ANPRM Frequently Asked Questions (FAQs) July 2011

Human Subject Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.

Frequently Asked Questions

Why is the Federal government proposing changes to the Common Rule?

This regulatory review effort is primarily about enhancing protections for human subjects.

The federal government is considering changes to the Common Rule (45 CFR 46) for two reasons:  (1) the human subject research landscape has changed dramatically since the early 1980s when the current regulations were first being formulated and (2) in light of that, there is a need to address effectiveness and the efficiency of the regulations for human subject protections in the current research environment.

Since the promulgation of the Common Rule, there have been major increases in the volume of research, in multi-site studies, and in health services and social sciences research.  New technologies for research—genomics, imaging, informatics—have also been developed and have altered the methods and aims of research with human subjects.

These changes in the landscape have highlighted various issues regarding the efficiency and effectiveness of the current regulatory framework.  The unnecessary burdens and workload carried by Institutional Review Board (IRBs) is often cited.  Certain regulatory requirements of government agencies could be clarified and streamlined.  Moreover, the regulatory framework does not appropriately calibrate research review and does not focus the review where it is needed most.  The requirements and practices for informed consent should be enhanced to augment the quality and appropriateness of information conveyed to potential human subjects.

For these and other reasons, the federal government has concluded that change is needed and would yield significant benefits—both to investigators and to human subjects.

In brief, what aspects of the Common Rule is the government reexamining?

The government has two overarching goals with respect to the revisions it is considering to  the Common Rule:  (1) to enhance the protection of research subjects and (2) to improve the efficiency of the review process.

To accomplish these goals, seven possible regulatory reforms are envisioned and described in the ANPRM:

  1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
  2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  3. Updating the forms and processes used for informed consent.
  4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
  6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  7. Providing uniform guidance on federal regulations.

How in particular would these changes enhance human subject protections?

The changes under consideration will extend federal oversight to non-federally funded studies, i.e., those at institutions that receive any funding from Common Rule agencies for human subjects research.

The changes under consideration would also give subjects the opportunity to decide whether their biological specimens may be used for future research and, if so, to specify types of research in which their biospecimens may not be used.

If the risk-based framework for IRB review were more rationally refined, IRBs would be better able to concentrate their resources on the review of research that poses higher risk to subjects.

In addition, the changes under consideration would facilitate and enhance informed consent by creating and utilizing standardized templates and explicitly delineating the information that potential research participants should know.   This would have two benefits.  The IRB’s task of reviewing proposed consent forms will now be greatly facilitated, and individuals contemplating participation in research will be better and more consistently informed.

With respect to informational risks, new data security and information protection standards would be adopted, thereby reducing the potential for violations of privacy and confidentiality.

Finally, the changes would systematize the collection and analysis of unanticipated problems and adverse events across all trials. Such a system would replace the complicated array of definitions and reporting requirements with harmonized rules. Consolidation of data reported using consistent vocabularies and terms would allow for more powerful and meaningful analyses of safety information across types of research studies. The ANPRM also considers a number of changes to improve the current system for the real-time prompt collection of data that will help enhance patient safety measures. 

What opportunities will the public have to express its views about these matters?

First, an Advance Notice of Proposed Rulemaking (ANPRM) has been published in the Federal Register that describes the changes under consideration and invites public comments. The public will have 60 days to provide comments.   During this comment period, the government will also provide a forum for stakeholders and interested members of the public to voice their opinions about these matters.  All comments collected during this process will be vital to the process of producing a final draft of the revisions under consideration in the Common Rule.

What is an "Advance Notice of Proposed Rulemaking (ANPRM)"?

Before the federal government implements new regulations, it must typically issue a “Notice of Proposed Rulemaking” (NPRM).  The purpose of such a notice is two-fold:  (1) to inform the public of the specifics of the proposed regulations and (2) to provide the public with the opportunity to react to and comment on the proposed regulations.  The public is offered an opportunity to comment, and its views are taken into account in developing and implementing the final regulations.

An Advance Notice of Proposed Rulemaking (ANPRM) may precede the issuance of an NPRM if the government needs public input on various issues before proposing a rule.  This ANPRM— Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators —presents and seeks comment on specific issues regarding possible changes to the Common Rule; it also raises questions about matters that may not appear as changes in the rule itself but are closely related to its implementation. 

The aim of this process—of issuing and gathering comments on first an ANPRM and then an NPRM—is to ensure a broad-based input from the multiple groups and organizations with an interest in the ethics and regulation of human subject research.

After the government collects comments on the ANPRN, what will happen next?

Public comments will be used in the process of developing specific proposed revisions to the Common Rule.  These draft revisions will be publicized in a Notice of Proposed Rule Making and the public will have an additional opportunity to comment before any changes to the Common Rule are finalized. 

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