By Lauren Solberg, JD, MTS
Member, Knowledge Center Advisory Group

PRIM&R’s Knowledge Center Advisory Group recently developed an online tool that connects users to Office for Human Research Protections (OHRP) materials that can be used to understand the regulations at 45 CFR 46 Subpart A.  In developing and finalizing this educational resource, we realized that while we frequently use terms like “statutes,” “regulations,” and “guidance,” it isn’t always clear what they mean or how they differ.  This summary should clarify these differences and help you to use the annotated regulations tool effectively.

Federal agencies like the Department of Health and Human Services (DHHS) can promulgate (or issue) regulations, often referred to as rules, like 45 CFR 46 when Congress passes a law – called a statute – authorizing the agency to make these regulations. Federal statutes are codified (or organized) in the United States Code; federal regulations, which are also law, are codified in the Code of Federal Regulations. The statutes that delegated authority to DHHS to make rules governing the conduct of research with human subjects are 5 USC. 301; 42 USC 289(a); and 42 USC 300v-1(b).

The Administrative Procedure Act (APA) is a federal statute that prescribes how agencies can propose and finalize regulations.  Most agencies follow what is called an “informal rulemaking” process, also called “notice and comment rulemaking.”  In notice and comment rulemaking, the APA requires agencies like DHHS to publish a Notice of Proposed Rulemaking (NPRM) in which the agency publishes draft regulations, a discussion of the substance of the proposed regulations, or a description of the subjects and issues involved.  The NPRM must include a request for public comments about the proposal.  This requirement under the APA is why, in 1973, the Department of Health, Education & Welfare – now DHHS – published an NPRM in the Federal Register to propose a new regulations at 45 CFR 46 on the conduct of human subjects research.  It is also why an NPRM was just published requesting comments on the proposed changes to 45 CFR 46.

Members of the public must be given a reasonable time period to comment on the proposed rule, generally between 30 and 60 days.  The agency that issued the NPRM must consider the public comments before it ultimately publishes the Final Rule (the final set of regulations) in the Federal Register.  The Federal Register is a daily periodical in which agency notices, proposed and final rules, Presidential Documents, and other “significant documents” are printed.  In 1981 when DHHS published the Final Rule amending the 1974 version of 45 CFR 46, it also published a response to public comments requested in its NPRM issued in 1979.  In the recent NPRM, DHHS discussed the public comments it received on the Advanced Notice of Proposed Rulemaking (ANPRM), which was published in 2011.

Guidance, however, works a bit differently.  Agencies regularly publish “interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice,” materials that are often referred to as “guidance.”  Guidance helps people and institutions understand the regulations an agency has promulgated; in particular, it helps them understand how an agency interprets a regulation or how to comply with a regulation.  While guidance does not have the force of law, people and institutions tend to rely on it; however, many guidance documents will include a statement that they are non-binding on the agency – which means the agency can change its mind about the contents of the guidance.  The APA exempts guidance from the notice and comment requirement, which means that agencies are not required by the APA to request comments on guidance prior to issuing them.  However, agencies like the FDA publish notices requesting comments on draft guidance before publishing the final version; OHRP often does so as well (for example, a request for public comments on the draft OHRP Guidance on Engagement of Institutions in Human Subjects Research was published in the Federal Register in December 2006, with the final version published in the Federal Register in October 2008).

Reference

• Bressman, L. S., Rubin, E. L., & Stack, K. M. (2010). The Regulatory State. Aspen Publishers.