CIHR Consultation: Developing a CIHR Access to Research Outputs Policy

Background

1. CIHR is currently developing a Research Outputs Access Policy, in order that researchers, health professionals, policy makers, and the public have greater access to research results. CIHR believes that a greater dissemination of research will encourage the advancement of science and the translation of research results into policy, new technologies, and health-related standards and best practices that will benefit the health of Canadians and others.

2. As stated by the International Advisory Committee to the President of the CIHR, "...open access publishing is consistent with the goal of CIHR to promulgate knowledge and the expectation that funded research be disseminated to maximize the impact and utility of the work." The importance of access to research outputs has been recognized by other research funding bodies, including the U.S. National Institutes of Health, U.K. Medical Research Council, Wellcome Trust, and the Australian Research Council and National Health and Medical Research Council.

3. To help guide policy development, CIHR established an external Advisory Committee on Access to Research Outputs (See Appendix 1 for membership). The committee, chaired by Dr. James E. Till, is composed of researchers from various health research disciplines who have provided support to CIHR in the development of the draft policy. The work of the committee was also informed by input that CIHR gathered from researchers and stakeholders through an online survey that was conducted in April 2006. The survey requested comments on key issues relating to developing an Access to Research Outputs policy. In general, respondents supported the idea of CIHR establishing an access policy, particularly one that would be broad in scope. Many respondents encouraged CIHR to review the policies of other national and international research funding agencies for direction.

Consultation: Draft Policy

4. On October 11, 2006, CIHR posted the draft access policy on the Internet and launched a consultation process to gather feedback from the research community, stakeholders and the public. CIHR received approximately 150 submissions in response to the Access to Research Outputs policy. Feedback was received from CIHR-funded researchers, government organizations, library associations, publishers, research centres, and scholarly associations among others.

5. Comments on the CIHR draft Access to Research Outputs policy fall into the following categories:

  • General comments;
  • Peer-reviewed publications;
    • Embargo period
    • Open access publication fees
    • Copyright
  • Research materials;
  • Research data;
    • Consent
    • Data archiving funds
    • Exclusive use of data
    • Administrative data
    • Privacy, Confidentiality, Ethics;
  • Research outputs access plan;
  • Intellectual property; and
  • Recommendations

General comments

6. In general, respondents were supportive of the development of a policy promoting access to research outputs. As stated by one researcher "As a publicly funded agency and in line with the scientific endeavour, it is essential that the research outputs and data generated be fully accessible by the public, with, of course, safeguards for the protection of privacy and intellectual property rights." Furthermore, many researchers recognized that "making research outputs available to a wider number of people would be very useful for the scientific community and could facilitate new collaborations between researchers." However, other respondents felt that CIHR should not be proceeding with a policy that would require CIHR-funded researchers to "do more science with less money" given: (i) cuts to operating grants; and (ii) the small number of grants currently being funded. Undoubtedly CIHR faces challenges in developing a policy requiring the sharing of unique data, materials and publications, however, as stated by one respondent "there are a series of other challenges with the current state of affairs that I personally feel are more problematic with respect to the advancement of science. This includes publication bias, outcome reporting bias, general non-analysis of some of the data for a variety of reasons, etc. If we don't make the proposed changes, then I think we need even more creative thinking to overcome the existing obstacles."

7. Some researchers felt that it is impractical to treat all research grants equally, particularly those funded with partners where CIHR contributes only a small fraction of the total grant awarded. "A substantial part of the research (especially clinical or population based) funded by the CIHR are projects for which CIHR is not the sole funder. For major projects (e.g., those thru UI collaborations, or others) CIHR is a minor funder ...often less than 25% of the funding, and at times even only about 10% ...In raising funds from other sources (especially industry) there are confidentiality agreements that investigators have to accept, and further these companies provide funding in exchange for their first rights for IP...and potential revenues that emanate from it." Furthermore, some researchers felt that in international collaborative studies it was unreasonable to expect coordination across multiple funding sources (public or private).

