CRISPR regulation

As the debate about heritable genome editing unfolds, divergent perspectives are coming more clearly into view. Those who see it as offering little or no benefit while posing unacceptable societal risks support either the currently prevailing policies that ban it outright, or a moratorium that leaves the option of prohibition on the table. Enthusiasts, in contrast, speak of a “responsible path forward.” They dismiss the need for anything called a moratorium, and backpedal on the commitment to broad societal consensus made at the first International Summit on Human Gene Editing, in 2015.

There is one point of agreement: nearly everyone says they favor public engagement in the decision. But as suggested by the contributions to the Spring 2019 edition of Issues, there are important differences over just what kind of public engagement and deliberative process each has in mind.

The Center for Genetics and Society, a public interest and social justice organization, has long pressed the case for prohibiting human germline modification. We are confident that a meaningful deliberative process will conclude that this use of powerful genetic tools has no place in a just and fair future. We suggest that such deliberations will require first, an expansive model of public engagement; second, a significant reframing that puts social context and consequences rather than physical risks at the forefront; third, a concerted effort to clear up confusions that currently distort public understanding; and finally, the time, financial support, and human resources to make these criteria feasible. Some thoughts on each follow.

Broad and inclusive participation. Genuine public debate must involve a far wider range of voices and concerns than those included so far. Among the all-but-missing are scholars in the social sciences and humanities, and public interest advocates for reproductive, racial, disability, and LGBTQ rights and justice. The small number of these representatives presenting or participating at the two international scientific summits on human genome editing falls dramatically short of meaningful public participation.

Center the social. Most considerations of heritable genome editing focus on technical and scientific matters. Concerns grounded in recognition of systemic patterns of social discrimination and stratification, powerful commercial dynamics, and historical contexts including widespread eugenic abuses are seldom investigated. Although these issues are ill suited for laboratory experiments, they bear importantly on the likely consequences of heritable genome editing and require careful collective consideration.

Confront misunderstandings. Meaningful deliberations will require clearing away a number of confusions that have become widespread. Among these is the frequent characterization of heritable genome editing as a medical intervention, when it is much better understood as a way to satisfy parental preferences for genetically related children. Most people haven’t considered this point, in part because media accounts downplay or ignore the existing methods by which at-risk parents can avoid passing on serious genetic diseases. In our review of articles and commentaries on heritable genome editing in three prestigious newspapers over an 18-month period, fully 85% failed to mention this.

Support meaningful public deliberations. The international summits on human genome editing were multiday events with hundreds of participants and voluminous media coverage. Nothing close to the resources expended on those meetings has been available to convenings—or to any other deliberative process—with majority participation by nonscientists. Democratic governance requires adequate time, hard work, and human and financial resources.

The coming policy decision about altering the genes of future generations carries huge stakes, including the prospect of dividing future societies into genetic “haves” and “have-nots.” This is one we have to get right.

Marcy Darnovsky

Executive Director
Center for Genetics and Society

In the workplace, people work better, harder, smarter, and have more job satisfaction when they are paid fairly, where transparency of governance is the norm, and where all workers feel they have a voice and perhaps even a stake in how the company is run. When policy and management create an adversarial, disrespectful, authoritarian environment, workers are more likely to be surly, apathetic, resentful, pissed-off. Governance needn’t be a popularity contest; expertise needn’t be devalued. Decision-making simply needs to be open, fair, just. It’s about the process, and it’s not hard to spot.

Such a process is what I understand Françoise Baylis to be calling for in “Human Genome Editing: Our Future Belongs to All of Us” with respect to citizenship and germline gene-editing policy. As she has noted elsewhere, when scientists control ethics discussions, the conversation tends to focus on only two issues: safety and efficacy. In considering germline gene therapy, safety and efficacy are necessary but not sufficient. Baylis insists that germline engineering raises significant questions of risk, equity, and justice that need to be at least heard and seriously discussed if we are to proceed ethically.

Consensus-building will slow down the science a bit. This frustrates scientists who believe that maximum speed must be sustained in the march toward new therapies. Some scientists have essentially told ethicists and other nonscientists, “Get out of the way.”

