Young Surgical Investigators:

A Summary of Recommendations for First-Time Grant Writers

Research by Young Surgical Investigators

In an initiative to assist young surgical investigators who have not yet become successful in obtaining extramural, peer-reviewed grant support for their work, the Surgical Research and Education Committee of the American College of Surgeons has convened biennial Conferences for Young Surgical Investigators. The goal of these conferences, held in proximity to the campus of the National Institutes of Health and with numerous staff members of the NIH in attendance, has been to introduce young surgeons to the process, the content, the style, and the people involved in successful grant writing and interactions with the NIH. It is essential that young surgical investigators recognize that the NIH is not a "black box" it is made up of many dedicated, knowledgeable, and committed staff people who are there to help and to see that good research is funded. The more communication that young investigators establish and maintain with the NIH staff in their area, the more likely it is that their grant applications will be funded.

Nearly all research performed by surgeons has direct implications for patient care, and the boundaries between clinical care and basic research performed by surgeons are blurred. Surgeons are uniquely positioned, as clinicians and scientists, to raise important questions and bring basic research advances to the bedside. Thus, surgical research is clinical research in the broadest sense. At present, clinical research in surgery is inadequately supported, and surgical faculty are under more and more pressure to spend time increasing their clinical practices. Department funds have dwindled under pressure from competitive practice environments, and it is important to assist new faculty members to become efficient and effective in research and in the obtaining of extramural grant funds. The Surgical Research and Education Committee offers the Young Surgical Investigators Conference and this brochure as part of this effort.

Many practical points made at the Young Surgical Investigators Conferences are reproduced here for dissemination to young surgical faculty members as a rough guide through the maze of grant-writing and application.

• Establish a reasonable and testable hypothesis and a strong research plan. The elements used by reviewers in scoring grant applications are: significance, approach, innovation, investigator, and environment.
• Find out how the system of grant-writing and application works. Know the timetables, read the instructions carefully, and consult with researchers (in or outside of your department) who have been successful in obtaining a grant from the NIH, especially if they have had an appointment to a Study Section.
• Call the NIH and get to know the staff people in your area of investigation. Talk with the Scientific Review Administrator (SRA) of the Study Section that will likely review your grant application and the program staff people in the Institute under which your research will fall. Tell them your areas of interest and expertise and ask them their advice about the best mechanism of funding for you.

A number of different types of grant applications and funding mechanisms are available. The RO1 grant award is the "gold standard" and may not be the best place to begin. The R29 FIRST Award is an excellent mechanism for new investigators. The application is reviewed using usual criteria and rigor, but the track record of the investigator is reviewed with the understanding that the individual is a first-time applicant and may have only an early record of research accomplishments. The "K" awards are for career development training and are given to qualified individuals with clear research potential, but who are not yet at the point of an independent research career. Applications for "K" awards are reviewed with a somewhat different, perhaps more lenient, mechanism. (These awards are summarized on page 5.) Although the R29 and "K" awards require at least a 50% time commitment, this percentage is based on a 40-hour week, making application feasible even for young surgeons with other time commitments. Call the Grants Information Office of the NIH at 301/435-0714 for further information.

Remember, the system is not monolithic, and individuals vary in their interpersonal skills, experience, and knowledge. The better the reviewers at NIH come to know and like you, the more help you will receive.

When preparing your grant application, review the membership of the Study Section you believe will be assigned to review your grant. You will undoubtedly recognize some of the names on the roster, and these are the individuals who will likely review your application. It is a wise tactic to quote their work at some time in your application. It is best that you do not dispute their findings; if you do, you should do so in a respectful and tactful manner. The Study Section rosters are listed on the NIH's web site (http://www.nih.gov).

Indicate the focus of your research in a cover letter and suggest why and where you prefer that the application be sent for review. You will be promptly notified as to where it has been assigned by the Center for Scientific Research (CSR) (formerly the Division of Research Grants, DRG). If you believe that the assignment is inappropriate, immediately call the Referral and Review Branch of the CSR at 301/435-0715 and/or send a fax stating your concerns to 301/480-1987. Dr. Suzanne Fisher or one of the other members of the Referral Section will work with you in the assignment process. If you wish the NIH to consider a change in assignment, do not delay calling when first notified; delay may mean missing a review cycle.