8. Several respondents were concerned that the CIHR policy did not specifically address regular clinical trials, and in particular access to clinical data and databases. According to one researcher "Those trials that involve industry partners, which may be more suspect in terms of selective reporting of outcomes in some critic's opinions, should be included. It is very concerning that hundreds of millions of dollars are spent on important clinical trials in Canada as elsewhere, yet the information needed to make an appropriate benefit:harm or cost-effectiveness decision especially for new drugs, is not available at all or is only available in an obscure part of an FDA reviewers' report at the FDA Website."

9. Some researchers felt that taking a researcher's track record of providing access to research outputs into consideration for future funding was an aggressive approach. One researcher felt that if this was the case, then applicants should be given much more information about the criteria that would be used to assess these plans. Moreover, some respondents felt that there were no systems in place to monitor compliance with the policy.

10. Some researchers expressed concern that encouraging open access publishing and sharing of data and materials would have a negative impact on career advancement. Researchers felt that sharing data that has not been completely utilized may lead to fewer publications and the appearance of lower productivity, which could compromise the evaluation of a candidate for promotion in a university or other organization.

11. Several of the library associations encouraged CIHR to sign one of the major declarations in support of open access and to adopt the definition of an open access publication in the CIHR policy. The most common declarations cited were the Berlin Declaration and the Bethesda Statement. (See Appendix 2 for more information on these declarations.)

12. Some respondents felt that CIHR's policy requires greater emphasis on the need for long-term preservation of research papers and data. It was suggested that the open archives, repositories, and databases that CIHR-funded researchers would use to deposit research outputs be extended to those that are "committed to and have a strategy for the long-term preservation of their electronic content."

13. To ensure the ethical conduct of research involving Aboriginal peoples it was suggested that the CIHR policy reference the CIHR Guidelines for Health Research Involving Aboriginal Peoples (currently in draft) paying particular attention to confidentiality, ownership and sharing of materials and data. Some researchers were concerned that "data that can lead to a geographic location (which should not be divulged) or traditional knowledge that should be protected for cultural reasons. Our Aboriginal researchers were certainly the most concerned by the draft policy and felt that it would reduce the already very low level of participation that we have from their communities."

14. The CIHR policy would be improved if it provided legitimate and acceptable reasons for restricting access to research outputs.

Peer-reviewed Publications

15. It was recommended that CIHR remove the phrase "make every effort" from the peer-reviewed publications section in order to ensure that author's comply with the policy.

16. A small number of respondents wanted to know how author's who publish in journals not listed in PubMed make their papers openly accessible. CIHR's draft policy suggests archiving these papers in institutional repositories or other disciplinary archives that follow specific open access archiving guidelines.

17. The Canadian Publishers Council (the Council) questioned "whether there is any lack of "access" to research outputs." Furthermore, the Council felt that the CIHR option of archiving publications "is not ready to provide a stable and low-risk alternative to the current distribution models." The Council questioned whether "the author's last version" or "the published version will be archived." The CIHR policy calls for grant recipients to archive the final peer-reviewed full text manuscript (i.e., postprint).

18. Several publishers and publisher associations did not think that PubMed Central could handle the volume of material that would be expected if this policy was mandated.

Embargo period

19. The Canadian Psychological Association, publishers (including the Canadian Publishers Council and the Canadian Association of Medical Publishers) and editors felt that requiring researchers to provide open access to publications within six months was too soon after publication. These groups felt that extending this period to twelve months would cause less damage to the economic base of journals because the full value of investments may not be realized in the six month period following publication. Furthermore, these groups felt that the six month embargo period might limit authors publishing options because not all journals allow archiving six months after publication. Conversely, many library associations and some researchers felt that six months was very generous and that "It would be well within CIHR's mandate as a public agency to require immediate open access to the research it funds."

