Archive for February, 2008

Much ado about the Harvard OA policy

The lyrics of one of Tom Lehrer’s most memorable songs come to mind: Fight Fiercely, Harvard!

Fight fiercely, Harvard, fight, fight, fight
Demonstrate to them our skill
Albeit they possess the might
Nonetheless we have the will …

During the two weeks since the vote on February 12 by the Faculty of Arts and Sciences at Harvard to adopt an open access policy, there has been much comment and debate. Some examples:

Harvard Faculty Adopts Open-Access Requirement, The Chronicle of Higher Education News Blog, February 12, 2008. Excerpt:

The new policy will allow faculty members to request a waiver, but otherwise they must provide an electronic form of each article to the provost’s office, which will place it in an online repository.

Harvard faculty votes on Internet-based open “publishing”. Hilary Spencer, Nature Network forum, February 13, 2008. Excerpt:

Universities have long been interested in retaining some of the fruits of their researchers’ work, whether it has been via institutional repositories, databases, or eprint servers. In addition to making the results of research openly available, and thus benefiting the community as a whole, this proposal seems in part to be an attempt by Harvard to also retain copyright and distribution/licensing rights for their researchers’ work.

Harvard first to force open access, Andrea Gawrylewski, The Scientist.com blog, February 13, 2008. Excerpt, quoting Joseph Esposito:

The implications of Harvard’s decision are broad, but one thing that is likely to happen as a direct result of the decision is that companies with Open Access services may get acquired by traditional publishers …

Harvard open-access policy – can you please be more specific? Noah Gray, Action Potential, February 14, 2008. Excerpt:

That brings us to the main point. Harvard is extremely vague about exactly what this proposal covers. A smart move, if you ask me, because now they can stress any position or interpretation that they want, based on the response they receive.

Blog-style annotation and in-depth criticism: New niche for academic journals, in wake of Harvard open-access move? David Rothman, TeleRead: Bring the E-Books Home, February 17, 2008. Excerpt:

Will this kill off academic journals? Not all of them.

The smarter ones could adapt with better-than-ever peer review procedures and maybe even use a blog approach. They could link to the best research and also comment on the worst, while offering far, far more depth than a blog would.

Open access publishing: Harvard ups the ante, Elizabeth Pisani, The Wisdom of Whores, February 18, 2008. Excerpt:

The proposal, reproduced below, is a bit hazy on the timing of public posting. Does a piece of research only become a “scholarly article” once it has appeared in a journal?

Harvard adopts opt-out open-access policy, Nature 2008(20 Feb); 451: 879. (Subscription required). Excerpt:

Stuart Shieber, the computer scientist at Harvard who proposed the scheme, says that any request for an exemption will be granted. The university has not yet worked out how to define what constitutes a ‘final’ draft of a scholarly paper, nor come up with a time limit for submission.

Many comments have been compiled by Peter Suber and Gavin Baker in posts to Open Access News, and they provide a very useful guide through much of the labyrinth. In the list provided below, I’ve included a few excerpts that I thought were especially noteworthy.

Variations on the theme of the Harvard OA policy, February 22, 2008. About a post by Stevan Harnad, The Hybrid Copyright Retention and Deposit Mandate, Open Access Archivangelism, February 22, 2008.

More comments on the Harvard OA policy, February 22, 2008. One of the five comments is from John Mark Ockerbloom in Everybody’s Libraries. An excerpt:

This mandate is faculty-friendly as well as being open-access friendly, in that it minimizes the extra work faculty have to do and assures them the last word in access control, should they decide to exercise it. And that, I believe, is crucial to its having been adopted at all, and to its subsequent acceptance by faculty.

Stevan Harnad replies to Mike Carroll, February 21, 2008. Peter Suber adds some comments of his own. One of his comments is:

Because Harvard’s is the first university-level mandate to focus on permissions rather than deposits, it deserves a chance to show how well it can work.

More on the Harvard policy, February 21, 2008. Excerpts from an article by Lila Guterman in Chronicle of Higher Education, February 21, 2008 (accessible only to subscribers). Example:

Mr. Thatcher and others also wonder whether Harvard faculty members will actually make the effort to comply with the policy. But open-access supporters observe that faculty members themselves were the ones who voted for it.

