by Charles Walter and Edward P. Richards, III.
Our previous articles, When Does The Freedom Of Information Act Apply To Data Produced Under A Federal Grant? (Parts I & II), reviewed the development of the new federal regulations on public access to research data from studies funded by the federal government. Research data collected by federal employees, such as scientists at NIH, has always been available to the public through the federal Freedom of Information Act (FOIA). These new rules, embodied as revisions to Circular A-110, extend the reach of the federal FOIA to some research data developed with federal support, but held by scientists working in institutions outside of the federal government. This article discusses the policy behind these regulations, their impact on researchers, and how they are extended by parallel state laws.
At first glance, the ordinary citizen might think that data not linked to national security produced with the aid of federal funds is in the public domain. After all, if public funds are used to produce the data, why shouldn't the public have access to it?
Some research scientists argue that data shouldn't be released if (they claim) it compromises the conduct of their research. But science has traditionally thrived on the sharing of information, the testing of data gathered by others, and cross-pollination of ideas. Indeed, not one scientist can claim that s/he does not "stand on the shoulders" of predecessors and colleagues. Without data sharing, science would come to an abrupt halt.
Only fifty years ago, many scientists believed that even "national security" was not a sufficient basis for keeping the results of scientific experiments secret. Some shared research data in nuclear physics with scientists from other nations rather than permit a single organization to monopolize new information about the nature of matter. Whether these scientists were supernational heroes or naive is beside the point. Certainly they acted at their own peril from a strong conviction that knowledge about the nature of the universe belongs to everyone. They put science first, even ahead of country and themselves.
Attitudes have changed. Competition for scarce research dollars needed for ever-increasingly expensive research tools and salaries needed by an even faster growing population of research personnel provides fertile soil for suspicion, distrust and secrecy. Universities and other research institutions are squeezed between the exploding cost of running a research enterprise and the diminishing share of those expenses paid for by state and federal research dollars. Most have encouraged researchers to seek funds from private businesses and to conduct joint research programs with industry partners. The result is an unprecedented invasion of biotech, computer and other profit-making companies into academia. This invasion brings with it new loyalties to shareholders and profits. Researchers at most institutions also share in the profits from any patents they produce. These new loyalties compete with, or even replace the old loyalties to science and provide additional motivations for secreting important data from other scientists. Today many scientists have become "profit centers" for their institutions. The competition for federal research grants and the profit motif have replaced free will in setting goals for scientific research. As we pass from a world wherein we asked "What do I envision?" to one wherein we ask "What do I see?" we should recall Plato's question from the parable of the caves:
"...how could they see anything but the shadows if they were never allowed to move their heads?" Book VII, Republic.
Some scientists claim that sharing data would compromise intellectual property rights. This claim raises two questions:
(1) Whose property rights?
(2) Is it true?
In response to (1), many argue that data produced with the aid of tax money and the inventions derived from such data belong to the public. Just as otherwise copyrightable works created by federal employees during their employment are not eligible for copyright protection, many argue that all intellectual property not linked to national security should not be eligible for monopolistic protection under federal and state property law. Indeed, the clear intent of the founding fathers when they included Section 8(8) in Article I of the U.S. Constitution was that the purpose of such protection is to promote the progress of science and useful arts:
Section 8. (1) Congress shall have the power ...
(8) To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writing and discoveries;
Thus, by these terms, Congress is granted the authority to give authors (copyright) protection to promote the progress of science or knowledge, and inventors (patent) protection to promote the progress of useful arts. For additional information about these forms of intellectual property protection, see Charles Walter, Engineering and the Law Part I: About Intellectual Property, 5(2) IEEE Engineering In Medicine And Biology Magazine 43 (1986).
Section 8(1) of the U.S. Constitution creates the entire universe of legal protection available to Congress "to promote the progress of ... useful arts." That universe is expressly limited to "securing for limited times to ... inventors the exclusive right to their ... discoveries." Congress has elected exercise its authority by permitting inventors to obtain patents which may be obtained only for qualified inventions, only for twenty years, etc.