Open access publication fees

20. Most researchers favoured open access publishing over self-archiving as the means for providing free digital access to peer-reviewed publications. However, many researchers and publishers requested that CIHR provide additional grant funds to cover this cost similar to the policy adopted by the Wellcome Trust, which reimburses the publishing expenses of grant recipients. One researcher felt that "by supporting publication fees, Canadian research will be able to be published in open access journals, in a manner competitive with other international funding institutions, and this will provide important international visibility to Canadian research and maintain our competitiveness on the world stage." Publishers also encouraged CIHR to make available the necessary funding for open access publishing. Several respondents felt that the draft policy might be improved if it was more explicit about how fees for publication in open access journals would be covered. Only one respondent acknowledged that publication fees are considered an eligible expense for disseminating research results in CIHR funding programs.

Copyright

21. Many researchers were concerned that requiring papers to be openly accessible would limit the number of journals that researchers could submit their papers for publication because there were a limited number of open access journals. Most researchers did not acknowledge that CIHR had provided two options for making publications openly accessible (open access journal publishing and self-archiving). For example, one researcher noted that papers in the journal Stroke were only freely available after two years and therefore it would be impossible to provide free access after six months. However, Stroke's copyright policy states that peer-reviewed manuscripts accepted in the journal for publication can be archived immediately upon acceptance. Some researchers questioned whether CIHR was "suggesting that researchers not publish in journals like Nature and Science." However, Nature and Science permit authors to archive the peer-reviewed manuscript (not the publisher's version/PDF) in PubMed Central, institutional repositories, or the author's web site within six months after publication.

Research materials

22. Most researchers felt that the requirement to share research materials and tools was acceptable and generally consistent with current research practice. One researcher noted that they already share research materials with qualified researchers on the condition that they have peer-reviewed funding and ethics approval for the proposed research. Some researchers questioned how the contribution of the developer of these materials or tools would be recognized in the publications that arise from secondary research.

23. There was some disagreement on whether it is reasonable to expect sharing of source code, code books, research tools for evaluation, questionnaires, data abstraction forms, protocols, and software. Some researchers felt that this would be easy; however users of administrative data1 felt that making source code and software available would be a very onerous requirement. Respondents felt that additional CIHR funds would help compensate the time required to document concepts developed (including programming code) for users of administrative data. The Institutes for Clinical Evaluative Sciences (ICES) noted that their researchers would be unable to share their "customized (and proprietary) algorithm" used to strip personal identifiers from personal health information because of privacy obligations limit access. ICES also noted that the usefulness of source code used to extract information from administrative databases is often limited to the particular institution and province where it was developed.

24. Some researchers were concerned that CIHR's policy for sharing research materials freely for non-profit use was "over-simplified". Researchers from Pillars 3 and 4 noted that it is not always possible to distribute questionnaires and clinical measures freely or at cost. In some cases it is essential that commercial publishers distribute this material, otherwise it will not be used to improve scientific knowledge or clinical practice. However, an epidemiologist responding to the consultation expressed concern that researchers were patenting questionnaires that had been validated with public funds.

25. Some researchers were concerned that "research materials" included research samples (e.g., urine, blood, DNA) and felt that sharing this material would be a disincentive, particularly for investigators involved in large studies, and potentially problematic as related to patient consent for secondary analysis.

26. It was recommended that the CIHR policy on sharing research materials acknowledge policies restricting the distribution of identified agents or materials (e.g., potential pathogens or hazardous materials) which pose a safety or security risk. It was suggested that the CIHR policy provide greater detail and examples of appropriate restrictions for sharing materials.

27. Some researchers questioned whether the CIHR policy required grant recipients to share their research materials with foreign not-for-profit organizations or institutions.

