Several members of the GSA community were elected to the National Academy of Sciences (NAS) at their annual meeting this year. Election to NAS is considered one of the highest honors for scientists in recognition of their distinguished and continuing achievements in original research. Congratulations to the following outstanding scientists:

	Bonnie Bartel  Ralph and Dorothy Looney Professor of Biochemistry and Cell Biology, department of biosciences, Rice University, Houston GSA Board of Directors, 2011-2013 GENETICS Editor, 2002 -2012
	James J. Bull Johann Friedrich Miescher Regents Professor, department of integrative biology, The University of Texas, Austin GENETICS Editor, 2010-2014; Associate Editor, 2015; Author, 2013 G3 Author, 2013
	Hongjie Dai J.G. Jackson and C.J. Wood Professor of Chemistry, department of chemistry, Stanford University, Stanford, Calif.
	Joseph DeRisi investigator, Howard Hughes Medical Institute; and professor and chair, department of biochemistry and biophysics, University of California, San Francisco
	Mary Lou Guerinot professor, department of biological sciences, Dartmouth College, Hanover, N.H.
	Philip Hieter professor of medical genetics, Michael Smith Laboratories, University of British Columbia, Vancouver, Canada GSA President, 2012; Vice-President, 2011 GSA Board of Directors, 1995-1997 GENETICS Author, 2013, 2014
	Hopi E. Hoekstra investigator, Howard Hughes Medical Institute; and Alexander Agassiz Professor of Zoology, departments of organismic and evolutionary biology and of molecular and cellular biology, Harvard University, Cambridge, Mass. GENETICS Author, 2013
	Krishna K. Niyogi investigator, Howard Hughes Medical Institute; faculty scientist, physical biosciences division, DOE-Lawrence Berkeley National Laboratory; and professor, department of plant and microbial biology, University of California, Berkeley
	Amita Sehgal investigator, Howard Hughes Medical Institute; and John Herr Musser Professor of Neuroscience, Perelman School of Medicine, University of Pennsylvania, Philadelphia TAGC Keynote Speaker, 2016
	Geraldine Seydoux investigator, Howard Hughes Medical Institute; and professor, department of molecular biology and genetics, Johns Hopkins University School of Medicine, Baltimore GSA Board of Directors, 2005-2007 G3 Author, 2013; GENETICS Author, 2014

NAS members are elected by current active members through a selective process that recognizes individuals who have made major contributions to the advancement of scientific research. The newly elected members raise NAS’s total active membership to 2,291 and the number of international members to 465.

The National Academy of Sciences is a private, nonprofit institution that was established under a congressional charter signed by President Abraham Lincoln in 1863. It recognizes achievement in science by election to membership, and collaborates with the National Academy of Engineering, Institute of Medicine, and National Research Council to provide science, technology, and health policy advice to the federal government and other organizations. Membership in the NAS is widely regarded as a mark of excellence in scientific research.

Additional Information:

• “National Academy of Sciences Members and Foreign Associates Elected” May 3, 2016.

A proposed rule from the U.S. Department of Labor could soon mandate that postdocs making less than $50,440 per year will be eligible for overtime pay at 1.5 times their hourly rate. Research labs are generally not prepared to track overtime hours and many do not have the additional funds available to pay postdocs above their current stipend. As the Department of Labor deliberates on the final rule, many questions remain. We outline the issue along with some concerns and potential outcomes in this post.

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Postdocs often join research groups to expand their training and expertise in a well-defined corner of science by training with an established and respected mentor. In fact, this once optional training period has become almost required in the life sciences.

In many ways, a postdoctoral position is like other early career positions outside of academia: the hours are long, the daily tasks aren’t always glamorous, and your boss–or primary investigator (PI) in the case of a postdoc – can influence your future success. However, postdocs are anything but green entry-level employees; they are highly trained individuals who have worked on an independent research project in a research laboratory through 5-7 years of graduate study.

When it comes to pay for postdocs, most universities follow the minimum salary guidelines for trainees set by the National Institutes of Health (NIH) for those on National Research Service Award traineeships and fellowships, which pays a first year postdoc with no experience $42,840  But everyone isn’t paid from this type of grant and many earn salaries lower than this minimum.  One survey reports that the earnings vary between $37,000 and $63,000 per year for postdocs in the United States.  Add this to the fact that many of the nation’s top universities where postdocs congregate are located in some of the country’s most expensive cities. Consider this monthly salary for a single individual living in Boston—which is home to several of the top genetics programs in the country— where the average rent for the metropolitan area was $1200 per month in 2014. It’s probably no surprise that postdocs quickly saw President Obama’s announcement to alter overtime exemption requirements as an opportunity to shed light on their situation.