Clearly, Section 8(1) does not grant Congress authority to grant anyone secrecy over the nature of their discoveries. In fact, the goal of Section 8(1) is plainly the disclosure of underlying technical information. It would stand Section 8(1) on its head to interpret it to permit researchers to keep their information secret, as secrecy would clearly not "promote the progress of science and useful arts."
Obviously, Congress may use other means of promoting science, including making research funds available for qualified applicants. However, in doing so, Congress is expressly limited by Section 8(1). It cannot promote the progress of useful arts by granting secrecy to inventors' data. It would seem therefore that any law granting secrecy to data obtained under federal grants intended to promote research may suffer from constitutional problems.
Individuals clearly subject themselves and their discoveries to Section 8(1) when they apply for a U.S. patent. If patent applicants withhold relevant information or data from their patent application, any patent issuing from the application may be invalid. But are inventors and their data generated under sponsorship of a federal grant designed to promote the progress of scientific research limited constitutionally by the universe set forth in Section 8(1) even if the data has not been the subject of a patent application? Or, more importantly, since it is constitutionally impermissible for Congress to grant individuals secrecy for such data gathered at public expense, can that data be maintained secret under law, or must it be disclosed under the FOIA?
It is ironic that scientists would cite patent laws as a reason for secreting scientific data obtained at public expense when the fundamental purpose for providing for patent protection in our Constitution was to encourage disclosure and thereby promote the useful arts for public benefit. Patent protection is intended to encourage private investment in research, not to reward scientists for using tax money for their own benefit while doing what they're already being paid to do. Thus, the argument that sharing scientific research data produced under a federal research grant would interfere with intellectual property rights is disingenuous at best.
The answer to (2) - whether disclosure would compromise intellectual property rights - is "Probably not." First, it should be understood that "facts" and "data" are not protected per se by patents or copyrights. It is the useful invention that is protected by a patent and the creative work that is protected by the copyright, nothing more. Moreover, the rule that inventors must be diligent in seeking patent protection is strictly applied. This means that the time between discovering an invention and applying for a patent for it should be no longer than diligence permits. And as long as one is diligent, the first to discover the invention, even if s/he is not the first to apply for a patent on it, is entitled to the patent. In addition, one has a year after public disclosure of an invention to apply for a patent. And since copyright protection attaches at the moment a creative work is fixed in a permanent media, sharing data is not an issue in whether or not a work is copyrighted.
Notwithstanding all the above, the Freedom of Information Act (FOIA) has safeguards protecting legitimate owners of intellectual property from having to disclose anything that would compromise their rights in such property. See Part I of this series on revised Circular A-110. Thus, the claim that disclosure of information under the FOIA would compromise patent and copyright property rights is spurious.
Another objection of sharing data is that it might compromise patient privacy. However, the FOIA also has safeguards protecting the identity of patients from disclosure. See Part I of this series on revised Circular A-110. Thus, the claim that disclosure of information under the FOIA would compromise patient privacy is also spurious. Since the publication of these regulations, and our earlier articles, the Department of Health and Human Services has promulgated sweeping rules on the privacy of personal medical information. These rules assure that there will be no release of personal medical information under federal law, without specific authorization by the patient.
As described in Part II of this series about revised Circular A-110, FOIA access to data produced with federal support is limited to data that are cited publicly and officially by a federal agency in support of an action that has the force and effect of law.
The National Institutes of Health (NIH) has notified its grantees and applicants that Circular A-110 was revised. This notification provides guidance explaining how data access is achieved when a request is made under the FOIA.
Of course, the NIH guidance begins by stating that "NIH encourages sharing of research data." But then the NIH guidance on the applicability of revised Circular A-110 states:
"The amendment to OMB Circular A-110 applies only to data produced with Federal support that are cited publicly and officially by a Federal agency in support of an action that has the force and effect of law.
Agency actions that have the force and effect of law include:
This amendment applies to data that are first produced in a project that is supported exclusively with Federal funds or in a project with both Federal and non-Federal support. The amendment applies only to data first produced under a competing award issued after the effective date. It applies to data collected by institutions of higher education, hospitals, and non-profit institutions that receive grants and other financial assistance provided by Federal agencies.
It does not apply to data collected by commercial organizations.