Research data

28. Some researchers felt that CIHR's proposal for sharing research data was an excellent and welcomed idea. According to one researcher "Any data arising from a publicly funded study should be archived into a public space." In fact, many researchers stated that they already share original data when requested under the condition that the investigators "try to ensure that the meta-analysis protocols are rigorous and that the investigators are bona fide before handing over data." CIHR and other funding agencies view data sharing as a means of promoting collaboration, enabling verification and audit, reducing duplication, and maintaining the high ethical standards and quality of the funded research. As stated by the one researcher "Incorrectly analysing data is one of the reasons why we need to make data publicly available, not a reason to prevent it from happening because right now, we have no way of verifying if the original investigators appropriately analysed their data."

29. Some researchers did not think that data sharing should be a component of this policy because of the high risk of abuse, misinterpretation, and irresponsible use of data. According to one researcher "data can be analyzed in many ways and some analyses are clearly wrong. By making available such data without appropriate collaborations or other controls may lead to erroneous results and conclusions that would be outside of the original investigators' control. Such situations, especially for sensitive data that have broad public health and other implications needs, to be avoided at all costs." Others felt that voluntary data sharing with the collaboration of principal investigators was a more effective method of ensuring the availability of scientific evidence. One respondent wondered whether a principal investigator was at risk of legal action by a secondary researcher if errors were found in the data or whether CIHR-funded researchers would be liable for data misuse.

30. Several respondents called for open access to data from clinical studies. According to one investigator "My colleagues and I are becoming increasingly concerned that incomplete or selective reporting of results (to favour 'positive' results) may lead to inappropriate, perhaps even damaging, change in clinical practice."

31. Some researchers suggested that the data sharing process should be coordinated through the principal investigator after a descriptor of the datasets has been posted online. Interested researchers and/or collaborators would apply through the principal investigator to use the dataset. The data request would be handled in one of two ways. First, if the request was related to an area of interest of the principal investigator then the researcher requesting data would be a collaborator; or if the data was requested for a completely unrelated research question then it could be released without expectation of participation or collaboration. Alternatively, many researchers felt that it was CIHR's responsibility to establish a data warehouse so that researchers would not spend their time administering data requests. Some researchers questioned whether co-authorship would be expected when sharing data.

32. One respondent questioned whether the CIHR policy required investigators to provide metadata in both official languages when sharing datasets.

33. One researcher was unsure about how CIHR defined "experimental data", which was required to be deposited into an appropriate public database. In particular, this researcher wondered whether "raw data collected in a RCT needs to be archived in a database." Several researchers expressed concern that patients would be deterred from participating in studies "when they would be informed that data they provide may be archived or shared in the future with unnamed individuals." It was suggested that CIHR amend the section on Research Data to state "Grant and award holders should strive to make final data sets, generally in electronic form, available to other researchers upon receipt of a suitable and scientifically justified formal request after the publication date of a peer-reviewed publication." The addition of this phrase might "prevent frivolous data mining or non-scientific use of other researcher's data."

34. In regards to data preservation, some researchers felt that there should be no destruction date for health research data.

Consent

35. Several researchers and Institutions questioned how consent forms would have to be worded to make it clear to participants that the study data may be used by other researchers for secondary analysis and study. It was suggested that this may affect whether people agree to participate in research studies. There was also concern that a data sharing policy would require investigators to revise consent forms and resubmit them to research ethics boards.

Data archiving funds

36. Many researchers called for CIHR to provide funds through budget line items in grant applications to ensure data maintenance, documentation, sharing and storage. Some researchers felt that it would be possible to provide electronic access to those data sub-sets that are linked to a publication, but not the full data. However, to do this would require time and planning, which researchers should be allowed to budget for in grant applications. Some other costs that researchers felt that CIHR grants should cover include: data entry, funding for database managers, data dictionary construction, support for troubleshooting, statistical expertise to analyze the data, and someone with both broad and specific expertise to review the literature and write-up the results. Finally, an additional cost was called for to manage the files and convert them into a form that could be posted for public access.