Mike Carroll on OA, copyright, and the NIH and Harvard policies, February 20, 2008. About a cluster of three related posts by Mike Carroll. Excerpt from the first, NIH and Harvard – It’s About Values:

The key point is that this really is not a technical conversation. It’s a conversation about values….

“Other schools should follow Harvard’s lead”, February 19, 2008. Provides excerpts from: Open access to brilliant insights, Boston Globe, February 19, 2008.

More comments on the Harvard OA mandate, February 17, 2008. Two of the three articles cited suggest that other institutions should follow Harvard’s lead.

More on the Harvard mandate, February 15, 2008. Excerpts from: Heidi Ledford, Harvard adopts open-access policy, Nature News, February 15, 2008. One of the two excerpts:

[T]he university has not yet established a time limit for submission, nor have they defined what constitutes a ‘final’ draft of the paper. Harvard intends to establish an ‘office of scholarly communication’ to define these issues….

More comments on the Harvard OA mandate, February 15, 2008. Five comments are cited. One is from Dorothea Salo at Caveat Lector: Pyrrhic Victories: Excerpt:

I have a feeling the deafening silence coming from publishers right now is deliberate. Their only realistic hope is that the Harvard policy sinks like a stone in a vast sea of institutional indifference, and the best way for them to create that outcome is to keep their mouths shut so that the initial flurry of coverage and interest fades quicker.

Three on the Harvard OA mandate, February 14, 2008. Three comments are cited. The third (see heading: Shieber: Librarians Very Involved with Harvard OA Motion) quotes Stuart Shieber:

Open access repositories are not a substitute for journals. They are a complement to them. It is important that those processes continue, and to the extent that they involve expenses, universities and funding agencies will have to continue to pay for them.

Stevan Harnad’s proposed revisions to the Harvard policy, February 14, 2008. See: Weaken the Harvard OA Mandate To Strengthen It, Open Access Archivangelism, February 14, 2008. Excerpt (quoting Terry Martin of Harvard Law School, to whom Stevan Harnad is responding):

Stevan, I’m sure your version is preferable to the one actually passed by FAS. Some of us urged a more forceful approach. However, those with a better political sense thought otherwise.

More on the Harvard OA mandate, February 14, 2008. The several articles cited include one from T. Scott Plutchak at T. Scott. Excerpt:

That it [the Harvard policy] is driven by the faculty rather than being imposed from the outside is a very positive sign. Most important, however, is that a major university is taking a significant step towards managing its own scholarly production.

Roundup of commentary on Harvard OA policy, February 13, 2008. The various articles cited include one by Gavin Baker, Harvard faculty say yes to OA, Journal of Insignificant Inquiry, February 13, 2008. Excerpt:

… I want to focus on the fact that the faculty, through their own governance process, themselves approved this mandate.

Text of the Harvard policy, February 12, 2008. Excerpt:

To assist the University in distributing the articles, each Faculty member will provide an electronic copy of the final version of the article at no charge to the appropriate representative of the Provost’s Office in an appropriate format (such as PDF) specified by the Provost’s Office. The Provost’s Office may make the article available to the public in an open-access repository.

It’s obvious from all of these comments that the Harvard policy has been spectacularly successful at raising awareness about OA. But, to continue to be influential, the policy must be implemented successfully. Do faculty members at Harvard “have the will” to do this? Or, might they be apathetic (in the well-chosen words of Dorothea Salo, a “slumbering behemoth“) and, by ignoring the policy, thus defeat it?

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Assessing health services research journals

Public policies about health services vary greatly both between and within countries. “Health services research” (HSR) is a field of research that deals with various aspects of health systems. It’s a field that’s of interest not only to those who do the research, but also to those who make decisions about health policy, and to those who are affected by such decisions. For examples of articles about HSR, see the collection published by CMAJ.

How to assess existing HSR journals? Which HSR journals publish articles that are openly accessible, and hence, are readily available to all those with an interest in health policy and services?

First, a Canadian perspective. Canada’s unique policies for the delivery of health services merit research that has a focus on this particular health system. An example of a Canadian health services research journal is Healthcare Policy. This journal published its first issue in September of 2005. See: Healthcare Policy journal, CIHR Institute of Health Services and Policy Research (IHSPR). Excerpt:

Healthcare Policy is designed to be a key knowledge translation vehicle to stimulate communication and cross-fertilization between researchers and health care decision makers.

