La Noue Reviews Ethical Imperialism

Political scientist George La Noue terms Ethical Imperialism "a powerful indictment of the IRB regime."

[George R. La Noue, Review of Zachary M. Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009, Law & Politics Book Review 20 No. 11 (October, 2010): 616-618.]

La Noue, who has himself written about the IRB controversy, notes that "Universities might seem to be a most unlikely place to welcome and implement a process that is in effect a form of prior censorship. Reconciling the IRB process with legal or professorial concepts of academic freedom is extremely difficult." He finds that "Schrag provides a carefully researched and well written historical perspective providing all members of the academy with essential information to reconsider the role of IRBs."

La Noue calls for more study of the constitutionality of current IRB regulations and practices, a subject I would prefer to leave to the law professors. He also concludes that

What is missing is comparative empirical research about the standards and procedures of a variety of IRBs in different settings. While it seems intuitively unlikely that the process is always fair, objective and consistent, from IRB committee to committee, campus to campus, beyond anecdotes what proof exists? Without an appropriate factual basis, courts would struggle with both the compelling interest and narrow tailoring prongs that constitute the strict scrutiny test that should apply to censorship. Schrag’s book provides a necessary and very carefully researched historical context for the debate about IRBs, but the next step needs to be taken by professional associations and social scientists to study their actual practice to see if the current system can be improved.

I concur, though I would suggest that we in fact need two separate branches of such emprical study. One would continue the work of Maureen Fitzgerald and Laura Stark, both of whom have observed committees in action without finding huge variation from campus to campus, or even--in Fitzgerald's case--country to country.

A second branch would look at the development of human research protections policies. Read through this blog, and you will find enormous variation in casts of characters involved in shaping university policies on human subjects, from research offices that feel free to make up whatever rules they want, to the participation of university-level faculty committees, to the involvement of departments most affected by a given policy.. I don't know of any scholarship that has examined this variation in depth.

I hope that other scholars heed Professor La Noue's call.

Is Facebook Data Mining Human Subjects Research?

Recent law-school graduate Lauren Solberg finds that "data mining on Facebook likely does not constitute research with human subjects, and therefore does not require IRB review, because a researcher who collects data from Facebook pages does not 'interact' with the individual users, and the information on Facebook that researchers mine from individual users' pages is not 'private information.'"

[Lauren Solberg, "Data Mining on Facebook: A Free Space for Researchers or an IRB Nightmare?" article under review, University of Illinois Journal of Law, Technology & Policy 2010 (2). The article has been accepted for publication, but the journal is still soliciting comments.]

Solberg challenges policies now in place at Indiana University and the University of Massachusetts Boston, where researchers must get Facebook's written permission or the written permission of every individual who is studied. These policies, she argues, impose unnecessary burdens on researchers and IRBs alike. (The two policies are identical, but it's not clear which university borrowed from the other.)

She argues that most data mining projects do not meet the regulatory definition of human subjects research. Reading existing profiles is not interaction with an individual. Nor is a Facebook profile that is open to strangers private information, i.e., "information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)." If a college admissions officer or a potential employer can read your profile, you've lost little by having an anthropologist read it as well.

This analysis seems sound, but it's not clear to me that anyone disagrees. In particular, the third university Solberg mentions, Washington University in St. Louis, applies its policy only to "
Any activity meeting the definition of 'human subject research' which is designed to recruit participants or collect data via the Internet." It then lists several examples, most of which involve interaction with living individuals. Thus, I doubt Solberg's claim that "researchers at Washington University need only inform Facebook users that they are recording information that is posted on their pages." Rather, if the project does not meet the definition of human subject research, then Wash U. researchers need not do even that much.

Solberg's article skirts some interesting questions. One concerns the boundaries of a reasonable expectation of privacy. Thus, Michael Zimmer gives the example of a study by Harvard graduate students of the Facebook profiles of Harvard undergraduates. If an undergraduate had made some information visible only to other Harvard students (a choice Facebook's software allows), and a Harvard student-researcher sees it, does that change Solberg's analysis?

