The Effect of Public Disclosure Laws on Biomedical Research

Abstract

The Freedom of Information Act (FOIA) and state ‘open-records’ laws govern access to records in the possession of federal agencies and state entities, such as public universities. Although these laws are intended to promote ‘open government’ and to assure the existence of an informed citizenry capable of holding government officials accountable for their decisions, an inherent tension exists between the public's access to information and biomedical research institutions’ need to ensure the confidentiality of proprietary records and to protect the personal safety of employees. Recognizing these and other conflicts, the federal FOIA and state public-disclosure laws contain express exemptions to protect sensitive information from disclosure. Although some state open-records laws are modeled after the federal FOIA, important differences exist based on the language used by the state law, court interpretations, and exemptions. Two specific types of exemptions are particularly relevant to research facilities: exemptions for research information and exemptions for personal information. Responding to FOIA and state open-records requests requires knowledge of relevant laws and the involvement of all interested parties to facilitate a coordinated and orderly response.

The Freedom of Information Act (FOIA) and state ‘open-records’ laws are intended to promote open government and to assure the existence of an informed citizenry capable of holding government officials accountable for their decisions.¹ These laws seek to accomplish this objective by providing citizens access to records in the possession of the federal, state, and local governments. In many cases, citizens’ review of government records enhances democracy and serves as a check on corruption by allowing citizens to hold public officials accountable for their use of tax dollars.²³ However, an inherent tension exists between the public's access to information and biomedical research institutions’ need to ensure the confidentiality of proprietary records and protect the personal safety of employees.¹⁹

Public and private research institutions routinely develop and submit confidential and proprietary information to federal agencies such as the Food and Drug Administration, NIH, and USDA. In addition, many public universities, which are subject to state open-records laws, develop new and innovative research models, conduct research for private companies, and employ biomedical research scientists. In many cases, federal laws and regulations require the submission of confidential information as a precondition to receiving funding, gaining approval, or maintaining compliance with governing laws and regulations. Institutions submitting confidential information often function in highly competitive markets and rightly expect government agencies to maintain the confidentiality of their documents. Public disclosure laws fundamentally conflict with the research institutions’ confidentiality expectations and have the potential to jeopardize the viability and profitability of pending and future research. Recognizing these and other conflicts, the federal FOIA and state public-disclosure laws contain some protections for trade secrets and other forms of proprietary information.⁹

Another intrinsic tension exists when documents submitted to or obtained by federal agencies contain the personal information of research scientists. Researchers submitting their personal information as part of a grant application, or for other reasons, often do so with the expectation that only agency employees or other officials will have access to those portions of the applications—not animal rights groups or the general public. The disclosure of this information threatens researchers’ personal privacy and, in some cases, may threaten their safety or economic wellbeing. According to recent reports, acts of violence and harassment directed at biomedical scientists who use animals in their research have increased dramatically in the last decade.³ These actions affect the entire biomedical research community because they have the potential to disrupt scientific research projects, increase the costs associated with medical research, discourage young researchers from entering the field, and threaten the safety of the biomedical researchers and their families.

During the 1980s and 1990s, research facilities were the primary target of animal rights activists.³ However, in response to increased security at research institutions and the proliferation of information about the individual researchers online, some activists have shifted their focus from research labs to the private homes of research scientists.³ To identify and obtain information about research projects and researchers using animals, many animal rights activists have turned to the federal FOIA and state public-disclosure laws. Recognizing the necessity of protecting personal information contained in government records, the FOIA contains an express exemption for personnel files.¹⁰ This exemption generally has been found to protect the home address, social security numbers, and other similar information⁶ but, in some cases, information that has the potential to endanger biomedical research scientists has been determined not to be exempt from disclosure.¹⁵

Here we discuss the implications of federal and state public disclosure laws and their effect on the biomedical research community. To provide the necessary background, we begin by describing the federal FOIA and its exemptions. Specifically, cases filed by animal rights groups to obtain access to records by using the FOIA are used as examples of the application of exemptions. We then describe state open-records laws and particular exemptions relevant to biomedical research documents. We conclude by identifying several proactive steps research facilities can take to ensure that sensitive biomedical research information is identified and protected appropriately.

