How to Assist and Manage Grant Applications
The following case scenarios are to assist you in thinking how challenges in applying for a grant could be handled effectively. The cases provide useful tools and resources for mentors and mentees to successfully build on their grant portfolio.
- Support for mentoring: K24 and other awards
- Are there benchmarks to review before applying for K24 awards?
- Initial grant steps for mentees
- UCSF career development awards
- NIH career development awards
- Developing a strong career development plan for a mentored K award application
- CTSI resources for K awardees
- NIH diversity support
- The score is close but not close enough
- "Early stage investigator"—NIH incentives for new investigators
- NIH application mix up—what to do?
- NIH application mix up—application reviewed in the next cycle
- Support for senior researchers—method to extend research in time awards
- UCSF Center for BioEntrepreneurship (CBE) and government small-business grants
- Funding for care expenses during conference travels
- Deficient proposal for pilot funding
- Already fully funded faculty member is asked to help with department grant application for a center grant
- Mentee needs chair support for K application
- Mechanisms to assist first-time applicant success
- Explaining personal circumstances
- NIH K award success rates
- Moving forward after R01 application fails
- Mentee transitioning to educational research
- Support for travel to a conference
Case Scenarios: IRB Pitfalls and Solutions
The following case scenarios provide examples of common problems experienced by researchers applying to the CHR and guidance for meeting the requirements of the IRB and minimizing delays in the approval process. The cases also provide useful advice and resources for mentors and mentees to successfully navigate the IRB approval process.
- When to apply to the Committee on Human Research—just in time?
- Concept of "information risk"
- Expedited applications for international research
- Dueling institutional review boards
- Committee on Human Research Application: a stitch in time saves nine
- Use of pre-existing data and specimens
- Data and safety monitoring plans
- Conflict of interest
- IRB approval for international rotations
- Does mentee need patient consent for an observational trial?
How to Assist and Manage Grant Applications
Support for mentoring: K24 and other awards
You have completed the UCSF CTSI Mentor Training Program, have been asked to increase your mentoring of young investigators—but no one has discussed support for this time. You heard about applying for a K24 the Mid-Career Investigator Award in Patient Oriented Research. Who could help? What resources are available where and when?
Are there benchmarks to review before applying for K24 awards?
The library of successful K24 applications is great, but what are some of the reasons given when applications are unsuccessful? Are there any benchmarks as to how much current/prior funding, how many mentees, etc. one should have before applying for this award?
Initial grant steps for mentees
Your mentee has been productive with secondary data analysis and writing manuscripts but has not obtained any prior funding. Where should they start?
UCSF career development awards
Your Mentee has been successful with manuscripts, and intramural awards to obtain pilot data, and now is ready to try for a Career Development Award. What are the UCSF Career Development Awards that are available?
NIH career development awards
Your Mentee has been successful with manuscripts, and intramural awards to obtain pilot data, and now is ready to try for a NIH grant. What resources are available?
Developing a strong career development plan for a mentored K award application
Your mentee submitted a mentored K award application (K01, K08, K23) but did not receive a fundable score. Reviewers liked many aspects of the research plan but criticized the career development plan as weak.
CTSI resources for K awardees
Your mentee has received a K23 or K08 award. Are there campus resources for him/her?
NIH diversity support
Your mentee may qualify as an underrepresented minority or from a disadvantaged background. Who qualifies and what is available from the NIH?
The score is close but not close enough
Your mentee sent in a K23, received a 150 (old scoring but concepts are the same) but according to the project officer funding appears to be at 145. What now? Who do you know to call at the NIH? What other senior mentors might know colleagues at that institute? Is calling a good idea? Have you called in the past for yourself or others? How could you support your mentee?
"Early stage investigator"—NIH incentives for new investigators
Your mentee wants to apply for new investigators incentives provided by the National Institutes for Health. What is this new policy? And who qualifies?
NIH application mix up—what to do?
Your mentee submitted a K application and earmarked for NIH Institute X after plentiful pre-submission discussion with Program Official at NIH Institute X. However, the application was supposed to be reviewed but your mentee was informed that it had inadvertently been routed to the NIH Institute Yto see if they were interested. Because of this, the application was not reviewed and was placed into the next cycle.
NIH application mix up—application reviewed in the next cycle
The application of your mentee was not reviewed and was placed into the next cycle. Within the cycle the application was reviewed. Priority score 143 (old scoring but the concepts are the same). The program official states that in the past K awards were funded within the range from 150 to 160. The funding decision, however, cannot be made final because this has to go into the next fiscal year funding pool because of delay. The NIH Institute XCouncil meets to review the priority scores and resets the K Award payline at 140. Your mentee is told to resubmit his application. Should the lead mentor send a letter of complaint?
Support for senior researchers—method to extend research in time awards
What is a Method to Extend Research In Time (MERIT) award? How do I get one?
UCSF Center for BioEntrepreneurship (CBE) and government small-business grants
Your mentee is interested in early-stage Research & Development funding. What sources would you recommend?
Submit your case or comment: We are interested in your strategies and experiences on what works or is less helpful.
Funding for care expenses during conference travels
Your mentee would like to attend a national or international meeting, but s/he is with significant elder care responsibilities. S/he asks you whether you know any funding opportunities that support care expenses while faculty travel to conferences.
Deficient proposal for pilot funding
Your mentee has a pilot project idea of a randomized controlled trial to test a new behavioral intervention and has written up a basic study proposal. She has had some basic research methods training (summer Designing Clinical Research course at UCSF), but has not taken any advanced coursework. She is able to secure some internal funds to support this pilot study and asks you for your help in submitting the project proposal. You review her 2-page proposal and find many areas of deficiency with the study design, sampling, randomization, and blinding. Where can you direct your mentee for additional help in refining her plan?
