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Common Rule Agencies Release Proposal for 6-Month Delay of Revisions, Optional Implementation of “Burden-Reducing” Provisions; Comments Sought for 30 Days

On April 20, the 17 agencies regulated under the Common Rule, the set of regulations governing human subjects research, released a Notice of Proposed Rulemaking (NPRM) that would delay implementation of revisions to the Common Rule by an additional six months, setting a new compliance date of January 21, 2019. The stated rationale for the delay is to “provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements.” The Obama-era changes had been originally scheduled to go into effect on January 19, 2018 but were delayed by an Interim Final Rule announced in January 2018 that pushed the compliance date by six months, to July 19, 2018, and indicated that further delays might be proposed. The rulemaking process to update the Common Rule has been in progress since 2011 (read COSSA’s summary of the proposed changes). The regulations themselves have not been updated since 1991.

During the six months between the current implementation date of July 19, 2018 and the new proposed date of January 21, 2019, institutions would have the option to allow studies to take advantage of three “burden-reducing” provisions within the revised Common Rule (comparisons between the current and revised regulatory text are below). The three provisions are:

  1. The elimination of the requirement that institutional review boards (IRB) review grant applications for covered studies.
  2. The definition of “research,” which excludes four categories of activities from being considered “research”: scholarly and journalistic activities; public health surveillance activities; collection and analysis of information, biospecimens, or records for criminal justice or criminal investigation purposes; operational activities in support of intelligence, homeland security, defense, or national security missions.
  3. The elimination of annual review for research eligible for expedited review and for research that progressed to the point that only involves data analysis or accessing follow-up clinical data.

The revisions to the Common Rule do not require that research initiated prior to its implementation date (January 21, 2019 under the newest NPRM) comply with the new rules. However, any studies that elect to take advantage of the three provisions above must comply fully with the new requirements once they come into effect in January 2019.

The NPRM requests feedback on the proposed implementation plan (a further six-month delay with the option to implement the three provisions), as well as the advisability of several alternative plans:

  • Delay the compliance date until January 2019 without allowing the implementation of the three provisions.
  • Delay the compliance date beyond January 2019.
  • Do not delay the compliance date and allow all the regulations to go fully into effect on July 19, 2018 as currently scheduled.

The 30-day comment period closes on May 21, 2018.


THREE BURDEN REDUCING PROVISIONS ALLOWED TO GO INTO EFFECT UNDER THE APRIL 2018 NPRM:
Comparisons to Current Regulations (in blue)

1. DEFINITION OF RESEARCH

REVISED RULE
§ __.102 Definitions for purposes of this policy.
(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

CURRENT RULE
§46.102 Definitions.
(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

2. ELIMINATION OF IRB REVIEW OF GRANT APPLICATIONS

REVISED RULE
§ __.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
(d) Certification is required when the research is supported by a Federal department or agency and not otherwise waived under § __.101(i) or exempted under § __.104. For such research, institutions shall certify that each proposed research study covered by the assurance and this section has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB.

CURRENT RULE
§46.103 Assuring compliance with this policy – research conducted or supported by any Federal Department or Agency.
(f) Certification is required when the research is supported by a federal department or agency and not otherwise exempted or waived under §46.101(b) or (i). An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by §46.103 of this Policy has been reviewed and approved by the IRB. Such certification must be submitted with the application or proposal or by such later date as may be prescribed by the department or agency to which the application or proposal is submitted. Under no condition shall research covered by §46.103of the Policy be supported prior to receipt of the certification that the research has been reviewed and approved by the IRB. Institutions without an approved assurance covering the research shall certify within 30 days after receipt of a request for such a certification from the department or agency, that the application or proposal has been approved by the IRB. If the certification is not submitted within these time limits, the application or proposal may be returned to the institution.

3. NO ANNUAL REVIEW FOR CERTAIN CATEGORIES OF RESEARCH

NEW RULE
§ __.109 IRB review of research.
(f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:

(i) Research eligible for expedited review in accordance with § __.110;

(iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:

(A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or

(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

CURRENT RULE
§46.103 Assuring compliance with this policy – research conducted or supported by any Federal Department or Agency.
(b) Departments and agencies will conduct or support research covered by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB provided for in the assurance, and will be subject to continuing review by the IRB… [emphasis added]

§46.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.

(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117.

