Openness to protect human subjects in research

The Department of Health and Human Services recently published a proposal to update the federal regulations that govern research on human subjects. It’s a very interesting proposal with a lot of potential changes on the table, and has received more than 1,000 comments (rare for this sort of thing). Yesterday, I submitted comments on the proposal. Unfortunately, I had to deal with a personal matter just as the comments were due, so they’re less detailed and less polished than I would have liked. The comments are below: (Update: my comments are now available on as well.)

I welcome the opportunity to comment on the Department of Health and Human Services’ (HHS) advance notice of proposed rulemaking (ANPRM) on human subjects research protections. Modernizing federal regulations to better protect human subjects could advance science and bolster public trust in the research system, strengthening the economy and improving health while upholding human rights.

I submit these comments in my personal capacity, representing solely my own opinion. However, my background may inform the reading of these comments. I have participated in research as a human subject, including survey research as well as greater-than-minimal risk research. Professionally, I research government transparency, including topics such as scientific integrity, focusing on the role of information in improving lives and increasing democratic accountability. Previously, my work focused on public access to scientific information. In addition, I am a graduate student in the School of Library and Information Studies at Florida State University, studying information seeking and use.

In my opinion, several of the information management reforms proposed in the ANPRM could enhance the protection of human subjects and increase public trust in the research system. These changes could benefit the research system by aiding in the recruitment of human subjects. In addition, HHS should consider other reforms not specifically proposed in the ANPRM.

I recommend that HHS consider amending the federal rules on human subjects protection to:

  1. Respect and enhance scientific openness;
  2. Empower research participants and their communities;
  3. Minimize and mitigate information risks; and
  4. Collect the data necessary for system oversight.

1. Human subjects research protections should respect and enhance scientific openness

Openness is a fundamental characteristic of science, and human subjects research protections should respect and enhance scientific openness. I applaud HHS’ consideration of increasing the reuse of existing data and biospecimens (see Question 23). HHS should seek ways to expand appropriate sharing of data and biospecimens, while mitigating information risks to such sharing (see #3).

Openness can strengthen human subjects protections in other ways as well. Articles 20 and 21 of the Helsinki Declaration prohibits the repetition of a study where the outcome is already known, to avoid exposing human subjects to unnecessary risk. As a result, prompt and widespread communication of results is necessary to ensure human subjects are protected, along with sharing and reuse of data and biospecimens. To avoid unnecessarily exposing human subjects to the risks of research, HHS should ensure that the results of human subjects research are rapidly and effectively disseminated to the research community, such as under the National Institutes of Health (NIH) Public Access Policy.

2. Human subjects research protections should empower research participants and their communities

Although human subjects protection is the responsibility of the research and oversight community rather than of the subject, federal regulations should empower subjects to protect themselves to the greatest extent possible. HHS’ consideration of mechanisms to improve informed consent is particularly important in this regard (see Questions 35-53). HHS may also wish to consider readability and comprehension testing to improve consent forms. HHS should also ensure that subjects and potential subjects are informed of potential risks through public access to the proposed database of adverse events reporting (see Question 69).

With regard to the extension of federal regulations to some non-Federally funded research (Question 71), without prejudice to the resolution of the overall question, it is important that subjects and potential subjects be informed of the protections applicable to the context. HHS should require studies to inform subjects whether or not the federal human subjects research protections apply to the study, with a brief description of said protections and a reference to an easy-to-understand website with additional information.

Because the goal of human subjects research is ultimately to improve health, it is important that human subjects research protections leverage opportunities to do so, both for the subjects specifically and for their communities. Access to information is a key method for doing so. For instance, results should be returned to research participants whenever possible, including publications describing overall results of the study (see Question 18). Public access to research results (see #1) and to trial information (see #4) also would advance this aim.