Exclusive use of data

37. A major concern held by many investigators was that sharing data after the first publication might result in publication duplication or would limit opportunities for secondary analysis (e.g., longitudinal follow-up). Several researchers felt that CIHR (with the involvement of the research community) should establish clear guidelines regarding the release and availability of research data, such as establishing a reasonable embargo period and ensuring that principal investigators are involved in the data sharing process. One respondent acknowledged that data sharing as pertaining to a specific analysis was appropriate and indeed common practice in some disciplines, however, it would be unacceptable to expect free access to a project's entire data set after the first peer-reviewed publication. In Pillars 3 and 4 in particular, "it is typical for a single project to produce several core publications over the first 5 years following a project's completion". The most common suggestion was to allow an extended period of exclusive use of data following the publication of the primary paper (up to 5 years) after which the data would be openly available. One researcher suggested that after a paper is published, the data used in that publication should be archived "in a reputable and accessible source within 12 months. For other data, from the same study, the investigators should be given sole privileges for publication, for a period that is at least as long as it took to conduct the research (with an upper maximum of 5 yrs after publication of first results)."

38. Alternatively, some researchers suggested that data should become openly available after a set number of publications were released (dependant upon the research project). However, this will have challenges as demonstrated by the following comment "One of my projects, begun in 1979, is still providing original material for me to analyse and publish, after about 50 publications that have come out of it. There is no simple formula like "one project = one publication". The PI of an epidemiologic project must be able to expect the ability to freely exploit the data that he/she has generated. Why would someone put in the years of effort needed to create a large database only to become a user like any other after the first paper is published?"

Administrative data

39. The following institutions responded to the consultation to express concern over requirements to share administrative data: Manitoba Centre for Health Policy; Institute for Clinical Evaluative Sciences; and the Centre for Addiction and Mental Health. Respondents noted that there are severe restrictions on disseminating data containing information on "provincial medical services plans, vital statistics and hospital discharge data." It is common for researchers to be required to return this administrative data to the custodian once analysis has been completed or even to destroy the data sets after completion of original study aims. Furthermore, Human Subjects Review Boards and administrative data stewards do not allow third party uses, and in many cases these stewards actually own the data set, as such it would be impossible to share this data or archive it in a publicly available database. For example, ICES is a prescribed entity under Ontario's privacy law that allows access to personal health information for analysis and compiling statistical information about Ontario's health care system. However, this privilege brings obligations including upholding restrictive policies that do not allow sharing of source data outside of ICES.

40. Many researchers acknowledged that greater access to data would benefit research in Canada. However, many expressed concern that they would be expected to release data while their access to data, particularly administrative data, is being increasingly restricted. Some researchers called for CIHR to "lobby politicians to ease some of these restrictions and perhaps even be so bold as to REQUIRE administrative data holders to make their data available for research purposes (as long as standard ethics requirements are met)." Many respondents felt that only with greater access to these types of data would they be able to address the challenges facing the health of Canadians.

Privacy, confidentiality, and ethics

41. CIHR received a significant amount of feedback from researchers and administrators expressing concern over sharing data obtained through governmental and other sources that are governed by Provincial/Federal privacy legislation, custodial, and institutional (i.e., university or hospital) policies. Respondents felt that making "final data sets" available upon request was impractical and may violate provincial and Statistics Canada privacy policies. Some respondents expressed concern that "anonymisation does not always protect confidentiality - particularly when small sets of research subjects are involved, for example from small indigenous communities." Moreover, one responder felt that many researchers were not properly trained to be able to ensure that microdata preserve identity, anonymity, and consequently confidentiality. Many researchers felt that data oversight mechanisms needed to be in place to ensure the preservation of privacy rights of study participants. CIHR is cognisant of the fact that the proposed policy lacked guidance on this particularly important area. However, it was never CIHR's intention to supersede institutional or other policies in the jurisdiction(s) where the research is being or has been conducted. Researchers must comply with applicable privacy legislation and policies, as well as with the Tri-Council Policy Statement on Ethical Conduct for Research Involving Human Subjects. CIHR considers potential risks to the protection of privacy and confidentiality of human subjects to be a valid exception to the expectation of data sharing.

