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Revised Rules for Human Research Conduct Proposed: First New Changes in Nearly 30 Years

Moran, Mark

doi: 10.1097/01.NT.0000405133.90671.f5
ARCHIVAL PHOTO dated 1953 showing a doctor drawing blood from a participant in the Tuskegee Syphilis Study Service syphilis experiment, conducted between 1932-1972, in Tuskegee, AL, by the US Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the US government

ARCHIVAL PHOTO dated 1953 showing a doctor drawing blood from a participant in the Tuskegee Syphilis Study Service syphilis experiment, conducted between 1932-1972, in Tuskegee, AL, by the US Public Health Service to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the US government

Neurology researchers and ethicists are hailing the new rules proposed by the federal Department of Health and Human Services (HHS) governing biomedical research involving humans.

They say the proposed rules — which the HHS has posted in advance to permit public and professional feedback before they are finalized — are urgently needed to relieve researchers and institutions of administrative burdens associated with compliance with current regulations that have grown like topsy-turvy in the decades since the original rules for assessing risk were formulated in the 1970s and 80s. Those original rules governing informed consent and the conduct of research involving humans became accepted by multiple federal agencies that oversee research and codified as the “Common Rule.” The HHS is seeking all comments back by Sept. 26, 2011.

A principal and defining feature of the new rules proposed by HHS is to streamline and standardize informed consent and reporting requirements and — especially — to tailor administrative requirements for reporting to the level of risk involved in different studies. [For more on the rules, see “Proposed Rules on Research Conduct: Key Provisions.”]

At press time, a spokesperson for the AAN said the voluminous proposed rules were still under review by the Academy's government relations and regulatory affairs team. But researchers and ethicists who spoke with Neurology Today and who are familiar with the broad outlines of the proposals give them a thumbs-up.

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“I think the proposed rules are long overdue,” said James Bernat, MD, the Louis and Ruth Frank Professor of Neuroscience and Professor of Neurology and Medicine at Dartmouth-Hitchcock Medical Center and former chair of the AAN Ethics, Law & Humanities Committee.

“There has been a general understanding for some time now that the Common Rule achieved a lot of what it was intended to achieve, but that the research landscape has evolved a great deal over the last twenty years and as a result the Common Rule no longer really is appropriate to the current research environment.”

Dr. Bernat said the new HHS rules incorporate a number of revisions to the Common Rule that have been advocated by scholars and ethicists. Principal among these are changes that would recognize differences in risk potential associated with different kinds of research and that would adjust administrative reporting and informed consent requirements to match the level of risk.

“One prominent change in the last twenty years is the growth in social science research, much of which is based on surveys,” Dr. Bernat explained. “This is research with really minimal risk to human subjects, but currently it is subject to the same level of scrutiny by Institutional review boards as research with higher associated risk. So a lot of research, regardless of its risk to human, is forced to comply with a mold that was designed to protect vulnerable human subjects.”

Under the Common Rule, there is a list of research protocols, approved by the Secretary of HHS, that constitute “minimal risk” and that are eligible for “expedited review” with one reviewer instead of a convened IRB. But the new rules would allow that list to be updated regularly.

Moreover, under the proposed rules continuing review would not be required of studies that are eligible for expedited review unless the reviewer, at the time of initial review, determines that continuing review is required, and documents why.

Neuroscience research and ethicist Judy Illes, MD, Canada Research Chair in Neuroethics, and professor of neurology in the faculty of medicine, at the University of British Columbia, called the rules “an enormous step forward” and said they would help to alleviate the antagonism that has developed over the years between research scientists and institutional review panels.

“What has happened with all good intentions is that there has been IRB oversight mission creep,” Dr. Illes told Neurology Today. “In our efforts to protect and inform subjects we have really spiraled out of control in terms of the administrative load required to adhere to current regulations for informed consent.”

“The updated rules seek to appreciate that there are different levels of risk and that those different levels can be appropriately managed with different levels of administrative oversight and frequency of reporting,” she said. “What we have seen between IRBs and investigators is increasing antagonism to the point where they are no longer acting as partners, so we welcome this significant effort on the part of HHS.”

But Dr. Illes pointed out as well that there are also new areas of regulation in the HHS rules that seek to address research made possible by new technology, including some research that may be especially important to neurology.

For instance, under the Common Rule research using existing biospecimens can be done without consent by stripping the specimens of identifiers. But under the new rules, written consent would need to be obtained using a standard, short form by which a person could provide open-ended consent for most research uses of a variety of biospecimens (such as all clinical specimens that might be collected a particular hospital).

Dr. Illes said the evolution of technologies to probe the brain has implications for privacy, and the use of bio-repositories and tissue banks allowing researchers to share and to mine data repeatedly requires a new regulatory approach. And she called the requirement that individuals be given the right to consent, using an open-ended consent form, a balanced and useful solution.

“For those of us in the field of neuroethics, we recognize the special status of the brain as the source of our neurological but also our personal well-being,” Dr. Illes said. “So we are talking about protecting the right of research participants to make decisions about — and be partners in — research on the very organ we use to make decisions.”

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  • For all of the U.S. sites in a multi-site study, there would be a single IRB of record. Under the current Common Rule, an IRB at each institution involved in a study has to approve the research.
  • The new rules aim to provide greater specificity about how consent forms should be written, and what information they should contain, so they can be shorter, more user-friendly, less confusing, contain all of the key information, and can serve as an aid to help someone make a good decision about whether to participate in a study.
  • A single web site would be established where adverse events can be reported electronically, thus meeting all federal reporting requirements, with the resulting data being stored in a single database.
  • Reporting requirements would be harmonized across agencies.

The new proposed rules were posted on the Federal Register on July 25 and appear under the title, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” The advance notice of the proposed rules are online at

©2011 American Academy of Neurology