SODM Research News
In an effort to unclutter your inboxes, the SODM Research Newsletter will no longer be emailed to your inbox. Instead, up to date information can be found on this page. Time-sensitive or urgent notices will continue to be sent via email as well as posted. You can always look back at previous newsletters and archived items.
As always, please feel free to direct any questions or concerns firstname.lastname@example.org.
Updates on COVID-19 and Its Impact on Research
As updates and guidance specific to research are made available, we will do our best to post the information here. If you have specific questions about your research, please contact Tricia Ribeiro at 368-7573 or email@example.com.
With the rapidly changing situation, there are a number of sites serving as hubs for information. Please check these sites for the most up-to-date info.
Case Western Reserve University Sites
CWRU has a central site for all information that has been shared University-wide. Please check there first, as it will most likely be the first one updated: https://case.edu/studentlife/healthcounseling/health-services/health-updates.
The Office of Research and Technology Management (ORTM) has created a site that is being updated with the latest information specific to research: https://case.edu/research/about/hot-topics/coronavirus-and-your-research-program.
Human Resources (HR) has created a website with FAQs regarding the transition of most employees to remote work: https://case.edu/hr/faqs/covid-19-and-work.
NIH Coronavirus Information Hub: https://grants.nih.gov/grants/natural_disasters/corona-virus.htm
PCORI Applicant and Awardee FAQ: https://www.pcori.org/funding-opportunities/applicant-and-awardee-faqs-related-covid-19
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Guidance Specific to Research in the SODM
Below are links to guidance that is applicable to active projects in the SODM. Other sponsors have posted information as well. Links to that information can be found on the ORTM site noted above.
3/30/2020: Due to the rapid changes and notices, please see the sites listed above for the most recent information. Any info that is not reflected in the links above will be posted here if needed.
3/19/2020: The OMB has issued Memo M-20-17 which clarifies the flexibilities allowed to federal granting agencys in assisting their awardees.
3/17/2020: Email on Research Restrictions and Additional Guidance from Dr. Sue Rivera, Vice President for Research and Technology Management.
3/13/2020: NIH Guidance on Travel and Meetings
This guidance addresses a number of administrative questions that have come up with regards to NIH projects.
3/12/2020: NSF has developed a new website for the research community with detailed guidance on the Coronavirus (COVID-19). This includes guidance for awardee organizations, researchers and reviewers of NSF proposals. Please note that this website will be updated as new developments arise.
3/11/2020: Diane Domanovics, Assistant Vice President for Sponsored Projects, sent the information below in an email to the Research Directors of all the schools. That email in its entirety has been posted below for your information.Good Afternoon:
Guidance for the federal agencies has be issued from OMB, thought I would share the attached. Also, listed below is some helpful information you may be interested in regarding COVID-19. Stephanie (Endy, Associate VP for Research) is also maintaining a website which includes helpful information and it can be found here - https://case.edu/research/about/hot-topics/coronavirus-and-your-research-program.
Feel free to share this information as appropriate. If further information is provided, I will send along.
NIH LATE APPLICATION POLICY Due to Public Health Emergency for United States for 2019 Novel Coronavirus (COVID-19)
General Frequently Asked Questions (FAQs) - Proposal Submission and Award Management Related to COVID-19
Specific Funding Opportunities relating to COVID-19
NIH - Notice of Special Interest (NOSI) regarding the Availability of Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus (2019-nCoV)
NSF 20-052 - Dear Colleague Letter on the Coronavirus Disease 2019 (COVID-19)
How to UCITE: Nord Grants
UCITE Director Matthew Garrett will share ideas to help faculty translate innovative teaching and learning projects into Nord Grant proposals at an event on Friday, March 6, from 12:45 to 2 p.m. in the Herrick Room of the Allen Memorial Medical Library. Nord Grants are one-year awards which support UCITE’s goal of empowering people to learn through the development of innovative faculty teaching and research projects that directly benefit student learning. Projects may be created by individual faculty members or in collaboration with others, including members of educational and cultural institutions external to CWRU. Pizza and sodas will be provided. To register, please email firstname.lastname@example.org.
