Source: https://www.cossa.org/tag/human-subjects/
Timestamp: 2019-04-25 02:33:24+00:00

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The Office of Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) has released draft guidance for transitioning studies to the revised Common Rule. The Common Rule is the set of regulations governing research involving human participants. After a lengthy revision process (see COSSA’s previous coverage), changes to the Common Rule updating a number of its provisions took effect on January 21, 2019. The draft guidance released by OHRP gives details on how an institution may voluntarily transition a study initiated before the implementation date to the new regulations. The complete draft guidance can be accessed on the OHRP website. Comments on the guidance are requested by February 11, 2019 and may be submitted via regulations.gov.
In light of the new requirements taking effect, OHRP has also released more details on how institutional review boards (IRBs) should approach continuing review for studies eligible for expedited review under the new Common Rule on its website.
On July 20, the Office for Human Research Protections (OHRP) the Department of Health and Human Services (HHS) released three draft guidance documents that relate to the three provisions in the revised Common Rule that institutions may choose to implement during the period between July 19, 2018 and January 20, 2019, when the revised Common Rule becomes effective (see COSSA’s coverage of the delay).
OHRP will issue a formal Notice of Availability about these guidance documents in the Federal Register but has posted the draft documents on its website in recognition of the beginning of the general compliance delay period, which began July 19, 2018. More of COSSA’s coverage of the Common Rule can be found here.
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.
The elimination of the requirement that institutional review boards (IRB) review grant applications for covered studies.
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.
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.
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.
§ __.102 Definitions for purposes of this policy.
(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.
§ __.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.
§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.
§ __.109 IRB review of research.
§46.109 IRB review of research.
(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.
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.
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.
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.
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.
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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