Clinical Investigator Award: Frequently Asked Questions 

Background:  In 2007, the Society of Surgical Oncology established the Clinical Investigator Award (CIA) Program with the goal of promoting post-fellowship, patient-oriented research through the training of surgical oncologists in clinical and translational science. Each Award consists of $100,000, disbursed in two yearly installments of $50,000. To date, twenty-eight Clinical Investigator Awards totaling more than $2.8 million dollars have been granted to researchers.  

Besides SSO, the Awards have been generously supported by educational grants from the following organizations: 

• Genentech
• Amgen
• AstraZeneca

• Sanofi Aventis
• Susan G. Komen for the Cure®
• Myriad Genetics

Beginning with the 2013-2015 awards cycle, the administration and management of the CIA program has moved under the auspices of The SSO Foundation, (formerly the James Ewing Foundation), including the solicitation of the CIA grant funding and support.

Questions and Answers

Q: What are the timelines for the Clinical Investigator Award cycles?

Spring:

• Surgical Oncology Research Proposals due in early January.

• Award winner(s) notified at the Annual Cancer Symposium

• Two-year Grant cycle begins April 1, ends on March 31.

• Second-year installment payments are released after mid-term reports are submitted.

Fall (if cycle is applicable):

• Research Proposals due in early July.

• Award winner(s) notified in early September.

• Two-year Grant cycle begins October 1, ends on September 30.

• Second-year installment payments are released after mid-term reports are submitted.

Q: Regarding the percentage of effort required to complete the research project, is this 25% overall, or per year?

A: In past years, award recipients were required to commit a minimum of 25% effort per year for the two-year grant.  Effective Spring 2014, it is no longer necessary for the applicant to commit at least 25% effort to the research project this award will support.  Time committed should be reflected in the research proposal budget and will be taken into consideration as part of the overall assessment of the project.

Q: I am both the applicant and the PI on the project. Can my time be unpaid, or at least partially? 

A. Yes, you may designate effort on the CIA that is funded by another source (which should be declared).

Q: What is the preferred formatting of the Proposal?

A: Recommended composition of CIA Research Proposal:

  • Cover Page - 1 page
  • Bio sketch - 3 pages
  • Supporting Letters - 4 pages
  • Literature References -1 page
  • Abstract, Research Plan & Training Environment - 8 pages
  • Budget -1 page
  • Appendix - up to 5 pages

Note: Applications that exceed the page limitations will not be reviewed.

Q: What is the average number of applications submitted? How many CIAs are awarded each year? 

A: The number of submitted applications range from four to twenty submissions per year. In recent years, the SSO Foundation has funded two proposals per year.  The number of proposals that are funded each year is based on the level of industry support received.

Q: Am I eligible to apply for a Clinical Investigator Award Grant if I am not yet a member?

A: An applicant must be a full SSO member for at least 6 months prior to proposal submission to be eligible for the CIA award.

Q: Am I eligible to apply for a Clinical Investigator Award Grant if I have been previously awarded a CIA grant?

A:  Yes, previous CIA awardees may submit a proposal for consideration.  

Q. I am a SSO member from Canada.  Can I apply for this grant?

A: Yes, international members are eligible to submit a proposal for the award.

Q: I currently have a K award. Am I eligible to apply for this grant?

A: Yes, you would be eligible to submit a proposal for the award.
 
Q: I am a pediatric neurosurgeon who runs a basic science research program/ laboratory. I study cancer stem cell populations in brain tumors, and much of our research focus is translational and all of it is patient-based. However, this work would not be ready for immediate clinical trials, but may involve discovery of targeted molecular therapies for brain tumors/drug discovery. Please advise if this work might be eligible for CIA funding. 

A: The CIA requirements state that the proposed research needs to be intimately linked to a clinical trial, and in which the applicant plays a central role in the conduct of a specific clinical research project. This might include a leadership role in a cancer trial, in cancer outcomes research, or a translational research project related to a prospective clinical trial.  The clinical research focus must be hypothesis-driven and must have a direct patient-oriented focus.  

Any clinical trial may be investigator-initiated, industry-driven or organized by a cooperative group. While the applicant need not be the principal investigator of the trial, nor the lead institutional investigator, how participation in the trial will serve to enhance his/her research experience must be clearly articulated.  It is anticipated that applicants will be early to mid-career and seeking extramural support to further their goals of establishing an independent career in clinical cancer research.  The potential and track record of the applicant, the training plan and environment, and the scientific merit of the clinical trial will comprise the review criteria.

