II.3 Ethical Standards and Practices Protect Patient Confidentiality

In addition to the confidentiality protections afforded under FOIA's exemption for nondisclosure of private medical data, fields involving human subject research have long-standing practices that protect the confidentiality of research participants. Practitioners in these research fields already follow strict coding and screening procedures for non-disclosure of patient data.

As discussed below, many of the frequently cited concerns over disclosure of medical subject data are therefore misplaced. The argument that the new data access law would permit study participants to determine their status as either a case or control group member, for example, is not well founded. Ethical requirements regarding non-disclosure of patient identity, existing coding and screening techniques, and professional data control practices protect against identification of individual subjects.

The likelihood that the data access revisions currently proposed will result in breaches of confidentiality of human subjects participating in federally funded research is therefore minimal. Given the current ethical standards established for conducting research in the United States and the technology presently available for collection, transmission, central storage, and processing of data prior to its release to interested parties, the risk of compromising the confidentiality of human research subjects in federally sponsored studies is not likely to be increased as a consequence of implementing OMB Circular A-110.

The following explicitly describes that maintenance of human research subject confidentiality is a continuum, beginning with review of study protocols prior to implementation through adoption of procedures by managers of large databases to minimize co-mingling of subject identifiers with information collected. Furthermore, the distribution of these databases to a wider audience does not jeopardize the anonymity of human subjects participating in these studies nor does it dissuade participation in future research endeavors.

One of the fundamental principles of the protection of human subjects who participate in federally sponsored research studies is the maintenance of confidentiality of data collected. The cornerstone and first step in this process is the review of research protocols by an organization's Institutional Review Board prior to submitting a proposal to seek funding from federal agencies. Institutional Review Boards are responsible for reviewing whether appropriate procedures are incorporated into research protocols to ensure both the confidentiality of data and the privacy of subjects. Upon collection of patient information and identifiers, often including a subject's name, address, age, gender, race/ethnicity, and social security number, which are potentially accessible to the entire local research team, the risk for breaching confidentiality is increased significantly.

The risk is minimized considerably by training and educating staff with direct contact with study subjects and access to their research records about privacy protection and carefully monitoring their performance, essential components of all well-designed and appropriately managed research studies. After transmission of data to a central site for combination, well-developed and redundant procedures are implemented to safeguard subject confidentiality. In many studies, most notably randomized clinical trials, procedures for data flow from the local collection site to a central data repository excludes transmission of subject identifying information. In research studies where central storage of patient identifiers is necessary, multiple procedures are routinely implemented to minimize the risk of loss of privacy.

Safeguards include, but are not limited to, electronic storage of patient identifying information from other files, physical separation of pages containing personal identifying information from other pages of the data forms, and prohibition against distribution/ publication of data listings that contain subject name, name code, or any other identifiers associated with a specific patient. The costs associated with safeguarding the confidentiality of research subjects are minor in comparison to other research project expenditures, and the efforts described above to protect privacy have become standard operating procedures for the vast majority of federally funded researchers. Finally, while additional effort is required and modest costs are incurred when preparing database devoid of personal identifiers for use by parties other than the investigators that initially collected and analyzed the data, such procedures are well-tested and routinely implemented by federally and non-federally funded researchers alike.

During the past twenty years or more, large databases containing information from federally funded research studies have been routinely made available to interested parties by agencies such as the National Center for Heath Statistics (NCHS) and the Centers for Disease Control and Prevention (CDC). The NCHS Staff Manual on Confidentiality and the counterpart Staff Manual of the CDC contain detailed procedures for safeguarding the privacy of individuals when the agencies' data are released to the public. No instance of breach of confidentiality of study subjects or negative impact on participation in future investigations has ever been reported.³³

In keeping with this practice, CRE recommends that OMB expressly require that the names and other data or information which would identify patients or research subjects in any medical or similar report, test, study, or other research project be deleted before the data are made available for public disclosure.

³³ NCHS Staff Manual on Confidentiality, U.S. Dept. of Health and Human Services, Public Health Service (Sept. 1997), Forward. CRE cites these NCHS and CDC materials, not necessarily as models for each awarding agency to follow in conforming with OMB's revisions to Circular A-110, but as examples of what standards already have been adopted to safeguard research data from and the protect the confidentiality of human subject research participants.