Already fully funded faculty member is asked to help with department grant application for a center grant
A faculty member is fully funded with NIH grants. A department decides that they wish to put an application together for a center grant. The department decides its faculty member is needed to help them get this grant and "requires" the faculty member to write the grant even though the faculty member has no effort to do this.
Mentee needs chair support for K application
Dr. Bright is in the last year of her fellowship and planning on a career as a clinician-scientist doing clinical research. She has been very productive and is ready to submit a K award. She needs institution support for her application but your Department Chair is not ready to make the commitment. What can be done to help this productive researcher to realize her goal?
Mechanisms to assist first-time applicant success
My mentee is a new investigator—aren't there mechanisms to assist first time applicants to be successful?
Explaining personal circumstances
How do I explain personal circumstances that may have reduced my productivity?
NIH K award success rates
What is the success rate for NIH K awards?
Moving forward after R01 application fails
You are mentoring someone who is a successful Associate Professor who has built up a research program in an independent fashion. She has plenty of top journal articles, superb productivity and findings on pilot funding, and has received solid reviews on an R01 that logically flows out of the journal articles and the pilot grants. The score is very close and she doesnt get funded. Her previous NIH grants were funded and she has a solid track record at NIH.
The Program Officer at NIH was wholly supportive of the R01 submission all the way through the process but after this, the PO now tells her to scale back to an R21 because the project is "too innovative" to be an R01. Scaling back to an R01 at this point feels odd to the mentee given the large pilot progress and publications—and this news seems to squelch the hopes of the mentee receiving of an R01 in this research area that she's worked at for a long time.
How to advise the mentee to move forward and also to not lose all hope?
Mentee transitioning to educational research
Your mentee, who has several publications and who has successfully competed for a few small local awards now expresses an interest in transitioning from clinical research to educational research, as that is where she would like her career to head. Do you encourage her? What UCSF resources are available for educational research?
Support for travel to a conference
Your mentee is going to present at a conference. Are there funds available for travel?
Case Scenarios: IRB Pitfalls and Solutions
When to apply to the Committee on Human Research—just in time?
Your mentee is in the final stages of writing his/her first grant application for the National Institutes of Health (NIH). While completing the face page and the "Human Subjects" section at the end of the grant application, s/he panics because s/he has not yet filed a Committee on Human Research (CHR) application for the project. What do you advise?
Concept of "information risk"
In a study of an experimental marker for congestive heart failure, subjects will have a blood draw sent for Brain Naturetic Peptide (BNP; a test for congestive heart failure) and the new marker. The risk section of the Institutional Review Board (IRB) application and consent form mentions only "Risk of blood draw includes pain, bruising, etc." The Committee on Human Research (CHR) sends the application back with a contingency that your mentee explains which, if any, test results will be given to the subjects and whether that constitutes a risk. How would you help?
Expedited applications for international research
Your mentee consults with collaborators in Brazil to develop a case control study of HIV risk factors that will use a questionnaire to ask about sensitive risk behaviors (e.g., sexual behavior and injection drug use). You direct him/her to read the Committee on Human Research (CHR) flow diagram and see if they need to submit a "Full Committee" application because of the sensitive information risk, noting that the local IRB in Brazil will also approve the study.
Dueling institutional review boards
Your mentee is excited to be the newly-chosen Principal Investigator of the UCSF clinical site of a multi-center clinical trial. The protocol has been submitted to the coordinating center's Institutional Review Board at the University X in another U.S. city, and "boilerplate" consent forms have been provided to each clinical site. Your mentee wonders whether s/he needs to seek local Committee on Human Research (CHR) approval, and frets that any changes mandated during the CHR review will conflict with the central protocol.
Committee on Human Research Application: a stitch in time saves nine
To save time, the junior faculty cuts and pastes text directly from their NIH grant application into their CHR application. The result is that the background section of the CHR application is way too long (5 pages instead of 1 to 1.5 pages) and includes nonsense sentences due to faulty cutting and pasting, all of which irritated the Committee on Human Research (CHR) member who sent the application back to your mentee with multiple contingencies. What could the mentor advise his mentee?
Use of pre-existing data and specimens
You mentee wishes to evaluate prevalence of anemia in his/her clinic population. A computerized lab system makes it easy to obtain serial Complete Blood Count (CBC) measurements. Your mentee wants to know if Institutional Review Board approval is needed and if so, what level of review would be appropriate.
Data and safety monitoring plans
Your mentee is preparing a grant application and is puzzled by the requirement for a "data and safety monitoring plan" section. S/he is preparing a grant for a prospective cohort study of estrogen use, not a clinical trial. What can you advise regarding the content of the data and safety monitoring plan?
Conflict of interest
Last year, your mentee received a small grant from a company to study aspects of hepatitis C virus (HCV) in the laboratory. Now the company announces a new recombinant vaccine for HCV and launches a series of Phase 1 trials of the vaccine. Your institution is chosen as a site, and your mentee plans to enroll his Injection Drug Using (IDU) clinic patients into the trial. Does s/he need to worry about a conflict of interest?
IRB approval for international rotations
A second-year resident who is your research mentee wants to do a simple study during her third-year international, clinical rotation in collaboration with a PI at the host institution. It is a cross-sectional survey assessing the needs of patients for expanded clinical care in your research area. She obtains permission from the PI to do the study three months before her rotation begins and has not yet submitted any CHR paperwork. How would you go about mentoring her?
Does mentee need patient consent for an observational trial?
Your mentee would like to perform a "natural" clinical trial where the decision to administer EPO in patients at risk for developing post-surgical anemia rests upon insurance/self payment coverage. Since this is a purely observational study where investigators are not controlling who receives treatment, and are not altering current data collection protocols, is it necessary to consent patients to participate in this prospective study?