Blog Archives

NIH Releases Data Science Strategic Plan

On June 4, the National Institutes of Health (NIH) released its first strategic plan for data science. The strategic plan will serve as a roadmap for modernizing the NIH-supported biomedical data science ecosystem and provide leadership within the broader biomedical research data community. NIH will begin implementing the plan over the next year and focus on usability of NIH-funded biomedical data sets and resources, integration of existing data management tools and development of new ones, and the growing costs of data management. NIH will seek community input during the implementation phase and plans to hire a Chief Data Strategist to help advance data science across the intramural and extramural research communities. Read more here.

Tagged with: , , , ,
Posted in Issue 12 (June 12), Update, Volume 37 (2018)

Census Issues Request for Comment on Decennial Data Collection

In compliance with the Paperwork Reduction Act, the Census Bureau issued a request for comments on the 2020 Census on June 8. The request provides an opportunity for feedback on the Bureau’s proposed information collection activities associated with the 2020 Census, including the addition of a citizenship question (which COSSA opposes). Comments must be submitted by August 7, 2018. More information is available in the Federal Register notice.

Tagged with: , , ,
Posted in Issue 12 (June 12), Update, Volume 37 (2018)

Minerva Initiative Releases 2018 Funding Opportunity Announcement, Topics of Interest

The Minerva Research Initiative, the social science research program administered jointly by the Office of Basic Research and the Office of Policy at the U.S. Department of Defense, has released its 2018 funding opportunity announcement (FOA) and 2018 topics of interest. The Minerva Research Initiative supports university-based, unclassified, research in areas of strategic importance to U.S. national security policy. Research topics of interest for 2018 include: sociopolitical (in)stability, resilience, and recovery; economic interdependence and security; alliances and burden sharing; fundamental dynamics of scientific discovery; adversarial information campaigns; automated cyber vulnerability analysis; and security risks in ungoverned and semi-governed spaces.

White papers in response to the FOA are due on June 19 and full proposals must be submitted by August 14. More information can be found on the Minerva Research Initiative Website.

Tagged with: , , ,
Posted in Issue 12 (June 12), Update, Volume 37 (2018)

BLS Releases New Data on the “Gig Economy”

The Bureau of Labor Statistics (BLS) has released new data on contingent and alternative employment arrangements, the first data of its kind released since 2005. The data includes totals for contingent workers (whose jobs are temporary or otherwise not expected to last), independent contractors, on-call workers, temp workers, and workers provided by contract firms. In addition to this data, BLS is testing questions on short-term work found through websites or mobile apps and expects to release data on this population in September. More information about the release is available on the BLS website.

Tagged with: , ,
Posted in Issue 12 (June 12), Update, Volume 37 (2018)

National Science Board Elects New Leadership

On May 3, the National Science Board (NSB), the governing body of the National Science Foundation, announced that Diane Souvaine and Ellen Ochoa will serve as the Board’s new Chair and Vice Chair, respectively, for the 2018-2020 term. Souvaine has been a member of the NSB for ten years and most recently served as the Vice Chair. Souvaine is a professor of computer science at Tufts University whose research contributions include solving challenging problems in computational geometry and helping extend the results of straight-edged computational geometry into the curved world. Ochoa is an astronaut and the director of the Lyndon B. Johnson Space Center. Souvaine will be replacing Maria Zuber, whose term expired this month. More information about Souviane and Ochoa’s election is available on the NSB website.

Back to this issue’s table of contents.

Tagged with: , ,
Posted in Issue 10 (May 15), 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.

Back to this issue’s table of contents.

Tagged with: , ,
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.

Back to this issue’s table of contents.

Tagged with: , ,
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.

Back to this issue’s table of contents.

Tagged with: , , ,
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.

Back to this issue’s table of contents.

Tagged with: , ,
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.

Back to this issue’s table of contents.

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

Subscribe

Click here to subscribe to the COSSA Washington Update, our biweekly newsletter.

Archive

Looking for something from a previous issue of the COSSA Washington Update? Try our archive.

Issues

Browse by Month