FABBS Advocacy Update
Tuesday, July 24, 2018
Posted by: Paula Skedsvold
FABBS Member Societies and Affiliates:
I hope you are enjoying the summer months. I wanted to share an update with you about a number of things that we are working on for you.
(1) I am pleased to report that on Friday we received word from NIH’s Deputy Director, Larry Tabak, stating that NIH had issued a notice delaying enforcement of registration and reporting policies for basic science studies involving human participants. The note and links follow:
My NIH colleagues have taken in consideration your questions and developed the Guide Notice, published today, that confirms a delayed enforcement of registration and reporting policies for prospective basic science studies involving human participants under NOT-OD-16-149. (Studies subject to FDAAA still must report as required by this law.) In the interim, we will publish an RFI to collect more feedback from the community on the elements of registration and reporting best suited for prospective basic science studies involving human participants.
In addition, we have confirmed the temporary period of leniency for applications submitted to an incorrect FOA based on the study-type designation.
We continue to expect Good Clinical Practice (GCP) training (NOT-OD-16-148) for all personnel involved in the conduct, oversight, or management of prospective basic science studies involving human participants. As I stated in our meeting, this is a basic training offered in free and short-duration modules (one example is the NIH Office of Behavioral and Social Sciences Research training), and we believe scientists working with human participants should take this.
In the Fall, NIH will publish additional FOAs specifically for prospective basic science studies involving human participants, and my colleagues will continue to refine these details with a commitment to community engagement. The review criteria asking the fundamental question as to whether the study is “needed to advance scientific understanding” will remain, and I think you will agree that this a reasonable question for peer reviewers to consider.
All in all, we consider this a very positive development. After a year of working on this issue at many levels, NIH has agreed to allow basic scientists to use existing basic science portals to register and report research. NIH is also working toward issuing FOAs for prospective basic science studies involving humans, and in the interim will be flexible on FOA submissions. We consider both of these to be positive changes.
Investigators who receive NIH funding will still be required to take Good Clinical Practice Training if the award continues to be defined as both basic science (see the Guide Notice for the definition) and a clinical trial (through those case studies that still exist). While basic research involving humans is already captured under the human subjects protection regulations, NIH considers this additional training necessary. Apparently, if the research is currently or eventually excluded from the clinical trial case studies, then Good Clinical Practice training would not be necessary. I am basing this on a communication I have from NIH, and if we get additional clarification on this point, I will share it with you. My hope is that NIH is going to use the next 14 months of delayed enforcement and flexibility to complete the work of removing basic science from the clinical trial case studies, or better yet, move to a system that allows the investigator to make the determination.
In addition, investigators who meet both the definition of basic science and a clinical trial will be required to complete the Human Subjects and Clinical Trial Information Form. I am hoping that NIH is also planning to rework the form in the short term so that it is user-friendly to basic scientists. We will ask them.
NIH is expected to release a RFI seeking input from the basic science community regarding the best standards for registration and reporting this research. We will share that with you when its complete. For now, we hope this news is helpful to you in your planning.
(2) NICHD recently released information about its strategic planning process and importantly, the working group members. We will look for opportunities for input with NICHD and these working group members. Please let us know if there is something in particular from your society that you think should be on our radar during this process. Here’s a link to the web page: https://www.nichd.nih.gov/about/org/strategicplan
(3) In March 2018, the President’s Management Agenda established a new goal of leveraging data as a strategic asset, recognizing the vast benefits government data can have for the American public. This formal goal commits senior executive branch leaders to develop a written Federal Data Strategy by April 2019, along with a plan for agencies to implement the strategy. To ensure the Federal Data Strategy is comprehensive and actionable, individuals with knowledge, experience, and perspectives about government data that could inform the next upcoming phase of the plan’s development are invited to provide direct input.
On Monday, July 30, the Bipartisan Policy Center will host an Open Forum on the Federal Data Strategy, providing a public opportunity to highlight best practices for the strategic use of government data. During the forum, individuals will have the opportunity to directly provide input on best practices to inform the upcoming phase of work for federal staff developing the strategy, including leaders focused on the four areas of: (1) Enterprise Data Governance; (2) Access, Use, and Augmentation; (3) Decision-Making and Accountability; and (4) Commercialization, Innovation, and Public Use. Additional details and additional opportunities to provide feedback on other aspects of the strategy are available at strategy.data.gov.
(4) Despite efforts on numerous fronts, it is likely that the NSF Social, Behavioral, and Economic Sciences Directorate will receive a cut in funding for FY 2018 (which ends on Sept. 30, 2018). My conversations with Hill staff indicate that there was nothing that could be done. The cut is not coming from either the House or Senate Appropriations Committees, but rather from the White House Office of Management and Budget (OMB). You may recall that the President’s budget request for FY 2019 called for significant cuts in the SBE Directorate. Although the House and Senate seemed to have stepped up and are protecting all the Directorates for FY 2019, there appears to be nothing that they can do for FY 2018. FABBS weighed in earlier this year with the NSF Examiner at OMB and also with House and Senate appropriations staff in the hopes that there would be no targeted cuts to funding for any NSF Directorate, including SBE. I will share more details on NSF SBE’s final appropriations for FY 2018 when they become available.
(5) FABBS welcomes the Society for the Psychological Study of Social Issues as a new member! Previously this year, FABBS welcomed the Vision Sciences Society and the Society for Research in Child Development. We will look forward to meeting their representatives at our Annual Meeting in December.
(6) SAVE THE DATE: The annual meeting of FABBS Council of Representatives, member society Presidents, and Executive Directors will occur on Monday, December 3, 2018, in Washington, DC. On Sunday evening, December 2nd, we will host a casual dinner for FABBS Board and meeting attendees. Please mark your calendars. We will send more information later.