I.3.2 Professional Organizations and Journals

I.3.2.a National Research Council of the National Academy of Sciences

In 1985, the National Research Council ("NRC") issued a study in which it attempted to comprehensively study data access policies throughout the scientific community.¹² NRC's conclusions and recommendations include:

Sharing data should be a regular practice.

Investigators should share their data by the time of publication of initial major results of analyses of the data except in compelling circumstances.

Data relevant to public policy should be shared as quickly and widely as possible.

Plans for data sharing should be an integral part of a research plan whenever data sharing is feasible.

Investigators should keep data available for a reasonable period after publication of results from analyses of the data.

Government funding agencies, in particular, should require applicants to guarantee data sharing or to justify explicitly in their proposals why sharing would be inappropriate.

I.3.2.b Institute of Medicine of the National Academy of Sciences

In 1989, the Institute of Medicine published a report of a study on the responsible conduct of research in the health sciences in which it was recommended that "[a]n interdisciplinary committee should be convened to study the issue of rights and responsibilities of all relevant parties to research data and to prepare model guidelines for data sharing and data access."¹³

I.3.2.c American Physical Society

APS ethics guidelines state that "[R]esearch data should be immediately available to scientific collaborators. Following publication the data should be retained for a reasonable period in order to be available promptly and completely to responsible scientists. Exceptions may be appropriate in certain circumstances in order to preserve privacy, to assure patent protection, or for similar reasons."¹⁴

More recently, in 1997 in commenting on proposed Federal legislation on database restrictions, the Society reiterated its commitment to data access¹⁵:

The open flow of scientific data is essential to the progress of science. The American Physical Society is therefore greatly concerned by proposed legislation and treaties which would impose, through copyrighting of data bases, severe restrictions upon the fair use of scientific data, the generation of which was supported by public funds. The Society supports a balanced approach to copyright laws, which maintains the traditional principles of fair use and of expiration of copyright after a reasonable period, while still protecting intellectual property rights of authors and publishers.

I.3.2.d American Sociological Association

The Association's code of ethics states¹⁶:

Sociologists share data and pertinent documentation as a regular practice. Sociologists make their data available after completion of the project or its major publications, except where proprietary agreements with employers, contractors, or clients preclude such accessibility or when it is impossible to share data and protect the confidentiality of the data or the anonymity of research participants (e.g., raw field notes or detailed information from ethnographic interviews).

Sociologists anticipate data sharing as an integral part of a research plan whenever data sharing is feasible.

I.3.2.e American Society for Microbiology

In a recent letter to the House Judiciary Committee commenting on proposed legislation on database restrictions, the ASM stressed the importance of balancing the research community's need for access to underlying data with reasonable intellectual property concerns¹⁷:

The American Society for Microbiology (ASM) subscribes to the principle that knowledge generated by science is intended to benefit all humanity, and that such benefit cannot be realized without full and open access to information.

The continued development of vital areas of research, such as genomic studies, combinatorial chemistry and bioinformatics, is database dependent. There is need, therefore, to guard against entrepreneurs who will repackage, claim copyright and charge educators and researchers for the use of data which is already, or would otherwise be, in the public domain. Important genetic resources and details of drug design compiled on a continuing basis and released to the public by the National Institutes of Health and by other agencies, could be commercialized by enterprising individuals, defeating the attempt to make this information available to all to use in the search for new drug targets and drugs to treat genetic disorders and infectious diseases.

I.3.2.f American Statistical Association

The Association's current ethics guidelines state that statisticians should "make data available for analysis by other responsible parties with appropriate safeguards for privacy concerns."¹⁸

The ASA is in the process of considering revisions to the above guidelines. On December 22, 1998, it issued a "Final Draft for General Comment"¹⁹, which states that it is the responsibility of statisticians towards other statisticians or statistical practitioners to --

Promote sharing of (nonproprietary) data and methods. As appropriate, make suitably documented data available for replicate analyses, metadata studies, and other suitable research by qualified investigators.

I.3.2.g International Statistical Institute

The Institute's Declaration on Professional Ethics (1985), in the section on "Obligations to colleagues" states:

3.2 Exposing and reviewing methods and findings

Within the limits of confidentiality requirements, statisticians should provide adequate information to colleagues to permit their methods, procedures, techniques and findings to be assessed. Such assessments should be directed at the methods themselves rather than at the individuals who selected or used them." International Statistical Institute, Declaration on Professional Ethics § 3.2 (adopted Aug. 1985).

I.3.2.h American Chemical Society Journals

The instructions to authors for submission of materials for publication in the ACS's various journals encourage investigators to provide details of the data or materials underlying their submissions in the form of "Supporting Information", which ACS then makes available to the public in electronic format through its Internet site. The existence of such supporting information in a separate paper is noted at the end of the journal publication. For example, the "Notice to Authors of Papers" for the Journal of the American Chemical Society contains the following information:

Supporting Information. Most manuscripts contain material which is not needed for reading the paper, but which should be available to document the experiments or calculations for workers carrying out further work on the subject of the paper. This may include tables, illustrations, derivations, or even discussion. Such information should be published in the "Supporting Information" section of the article. This section may also include additional material or discussion that is primarily of interest to specialized readers. Authors are encouraged to make use of this resource in the interest of shorter articles that not only save journal space but also result in more focused presentations.
All Supporting Information will be made available free of charge on the World Wide Web . . . .