• Read the instructions in the grant application packet. Follow the instructions to the letter. Do not exceed page limits. Meet all deadlines.
• It is essential to focus the application. Place yourself in the position of the reviewer and make the grant application as easy to read as possible. Be enthusiastic. Do not include lengthy appendices that require much paging back and forth. Do not use a series of obscure abbreviations. Spell everything out (within reason) and avoid all but the most common acronyms. Keep the reviewer interested and involved and make every effort to keep the format consistent and readable. An annoyed or bored reviewer is not likely to give a favorable review.
• The CSR has now adopted a system of triage for grant applications. If the primary and secondary reviewers of your grant agree that it is not competitive, and no objection is raised at the Study Section meeting, the grant is not discussed and brief critiques from the reviewers will be mailed to you promptly. Indications of how the application scored in terms of significance, approach, innovation, investigator, and environment will be apparent. Use these criteria to evaluate the direction you should take when revising the application for resubmission.
• If the grant was turned down, revise it according to each and every criticism and turn it in again at the very next cycle. Point out carefully how each criticism has been addressed. The same reviewers will likely review it again, and, if you have a good hypothesis and address each criticism squarely and fairly, it is likely that you will eventually get funded. If you wait to resubmit at a later cycle, the composition of the Study Section may have changed, and you may receive an entire new series of criticisms. Persistance pays great dividends. Remember that an average of 2.1 submissions are required before a priority score at the funding level is reached.
• Dr. Harold Varmus, Director of the NIH, announced at the May 5, 1997, meeting of the Peer Review Oversight Group (PROG) that use of five explicitly stated review criteria will be implemented across the NIH, effective for unsolicited research grant applications submitted on or after October 1, 1997. The new criteria will be used when reviewing these applications in the February 1998 review cycle. Within the peer review process at the NIH, a single, global score will be assigned by each reviewer for each scored application. This score should reflect the overall impact that project could have on the field, with emphasis on each criterion varying from one application to another, depending on the nature of the application and its relative strengths.

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Budget items to consider when writing a proposal - Table

Do's

Personnel

• Describe all personnel whether professional or nonprofessional by name, position, and proposed time and efforteven if no salary is involved
• Justify job descriptions
• List dollar amounts separately for each individual
• Request only consultants who have agreed to participate

Equipment and supplies

• Request and justify all equipment necessary for the completion and performance of the proposed research
• Request and itemize supplies needed for completion of the proposed research
• Justify species, number, and cost of all animals
• Request costs for patient care, where appropriate
• Add subtotals

Other support

• Describe for each professional including the investigator listed on page 2 of application the time and effort required; describe all other
  • active support
  • applications and proposals pending review or funding
  • applications and proposals planned or being prepared for submission

Travel

• Request travel monies and describe the purpose of the travel

Don'ts

Personnel

• Exceed 100% for the collective sum of percentages of time and effort proposed for each individual
• Request consultants that cannot be justifiedeither by lack of expertise or level of effortfor the proposed research.

Equipment and supplies

• Request to purchase equipment that appears to be duplicative (for example, investigator in previous proposal would have had to have such equipment to conduct the research)
• Add supplies indiscriminately
• Propose to use animal species that cannot be correlated to human data or that are not appropriate for the proposed area of research
• Request funds for coverage of laboratory tests which are routinely provided as part of a patient's basic tests
• Forget to check budget for errors

Other support

• Forget to propose how priorities will be rearranged so as not to exceed 100% time and effort
• Forget to address in detail potential overlap in scientific content between current proposal and others submitted
• Request travel for meetings not appropriate for the proposed area of research

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Review Criteria

The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. In your written review, you should comment on the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Please address each of these criteria and consider them in assigning the overall score, weighting them as you feel appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high-priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward.

1. Significance

Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

2. Approach

Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

3. Innovation

Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

4. Investigator

Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?

5. Environment

Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

Use the American College of Surgeons as a resource. Members of the College's Surgical Research and Education Committee are experienced and knowledgeable and can advise you directly or provide you with names of other contacts in your field.

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Summary guidelines for a successful application - Table

Good idea

• Hypotheses
  Significant; testable; supporting rationale
• Aims
  Focused; test hypotheses; not overly ambitious; not superficial
• Preliminary data
  Rationale for hypotheses; demonstrate capability; correct interpretation
• General considerations
  Not merely data gathering; describe next logical steps

Good science

• Planning
  Logical organization; rationale for methods selected; alternatives; controls
• Detail
  Brief when PI's methods; extensive when methods of others
• Critical assessment
  Problems and pitfalls; assumptions and limitations; justify level of sophistication
• Statistical aspects
  Statistical design/power; supportive consultant

Good application

• Basic considerations
  Read and follow all instructions; clear and lucid style; never assume reviewers "will know what you mean"; seek presubmission review by colleagues
• Administrative
  Obtain appropriate signatures
• Duration and budget
  Moderate and realistic period; only appropriate funds to accomplish research
• Justification
  Personnel: the role and percentage of effort; equipment: necessity and availability
• Consultants
  Technical advice in preparing application; supportive letter
• Research plan
  Follow page limits and suggestions above; proper care and approvals for human subjects and vertebrate animals
• Appendix
  Include appropriate supplementary data; do not include essential material
• Amended application
  Assess whether amended proposal is likely to be successful; be responsive to reviewer's critiques; be positive; do not be vindictive and sarcastic