It does not apply to most data collected by State and local governments. It applies to new and competing continuation awards that are made after the effective date of the amendment. This is to say, it applies to Type 1 and Type 2 grants (i.e., new and competing continuations) as well as Type 3 (competitive supplements) awards made after the effective date. It does not apply to Type 5 (i.e., non-competing continuations) awards. Amended A-110 does not apply to data collected under contracts, but contract data can be accessed through FOIA (independent of A-110) if in the possession of a government agency. For data that are already available to the public through an archive or other source, requestors will be referred directly to the public source.
The NIH guidance notice continues with the following comments about the definition of the terms in revised Circular A-110:
"The term, Research Data, is defined as the recorded factual material commonly accepted in the scientific community as necessary to validate research findings.
It does not include:
drafts of scientific papers
plans for future research
communications with colleagues
physical objects (e.g., laboratory samples, audio tapes, video tapes)
materials necessary to be held confidential by a researcher until publication in a peer-reviewed journal
information which is protected under the law (e.g., intellectual property)
personnel and medical files and similar files, the disclosure of which would constitute unwarranted invasion of personal privacy
information that could be used to identify a particular person in a research study.
Published is defined as when either:
research findings are published in a peer-reviewed scientific or technical journal; OR
a Federal agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law.
The NIH has also prepared the following overview of the process for using the FOIA to access research data obtained under a NIH grant:
"(1) The requestor prepares a FOIA request. The request must include:
(a) The specific regulation or administrative order citing the data being requested;
(b) The publication cited in the regulation or administrative order;
(c) The grant number under which the data were produced; (Information on grants, including grant numbers, is available on the NIH web site in CRISP)
(d) A specific description of the data being sought;
(e) A statement that the data are being requested under the amendment to Circular A-110 (45 CFR 74.36).
(2) NIH asks the requestor to send the request to the FOIA coordinator for the NIH Institute or Center (IC) funding the grant. A list of IC FOIA coordinators is provided on the NIH FOIA web page. (See http://www.nih.gov/od/foia/index.htm)
(3) The FOIA coordinator for the funding IC processes the request.
(4) The FOIA coordinator notifies the funding IC's grants management office and sends a letter to the Office of Sponsored Research at the grantee institution with a copy to the Principal Investigator notifying them about the request. Included with that letter will be guidance provided by the NIH FOIA office on how to respond to this request.
(5a) If the data are already available to the public through an archive or other source, the A-110 amendment allows the FOIA coordinator to direct the requestor to the public source. And the process stops here.
(5b) However, if the data are not publicly available, the grantee institution and the investigator are required to provide data that are consistent with the definition of research data (see definitions above) and deemed responsive to the request. The amendment to A-110 provides for a reasonable fee to cover costs incurred in responding to the request. The fee will include both the costs to the NIH and the costs incurred by the grantee institution, which will be accounted for separately. To accomplish this, the FOIA coordinator:
(6) Asks the grantee institution to estimate cost of providing the data; and
(7) Tells the requestor the estimated cost of producing the data.
(8) If the requester has a history of not paying for costs related to either FOIA or A-110 or if the estimated cost is greater than $250, then prepayment will be requested.
(9) Prior to sending the data to the appropriate NIH FOIA coordinator, the grantee institution and the investigator redact the data to remove personal identifiers and other information in accordance with amended A-110 definitions (see above) and FOIA procedures.
(10) The grantee institution transmits the data to the FOIA coordinator of the funding IC along with an accounting of all associated costs.
NIH will develop guidance on how to estimate associated costs.
(11) The FOIA coordinator and a knowledgeable program official from the funding IC review the submitted data.
(12) The FOIA coordinator responds to the requestor, issues a final invoice for the fees, and transmits the data.
NIH has provided its grantees and applicants with a list of frequently Asked Questions:
Q: For the past five years, an NIH-supported study has been collecting data on traffic-related deaths. In June, 1999, this study was cited in a federal regulation. Can the underlying data be requested under the A-110 amendment?
A: No. Only data collected under grants awarded after the effective date of the amendment are affected.
Q: How should telephone calls requesting data under the A-110 amendment be handled?
