PFA - Patient Centered Outcomes Research Institute

PCORI’s 4 PFA AreasPCORI’s PFAs focus on four areas of research addressing currently unmetneeds of patients, their caregivers, clinicians and other healthcare systemstakeholders.• Assessment of Prevention, Diagnosis, and Treatment Options• Improving Healthcare Systems• Communication and Dissemination Research• Addressing Disparities9

Communication and DisseminationResearchProjects that address critical elements in the communication and disseminationprocess among patients, their caregivers and clinicians.In this PFA we seek to fund projects that:12• Address critical knowledge gaps in thecommunication and dissemination process• Gaps to consider:‣ The communication and dissemination ofresearch results to patients, theircaregivers, and clinicians‣ The communication between patients,caregivers, and clinicians in the service ofenabling patients and caregivers to makethe best possible decisions in choosingamong available options for care andtreatmentAvailable funds: $12 MillionExpected awards: 14 awardsMaximum project period: 3yearsLetters of Intent due: June 15Applications due: July 31Initial funding period: January2013

PRELIMINARY CHECK

Partnerships & StakeholdersPCORI requires stakeholder involvement unless the applicant sufficientlyexplains why such an arrangement is not feasible.Projects must include stakeholders as partners with significant involvement atall appropriate stages of the project.Who are stakeholders?• Patients• Patient-advocacy groups,• Community groups,• Caregivers,• Health care providers,• Relevant professional associations, and• Others who can bring insights on thepatient perspective.16

PCORI Online SystemEnter all required fields to register*Note that your e-mail address will serve as your login name.19

LETTER OF INTENT PROCESS:PCORI ONLINE

Letters of Intent21A Letter of Intent must be submitted by 11:59 PM EST June 15, 2012 in order to Apply forthe PFA Descriptive title of proposed research Legal name of the applicant organization Name, institutional affiliation address, and telephone number of the PI Names and institutional affiliation of other key personnel and significantcontributors Participating institutions and organizations A brief summary of the proposed research questions and methods A paragraph describing the significance of the research project relative tothe stated goals of this PFA Identify the area of interest(s) the proposed project will address Contact information for the institutional official for PCORI to contact aboutthe application

Create and Submit LOILetter of Intent (LOI) Main Page– Use the left-side navigational links to guide you through LOI creation and submission.– The Validation Summary informs you of the status of each component of your LOI.– On each component page, use the “Save” and “Save and Continue” buttons to save yourwork and to continue to the next section of the LOI. You must save your informationbefore navigating away, or work will be lost.– Fields marked with a red asterisk (*) are required.24

Create and Submit LOIPrincipal Investigator Contact Information– Enter/update the PI’s contact information, including name, organization, address, phone,and email.– If Grantee Organization does not exist in the PCORI system, you will be required to enteradditional organization information (name, DUNS/EIN #, address, organization type).25

Create and Submit LOIProject Details– Enter/update Project Details, including title, start and end dates, projected amountrequested, and technical abstract.26

Create and Submit LOITechnical AbstractThis technical abstract should be written so that it can be separated from the application andthe project still fully understood. It must include:– Background: State the problem or question the research is designed to address.– Objectives: Briefly describe the specific aims of the study, including the specific researchquestion(s) and the long-term objectives.– Methods: Give a concise description of the study population, sample size, and analyticmethods that will be employed.27

Create and Submit LOIKey Personnel– Enter Key Personnel information, including name, contact information, and role.– If Grantee Organization does not exist in the PCORI system, you will be required to enteradditional organization information (name, DUNS/EIN #, address, organization type).28

Create and Submit LOIKey Personnel– Use the Key Personnel list to view Key Personnel information and add, edit, or delete keypersonnel:29

Create and Submit LOIAdditional Project InformationYou will be required to answer the following questions related to your project:– What diseases or conditions does your proposal address? Please select up to three.– Does your proposal include a vulnerable and/or underserved population? Please select upto three.– What specific area of the PCORI priorities does your application address? (Seewww.pcori.org/priorities for a list of PCORI priorities.) Please select from list.– What study design does your research use? Please select from list.– Does your application include specific analytic methods? Please select from list.30

