SODM Research Newsletter
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 email@example.com.
KL2 Scholars Mentored Career Development Opportunity
Qualified candidates are being offered an opportunity to apply to an innovative career development program whose purpose is to train clinician investigators interested in multidisciplinary clinical research. The CTSC KL2 is designed to train the nation’s future leaders in clinical and translational research, and is part of the NIH Roadmap aimed at “re-engineering the clinical research enterprise.” Each scholar will embark on a 4 year program of intensive training in multidisciplinary team-based, patient-oriented clinical research, combining an innovative curriculum with mentored research experiences.
- Hold an M.D., Ph.D., D.D.S., Pharm.D., Psy.D. or an equivalent doctoral degree
- Have demonstrated a keen interest in clinical research
- Must have a desire and commitment to learn how to work with scientists from different disciplines
- Must incorporate multiple perspectives into research plan and methods that reflect an alternative to their own training
- Need to hold a position in one of the CTSC partner Institutions on or before May 1, 2019
- Are U.S. citizens or have permanent resident status
- Applications are encouraged from physicians, nurses, dentists, social and behavioral scientists, engineers, biostatisticians, epidemiologists, bioethicists and other professionals with expertise relevant to clinical research.
Please see the KL2 website for more information and application instructions. Letters of Intent are due by August 12, 2019 for the May 2020 program year.
HIPPA and Compliance Refresher
As we approach a new academic year, it’s a good time to make sure everyone is aware of the policies and regulations that involve our patients, academics, and research.
We encourage you to join us on Wednesday, July 17, 2019 from 12-1pm in the Samson Pavilion, 139 for a presentation on University policies and regulations regarding HIPAA and compliance issues.
Kimberly Volarcik, Research Compliance Officer and Executive Director of the Case IRB and Andy Jarrell, Associate University Compliance and Privacy Officer, will present an overview of these important topics, address common issues that arise in the University and the SODM, and answer any questions you may have. The session will be geared towards faculty and staff, but students are welcome to attend as well.
RSVP to firstname.lastname@example.org by Friday, July 12. Please feel free to send your questions for the presenters early to be sure they are addressed.
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.