3. Human subjects research protections should minimize and mitigate information risks

The adequate protection of research participants’ privacy is critical to the functioning of the research system and an important factor in the successful recruitment of human subjects. To prevent the damage that data breaches could wreak on the research system, human subjects research protections should ensure proper data security, such as by establishing mandatory standards for data security as proposed in the ANPRM. In addition, promptly notifying individuals of data breaches, as proposed in the ANPRM, is important to mitigate the impact of any security failures.

However, while it may be necessary to reexamine the role of institutional review boards (IRBs) in ensuring data security, HHS should be hesitant to eliminate such a role altogether. Through their approval and oversight, IRBs are the institutional guarantors of human subjects protection, and HHS should be cautious to remove vital aspects of that protection from the boards’ purview. HHS should carefully consider the most effective role of IRBs in ensuring data security: for instance, whether inspector certification of compliance and retrospective IRB audits would ensure protection.

4. Human subjects research protections should collect the data necessary for system oversight

The ANPRM correctly identifies the need for effective data collection and information management in conducting oversight of human subjects research protections. However, HHS should consider expanding required reporting where necessary, in addition to streamlining existing reporting requirements.

For instance, with regard to Question 70 re:, the recent report of International Research Panel of the Presidential Commission for the Study of Bioethical Issues identifies needed improvements to trial registration and reporting, including increased reporting and public access to information.

In another example where increased reporting and transparency could strengthen oversight, Menikoff in 2010 proposed that investigators should disclose their consent forms. Such disclosure, the author argued, would ultimately improve the quality of consent forms, in addition to allowing potential subjects to more easily locate appropriate trials.


Gavin Baker

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Florida State University adopts open access resolution

I’m pleased to announce that tonight, Florida State University’s faculty senate unanimously adopted a resolution supporting open access. (I’ve been a M.S. student in the School of Library & Information Studies since 2010; unfortunately, I didn’t know about this effort until tonight.)

The resolution itself would have been cutting-edge five years ago. The text is weak compared to policies at leading institutions: it “endorses the storage and preservation of scholarly publications in Florida State University’s open access institutional repository”, directs the libraries to “develop policies and procedures”, and calls for an annual report. Unfortunately, that’s as far as it goes. Based on the plain text of the resolution, there’s no mandatory deposit, the key element of successful open access policies. As a result, we can expect compliance to be weak. However, as Micah Vandegrift, Scholarly Communications Project Manager at FSU, notes, it’s a first step. Hopefully this resolution will spark a dialog, creating greater awareness and understanding, leading to the adoption of a mandatory policy in the near future. Meanwhile, kudos to the FSU faculty and those who worked to develop this policy.

Of course, I would be remiss not to add that my alma mater, the University of Florida, also has taken some positive steps in the open access arena lately (see: this, this, this).

Posted in Academia, Florida, Open access, Science | Leave a comment

NSF Should Not Remove Dissemination from Merit Criteria

Since my prior post about the National Science Foundation’s consultation on its merit review criteria, NSF released a proposed set of revised criteria which aim to clarify and simply the criteria and their purpose. Unfortunately, the revised criteria would remove the current criteria’s consideration that the project’s results should be broadly disseminated. This would be a step backward for the free flow of scientific information unless NSF strongly urges broad dissemination in the accompanying guidance it expects to release.

On July 17, I submitted these comments on the proposed revisions:

I am disappointed that the National Science Foundation’s proposed Merit Review Principles and Criteria removes the criteria’s reference to the broad dissemination of results. NSF should retain and strengthen this consideration of merit review, as I wrote in my previous comments to the Task Force on Merit Review; see Broad dissemination must be a high priority for NSF-funded research.

If NSF proceeds with the proposed criteria, it should ensure that its guidance for investigators, reviewers, and staff resolutely expresses the importance of ensuring the broadest possible access to research results. As I wrote in my previous comments, this should include updating the list of representative activities provided to investigators, particularly to encourage investigators to provide open access to their publications.

Thank you for the opportunity to comment on the proposed merit review criteria. Please do not hesitate to contact me with any questions.

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Peter Suber wins ALA’s Patterson Award

I missed the news last week, but I’m extremely pleased to learn that Peter Suber will be the recipient of this year’s L. Ray Patterson Copyright Award by the American Library Association. It’s incredibly well-deserved.

Peter, of course, was my editor at Open Access News, and it was an honor to work with him. You could hardly have asked for a better boss, and I learned a tremendous amount.

Before OAN, though – and since – Peter has always been there for me. He helped publicize my work for open access at the University of Florida and with Students for Free Culture, when I thought I was a lonely outpost in the hinterlands. When I was developing SPARC’s student outreach campaign, he was a tremendous resource. When I decided to try my hand at freelancing, he helped me understand what it would mean. When I started pondering going to grad school, he helped me think it through.

And I’m far from the only one. Peter is the glue that holds the open access movement together. Much more could be said about Peter’s talents and accomplishments, but that might be the most important thing to know.

I had the good fortune to be working for ALA during last year’s Patterson Award ceremony. It is, I think, a tremendously important award. Take a look at the past recipients and you’ll see what I mean. They’re the people who the future will thank.

Posted in Copyright, Libraries, Open access, Students for Free Culture | Leave a comment

Comments on NSF’s Merit Review Criteria

Today, I submitted these comments to the consultation on the National Science Foundation’s Task Force on Merit Review (see). They are provided solely in my personal capacity.

What do you see as the strengths and weaknesses of each criterion?

The current Broader Impacts merit review criterion includes the consideration, “Will the results be disseminated broadly to enhance scientific and technological understanding?” NSF should retain and strengthen this consideration of the merit review.

Broad dissemination must be a high priority for NSF-funded research. As a federal agency operating with taxpayer funding, NSF has a responsibility to maximize return on investment by removing barriers to access for the scientific community, as well as to ensure access for taxpayers. In addition, broad and equitable dissemination of scientific information advances the goals of the Universal Declaration of Human Rights, which affirms that “everyone has the right freely to … share in scientific advancement and its benefits,” and the International Covenant on Economic, Social and Cultural Rights, in which governments agree to take the steps “necessary for the conservation, the development and the diffusion of science;” the United States is a signatory to both documents.

Under the current criteria, which are more than a decade old, proposals may be inadequately reviewed with regard to the dissemination consideration. During that time, the landscape of scholarly publishing and information has undergone significant changes. In particular, the exceptional opportunities created by the Internet behoove NSF to ensure that its funded research takes full advantage of the new technology to maximize cost-effective dissemination.

At present, broad dissemination of results is promoted through two avenues at NSF: the merit review criteria, which investigators must address in their proposals, and the Award and Administration Guide (AAG), which governs projects after an award is issued. This dual approach is beneficial and should be maintained and strengthened.

NSF establishes minimum requirements for dissemination in Chapter VI.D.4 of the AAG. In particular:

  • “Investigators are expected to promptly prepare and submit for publication … all significant findings from work conducted under NSF grants;” and
  • “Investigators are expected to share with other researchers, at no more than incremental cost and within a reasonable time, the primary data, samples, physical collections and other supporting materials created or gathered in the course of work under NSF grants.”

This policy is underpinned by Sec. 7011 of the America COMPETES Act of 2007, which requires NSF to enforce the standards by making any researcher who fails to comply ineligible for future funding.

Additionally, Sec. 7010 of the 2007 COMPETES Act requires NSF to make project reports freely available to the public online, along with citations to any publications resulting from NSF funding. This provision of the law is implemented by Chapter II.E.3 of the AAG, which requires grantees to submit a report describing the project outcomes, written specifically for the public, to be made freely available via

In addition to the baseline standards of the AAG, investigators are required to address the dissemination consideration of the Broader Impacts merit review criterion. This dual approach is beneficial because it encourages creative approaches to dissemination beyond the minimum, as appropriate to the proposed activity. Moreover, by including dissemination in the merit review criteria rather than only in post-award requirements, NSF ensures that investigators plan for dissemination beginning from the proposal stage, a valuable way to keep dissemination in mind throughout the project’s life cycle.

Unfortunately, both aspects of this approach currently are insufficient. Both the dissemination requirements of the AAG and the dissemination consideration of the Broader Impacts criterion should be updated and strengthened.

While NSF is to be recognized for its leadership in recently requiring investigators to develop data management plans, in other regards the AAG is outdated and should be reformed. Most importantly, NSF has not implemented a requirement that its funded investigators provide public access to resulting peer-reviewed manuscripts, rather than merely the citations to those publications. Among federal science agencies, the National Institutes of Health (NIH) is the current leader in this area, having adopted a mandatory public access policy as required by Sec. 218 of the Consolidated Appropriations Act, 2008. Dozens of other public and private research foundations worldwide have successfully adopted similar policies. NSF should incorporate a similar mandatory policy in the AAG. Furthermore, NSF should improve on the NIH policy by reducing the “embargo” period when manuscripts can be withheld from public access from the current maximum of twelve months to a six-month maximum, as several other research funders worldwide have done.

However, as this comment is directed to the Task Force on Merit Review, I will focus on the dissemination consideration of the Broader Impacts criterion, rather than the requirements of the AAG. To be clear, even if the dissemination requirements of the AAG are strengthened, the dissemination consideration of the merit review criteria also should be retained and strengthened.

The first regard in which the dissemination consideration of the merit review criteria is inadequate is its construction. Currently, broad dissemination is a consideration only of the Broader Impacts criterion, not the Intellectual Merit criterion. However, dissemination is properly understood as fundamental to both the intellectual merits of the proposed activity as well as its broader impacts.

The thrust of the current consideration is that maximizing the social value of the funded project requires communicating the project’s results to relevant audiences outside the research community, such as industry and policymakers, and to the public to enhance the public understanding of science. This is useful strategy to increase the broader impact of NSF funding and should be maintained. In particular, it supports the requirements of Sec. 526 of the America COMPETES Reauthorization Act of 2010, which directs NSF’s Broader Impacts criterion to advance the goal of “increased public scientific literacy.”

However, even within the academic community, the broad dissemination of research results cannot be taken for granted. Access barriers imposed by the high and rising cost of serials and monographs can significantly hamper the circulation of knowledge. These barriers can be particularly imposing to researchers and students at smaller institutions and in developing countries. Additionally, reticence to share data or materials with other researchers, or delays in doing so, also hinder the progress of science.

Thankfully, online technologies enable innovative approaches to the broad dissemination of research information which previously was only shared in small circles. These approaches already have begun to bear fruit. For instance, the NIH-supported Alzheimer’s Disease Neuroimaging Initiative was recently highlighted by the New York Times for its innovative approach to data sharing which is already being emulated. Given the promise of openness, the Board should ensure that the merit review criteria promote the broadest possible dissemination of results.

What changes, if any, would you like to see made to the merit review criteria?

If the Board retains the current criteria, it should add a consideration for broad dissemination in the Intellectual Merit criterion, in addition to the current consideration in the Broader Impacts criterion. Such a consideration might read, “Will the proposed activity ensure the broadest possible access to its results within its own field or across different fields?”

Alternatively, the Board might adopt a single consideration that addresses broad dissemination both within and beyond the research community.

What role should the institution play to ensure that the intellectual merit and broader impacts in NSF proposals can be realized?

NSF should provide additional guidance to proposers on how best to address the dissemination consideration. The Task Force will be aware of Sec. 526 of the COMPETES Reauthorization Act, which directs NSF to better inform proposers as well as staff and reviewers about the Broader Impacts criterion’s requirements, among other changes. The process of implementing these statutory provisions offers a timely opportunity for NSF to suggest “proven strategies and models” for cost-effective broad dissemination.

Currently, NSF provides a list of examples of representative activities for the dissemination consideration. These examples should be updated to better take advantage of proven strategies. Most critically, NSF should encourage investigators to provide open access to their publications by publishing them in an open access journal or by depositing them in an open access repository immediately upon publication, under an open copyright license. NSF could also encourage investigators to consider the impact of their publishers’ policies and pricing on the broad dissemination of their research. Further, NSF should encourage investigators to post their data online for free public access, and to freely distribute online any software created resulting from NSF funding under a free software license, depositing both in appropriate repositories as applicable.

Beyond mere suggestions of activities, NSF should refer investigators to resources on how to accomplish these activities, such as existing guides prepared by the library community and others. NSF should also encourage institutions to play a more proactive role in supporting investigators in maximizing the dissemination of their research, including collaboratively sharing resources and strategies between institutions.

Additionally, NSF should ensure that these resources and guidance are available to its reviewers and staff, and that they duly take into account these activities in reviewing proposals’ commitment to broad dissemination of research.

What impact, if any, has NSF’s two review criteria had on how you think about developing your research projects?

Any other comments?

Thank you for the opportunity to comment on the merit review criteria. Please do not hesitate to contact me with any questions.

Posted in Academia, Copyright, Creative Commons, FOSS, Open access, Publishing, Science | Leave a comment

Culture justice: a new frame for free culture

I’m at the Students for Free Culture conference, catching up with old friends — including the current leaders of Florida Free Culture, which I realized is 5 years old this month. This morning a phrase popped into my head that I’d never heard before, but could be valuable to the free culture movement going forward: “culture justice”.

The term is obviously coined by analogy to “environmental justice”, an incredibly powerful idea that succeeds at articulating the costs of environmental degradation. Most simply, environmental justice is the concept that damage to the environment disproportionately affects the most vulnerable human populations. It’s an obvious idea once you think about it: if you’re poor, a child, elderly, disabled, or otherwise disadvantaged, you have fewer resources to cope with (or move away from) environmental perils in your environment. In some sense, it’s an argument against inequality per se (and rightly so), but it also accounts for the fact that some inequality will always exists and helps clarify the burdens that are inequitably distributed.

Culture justice is my attempt to do the same for topics that the free culture movement is concerned with. (The term “information justice” already has some traction, but I prefer a frame that includes access to and participation in culture, not just access to information.) This approach is particularly valuable to the free culture movement (with its roots in elite law schools) and SFC (with its roots at elite colleges).

In his presentation today, Eric Frank of Flat World Knowledge made the argument for open textbooks by pointing out that most of the growth in higher education has come from students with low-SES backgrounds, many of them first-generation college students, attending schools where they pay less than $5,000 in tuition per year. No one clapped. Unfortunately, most of the students in this room are not those students.

SFC’s base has been in the Northeast and West Coast. Although women have had important leadership roles, it’s always been dominated by men. Some panels today couldn’t find a single woman among the five participants. There is a significant place for higher-SES ethnic minorities, such as East Asians and South Asians, there’s a paucity of participation from lower-SES ethnic minorities, such as blacks and Hispanics. Most are training for high-status careers in IT. My point isn’t to smear SFC, but to point out some of its privileges. (I should point out, many of its leaders are acutely aware of them.)

To be fair, white male software engineers and tech enthusiasts have legitimate issues with public policy and dominant institutions. That’s my background in the free culture movement. But its claims will have greater resonance if they’re drawn more broadly. This has been a perpetual aim for SFC.

Culture justice takes this further by attempting to articulate a general framework for the role of social privilege in cultural policy.

One example is re-use of copyrighted material. Less privileged users will have less knowledge of their rights under the law, less ability to negotiate licensing, and in some cases even less protection under the law (see e.g. discussions of gender in fan fiction).

Similarly, Net neutrality is ultimately an argument about privilege and justice.

This is far from an exhaustive list, but it’s enough to make me think that culture justice (under whatever name) could be an important and valuable frame for the free culture movement. Freedom is an important frame, but so is justice. In some cases they may work at cross purposes, but they can also reinforce each other in important ways.

What do you think?

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Cutting carbon doesn’t have to be hard

Generally, I try to keep this blog focused on information policy, but I can’t help myself. I’ve had climate on the brain thanks to Copenhagen, but the confluence of news items that crossed my desk today is striking.

Much of the American media coverage of climate change is of the political back-and-forth about the costs of addressing climate change. It goes something like this: “Democrats today called for action to stop global warming, but Republicans said we can’t afford the cost to the economy. In other news, [insert celebrity sex scandal] …” There’s rarely a discussion of what those costs might actually be, just an intimation that they must be high.

Certainly there are costs (although there are also benefits — and there are staggering costs to inaction, too). But the three items I spotted this morning highlight the argument that much can be done, today, with existing technology, at relatively little cost and with relatively impact on the much-ballyhooed “American lifestyle”:

  1. A mocking piece in today’s Guardian pokes fun at U.S. Energy Secretary Steven Chu’s fascination with old-hat technologies. Those of us who’ve seen Secretary Chu’s efficiency roadshow before, though, know that he’s not excited because he thinks these technologies are new and cutting-edge — he’s excited because they’re old, easy and cheap. The Guardian column only reinforces Chu’s point: in Europe, these approaches to energy efficiency are passé. So we don’t have to wait for cutting-edge, expensive, untested strategies to cut greenhouse gas emissions: even an advanced economy like the U.S. can make a big dent just by adopting some of the many cost-effective, tried-and-true tools already at our disposal.
  2. ScienceInsider points to a new National Research Council report that estimates just how much could be saved. According to the report, adoption of existing or imminent technologies could reduce U.S. energy use by one-fifth in ten years. In other words: despite population and economic growth, energy use could decrease (in absolute terms) rather than increase, simply by adopting technologies that already exist or are expected to enter commercial availability in the next ten years.

    Just to spell it out, there’s a lot of economic good news in that scenario. Despite upfront costs, consumers save money on long-term energy costs. Meanwhile, a lot of people make a lot of money: namely, the manufacturers of those devices and their supply chains, through to the retailers who sell them and the contractors who install them. Basically, it’s good for everybody except energy companies — which brings me to the final item…

  3. Avaaz and Oil Change launched petitions to end the U.S.’s staggering $10 billion annual taxpayer subsidies to fossil fuel companies. (There seems to be some debate about the exact number, but at any rate, it’s huge.) Why we should subsidize these companies at all is difficult to fathom. If we simply eliminated the subsidies, fossil fuels would be less competitive. If we re-directed the funding to clean energy or efficiency, the gains would be even greater.

I doubt that these simple fixes alone would get us to 350. But it’s clear that there is much low-hanging fruit, perilously ripe for the picking — a fact all too often missing from the narrative around climate change.

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OA + POD + competition?

Here’s a question I thought of recently. I’ve asked a few smart people and none of them were sure of the answer, either, so:

There’s a bit of buzz about OA + POD (open access + print-on-demand) as a model for books, particularly for small scholarly publishers like university presses. Consider the following: a book published gratis OA + POD, with no copyright license, all rights reserved (ARR).

  • If I legally acquire a digital copy of the book (downloaded with rightsholders’ permission), under copyright, am I permitted to print a copy of the book for personal use?
  • If not: would fair use or another exception apply?
  • Is the fair use analysis affected by the offering of print-on-demand?
  • If I am permitted to print a copy for personal use: am I allowed to pay someone else to do the printing for me, e.g. by bringing the file to a commercial copyshop?
  • If so: Do ARR publishers know that?
  • What if the copyshop advertises that they will download and print the file for the customer?

Now consider a book published OA + POD, with a Creative Commons NonCommercial (NC) license.

  • Presumably I am now unambiguously permitted to print a copy of the book for personal use.
  • Am I allowed to pay someone else to do the printing for me, e.g. by bringing the file to a commercial copyshop?
  • If so: Do NC publishers know that?
  • What if the copyshop advertises that they will download and print the file for the customer?

Similar questions apply to related scenarios, e.g. paying an intermediary to download the file for you and deliver it on physical media, or to format and deliver it for an e-reader.

Posted in Copyright, Creative Commons, Open access | 1 Comment