CAH Proposal Submission Process Kristin Wetherbee October 10 th and 11 th, 2012.

Slides:



Advertisements
Similar presentations
The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.
Advertisements

VCOM Conflict of Interest Policy Overview of Financial Conflict of Interest Related to Research December 4, 2013.
Is it Research?. Is It Research? 2 Elements –The project involves a systematic investigation –The design (meaning goal, purpose, or intent) of the investigation.
1 UMass Dartmouth Conflicts of Interest Policies UMass Dartmouth Liz Rodriguez February 17, 2011.
AGENDA  Introduction & General Overview  Types of Audits  Types of Investigations  Audits  Investigations  Closing Remarks.
Ethical Considerations when Developing Human Research Protocols A discipline “born in scandal and reared in protectionism” Carol Levine, 1988.
Responsible Conduct of Research & Research Compliance Adam J. Rubenstein, Ph.D. Director of Research Compliance Old Dominion University Office of Research.
Exempt Research Mary Banks BS, BSN IRB Director CRC IRB and BUMC IRB.
Presented by the Office of Contracts and Grants University of San Francisco November 2011.
IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University.
Responsible Conduct in Research
Office of Research Integrity Office of Research Integrity Orientation Session November 8, 2012 ECSS
Promoting Objectivity in Research by Managing, Reducing, or Eliminating Conflicts of Interest UT HOP UT HOP The University of Texas at Austin.
Office of Sponsored Programs Valerie Howard, Director Phone: Fax:
Indiana University East March 10, 2009 Teresa Miller, Manager Office of Research Administration – Grant Services.
Research Conflicts of Interest: Identifying and Minimizing COI from the Perspectives of Sponsors, Faculty and the IRB Research Conflicts of Interest: Identifying.
Research Compliance Presented by Research and Graduate Studies Elizabeth Peloso.
Responsible Conduct of Research (RCR) Farida Lada October 16, 2013
April 2011 Conducting Research at SPC Approval Process and Procedures Center of Excellence for Teaching and Learning.
 Understanding the IRB Process University of Tennessee Health Science Center Institutional Review Board.
WHO IS WATCHING? WHAT ARE THEY WATCHING? WHY SHOULD I CARE? WHAT SHOULD I DO?
Science & Engineering  New Faculty Orientation Research at Rice Nancy Nisbett, Director Office of Sponsored Research.
Responsible Conduct of Research (RCR) What is RCR? New Requirements for RCR Who Does it Affect? When? Data Management What is the Institutional Plan? What.
WORKING WITH SPO AND IAO Lynne HollyerNoam Pines Associate Director Research Administrator Industry Alliances OfficeSponsored Projects Office
Nuts and Bolts of Proposal Development Josie Causseaux May 24,
Office of the Vice Chancellor for Research 1 Update on PHS New Rule on Financial Conflicts of Interest (FCOI) Presentation to Business Managers January.
Sponsored Programs Services (SPS) PROPOSALS. What is the PI’s role in the proposal?  Contact the central pre-award center,
Managing Your Grant Award August 23, 2012 Janet Stoeckert Director, Research Administration Sr. Administrator, Basic Sciences Keck School of Medicine 1.
Teaching Research Methods (Classroom Protocols) Boston University Charles River Campus Boston University Medical Center Mary A. Banks BS, BSN IRB Director.
Institutional Review Board for Human Subject Research: Does Your Research Need One? Merle Rosenzweig Michael Unsworth.
RESPONSIBLE CONDUCT IN HUMAN SUBJECTS RESEARCH MARGARITA M. CARDONA DIRECTOR OF SPONSORED RESEARCH Institutional Review Board.
Fundamentals for Faculty Andrea Deaton, CRA Executive Director Office of Research Services
The Institutional Review Board: A Community College Toolkit Dr. Geri J Anderson.
How to Successfully Apply to the IRB Richard Gordin, IRB Chair True Rubal, Administrator / Director For the Protection of Human Participants in Research.
IRB BASICS: Issues in Ethics and Human Subject Protections Prepared by Ed Merrill Department of Psychology November 12, 2009.
Debra Murray, Georgetown University Tolise Miles, Children’s National Medical Center Clairice Lloyd, Georgetown University Medical Center Pre-Award and.
Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Human Subjects Research and the Marian University Institutional Review Board (IRB)
Institutional Review Board Issues for Classroom Research Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen,
NAVIGATING THE IRB PROCESS University Institutional Review Board California State University, Stanislaus.
Office of Sponsored Projects The Funding Life Cycle.
AAHRPP ACCREDITATION (Association for the Accreditation of Human Protection Programs)
CUNY Human Research Protection Program (HRPP) School of Professional Studies April 18, 2013
WELCOME to the TULANE UNIVERSITY HUMAN RESEARCH PROTECTION OFFICE WORKSHOP for SOCIAL/BEHAVIORAL RESEARCH (March 2, 2010) Tulane University HRPO Uptown.
Paul Kelly Facility Research Compliance Officer for the Ralph H. Johnson VA Medical Center.
The University of Texas at Arlington Office of Research and Office of Accounting and Business Services Brown Bag Training Session One: INTRODUCTION.
 Welcome ◦ Amanda Athey, Director, Graduate School  Student Experience  Funding Opportunities ◦ Rebecca Drake, Research Administrator, Office of Research.
Paul Hryvniak MS, CIP Alyssa Speier, MS, CIP September 30, 2014 Student Human Research Education Session Tel:
Office of Sponsored Projects The Funding Life Cycle.
 What is an IRB and why do we need one at Western?  Who needs to submit proposals to the IRB?  If approved, how long is your proposal good for?  Is.
Research Ethics Office of Research Compliance. Responsible Conduct of Research (RCR) Covers 9 content areas –Animal Subjects (IACUC) –Human Subjects (IRB)
THE INSTITUTIONAL REVIEW BOARD. WHAT IS AN IRB? An IRB is committee set up by an institution to review, approve, and regulate research conducted under.
What Does Every Graduate Student Need to Know about RCR Jo Ann Smith, PhD, CRA Griselle Báez-Muñoz University of Central Florida Office of Research & Commericalization.
PROPOSAL REVIEW AND SUBMISSION FYAP May 5, 2016 Julie Wammack Sponsored Research Administration.
IUP Research Institute Post-Award Services
IRB BASICS Ethics and Human Subject Protections Summer 2016
APEP Research Information Session Kristin Wetherbee Director, CAH Research Office Pamela McGlinchey Coordinator, CAH Research Office 09/29/2017.
University of Central Florida Office of Research & Commercialization
Conducting Human Subjects Research
New Faculty Research Services Office of Research (OOR)
Proposal Routing Overview
Conducting Human Subjects Research
University of Central Florida Office of Research & Commercialization
Conducting Human Subjects Research
CUNY Human Research Protection Program (HRPP)
Rutgers Export Compliance Officer
I want to submit a grant. What do I do?
What the IRB is looking for when reviewing your protocol
Human Participants Research
A Look at the Pre-Award & Contract Services Office
Research with Human Subjects
Presentation transcript:

CAH Proposal Submission Process Kristin Wetherbee October 10 th and 11 th, 2012

Gather support Enter PTF Submit application Research Reporting Certify effort Write proposal Contact CAH Research Finalize budget Start with an idea Find funding opportunity Discuss with chair Idea and Background (1 – 2 months) Develop Proposal (2 - 4 months) Proposal Submission (1 - 3 weeks) Award Admin (Grant length) Grant Process

Proposal Submission Process ORC Proposal Transmittal Form (PTF) Internal UCF form routes electronically for approvals from: PI Co-PI(s) Chair(s) Research Office(s) Dean(s) ORC Fully approved to ORC 48 hours prior to proposal deadline Agency Proposal Package Documents required by the funding agency: Proposal Budget and narrative Timeline Bios Appendices To CAH Research Office 5 days prior to deadline to review and format per agency guidelines

Proposal Transmittal Form The PTF is found in ARGIS or myRESEARCH found at The CAH ARGIS Procedure Guide has more information about PTF creation. It is found at

PTF Special Considerations

How do I know if a project needs IRB review? Meets federal definition of research: Systematic investigation designed to develop or contribute to generalizable knowledge Meets definition of human subject: Investigator will gather data about living individuals through intervention or interaction OR investigator will gather data about living individuals that is private AND identifiable. Types of IRB Reviews: Full Board Protocol Review - more than minimal risk Expedited - minimal risk Document review Surveys Specimen collection Routine noninvasive procedures Exempt - minimal or no risk Instructional strategies Educational tests Publicly available data and some prior studies where participants cannot be identified Some taste and food quality studies Human Subjects