(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

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Posted in Issue 9 (May 2), Update, Volume 37 (2018)

Common Rule Implementation Delayed Six Months; Further Delays Likely

The 16 U.S. federal agencies subject to the Common Rule, the set of regulations governing research involving human subjects, announced a six-month delay on the implementation of revisions originally announced in January 2017 (see COSSA’s analysis of the changes). The delay was announced as an Interim Final Rule in a Federal Register notice published on January 17, 2018, two days before the changes were scheduled to go into effect. According to the notice, federal agencies subject to the Common Rule are “in the process of developing a proposed rule to further delay implementation of the 2018 requirements,” and the six-month delay will allow for a full notice and comment period on this proposal. Details on what this second delay would entail—including whether the agencies are considering more substantive changes to the revisions—are not provided. A statement issued by the Department of Health and Human Services suggests a possible proposed implementation date of January 21, 2019, but this could change. As the regulations currently stand, the new implementation date is July 19, 2018.

The fate of the changes had been left in limbo since the presidential transition, as one of the Trump Administrations’ first acts was to freeze the implementation of new regulations pending review by the Office of Management and Budget, leading to uncertainty over when—and whether—the changes would go into effect.

A number of the changes to the Common Rule were designed to make the regulations less burdensome for research that posed no or minimal risk to participants, like a lot of social and behavioral research. Until the changes are implemented, research involving human subjects will continue to be guided by the existing regulations, which have not been updated since 1991. You can follow COSSA’s ongoing coverage of this issue here.

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Posted in Issue 2 (January 23), Update, Volume 37 (2018)

Delay to Common Rule Implementation Likely

On January 4, the Department of Health and Human Services submitted a final rule for approval by the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA), which would indefinitely delay implementation of revisions to the Common Rule, the set of regulations governing research involving human participants (see COSSA’s analysis of the changes, which were announced in the final days of the Obama administration). This rule replaces an earlier proposal to delay implementation that was submitted in October but never approved by OIRA (see COSSA’s discussion), which would have allowed certain “burden-reducing” provisions of the Rule to go into an effect as scheduled while delaying the remaining pieces of the revision for one year. The new rule would delay the entirety of the revisions to the Common Rule for an unspecified period of time.  The original implementation date for the revisions is January 18, 2018, so OIRA would need to approve the new rule by then in order to avoid the regulations taking effect. It is unclear what the impact would be if OIRA were to approve the delay after the January 18 deadline.

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Posted in Issue 1 (January 9), Update, Volume 37 (2018)

HHS May Delay Common Rule Implementation

On October 7, the White House Office of Information and Regulatory Affairs issued a notice that it is reviewing a rule that would delay the implementation date for most of the changes to the Common Rule, the set of regulations governing research involving human participants, by one year, pushing the effective date for the changes from January 2018 to January 2019 (see COSSA’s analysis of the changes, which were announced in January of this year). The delay would still allow “the use of three burden-reducing provisions during the delay year,” but there is little clarity on what those provisions are or when more details will be made available.

One hint may be found in a letter sent by four higher education associations in June that asked for a year-long delay in the compliance date for most of the changes to the regulations, while allowing burden-reducing provisions to move forward. The letter identified those provisions as “certain exclusions and exemptions, elimination of the continuing review requirement for certain types or stages of research and elimination of IRB [internal review board] review of grant applications.” If the Department of Health and Human Services (HHS) concurs with the recommendations in the letter, the provisions allowed to go into effect as originally scheduled may well include several of the changes that aim to make research involving human participants less burdensome for low-risk social and behavioral research.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

Human Subjects Advisory Committee Seeking New Members

The Secretary’s Advisory Committee on Human Research Protections (SACHRP), the advisory body to the Health and Human Services (HHS) Secretary and the Office of Human Research Protections (OHRP), is soliciting nominations to fill four vacancies in 2017. SACHRP provides scientific expertise and recommendation on matters related to the protection of human subjects in scientific research. The Committee will likely play an important role as OHRP implements the revisions to the Common Rule (see COSSA’s coverage). Experts are sought from fields including “public health and medicine, behavioral and social sciences, health administration, and biomedical ethics.” Nominations must be received no later than September 18, 2017. More information is available in the Federal Register notice.

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Posted in Issue 16 (August 8), Update, Volume 36 (2017)

HOT TOPIC: HHS Announces Final Changes to Human Subjects Research Regulations

During the final days of the Obama Administration, the U.S. Department of Health and Human Services (HHS) released the final text for its changes to the Common Rule, the regulations that govern research with human subjects, completing a revision process started in 2011. The Common Rule, which was last updated in 1991, affects research supported by 16 federal departments and agencies, including the Departments of Health and Human Services, Agriculture, Defense, Education, Commerce, Labor, and Veterans Affairs, as well as the National Science Foundation.