NIH Regional Workshop on Sexual and Gender Minority (SGM)-Related Health Research
The NIH FY 2016-2020 Strategic Plan to Advance Research on the Health and Well-Being of Sexual and Gender Minorities includes goals and objectives that aim to increase and improve SGM health research supported by NIH. Goal Three of the strategic plan is to Strengthen the Community of Researchers and Scholars Who Conduct Research Relevant to SGM Health and Well-Being. To achieve this goal, in part, the SGMRO will host this regional workshop in SGM health research to build capacity within the extramural research community.
The goals of the Regional Workshop are to increase understanding of the NIH structure and processes, encourage mentoring relationships within the extramural research community, enhance capacity to conduct SGM research, and provide researchers with the opportunity to interact with NIH staff and established researchers in SGM health. The Regional Workshop is being held on April 2, 2020, in collaboration with Equitas Health and The Ohio State University in Columbus, Ohio.
To learn more and register, please visit https://dpcpsi.nih.gov/sgmro/regionalworkshop. The workshop is free to attend but space is limited.
Get Help to Get Funded!
Would you like some help finding research funding? Let the Office of Research and Competitive Awards Development help with the process from identifying potential sponsors and program announcement to application preparation and submission. The office, led by James Southworth and Sally Garrett-Kayro, focuses on non-federal research sponsors and has already helped quite a few SODM faculty submit and are ready to help you too! You can review a presentation they recently gave to the SODM Faculty Research Committee that provides some details on their office and their goal of increasing non-federal research dollars to campus.
Research ShowCASE - Share Your Work and See What's Happening
The CWRU Office of Research and Technology Management invites you to participate with other CWRU faculty, staff and students by presenting your work at Research ShowCASE 2020 on Friday, April 17, 2020 from 9:30am-3:00pm in the Veale Convocation Center.. The event will provide an opportunity for CWRU researchers to display your research in a traditional scientific poster or other creative means. We encourage University Hospitals, Cleveland Clinic, MetroHealth Medical Center and the Louis Stokes Cleveland VA Medical Center researchers to participate.
In addition to the opportunity to display and share your work, undergraduate and graduate students, professional students and postdoctoral scholars are encouraged to participate in the research competition, which will include having your presentation evaluated and feedback provided. Cash prizes will be awarded to winning entries.
In order to display your work at Research ShowCASE, you will need to submit an online abstract describing your research. If you are a student or post-doc, your faculty adviser will need to approve your submission.
Registration is only required if you would like to present your work. No registration is needed to attend the event.
DEADLINE EXTENDED! Submit Your Abstract by Sunday, March 1 (11:59 pm)!
Graduate and professional students, post-docs, faculty, staff and affiliates
Submission dates: Now through February 16, 2020
Submission URL: https://case.edu/research/research-showcase
Submission dates: February 1 through March 20, 2020
Submission URL: https://case.edu/source/share-your-work/present-at-intersections.
High school students working with CWRU researchers
Submission dates: Now through March 20, 2020
Submission URL: https://case.edu/research/research-showcase
Unified Search Tool
A Unified Search Tool has been launched to assist faculty in finding additional funding opportunities, research events, and professional development opportunities. The site can be found at cwru.inforeadyscale.com. If you would like to publicize a funding opportunity, research event or professional development please send an email to email@example.com.
Spring 2020 Educational Offerings
The Office of Research and Technology Management has posted their schedule of courses/seminars for Spring 2020. Take a look at what's coming up here and learn something new or brush up on old skills. Registration and a full schedule of courses (including some at UH) can be found on the ORTM Research Events Calendar.
Biomedical Innovation and Entrepreneur Club
The Biomedical Innovation and Entrepreneurship Club (BIEC) is a casual happy hour hosted monthly by the School of Medicine Office of Translation and Innovation to inform and inspire students, staff, post-docs and faculty. The focus is biomedical innovations, and the events include one hour of casual discussion with an expert, plus one hour of networking and happy hour food and beer. These are hosted on campus and free to all.
