HHS’ Advanced Notice of Proposed Revisions to the Common Rule
On July 22, 2011, The Office of the Secretary of Health and Human Services and the federal Office of Science and Technology published proposed reforms to the federal human subject regulation codified 30 years ago at 45 CFR Part 46. Twenty years ago these regulations were adopted by 15 U.S. federal departments and agencies and have since been known as the Common Rule. Federal Drug Administration regulations which apply to drug and device research are separate but similar.
The advances in human subject research and health information technology, especially involving genetic research, have raised issues and opportunities not clearly addressed by the current regulations. The Agencies’ purposes in revising the Common Rule are to:
- Enhance the protection of research subjects; and
- Improve the efficiency of the process of reviewing research proposals.
HHS’ Advanced Notice of Proposed Rule Making presents the first of two opportunities to comment before the proposals are finalized. Several organizations and individuals have requested that HHS double the 60 day Advanced Notice comment period to 120 days. Whether or not the deadline is extended, another Notice of Proposed Rule Making will be open for public comment, once HHS drafts the Final Proposed Rules it develops with the stakeholder input being elicited now.
The most significant proposed reforms are:
- Requiring consent for research use of any biospecimens collected, after the effective date of the proposed revisions.
Currently, researchers may use existing biospecimens without a patient’s consent, provided the specimen is stripped of identifying information. NYS already requires consent for use of de-identified biospecimens collected for genetic research.
- Establishing mandatory data security and information protection standards to eliminate the need for Institutional Review Boards (IRBs) to review informational risks of research.
These standards are being designed to mirror those in HIPAA/HITECH and would include breach notification. They may also, however, mandate encryption of data, which is now a voluntary “reasonable safeguard” under HIPAA/HITECH. Nonetheless, in practice, most institutions are striving to encrypt data. Given the increased data protection afforded by encryption, the current regulations excuse providers from patient notification regulations imposed when non-encrypted data is lost or stolen.
- Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
These proposed revisions are designed to reduce detailed IRB review of minimal risk research. These revisions include: a. Revision of the rules for continuing review.
b. Revision of the regulations for expedited review.
c. Revision of the regulations regarding studies considered exempt, including the creation of a new “Excused” category for low risk studies that meet new data security requirements. IRB review would not be required for studies in the new “Excused” category.
- Mandating the use of a single Institutional Review Board of record for all domestic sites of multi-site studies.
- Updating forms and procedures to simply the informed consent process.
- 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.
- Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving any funding from the Common Rule agencies.
- Harmonizing and providing uniform guidance on federal regulations relating to human subject research.
In addition to requesting comments on these and other proposed revisions, the agencies invite input on 74 specific related questions. The Association of Academic Medical Centers is among industry organizations preparing comments on behalf of its members.
Full text of the ANPRM and comments submitted to date are available at::
http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html
Absent an extension by HHS, comments are due by 5:00 p.m. Monday, September 26, 2011.
Prepared by: Karen L. Illuzzi Gallinari, Esq.
Director of Regulatory Affairs for Research
Montefiore Medical Center, Bronx, New York