42. Several researchers recommended that the policy specifically reference privacy legislation, which would encourage compliance with CIHR's policy and the applicable privacy legislation.

43. Some researchers working with provincial health authorities noted that final data sets from research involving "multi-year files of different formats on hundreds of thousands of people with millions of records" are often not created in order to minimize threats to privacy.

Research outputs access plan

44. Respondents called for more information about criteria that will be used to assess whether a plan is adequate, and whether funding would be contingent on the assessment of their plan.

45. There was concern that there would be problems with reviewing research output plans. One researcher noted that Knowledge Translation (KT) plans have been commonplace in pillar 3 and 4 applications for some time, yet most reviewers remain ill-equipped to appraise them. Furthermore, it was suggested that the relationship between the access and KT plans be clarified.

Intellectual property

46. Research from ICES questioned whether the CIHR policy is in line with intellectual property laws in Canada.

47. Respondents felt that there was a lack of guidance on patenting and intellectual property (IP) protection of discoveries and knowledge developed by CIHR researchers. One researcher felt that the policy required a balance between creating products for Canada (competitiveness) and unrestricted sharing of information. CIHR considers it acceptable for investigators to restrict access to their work until the patents have been filed. The same can be said for investigators employed by institutions that consider such products to be the IP of the institution, not the individual researcher. The goal of CIHR's policy is to encourage greater sharing and access to research results, moreover, CIHR are keenly aware of the importance of IP in the research process. CIHR does not retain or claim any ownership of, or exploitation rights to IP developed with CIHR funding. The IP is owned by the institution and/or by the grant or award holder and associates, depending on local policy. It is understandable that certain materials may be restricted in order to exploit the IP for commercial gain. CIHR would encourage grant holders to avoid unduly restrictive agreements that will inhibit access to research outputs and thus scientific progress.

48. Researchers from Laurentian University expressed concern that Native peoples should decide, and not necessarily researchers, who should have full access to the research data and outputs that are related to their 'community'. They felt that CIHR policy should somehow maintain the principles of OCAP (Ownership, Control, Access & Possession) that are espoused by the National Aboriginal Health Organization as well as many First Nations and Native communities across the country. Furthermore, "Another issue that arises is around intellectual property rights and this is especially relevant to Native peoples where traditional knowledges of medicinal practices may be kept confidential for reasons related to experiences of theft of this knowledge."

Recommendations

49. It was suggested that CIHR implement a "page-charge reimbursement mechanism" that would lie outside of the grant itself. This would allow authors to get reimbursed for page charges for publications that were not anticipated in the grant application and may appear years after the grant has run out.

50. One researcher suggested that CIHR establish a peer review committee to review whether requests for data access are valid and worthwhile, which would prevent data misuse.

51. Some researchers suggested that CIHR mandate "a timeline for submission to a peer-reviewed journal (e.g., so many months after final data point collected)." Researchers were concerned that many studies that have been finished for years have still not been written up. Other respondents suggested a similar approach with regards to access to research data, which is to say that if papers have not been published within a certain time period then all data must be released.

52. "CIHR should consider the imposition of a viral license. Such a license would provide that those who receive data or material (who may or may not be subject to CIHR rules) must also make altered data/material available."

53. One researcher provided a suggestion for the data sharing process for a research project involving approximately 60 investigators. Before data were assembled, investigators were invited to propose draft titles for articles, which were eventually circulated so investigators could identify all potential areas of overlapping interest, collaboration, and conflict. According to this researcher, "These were almost 100% resolved harmoniously before any data were sent to the investigators." Progress for each article was tracked, and when little progress was made after a pre-determined time someone else could take the lead on that article. For outsiders requesting data, the list was scanned for overlap and if there was overlap they were put into contact with the investigator with similar interests. If there was no overlap, the outside investigator was assigned a team member who would help familiarize them with the data set. In the end, a data set was compiled for public use and was accompanied by a list of topics already published or in progress, which was available to anyone outside of the study.

