New NIH Requirements: For Registering NIH-Funded Clinical Trials on Clinicaltrials.gov and for Good Clinical Practice (GCP) Training

As of January 2017, NIH has implemented two new requirements in regards to clinical trials.  These requirements are related to registering clinical trials on clinicaltrials.gov and good clinical practice (GCP) training.  In order to address these new requirements, the CRC IRB has revised the IRB forms to include sections for clinical trials registration and good clinical practice training in addition to developing processes to meet these requirements. As these requirements are a big change, especially for social-behavioral research that was previously not subject to clinical trials registration and GCP training, we want to provide some information on how we are working to ensure compliance efficiently.  Please note that our process includes working with researchers on an individual basis and working with our colleagues outside of BU to ensure compliance, promote efficiency, and to communicate with the federal agencies.  This includes having individuals in the Research Compliance Department participate in committees and associations that bring together other universities and academic medical centers in order to work together to communicate with and address concerns to the federal agencies.  This includes participating in the following committees/associations: the Federal Demonstration Partnership (FDP) which is an association of federal agencies, academic research institutions with administrative, faculty... More

Memo: Lab Animal Per Diem Rate Changes, August 16, 2017

TO: Boston University Deans, Department Chairs, Principal Investigators, Department Administrators, and Grant Administrators FROM: Gloria Waters, Vice President and Associate Provost for Research Karen Antman, Provost, Medical Campus, and Dean, School of Medicine DATE: August 16, 2017 SUBJECT: Lab Animal Per Diem Rate Changes Boston University manages its animal facilities as efficiently as possible to keep animal rates affordable. We annually review costs and charges to Principal Investigators (PIs) who use our Animal Science Center (ASC) to establish competitive rates while remaining fiscally responsible. Below are the new animal rates for both the Charles River and Medical campuses effective September 1, 2017. The uniform pricing reflects increasing numbers of faculty who collaborate across the University campuses. Boston University subsidizes the costs of animal housing as part of its investment in the research enterprise. The table below shows the University subsidized cost charged to BU PIs for federal grants, as well as the full cost of the per diems for the individual species. Subsidized rates are only for research funded by federal, foundation, or private grants that carry the full BU-negotiated facilities and administrative (F&A) rate. The full direct cost rates must be used for foundation grants that do not carry the full BU negotiated F&A rate as per recent AAU and BU responses... More

Additional Changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials

Notice Number NOT-OD-17-066 expands the National Institutes of Health, Agency for Healthcare Research and Quality, and National Institute for Occupational Safety and Health post-submission materials policy to include citations to issued patents as allowable post-submission materials. This notice applies to applications submitted for proposals due on or after Sept. 25, 2017. Post-submission materials are those submitted after submission of the grant application but prior to initial peer review. They are not intended to correct oversights or errors discovered after submission of the application, but rather allow applicants the opportunity to respond to unforeseen events.

New NSF Proposal and Award Policy Newsletter

NSF now issues a quarterly publication that shares information on upcoming changes and clarifications to policies and procedures that affect the preparation and submission of NSF proposals and management of NSF awards. Read the first issues of the newsletter.

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Implementation of the Research Terms and Conditions

Revised Research Terms and Conditions (RTCs) have been issued, as announced in the March 14, 2017 Federal Register. The RTCs address and implement the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR 200) issued by the US Office of Management and Budget (OMB) and are made available to research agencies for use with research and research-related awards. The RTCs incorporate the entire Uniform Guidance by reference and clarify or supplement existing provisions where appropriate. NSF continues to serve as the sponsor of the updated RTCs. Participating agencies will implement the RTCs as indicated in the Agency Implementation Statements. They will each post agency-specific requirements on the NSF RTC site. Learn more about the revised RTCs, documents available, and the agency-specific requirements. You can find the Prior Approval Matrix, Subaward Matrix, and National Policy Requirements on the NSF website, as well.

