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By Lisa M. Campbell and Timothy D. Backstrom

On December 6, 2018, the U.S. Environmental Protection Agency (EPA) announced it was proposing a rule (83 Fed. Reg. 62760) to harmonize the EPA-specific regulations regarding research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes with the revised regulations of the Federal Policy for the Protection of Human Subjects (Common Rule) issued on January 19, 2017 (82 Fed. Reg. 7149).  Specifically, EPA is proposing to amend subparts C, D, K, and M of its regulations relating to human research.  Subpart K, titled “Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults,” contains the majority of the revisions.  Subparts C and D will be revised to update several numerical citations and subpart M will be revised to correct a typographical error. 

By way of background, the Common Rule governs research with human subjects conducted or supported by federal agencies, but EPA has also promulgated parallel requirements governing research conducted by third parties and then submitted to EPA for regulatory purposes.  In particular, Subpart K addresses human research that may be conducted by third parties and then utilized to support registration of pesticides.   Congress mandated various revisions to the Common Rule (including additional requirements for research involving pregnant women, fetuses, and children), and EPA is now modifying the EPA-specific requirements for human research to assure consistency and uniformity.  These changes are also intended to assure that a single Institutional Review Board (IRB) review meeting the requirements of the Common Rule will be sufficient for any given study.

The proposed rule states that subpart K, “in establishing a process for review of third-party research involving intentional exposure of human subjects, borrows heavily from the provisions contained in the previous version of the Common Rule,” and that it will be revised to “maintain consistency of [IRB] review between agency-conducted or agency-sponsored human research and third-party human research.”  EPA states the consequence of not resolving these discrepancies will be to “create confusion and, more seriously, potential compliance and/or legal liabilities for researchers, institutions, and sponsors who must follow EPA regulations.”  Comments on the proposed rule are due by February 4, 2019

Compliance with the revisions to the Common Rule originally was set for January 19, 2018, but it has been extended to January 21, 2019.  The compliance date for the “cooperative research” Section remains January 20, 2020.  This proposed rule to revise the requirements for third-party research submitted to EPA would not make substantive changes to the previously adopted final revisions to the Common Rule.  The final rule states that cooperative research projects are “those projects covered by this policy that involve more than one institution,” any institution located in the United States that is engaged in cooperative research must “rely upon approval by a single IRB for that portion of the research that is conducted in the United States,” and the reviewing IRB “will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the federal department or agency supporting the research.”

More information on the revision to the Common Rule is available in our blog item “Federal Agencies Announce Revision to Modernize Federal Policy for the Protection of Human Subjects” and on our blog under key phrase Common Rule.


 

By Timothy D. Backstrom and Lisa M. Campbell

On June 19, 2018, 16 federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing studies with human subjects that are sponsored or utilized for regulatory purposes by the federal government (83 Fed. Reg. 28497).  These revisions to the human testing policy were adopted on January 19, 2017, in a final rule (82 Fed. Reg. 7149) that amended and expanded the “Common Rule” governing human testing originally promulgated in 1991.  The 2017 revisions to the human testing policy were originally scheduled to take effect on January 19, 2018, but the agencies published an interim final rule on January 22, 2018, that delayed the effective date for the new policy until July 19, 2018.  Thereafter, on April 20, 2018, the same 16 agencies published a proposed rule (83 Fed. Reg. 17595) to delay the general compliance date for an additional six-month period, and to allow regulated entities to implement certain burden-reducing provisions during this interim period. 

The rule delaying the effective date of the 2017 revisions for an additional six months takes effect on July 19, 2018.  In the period between July 19, 2018, and January 21, 2019, regulated entities must continue to comply with the requirements of the human testing policy as it was in effect prior to the 2017 revisions.  Notwithstanding this general rule, affected institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions.  Those three provisions are:

  • The revised definition of “research,” which deems certain activities not to be research covered by the Common Rule;
  • The elimination of the requirement for annual continuing review with respect to certain categories of research; and
  • The elimination of the requirement that institutional review boards (IRB) review grant applications or other funding proposals related to the research.

The principal purposes of the additional delay in implementation of the 2017 revisions to the human testing Common Rule are to allow more time for affected institutions to prepare for compliance and for the federal agencies that have adopted the new policy to issue further guidance.  The final rule states that the agencies do not expect that any additional delay in the implementation of the policy will be needed.

More information on the federal policy for the protection of human subjects is available in our blog under key phrases human subjects and common rule.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule.  Final revisions were published on January 19, 2017.  On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies published a Notice of Proposed Rulemaking (NPRM) proposing revisions to each agency’s codification of the Federal Policy for the Protection of Human Subjects, originally promulgated as a Common Rule in 1991.  80 Fed. Reg. 53931.  On January 19, 2017, HHS and other federal departments and agencies published a final rule revising the Federal Policy for the Protection of Human Subjects.  82 Fed. Reg.  7149.  The revised policy, referred to as the “2018 Requirements,” was scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018, with the exception of the revisions to the cooperative research provisions for which the compliance date is January 20, 2020

After publication of the 2018 Requirements, representatives of industry, including organizations representing recipients of federal human subjects research awards, expressed concern regarding their ability to implement all of the 2018 Requirements by the scheduled general compliance date.  Stakeholders requested a delay in the general compliance date of the 2018 Requirements with the exception of certain burden-reducing provisions of the 2018 Requirements, including certain carve-outs from the definition of “research” exemptions, elimination of the continuing review requirements for certain categories of research, and the elimination of the requirement that institutional review boards (IRB) review grant applications.  The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) also recommended in August 2017 that implementation of the 2018 Requirements should be delayed.  The new effective date is July 19, 2018.  Comments are due by March 19, 2018.

More information on the Common Rule is available on our blog. 


 

By Lynn L. Bergeson and Margaret R. Graham

On January 19, 2017, the U.S. Environmental Protection Agency (EPA), together with a host of other federal agencies, announced revisions via a final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991.  82 Fed. Reg. 7151.  The Federal Register publication states that this final rule is intended to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators, and “these revisions are an effort to modernize, simplify, and enhance the current system of oversight.”  The rule will become effective on January 19, 2018.  The compliance date is also January 19, 2018, with some exceptions.

The final rule differs in important ways from the proposed rule issued on September 8, 2015; most significantly, several proposals are not being adopted.  Other minor changes have been to improve the rule and for purposes of clarity and accuracy.  Some of the changes include:

  • It does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.
  • To the extent some of the proposals relied on standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance.
  • It does not expand the policy to cover clinical trials that are not federally funded.
  • It does not adopt the proposed new concept of ‘‘excluded’’ activities.  Generally, activities proposed to be excluded are now either described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
  • The proposed revisions to the exemption categories have been modified to better align with the longstanding ordering in the final rule. It does not include the proposed requirement that exemption determinations need to be made in specified ways.
  • It does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens.
  • It does not adopt the most restrictive proposed criteria for obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.

The final rule makes the following significant changes to the Common Rule:

  • Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
  • Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens.  Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
  • Establishes new exempt categories of research based on their risk profile.  Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
  • Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective three years after publication of the final rule.
  • Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.

More information on the Federal Policy for the Protection of Human Subjects is available on the U.S. Department of Health & Human Services’ website