The legislation in question is the Fair Labor Standards Act (FLSA), which establishes minimum wage, overtime pay, and other employment standards affecting employees in the private sector and in Federal, State, and local governments. The proposed change to FLSA would mandate that employees with a salary under $50,440 would be classified as “non-exempt” and be eligible for overtime pay at a rate of 1.5 times the hourly rate.

Postdocs across America rallied behind the proposed rule change, signing petitions and writing letters asking for an increase in minimum salary to $50,440 or to be considered for overtime pay. Organizations like the National Postdoctoral Association and the University of California’s postdoctoral union, UAW Local 5810, wrote position statements urging the Department of Labor to implement the proposal, converting a large sector of the scientific workforce from exempt to non-exempt status. Other groups like the American Society for Biochemistry and Molecular Biology and the American Association of Medical Colleges issued statements advocating for any change to be incremental. With the comment period now closed, the Department of Labor is deliberating on the information gathered and will issue its final ruling in July 2016, according to the proposed timeline.

While we can’t say what the final ruling will be, GSA explores some of the potential outcomes for postdocs and the scientific enterprise if the rule is implemented to require that postdocs paid under $50,440 be paid overtime.

In one scenario, an institution could pay postdocs overtime. This possibility requires a significant administrative burden on the PI, the postdoc, and the institution. The postdoc would have to document all hours worked to determine which should be considered for overtime—a departure from the average academic laboratory culture. The PI would have a more difficult time estimating the cost of postdocs for budgets in grant proposals and justifications. Paying overtime to postdocs who regularly work well beyond 40 hours per week would likely cause a reduction in such positions in even well-funded research groups.

In another scenario, an institution could opt to raise the postdoc salary to at least $50,440. This option would require PIs to identify ways to meet the higher salary requirement from existing grant funds—at least for the first year or two of implementation. Funding Agencies could increase the amount of funding per grant to offset these costs, but this would require steep budget increases from Congress. It is more likely that providing this raise will lead to a reduction in postdoc positions across labs.

In a third scenario, the Department of Labor could explicitly exempt postdocs or training positions more generally from these classifications. Currently postdocs paid from research grants awarded to their PI are generally considered employees by institutions, while postdocs with individual fellowships and traineeships are classified as trainees. Should the rule be amended to include language specific to postdocs, this discrepancy would have to be addressed. If the proposed policy mandates that institutions change the way they classify postdocs, then the rule will impact benefits, visas, taxes, and more.

Rapid changes to the system could have dramatic implications. Even the National Postdoctoral Association has called for a graduated approach to increasing stipends. Without an increase in federal funding, the long term effect would inevitably be a reduction in the number of academic postdocs. Studies on the biomedical workforce have called for such a decrease for years (e.g., a 2000 report from the National Academies of Sciences, Engineering, and Medicine) as a remedy to the low postdoc salary; however, phase-in would not be simple.

NIH raised its minimum postdoc salary for fellowship recipients by 7% in 2014 and again by 2% in 2015 in response to a 2012 Report from the Biomedical Workforce Working Group that called for stipend levels to “better reflect years of training.” If the implementation time for these recommendations is a bellwether, it could take a few years for the agency to change its salary policies in response to the forthcoming ruling by the Department of Labor.  Unofficial comments from well-informed NIH employees suggest that the agency hopes for an exception or clarification of how it should proceed in the final rule. Congress could also impact the way NIH responds through the legislative process.

While we await the final word on the revised Fair Labor Standards Act, one thing is clear: anyone with a stake in postdoctoral training should be prepared for potential changes.

Do you think academic postdoc salaries should be raised through the mechanism of overtime or a Department of Labor salary minimum? How would an increase in postdoc salary impact your research lab? Share your comments below.

Last week, the National Academies of Science and Engineering joined forces with the Chinese Academy of Science and the Royal Society of the United Kingdom to host an International Summit on Human Gene Editing in Washington, DC. Top scholars in genetics, bioengineering, ethics, and law debated the merits of human gene editing; however consensus was far from achieved. In fact, the repeated reminders of “unknown unknowns” and references to Brave New World left participants wondering how such disparate opinions could be formed into a single set of guidelines from the summit organizing committee.