The peer-review process uses several metrics, including but not limited to importance of the hypothesis, quality of the science, novelty, applicability, track record of applicant, etc.  Clinical trials that address underlying mechanism as well as the outcome of an intervention are typically more insightful than those that address only the outcome of an intervention.

Q: Should we use the NIH salary cap when preparing the budget?

A: No, it is not necessary to use the NIH salary cap when preparing the budget.

Q: Are Award winners expected to present or publish their research findings? 

A: Yes, each CIA recipient is provided a slot during the Annual Cancer Symposium to present a summary of their completed research. Award recipients are encouraged to submit a full manuscript to the Annals of Surgical Oncolology for publication consideration. 

Q: It seems that the larger, more established institutions are represented in awarding the grants. I’m in a small practice--do I have a chance? 

A:  The Committee has recently revised the scoring weight of the “Institutional Resources” category, which heavily favored the larger training environments with robust infrastructure.  The grant applications are scored higher based on science and potential impact, and the qualifications of the applicant.  The Committee members score the applications based on objective criteria, while recognizing that quality research requires abundant resources.  

Q: Are SSO Fellowship and Research Grant Committee as well as the Training Committee members eligible for an Award?

A: No, as long as they are serving on these Committees, they are ineligible to compete for a CIA. 

Q: Does the Committee critique or provide feedback on proposals not accepted for a Clinical Investigator Award?

A: There are no written critiques of the individual grant applications, or any feedback that the Committee can provide.  

Q: For a clinical research proposal, what if the IRB approval is pending? The proposal calls for a prospective longitudinal cohort study. The institutional approval of the informed consent is often the rate-limiting step.

A: Your proposal should clearly indicate that IRB approval is pending.  If named an Award recipient, you would need to provide evidence of final IRB approval before funding is provided.

Q: I will be applying for the CIA.  Our standard consent form is six pages long and this particular protocol has two separate consents. How do I attach both and not exceed the five-page Appendix limit? 

A: You can submit just the first page of both consent forms with the IRB approval indicated. 

Q: While our IRB approval is, at this time, only partially approved, the protocol itself exceeds 80 pages.  Can you please advise how we can proceed to meet all the guidelines?

A: Applicants should be able to summarize their protocol appropriately.  A wise use of the appendix would be to include the face sheet of the IRB "partial" approval that indicates stipulations for full approval.

Q: On the Award Criteria page, Item F. Appendix:  do you require an approved IRB at the time of application submittal – or can this be a “just in time” submittal – approved IRB upon notification of award?

A: The proposal should clearly indicate that IRB approval is pending.  If named an Award recipient, you would need to provide evidence of final IRB approval before funding is provided.

Q: When the application guidelines do not specify indirect costs (IDC), our Research Admin department wants documentation from the sponsor as to allowable IDC on the application. Can you stipulate what the average IDC rate is on Clinical Investigator Awards?

A: The "allowable" IDC is at the discretion of the applicant’s institution.  We have seen a range of budget proposals, with indirect costs of 0% to 25% requested.  An "average," while calculable, does not provide any real guidance.  The best applications will be funded, and the criteria include a myriad of factors, including but not limited to the qualifications of the applicant, the strength, novelty and clinical relevance of the proposal, the quality of the research environment and an analysis of the budget.

Q: How is staff support defined?  Are other surgeons included in this definition, or does it encompass staff such as statisticians and research nurses only?

A: Yes to all of these, as long as they are justified in the budget.

Q: Could you help me with whether or not funds could be used for clinical trial costs (research coordinator, drug, drug costs)?

A: Yes, the funding can be used for clinical trial needs such as clinical research staff support as well as drugs and drug costs.   

Q:  I will be transferring to a different University program later this year. Is it possible to transfer remaining Award funds to another Institution?

A:  To change the conditions of the award (e.g. performance site), you would need to officially request such transfer.  The request should explain the circumstances, including important/relevant resources, key personnel, institutional support and departmental support.    

Q: I need an Extension to complete my CIA research project.  What should I do?

A: Requests for No-cost Extensions (NCE) must be made in writing to the Research Committee Chair by the end of the first year of the grant. Only one Extension will be allowed per Award, pending approval of the full Committee, and possibly the Grantor. 

Q: How does the SSO Foundation handle the matter of unexpended funds?

A: The SSO Foundation requests that unused grant funds are returned to the Foundation’s account for future CIA recipients. 

If you have additional questions, please contact The SSO Foundation during business hours at 1-847-427-1400, ext. 107, or email ssofoundation@surgonc.org.



The SSO Foundation

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Office: (847) 427-1400
Fax: (847) 427-1411
Email: SSOFoundation@surgonc.org
Web Site: www.surgonc.org

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