A: All investigators are free to share their data if they so choose. In doing so, all parties should be aware of the need to adhere to human subjects protections, including the protection of confidentiality. However, when a request will be addressed through amended A-110, the caller should be referred to the FOIA office at the funding NIH Institute or Center.
Q: Do Certificates of Confidentiality protect against a request for data under FOIA or the A-110 amendment?
A: No. A Certificate of Confidentiality protects identifying information of subjects. It does not exempt the entire data set. However, it should be noted that identifying information is also protected under FOIA as well as under the A-110 amendment.
Q: Are data collected under an SBIR or STTR accessible through the A-110 amendment?
A: No, commercial organizations are exempted.
Q: What happens if a FOIA request is made for data that are available to the public in an archive?
A: The FOIA officer will refer the requester to the archive where the data are available.
Q: I am an investigator working on a topic that is often cited in regulations. Therefore, I would like to plan to archive the data to be collected in my next project. Can I request funding in the application to archive the resulting data?
A: Yes. You should describe the archiving plan in the study design and include information about this in the budget justification section of the application.
Q: Besides archiving, what other things should I be thinking about?
A: You may also want to think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Q: How long does NIH require data to be stored after a project is completed?
A: For three years after the submission of the financial status report.
Q: Does that mean that data are only accessible for three years after the close out of the grant?
A: No. If an investigator or grantee institution chooses to keep records longer than three years, then they must be made available in response to a request under the A-110 amendment.
Q: What happens if the PI has moved?
A: Research grants are awarded to Institutions, not individuals. The FOIA office will send the request for data to the Office of Sponsored Research at the grantee institution and will send a copy to the PI. The FOIA office will work with the grantee institution to locate PI and to fulfill the request for data.
Q: What happens if either the investigator or grantee institution refuses to comply with the request?
A: This would be viewed as a material failure to comply with the terms and conditions of award, and NIH would initiate appropriate enforcement action. This could result in withholding of future support or imposing additional restrictive terms and conditions of award to the grantee institution.
Q: A research project has just received a very small amount of support from the NIH as well as a much larger award from a private foundation. Thus, the data will be produced with the combined support. Would the data be accessible under the A-110 amendment?
A: Yes. As long as the data collection occurred with some Federal support, regardless of level or amount, the grantee institution would be required to provide those data.
Q: Can data collected under a training grant be requested under the A-110 amendment?
A: This is a complex issue, and so the answer is maybe. Fellowships are awarded to individuals, not institutions. Therefore, data collected under fellowship grants may be exempted. If data are collected under a training grant awarded to an institution of higher education, hospital, or other non-profit institution, are published, and are cited in a regulation, the data would be accessible under the A-110 amendment. If a trainee works on a research project that is not Federally funded, the data associated with that non-Federal award could not be requested under the amendment to A-110.
Q: A competing continuation for a longitudinal study will be renewed after the effective date or the A-110 amendment. This will pay for years 9 through 12 of data collection. Are the data collected in years 1 through 8 accessible under this amendment?
A: No. The only data that are accessible are those collected under the award issued after the effective date of the A-110 amendment.
Q: The State Health Department received a grant to study emphysema. Are the resulting data accessible under amended A-110?
A: If the State Health Department collected those data, they are not accessible under this specific provision. However, if the State Health Department contracted data collection to an institution of higher education or other non-profit organization, then the data would be accessible.
Q: An abstract was published in the Report of 10th Annual Meeting of Snail Physiologists and cited in a Federal regulation. Are those data accessible under amended A-110?
A: It depends. If the abstract is based on preliminary analyses (as abstracts often are), then the data would be excluded since they do not fit the amended A-110 definition of research data. However, if the abstract is not based on preliminary analyses and is cited by a Federal agency in a regulation, then the data may be accessible.