The FOIA

The FOIA was enacted in 1966 after 11 y of investigation, legislative development, hearings, and deliberation in the House of Representatives and half as many years in the Senate.²⁶ Its basic purpose “is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed.”⁵ To accomplish this purpose, the FOIA was enacted as the first comprehensive law in the United States that gave the public an affirmative right to review and copy government records. However, recognizing the potential conflicts with fundamental societal values and security, the FOIA contains 9 express exemptions intended to strike an appropriate balance between the societal interests in disclosure of information and legitimate government objectives.¹¹

Since its enactment in 1966, the FOIA has been amended several times: in 1967, 1974, 1976, 1978, 1984, 1986, 1996, 2002, 2007, and 2009.⁸ Generally, these amendments have clarified the scope of the law to ensure that the nonexempt records are required to be provided to requestors and records intended to be exempt are protected from disclosure.

The Electronic Freedom of Information Act Amendments of 1996 (E-FOIA) are noteworthy as they required federal agencies to make certain types of records, created by the agency on or after 01 November 1996 available electronically.⁷ Agencies must also provide electronic reading rooms to allow citizens to access frequently requested records online. Given the large volume of records requested and limited governmental resources, the amendment also extended the agencies’ required response time to FOIA requests. Formerly, the response time was 10 d and the amendment extended it to 20 d.⁷

In recent years federal agencies have increasingly posted information online. The USDA Animal and Plant Health Inspection Service's (APHIS) most recent FOIA Annual Report shows that in FY2010, the agency received approximately 40% fewer FOIA requests than in the previous year.³² Although the decrease is likely due to a number of factors, in a section entitled Steps Taken to Increase Proactive Disclosures, the Chief FOIA Officer's report states, “APHIS created a searchable database that allows the public access to over 50,000 inspection reports covering the last three years. Once the [Animal Care] inspection reports were posted, the number of incoming FOIA requests were reduced by 35%.”³¹ In addition to posting inspection reports, APHIS now posts on its website Annual Reports of Research Facilities, completed FOIA requests, and FOIA logs.³⁰

FOIA Exemptions

As noted previously, the FOIA contains 9 categorical exemptions intended to protect sensitive information from disclosure.¹¹ When a federal agency receives an FOIA request seeking agency records, it must determine whether the documents are protected from release by an exemption. If no exemption applies, the agency generally must provide the requested information. When determining whether an exemption applies, the exemptions “must be narrowly construed” and “the burden is on the agency” to show that the exemption applies.¹⁷ This presumption of disclosure is meant to ensure that federal agencies do not withhold information that is not in fact protected by an exemption. The 9 exemptions to the FOIA authorize agencies to withhold sensitive information. The exemptions protect: (1) records that are specifically authorized under criteria established by an Executive Order to be kept secret in interest of national defense or foreign policy and are in fact properly classified pursuant to such Executive Order; (2) records related solely to the internal personnel rules and practices of the agency; (3) records specifically exempted from disclosure by statute, provided that such statue requires that the matters be withheld from the public in such a manner as to leave no discretion on the issues or establishes particular criteria for withholding or refers to particular types of matters to be withheld; (4) records containing trade secrets and commercial or financial information obtained from a person that are privileged or confidential; (5) interagency or intraagency memoranda or letters that would not be available by law to a private party in litigation with the agency; (6) personnel, medical, or similar files the disclosure of which would constitute an unwarranted invasion of personal privacy; (7) certain records compiled for law enforcement purposes; (8) records that are contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of any agency responsible for the regulation or supervision of financial institutions; and (9) geologic and geophysical information and data, including maps, concerning wells.¹¹ Exemptions 4, 6, and 7 are the most commonly used to protect information related to or obtained from biomedical research institutions.^22,32