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Clinical Studies (special features) - Table

Good biological and clinical science

• A significant biological or clinical problem; describe the likelihood of altering current clinical practice.
• Research based on logical, well-defined, and testable hypotheses and associated specific aims.
• Demonstrated critical assessment of preliminary data and literature.
• Well-defined, justified use of human subjects; compare with the value of similar studies in animals.
• Full consideration of human-subject issues
• Consideration of any potential medical problems or side effects arising from the new procedures.
• Appropriate and accurate methods for clinical and biological patient assessment; if methods utilized are somewhat simplistic and possibly unsophisticated, explain how the technology to be utilized is powerful enough to answer the questions posed.

Data quality

• Criteria for collecting, analyzing, and assessing clinical and laboratory data; define the accuracy of all data collected, including intra- and interoperator errors.
• Compliance monitoring.
• Monitoring procedural rigor for issues such as randomization and dosage modification.
• Monitoring by statistical unit (and PI where appropriate) for treatment benefits and side or toxic effects.
• Collaborative, multiinstitutional studies require special organizational structures to ensure the uniformity of testing at each clinical unit.

PI qualifications and experience

• Strong qualifications as a biological or clinical investigator.
• Prior experience in clinical studies.
• Basic science skills may not translate to clinical studies.

Statistical design

• Statistical methods should be appropriate for data to be collected.
• If possible and appropriate, consider randomized, double-blind prospective study designs.
• Carefully estimate the incidence of the observed effect in normal or control populations.
• Show proper selection of control populations, including matching for age, sex, race, color, clinical conditions, and so on.
• Provide the statistical rationale and methodology to determine the number of subjects required for each subject cohort; dropout and withdrawal must be considered; statistical power assumptions should be well defined.
• Typically, statistical consultants are required in the preparation of applications and the performance of studies; often, independent data units or centers are established to implement the study and allow the PI to remain unaware of patient assignment to treatment or control groups.

Patient population

• Well-defined, homogeneous subject population and control.
• Clearly defined entry criteria.
• Clearly defined exclusion criteria based on current or past diseases, utilization of specific medications, or the results of laboratory and clinical tests.
• Clearly defined recruitment procedures to be followed.
• Availability of a suitable patient population, as well as any prior experience with that group of individuals.
• Prior experience in recruiting and entering in a clinical study.

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Summary

• You will not be funded unless you apply!
• Almost no one is funded with the first application; it's the repeated effort that succeeds.
• Address the criticisms of your proposal resubmit in time for the next cycle the likelihood of success will be improved.
• NIH funding, while difficult to obtain, is the "gold standard" of peer review. It is less encumbered than funding from industry, much more prestigious, and permits you to develop your research concepts in an atmosphere of scientific freedom.

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Online Access to the Study Section Rosters

Using a web browser (such as Netscape), go to: http://www.nih.gov

This will bring you to the NIH Home Page, where "Grants & Contracts" can be accessed. Of special interest are the "NIH Guide to Grants and Contracts," "NIH Research Training and Career Development Opportunities," "NIH Peer Review Notes," a listing of NIH Research Grants and Contracts, and "Division of Research Grants Study Section Rosters."

"CRISP" is a full-text, searchable database on intramural and extramural research programs of the NIH and the FDA. This information is especially helpful when current research directions are of interest.

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Key Contacts at NIH (Selected Institutes)

* Print table in landscape mode.

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Surgical Research Committee

• Alden Hood Harken, MD, FACS, Oakland, CA (Chair)
• Alexander W. Clowes, MD, FACS, Seattle, WA (Vice Chair)
• Clyde F. Barker, MD, FACS, Philadelphia, PA
• David S. Baskin, MD, FACS, Houston, TX
• Robert Daniel Beauchamp, MD, FACS, Nashville, TN
• John D. Birkmeyer, MD, FACS, Ann Arbor, MI
• Colleen M. Brophy, MD, FACS, Phoenix, AZ
• David R. Flum, MD, MPH, Seattle, WA
• Shukri F. Khuri, MD, FACS, West Roxbury, MA
• Michael T. Longaker, MD, FACS, Los Altos, CA
• Jeffrey F. Moley, MD, FACS, St. Louis, MO
• Sean J. Mulvihill, MD, FACS, Salt Lake City, TU
• Robert W. Thompson, MD, FACS, St. Louis, MO
• Courtney M. Townsend, Jr., MD, FACS, Galveston, TX
• Garth L. Warnock, MD, FACS, Vancouver, BC

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American College of Surgeons
633 N. Saint Clair
Chicago, IL 60611-3211

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Surgical Research Committee

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by the American College of Surgeons, Chicago, IL 60611-3211