Examples of our previous events: technology transfer and licensing, LaunchNet and ThinkBox, alumni entrepreneur panels, innovation symposium
Take a look at the listing of upcoming events and see what looks interesting!
Case-Coulter Translational Research Partnership Funding Opps
The Case-Coulter Translational Research Partnership (CCTRP) has announced that it is accepting applications for its 2020 pilot and full funding programs. The CCTRP seeks to reduce the market risk of promising new clinical products arising from the research programs of BME and affiliated Case faculty. Successful projects will thus often focus on the development of prototype products, building relationships with companies, performing clinical feasibility studies, obtaining regulatory approval, and other activities that companies or business experts indicate are the essential last steps before a license can be negotiated or a startup launched.
The CCTRP awards funding at 2 different levels, pilot and full projects:
Pilot projects up to $25,000 can be applied for on a rolling basis but will be considered quarterly. Pilot projects will typically be for a six-month period with specific milestones defined with the intent of participation in the annual full Coulter award cycle. Apply using the same instructions with a focus on the necessary steps that will position PI for a successful full CCTRP application the following year. The individual component sections can be scaled back, but the PI is responsible for making his/her case. There are no CCTRP OC presentations for pilot projects.
Full projects will typically be for an initial one-year period with specific milestones defined on a quarterly basis; in special circumstances, proposals can span more than one year but must be approved prior to submission. Continuation and renewal applications will be evaluated on a competitive basis with new applications, and must have a comparison of milestones achieved vs. those planned in the original award. An important part of the proposal is the commercialization opportunity and the idea or vision for the end product. Examples of preferred future outcomes include inventions, patents, improved diagnosis and treatment of disease, commercial products, licenses, commercial partnerships and start-up companies.
Reminder! Understand the SODM Business Meals Policy
The SODM Office of Finance and Administration has issued a reminder regarding the reimbursement of local meal expenses using University funds. This same policy also applies to meals charged to sponsored projects funds.
In the majority of cases, local meal expenses (meaning meal expenses incurred while an employee is not on travel status) are unallowable. Such expenses would only be permitted if the meals were specifically requested in the project budget and approved by the sponsor. It is extremely uncommon for meals to be allowed on research projects. Other projects, such are large clinical trials, conference grants, or training grants may include a component that allows for local meals.
If you are unsure or have questions about the allowabilty of an expense on a sponsored project, please contact Tricia Mehosky Ribeiro. As with meal expenses billed to non-sponsored speedtypes, if an expense is determined to be unallowable on a sponsored project speedtype, it will be moved to the project's cost share.
CRSP 401 – Introduction to Clinical Research Course Announcement
The Office for Education in Clinical Research is accepting applications for CRSP 401 “Introduction to Clinical Research”. Course schedule is July 6 through July 24, 2020, Monday, Tuesdays, Thursdays, and Fridays from 8:00 a.m. – 11:00 am, and Wednesdays from 9:00 am – 12:00 pm.
Application forms, details, and step-by-step instructions are posted here. This course can be taken for credit or as a Non-Degree Clinical Research Fellow (Non-CRF) for no credit.
Contact firstname.lastname@example.org with any questions or concerns.
Linking eRA Commons Profile to ORCID
The NIH Office of Extramural Research encourages everybody from graduate students to senior scientists to register for an ORCID account and link it to their eRA Commons personal profile. Starting October 1, 2019, ORCID identifiers will be required for individuals supported by institutional research training, career development, and other research education awards. xTrain appointments will not be accepted for agency review if potential appointees do not have an ORCID iD linked to their eRA personal profile. ORCID iDs will also be required for PD/PIs on individual fellowship and career development applications submitted for due dates on or after January 25, 2020.
HIPAA and Compliance Refresher (Slides posted below)
Representatives from the CWRU IRB Office and the Compliance Office recently presented a HIPAA and Compliance overview to SODM faculty, staff, and students. If you missed the event, please feel free to take a look at the slides from the IRB Office and University Compliance.