FOIA exemption 4 prevents commercially valuable research information being released to the public or competitors by exempting “trade secrets and commercial or financial information obtained from a person [that is] privileged or confidential.”⁹ Two broad categories of information are covered by this exemption: trade secrets and information that is either commercial or financial and obtained from a person and privileged or confidential.³³ In the only federal appellate court decision addressing the submission of a grant application, the DC Court of Appeals found that “a noncommercial scientist's research design is not literally a trade secret or item of commercial information, for it defies common sense to pretend that the scientist is engaged in trade or commerce.”³⁵ However, the court noted that although an individual grantee “could conceivably be shown to have a commercial or trade interest in his research design…the burden of showing the trade or commercial character of the research design” is on the agency.³⁵ Similarly, the DC District court in Physicians Committee for Responsible Medicine v. National Institutes of Health ruled that a noncommercial scientist's research design was not protected from disclosure by exemption 4 when the research scientist was not able to show that disclosure could result in substantial competitive harm.²⁵

FOIA exemption 6 permits the government to withhold information in “personnel and medical files and similar files” when the disclosure of such information “would constitute a clearly unwarranted invasion of personal privacy.”¹⁰ When information requested falls within the scope of exemption 6, the government effectively balances the privacy interests of the individual against the public interest served by disclosure.¹³ In making the determination, the agency is prohibited from considering the identity or motive of the requestor and generally is not required to notify the person whose records are being requested.^5,12 Under this balancing test, courts have held that personally identifying information such as social security numbers, home addresses, place of birth, and employment history can be withheld.¹⁸ However, courts have been reluctant to expand the scope of exemption 6 to include information that does not apply to “a particular individual.”¹⁵

In the 2001 case of In Defense of Animals v. Department of Health and Human Services, the court used exemption 6 to justify withholding the names of members of an IACUC when the director's home had been picketed and he had received threatening mail and phone calls.¹⁴ In determining whether the disclosure of committee members’ names compromised a significant privacy interest, the court held that the “harassment by groups that oppose using animals in research” suffered by the director would “reasonably be expected to be made to the current members if their names are disclosed” and thus the Committee members’ names were withheld under exemption 6.¹⁴ The court noted that “although IDA no longer seeks additional information beyond the names such as the addresses, other people could use the members’ names to obtain addresses and telephone numbers.”¹⁴

In contrast, in the 2008 case of In Defense of Animals v. National Institutes of Health, NIH and Charles River Laboratories argued that animal care workers at the Alamogordo Primate Facility and other facilities had received specific and detailed threats to their safety and, under exemption 6, the disclosure of certain documents about the facility would constitute a clearly unwarranted invasion of the laboratory workers’ personal privacy.¹⁵ To support this contention they argued that “individuals with intent to harm animal care workers would be able to target the location with the greatest concentration of workers if this information is released.”¹⁵ The court ruled that exemption 6 was not applicable because the requested information was not associated with any particular person.¹⁵

These cases suggest that if there is a threat to a specific person whose information is being requested, courts are more likely to interpret exemption 6 to protect the records from disclosure. This situation highlights a key problem: animal rights organizations often need a researcher's information before they can target them, rather than after the researcher has already been targeted. Requiring a researcher or university to document harassment or a high probability of victimization weakens or nullifies the prophylactic effect of exempting personal information.

State Open-Records Laws and Exemptions

In addition to the federal FOIA, every state has a law that governs access to records in the possession of the state and local governments and other public bodies, such as public universities. The extent of information required to be released to the public under these laws vary, as do their names. For our purposes here, we refer to such state laws as open-records laws, recognizing that names of these laws include Sunshine Laws, Freedom of Information Laws, Public Records Laws, Open-Records Laws, and others.

