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)

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