An excerpt from the home page of the journal. It is:

For health system managers, practitioners, politicians and their administrators, and educators and academics. Authors come from a broad range of disciplines including social sciences, humanities, ethics, law, management sciences, and knowledge translation.

The publisher of this journal is Longwoods Publishing. The SHERPA/RoMEO summary of publisher copyright policies & self-archiving for Longwoods Publishing indicates that a post-print (i.e. final draft post-refereeing) may be archived 12 months after date of online publication. Information about this 12-month embargo is included in the License to Publish (PDF, 190 KB).

This 12-month embargo can be avoided if authors select the Optional Open Access paid-OA option that’s available for Longwoods’ four journals. Fee for 2008: $2,500.

For an appraisal of the Optional Open Access policy, see: Longwoods Press rolls out Open Access policy, by Greyson, Social Justice Librarian, January 10, 2008. An excerpt from one of Greyson’s comments that follow the appraisal highlights the importance of independent Canadian journals:

I think it’s deeply important for us to continue to have independent Canadian journals, particularly in health policy where our concerns are often quite different from those in the US.

From a broader perspective, results obtained from the application to health-related issues of research methods derived from a range of disciplines, including the social sciences, are reported in a variety of journals. There are sites that permit a variety of journals in a particular topic area to be ranked according to specified measures of impact.

For example, the Longwoods journal Healthcare Quarterly is currently ranked #1201 in a SCImago ranking of journals in the Subject Area: “Medicine” and the Subject Category: “Medicine (miscellaneous)”. However, Healthcare Quarterly is a journal that has a focus on:

Best practices, policy and innovations in the administration of healthcare. For administrators, academics, insurers, suppliers and policy pundits.

So, it’s a journal intended for research on healthcare policy and services. It seems inappropriate to classify it as a “Medicine (miscellaneous)” journal.

The Longwoods journal Healthcare Policy wasn’t found in the SCImago database via a Journal Search, so it isn’t included in any rankings.

Another website that can be useful for the evaluation of journals is eigenFACTOR.org. There’s a claim on its “why eigenfactor?” page that it “ranks journals much as Google ranks websites. One option that’s provided is a “cost-effectiveness search“. When this search was done for the “field: medicine” and “fine category: health policy and services”, the cost-effectiveness search results yielded a total of 28 journals. The five top-ranked journals were: Health Affairs, Medical Care, American Journal of Managed Care, Milbank Quarterly and Health Services Research.

Neither of the Longwoods journals Healthcare Policy nor Healthcare Quarterly are included in the eigenFACTOR.org database, so they don’t appear among the 28 journals ranked in the results this particular search.

Similarly, SCImago can be used to obtain rankings of journals in the “Subject Area: Social Sciences” and the “Subject Category: Health (social science)”. They can be ranked by H index, or ranked by SJR (SCImago Journal Rank). Healthcare Quarterly wasn’t found among the 81 journals ranked in the results of this search. Apparently, this is because Healthcare Quarterly has been put into the Subject Area category: “Medicine” and the Subject Category: “Medicine (miscellaneous)”, as noted above. If it had been included, it would have been ranked about 68th of 81 Health (social science) journals, when ranked by SJR.

As is also noted above, Healthcare Policy is currently not included in the SCImago database.

Four of the five journals identified above (as highly ranked in terms of cost-effectiveness) were also found among the top ten journals when ranked according to either H Index or SJR. These four journals and their publishers are listed below. Also included is information about their compliance with the access policies of a range of funding agencies (according to the SHERPA/RoMEO database).

1) Health Affairs (Project Hope): A search of the SHERPA/RoMEO database yielded no information about compliance of this journal with the access policies of funders, nor was I able to find any relevant information via the journal’s website.

2) Medical Care (Lippincott Williams & Wilkins): Results from the SHERPA/RoMEO database indicate that this journal is non-compliant with the access policies of the funders that are identified.

3) Milbank Quarterly (Blackwell): Results from the SHERPA/RoMEO database indicate that this journal is compliant with the access policies of all of the funders that are identified. However, the exact duration of any embargo period, post-publication and prior to provision of free accessibility, isn’t specified for this particular journal. A visit to the journal’s website also didn’t yield this information.

4) Health Services Research (Blackwell): Results from the SHERPA/RoMEO database indicate that this journal also is compliant with the access policies of all of the funders that are identified. However, according to the Copyright Assignment Form, the policy of HSR about postprints is:

Posting of the published Article on an electronic public server can only be done with written permission from Blackwell Publishing.

In contrast, the policy for Standard Blackwell Publishing Journals is that postprints may be posted:

… on free public servers in their subject area after the embargo period stipulated by the journal has been passed (note that the embargo period will vary by journal, e.g. 6 months or 12 months, and that some journals do not have any embargo on self-archiving at all …

Thus, the policy about postprints (author’s final version after peer review) for HSR appears to differ from that of other Blackwell journals.

Some, but not all, Blackwell journals offer a hybrid OA option, called Online Open. According to a list dated May 11, 2007 [xls file], Health Services Research is one of the journals that offers this option. The fee for 2007 is US$2,600. (According to the list dated May 2007, Milbank Quarterly does not offer this hybrid OA option).

There are, of course, other journals devoted to various aspects of research relevant to health policy and health services. Two examples of Open Access journals are BMC Health Services Research (published by BioMed Central; the article-processing fee for 2008 is US$1,870), and Health Research Policy and Systems (published by BMC in collaboration with the World Health Organization; the current fee is US$1,675).

A comparison of SJR data from SCIamgo for these two journals and for the journal Health Services Research indicates that the SJRs for all of these journals have increased after 2003, and that the SJRs for the two BMC open access journals in 2006 were similar to the SJR for Health Services Research 5-6 years earlier.

So, what lessons might be learned from these comparisons? Some points to consider:

a) The policies of publishers about Green OA (archiving of post-prints) for these journals range from non-compliant (Lippincott Williams & Wilkins) to complex (Blackwoods) and/or obscure (Project Hope, Blackwoods). The effort required to try to obtain unambiguous information about these Green OA policies is sometimes ridiculous, to an extent that is almost comical.

b) The preferred alternative to Green OA is Gold OA (paid open access to the full text of journal contents). The most prominent OA publisher in the HSR field is BioMed Central (BMC).

c) Some publishers (e.g. Blackwell, Longwoods) do provide Hybrid OA (paid access to individual articles), but the article-processing fees are expensive (e.g. in comparison with BMC’s Gold OA journals). Such programs may also have other drawbacks. See Peter Suber’sNine key questions to ask about any hybrid journal program“, SPARC Open Access Newsletter, issue #101, September 2, 2006.

d) The warning at the SHERPA/RoMEO site should be noted: “All information is correct to the best of our knowledge but should not be relied upon for legal advice“. When a publisher’s policies vary from journal to journal, the information may be correct for one journal, but not for another.

e) Sites designed to permit comparisons of journals, such as SCImago and eigenFACTOR.org, may neglect or misclassify some journals (especially, “niche journals“). It would be prudent not to use any single site of this type as the sole source of information for an assessment of journals. Journal comparisons need to take into account multiple variables, not all of which are likely to be incorporated into any particular source of information.

Added July 2, 2008: Cite as: Till J. Assessing health services research journals. Be Openly Accessible or Be Obscure blog. Self-Archived at WebCite® 2008-Jul-2 [http://www.webcitation.org/5Z0qWEdGm]

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Free articles about human gene therapy trials

The January 1, 2008 issue (vol. 19, no. 1) of the journal Human Gene Therapy includes an editorial and five commentaries about adverse events and informed consent in human gene transfer trials. See: Debate over Safety of Gene Therapy Trials Focuses on Issue of Informed Consent, by Vicki Cohn, Press Release, Mary Ann Liebert, Inc., January 22, 2008. All of these articles are currently freely accessible:

1) Adverse Events in Gene Transfer Trials and an Agenda for the New Year, by James M. Wilson, the Editor-In-Chief (Human Gene Therapy. January 1, 2008, 19(1): 1-2. doi:10.1089/hum.2008.0104). Excerpts:

The fact is that gene therapy is, and will remain, a highly visible area of translational research with elevated scrutiny.