State open-records laws, like the federal FOIA, are intended to promote government transparency and openness by permitting persons to request information from state entities. Many state open-records laws permit any person to request records; however, some states only permit citizens to make such requests.² Although some state open records laws are modeled after the federal FOIA, important differences exist based on the language used by the state law, court interpretations, and exemptions. For example, some state courts have held IACUC minutes are subject to disclosure, whereas courts in other states have held that IACUC are not public bodies and that their records therefore are not subject to disclosure.²⁰

Perhaps one of the most striking differences between the various states’ open-records laws is the amount of information protected from disclosure by exemptions. The federal FOIA has only 9 exemptions, and some states, similarly, have a limited number of exemptions. Other states, however, have a much broader array of exemptions, with some state open-records laws containing 50 or more specific exemptions. These exemptions can be very important to research facilities, because some exemptions are specifically intended to prevent the disclosure of sensitive research information and personal information.

Research Exemptions in State Laws

In many cases, nonpatentable research information may not be protected under a trade secrets exemption. Recognizing this fact, several states exempt information concerning research from their state open-records laws. In some cases, these exemptions have effectively prevented the public disclosure of research information. For example, in the 1995 case of Robinson v. Indiana University, Robinson requested the details of an animal research project including information on the researcher, the care and use of the animals involved, the nature of the research, and procedures involved.²⁷ Indiana University denied his request, citing an exemption in the Indiana Public Records Act that exempts:

(6) Information concerning research, including actual research documents, conducted under the auspices of an institution of higher education, including information: (A) concerning any negotiations made with respect to the research; and (B) received from another party involved in the research.¹⁶

The Court of Appeals of Indiana determined that the records requested qualified as “information concerning research” and concluded that the records were therefore exempt.²⁷ In its analysis, the court distinguished the 1991 North Carolina case of S.E.T.A. UNC-CH v. Huffines,²⁹ where similar records were disclosed, by stating that the “critical distinction between the present case and S.E.T.A…[is]… North Carolina's Public Records Act does not contain a concerning research exception.”²⁷ The existence of the research exemption in the Indiana case was, therefore, a deciding factor in the court's holding that disclosure of the records was not required.

In cases where the requested documents are of commercial value, the information is more likely to be withheld because many state open records laws contain exemptions protecting trade secrets and commercial and propriety information. For example, in the 2008 case of Mississippi State University v. People for the Ethical Treatment of Animals, PETA attempted to gain possession of university animal research documents pursuant to the Mississippi Public Records Act.²¹ PETA sought disclosure of IACUC records for projects, tests, and experiments funded by Iams Corporation.²¹ This request included animal care protocol review forms, which contained the name of the principal investigator(s); title of the project; project and summary; proposed species and numbers of animals; experimental design; care and use of the animals; names and qualifications of personnel involved in the project; protocol updates and amendments; and history of protocols.²¹ Mississippi State University asserted that the records were exempt from disclosure under the state exemption for trade secrets and proprietary commercial and financial information. The chancery court disagreed and ordered the university to release the records to PETA.²¹ Mississippi State University appealed, and in a 6-to-3 decision, the Mississippi Supreme Court held that the records were exempt because substantive portions constituted “trade secrets and commercial and financial information of a proprietary nature.”²¹

Exemptions for Personal Information in State Laws

Over the last 2 decades, in addition to exemptions for research information, several states have enacted exemptions designed specifically to prevent the disclosure of the personal information of persons involved in research. Oregon has such an exemption that protects from disclosure the “name, home address, professional address, or location of a person that is engaged in, or that provides goods or services for, medical research at Oregon Health and Science University that is conducted using animals other than rodents.”²⁴ Utah enacted a similar exemption in 2008 to protect from disclosure the name, home and work addresses, and telephone numbers of persons who use animals in medical or scientific research conducted within the state higher education system.³⁴

