January 24, 2017 5:05 pm
As many of you know, the long-awaited final rule updating the Common Rule (“Final Rule”) was issued officially January 19 (after an unofficial release to the public yesterday). Like many of you, we are in the process of digesting and analyzing the new regulations and how they alter the current Common Rule, as well as how they differ from the Notice of Proposed Rulemaking (“NPRM”) for the Common Rule that was published sixteen months ago.
As Verrill Dana did with the NPRM, we have created a redline of HHS’s current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the Final Rule. You can find and download a copy of this redline here.
By way of brief recap, in September 2015 the U.S. Department of Health and Human Services (“HHS”), along with fifteen other federal departments and agencies, published a NPRM for the Federal Policy for the Protection of Human Subjects, known as the Common Rule. (HHS’s Common Rule regulations are found at 45 C.F.R. Part 46, Subpart A.) The NPRM proposed a number of significant changes to the rules for oversight and conduct of human subjects research, including certain requirements concerning the use of non-identified biospecimens in research and IRB review for multi-site studies. HHS received over 2,100 comments in response. (more…)
May 18, 2016 9:34 am
Whether or not you agree with its position, there is no denying that in its recently released report, “Dead on Arrival,” the Goldwater Institute takes a passionate stance on the current status of the federal “Compassionate Use” program and its counterpart, the increasingly vigorous state-led initiative known as the “Right to Try” movement, a statutory phenomenon initially ignited by the Goldwater Institute, a private think-tank.
“Compassionate Use”, formally referred to as “Expanded Access”, is a process by which terminally ill patients can petition the Food and Drug Administration (“FDA”) and drug manufacturers for access to investigational drugs that have not yet been approved by the FDA. The process for accessing these investigational drugs has been criticized as time consuming and arduous. In addition to meeting a litany of eligibility criteria, applicants must find a physician who is willing to submit an application on their behalf, convince the drug manufacturer to provide the sought after treatment, and obtain approval from the FDA. Even if the FDA approves an applicant’s Expanded Access request, it cannot require a reluctant drug manufacturer to provide access to its investigational drugs. In response to these criticisms, the FDA has recently revised the Expanded Access application form to streamline the process and has reported data which show an extremely high approval rate by the FDA for Expanded Access requests.
Pulling no punches, the Goldwater Institute unequivocally states that the current Expanded Access program is challenging by design. The bulk of the Goldwater Institute’s criticism falls on the process the FDA uses to approve new drugs to market generally, outside of the Expanded Access pathway. The only way to receive approval to market a drug is through clinical trials, for which the FDA utilizes an “all or nothing” approval approach. In other words, if the clinical trial fails at any level, the drug will never hit the market. This encourages drug manufactures to be extremely risk averse and creates disincentives for companies to make investigational products available to patients in need. Companies don’t want to take any chances providing a drug through Expanded Access, lest a reportable adverse event (like death) experienced by a “risky” patient off-protocol bring the on-going trial to a halt. (more…)
January 22, 2016 12:35 pm
A recent insights article by Kate Gallin Heffernan published in BNA’s Medical Research Law & Policy Report discusses the Congressional inquiry into the National Football League’s alleged refusal to permit its $30 million previously donated by the League to the Foundation for the NIH to support research at Boston University into chronic traumatic encephalopathy (CTE).
Reproduced with permission from Medical Research Law & Policy Report, 15 MRLR 61 (Jan. 20, 2016). Copyright 2016 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>:
“The NFL-NIH Research Partnership: Why Congress is Worried?“
January 5, 2016 5:48 pm
The Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), proposes a new provision that would require a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency to be posted (within 60 days after the trial is closed for recruitment) on a publically available federal website that would be established for such purpose.
In Part 3 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM, we address the rationale behind this proposal and its potential benefits, downsides, and missed opportunities.
Thanks to a 30-day extension of the public comment period for the NPRM, HHS extended the comment period to January 6, 2016 – and that has come! The ACRG has prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed changes.
ACRG Rapid Rundown: Three Things You Need to Know (more…)
November 25, 2015 5:44 pm
To rely or not to rely? Under the recent Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), this would generally no longer be a question in the U.S. Part 2 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM addresses the NPRM’s proposal to require U.S. institutions engaged in domestic cooperative research to rely on a “single IRB” to provide review of the research on their behalf in most circumstances. This proposal remains a constant from the Advanced Notice of Proposed Rulemaking (“ANPRM”) that was published in 2011, despite comments from the regulated community suggesting that HHS take steps to encourage various types of IRB reliance arrangements but stop short of a mandate. We expect that many institutions may be planning to comment again on whether single IRB review should become a mandate and on the associated relative burdens and benefits of such review (whether it is mandatory or permissive). This blog post does not comment on logistical implementation issues or on the cost assumptions provided by HHS in support of the proposal. Rather, we outline below some additional questions and issues that organizations may wish to consider or address in submitting comments on the proposal.
Thanks to a just-granted 30-day extension of the public comment period for the NPRM, comments on the NPRM are now due to HHS by January 6, 2016. The ACRG has prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed changes.
ACRG Rapid Rundown: Six Things You Need to Know ... read more
November 24, 2015 11:30 am
Earlier this morning, Health and Human Services and the fifteen other federal departments and agencies with which it is collaborating on the Common Rule Notice of Proposed Rulemaking (“NPRM”) announced that the NPRM comment period, which was scheduled to end on December 7th, will be extended for 30 days. The new deadline for comments is January 6, 2016. A copy of the notice can be found here. Another reason to be grateful this Thanksgiving!
November 9, 2015 5:53 pm
As we previously announced, sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”). The Common Rule NPRM is the latest development since the Advanced Notice of Proposed Rulemaking (“ANPRM”) was published on July 26, 2011. The Academic and Clinical Research Group (“ACRG”) will be publishing a series of topic-specific blogs in the coming weeks to assist institutions in digesting various aspects of the proposed regulations, preparing to submit any comments by the December 7, 2015 deadline, and grappling with implementation changes once the final rule issues. We have also prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed revisions.
In this installment, we discuss the NPRM’s proposed changes to biospecimens research. The NPRM did not back down from one of the more controversial aspects of the ANPRM, proposing a fundamental shift in the applicability of the human subjects protection framework to non-identified biospecimens research. However, once the shock of the new definition of “human subject” wears off, the reality is that most of the changes codify how the research community has tried to apply the existing Common Rule to the challenging arena of biobanking, secondary research, and genomic and other “omics” research. That said, many of the carve-outs (i.e., exclusions and exemptions) intended to balance this shift are more restrictive than at first they seem. ... read more
October 7, 2015 3:42 pm
In the short time since our first Client Advisory on the recently issued Notice of Proposed Rulemaking (“NPRM”) for the Federal Policy for the Protection of Human Subjects (“Common Rule”) (80 Fed. Reg. 53933 (Sep. 8, 2015)), we have been working, along with many of our clients, to map out the “big picture” in terms of the proposed regulations’ broader scope of covered research, the expanded definition of what constitutes a human subject, the new category of excluded activities, and the modified exemptions and implications of being exempt. ... read more
September 22, 2015 4:41 pm
For those of us who work in the clinical research field, the last two days have been quite exciting. At long last, the Notice of Proposed Rulemaking for the Common Rule is here, and the field is alive with talk of the proposed changes and the various ways in which the changes would impact the conduct of research in the U.S. ... read more