Create and Submit LOIReview and Submit– Click “View PDF” to view the full LOI as a PDF.– “Validation Status” informs you of the completeness of each section. When all sectionsare complete, click the “Submit” button.31

Budget RequirementsHumanSubjectsAllowableCostsIndirect CostsDirect Costs• PCORI adopts the human subjects requirements of HHS• IRB approval must be received prior to award• Salaries (PI salary cap is $200,000 per full year) plus fringe• Consultant fees• Equipment• Supplies• Project-related travel• Consortium/Contractual direct costs• Limited to 40% of direct costs and other allowable costsexcluding equipment.• Indirect costs for subcontracts may not exceed $25,000• Maximum of $500,000 year.• If greater than 500K, pre-approval must be obtained fromPCORI before the application is submitted.32

Budgets over $500,000PCORI requires that budgets exceeding $500,000 per annum seek pre-approval priorto submitting an application.To seek approval:• Please submit a request for approval through the PCORI website:http://www.pcori.org/funding-opportunities/contact/• Select the “Approval For Funding>500” question type and attach the followingexcel template with your budget detail:http://www.pcori.org/assets/PFA-Budget-Template.xls• Include a clear explanation of why your budget exceeds the limit.PCORI will convene to discuss these proposals and provide approval prior to theapplication deadline.33

FAQS

Eligibility FAQsAre federal agencies eligible to apply for funding from PCORI?Yes, federal agencies are eligible to apply. Applications may be submitted byany private sector research organization, including non-profit and for profitorganizations, any public sector research organization, universities, colleges,hospitals, laboratories, healthcare systems, and units of state and localgovernments. All US applicant organizations must be recognized by theInternal Revenue Service.Are foreign organization eligible to apply for funding from PCORI?Foreign organizations and nondomestic components of organizations basedin the United States may apply, as long as there is demonstrable benefit tothe US healthcare system and US efforts in the area of patient-centeredresearch can be clearly shown. Individuals may not apply.35

Multiple Submissions FAQsCan grant applications be submitted to PCORI and to other fundingagencies at the same time?Applications of a similar research nature may be submitted to multiplefunding agencies in addition to PCORI. Please notify PCORI immediately ifyour application is selected for funding by another organization, as PCORIdoes not allow duplicate funding for the same activities should multipleagencies provide awards.My grant application was rejected from another agency, can I still submitit to PCORI?PCORI will accept research proposals that have been considered by otherfederal agencies and were not selected for funding. Please be advised thatthe revised application reflects PCORI national priorities and meets PCORI’sapplication guidelines.36

Additional FAQsMay I speak to a scientist regarding the suitability of my application?PCORI will consider studies that are comparative and that include patientcenteredoutcomes. We encourage you to carefully read the PCORI FundingAnnouncements (PFAs) and other background material on our website tounderstand our goals and the PFA you are considering.PCORI encourages open communication while ensuring each applicant hasequal access to information. We implemented an online inquiry systemwhere questions will be answered as soon as possible. All information ismade equally available to all interested parties on the FAQ webpage.Please visit the PCORI website to view the FAQs:http://www.pcori.org/funding-opportunities/funding-announcements/faqs/38

Important PCORI websites– General announcements: www.pcori.org– Contact for Any Questions: http://www.pcori.org/funding-opportunities/contact/– Frequently Asked Questions: http://www.pcori.org/funding-opportunities/fundingannouncements/faqs/– Apply to be a Reviewer: http://www.pcori.org/reviewer-application/– Glossary: http://www.pcori.org/glossary/– Budget Template & Allowable Cost: http://www.pcori.org/assets/PFA-Budget-Template.xls– Applications Guidelines: http://www.pcori.org/assets/PFAguidelines.pdf– PFAs: http://www.pcori.org/funding-opportunities/funding-announcements/41– Apply Online: http://contracts.pcori.org/

Apply to be a Reviewer– PCORI invites all professionals who are interested in PCOR to apply to be a scientific or astakeholder reviewer through our website: http://www.pcori.org/reviewer-application/.42