The final statement from the organizing committee, released at the conclusion of the summit, signified that this gathering would not be the place where final decisions were made. Instead, the committee used the three days of insightful perspectives to develop a framework for how information should be collected. The point of the summit was not to answer the looming questions surrounding human gene editing; rather, it was to determine what questions to ask—and of whom—in order to begin developing recommendations on how to move forward with this technology.

The mix of individuals in the room reflected the planning committee’s efforts to include—but not be limited to—the “usual” perspectives we often hear about these issues. Speakers included important insights and an excellent overview of the process of gene editing and its development in basic research labs, including input from GSA members Jennifer Doudna (UC Berkeley) and Maria Jasin (Memorial Sloan Kettering Cancer Center), GENETICS Associate Editor George Church (Harvard University), George Daley (Harvard University), Emmanuelle Charpentier (Laboratory for Molecular Infection Medicine Sweden, Helmholtz Centre for Infection Research, Medical School of Hannover, and Max Planck Institute for Infection Biology), Jonathan Weissman (UC San Francisco), and Bill Skarnes (Sanger Institute). Videos of the scientific perspectives they and others shared at the meeting can be found here, but the scientific researchers’ perspective held a common theme: basic research on human gene editing must continue if ever we are to understand the risks and advantages to applying the science for a therapeutic purpose.

There has already been a steady stream of articles on the scientific issues involved with gene editing, so this post will not focus on that, except to emphasize that gene editing is not a new topic: although the technologies continue to evolve, CRISPR-Cas9 is only the latest in a series of advancements that have made this easier to do. In addition, many in the model organism communities have led the way in not only developing these techniques, but in conducting the essential background research that can inform the consideration of the opportunities, risks, and implications of gene editing.

An especially interesting part of the summit was the opportunity for scientists to hear important philosophical and ethical perspectives from leaders across diverse social science fields—voices that they may not typically hear in their daily consumption of news and research, or interactions at conferences.

These voices were introduced in a philosophical debate on human rights and consent in the context of reproduction. John Harris (University of Manchester), vehemently argued that the rights of a future child could not be violated because he or she is not yet born; Hille Haker (Loyola University Chicago) opposed this thinking, calling for a moratorium on human germ line gene editing for at least two years citing the lack of consent of the future child. Marcy Darnovsky (Center for Genetics and Society) reminded the room of the societal implications of germ line editing, warning that parents will want to choose traits that society values most. Sharon Terry (Genetic Alliance) provided the patient perspective stating “we need hope not hype.”  With these talks, the question shifted from can we edit the human germ line to should we?

Representatives from South Africa, Nigeria, Israel, China, Germany, India, and Sweden made the realities of medical tourism clear, calling for global collaboration to inform national laws. They also stressed the importance of recognizing and respecting differences among cultural norms across nations. For example, in Israel parenting a genetically related child is considered a right that is reflected by government financed health care coverage for women to receive unlimited in vitro fertilization (IVF) to produce up to two children. In addition, most couples there agree to genetic screening. Such views could make Israeli society more amenable to a technology that could improve the outcome of IVF. Conversely, Germany has passed national legislation outlawing human germ line gene editing and attaching a five year prison sentence to its violation.

The question of how to ensure equitable access to human gene editing technology was addressed by an outstanding panel of social scientists who drew very clear lines between the introduction of new technologies and therapies and the inequitable means by which they are available to the public. Ruha Benjamin (Princeton University) saliently described existing practices as “trickle down biotechnology.” Catherine Bliss (UCSF), author of Race Decoded, closed the summit by providing the historical context of race in genomic research, serving as an all-too-appropriate bookend to the summit’s opening talks from Alta Charo (University of Wisconsin) and Daniel Kevles (Yale University) on eugenics in America and beyond.

While the Summit served as an excellent opening dialogue, it ended like many scientific experiments: with more questions to answer. Who should have been included in this conversation, but was not? How much basic research is enough to convince the public of the safety of human germ line gene editing? Can the costs of this technology be mitigated for equitable access? Is there a way to govern the use of this technology such that the blurry line between therapy and enhancement is not crossed? It is the charge of a new committee, led by Alta Charo and Richard Hynes (Massachusetts Institute of Technology) to find answers to these questions.

For now, the International Summit on Human Gene Editing planning committee urges the continuation of basic research in this area and calls human germ line editing in the clinic “irresponsible” at this time.