When a state entity receives a request for information under the open-records law, the entity generally must release the information unless it is protected by an exemption. In some cases, the information of persons involved in research has been disclosed because the state's open-records law did not contain an exemption. For example, in the 1994 case State ex rel. Thomas v. Ohio State University, Thomas requested records containing information about specific researchers that were under the control of Ohio State University (Ohio State) pursuant to the Ohio Public Records Act.²⁸ Ohio State provided the documents but redacted names and addresses of individual researchers for security reasons.²⁸ Ohio State argued that the “identity of individuals engaged in specific scientific research projects using animals must be found to be constitutionally protected from public disclosure” and urged the court to adopt a balancing test similar to the one performed under exemption 6 of the federal FOIA.²⁸ The state court rejected this argument and held that, unlike protections for Social Security Numbers, there was no specific statutory or constitutional exemption in state law that protects public employee's names and addresses, stating:

There is no similar legislative scheme protecting the names and work addresses of public employees in general or animal research scientists in particular. In addition, although there is evidence of an increase in reported incidents of threats, harassment, and violence against animal research scientists, there does not appear to be the same “high potential for …victimization” found by the court to be apparent from the disclosure of SSN.²⁸

This case, like In Defense of Animals v. National Institutes of Health,¹⁵ demonstrates the difficulties public institutions face in protecting personal information and the inherent hesitancy of courts to allow the withholding of information that is not specifically covered by an exemption. Absent statutes directing public bodies to redact the private information of research scientists, the presumption is that such information should be released.

Preparing for and Responding to Public Information Requests

Preparedness is the key to an appropriate and efficient response to a FOIA or state open-records request. Research institutions subject to the federal FOIA or a state open-records law should identify a point person within the institution to keep all relevant parties informed and coordinate an orderly response. The point person should be familiar with the sensitive nature of animal research documents and have a full understanding of all relevant laws and regulations. Depending on the administrative structure of the institution, the point person may be someone within the legal counsel's office or someone within the research department. Because the research department often needs to be involved in document responses, all relevant persons should know who the point person is and the appropriate institutional procedure for responding to a federal FOIA or state open-records request.

Most research institutions, both private and public, have document retention policies that specify the length of time that a particular document should be retained. In addition, most states and the federal government have laws requiring that certain types of documents be maintained. Research institutions should ensure that records required by law or otherwise necessary for business, research, or operational purposes are kept. After the retention period has ended, retention of documents is generally not necessary.

In preparing documents that will be subject to a FOIA or open-records request, a research facility should consider ensuring that the documents—especially frequently requested documents—are ‘FOIA ready.’ This status means that the documents are factual, devoid of extraneous information, and accurately reflect an institution's animal care and use program. Because information obtained by animal rights groups under the FOIA or a state open-records law often is posted online, research facilities should consider conducting a risk analysis to determine what consequences may ensue if the information in their records were posted on a public website.

After receiving a FOIA or open-records request, the institution's legal counsel should determine whether sensitive information falls within the scope of an exemption. Research institutions responding to a FOIA or state open-records requests also should accurately estimate the cost associated with responding to the request. In the case of open-records requests, state law usually dictates what costs public institutions can require the requestor to pay. Some states allow public institutions to charge the total cost of responding to records requests (personnel costs, copies, shipping, overhead, and so forth). Other states, however, may permit charging only some costs, such as the cost of making copies. If state law does not allow the research institution to charge the actual cost of responding to the request, the institution should nevertheless consider keeping a log of the expenses to determine whether it is responding in the most efficient manner. Federal regulations also permit certain costs to be recouped in some situations.⁴

As animal rights organizations increasingly turn to the federal FOIA and state open-records laws to obtain information about research, research facilities should ensure that they understand and comply with all relevant laws and regulations related to the disclosure of such information. In particular, research facilities should assess carefully whether exemptions for research information or personal information can be used to protect sensitive information from disclosure.