Arrogance, hubris, and unintended consequences are all-too-common themes in the history of human genetic manipulation. Perhaps science with high moral and ethical stakes should be slowed down a bit. I wish bioethicists and other critics had been in the way when Harry Laughlin, of the Eugenics Record Office in Cold Spring Harbor, New York, lobbied a century ago for eugenic sterilization laws. I wish they had been in the way when Stanfield Rogers in 1970 and Martin Cline in 1980 performed rogue gene therapy experiments on people. I wish they had been in the way when unforeseen consequences of gene therapy caused the death of the American teenager Jesse Gelsinger in 1999 or the two French girls who in 2002 successfully incorporated a gene to repair their severe immunodeficiency but succumbed to iatrogenic leukemia. Bioethicists and other concerned citizens: get in the way!

Even conscientiously inclusive scientific projects can go awry when they lack broad consensus among stakeholders. Case in point: the Human Genome Diversity Project of the 1990s. Politically progressive scientists seeking to broaden ethnic representation in DNA databases were shocked to learn that the indigenous peoples whose DNA they wanted to “rescue” didn’t want scientists taking parts of their bodies to use for their own purposes. Similarly, health care workers in developing countries have learned that medical aid is received much more favorably when they take care to enroll the affected communities. When researchers and health care workers do otherwise, it feels like biomedical colonialism.

In short, it is perfectly possible to know “broad international consensus” when we see it, and the historical record is rife with cautionary tales of science gone askew when such consensus fails to be reached.

Nathaniel Comfort

Institute of the History of Medicine
Johns Hopkins University

I read with the interest the thoughtful article by Mohammed Ghaly on “Islamic Ethical Perspectives on Human Genome Editing.” It should be noted that this discussion is timely given the recent events that reminded us once again how science tends to move ahead of ethics, and the consequences of such gaps as exemplified by the announcement of the birth of two genetically edited babies in China. The latter development has created an outcry not only from the public but from the very scientific community that developed the enabling tools for such editing.

As with many contemporary ethical questions, the religious establishment often has one or more stances that can influence public opinion, and these positions should not be ignored since public engagement in the ensuing debate is key to addressing these questions. Ghaly was careful in listing the different opinions among Muslim scholars with respect to genome editing and the basis of such opinions. In general, he painted a favorable picture in which approval is the rule rather than the exception, which is an encouraging start.

Unfortunately, it is unclear what the relative distribution is among Muslim scholars of the contrasting opinions. This is key because Ghaly seems to suggest the presence of a liberal school of thought that supports even the most hotly contested application of genome editing—that is, germline editing for the purpose of enhancement. But the article provides little with regard to how this camp favors permissibility of such drastic actions to alter the human race in the face of unpredictable risks, to say nothing of the issue of inequality between those who can afford this technology and those who cannot, or even the very basic issue of fairness of resource allocations, all of which are fundamental principles in the Islamic Law.

Ghaly correctly pointed out the seeming obliviousness to the issue of consent among future descendants, but it should be clearly stated that even the apparent dismissal of the issue of consent among one’s own children on the basis of guardianship laws seems out of context. Indeed, it is hard to see the analogy between the power of guardianship granted by Islam to the parents to act in the best of interest of their children when making decisions about their treatment, and the power to override the children’s consent about what will be a permanent and transgenerational change.

The danger of curious, unilateral, and uninformed religious opinions about such an extremely complicated and multifaceted issue of societal importance as genome editing cannot be overemphasized. It is precisely for this reason that the institutions of religious rulings on contemporary issues that Ghaly mentioned must take up the issue of genome editing and analyze it systematically with input from subject matter experts. For now, however, the sense of optimism conveyed by Ghaly is a reason to believe that the discourse around genome editing among Muslim scholars will at the very least not stifle the adoption of this disruptive technology and may very well embrace it in positive ways to improve human well-being.

Fowzan S. Alkuraya

Head, Developmental Genetics Unit
King Faisal Specialist Hospital and Research Center
Riyadh, Saudi Arabia

The authors of the articles on the reality and future prospects of genetically engineered babies offer reflections on the appropriation of human biology by technology so as to improve the outcomes—a bioengineering strategy much like our species has done with plants and animals over past millennia. As Peter Mills points out in “Three Venues for Discussing Human Gene Editing,” these are not therapeutic interventions, since there are not yet any existing persons to be treated. Says Mills: “What is at stake in the use of genome editing is bringing about the birth of a human being with one set of genetically conditioned features rather than another set.”

Is this a path that would be destructive for the human species to go down? Many deliberative bodies have concluded that it is. In her article, Françoise Baylis acknowledges that “the [global] political consensus on heritable human genome editing…inclines toward an outright ban.” The Council of Europe’s Convention on Human Rights and Biomedicine, for example, which is legally binding on 29 countries, prohibits any gene alteration to a human embryo that would affect the genomes of the modified person’s descendants.

But with the advent of purportedly precise CRISPR-based techniques, neither Baylis nor the other commentators are having this. Baylis asserts that “we should be asking the world’s citizens to identify their interests and ideas about how heritable human genome editing technology might make their lives go better, or not.” Henry T. Greely in his article, “How Should Science Respond to CRISPR’d Babies?” avers that “demanding social acceptance before using it to make babies is both legally and politically right,” though he derides calls for even a limited-duration moratorium. Mohammed Ghaly, consulting the Islamic religious literature, concludes in his article that “there is no one-size-fits-all moral judgment that views genome editing as a single block or indivisible whole,” and that it depends on “a number of circumstances.”

The contributors seek to revisit whatever firm prohibitions are currently in place in order to accommodate interest groups that include innovative scientists and avid entrepreneurs (often the same cohort), and the objective that Mills expresses as “delivering a valued outcome as well as or better than incumbent technologies or having desirable features that those incumbent technologies lack.” The important question for him is “not ‘why do we need it?’ but, once we have it, as we one day very likely will, ‘what might we do with it?’” This (to remind the reader) relates to the civilizationally weighty prospect of bringing human beings into the realm of manufacture.

The permanent bans that have been enacted, however, reflect the reality of modern developmental biology much more faithfully than do the authors’ speculations as to future benefits of embryonic gene modification. The question of whether embryos can be safely or predictably engineered has long been settled: they cannot. This is clear from experiments on animal embryos, where altered genes are often seen to behave in unpredicted ways, and in human population studies, where genetic mutations that had been found to cause disease in some individuals or groups turned out to be perfectly harmless in others. This is entirely independent of how accurately CRISPR can be made to function. Any attempt to edit even a single base-pair in an embryo will be uncontrolled human experimentation of the kind prohibited by international legal conventions that have much broader agreement than those pertaining to germline modification.

Each of the contributors calls for some kind of international, or at least transnational, deliberation leading to accords on circumstances under which human gene modification can appropriately be performed. They all assume that it will happen, but they want it to be with a “broad social consensus,” unlike the recent case in China. Baylis expresses the wish that “We should all have a say in whether to proceed with heritable genome editing.” But the history in the United States of more obviously pressing issues such as climate change or gun control suggests that “we” is a nebulous notion, generally constituted more by money and political power than by philosophical rigor or even scientific probity. (It should be recalled that a broad social consensus for the clinical approval of three-parent embryo construction was reached in the United Kingdom through countless assertions by interested parties, over several years, uncontested by other scientists or bioethicists, that it was “mitochondrial replacement” or “mitochondrial transfer,” when it was actually nuclear transfer.)

We suggest that as with many previous cases, such deliberations will most likely come to a consensus to proceed with caution on a form of human experimentation that should never be undertaken. It is highly irresponsible to entertain the idea of using experimental gene manipulation on prospective human beings.

A call for a permanent ban will not attract universal assent, but affirming that such forms of human experimentation should be beyond the pale is the only ethically sound position.

Stuart A. Newman

Department of Cell Biology and Anatomy
New York Medical College

Tina Stevens

Department of History, emerita
San Francisco State University

They are the authors of Biotech Juggernaut: Hope, Hype and Hidden Agendas of Entrepreneurial Bioscience (Routledge, 2019)

The term “ethics dumping” was first used by the European Commission to describe the export of research practices that would be considered unethical within the European Union to countries with lower or absent legal or ethical standards or review processes. Many people based in lower- or middle-income countries know that this practice is common and relevant for the genomics era as much as it is for other types of health research. For instance, in a recent study Roger Chennells and Andries Steenkamp trace how the involvement of the San population in southern Africa constitutes a clear example of the export of unethical genomics research practices to African countries.

It should therefore not come as a surprise that we are starting to see the emerging contours of what could be framed as ethics dumping in the context of gene editing experiments. Although not yet considered thus, there are important questions that need to be investigated around the gene editing experiments conducted by He Jiankui, as described in several of the articles on human gene editing. Framed largely as an instance of isolated scientific misconduct by a rogue Chinese scientist, it is also true that He not only trained in the United States but continued to reach out to scientists based in that country, some of whom are now under investigation. What merits investigation is the extent to which He’s actions constituted not just the actions of a rogue scientist working alone, but how the international medical research community could have enabled or empowered him to do what he did and whether this could reasonably be considered a case of ethics dumping.

With the incredible speed of developments in human genome editing, and the presumed absence of regulation for gene editing research in most lower- and middle-income countries, there is a real risk that companies and research institutions from higher-income countries will turn to lower- or middle-income countries to conduct gene editing research on humans. Such research should clearly be permissible if it is in the interests of the populations of those countries and if it is done in a way that is respectful, fair, honest, and based on care for the people who are involved in the research. An example could be gene editing research on sickle cell disease that includes genuine intellectual leadership by scientists from lower- and middle-income countries. Research that does not meet such standards should be discouraged.

Jantina de Vries

Associate Professor of Bioethics
Department of Medicine
University of Cape Town

The source of UFO fascination

In “UFOs Won’t Go Away” (Issues, Spring 2019), Keith Kloor asks a broad question about the pesky tenacity of belief in unidentified flying objects: “Who benefits from these tales of close encounters?” It’s a good question: besides Bigfoot and other cryptids, it’s hard to think of another meme as persistent in conspiracy culture as UFOs.

There are places in the United States where the practical benefit of UFO tales is plain to see: back when I was a graduate student in astronomy, I took a side trip on my way to a telescope to visit Roswell, New Mexico. On Roswell’s main strip, silver-and-green-painted gift shops sell alien-themed everything. Many items are emblazoned with Roswell-specific things, but others draw from the deeper well of conspiracy theories: I left with a shot glass warning “Keep Out! Area 51 Restricted,” despite the fact that Area 51, the worst-kept secret of secret military installations, is hundreds of miles away in Nevada.

Gift shops aside, it’s not always clear who benefits from belief in UFOs. Kloor deftly summarizes the tangled threads of UFO history, from its roots in the Cold War to how true military concerns later intermixed with pop culture, creating the virtual Roswell strip that now lives in our media. It makes sense that the military would be interested in investigating anything airborne and unidentified—after all, much Cold War anxiety came from a literal UFO: the Russian satellite Sputnik, whose persistent beep launched much of the US space program. As Kloor discusses, a sustaining element in UFO subculture is this involvement of the military itself—in particular, an ongoing cast of characters fresh out of service from the Department of Defense, ready to lend the heft of their credentials to media commentary.

Beyond press attention, one wonders not only who benefits from UFO stories but also what that benefit is. Though Kloor mentions the “thriving UFO marketplace,” the benefit doesn’t necessarily seem to be money—after all, Luis Elizondo, the ex-military official formerly in charge of the Pentagon program that investigated UFOs, told Kloor that he refused a speaking fee for a recent talk. Tom Delonge, formerly of the band Blink-182 and now founder of the UFO-centric organization To the Stars Academy of Arts & Science, is essentially personally bankrolling his own organization, which is operating at an accumulated deficit of $37 million. Certainly, aliens are a perennial favorite at the box office, but by and large alien films and similar cultural commodities are capitalizing on existing interest in aliens, rather than being creations by true UFO believers.

My own research delves into questions of how we might discover life in the universe, including the search for extraterrestrial intelligence (SETI). Although I don’t believe that aliens are visiting Earth, I do chafe at how taboos can inhibit discussions about finding life. Even among astronomers—who are arguably intelligent life forms, who build technology such as telescopes and spacecraft to search for life—SETI and similar efforts are sometimes relegated to the fringe. In this way, I understand the quest for legitimacy that lies at the heart of people’s fervent belief in UFOs—a hunger fueled by a heady combination of credentialed commentators and just enough opacity to keep anybody guessing.

Lucianne Walkowicz

Adler Planetarium

Sexual harassment

Sexual and gender harassment, whenever they occur, are detrimental to the research environment and damaging to the research integrity of a laboratory, to the organizational unit, and to the wider community. They violate not only the person so treated but also the integrity of the research environment. It is this issue that is the subject of Frazier Benya’s excellent article, “Treating Sexual Harassment as a Violation of Research Integrity” (Issues, Winter 2019).

As articulated by Benya, the real issue is how to evolve our policies and processes so as to deal with sexual harassment. She proposes two broad categories of activities. The first step is to expand responsible conduct of research (RCR) training to include problems of sexual harassment. However, as she states, and as pointed out in the National Academies report Fostering Integrity in Research, published in 2017, RCR training, although necessary, is not in its current form as effective as it needs to be. The question that must be continually asked is how can we do better. The issue of RCR training in fact will be the topic of several workshops being organized by the National Academy of Engineering, with the first set for October 2019.

The second, and more challenging, step is to integrate sexual harassment into the broader framework of the fostering of research integrity. To do this will be complex and not easy, and this integration will require a number of important changes and/or additions to what we now do. It should be noted that the recent National Academies report on sexual harassment did not recommend including it in the definition of research misconduct but rather to hold it as being equally important as research misconduct. On the other hand, the American Geophysical Union has a very much broadened definition of research misconduct, one that includes sexual harassment.

If we stay with research misconduct being defined as falsification, fabrication, and plagiarism, then sexual harassment is in the category of a detrimental research practice (DRP). Any DRP is a form of misconduct; however, one might argue that some DRPs are more severe than others, with sexual harassment violations of research integrity being one of the most damaging of the DRPs. Benya identifies six changes or additions to the current system that need to be implemented. As an example, she indicates that there may need to be penalties for sexual harassment violations of research integrity. If there are to be penalties for sexual harassment violations, maybe there should be some type of penalty for other DRPs.

Clearly there are many issues that still need to be worked out when it comes to research integrity. In a recent commentary in Nature (Gunsalus et al., 2019), the authors propose the establishment of a Research Policy Board. Its purpose would be to provide a continuing organizational focus for fostering integrity. The board would work with all stakeholders in the research community, with the goal being to share expertise and approaches for addressing and minimizing research misconduct and also detrimental research practices such as sexual harassment.

Just recently the National Academy of Sciences at its annual meeting held a symposium on “Establishing the Trustworthiness of Science,” and it was encouraging that this topic is getting this kind of attention. The trustworthiness of science is fundamentally based on research environments having a culture of integrity. To continue efforts to foster such a culture, the next step as indicated in the Nature commentary is to bring together representative stakeholders in a workshop in order to further assess the need for a Research Policy Board and to look at what models might exist for such an entity, what strategic partnerships would need to be built, particularly with groups that already have “pieces” of the integrity space, and how such a board would be funded and sustained.

The bottom line is how can the research community address the various factors—whether it be actual research misconduct or the misconduct of a detrimental research practice such as sexual harassment—that are needed to foster research integrity. It is not simply that we as a community can do better. We need to do better, and we must do better.

Robert M. Nerem

Institute Professor Emeritus
Parker H. Petit Institute for Bioengineering and Bioscience
Georgia Institute of Technology

The patent perplex

The modern patent system rests on the assumption that the temporary monopolies that patents provide are necessary to encourage invention, and thus produce economic growth and social benefit. But patents, as Stephen J. Miller clearly shows in “What Do Patents Mean?” (Issues, Spring 2019), are far more than simple legal and technical instruments that stimulate innovation and markets. They take on different meaning, he demonstrates, depending on particular business and university strategies, or on the perspectives of individual patent examiners and judges. In making this argument, Miller echoes the findings of a small body of qualitative—and specifically interpretative—social science and humanities research that has shown how patents and innovation are shaped, in fundamental ways, by historical, social, and political context.

Most studies of patents take a quantitative approach, and tend to treat patents as objective indicators. But qualitative scholarship can add analytic depth about how patents and patent systems work, including the values, assumptions, relationships, and social structures that underlie them, along at least four lines of inquiry.

