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Longwood Research Administration Digest
Thursday, January 14, 2021

Federal News


Preliminary Data/Post-Submission Material

NIH will continue to accept a one-page update with preliminary data as post-submission materials for applications submitted for the August/October 2021 council. This applies to applications submitted for the January 25, 2021 due date for Summer 2021 review meetings. Read NOT-OD-20-179.

NIH Projects by State

Search the new RePORTER site map visualization tool, which identifies active NIH projects by state. Maps are fast and interactive allowing users to find results in your local area. Visit https://reporter.nih.gov

Federal Holidays Next Week

NIH will be closed on Monday, January 18, 2021 (Martin Luther King, Jr. Birthday). and Wednesday, January 20, 2021 (Inauguration Day). Grant application due dates automatically extend to the next business day.

All About Grants Podcast

Human Subjects’ Research Post-Award is the final podcast in NIH's three-part series. Refer to the MP3 recording/transcript with Lyndi Lahl, Human Subjects Officer, NIH Office of Extramural Research. Learn about post-award requirements, annual progress reporting, protocol changes and unanticipated problems.

University News


Update: National Defense Authorization Act (NDAA)

With the congressional vote (81-13 in the Senate and 322-87 in the House) to override the Presidential veto, the National Defense Authorization Act (NDAA for FY 2021) is now officially enacted. The NDAA maintains restrictions from previous years (e.g. Section 899 restriction on use of equipment or services from companies such as Huawei, ZTE, etc.) and includes a new Section-223 which has a direct impact on universities. The full text of Section-223 is included as Attachment-1. This new section introduces a number of requirements for any application for a research and development award. The following is a high-level summary:
  • Each covered individual listed on the application (the definition provided is similar to key personnel) must disclose all current and pending support, certify the information is accurate at the time of the application, update the information at the time of the award, and provide updates as requested by the agency.
  • The definition of current and pending research support in the act requires the disclosure of resources regardless of “whether the resource is made available through the entity applying for a research and development award or directly to the individual."
  • The entity applying for the award certify that each covered individual who is employed by the entity and listed on the application has been made aware of the disclosure requirements.
  • Introduces enforcement measures against:
    • The individual who knowingly fails to fully disclose. The enforcement measures include potential rejection of the application, temporary or permanent debarment, and referral to federal law enforcement agencies to determine whether any criminal or civil laws were violated.
    • The entity, if the entity knew that a covered individual failed to disclose the required information and the entity did not take steps to remedy such nondisclosure before the application was submitted or did not inform the individuals of their disclosure requirements.
Questions regarding the NDAA and/or the above summary? Contact Rachel Cahoon.

GMAS Release January 18, 2021

Available Monday January 18, 2021, the release includes integration with the new Outside Activity and Interest Reporting System (OAIR) and the retirement of the COI and OAR approvals. This new integration streamlines the institution's obligation to collect and review outside activities and interests for investigators associated to grant applications and awards. Visit the GMAS website

FY21 Q2 ecrt Review Period

Mark your calendar. FY21 Q2 ecrt Review Period begins Wednesday, January 20, 2021. The certification period opens Wednesday, February 10, 2021. The certification deadline is Thursday, March 11, 2021. Start the review period as soon as possible, to ensure all statements are ready to be certified in a timely manner. Questions or concerns? Contact your department Primary Effort Coordinator (PEC), the HMS Tub Effort Coordinator (TEC), and/or Mark O'Brien.

Events/Trainings


Making 2021 a Breakthrough Year

Join colleagues for this collaborative, interactive Goal Planning Workshop. Illuminate paths to grow professionally in 2021 and discuss setting strategic goals and successfully achieving them by embracing a growth mindset and new habits. Hosted by the JCSW Community Engagement Committee. 

IRB Pop-up Clinic

Questions about the IRB process, need submission assistance, or want to know more about ESTR? Zoom login info sent prior to the session. Sponsored by the Office of Regulatory Affairs & Research Compliance. Contact Alexis Fagan. 
  • Friday, January 22, 2021,11:00 AM to Noon

IRB Basics 

Learn how to determine which kind of IRB determination is necessary. This presentation will cover Not Human Subjects Research and exemption determinations; when reviews are conducted on an expedited basis vs. convened IRB “Full Board” Review. Discuss common road blocks (how to avoid them), FAQs, recommendations, and students conducting human research. Presented by Alyssa Speier, Associate Director, Office of Regulatory Affairs and Research Compliance and Amy Harchelroad, QA/QI Specialist

Responsible Conduct of Research (Harvard Chan School)

This course meets requirement for trainees, fellows, participants, and scholars receiving support through any NIH training, career development award, research education grant, or dissertation research grant. Harvard Chan School’s, as well as other Harvard catalyst institutions’ graduate students, post-doctoral fellows, and junior faculty members may take the course without paying tuition and are expected to attend a minimum of six lectures, participate in class discussions, complete all case study assignments and the course evaluation. Visit the Office of Regulatory Affairs and Research Compliance website.  
  • Fridays, January 29 to March 12, 2021, 11:30 AM to 1:00 PM

University Research Management Meeting

Held bi-monthly and open to the sponsored research community across all schools. The focus of these meetings will be University-wide issues, initiatives, and updates. The meeting is optional, but you are welcome to attend, participate, and encourage colleagues to join. Questions? Contact Christina Kennedy.
  •  Wednesday, February 10, 2021, 2:00 to 3:00 PM, Agenda TBD. Register 
HMS Office of Research Administration publishes the RAD on Thursdays. Submissions are welcome for consideration. Forward research administration news, updates, and relevant trainings. Contact Christina Kennedy by end of day on Wednesday. To subscribe and reference past issues, visit ORA's website
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