While the revisions to Circular A-110 generated substantial controversy, federal researchers were already subject to the federal FOIA, which is much more expansive than requirements of Circular A-110. Less well known is that researchers who are employees of states, or who work at state institutions, are subject to state FOIA acts that parallel the federal law. Thus researchers at state universities, state hospitals, and other state facilities may have to provide public access to their data, subject to the restrictions of their specific state laws. These laws vary greatly, with some providing little access, and others providing broader access than the federal laws. Since they only apply to state institutions and employees, researchers in private institutions are only subject to the federal laws. Institutional Review Board (IRB) records are a good example. IRB records are not covered by the FOIA provisions of Circular A-110 and thus are not accessible under federal law unless held by a federal institution. In many states, IRB committee records are available through the state FOIA law. Thus IRB comments and reviews by private institution IRBs will have much greater privacy protections than IRB records in state institutions. Access to information related to human subjects research, both public and private, will be limited by the new federal privacy rules restricting access to personal medical information. (The Society of Professional Journalists maintains a list of state and federal FOIA resources: http://www.spj.org/)
What is most interesting about the revision process for Circular A-110 is that conservative members of Congress introduced legislation that would have given the public liberal access to data obtained under federal research grants and the present administration narrowed the scope of public access. The politics involved who was clamoring for access, and why, not what scope of access was appropriate for the public welfare. As described in Part II, the original legislation was driven in part by pressure from special interest groups that wanted access to research data for commercial and political purposes. One such special interest group comprised entities who oppose laws intended to preserve the environment. They want access to research data that could be used to oppose Environmental Protection Agency findings and legislation resulting from them. While such data should be available for independent analysis, such requests, if not controlled, could also be used to intimidate researchers by tying up their staff and other resources in providing access to the data. Thus, the political drama described in Parts I and II unfolded, converting a two-sentence provision in Public Law 105-277 encompassing "all data produced under an award" into limited access comprising data that were "publicly and officially cited by a Federal agency in support of an agency action that has the force and effect of law."
Of course, polluters are not the only group that needs assess to information. Labor unions need information to support strong work-safety rules. Physicians need information to treat patients. Scientists need information to do research. In short, the need for information is not a partisan issue. The following two examples illustrate situations where access to data now not available under Circular A-110 would be in the public interest.
The revision to Circular A-110 does not give a scientist the right to obtain research data from a colleague unless the data has been publicly and officially cited by a Federal agency in support of an agency action that has the force and effect of law. This does not promote the traditional role of data sharing in scientific research. On the contrary, it impedes scientific progress.
There are many instances where science could benefit from the disclosure of research data obtained with support from Federal tax dollars. For example, unpublished data underlying published estimations, extrapolations, interpolations and other calculations should be available as a matter of course to all interested parties. Data in non-referred publications should be available as well. And grant applications should be treated in the same manner as patent applications: So-called "preliminary data" and other unpublished data submitted to support grant applications for public tax dollars should be available for public inspection. The idea of awarding tax money to institutions on the basis of secret information is as repugnant to science as it is to a free society.
Nor does the revision to Circular A-110 give a patient or her physician the right to obtain research data relevant to the patient's treatment unless the data has been used by the Federal Government in developing an agency action that has the force and effect of law. Selected statistics derived from data contains far less information than does the original data itself. Therefore, when publications report merely statistical calculations, as opposed to the underlying data, there may be insufficient information for a patient in a specific situation to make an informed decision concerning treatment. A patient should be entitled to information obtained at taxpayer expense if that information might help in their treatment. Similarly, a physician should be entitled not only to published statistical calculations, but also to all the data and other information underlying it, except, of course, information that would violate the privacy of other patients.
Scientific research has become a high cost/high stakes game. This has fostered a culture of secrecy and competition that threatens to undermine the free exchange of scientific information. The public feels, correctly, that it should have access to the information produced with public monies. At the same time, scientists have become pawns in litigation over the promulgation of federal regulations and even in general litigation. As part of its antitrust defense, Microsoft subpoenaed two professors who had written a book on Internet browsers. Microsoft claimed, under federal discovery rules, that it was entitled to any information that might help defend it's case, and the professors unpublished notes from interviews with computer company executives might be helpful. In that case, the court created a limited privilege for professors (In re Cusumano, 162 F.3d 708, 714 (1st Cir. 1998), but made it clear that even private litigants have significant access to research data and notes, with little regard to the disruption such access would cause to the professors. The very culture of science depends on the resolution of the tension between free exchange of information and the potentially crippling effect of unfettered access on the scientific enterprise.
The Law, Science & Public
Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation
See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster