Orientation to Research & Sponsored Projects Session II: Preparing Your Proposal September 15, 2010 1
Welcome & Introductions Agenda Ann Q. Gates, Associate Vice President for Research Overview: Roles & Responsibilities Proposal Development Staff Resources Creating a Network Developing a Timeline Proposal Preparation Developing a Proposal Budget IRB: Human Subjects in Research Intellectual Property Processing Your Proposal
Overview: Roles & Responsibilities Role of the Principal Investigator (PI) Submit the Notice of Intent Know capabilities - (knowledge & time) Meet compliance requirements Disclose conflict-of-interest, of interest, if appropriate Write proposal responsive to agency s mission & goals Obtain approvals through administrative process Submit proposal to ORSP 5 working days prior to submission Role of Research & Sponsored Projects Assist in finding & analyzing funding solicitations Assist with budget development prepare budget forms Assist with the review, edit, and provide institutional data and writing Provide final review and check solicitation requirements Prepare transmittal documents Submit the proposal to the sponsoring agency
PROPOSAL DEVELOPMENT
Proposal Development Staff Resources Funding opportunities notification Proposal development Review of solicitation guidelines & requirements Proposal Development Team: Ann Q. Gates Flo Dick Claudine M. Riccillo Malu Picard-Ami Proposal budget development Proposal submission Research Administrators: Michelle Kistenmacher Teresa Almengor Marisa Sanchez Tom Osteen Sona Kumar 5
Proposal Development Staff Resources Research Compliance Human subjects Biosafety-Recombinant DNA intellectual property Animal use & care Conflict of interest t certifications & assurances Athena Fester Susan Avena Cindy Crews Manuela Dokie
Creating a Network Activity Log on to the Expertise System (Click anywhere on image) Sign in using your e-mail user name and password Chose edit View your page Browse tabs Faculty Centers Technologies Facilities Equipment Labs & Groups https://orspprofile.utep.edu/profilesystem/
Developing a Proposal Timeline Plot out time from start to deadline on a calendar Break out the sections as outlined in the solicitation Determine time needed to complete each section Determine a deadline to complete each section Assign tasks if you have a team Schedule progress meetings if you have a team Use a Gantt chart, Excel, Visio or any project management sofware to develop a visual representation of your timeline
Proposal Preparation Outline the motivation for your work Define your project goals and hypothesis if applicable Map your goals to the program goals and ensure that there is a match Define your objectives and methods/activities Define the significance (intellectual merit) of your project Define the broader impacts Seek critical review of the major sections of your proposal from internal reviewers, ORSP Proposal Development Team, and external reviewers
DEVELOPING A PROPOSAL BUDGET MICHELLE KISTENMACHER, RA MANAGER TERESA ALMENGOR MARIA ISELA HERNANDEZ IRENE HOLGUIN SONA KUMAR TOM OSTEEN MARISA SANCHEZ
Developing a Proposal Budget A proposal is a request from an external sponsor for financial support of a research, training, equipment or outreach project The budget is the principal investigator s (PI) best estimate of the financial support needed to carry out the technical proposalp A budget that is prepared for a proposal to be submitted to a federal, state, or private agency must be consistently ss ypriced relative to proposed work and should be supported by policy, schedules, or memos regarding the costs cited
Developing a Proposal Budget The Proposal Budget Is a basic component of a proposal p Projects and estimates project expenses Reflects the scope of work Demonstrates investigator s capability to plan and manage a project Provides costs that are reasonable, allowable, and allocable
Developing a Proposal Budget The Proposal Budget Consists of the following elements: Personnel PI and Co-PIs Other Professional Students Secretary (in rare instances) Other Personnel Travel National Conferences to present research Local Mileage to perform the project
Developing a Proposal Budget (Continued) Participant support t Equipment Greater than $5,000 with a useful life of more than one year. Not computers Consultants Subcontracts Other direct costs Materials and supplies Publication costs Things that t don t fit anywhere else
Developing a Proposal Budget The ORSP Research Budget Tool
Activity: Using the Research Budget Tool to Develop Your Budget TASK Log on to the ORSP Website: http://research.utep.edu/orsp Select Tools & Templates Select Research Budget Tool in drop-down down box Click Download: Research Budget Tool
IRB: HUMAN SUBJECTS S IN RESEARCH ATHENA FESTER
IRB: Human Subjects in Research The IRB and its Importance The Institutional Review Board (IRB) is a committee representing various research disciplines that oversees all research involving human subjects conducted by faculty, students, or staff who might use any University property or non-public information i to contact human research subjects Federal law requires that an IRB be established to review all q studies involving human subjects (both funded and unfunded protocols)
IRB Roles and Responsibilities To review, approve, disapprove, suspend, request modifications and/or terminate and submitted studies To process study submissions through expedited, exempt, or full board review To ensure research is being conducted in an ethical manner Ultimately-to safeguard safety for human participants y g y p p volunteering for research projects conducted by students, staff, or faculty
PI Roles & Responsibilities Assurance of safe and ethical study conduct by self and through supervision of study team Compliance for Human Subjects and Research training for self and all study team members Follow through on IRBNet submissions-initial, continuing review, amendments/modifications and study closure Acquisition of proper letters of collaboration to include other IRB approvals, site affiliates and letters of cooperation Proper use of IRB approved and stamped documents
Advisor Roles & Responsibilities To properly guide and mentor student through h the research process Ensure student is conducting and following ethical and safe research practices Ensure student has obtained proper approval to conduct research (internally and externally) Upon completion, ensure student s data is authentic and study Upon completion, ensure student s data is authentic and study has been properly closed
Research Submissions and Exemptions All studies utilizing data collected from human participants must be submitted for IRB review through IRBNet.org. PI s DO NOT make the determination that their study is Exempt. The IRB Chairperson or designated person will make that determination A request for Exemption may always be submitted if the study falls into one of the allotted categories Grant submissions/applications (external and internal) and IRB submissions i are two different areas Most funding agencies will want to see an IRB review determination letter (approval, exempt, deemed not research)
Research Submissions and Exemptions Certain activities may be exempt from IRB review because they fail to meet the definition of research: Program evaluation Service surveys Quality assurance / quality improvement Biographies or oral histories
Submitting Your IRB Protocol IRBNet accessed via www.irbnet.org Energizers (http://research.utep.edu/default.aspx?alias=research.utep.edu/irb) Registration Creating a new study package o o o Proposal Informed Consent Study Documents (surveys, questionnaires, etc) For assistance or in-depth training, please contact Athena Fester at (915) 747-8841 or via e-mail at afester@utep.edu to schedule an appointment.
IRB: Human Subjects in Research In Closing.. Even when clear ethical standards d and principles i exist, there will be times when the need to do accurate research runs up against the rights of potential participants. p No set of standards can possibly anticipate every ethical circumstance. As you work with the IRB to resolve such issues, keep in mind the Belmont principles p of Respect for Persons, Beneficence, and Justice, and thoughtfully place yourself in the subject s position.
INTELLECTUAL PROPERTY INTELLECTUAL PROPERTY SUSAN AVENA
Intellectual Property Intellectual property (IP) is the physical embodiment of an idea Examples: research data, compounds, materials (biological, chemical), publications, presentations The Office of Technology Transfer is responsible for the management and protection of the intellectual property assets of the university Our mission is to help turn scientific discovery into tangible Our mission is to help turn scientific discovery into tangible products by evaluating disclosures for its patentability and potential commercial possibilities
Intellectual Property: Invention Disclosures Before the invention: Make sure you keep proper documentation Notebooks should be bound, pages numbered, entries dated, detailed descriptions of tasks per researcher, and contain data, figures, photos Important entries signed and countersigned by a witness Once the invention is made: All inventions should be reported to the Office of Technology Transfer prior to public disclosure If the invention was federally funded, the Office of Technology Transfer will report the invention to the agency and all subsequent actions relating to the invention
Intellectual Property: Avoid Public Disclosure Public Disclosure is: Presenting at a professional meeting Presenting to a class Publication The Law: The U.S. and Canada allow one year from the date of public disclosure to file a patent Lose the right to file in foreign countries with public disclosure Disclosure can compromise your invention and lose marketability without foreign patent rights
Invention Disclosure Process Submit Invention Disclosure submitted to OTT OTT will help inventor in preparing a presentation to the Intellectual Property Committee (IPC) IPC makes recommendation to VPR on whether to file a patent application CONTACTC CONTACTC Tony Woo Susan Avena Assistant Vice President for Manager Research & Technology Transfer savena@utep.edu / 747-7007 7007 awoo@utep.edu / 747-5860 Website: http://research.utep.edu/techtransfer h t /t
PROCESSING YOUR PROPOSAL
Processing Your Proposal: Final Steps Transmittal Form o o Signatures Attachments Final Review Electronic Submissions of Proposals o Grants.gov o NSF o NIH o DoD o DOE o US DOED o NEH o Homeland Security
Review: Proposal Development Process Identify the opportunity Identify team members, if applicable Submit an NOI Contact IRB, IACUC, or Tech Transfer if applicable Work with the Proposal DevT Discuss your ideas with PO Develop outline and timeline Work with RA on a budget Prepare and refine proposal Send draft for DevT and external review Secure institutional approvals Submit the final proposal
Contact Information & Resources ORSP Proposal Development Team http://research.utep.edu/default.aspx?tabid=59955 ORSP Research Administrators http://research.utep.edu/default.aspx?tabid=61607 ORSP web page http://research.utep.edu/default.aspx?alias=research.utep.edu/orsp Expertise System https://orspprofile.utep.edu/profilesystem/ t / t /
Reflection What did you learn today that was new? What would you like to learn more about? What elements of the workshop did you find the most relevant?