Updated Fringe Benefit and F&A Rates for FY2020
The Office of Research Administration has announced new fringe rates for fiscal year 2020 (July 1, 2019 - June 30, 2020). Beginning July 1, the federal fringe rate decreases to 32%. The non-federal rate remains at 33% and the term rate increases to 18.5%.
As a reminder, the negotiated F&A rate will increase to 61% for FY2021 (July 1, 2020 - June 30, 2021).
Please be sure to use the updated rates for all of your sponsored project budgets.
Details of all University Rates can be found on the Commonly Requested Info sheet posted by ORA.
NIH Salary Cap Increases Effective January 6, 2019
The NIH has announced that the salary cap for grants and cooperative agreements increased from $189,600 to $192,300. The new higher limit will apply to awards issued after January 6, 2019. As budgets are prepared, please be sure to use the updated salary cap. The budget templates available on our site allow for the user to manually update the cap used.
For more information, see the full announcement at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-099.html.
Information on Submitting an NIH RPPR with Human Subjects
If you are PI on an NIH-funded project that involves human subjects, you already know that the NIH implemented the Human Subjects System (HSS) last year as a way to obtain more details about planned studies during proposal and timely information about subject enrollment.in active projects. With this change in system, PIs who have submitted RPPRs in the past year have had to take an extra step in order to update their enrollment data by going outside of the NIH Commons to ASSIST system. Until now, there's not been much guidance on how this needs to be done.
In late January, the NIH posted more information on this process that includes instructions. Please review the NIH eRA blog posting to ensure that all of the needed data gets to the NIH with your RPPR.
Implementation of Revised Common Rule
The Common Rule governs all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that chooses to implement these regulations. The Common Rule is published in the U.S. Code of Federal Regulations in Title 45 Part 46. In 2017, the Common Rule was revised and after numerous delays, it will go into effect on January 21, 2019. Any new study approved on or after that date will have to comply with the new regulations.
The biggest changes involved the Informed Consent and Continuing Reviews. There are other changes that may not present as large an impact on our researchers, but should be reviewed by the research community.
More information on the revised Common Rule, its implementation, and its impact on human subjects studies on campus can be found on the Office of Research and Technology Management's informational page.
Additionally, University Hospitals is offering sessions to give an overview of the changes and how they will impact research. While these sessions are geared to UH researchers, the information about the Common Rule is applicable to all researchers. Sessions will be held on Tuesday, January 22, Friday, January 25, and Tuesday, January 29. Registration information for these and other sessions can be found at the CWRU Research Events Calendar website.
New Requirement for IRB Protocols that involve UH Patients and/or Data
Update 12/19/2018: UH has issued a new guidance memo regarding this policy stating that rather than requiring the overall IRB PI to be changed to the UH PI, the Case investigator may remain as the overall PI, but a UH-affiliated person must be listed as the Site PI. This appears to eliminate the need for changing everything - protocol, consent forms, contact info, etc. - to reflect a new PI.
You can read the full memo for more details of the change. Please direct any questions to the UH IRB office at 216-844-1529.
Update 11/19/2018: UH has extended the deadline for this policy until December 31, 2018 per their recent memo. As noted, CWRU and UH are having ongoing discussions regarding the best ways to implement this policy. If you have questions, please contact Tricia at 368-7573 or email@example.com to discuss the process.
Update 10/26/2018: There are a number of faculty who have admitting/clinical privileges at UH who have asked if those privileges are sufficient to be considered a UH PI by the IRB. According to Beth Hagesfeld, Manager of the UH IRB, these alone do not necessarily satisfy the UH IRB's requirement to be considered to a UH PI. However, their office is willing to consider specific situations and possibly approve exemptions.
In addition to questions regarding status, the UH IRB office also has some How-To Guides that will help facilitate the process of updating study documents (consents, protocols, and anything else that mentions the name of the PI) if a PI change is needed. Please contact the UH IRB office at 216-844-1529 to request those.
