Grant Writing 101. Predoctoral Clinical Research Summer Internship Program. July 27, PDF Free Download

Predoctoral Clinical Research Summer Internship Program Grant Writing 101 Rebbecca Moen, MBA Associate Director Office of Clinical Research Academic Health Center E-mail: ramoen@umn.edu July 27, 2007

Writing a Grant is like Dating

Overview Dating Metaphor 1. Understand the language 2. Know where to look 3. Get prepared 4. Go on the date 5. Have backup in case of disaster Real Topic Research Funding Lexicon Finding Funding Sources Grant Prep Work Writing the Grant Resources

Understand the Language Fun Loving NSNDSWMISONSNDSWF25-30YO A Asian B Black BI - Bi Sexual C Christian D Divorced DDF - Drug/Disease Free F Female FTA - Fun Travel Adventure G Gay GSOH - Good Sense of Humor H Hispanic ISO - In Search Of J Jewish LD - Light Drinker LDS - Latter Day Saints LS - Light Smoker LTR - Long Term Relationship M Male MM - Marriage Minded NA - Native American NBM - Never Been Married ND - Non Drinker NS - Non Smoker P Professional S Single SD - Social Drinker SI - Similar Interests SOH - Sense of Humor W White W/ - With Wi Widowed W/O - With Out YO - Years Old

Research Funding Lexicon RFA for PPG from NINDS is out. TDC = $2M in FY1. BAA - Broad Agency Announcement (DOD) CFR - Code of Federal Regulations COS - Community of Science DARPA - Defense Advanced Research Project Agency DC - Direct Costs DHHS - Department of Health and Human Services DOD - Department of Defense DRG - Division of Research Grants (NIH) F&A - Facilities and Administration (Indirect Cost) FB - Fringe Benefits FTE - Full-Time Employee FY - Fiscal Year HCFA - Health Care Financing Administration HHS - Department of Health and Human Services HRSA - Health Resources & Services Administration I/C - Indirect cost rate IACUC - Institutional Animal Care and Use Committee IBC - Institutional Biosafety Committee IDC - Indirect Costs IND - Investigational New Drug IRB - Institutional Review Board JIT - Just-In-Time procedures MOU - Memorandum of Understanding MTDC - Modified Total Direct Cost NIH - National Institutes of Health NSF - National Science Foundation PHS - Public Health Service PI - Principal Investigator PPG - Program Project Grant (NIH) RFA - Request for Applications RFP - Request for proposal SBIR - Small Business Innovation Research SOW - Statement of Work SPA - Sponsored Project Administration TDC - Total Direct Costs VA - Department of Veterans Affairs http://www.research.northwestern.edu/research/osr/acronyms.html

Research Funding Lexicon

Research Funding Lexicon NIH Institute or Center Abbreviations National Cancer Institute NCI CA National Center for Complementary and Alternative Medicine NCCAM AT National Center for Research Resources NCRR RR National Center on Minority Health and Health Disparities NCMHD MD National Eye Institute NEI EY National Heart, Lung, and Blood Institute NHLBI HL National Human Genome Research Institute NHGRI HG National Institute of Allergy and Infectious Diseases NIAID AI National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS AR National Institute of Biomedical Imaging and Bioengineering NIBIB EB National Institute of Child Health and Human Development NICHD HD National Institute of Dental and Craniofacial Research NIDCR DE National Institute of Diabetes and Digestive and Kidney Diseases NIDDK DK National Institute of Environmental Health Sciences NIEHS ES National Institute of General Medical Sciences NIGMS GM National Institute of Mental Health NIMH MH National Institute of Neurological Disorders and Stroke NINDS NS National Institute of Nursing Research NINR NR National Institute on Aging NIA AG National Institute on Alcohol Abuse and Alcoholism NIAAA AA National Institute on Deafness and Other Communication Disorders NIDCD DC National Institute on Drug Abuse NIDA DA National Library of Medicine NLM LM John E. Fogarty International Center FIC TW

Research Funding Lexicon Grants & Coop. Agmts Solicited Program Announcements (PA) Requests for Applications (RFA) Unsolicited Investigator Initiated Contracts Solicited (generally) Request for Proposals (RFP) Broad Agency Announcements (BAA) Standard Cycle Due Dates for New Grants Generally One-Time, Off-Cycle Due Dates

Research Funding Lexicon F T K R U P N F = Fellowship Grants T = Training Grants K = Career Development Grants R = Research Project Grants U = Cooperative Agreements P = Program Project or Center Grants N = Contracts Number (e.g., K23, R01) designates a particular Funding Activity

Know Where to Look

Finding Funding Sources Federal - NIH Foundations and Professional Societies Industry Institutional

Finding Funding Sources NIH http://grants1.nih.gov/grants/guide/index.html

Finding Funding Sources Foundations and Professional Societies Community of Science http://www.cos.com/