A second question concerns the authority of university research offices and IRBs to insist that researchers abide by website terms of service. Notably, the Indiana and UMASS policies do not cite federal human subjects regulations as their authority. Rather, they claim that Facebook and Myspace "explicitly state that their sites are not intended for research but for social networking only."

Solberg writes that evaluating such claims is "outside the scope of this article," but they are interesting in three ways. First, they may be factually false; I could find no such explicit statements in the Facebook or Myspace terms of service. Second, they are divorced from federal regulation. For example, the Facebook terms of service do not distinguish between living and dead Facebook members, whereas federal human subjects protections apply only to the living. Finally, they are internally inconsistent. If Facebook and Myspace did prohibit the use of their sites for research, would not researchers still be violating the terms of service even if they got signed consent from individual members, as allowed by the policies? Just who are these two universities trying to protect?

Solberg concludes that "Unfortunately, and somewhat surprisingly, the OHRP has issued no guidance pertaining to Internet research in general, let alone guidance specifically relating to the issue of data mining on the Internet." To give the feds some credit, in summer 2010 (after Solberg wrote her article), SACHRP did sponsor a panel on the Internet in Human Subjects Research. It can take a long time from a SACHRP presentation to OHRP guidance, but the wheels may be moving on this one.

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Note, 19 November 2010: The original version of this post identified Ms. Solberg as a law student. She has in fact graduated. I have also changed the link about Michael Zimmer's work from his SACHRP presentation to his article, "'But the data is already public': on the ethics of research in Facebook," Ethics and Information Technology 12 (2010): 313-325.

Comments: FWA Forms Should Reflect Common Rule

On October 4, I reported that OHRP was inviting comments on drafts of new FWA form and FWA Terms of Assurance.

Prior to the October 25 deadline, OHRP received comments from only five individuals and two professional organizations, all of which are posted at regulations.gov.

Of these seven comments, three (including mine, of course) complained that the draft Terms of Assurance, like the existing ones, violate the Common Rule's pledge that an institution's statement of principles "may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself."

No one made a case for retaining the discrepancy between the regulations and the forms.

IRBs and Procedural Due Process

A law student finds that "current IRB regulations fail to provide procedural due process as guaranteed by the Fifth and Fourteenth Amendments of the United States Constitution."

[Daniel G. Stoddard, "Falling Short of Fundamental Fairness: Why Institutional Review Board Regulations Fail To Provide Procedural Due Process," Creighton Law Review 43 (June 2010): 1275-1327]

Stoddard notes a number of measures that might protect researchers against capricious IRBs but which are not currently required:

Federal IRB regulations are silent . . . regarding a number of specific aspects of IRB function including public attendance of IRB functions, a researcher's opportunity to hear and cross-examine information opposing that researcher's research, and a researcher's right to privacy with regard to an IRB's media interaction. IRB regulations additionally fail to address whether an IRB should base its decision exclusively on evidence presented to it, whether a researcher should have a right to a hearing before the IRB suspends research, whether a researcher has a right to judicial review of an IRB decision, and whether a researcher has a right to an attorney. Federal IRB regulations also fail to include a researcher's right to have informal communications with an IRB, a researcher's right to present further evidence to an IRB following a rejection, a researcher's right to consult with personnel opposing that researcher's research in an effort to understand and prepare to challenge them, and an IRB's obligation to evaluate its own functioning procedures periodically. (1290)

All of these measures could be helpful, but the question for Stoddard is whether their absence violates procedural due process. To answer that question, he turns to Mathews v. Eldridge (424 US 319 - Supreme Court 1976), a 1976 Supreme Court case named for the same HEW secretary who was sued for violating IRB procedures in Crane v. Mathews, 417 F. Supp. 532 - Dist. Court, ND Georgia 1976.

Mathews states that

the specific dictates of due process generally requires consideration of three distinct factors: First, the private interest that will be affected by the official action; second, the risk of an erroneous deprivation of such interest through the procedures used, and the probable value, if any, of additional or substitute procedural safeguards; and finally, the Government's interest, including the function involved and the fiscal and administrative burdens that the additional or substitute procedural requirement would entail.

Stoddard, it turn, argues that "The inability to contest or appeal an IRB decision is a substantial procedural shortcoming when evaluated under the three prong Mathews [v. Eldridge] balancing test."

The problem with this argument is that Mathews does not require the right to appeal, nor do other key precedents. In particular, Stoddard would be more persuasive had he addressed head-on what I take to be the federal court decision that most directly addressed due process and IRBs: Halikas v. University of Minnesota. Though Stoddard cites the district court's denial of a preliminary injunction to the plaintiff in that case, an aggrieved researcher, he does not analyze the court's reasoning behind that denial: "An IRB proceeding is, simply, not a federal criminal prosecution. Such a proceeding is governed by contracts and federal regulations which do not require, or provide, the full panoply of criminal procedural rights . . . Dr. Halikas voluntarily entered into an employment contract and conducted his research under the aegis of the University and its research-regulatory regime. He received the process which is his due." [Halikas v. University of Minnesota, 856 F. Supp. 1331; 1994 U.S. Dist.]

Nor does Stoddard analyze the final judgment in that case, which was not published. [Case number 4-94-CV-448, Federal District Court, Fourth Division, District of Minnesota; filed 18 May 1994; Judgment entered 9 June 1996. I am very grateful to Dr. Dale Hammerschmidt, one of the named defendants in the Halikas suit, for providing me with a copy of this document. I have posted it on my website (see previous link) so it will be easier to find in the future.]

In that judgment, the court found that "as the Eighth Circuit Court of Appeals has determined in similar cases, the Constitution requires only that Dr. Halikas receive: (1) clear and actual notice of the charges against him; (2) notice of the names of those bringing the charges and the specific nature and factual basis for the charges; (3) a reasonable time and opportunity to respond; and (4) a hearing before an impartial board or tribunal." It did not include the right to appeal as a component of procedural due process under the Constitution.

The "similar cases" which Judge James Rosenbaum used to reach this result were two cases in which employees of public universities contested their firing: Riggins v. Board of Regents of Univ. of Neb., 790 F. 2d 707, 712 (8th Cir. 1985) and King v. University of Minn., 774 F. 2d 224, 228 (8th Cir. 1985), cert. denied, 475 U.S. 1095 (1986).

This comparison casts doubt on Dr. Hammerschmidt's claim that Judge Rosenbaum "formally recognized the concept that the opportunity to conduct research upon human subjects is a privilege, rather than a right." ["'There is no substantive due process right to conduct human-subject research': The Saga of the Minnesota Gamma Hydroxybutyrate Study," IRB: Ethics and Human Research. 19 (May - Aug., 1997): 13-15. This is amplified in Steven Peckman, ["A Shared Responsibility for Protecting Human Subjects," in Institutional Review Board: Management and Function, ed. Robert J. Amdur, Elizabeth A. Bankert (Jones & Bartlett Learning, 2006), 17.]

To the contrary, Riggins specifically states that "Public employees may have a property right in continued employment." And King involved the dismissal of a tenured professor. By invoking these precedents, the Halikas decision suggests that while research is not a substantive due process right, researchers may have procedural due processs rights comparable to those enjoyed by public employees and tenured professors. Halikas makes no mention of research as a "privilege."

Though the Halikas judgment was sufficient to decide the case before the court, it left unanswered many questions about the rights of researchers who face IRBs. Are the procedural protections set forth in King and Riggins adequate to protect the right to research, academic freedom, or a property right in continued employment? Do professors in their capacity as researchers deserve more, less, or equivalent protections as professors in their capacity as teachers? What rights, if any, might student-researchers claim? Would Halikas or King have been decided differently had the plaintiffs offered free-speech claims? Does the "human research" in the judgment refer to social research as well as the medical research that was the subject of the IRB proceedings against Halikas? (The final judgment describes the IRB as a "medical research review body.") Does a board or tribunal have to be competent as well as impartial?

Halikas leaves all these questions unanswered. A careful analysis of that case would be a good starting place for further legal scholarship on the due process implications of IRB policies.

Hear Me Talk About My Book

Online Programming for All Libraries (OPAL) has posted recordings of my October 27 discussion of Ethical Imperialism as full streaming audio with text chat and a downloadable MP3 audio recording. The presentation lasts 64 minutes.

Ohio State Restricts LGBTQ Research, Ponders Reforms

Two Ohio State University professors, James Sanders and Christine Ballengee-Morris, complain about IRBs' impacts on research and teaching in their fields and report on efforts at reform.

[James H. Sanders III and Christine Ballengee-Morris, "Troubling the IRB: Institutional Review Boards' Impact on Art Educators Conducting Social Science Research Involving Human Subjects," Studies in Art Education: A Journal of Issues and Research in Art Education 49 (2008): 311-327. Yes, it's two years old, but I just found out about it recently.]

Many of the complaints are familiar enough. The authors--one in arts policy, the other in art education--lament biomedical models, delays in approvals, and "lengthy boiler-plate consent forms." Yet the article advances the conversation about IRBs in two interesting ways.

First, the article highlights the difficulty of getting IRB approval to study lesbian, gay, bisexual, transgender, and queer self-identified youth. The authors would like to know "how LGBTQ students experience the World Wide Web, art and culture, and their self-image, or how they establish resilient behaviors." But, they find, "Conservative IRB interpretations of federal regulations requiring parental consent of all human subjects under 18, may have failed to protect the rights and welfare of LGBTQ adolescent research participants, and further dissuade researchers from studying all but (safe) consenting adult heterosexual subjects."

Second, the article describes reform efforts at Ohio State. Advised by colleagues to "be intentionally vague . . . speak in generalities, or simply not tell what we were actually doing," the authors did consider "lying to a repressive and controlling body that claims to care about human subjects' protections and then denies autonomy or voice to those living with repression." Instead, they joined 160 faculty members to petition their Office of Research to reconsider its policies.

The result was the issuance in 2007 of the Report of the IRB Working Group for Research in the Social and Behavioral Sciences." That report offers a number of constructive suggestions. For example,

• Relaxing the requirement that all changes to a protocol be reported to the IRB, even if they "have absolutely no material impact on a human subject's participation in a study."
  
• Accepting that interviewers cannot foresee in advance all the topics they may raise in a conversation.
  
• Informing investigators about their right to appeal decisions to the IRB chair, the full board, or the institutional official.
  
• Listing approved protocols, so researchers do not have to reinvent the wheel when submitting their own projects.
  

The 2007 report ends with a strong call for IRB policy to be shaped by the faculty. It specifically recommends the active participation of the University Research Committee, which is comprised mostly of regular facutly:

It is also important that there be continuing transparency and communication of IRB policy and procedure development among the faculty, the Office of Research, the IRB Policy Committee, and ORRP [Office of Responsible Research Practices]. To ensure that such consideration and implementation occurs, we recommend that an ad-hoc subcommittee of the University Research Committee be appointed for this purpose. This subcommittee should receive regular reports from the IRB Policy Committee regarding the development of new policies related to the Working Group's recommendations and suggestions, and from the ORRP staff regarding progress in staffing, website development, and electronic submission procedures.

In the longer term, it is important for the University Research Committee to participate actively in the human subject protection program at Ohio State, and to assess and suggest additional improvements to the operations of ORRP and the IRB. We strongly encourage the University Research Committee to set up a means to do so.

As of their writing, however, Sanders and Ballengee-Morris had yet to see improvement:

In short, one is required to think through every possible contingency and clearly communicate how such contingencies would be addressed. While the process itself strengthens the research design, the unreasonableness of some alternative scenarios posed by those unfamiliar with the researchers' field of study have been stifling. In response, many students and colleagues have chosen to change methods or abandon their research problems, rather than be subjected to this arduous, frustrating, and at times, humiliating process.

Dreger Wants to Scrap IRBs

On the heels of Laura Stark's Los Angeles Times op-ed calling for the replacement of local IRBs with centralized boards of experts, historian Alice Dreger has published her own call for a national system of ethics review based on expertise and transparency.

[Alice Dreger, "Nationalizing IRBs for Biomedical Research – and for Justice," Bioethics Forum, 22 October 2010.]

Troubled by her IRB's approval of a project she considers unethical, and by Carl Elliott's White Coat, Black Hat: Adventures on the Dark Side of Medicine, Dreger concludes that the system of local review is ineffective:

We’ve reached the point where many people in medicine and medical ethics don’t even expect IRBs to act as something other than liability shields for their universities. But do patients who come to us only to be turned into subjects know that? Do they know that there is literally a price on their heads put there by research recruiters?

I’ve come to believe we need a radical solution. Maybe what we need is a nationalized system of IRBs for biomedical research, one that operates on the model of circuit courts, so that relationships cannot easily develop between the IRBs and the people seeking approval. This system could be run out of the Office for Human Research Protections and involve districts, similar to the federal courts system. Deliberations would be made transparent, so that all interested parties could understand (and question) decisions being made.

Think of the advantages: the possibility of actually focusing on the protection of human subjects first and foremost, free of conflicts of interest; the possibility of having nothing but trained professionals (not rotating unqualified faculty and staff) sitting on review panels; the possibility of marking biomedical research as clearly different from the social science and educational research unreasonably managed by many IRBs; the possibility of much greater transparency to those interested in seeing what’s going on; the possibility of having multi-center trials obtain a single approval from one centralized IRB, rather than trying to manage approvals from multiple local institutions. And the possibility of shutting down the deeply opaque, highly questionable private IRBs Elliott describes as being increasingly used by universities. (Go ahead, call me a Communist for caring about the Common Rule.)

Her Communist leanings aside, I don't know why Dreger presents her argument as a defense of the Common Rule, which fails to distinguish between biomedical and social research, puts ethics review in the hands of rotating unqualified faculty and staff, and keeps deliberations opaque. But her wish for the kind of coordination and transparency provided by the court system has a long lineage. I've quoted it before, and I'll quote it again:

The review committees work in isolation from one another, and no mechanisms have been established for disseminating whatever knowledge is gained from their individual experiences. Thus, each committee is condemned to repeat the process of finding its own answers. This is not only an overwhelming, unnecessary and unproductive assignment, but also one which most review committees are neither prepared nor willing to assume.

[Jay Katz, testimony, U.S. Senate, Quality of Health Care—Human Experimentation, 1973: Hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare, Part 3 (93d Cong., 1st sess., 1973), 1050].

It is not lack of good intentions or hard work that leads IRBs to restrict ethically sound surveys while permitting unethical experimental surgery. It is the ignorance and isolation identified by Katz in 1973 and still in place today.

Stark Wants to Scrap IRBs

Sociologist Laura Stark is a careful observer of the IRB system, having based her dissertation on archival research and direct observations of three university IRBs. In 2008, I complained that the dissertation, "Morality in Science," reported but failed to condemn bad IRB behavior. In a newly published essay, Stark takes a more critical stance.

[Laura Stark, "Gaps in Medical Research Ethics," Los Angeles Times, 8 October 2010.]

In her essay, Stark traces today's IRB system back to systems established in the 1960s at the NIH Clinical Center, which performed experiments on "hundreds of healthy prisoners, conscientious objectors, unemployed people and students living in their hospital as subjects." She finds that system included two basic flaws: it failed to inform the public about what was going, and it gave no voice to dissenting members of ethics boards. These flaws, she argues, remain in today's system of ethics review.

To remedy them, Stark proposes that the new Presidential Commission for the Study of Bioethical Issues "rebuild the regulations from the ground up." She writes,

New rules should include these changes:

Replace the thousands of local review boards that labor independently at universities and hospitals here and abroad with a small number of ethics-review networks organized around specific research methods rather than around institutions. The networks would be better equipped to handle multi-site studies that are now commonplace, and would remove the political biases of some outlier institutions.

Consider the advantages and disadvantages of outsourcing ethics review to private companies, which review research for a fee.

Finally, empower research participants by posting the results of ethics reviews online. The current system includes community representatives who presumably speak on behalf of research participants, but that's not good enough.

Though the essay does not specifically mention IRB review of research in the social sciences and humanities, the dissertation gives examples in which the lack of transparency and lack of expertise impeded such projects. Thus, Stark's call for expert boards and published results of ethics review could address non-biomedical research as well as the medical research that is her chief concern. And while Stark presents her proposals as ways to ensure better protection for research participants, they could also benefit those researchers who now fall victim to inexpert boards. Because the current system fails both researchers and participants, reform can benefit them both.

Stark should realize that the changes she proposes would require more than "rebuild[ing] the regulations from the ground up," since the requirement for local IRBs is encoded in federal statute, not just regulations. But a wholesale reconsideration of the IRB system by the presidential commission would be a fine first step.

Tell OHRP Belmont Isn't Everything

On September 23, OHRP posted drafts of new FWA form and FWA Terms of Assurance. It is collecting comments on the forms until October 25.

Here is what I have come up with so far. I would welcome comments on this draft for the next couple of weeks; I'd like to submit this comment by October 15 to be sure I make the deadline.

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To the Office for Human Research Protections:

Thank you for the opportunity to comment on the draft revision of the "Terms of the Federalwide Assurance for the Protection of Human Subjects." I have two comments on this draft.

1. THE DRAFT SHOULD BE REVISED TO REFLECT THE PROVISIONS OF 45 CFR 46.103(b)(1)

I am disappointed that the current draft fails to correct a longstanding discrepancy between the Common Rule and OHRP's forms. 45 CFR 46.103(b)(1) requires that each institution receiving funding from a Common Rule agency submit an assurance that includes

A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself.

By contrast, the draft Federalwide Assurance requires U.S. institutions to pledge that they will be guided either by the Belmont Report, the Declaration of Helsinki, or "other appropriate international ethical standards recognized by U.S. federal departments and agencies that have adopted the Common Rule." I am unaware of any documents in this third category, nor of any element of the Common Rule that requires federal approval of a statement of principles.

Thus, while the Common Rule offers institutions complete freedom in their choice of ethical principles, the current and proposed Terms of the Federalwide Assurance limit them to one or two documents. This is like guaranteeing the freedom of religion, then requiring every citizen to adhere to either the Lutheran Book of Concord or the Articles of Religion of the Methodist Church.

Instead, the first paragraph should reflect the provisions of the Common Rule. I suggest the following language:

"All of the Institution's human subjects research activities, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), will be guided by a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. This requirement does not preempt provisions of this policy applicable to department- or agency-supported or regulated research and need not be applicable to any research exempted or waived under §46.101(b) or (i)."

2. THE DRAFT SHOULD BE REVISED TO REFLECT ACCURATELY THE AUTHORSHIP AND EVOLUTION OF THE TRI-COUNCIL POLICY STATEMENT

The current draft allows non-U.S. institutions to comply based on "The 1998 (with 2000, 2002, and 2005 amendments) Medical Research Council of Canada Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans."

This statement has two inaccuracies. First, the Medical Research Council no longer exists; it was replaced in 2000 with the Canadian Institutes of Health Research (CIHR). Second, the TCPS is authored not only by the CIHR but also by the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC). (That is what makes it a tri-council policy.)

Moreover, the Panel on Research Ethics plans to release a second edition of the TCPS in December 2010, and may amend it further while the new Terms of the Federalwide Assurance are still in effect. Rather than limit institutions to an outdated version of the TCPS, OHRP should allow non-U.S. institutions to abide by the current version.

U.S. Apologizes for 1940s Human Subjects Research

This is a little off topic for the blog, but today Secretary of State Hillary Clinton and Health and Human Services Secretary Kathleen Sebelius apologized to Guatemala for experiments done there in the late 1940s. Researchers led by a Public Health Service doctor conducted various studies of syphilis, some of which included the deliberate infection of people without their consent.

The story was brought to light by Susan M. Reverby, Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies at Wellesley College. Her article, "''Normal Exposure' and Inoculation Syphilis: A PHS 'Tuskegee' Doctor in Guatemala, 1946-48, will appear in the Journal of Policy History in 2011, in a special issue on human subjects research that I edited.

UPDATE: The New York Times has a more complete story, including a nice mention of the Journal of Policy History.