Original post 10/25/2018: In an emailed memo sent on October 25, 2018, the University Hospitals Clinical Research Center has announced that any study that uses UH patients or accesses UH data will be required to have a UH PI listed in the SpartaIRB system. This requirement is applicable to both new protocols and currently approved studies. All currently approved studies must submit an amendment to identify a UH PI and revised study documents, as applicable, by Thursday, November 25, 2018.
Questions can be directed to the UH IRB Administration Office at 216-844-1529. The memo regarding the changes can be found here.
**We are in the process of confirming with the UH IRB Office what their standard is for "UH PI". As many of our faculty have admitting/clinical privileges, it's unclear whether this is sufficient to be considered a UH PI with regards to the IRB protocol. As soon as we confirm these details, the info will be posted here and forwarded via email. In the interim, please feel free to contact Tricia Ribeiro by email or at 368-7573.
NIH Online Training and Information
The NIH offers lots of content to answer your research questions. While there are numerous options, a few that may be of interest are:
- Introduction to the Principles and Practice of Clinical Research: Training on the safe, effective conduct of Clinical Research. The course focuses on the spectrum of clinical research and the research process by highlighting biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more.
- Grant Application How-To and Tips for Success Video Series: Quickly learn how to access application forms, ensure your application is a good fit for an announcement, and make an important final check of your application after submitting.
- Protecting Human Research Participants: Though as of September 2018 the NIH has discontinued the formal training program, archived content is available for review. Please note that if you are looking to obtain certification in human subjects protection, CWRU offers the CITI program. More information on available training and obtaining credit can be found on the CREC website.
- All About Grants Podcasts: Interviews by and between NIH staff members discussing the ins-and-outs of the grant process.
Reminder Regarding Conflict of Interest Disclosures
As you may have seen in the October 10th edition of The Daily, the University is asking that everyone involved in research, no matter the funding source, ensure that their financial conflict of interest disclosure is up to date. Disclosures are required to be submitted annually, usually in the first few weeks of the calendar year. However, if there is any new information that needs to be added during the year, the disclosure should be updated through SpartaCOI.
There have been a number of new offerings on campus for research education as we kick off the new academic year. Topics include research administration, financial processes, IRB issues, and more! Check out the following links and register today!
- CWRU Research Events Calendar: Main listing and registration site for CWRU and UH training.
- CWRU Administrative Professionals Series (CAPS): This program covers sponsored projects, financials, travel, and other areas of core University processes in short sessions. Most are in-person classes, but a few are now online. There is an option of obtaining a certificate if the full curriculum is completed.
- Professional Development Series: Offered by CWRU HR, classes aim to advance individual and team performance.
UH Updates CREC Requirements
Beginning on September 15, 2018, UH will now require anyone listed as part of the Study Team on an IRB application/protocol must have a current CREC (Continuing Research Education Credit) certification before the approval can be made. Prior to this, the UH IRB only required that those involved in consenting subjects have this certification. The change brings the UH process in line with the CWRU process, which has always required a valid CREC certification for all members of a Study Team.
Initial CREC certification must be obtained via the CITI Basic Course and continuing certification is maintained by obtaining 12 credits within a 3 year period.
More information about CREC certification can be found on the CREC website.
Current certification status can be reviewed in Spiderweb. Log in with your Case ID and password and click on the "COI/CREC Summary" link in the left side menu. You will see a summary of dates of certifications and renewals. To see expiration dates and current credits, type your last name in the Search field and click the "Search" button.
Reminder! F&A Rate Will Increase in FY2021
As you prepare budgets for grant applications, please be sure to remember that the F&A rate will increase from 60% to 61% effective July 1, 2020. This means that as you create multi-year budgets, it may be necessary to change the F&A rate mid-project, and at times, mid-year.
Please be sure to review your budgets carefully to ensure you have calculated the budgets correctly. You may need to manually update budgets when using Sparta to create SF424 budgets as Sparta cannot support different F&A rates in the budget module. If assistance is needed in determining the correct F&A line, please direct any questions to Tricia Ribeiro.