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National Science Foundation Headquarters Moving – will impact your business with NSF

The National Science Foundation (NSF) is moving its headquarters to Alexandria, Virginia. NSF will have a new mailing address effective Monday, October 2, 2017, as follows: National Science Foundation 2415 Eisenhower Avenue Alexandria, VA 22314 Email addresses and phone numbers for NSF employees and NSF offices will not change. NSF plans to minimize the move’s impact on the research community as much as possible. There are a few important impacts listed below: Due to the move of NSF's Data Center, NSF.gov, FastLane, and Research.gov will be unavailable from Friday, June 30 at 8 p.m. until Tuesday, July 4 at 6 p.m. EDT. This move has been scheduled around a holiday weekend to minimize downtime and reduce the impact on the research community and NSF staff. During this outage period, proposals cannot be submitted in FastLane, and project reports and cash requests cannot be submitted in Research.gov. However, previously saved information and uploaded documents in FastLane and Research.gov, including in-process proposals and reports, will be accessible after the Data Center moves. The physical move to NSF's new headquarters will be phased over a six-week period, beginning Thursday, August 24 through Sunday, October 1. During this time, you may experience delayed response times when trying to communicate... More

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Technical Issue with ASSIST Budget Forms

Resolved on June 1, 2017 NIH is working on an issue with reviewing or creating the budget forms in ASSIST. This is preventing Sponsored Programs from reviewing pending proposals and anyone trying to update or create their budgets as the alert requests that we hold off on accessing these forms. We will be logging tickets with the help desk at NIH as per their suggestions for those proposals that are due today or tomorrow. We hope they can resolve this issue quickly but at present there is no anticipated resolution day/time. Please check the NIH ASSIST home page for updates.

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Federal Demonstration Partnership Subaward Template Update

There are recent changes to the Federal Demonstration Partnership (FDP) subaward agreement forms that BU uses. With these changes, beginning May 1, 2017, PIs will be required to share key compliance information with the Sponsored Programs Subaward Team before a subaward will be issued. In addition to confirming the subaward scope of work and budget, the Subaward Team will ask the PI to confirm whether the subaward activity involves work with human or animal subjects, embryonic stem cell use, or the exchange of human subjects data. If the subaward activity involves the exchange of human subjects data, the PI will be asked to complete an information form before human subjects data is exchanged. This will enable Sponsored Programs to assess whether a Data Use Agreement will be required. Please note that if a Data Use Agreement is required, this will not delay issuance of the subaward. Sponsored Programs will negotiate this as a follow-up action and incorporate it into the subaward agreement by amendment prior to the exchange of the human subjects data.

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NSF’s Standardizes Collaborators and Other Affiliations Information via Spreadsheet

Effective April 24, 2017, The National Science Foundation (NSF) initiated a new spreadsheet template for identifying Collaborators and Other Affiliations Information for Principal Investigators (PIs), co-PIs, and other senior project personnel identified on proposals. The new spreadsheet will standardize Collaborators and Other Affiliations (COA) information across the Foundation and will ensure that the information is submitted in a searchable format. Results from the pilot will be assessed and will determine how to proceed with this section of the proposal on a future date. See the NSF notification for complete information and links to the template and associated instructions. The spreadsheet template will also be directly linked to in FastLane.

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Grants.gov “Workspace:” Changes to the Federal Submission Process Coming December 2017

The traditional method of applying for grants to federal agencies by downloading a package of PDF forms and submitting via grants.gov will be phased out in December 2017. Learn more about the change on the grants.gov site. Sponsored Programs Recommendations: Continue using the available Adobe packages while we create Workspace user guides. If you chose to use Workspace to prepare and submit your proposal, you must adhere to the proposal submission policy in order to give us ample time to review and submit through this new system. Even if the application passes Workspace validations, it must still pass sponsor specific validations. For proposals to NIH we recommend using NIH ASSIST, not Workspace, as the NIH ASSIST validations are sponsor specific.