, weaknesses, and interests. The goal of the session was to help trainees define career paths that suit their personalities, needs, and wants. With a room abuzz with discussion, 75 minutes was undoubtedly too little time, and the TDC will be looking to expand the session at future meetings.

While the TDC-led lunchtime sessions were happening, ASHG staff were hosting the Trainee-Mentor Luncheons and newly introduced Round Table Discussions. These events focused on establishing trainee-mentor relationships and providing a more intimate setting to ask advice of a successful genetics professional. I myself am still in contact with the mentor who shared lunch with me in 2014. On the note of keeping in touch with mentors or networking contacts: remember that the mentors and Trainee Leaders at ASHG really care for your success as a trainee – we want to hear from you! Your emailed question or LinkedIn request (with an introductory message, of course) are welcome. So, take 30 minutes today to thank the mentors who spent time with you for their advice – you might just get a better response than you expected, and you’ll be on your way to building a network of professional contacts!

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TDC members Douglas Dluzen (far left) and Monika Schmidt (far right) with speakers at a trainee-organized invited session on rigor and reproducibility in genetics. (courtesy Ms. Schmidt)

The final trainee event of ASHG 2017 combined the best of mentorship and networking in an evening reception, Career Paths in Genetics. As a mentor at the TDC table, I and other TDC members were thrilled to answer questions from trainees about what being an ASHG Trainee Leader entails, and how the position provides an opportunity to advocate for trainees within the Society and at a federal level via FASEB. I also took a break to just ‘be a trainee’ per se, and heard a thrilling story about patenting BRCA1 from the intellectual patents mentor, discovered a whole new potential career path in scientific administration, and was offered very sage advice by a mentor from academia on maximizing upon my abilities post-PhD.

Reflecting on ASHG 2017

Every year I return from the Annual Meeting with renewed motivation for my research and a reading list as long as my arm, as is to be expected of any stimulating conference. I also came home hopeful that fellow trainees heard the same messages that I did over the five days in Orlando: it’s always the right time to say hello and explore potential new connections, pursue a new experience to build your skills, learn about yourself, and see what the world of genetics has to offer.

Monika Schmidt, BSc, is the 2017 Chair of ASHG’s Training & Development Committee, and has been part of the TDC since 2015. She first joined ASHG in 2014, the same year she started graduate studies.

Interested in a leadership position like Monika’s? Apply for 2018 Trainee Leadership Opportunities by Monday, November 6. For questions about these opportunities and other trainee issues, contact Monika on Twitter using #ASHGtrainee or by email

How I Work: Neil Lamb

Posted by: Kate Garber, Chair of the ASHG Communications Committee

In September, I interviewed Neil Lamb, PhD, Vice President for Educational Outreach at the HudsonAlpha Institute for Biotechnology, about his career trajectory, favorite resources, and current projects.

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Neil Lamb, PhD, HudsonAlpha Institute for Biotechnology (courtesy Dr. Lamb)

Kate: Tell us about your position and how it fits into your institution and its goals.

Neil: HudsonAlpha is a non-profit organization in Huntsville, Alabama, that focuses on using genomics to improve human health and global sustainability. My team’s mandate is to create a more genomically literate society and to foster the development of the next generation workforce in Alabama. Our efforts encompass many different activities including teacher training workshops, the development of educational kits, courses and seminars on biotechnology for the greater Huntsville community, and even the development of educational apps. I work with an incredible team that makes this all happen, and these programs reached 1.5 million people during the last school year.

As part of our efforts, we have partnered with the Alabama Department of Education, specifically at the K-12 level. We want students to understand the growing importance of genetics and genomics, to develop ways to meet the educational standards on these topics, to help teachers confidently teach these subjects, and to get students to make connections between potential careers and the facts in their textbooks. As part of this work, we identify learning gaps related to genomics and ask, “How can we step in and address them?”

Kate: What have been some of the biggest surprises to you about working with your state government? Do you have any advice about working with non-scientists in these types of situations?

Neil: The biggest and most pleasant surprise has been how engaged people are about genomics. No matter what level I’m working at, many people are beginning to recognize its importance, and they all want to know more. This curiosity is a great starting point, and it means we can easily find a talking point that interests people and use that as a springboard.

When talking with non-scientists, look for an area of common interest between what you’re doing and what interests the person you’re talking to. You might have to talk about multiple things until you see that light of recognition. When you do find an area of common ground, grab onto it and use it as a point of reference to start making connections.

It’s important to keep your conversation as free of jargon as possible, at least when you start. We are so used to the detailed language we use with our peers, it’s hard to take a step back and have a more general conversation, but it is so important to have people walk away understanding the importance of your work and the help you need, that you really must put it in terms they can grasp.

If you want to talk to someone about a very specific topic, walk them into that content by scaffolding it to something they already know and understand. It’s very difficult for somebody to internalize new knowledge if they can’t tie it to something they already know.

I believe that when you use public funding for your science, you have an obligation to explain to the public what it’s about. And this community outreach aspect was very important to the founders of HudsonAlpha, so I have the support of the larger organization in this.

Kate: How did your previous experience lead you to this job?

Neil: I look back at everything from my graduate training on, and each of those things prepared me for what I’m doing now. My graduate training and time on the faculty at Emory gave me an understanding of the field, the language, and the vocabulary I have needed. After my PhD, I spent two years working at a church doing communications work and outreach to families, which gave me the comfort and confidence to step into challenging conversations in a sensitive way and to talk about science to non-scientists. While at Emory, I directed a research-based DNA testing lab, which gave me familiarity with the tools, instrumentation, and challenges of DNA variant detection and interpretation. I also taught medical students at Emory, which confirmed my passion for teaching and emphasized to me that I’m a much stronger educator than a research scientist.

This recognition helped with the shift in my career. All of these experiences help me, as VP of Educational Outreach, talk about complicated topics that are often fraught with emotional and ethical issues to a broad range of individuals. They’ve helped me find the right analogies and language, and really translate science going on here and elsewhere into tools, applications, and experiences that engage students, teachers, clinicians, and the public. What I do today, I could not have done without the skills I learned at each of those previous jobs.

Kate: What are your favorite genetics websites and resources?

Neil: I spend a lot of time looking for recent genetic discoveries that I can share, and I use what I find as the sources for an annual guidebook on biotechnology that I craft. I’m always reviewing papers and summaries looking for materials. My go-to sources are things like The Scientist, GenomeWeb, and Genome magazine, and I spend a significant amount of time with the “This Month in Genetics” section of The American Journal of Human Genetics. (Note from Kate, who writes that section in AJHG: I absolutely did not bribe him to say that!)

For K-12 stuff that I recommend for students and educators, I’m a really big fan of learn.genetics out of Salt Lake City and Genome: Unlocking Life’s Code, which was developed with NHGRI for an exhibit and whose website has ongoing content and resources.

Kate: What are you currently reading/thinking about/working on?

Neil: We are putting an intentional emphasis on bioinformatics and computation. We are working on a project with two- and four-year schools across Alabama where students will be computationally modeling the impact of DNA variants that we are identifying in patient populations here at HudsonAlpha. We are trying to help undergraduates learn some of the concepts and tools around genomics, including bioinformatics tools and comparative genomics, so it’s going to be fun to watch how that evolves.

At the high school level, the state of Alabama has a number of projects underway to help celebrate the state’s bicentennial in 2019, and we have one project called “Bicentennial Barcoding”. We are working with high school classrooms across the state in partnership with wildlife preserves, nature centers, botanical gardens, and communities to identify native Alabama plants and then DNA barcode them.  We want students to recognize the rich diversity of plant life in the state and to think about ways to protect it, and then we want to tie genetics, biotechnology, and computation to it to give them a different angle to look at those plants.

These are just a couple of many projects they we have going on right now. They are great ways to look at how we can push what we do here at HudsonAlpha out into the community and really build excitement and enthusiasm in lots of places across the state.

Kate: What everyday thing are you better at than everyone else? What’s your superpower?

Neil: My superpower is communicating complex topics in an easy to understand way. That is the essence of who I am. There are a lot of things that I am not, but being able to communicate things in a way that people say “Oh, I get that!” – I’m really good at that, and I think that’s why this job at HudsonAlpha is a great job for me. It’s all about taking the science and its applications and finding ways to tell those concepts, tell those stories, so that people say “Wow! That’s cool!” or “Wait, that’s a job I could consider?” or “Now I understand that soundbite I heard on the radio”.

Kate: I would go one further and say that one of your other superpowers is getting people excited about this stuff. It’s not just the language you use, it’s also that you do it in such a way that I can see how excited you are and that makes me excited about it too.

Neil: One of my team’s philosophies is to think about how we can create sparks that ignite somebody else’s enthusiasm or love of learning or desire to want to know more.

Neil Lamb, PhD, is Vice President for Educational Outreach at the HudsonAlpha Institute for Biotechnology. He has been a member of ASHG since 2000, served on its Information & Education Committee from 2003-05, and chaired the I&E Committee from 2007-09.

 

 

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.