Senators Join Together in Support of the Institute for Education Sciences

On April 11, 19 Senators submitted a letter to the Senate Labor, Health and Human Services, and Education appropriations subcommittee, in support of the Institute of Education Sciences (IES). IES is the research and development agency of the Department of Education and also houses the National Center for Education Statistics (NCES). The letter calls for Congress to appropriate $670 million for IES, providing critical support for NCES as well as the National Center for Special Education Research, Regional Education Laboratories, and the National Center for Education Research.

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

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)

COSSA Washington Update, Volume 37 Issue 8

Featured News

COSSA in Action

Congressional News

Federal Agency & Administration News

Community News & Reports

COSSA Member Spotlight

Events Calendar

Posted in Issue 8 (April 17), 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)

Less Than Two Weeks Until COSSA’s Science Policy Conference and Advocacy Day

There are less than two weeks left until the COSSA 2018 Science Policy Conference and Social Science Advocacy Day on April 30 and May 1. Register today to ensure you don’t miss the keynote address delivered by Barnard College President Sian Beilock, plenary panels on communicating and reestablishing trust in social science, and breakout sessions on using social and behavioral science research to address timely policy issues. Click here to see the full lineup of sessions and speakers and check the COSSA website for the most up-to-date information on the conference. Remember: COSSA members and students are eligible for discounts on registration. Email jmilton@cossa.org for details.

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

Jerry Moran Tapped to Lead Senate CJS Subcommittee

This week, following the retirement of Senate Appropriations Committee Chair Thad Cochran (R-MS), long-time appropriator Richard Shelby (R-AL) was approved by the Senate Republican Caucus to take the helm of the powerful committee. Shelby’s promotion left a vacancy in the chairmanship of the Subcommittee on Commerce, Justice, Science, and Related Agencies (CJS), the subcommittee responsible for allocating money to the Department of Commerce, including the U.S. Census Bureau, the Department of Justice, and federal science agencies, including the National Science Foundation. Shelby selected Jerry Moran (R-KS) to lead the subcommittee. Moran, a lawyer and longtime state politician before his election to the Senate 2010, has most recently lead the Appropriations Subcommittee on Military Construction and Veterans Affairs. Jeanne Shaheen (D-NH) will continue to serve as the Ranking Member of the CJS Subcommittee.

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

House Subcommittee Discusses 2019 NIH Budget

On April 11, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) heard testimony from leadership of the National Institutes of Health (NIH) on the fiscal year (FY) 2019 NIH budget request. NIH Director Francis Collins, National Institute of Child Health and Human Development Director Diana Bianchi, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, National Cancer Institute Director Norman Sharpless, and National Institute on Drug Abuse Director Nora Volkow all testified at the hearing. NIH was lauded for its accomplishments by members of both parties, further solidifying its position as a bi-partisan priority. Subcommittee Chair Tom Cole (R-OK), Ranking Member Rosa DeLauro (D-CT), and other members of the subcommittee expressed concern with the $2 billion cut recommended in the President’s FY 2019 budget request, in stark contrast to the $3 billion increase NIH received in the omnibus FY 2018 spending bill. Committee members also discussed NIH activities related to the opioid epidemic, the flu vaccine, medical and recreational marijuana, and cancer detection. A recording of the hearing and written statements from Collins and Cole can be found on the House Appropriations Committee’s website. COSSA’s coverage of FY 2019 funding is available here.

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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)

PAA Congressional Briefing Explores Factors Affecting Life Expectancy

On April 9, the Population Association of America (PAA), a COSSA governing member, hosted a Congressional briefing entitled Grave Consequences: Why Some Americans Are No Longer Living Longer on the decline of average life expectancy among some groups in the United States. COSSA was a co-sponsor of the event.

Andrew Fenelon, researcher at the University of Maryland, spoke about the regional divergence in adult mortality. The Central South has a higher mortality rate than the rest of the country and has gotten worse over time, while the East Coast has shown significant improvements. Shannon Mannat, researcher at Syracuse University, presented on the significant increase in “deaths of despair,” which are deaths caused by drug overdose or suicide. However, she emphasized that we must focus on underlying factors that lead to opioid abuse, including economic insecurity and isolation from family and communities. The final panelist was John Haaga, Director of the Division of Behavioral and Social Research at the National Institute on Aging (NIA), who presented NIA research initiatives related to life expectancy, including behavioral and social research projects.

All the panelists acknowledged that improving Americans’ health must be a collaborative effort that includes reducing economic insecurity, fighting the opioid epidemic, improving community connectedness, and increased social science research. Andrew Fenelon stated, “Any policy, even if not directly related to health, is going to have health implications.”

This article was contributed by COSSA’s spring intern, Dakota Leonard of Arizona State University.

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

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