Overall, the changes look to be a positive development for the social and behavioral science research community. According to the executive summary, “The final rule is designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies such as behavioral and social science research.” The rule maintains several proposals from the earlier Notice of Proposed Rulemaking (NPRM) that aimed to reduce the oversight burden on researchers conducting studies that pose no or minimal risk to participants (like a lot of social and behavioral science research). It also declines to adopt several provisions that were controversial in the biomedical research community (although supported by some in the social sciences), including consent requirements surrounding work with de-identified biospecimens, which is likely to lead to a less contentious reception overall.

Read on for COSSA’s full analysis of the changes.

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Posted in Issue 2 (January 24), Update, Volume 36 (2017)

Academies Report Recommends Abandoning Proposed Changes to the Common Rule

On June 29, the National Academies of Sciences, Engineering, and Medicine released part 2 of its report Optimizing the Nation’s Investment in Academic Research (the first part had been released in 2015). Of particular significance to the social and behavioral science research community is a chapter within the report on the “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” In it, the panel issues a stinging criticism of the Department of Health and Human Services’ (HHS) September 2015 Notice of Proposed Rulemaking (NPRM) on the Federal Policy for the Protection of Human Subjects. The chapter argues that the NPRM should be abandoned and that it “would impose additional burdens that could be detrimental to important areas of research.”

COSSA’s comment on the NPRM, submitted jointly with the American Educational Research Association (AERA) and the Inter-university Consortium for Political and Social Research (ICPSR), was largely supportive of the proposal, particularly those provisions that made the regulations less burdensome for low-risk social and behavioral research. What is more, the recommendations made in this latest report are in many ways inconsistent with those of the National Research Council’s (NRC) 2014 report, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.   (more…)

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Posted in Issue 14 (July 12), Update, Volume 35 (2016)

Human Subjects Advisory Committee Seeking New Members

The Secretary’s Advisory Committee on Human Research Protections (SACHRP), the advisory body to the Health and Human Services (HHS) Secretary and the Office of Human Research Protections (OHRP), is soliciting nominations to fill four vacancies in 2016, including the position of Chair. SACHRP provides scientific expertise and recommendation on matters related to the protection of human subjects in scientific research. The Committee will likely play an important role as OHRP finalizes its announced revisions to the Common Rule (see COSSA’s coverage). Experts are sought from fields including “public health and medicine, behavioral and social sciences, health administration, and biomedical ethics.” Nominations must be received no later than March 21, 2016. More information is available in the Federal Register notice.

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Posted in Issue 3 (February 9), Update, Volume 35 (2016)

COSSA and Members Comment on Proposed Revisions to the Common Rule

COSSA, in conjunction with the American Educational Research Association (AERA) (a COSSA governing association) and the Inter-university Consortium for Political and Social Research, submitted comments on the Notice of Proposed Rulemaking (NPRM) for the Federal Policy for the Protection of Human Subjects or the “Common Rule” (click here for context on the NPRM). Overall, the comments are supportive of the proposed changes affecting the social and behavioral sciences and urge that “major and substantial improvements… not be delayed or deferred even if it is determined that some issues require further analysis before some rule changes can be made.” The comments also points out several sections where additional clarification would be useful.

The American Psychological Association (APA), Population Association of America (PAA) (COSSA governing associations), and the Society for the Psychological Study of Social Issues (SPSSI) (a COSSA member), also submitted comments on the NPRM, which are available on regulations.gov (docket ID HHS-OPHS-2015-0008).

Now that the window for public comment has closed, the Office of Human Research Protections will review all submitted comments and release a final rule. However, if the pace of the Common Rule revision process thus far is any indication, it will likely be several months, if not longer, before we see a final rule.

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Posted in Issue 1 (January 12), Update, Volume 35 (2016)

Deadline for Comments on Common Rule NPRM Extended

The Department of Health and Human Services has announced that it will extend the period for public comment on the Notice of Proposed Rule Making (NPRM) for the Federal Policy for the Protection of Human Subjects (otherwise known as the Common Rule) by 30 days. The new deadline is January 6, 2016. A summary of the major changes to the regulations proposed in the NPRM is available here.

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Posted in Issue 22 (December 1), Update, Volume 34 (2015)

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