latory action involves research on human beings. Since at least the early 1970s, he said, when the code of federal regulations to protect human participants in research was adopted by the Department of Health, Education, and Welfare, issues of protection, privacy, and confidentiality of participants’ medical information have been paramount. The issue of individual privacy remains a controversial issue nationally, and the DHHS has recently issued a final rule on the privacy of medical information—a long, complicated, and hotly contested rule. Basically, said Dr. Korn, our society continues to place a very high premium on the protection of individuals’ medical information, and this desire stands opposed to unlimited access to information used in research.
The wording of the Shelby Amendment. The Shelby Amendment took the form of a two-sentence rider to the Omnibus Appropriations Act for FY1999, Public Law 105-277, which reads as follows:
Provided further that the Director of OMB amends Circular A-110 to require Federal awarding agencies to ensure that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act.4
This amendment, which takes its name from its sponsor, Senator Richard Shelby of Alabama, precipitated a highly charged public debate, but only after it became law. Industry and regulated communities supported the measure as a fair way to challenge scientific studies that support costly regulations, tort suits, and dubious/questionable risk estimates. The scientific community opposed the amendment on the grounds that it would invite intellectual property searches by industry and scientific competitors, jeopardize the privacy of research subjects, decrease the willingness of research subjects to participate in studies, expose researchers to deliberate harassment, and increase costs and paperwork.
Revised OMB guidelines. The Shelby Amendment required OMB to modify OMB Circular A-110 so that it became the regulatory expression of the amendment. That section is titled “Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations.”
The OMB, as instructed, in early 1999 proposed guidelines for applying the amendment. These stimulated over 9,000 comments from the public to the OMB, which revised the guidelines twice. When the final guidelines were issued in late 1999, the OMB received 3,000 additional comments.