We welcome your opinions in the comment section below.

Related Headlines:

• International gene editing conference declines to ban eventual use in humans
• Scientists debate ethics of human gene editing at international summit
• Dare we edit the human race? Star geneticists wrestle with their power
• Top takeaways from day 1 of #GeneEditSummit
• A Conversation with CRISPR-Cas9 Inventors Charpentier and Doudna

The Committee on Gene Drive Research in Non-Human Organisms convened by National Academies of Sciences, Engineering, and Medicine held an information gathering meeting on October 28, 2015, to consider the Science, Ethics and Governance Considerations for Gene Drive Research.  This meeting comes as a component of a large Gene Drive study, which is set to review the state of the science of gene drive research that relies on genome editing techniques, such as CRISPR/Cas9 and other endonucleases or other genetic modification approaches, focusing on identifying the key scientific techniques for reducing ecological and other risks that should be considered prior to field releases of organisms carrying gene drives.

Committee co-chairs Elizabeth Heitman (Vanderbilt University) and James Collins (Arizona State University) opened the workshop by outlining the purpose of the Gene Drive Study and the objectives for the day. This was followed by a scientific discussion where Austin Burt, professor of evolutionary genetics at Imperial College London and co-author of Genes in Conflict, an extensive review of the biology of gene drive systems, gave a sweeping overview on the current state of the field and the possibilities and challenges of gene drives. Burt cautioned the committee to remember that gene drives release an organism into the environment, not just a single gene. To inform the committee on engineered nucleases, Shengdar Tsai, a postdoctoral scientist in Keith Joung’s lab at Massachusetts General Hospital and Harvard Medical School, shared experience with defining and identifying off-target sites, stating that “in some cases, off target sites can be cleaved with equal or higher frequency than on-target sites.” He also showed evidence that in silico methods fail to predict a majority of off-target cleavage sites and urged the committee to empirically assess the genome-wide potential for gene drive applications.

The scientific discussion closed with a conversation on the ecological and evolutionary conditions for gene flow led by Allison Snow, professor in the Department of Evolution, Ecology, and Organismal Biology at The Ohio State University and GSA member Nora Besansky, O’Hara Professor of Biology at the University of Notre Dame. Snow posed a central unknown question: Where will genes go and what happens if they get into the wild, underscoring the dearth of experience the field has with gene flow in plants outside of a small number of genetically engineered crops. She cited several key risks to avoid and called for an environmental risk assessment for each gene drive application to include information on reproductive rates, gene flow, potential for long distance dispersal, expected ecological and evolutionary effects, and level of uncertainty for predicting outcomes. Bersansky echoed the sentiments of Dr. Snow, noting that gene flow is a rare occurrence in multicellular animals, but it’s negative implications should not be underemphasized.

Four speakers were invited to present ethical considerations. The first, Francis Macrina, vice president for research at Virginia Commonwealth University, asserted the need for education to promote responsible research in gene drives, a reliance on scientific expertise to develop regulations, and a sense of shared responsibility among investigators, regulators, institutions, and publishers. The second speaker, Bruce Jennings, Director of Bioethics at the Center for Humans & Nature, suggested that the committee carefully conceptualize the power of gene drive technology (and upon whom it is imposed) to draw ethical criteria for governance. He further argues that we should place gene drive regulation in the broader context of global biotechnology regulation.  The final pair of talks on this topic where presented by Andrew Light, director, and Jesse Kilpatrick, assistant director, of the Institute for Philosophy and Public Policy at George Mason University. Their joint presentation brought forward the dichotomy of extrinsic considerations—such as safety, potential risk, and hazards—versus intrinsic considerations—such as whether gene drives are good for humanity and moral questions of “playing god.” Light and Kilpatrick recommended that the committee look for opportunities to bring moral and factual arguments together, using less polarizing language in public forums to help build consensus around the ethics of gene drive.

Because gene drives have clear applications in low and middle income countries, the committee invited Diran Makinde, director of the New Partnership for Africa’s Development Planning and Coordination Agency; Wannapa Suwonkerd, assistant director of the Office of Disease Prevention and Control in the Office of Administrative Health in Thailand; and Norma Padilla, director of the Center for Health Studies at the Universidad del Valle de Guatemala. Each of these speakers provided case studies for successful partnerships between researchers and local communities to reduce the prevalence of vector born diseases like malaria in their respective countries, highlighting the need for better training of local scientists who have ties to the community. The presenters also addressed the need for the scientific community to establish trust in areas where they plan to implement gene drive tests.