The British Medical Journal incorporates into its "Advice to Contributors," a statement entitled "Increasing the Accessibility of Data," in which six policy rationales are given in support of data access:

(1) Sharing of data cuts down on research costs.
(2) Replicating the findings of one study within other data sets increases their robustness.
(3) When an investigation is being planned, analysis of data from earlier studies can help in the formulation of the research question, the refinement of measurement instruments, and the calculation of sample sizes.
(4) New data sets can be created through linkage of different sets of records on the same people.
(5) Exercises that combine data, such as meta-analysis, build on results of primary studies; as meta-analyses combining data on individual patients become more common, their dependence on formal data sharing will increase.
(6) The ability of outside researchers to check whether the conclusions drawn from an analysis are justified increases confidence in these conclusions.

Publication of a research article in Cell is taken to imply that the authors are prepared to distribute freely to academic researchers for their own use any materials (e.g., cells, DNA, antibodies) used in the published experiments. In cases of dispute, authors may be required to make primary data available to the Editor. Nucleic acid and protein sequences as well as X-ray crystallographic coordinates should be deposited in the appropriate database." Cell,

I.3.2.k Cancer Research ²¹

It is understood that by publishing any work in Cancer Research the authors agree to make freely available to other academic researchers any of the cells, clones of cells or DNA or antibodies, etc. that were used in the research reported and that are not available from commercial suppliers. Also, authors may be required to make primary data available to the Editor-in-Chief in cases of dispute."

As a condition of publication in the Journal of the American Medical Association ("JAMA"), the author must certify that "if requested by the editors, I will provide the data or will cooperate fully in obtaining and providing the data on which the manuscript is based for examination by the editors or their assignees."²²

I.3.2.m Nature ²³

As a condition of publication, authors are required to make materials and methods used freely available to academic researchers for their own use. This includes antibodies and the constructs used to make transgenic animals, although not the animals themselves. Papers reporting protein or DNA sequences and crystallographic structure determinations will not be accepted without a Genbank or Brookhaven accession number, respectively; in the case of crystallographic coordinates only, access may be withheld at the discretion of the database for up to one year after deposition. Other supporting data sets must be made available on the publication date from the authors directly.

I.3.2.n Proceedings of the National Academy of Sciences USA ("PNAS") ²⁴

Authors must make

UNIQUE MATERIALS

(e.g., cloned

DNA

s; antibodies; bacterial, animal, or plant cells; viruses; and computer programs) promptly available on request by qualified researchers for noncommercial use." "[Database] [a]ccession codes must be supplied for publication.

I.3.2.o Science ²⁵

When a paper is accepted for publication in Science, it is understood that:

Any materials and methods necessary to verify the conclusions of the experiments reported must be made available to other investigators under appropriate conditions.

Archival data sets (such as sequence and structural data) should be deposited with the appropriate data bank and the identifier code should be sent to Science for inclusion in the published manuscript (coordinates should be released no later than 1 year after publication).

¹² Committee on National Statistics, Commission on Behavioral and Social Sciences and Education, National Research Council, Sharing Research Data, at 25-28 (Fienberg, S.E., Martin, M.E., and Straf, M.L., National Academy Press 1985).

¹³ The Responsible Conduct of Research in the Health Sciences, at 40 (1989).

¹⁴ Guidelines for Professional Conduct (Nov. 3, 1991). The APS is a scientific and educational association representing some 40,000 members in the fields of physics and health.

¹⁵ Statement on the Open Flow of Scientific Information (Adopted by APS Council April 19, 1997).

¹⁶ ASA Code of Ethics § 13.05(a), (b) (1997).

¹⁷ Letter dated March 9, 1998 from the American Society for Microbiology to The Honorable Howard Coble, Chairman, Subcommittee on Courts and Intellectual Property, House Committee on the Judiciary.

¹⁸ Ethical Guidelines for Statistical Practice (1989).

¹⁹ American Statistical Association Committee on Professional Ethics, Draft IV of Ethical Guidelines for Statistical Practice § II, F.1 (Final Draft, Dec. 22, 1998).

²⁰ "Information for Contributors" (1999).

²¹ "Instructions for Authors" (updated Aug. 25, 1998).

²² "Manuscript Criteria and Information (updated Jan. 1999).

²³ "Nature Extended Guide for Authors", § 4.3, "Materials."

²⁴ PNAS Online, "Information for Authors," "Journal Policies" §§ (viii), (ix) (revised Jan. 1999).

²⁵ "Information to Authors/Contributors."