ClinicalTrials.gov:  An Overview for Principal Investigators and Clinical Research Staff

Human subjects protections training, research conflict of interest training and disclosure, IRB application… 

As human subjects researchers, you have come to learn that these are among the few specific, unavoidable regulatory requirements that are just part of getting the job done.  If your research includes performing clinical trials (broadly defined!), then one other BIG, non-optional requirement is part of the list: ClinicalTrials.gov.

This public, online registry of clinical trials and their results, hosted by the Federal Government, is the subject of this month’s important presentation.  If you:

• Want to publish results of your study
• Secure NIH funding
• Avoid ridiculous potential fines (technically, as high as $10,000 per day! )

then you need to be well-versed in how to assure your study is compliant with existence of, mechanics of, and rules that require your study to be listed on the ClinicalTrials.gov website.

Jerri’s presentation to day will smooth the path for those of you unfamiliar with this, and will substantially broaden the knowledge and skills for those of you who already know about the registration system.

Join us for tasty sandwiches and an hour well-spent.  Pre-registration required.       

The seminar will be held in the Research Affairs main conference room from 12-1pm. Physicians attending this session will earn CME. 

You must register to receive credit and so we can have lunch ready for you.

Please click link to Register    

NOTE:  If you do register, please make every effort to attend, or contact us in advance, if you can, should your plans change. Seating is limited and we do maintain a waiting list. That will allow us to give you “ticket” to one of your research colleagues.

Thank you for your attention. We look forward to seeing you there.

A key goal of the institutional strategic plan for research, endorsed by the Board of Trustees, is to expand the population of faculty and clinicians involved in extramurally funded research. A mechanism that has been devised to meet that objective is to encourage faculty and healthcare providers from different backgrounds and capabilities to collaborate in the design of innovative, interdisciplinary research proposals.

Research Affairs is pleased to request applications for the 2017 Grants for Research and School Partnerships (GRASP) program. These awards provide support for new investigators from different schools to cooperate in pioneering research projects. GRASP is designed to be a training ground for collaborative partnerships with the goal of increasing the ability of new researchers to apply for extramural grants. More information is available on the GRASP webpage.

GRASP Letters of Intent due by Monday, September 18, 2017, 5:00 PM

GRASP Proposal Submissions due by Tuesday, October 10, 2017, 5:00 PM

Additional GRASP Programs Coming Soon!

In addition to the original GRASP program that has been in operation since 2010, three similar opportunities will be announced in the next few weeks. The new programs will encourage capable clinicians and specialists who do not have faculty appointments to pair with LLU faculty members and apply for support to conduct research. More detailed information will be provided in the corresponding Requests for Applications.

GRASP-MC: Like the original GRASP program, this mechanism requires two co-PIs. One must have a faculty appointment in an LLU school. The other co-PI must be an employee of LLUMC who is a non-MD healthcare provider or specialist with an advanced degree.

GRASP-FMG: Similarly, this mechanism requires two co-PIs. One must have a faculty appointment in an LLU school. The other co-PI must be an employee of the Faculty Medical Group who is a non-MD healthcare provider or specialist with an advanced degree.

GRASP-Intl: Like the above, this mechanism requires two co-PIs. One must have a faculty appointment in an LLU school.  The other co-PI must be an employee or faculty member of a Seventh-day Adventist healthcare institution, college or university outside of the United States.  The international co-PI must have an advanced degree or training in a specialty.

Stay tuned for additional information about these new GRASP opportunities!  

NSF Proposal & Award Policy Newsletter – March (sign up for mailing list - Policy Office website)

The Policy Office in the Division of Institution & Award Support at the National Science Foundation is pleased to announce the release of a new quarterly publication designed to provide information about upcoming changes and clarifications to policies and procedures that affect how you prepare and submit proposals and manage NSF awards.  The first issue of the NSF Proposal & Award Policy Newsletter is now available on the Policy Office website.

