Privacy and Health Research. u.s. Subjects-Protection Policy


A uniform "Federal Policy for the Protection of Human Subjects," often called the "Federal Common Rule," is promulgated by sixteen Federal agencies that conduct, support, or regulate research. It governs such matters as subject rights, informed consent, Institutional Review Boards, disclosure policy, recordkeeping, and a variety of other matters.66

The Office for Protection from Research Risks (OPRR), in the National Institutes of Health, serves as a resource and makes certain that the Federal Common Rule is implemented. Research institutions, such as academic medical centers, which wish to perform research on humans under Federal funding or other Federal auspices must negotiate and enter into a formal "Assurance" with OPRR stipulating the overall means by which the institution will protect subjects and designating an officer responsible for being sure the protections are implemented.67

Initial questions of any investigatory activity are: Is it "research"? Who are "subjects"? According to the Federal Common Rule, research is "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [italics added] (§_.102(d)). Human subjects are "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information" (§_.102(f)). Definitions such as these are not mere exercises. Rather, they determine how particular investigatory activities must be approached, whether they fall under Federal scrutiny, and whether they must be supervised by an Institutional Review Board.

The Federal Common Rule exempts from its IRB and other requirements "research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens... if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects" (§_.001(b)(4)). This is being reconsidered with respect to genetic analysis of stored tissues, now that the genetic mapping techniques have become so revealing.

Beyond the provisions of the Federal Common Rule, many additional regulations in various agencies cover aspects of research involving ionizing radiation, research on high-risk biological agents, alcohol and drug-abuse research, research classified under national security regimens, and other special circumstances.

(66) The basic policy for the Department of Health and Human Services is codified at 45 Code of Federal Regulations 46, subpart A. Other subparts cover protections for fetuses and pregnant women (subpart B), prisoners (subpart C), and children (subpart D), and deal with such issues as in-vitro fertilization (subpart B). The Rule's generic provisions are designated in the form "§_.000," with the generic rules given to the right of the decimal, after the regulation part number assigned by the particular agency. The Common Federal Rule with its preamble reasoning was published in Federal Register 56, 28002–28032 (1991).

Food and Drug Administration regulations appear at 21 Code of Federal Regulations 50 (informed consent) and 56 (Institutional Review Boards), and elsewhere.

(67) Aspects of practice, regulation, and ethical principle are helpfully woven together in Office for Protection from Research Risks, U.S. National Institutes of Health, Protecting Human Research Subjects: Institutional Review Board Guidebook (U.S. National Institutes of Health, Bethesda, Maryland, 1993, with later addenda).