I encourage the professional gene therapy societies and various related foundations to work together in the new year to undertake a critical review of the conduct of our clinical trials. As you can see in the following commentaries, these are very complex issues and conflicts and biases are at times unavoidable. However, it behooves us to get ahead of this issue and put in place more effective ways to ensure that research subjects who courageously give of themselves can do so with a full and unbiased understanding of the risks and benefits of their participation.

2) Case of Leukaemia Associated with X-Linked Severe Combined Immunodeficiency Gene Therapy Trial in London, by Board of the European Society of Gene and Cell Therapy, Executive Committee of the Clinigene Network of Excellence, and Executive of the Consert Integrated Project (Human Gene Therapy. January 1, 2008, 19(1): 3-4. doi:10.1089/hum.2007.1221). Excerpt:

However, retroviral and lentiviral SIN vectors remain to be proven clinically to provide both efficacy and a lower, ideally negligible, risk of adverse effects, and long-term follow-up of respective clinical trial patients is a clear necessity.

3) If It’s Broken, Shouldn’t It Be Fixed? Informed Consent and Initial Clinical Trials of Gene Therapy, by Arthur L. Caplan (Human Gene Therapy. January 1, 2008, 19(1): 5-6. doi:10.1089/hum.2007.1010). Excerpt:

Nothing can make the death of a subject in a clinical trial anything other than a horrible tragedy. There are, however, steps that could and should be taken to help ensure that when a death or adverse event occurs there is less room for doubt about the adequacy of informed consent.

4) Informed Consent in Human Gene Transfer Clinical Trials, by Jeffrey Kahn (Human Gene Therapy. January 1, 2008, 19(1): 7-8. doi:10.1089/hum.2007.1228). Excerpt:

The challenge of improving informed consent deserves the same attention as the science and medicine of gene transfer, and only when we meet that challenge can we claim that the subjects in HGT research are truly protected.

5) Protections for Participants in Gene Therapy Trials: A Patient’s Perspective, by Suzanne R. Pattee (Human Gene Therapy. January 1, 2008, 19(1): 9-10. doi:10.1089/hum.2007.1214). Excerpt:

Respecting participants by including them in the process respects the gravity of the request made of them – to give selflessly of themselves to benefit others.

6) Human Gene Therapy, Consent, and the Realities of Clinical Research: Is It Time for a Research Subject Advocate?, by Tomas Jose Silber (Human Gene Therapy. January 1, 2008, 19(1): 11-14. doi:10.1089/hum.2007.1217). Excerpt:

A research subject advocate could enhance the protection of participants in gene transfer research by advising the research team about participant concerns, by verifying the appropriateness of the Data Safety Monitoring Plan, by monitoring adverse events, and, most importantly, by the direct interaction with concerned families, stressing availability throughout the study while maintaining a working relationship with and independence from researchers.

For another example of the “elevated scrutiny” that human gene therapy is receiving, see a commentary about the articles listed above, On gene therapy and informed consent, by Alan Milstein, blog.bioethics.net, January 29, 2008. Excerpt:

January’s issue of Human Gene Therapy offers some intriguing commentary on the issue of informed consent in gene transfer trials.

I had represented the Gelsinger family after the death of their son in the experiment sponsored by Dr. Wilson and because I currently represent the family of Jolie Mohr, whose recent death renewed the debate over the informed consent process in this field of research.

See also: A comment from Paul Gelsinger on gene therapy and informed consent, blog.bioethics.net, January 31, 2008. The final sentence:

Anyone considering joining a clinical trial needs to be aware that they are dealing with a system that is seriously flawed.

Clinical trials of human gene therapy are of great interest from a variety of perspectives, including bioethical ones. They also provide an example of an aspect of biomedical and health-related research that’s of interest to many people, in addition to those researchers who are active in the field. Human Gene Therapy, and its publishers, Mary Ann Liebert Inc., should be thanked for providing free access to the thought-provoking articles published in the January 1, 2008 issue.

However, it should also be noted that Mary Ann Liebert, Inc. is listed in the SHERPA/RoMEO database as a publisher that’s non-compliant with the access policies of a variety of funding agencies. There’s a “Liebert Open Option” for Human Gene Therapy [PDF, 74 KB]. Fee: $3,000.

So far, I’ve not been able to find any information about how Mary Ann Liebert, Inc. plans to respond to the recently-revised NIH Public Access Policy.

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