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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)

Psychologist Kristina R. Olson Receives Alan T. Waterman Award

On April 12, the National Science Foundation (NSF) announced that the 2018 Alan T. Waterman Award, the nation’s highest honor for early career scientists and engineers, would go to social and developmental psychologist Kristina R. Olson of the University of Washington. Olson is the first social scientist to receive the award since 2005 and is recognized for her “innovative contributions to understanding children’s attitudes toward and identification with social groups, early prosocial behavior, the development of notions of fairness, morality, inequality and the emergence of social biases.” More information can be found here. Olson and other awardees will be recognized at a ceremony in Washington on May 2.

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Posted in Issue 8 (April 17), Update, Volume 37 (2018)

NIH Launches HEAL Initiative to Address the Opioid Epidemic

On April 4, the National Institutes of Health (NIH) announced a new effort to accelerate progress toward addressing the opioid addiction crisis. The Helping to End Addiction Long-term (HEAL) Initiative will use the increase in NIH funding provided by the FY 2018 omnibus bill to nearly double funding for research on opioid misuse/addiction and pain compared to FY 2016 ($1.1 billion compared to $600 million). The initiative will fund research in two broad areas: (1) Prevent addiction through enhanced pain management, and (2) Improve treatments for opioid misuse disorder and addiction. Within the preventing addiction portfolio, NIH proposes to launch a longitudinal study to follow patients at risk for chronic pain and to fund research on understanding “the genetic and social factors that put patients at risk for opioid misuse and addiction.” As part of its improving addiction treatment efforts, the Institute also plans to “assess the additive role of social and behavioral interventions” to Medication Assisted Treatment (MAT) programs. More information about the initiative is posted on the NIH website.

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Posted in Issue 8 (April 17), Update, Volume 37 (2018)

NIH Takes Next Steps in Agency Reorganization Plans

As part of the Trump Administration’s government reform agenda, including its comprehensive plan for reorganizing the executive branch and reducing the federal civilian workforce, the Department of Health and Human Services (HHS) has created an initiative called ReImagine HHS. As part of this initiative, the National Institutes of Health (NIH) launched Optimize NIH in December 2017 to improve organizational effectiveness and performance. NIH is working to equilibrate workload distribution across scientific review and grants and program management functions and anticipates that the Optimize NIH effort will be fully implemented over the next two to three years. Research functions are not expected to be among the first areas addressed as part of the activity. Rather, NIH will be looking at ways to streamline communications, ethics, and Freedom of Information Act requests across the agency.

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Posted in Issue 8 (April 17), Update, Volume 37 (2018)

2020 Census to Ask About Citizenship; COSSA Releases Statement and Action Alert

On March 26, Secretary of Commerce Wilbur Ross directed the Census Bureau to include a question about respondents’ citizenship in the 2020 Decennial Census. The decision was made in response to a request by the Department of Justice to add the question in order to support its enforcement of the Voting Rights Act, although it is unclear why current data is inadequate. Citizenship was last asked as part of the decennial census in 1950; since then it has been included on the census “long form,” which later became the American Community Survey (these differ from the decennial census in that they are sent to a sample of the U.S. population, not every household). In a memo outlining his decision, Ross stipulated that the question be asked last on the Census form. While the decision was reportedly made over the objections of the experts at the Census Bureau, the citizenship question was on the list of planned questions submitted to Congress on March 29.

The decision has raised concerns for those in the scientific community because the question was not part of the extensive research and testing the Census Bureau routinely conducts in the years leading up to a decennial census. The Bureau carefully evaluates all proposed changes to design and wording of the census to ensure that they do not affect the quality of the responses received. Asking about citizenship could alienate respondents in the immigrant community and potentially deter them from responding to the Census at all or answering inaccurately, resulting in an undercount of these populations and affecting the accuracy and integrity of the Census data. The Bureau is currently conducting the last major test of the 2020 Census operation, the 2018 End-to-End Test in Providence, RI, which is being administered without a citizenship question. Because the Bureau will not have been able to evaluate the impact of the question, we will not know how the question will affect responses until the 2020 Census is in the field. Given that the Census Bureau has a Constitutional obligation to count every member of the U.S. population, an increase in non-response would greatly increase the costs of the count, as more enumerators would need be sent to collect responses in person, at far greater expense than planned mail or internet outreach.

The decennial census is an irreplaceable source of data for researchers across the social sciences who use it to generate valuable findings about the U.S. population that can be used to inform evidence-based policies. In addition, information from the decennial census undergirds numerous other surveys and data sets at the Census Bureau and beyond, so a problem at the source would have far-reaching implications across the statistical system. COSSA strongly opposes the Department of Commerce’s decision and released a statement to that effect on March 27. In addition, COSSA issued an action alert to enable COSSA members to easily write to their Members of Congress and ask them to support legislation to remove the question. In addition, other COSSA members, including the American Statistical Association, Population Association of America, and the Social Science Research Council have released statements criticizing the decision.