54. There was a request for a Canadian repository of open access publications, which would provide permanent access to CIHR-funded peer-reviewed research for the benefit of Canadian and international researchers.

Appendix 1

Advisory Committee on Access to Research Outputs - Membership


James E. Till (Chair) Senior Scientist Emeritus,
Ontario Cancer Institute		 University of Toronto
Michel Bergeron Director,
Infectious Diseases Research Centre		 Université Laval
Barbara Neis Professor,
Department of Sociology		 Memorial University of Newfoundland
Jeanette Ward Professor,
Institute of Population Health		 University of Ottawa
Michael Rudnicki Senior Scientist and Director of the Molecular Medicine Program and the Sprott Centre for Stem Cell Research, Ottawa Health Research Institute Ottawa Health Research Institute
Louise Potvin Professor,
Department of Social and Preventive Medicine		 Université de Montréal
Geoffrey Hicks Director,
Mammalian Functional Genomics Centre, Manitoba Institute of Cell Biology		 University of Manitoba
Charlyn Black Director,
Centre for Health Services and Policy Research		 University of British Columbia
Francis Ouellette Director,
UBC Bioinformatics Centre, Associate Professor, Department of Medical Genetics		 University of British Columbia
Ian Graham
(ex officio)		 Vice-President,
Knowledge Translation, Research		 Canadian Institutes of Health Research

Appendix 2

Berlin Declaration2

Definition of an Open Access Contribution
Establishing open access as a worthwhile procedure ideally requires the active commitment of each and every individual producer of scientific knowledge and holder of cultural heritage. Open access contributions include original scientific research results, raw data and metadata, source materials, digital representations of pictorial and graphical materials and scholarly multimedia material.

Open access contributions must satisfy two conditions:

  1. The author(s) and right holder(s) of such contributions grant(s) to all users a free, irrevocable, worldwide, right of access to, and a license to copy, use, distribute, transmit and display the work publicly and to make and distribute derivative works, in any digital medium for any responsible purpose, subject to proper attribution of authorship (community standards, will continue to provide the mechanism for enforcement of proper attribution and responsible use of the published work, as they do now), as well as the right to make small numbers of printed copies for their personal use.

  2. A complete version of the work and all supplemental materials, including a copy of the permission as stated above, in an appropriate standard electronic format is deposited (and thus published) in at least one online repository using suitable technical standards (such as the Open Archive definitions) that is supported and maintained by an academic institution, scholarly society, government agency, or other well-established organization that seeks to enable open access, unrestricted distribution, inter operability, and long-term archiving.

Bethesda Statement3

Definition of Open Access Publication
An Open Access Publication4 is one that meets the following two conditions:

  1. The author(s) and copyright holder(s) grant(s) to all users a free, irrevocable, worldwide, perpetual right of access to, and a license to copy, use, distribute, transmit and display the work publicly and to make and distribute derivative works, in any digital medium for any responsible purpose, subject to proper attribution of authorship5, as well as the right to make small numbers of printed copies for their personal use.

  2. A complete version of the work and all supplemental materials, including a copy of the permission as stated above, in a suitable standard electronic format is deposited immediately upon initial publication in at least one online repository that is supported by an academic institution, scholarly society, government agency, or other well-established organization that seeks to enable open access, unrestricted distribution, interoperability, and long-term archiving (for the biomedical sciences, PubMed Central is such a repository).

1Data collected, usually by the provincial or federal government, for an administrative purpose and not necessarily for research. (e.g., prescription drug claims or health records)

2Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities, October 22, 2003.

3Bethesda Statement on Open Access Publishing, June 20, 2003.

4 Open access is a property of individual works, not necessarily journals or publishers.

5 Community standards, rather than copyright law, will continue to provide the mechanism for enforcement of proper attribution and responsible use of the published work, as they do now.