The final talks of the day focused on the broader topic of scales of governance for biotechnology. David Wirth, professor of law at Boston College, gave an overview of mechanisms to govern biotechnology, carefully noting that there is no clear regulation on an international scale. Megan Palmer, senior research scholar and Willam J. Perry Fellow in International Security at the Center for International Security and Cooperation at Stanford University, discussed U.S. governance of biotechnology, focusing on the gaps in implementation once oversight is in place. She urged the committee to think about how emerging technology shapes who has the capacity and power to govern and underlined the need to develop systems to manage and monitor the impact of biotechnology regulations. Zach Adelman, associate professor of entomology at Virginia Tech, shared his experiences in institutional governance, noting that existing NIH guidelines require institutional biosafety committees, which could regulate most laboratory gene drive experiments.

During the public comment period, GSA offered the following suggestions to the committee:

On behalf of the more than 5,500 members of the Genetics Society of America, many of whom have utilized gene editing technology in model organisms for decades, we are pleased to see the clear incorporation of scientific evidence into your considerations for the science, ethics, and governance of gene drive research.

To that end, we encourage the committee to continue to look closely to the model organism genetics community for information about the impact of genetic modification on populations. Indeed, these researchers’ experiences can calibrate the appropriate ethical responses to the scientific potential of gene drive research and its implications for society.

We are concerned that much of the public debate around these issues has not fully considered the actual scientific evidence on the safety and efficacy of genome editing and gene drive approaches. However, we are hopeful that this committee will [continue to] approach these issues with the appropriate regard for the peer-reviewed scientific literature and the expertise of researchers familiar with these process.

We therefore encourage the committee to continue to look to the model organism genetics community, incorporating their broad knowledge base of evolution, behavior, and reproduction as it moves toward recommendations for responsible Gene Drive Research.

The Genetics Society of America stands ready to work with the committee as you continue through the study process.

The entire workshop is available to view online.  Additional coverage on gene drives is available from Science magazine and NPR.

Relevant reading on Genes to Genomes:

Using genetic manipulation to fight disease 

Two members of the GSA community have been elected to membership in the National Academy of Medicine (NAM), formerly known as the Institute of Medicine. Election to NAM is considered one of the highest honors in the fields of health and medicine and recognizes individuals who have demonstrated outstanding professional achievement and commitment to service.

Mario R. Capecchi, PhD
Distinguished Professor of Human Genetics and Biology
University of Utah School of Medicine
Nobel Prize in Physiology or Medicine, 2007
National Medal of Science, 2001

Kevin Struhl, PhD
David Wesley Galser Professor of Biological Chemistry and Molecular Pharmacology
Harvard Medical School

GENETICS Author, 2008, 2001, 2000, 1999

NAM members are elected by current active members through a selective process that recognizes individuals who have made major contributions to the advancement of the medical sciences, health care, and public health. The newly elected members raise NAM’s total active membership to 1,826 and the number of international members to 137.

Established originally as the Institute of Medicine in 1970 by the National Academy of Sciences, the National Academy of Medicine addresses critical issues in health, science, medicine, and related policy and inspires positive actions across sectors. NAM works alongside the National Academy of Sciences and National Academy of Engineering to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. With their election, members make a commitment to volunteer their service in the Academies’ activities.

Additional Information:

• “NAM Elects 80 New Members,” October 19, 2015.

The Human Gene-Editing Initiative launched earlier this year by the National Academy of Science and the National Academy of Medicine held a public meeting to provide an overview of the state of gene editing science in preparation for an international summit to conducted in partnership with the Royal Society and the Chinese Academy of Sciences. The summit planning committee, led by Nobel Laureate David Baltimore of the California Institute of Technology, heard from leaders in the gene editing field as well as the public in this information gathering meeting.

Robin Lovell-Badge of the Francis Crick Institute set the tone for the day, providing the historical perspective of gene editing technology and its application in various organisms. This was followed by a robust discussion of current technologies by Jennifer Doudna of HHMI and UC Berkeley, George Church of Harvard Medical School, and Feng Zhang of the Broad Institute. The conversation moved to potential limitations of gene editing technology, including the efficiency and off-target implications of current techniques in a discussion led by Fyodor Urnov of Sangamo Biosciences and Richard Frock and Chad Cowan of Harvard University.