If you plan on submitting a grant to any funding agency please contact Cindy Dickson, x44571 or cdickson@llu.edu

From Grants.Gov Community Blog

Today, Grants.gov supports a growing community of applicants, grantors, and others interested in learning more about federal grant eligibility.

4 Ways to Learn Grants with Grants.gov [Video] https://youtu.be/bg2T_KQtSOA

If you plan on submitting a grant to any funding agency please contact Cindy Dickson, x44571 or cdickson@llu.edu

All informed consent documents/recruitment materials (for Full Board and Administrative submissions) marked-up with IRB reviewer’s comments will now be e-mailed to the PI/study contact as part of the review.  Contact us at x44531 or e-mail IRB@llu.edu if you have any questions or concerns about this. 

The IRB application forms below were revised on 2/16/17 to add questions about using materials that may require review by the Institutional Biosafety Committee.  Be sure to download the latest versions from the IRB Toolkit for Investigators to avoid delays in the approval process.  Contact us at x44531 or e-mail IRB@llu.edu if you have any comments/feedback.

• Clinical Trial
• Minimal Risk Studies
• Biospecimen Research

NIH’s Center for Scientific Review posted recordings of their most recent webinar series on peer review.

• 8 Ways to Successfully Navigate NIH Peer Review and Get a Fellowship Grant – covering things applicants need to know about the submission and review of a fellowship grant

• 8 Ways to Successfully Navigate NIH Peer Review and Get an R01 Grant – covering things applicants need to know about the submission and review of an R01 grant

• NIH Peer Review Briefing for Basic Research Applicants and Reviewers – covering NIH’s commitment to basic research and helping applicants and reviewers do their part in proposing and reviewing basic research

CSR is the portal for receipt and referral of NIH grant applications, and, for the majority of those applications, carries out the peer review process for assessing scientific and technical merit.

A number of NIH policies became effective in January. Here’s a brief recap:

Effective January 1, 2017:

Final Research Performance Progress Reports: As of January 1, NIH no longer accepts the Final Progress Report (FPR) form for most grants. Instead, grantees must provide final progress reports using the Final Research Performance Progress Report (Final RPPR) format, which is submitted electronically through a new eRA Commons module. Read more in the NIH Guide (NOT-OD-17-022) and Nexus, and read about the “Interim RPPR” further below.

Good Clinical Practice Training:  NIH expects NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials to have Good Clinical Practice (GCP) training. As long as steps are being taken to meet the policy expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be completed after the Jan 1, 2017 effective date. See last month’s Nexus for help identifying training opportunities.

Effective January 18, 2017:

Clinical Trial Reporting Requirements: NIH expects investigators conducting clinical trials (funded in whole or in part by the NIH) to ensure that these trials are registered at ClinicalTrials.gov within 21 days of first-patient enrollment and that the results information from these trials is submitted to ClinicalTrials.gov within one year of trial completion. NIH’s policy complements a new federal regulation to improve the accessibility of information on clinical trial availability and on the outcomes and results of completed trials. Read more on the Open Mike blog and in updated FAQs.

Effective January 25, 2017:

Application Appendix Materials: NIH eliminated most types of appendix materials for grant applications intended for due dates on or after January 25.  Applications will be withdrawn if they are submitted with appendix materials that are not specifically listed in NOT-OD-17-035, or specified in the specific funding opportunity announcement to which you are applying.

Post-submission Materials: NIH clarified the types of materials that can be submitted due to unforeseen events after submission of the grant application but prior to the initial peer review. The consolidated post-submission materials policy also makes changes related to how publications that have been accepted for publication should be communicated as a post-submission material (form and content), post-submission materials for training and fellowship applications, and the timing of post-submission materials submitted to the final due date of a Request for Application (RFA). For details, read more in the NIH Guide (NOT-OD-16-130).

Updated Application Font Guidelines: NIH updated its recommended font list and no longer requires that black text be used within grant application attachments. Read more in the NIH Guide (NOT-OD-17-030) NIH Guide.