First, it can offer unique insights into the relationship between patents and innovation. This includes investigating the motivations behind innovative activity, the circumstances where patents may stifle innovation, the role of intellectual property in comparison with other incentives for producing innovative and creative work, the similarities and differences in how intellectual property is treated across technical fields and industries, and the differences even within a technical field in terms of how players view and manage patents.

Second, it can help us develop a more nuanced understanding of intellectual property’s broader and sometimes indirect impacts. We tend to focus on how intellectual property rights shape science, technology, and commerce, but they influence politics and society too. For example, citizens are increasingly aware that patents can, in some cases, lead to high drug prices. Qualitative investigation can help us identify the complex circumstances in which patents limit access to technology, and cross-national approaches can help us identify policy levers that might be used to address these problems.

Third, we need to know how political context shapes both patent systems and patents themselves. My own research, for example, has shown that political culture, ideology, and history inform how patent systems understand their social and moral responsibilities and their roles in the governance of innovation more generally.

Finally, the qualitative research tool kit will be particularly useful for investigating the expanding world of alternative intellectual property regimes, including open science initiatives and public-private partnerships for drug development. Detailed ethnographic work and document analysis could identify how new rules for intellectual property and strategies for innovators are developing, from the bottom up. We need to fund this scholarship to enrich our understanding of the real world of intellectual property, and if considered seriously in our laws and policies, it can help ensure that patent and innovation systems fulfill their economic and social promises.

Shobita Parthasarathy

Gerald R. Ford School of Public Policy
University of Michigan

AVs and safety

The road to the widespread adoption of automated vehicles (AVs) is paved with promises of a safer means of ground transportation. But are such claims overblown? This is precisely the question asked by Diane E. Bailey and Ingrid Erickson in “Selling AI: The Case for Fully Autonomous Vehicles” (Issues, Spring 2019.

Let me state up front that it would be incorrect to say that AVs are the only solution to issues of road safety. It would also be incorrect to say that they are not likely to be a major part of any solution going forward. The potential safety benefits of AVs are difficult to ignore. For example, let’s assume that the use of AVs would save only 50% of the 1.3 million lives their advocates argue would be saved. Many people believe this would more than justify their use.

Unfortunately, much of the rhetoric surrounding AVs is coming from advocates of the technology. These are true believers who clearly assume that AVs are not only the primary but also the sole solution to road safety. It is also difficult to properly critique and discuss the technology for other reasons. In many ways, the technology is still in its infancy and constantly evolving. Further, there is not a clear and widely accepted definition with regard to what is or what is not an AV. For example, many scholars would question whether Tesla’s autopilot system should be considered an AV. This makes it difficult to discuss not only what AVs can do now, but what they might be able to do in the next five to 10 years.

Perhaps a more important question to ask is this: What conditions are needed for AVs to be a part of the solution? For example, what infrastructure changes are needed to promote road safety? This question allows not only for multiple approaches to road safety but also for the inclusion of the social and political realities that are often ignored when numbers such as 1.3 million lives are bandied about. Such questions might help steer the conversation on AVs toward more realistic goals.

Lionel P. Robert Jr.

School of Information
University of Michigan

What’s a wetland?

As a former federal government attorney who for 31 years supervised litigation involving the scope of the Clean Water Act (CWA), I very much appreciated Charles Herrick’s article, “Parsing the Waters” (Issues, Spring 2019), for its comprehensive review of the ebbs and flows of wetland protection policy in this country. He makes a compelling case for a holistic approach to wetland stewardship, one based on science and responsive to “the needs of a diverse array of stakeholders,” free of the “whims” and “ideological caprice” that have wreaked havoc in the past.

Herrick’s commendable goal unfortunately faces considerable headwinds. The problems go back to 1972 when Congress decided—almost as an afterthought—to provide some modicum of wetland protection through a framework under the CWA that was designed to regulate discharges of industrial pollutants into the nation’s waterways. That mechanism has worked remarkably well in reducing pollution in lakes, streams, and rivers, but grafting a wetlands protection feature onto a regulatory program for point-source discharges proved to resemble less a hand in a fitted glove than a rose in a fisted glove.