To learn more about the progress of gene editing in China, the committee invited Duanqing Pei and Qi Zhou from the Chinese Academy of Sciences (CAS). After a broad overview of gene editing research across China, Pei and Zhou focused their discussion on the impact of Chinese guidelines on human gene research, stating that  “Both Chinese scientists and the government are aware of the pros and cons of gene editing. CAS scientists have organized panel discussion meetings and coordinated with related agencies for regulatory policies on this issue.” The importance of clear guidelines for human gene editing on an international scale was underscored, citing regulatory challenges that can arise when collaborating internationally.

The last discussion topic for the day—led by Nancy Wexler of Columbia University and George Daley of Boston Children’s Hospital, HHMI, and Dana-Farber Cancer Institute—focused on approaches to treat, avoid, and prevent genetic disease. The two speakers highlighted key opportunities for human gene editing to reduce disease in children when their parents carry genes for maladies such as Huntington’s Disease, sickle cell anemia, or thalessemia.

During the public comment period, GSA offered the following comments to the committee, emphasizing the relevance of fundamental researchers in these on-going conversations.

On behalf of the over 5,000 members of the Genetics Society of America, many of whom have utilized gene editing technology in model organisms for decades, we are pleased to learn that the National Academies are taking an active interest in decision making regarding human gene editing. Indeed, new technologies, like CRISPR/Cas9, have democratized gene editing research by extending the range of organisms in which editing is feasible. As the committee considers standards, guidelines, and practices governing the use of gene editing technologies in biomedical research and medicine, GSA asks that the committee look to the fundamental research community for scientific insight into the risks and benefits of gene editing technology. While human gene editing may be a new frontier in science, it has been a trademark of model organism studies for some time. The expertise and experience garnered from these studies can inform the discussions at the international summit in the same way that they enhanced the recently held Genome Engineering meeting held at Cold Spring Harbor last month. We at GSA appreciate the opportunity to share our comments, and look forward to the outcomes of the International Summit this fall.

We will continue to follow the activities of the Human Gene Editing Initiative and share news and information as it is available.

A new report from the National Academies of Sciences, Engineering, and Medicine concludes that the continuing growth of federal research regulations and requirements is “diminishing the effectiveness of the nation’s research investment” by forcing investigators to spend more time on administrative and compliance matters, rather than research.

Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1 identifies specific actions to reduce the regulatory burden, with different recommendations aimed at Congress, the White House Office of Management and Budget (OMB), federal agencies, and academic research institutions.

The report calls for strengthening the partnership between the government and university research and urges the establishment of a government-enabled, private-sector Research Policy Board to support this partnerships and work to streamline research policies.

The Academies point out that different federal agencies have differing—and sometimes conflicting—guidance on compliance in areas such as financial conflict of interest, animal care, grant proposals, and the like.

Some of the specific recommendations in the report include the following:

• Congress should work with OMB to conduct a review of agency research grant proposal documents for the purpose of developing a uniform format to be used by all funding agencies;
• Congress should work with the White House Office and Science and Technology Policy (OSTP) and research institutions to develop a single financial conflict-of-interest policy to be used by all research funding agencies;
• Congress should instruct OSTP to convene representatives from federal agencies that fund animal research and from the research community to assess and report back to Congress on the feasibility and usefulness of a unified federal approach to policies and regulations pertaining to the care and use of research animals;
• OMB should require that research funding agencies use a uniform format for research progress reporting;
• Federal agencies should limit research proposals to the minimum information necessary to permit peer evaluation of the merit of the scientific questions being asked, the feasibility of answering those questions, and the ability of the investigator to carry out that research; and
• Universities should conduct a review of institutional policies developed to comply with federal regulations of research to determine whether the institution itself has created excessive or unnecessary self-imposed burden;

The study was mandated by Congress and supported, in part, by funds from the U.S. Department of Education and the National Institutes of Health. The committee is chaired by University of Texas president emeritus Larry Faulkner, with Rockefeller University vice president and general counsel Harriet Rabb serving as vice-chair.

Additional Information:

• “Inconsistent, Duplicative Regulations Undercut Productivity of U.S. Research Enterprise; Actions Needed to Streamline and Harmonize Regulations, Reinvigorate Government-University Partnership,” September 22, 2015.
• National Academies of Sciences, Engineering, and Medicine. 2015. Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press.