Finding Funding Sources Industry Community of Science (www.cos.com) Title Sponsor Amount Career Awards at the Scientific Interface (CASI) Burroughs W ellcome Fund (BW F) $500,000 Career Awards for Medical Scientists (CAMS) Burroughs W ellcome Fund (BW F); Career Development of Scientists $510,000 Clinical Scientist Awards in Translational Research Burroughs W ellcome Fund (BW F); Therapeutic Sciences $750,000 Fellowship in Health Literacy and Clear Health Communication Pfizer, Inc. $90,000 Pfizer Fellowships in Infectious Diseases Pfizer, Inc. $80,000 Mentors Industry Websites http://www.centerwatch.com/

Finding Funding Sources Institutional http://www.ahc.umn.edu/research/funding/home.html

Get Prepared

Prep Work Read the Solicitation Read the Solicitation Find someone internally who has the same grant Ask for a copy Talk with your Mentor/Chief/Chair about your idea Talk with colleagues about your idea Talk with laypeople about your idea Find out who will help with administrative items Read the Solicitation

Go on the Date

Writing the Grant Understanding the audience Guiding principles Developing a good story Managing the writing task

Writing the Grant The Audience Reviewers are overburdened Little time and cognitive energy Unlikely to read grant in one sitting Reviewers may not read your entire grant Reviewers must be willing to stand up for you Reviewers must be excited about your grant

Writing the Grant The Audience Be kind to reviewers Consistent with a critical long-term goal of the Agency for Healthcare Quality and Research (AHRQ), Duke University proposes the implementation of a health information technology to reduce the incidence of Adverse Drug Events (ADEs). This implementation will occur in three local partnering hospitals: Duke University Hospital, Durham Regional Hospital, and Raleigh Community Hospital, and will encompass a computerized system that will enable us to detect, monitor, and intervene in ADEs. The overarching objectives of this Implementation Project are to reliably measure and reduce the incidence of ADEs suffered by patients at these hospitals using a computerized system for ADE detection and intervention. This initiative will represent a collaboration between Duke Health Technology Solutions (Duke University Health System s information systems group), and the clinical leadership and Departments of Pharmacy of the three hospitals. The ultimate goal of surveillance for ADEs is to permit us to intervene upon and abort or ameliorate events before they occur or as they are occurring. A basic principle of safety in any industry is to build multiple layers of safeguards. DUHS currently uses several systems of error detection and alerting, including pharmacy system checking and laboratory alerting of clinicians for dangerous laboratory values. A continuous automated surveillance system will add another, more comprehensive layer of detection and prevention to the systems in place today. Ongoing monitoring for ADEs will provide a vital safety net, which will supplement the capabilities of future interventions to improve medication safety. For example, unlike computerized physician order entry (currently in implementation at two of the hospitals), the surveillance system will allow us to detect and intervene to prevent harm from errors that occur at all stages in the medication management process. ADEs that occur despite a correct initial medication order, due to subsequent change in patient status (e.g., deterioration of renal function over the course of hospitalization), can also be detected and intercepted using automated surveillance.(1;2) Finally, demonstrating a measurable decrease in ADEs requires quantifying the incidence of such events. However, most organizations do not know the true overall frequency of ADEs at their hospitals. The main reason for this is that quantification based on voluntary event reporting the principal method of measurement at most organizations, including ours underestimates the incidence of ADEs.(3;4) In part this is because caregivers hesitate to report events due to lack of time, fear of recrimination, and concerns of medicolegal exposure. Perhaps most importantly, many ADEs perhaps as many as 75% are not recognized as such by caregivers at the time of occurrence,(1) precluding the possibility of reporting (and intervention). An automated surveillance system permits credible, consistent, and continuous monitoring of ADE incidence. Population studies have shown that ADEs among hospitalized patients are frequent, and in many cases preventable.(5-7) ADEs comprise a large proportion of all adverse medical events. They constituted the largest single category of adverse events in the Harvard Medical Practice Study (19% of all events),(6) and are believed to account for over 100,000 deaths per year in the United States.(8;9) Recent targeted chart review studies have shown that between 10% and 20% of patients admitted to acute care hospitals suffer ADEs requiring medical intervention.(10) Chart review has traditionally been considered the gold standard for detection of ADEs. However the resource demands of large scale chart review make it impractical as a means of continual and comprehensive monitoring for ADEs. Multiple studies over the past decade have demonstrated the efficacy of automated surveillance methods for detecting ADEs. An early study by Classen et al.(1) using computerized surveillance over an 18 month period yielded 731 verified ADEs, compared with only 9 ADEs detected by traditional voluntary reporting. This study used a series of single-variant detection rules in the categories of chemistry, hematology, drug level, and drug order data.(11) A subsequent study by Jha et al. refined this methodology with the use of more complex rules. The authors showed a high rate of detection of ADEs (10% of admissions), and detection of 275 ADEs by computer compared with 23 by voluntary reporting during the study period. A chart review study was conducted in parallel, which suggested that the yield of automated detection could be further increased by the use of text screening tools to search narrative text for key words. ADEs detected by the automated system were more complete and of greater severity than those detected by chart review.(12) Pioneering work by several organizations has demonstrated the potential efficacy of computer-based automated ADE surveillance that 1) detects dangerous conditions that may lead to ADEs; 2) permits timely required to meet the Leapfrog standard. The methodology was developed under Dr. Kilbridge s management in collaboration with national experts in the field of medication safety and field tested at five different CPOE hospital implementations around the United States.(23) In addition, Dr. Kilbridge compiled a definitive study of the history of, and methodologies for, ADE surveillance for a hospital consortium.(2) Dr. Kilbridge has also conducted extensive research and consulting on best practices in the management of clinical information systems at hospitals around the United States.(24) Dr. Kilbridge s salary and associated indirect costs will be cost-shared by DUHS. II.b. Project Committee A Project Advisory Committee will be created to oversee the implementation of the ADE surveillance system. The committee will be chaired by Dr. Kilbridge in his role as Associate CIO for Patient Safety for Duke Health System. It will include representatives of each of the partner hospitals (CEO, Director of Pharmacy, and the Patient Safety Officer for each hospital) as well as key persons on the Implementation project team. Additionally, Dr. Nancy Allen-LaPointe, who is the Project Manager of one of the AHRQ-funded Center for Education and Research on Therapeutics (CERTs) will participate in this committee (see letter of support in Appendix A). Dr. Allen-LaPointe is a pharmacist by training and has been directly involved in several projects at Duke involving collaboration with pharmacists to improve patient safety and adherence to evidence-based therapies. Her experience in conducting these kinds of studies will aid the Implementation project team and her involvement will allow for potential collaboration with the Duke CERTs group. Figure 1. DUHS Adverse Drug Event System Implementation Project Administrative Organization Project Advisory Committee William Fulkerson, CEO DUH Dennis McQuaid, CEO DRH James Knight, CEO RCH Directors of Pharmacy (DUH, DRH, RCH) Patient Safety Officers (DUH, DRH, RCH) Duke CERTs Liaison (Allen-LaPointe) Subcontract Duke University Hospital (Partner) Asif Ahmad, Co-Investigator John Kessler, Co-Investigator Pharmacist Database Manager Programmers Duke University School of Medicine (Lead Partner) Peter Kilbridge, MD, Principal Investigator Project Manager Research Analyst Subcontract Durham Regional Hospital (Partner) Terry Mears, Co-Investigator Pharmacist Programmer Subcontract Raleigh Community Hospital (Partner) Janis Curtis, Co-Investigator Pharmacist Programmer II.c. Other Key Personnel Asif Ahmad, MBA will serve as a Co-Investigator for this project and will be entirely cost-shared by DUHS. As the Chief Information Officer at Duke University Health System and before that at The Ohio State University Health System, Mr. Ahmad has extensive experience in the implementation of clinical information systems that directly improve patient safety. He directed the successful implementation of CPOE across Ohio State s fivehospital environment using a commercial vendor product. Under his guidance the organization achieved widespread physician acceptance and use of the system across diverse clinical environments.(25) The health system was subsequently able to demonstrate significant improvements in patient safety and clinical process efficiency, including elimination of medication transcription errors, reductions in medication and laboratory turn-around times, and reductions in cost and length of stay in several settings.(26) These achievements are particularly pertinent to the current proposal as success will depend upon the integration of information from multiple clinical information systems, and across multiple locations.