The biggest challenge derives from the fact that the CWA’s geographic scope is “navigable waters,” ambiguously defined as “waters of the United States.” Most wetlands, the majority of which are on private property, are not what we traditionally think of as “navigable.” Sixteen years after unanimously declaring that wetlands are in fact within the intended purview of the CWA, the US Supreme Court reversed course and ruled 5-4 in 2001 that the purpose of the act is to protect traditionally navigable waters and that wetlands per se are protected only to the extent that they can be shown to affect the water quality of downstream lakes, streams, and rivers. This limitation ignores the many functions and values of wetlands that do not necessarily have a measurable impact downstream. The Supreme Court further muddied the waters in 2006 when it issued a fractured 4-1-4 decision that established three different possible approaches for determining whether a waterbody is protected under the CWA, without specifying which is controlling.

That was when Congress should have stepped in either to clarify its intent regarding the scope of the CWA or to enact new wetlands-specific legislation that strikes an appropriate political balance between protection and regulation, between private landowners’ rights and the public interest, between science and policy.

Congress, however, abdicated its responsibilities, and what we got instead was legislation through agency rulemaking. The Environmental Protection Agency (EPA) under the Obama administration promulgated a definition of “waters of the US” that was based on science and an appreciation of the values of wetlands, only for the new Trump EPA immediately to negate that approach in favor of the interests of landowners, farmers, and developers. This ping-pong approach is likely to continue until Congress starts making difficult policy calls.

I’m sure Herrick would agree that the nation would be better off if we deferred to science for the final word, but we both recognize how unlikely that is in the upside-down political world we presently inhabit.

Stephen Samuels

Former attorney in the Environment & Natural Resources Division at the US Department of Justice

Reforming scholarly publishing

Our present publishing system is not working well. The growth of Open Access (OA) has been slow, resisted by many publishers at the expense of the public purse. Researchers have outsourced our evaluation system to this dysfunctional industry, which continuously infringes basic academic freedoms and human rights. Plan S is the latest attempt to catalyze real change, surfacing new debates around scholarly communication. In “Open Science, Open Access, and the Democratization of Knowledge” (Issues, Spring 2019), J. Britt Holbrook does an excellent job of providing a nuanced and balanced overview of many of these critical issues, identifying that OA is not a universal solution or end goal. There are major intersecting and pernicious factors that need reform too: creating a healthier research environment, a fairer evaluation system, and more stable career prospects for researchers.

Plan S is not all just about OA. It calls for adoption of the Declaration on Research Assessment (DORA) to help improve research evaluation. If researchers remain constrained in their choice of publication venue, this sends out a strong message that this is what still counts—which is exactly what the architects behind Plan S are trying to challenge. It helps to rebalance the power more in the scholars’ favor; if a journal is not Plan S compliant, it will lose out, or must adapt.

We are now in a choppy transitional state. If publishers are forced to change their regressive business practices as a result of this, that is a good thing. But we need to remain mindful, as Holbrook points out, of the business savvy of some publishers. They have demonstrated historically that they are exceptionally good at staying ahead in this game and remaining adaptive to finding new ways to maintain profits, always as a priority over public access to knowledge. Standing against this is not easy. We need to act more principled, and more unified, in order to make sure that we are truly making sure science is a public good.

However, Holbrook notes that although OA does help to remove the paywall to knowledge, that does not necessarily make it more useful to society. It is just one steppingstone on a meandering path and requires an understanding of how science interacts with the wider public. If OA was ever truly about democratization of science for society, the way we have gone about it in Western society was never going to achieve this: you cannot reconcile this while financially supporting those elements of an aggressively commercial regime that will continue to do everything it can to stop progress.

Therefore, I completely agree with Holbrook that we should be looking at the success of community-driven initiatives in Latin America, such as SciELO and AmeliCA. These have demonstrated that it is possible to have sustainable, high-quality publishing initiatives in the hands of the research community. I think Plan S got it backward. By trying to impose a Eurocentric view of what the future of publishing should look like, it failed to look beyond its own borders to learn about what was happening elsewhere. Perhaps if we took that view from the start, instead of believing that we in the “global North” have the answers to all the problems (while also repeatedly demonstrating we have not), then we would be seeing a much more fair and equitable global scholarly publishing landscape.

Jonathan Tennant

Founder, Open Science MOOC

Cite this Article

“Forum.” Issues in Science and Technology 35, no. 4 (Summer 2019): 5–19.

Vol. XXXV, No. 4, Summer 2019