At this stage, the only avenues to removing the question are legislation or a court ruling. Two bills (H.R. 5359 and S. 2580) have been introduced by Democrats in Congress that would bar the Census from asking about citizenship, but neither has bipartisan support, making passage unlikely. In addition, more than one law suit has been filed against the Administration, arguing that asking about citizenship is an attempt to depress the count of minority populations.

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Posted in Issue 7 (April 3), Update, Volume 37 (2018)

Office of Management and Budget Releases President’s Management Agenda

On March 20, the White House Office of Management and Budget (OMB) released the President’s Management Agenda, which is a broad framework for bring additional efficiency to the federal government. Goals include accomplishing agency missions more effectively, better serving those receiving services from the federal government, and being better stewards of taxpayer dollars. To accomplish these goals, the Administration will first focus in information technology modernization across the government, data accountability and transparency, and modernizing the federal workforce. Progress on the President’s Management Agenda goals can be tracked online at performance.gov/PMA.  The President’s Management Agenda is expected to inform agency reorganization plans that will be released in the coming months.

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Posted in Issue 7 (April 3), Update, Volume 37 (2018)

OSTP Publishes Report on “Science & Technology Highlights” in the Trump Administration

Earlier this month, the White House Office of Science and Technology Policy (OSTP) published a 12-page report detailing the “tremendous” science and technology achievements made during the first year of the Trump Administration. According to the report, OSTP “has built a robust team of over 50 staff members,” although the size of the office is less than 40 percent of what it was under the previous Administration, and the President has yet to nominate an OSTP Director or a science advisor. The report describes accomplishments, such as the awarding of Nobel prizes to National Science Foundation-funded scientists whose research was supported during previous administrations, in the categories of Artificial Intelligence & Autonomy, Biomedical Innovation, Connectivity, Cybersecurity & Government IT Services, Digital Economy, Energy Dominance, Homeland Defense & National Security, Opioid Epidemic Response, Scientific Discovery, Space Exploration, and STEM Education.

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Posted in Issue 6 (March 20), Update, Volume 37 (2018)

NSF Releases Additional Details of FY 2019 Budget Request

On February 28, full details of the President’s fiscal year (FY) 2019 budget request for the National Science Foundation (NSF) were released. Preliminary details were unveiled on February 12 with the rest of the President’s FY 2019 budget.

The President’s request includes a total of $7.5 billion for NSF in FY 2019, which is flat with the FY 2017 enacted level (Note: FY 2018 appropriations have not yet been completed, so comparisons are made to the last enacted level). As previously reported, prior to enactment last month of a bipartisan budget deal to raise discretionary spending caps, the Administration’s budget proposal for NSF was $5.3 billion, a nearly 30 percent cut to the agency. Unfortunately, the newly released details show that the additional funding associated with raising the caps would not be spread evenly across the foundation. Instead, the request seeks to reprioritize funds toward NSF’s Big Ideas initiatives at the expense of several existing programs and activities. Of particular concern is the disproportionate treatment of the Social, Behavioral, and Economic Sciences Directorate (SBE) in the request, which would see a cut of 9.1 percent from FY 2017 (11.2 percent to its research and education activities). This is compared to the other directorates that would be held flat or cut by one or two percent.

Read on for COSSA’s full analysis of the NSF FY 2019 Budget Request.

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Posted in Issue 5 (March 6), Update, Volume 37 (2018)

National Institute of Justice Seeking Peer Reviewers

The National Institute of Justice (NIJ), the research and evaluation agency of the Department of Justice, is seeking to expand its pool of peer reviewers. NIJ’s grant making process relies on scientists and criminal justice practitioners to provide expertise and feedback on the scientific rigor and merit of applications. NIJ is specifically seeking research and technical experts in the following areas: human trafficking, firearms violence, mass shootings, school safety, terrorism, gangs, persistently violent communities, and hate crime. More information about becoming a peer reviewer can be found on the NIJ website.

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Posted in Issue 5 (March 6), Update, Volume 37 (2018)

Trump Releases FY 2019 Budget Request; Read COSSA’s Analysis of Social Science Impacts

On February 12, the Trump Administration began releasing details of its fiscal year (FY) 2019 budget request to Congress, although details for some agencies (such as the National Science Foundation and National Institutes of Health) have yet to be released and are expected in the coming days or weeks. In light of a recent bipartisan agreement to increase discretionary spending over the next two years, the White House Office of Management and Budget (OMB) released an addendum to the FY 2019 budget outlining a number of adjustments to the budget request. However, the President’s views the new spending caps as a “ceiling” for FY 2019 funding, not as a funding target. As such, the request violates the budget deal by seeking to shift $57 billion away from nondefense discretionary spending and over to the defense side of the ledger.

The bottom line when considering the Trump Administration’s proposals for FY 2019 is that it remains a political, largely symbolic document that outlines the Administration’s priorities for the year ahead; take note of the policy priorities contained within the budget as they could shape some legislative and/or executive actions later in the year. However, Congress is not likely to go along with the bulk of the President’s recommendations, especially cuts for research and domestic programs writ large.

Read on for COSSA’s full analysis of the President’s proposals as they pertain to social and behavioral science research. Supplements to this report will be issued as additional agency details are released.

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Posted in Issue 4 (February 20), Update, Volume 37 (2018)

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