Writing the Grant Guiding Principles We will review goals for writing Many good ways to achieve goals Look at lots of grants (good and bad) Strategies offered here are suggestions only Think about how you work best and develop a process that suits you

Writing the Grant Guiding Principles Not a scholarly manuscript Simple writing (like for a newspaper) Includes a bit of marketing and horn-tooting Complexity can generate confusion Non-grants: Makes some people think you re smart Grants: Makes people nervous about endorsing something they don t understand

Writing the Grant Guiding Principles Use frequent internal references Other sections Appendices Remind the reviewer Requires a good numbering system Redundancy is okay OK to use same wording in key sections

Writing the Grant - The Story The problem Gap in knowledge or lack of solution Importance Overall goal (long-term) Consider the broader research program Objective of your proposal Don t bite off too much! Rationale for your approach Why you are the right person(s) to do the work Your method (basic features) Tangible products of your work and why they are valuable What could go wrong and how you will deal with it What is exciting about all this?

Writing the Grant Writing Tips Block off regular writing periods and defend them against attacks! Start with main section headings Make yourself write something Different font colors (Blue): Notes and content Not responsible for how nice it sounds (Green): Text borrowed from other places Black: Text considered good enough for editing

Writing the Grant Writing Tips Think with your fingers Reduces memory load and anxiety When a section is not going well, start on a blank page and jot down the flow of points you need to make. Don t ever be a slave to text that s already written Print out sections and read somewhere else

Backup in Case of Disaster

Resources UMN Grant Funding Resources Workshops http://www.lib.umn.edu/registration/index.phtml#eventidxx18 NIH New Investigator Program http://grants1.nih.gov/grants/new_investigators/index.htm Proposal Writing Guides http://research.musc.edu/ord/granttips.htm Sample Grants Office of Clinical Research http://www.ahc.umn.edu/ocr/toolbox/write.html

Call me if you need help! Becky Moen 612.625.2691 ramoen@umn.edu

Grant Writing 101. Predoctoral Clinical Research Summer Internship Program. July 27, 2007