A Wrinkle in Common Rule Time

In an 11th hour—but nonetheless anticipated—move, the sixteen federal departments and agencies responsible for the Common Rule Final Rule that was slated to become effective tomorrow, January 19, 2018 (“Revised Common Rule”), have issued an Interim Final Rule (“IFR ”) delaying the effective date and the general compliance date of the Revised Common Rule for six months, until July 19, 2018. The IFR does not alter the compliance date for the Revised Common Rule’s provision on cooperative research (including its single IRB mandate); that date remains January 20, 2020.

The announcement provides a respite to those in the regulated community who have been working towards bringing their policies and procedures into compliance by January 19, 2018, despite the lack of any written guidance from the Office for Human Research Protections or others in the federal government regarding aspects of the Revised Common Rule that are ambiguous or otherwise challenging to implement. (more…)

NIH Updates Policy for Issuing Certificates of Confidentiality

On September 7, 2017, the National Institutes of Health (“NIH”) released a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109) (“the Policy”). This Policy flows from the Cures Act’s changes to when and how a Certificate of Confidentiality (“Certificate”) is issued, see Pub. Law 114-255, Section 2012 (December 13, 2016), and applies to research “in which identifiable, sensitive information is collected.” The Policy goes into effect on October 1, 2017, with retroactive implications; all NIH-funded research that was “commenced or ongoing on or after December 13, 2016” will be deemed to have been issued a Certificate pursuant to the Policy. NIH has indicated that guidance on the Policy is imminent; when issued, it will likely appear on the NIH’s Certificates of Confidentiality (CoC) Kiosk.

We have identified the following preliminary questions and concerns with the Policy and will be monitoring the forthcoming guidance to see whether and how it addresses them. Institutions also may want to assess the guidance against these concerns to formulate further questions to NIH to the extent troubling aspects of the Policy remain unclear. (more…)

The 2018 Common Rule: Implementation Checklist

As many of you know, most of the provisions of the Final Rule updating the Common Rule (“2018 Common Rule”) will go into effect, and compliance is required, on January 19, 2018. Notwithstanding some uncertainty with respect to the current Administration’s regulatory plans, as of now institutions should be taking stock of what needs to be done to bring IRBs and human research protection programs into timely compliance with the revised regulations. (more…)

Early Adoption Not an Option for Research Rule Changes

Portions of Kate Gallin Heffernan’s presentation at the American Health Lawyers Association conference on legal issues affecting academic medical centers and teaching institutions were quoted in a March 15, 2017 Bloomberg Law: Medical Research Law & Policy Report article entitled “Early Adoption Not an Option For Research Rule Changes.” Kate and her co-presenter, Laura Odwazny, commented on recent changes to human subject protection regulations known as the Common Rule published on January 19, 2017. The full article from Bloomberg Law is linked below.

Reproduced with permission from Medical Research Law & Policy Report, 16 MRLR 06, 03/15/2017. Copyright 2017 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com/>

Download PDF of “Early Adoption Not an Option for Research Rule Changes” from Bloomberg Law.

Just Under the Wire: The Final Common Rule is Here

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…)

If the Federal “Compassionate Use” Program is Flawed, Are State “Right to Try” Laws the Solution?

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…)