Human Subjects (cont.) Criteria for IRB Approval Minimized risk using sound research design; no unnecessary risk to subjects Risks are reasonable in relation to the benefits Subject selection is equitable Informed Consent sought for every prospective subject Documented informed consent Monitor data collected to ensure subject safety Subject privacy is protected and confidentiality will be maintained Additional safeguards in protocol to protect the rights and welfare of subjects vulnerable to undue influence

Intellectual Property Forms of intellectual property: Patents - protects an invention Copyrights - protects an original artistic or literary work Trademarks - typically protects brand names and logos used on goods and services Trade Secrets - generally protect particular types of confidential information from which the owner derives value based on its secrecy How the UCF Tech Transfer Office can help: Execute Non-Disclosure Agreements (NDAs) to control the sharing of confidential information Execute non-compete agreements with employees to control post-employment solicitations of other employees and other damaging competitive actions Assign rights of all work, inventions, etc. to institution (UCF) How ORC can help: Contracts with consultants and subcontractors to assign rights to UCF Contract clauses in agency contracts to assign rights to UCF or share rights

Export Control When to contact the UCF Export Control Office Sponsored Research: Proposal contains a subject or involves technologies listed on the Export Administration Regulations (EAR) Commerce Control List (CCL) and will not qualify as "fundamental research" due to access, participation, dissemination or publication restrictions The research will involve chemicals, select agents, toxins Research is related to items on the Int’l Traffic in-Arms Regulations (ITAR) U.S. Munitions List (USML) Pre-Award: Award doesn’t qualify for the fundamental research exclusion and involves tech listed in EAR or ITAR U.S. Munitions List and you plan to use foreign national(s) in the research Award is sponsored by the DoD or NASA and contains contractual restrictions Sponsor has requested a secrecy agreements that will impact publishing Sponsor will provide identified EC items or information as part of research Post-Award:

Export Control (cont.) When to contact the UCF Export Control Office General Activities: A person listed as a restricted party Hosting foreign nationals from a sanctioned/embargoed country Foreign Collaborations Foreign nationals who are not bona fide employees of the university participating in activities relating to defense articles on the ITAR U.S. Munition List (USML) or projects subject to access or dissemination restrictions Research Participation Travel to a sanctioned/embargoed country for official university activities Travel to any country with university equipment, select agents, or toxins International Travel Shipment of tangible items or research deliverables internationally International Shipping

America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES)America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act Requires that “each institution that applies for financial assistance from [NSF]…for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to [those]…participating in the proposed research project.” This includes:  Undergraduate students  Graduate students  Postdoctoral researchers CITI Training or another method of training needs to be documented in NSF proposals, see Responsible Conduct of Research (RCR)

Conflict of Interest statement on PTF COI also submitted annually through ARGIS Update if changes happen before next annual cycle PHS proposals require disclosure prior to submission PHS defines “investigator” as anyone involved in the design, conduct or reporting of research When in doubt, contact ORC For more information go to Conflict of Interest A potential COI exists when a university employee’s Significant Financial Interest, (anything of monetary value including salary, equity interest, and/or intellectual property rights) could directly and significantly affect the DESIGN, CONDUCT or REPORTING of research.

Research Misconduct Fabrication Making up data or results and recording or reporting them Falsification Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. Plagiarism The appropriation of another person’s ideas, processes, results or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion. What is research misconduct? Per NSF Applies to proposals, performing research, and reporting of researchhttp:// From:

iThenticate Plagiarism detection technology A tool to help faculty identify errors in documents Confidential and only accessible by the originating faculty and select ORC administrators Used by NSF to check for plagiarism in proposal submissions Required for proposals submitted on behalf of UCF iThenticate IS: Saving your proposals or journal articles in it’s database Policed by UCF or ORC For student papers (use turnitin.com) Available for college research admin to use on behalf of the PI iThenticate is NOT: For more info on UCF’s iThenticate process go to Access iThenticate at For Login info your name, UCF , and phone number to

Includes any documents required by the funding agency, generally: Proposal Budget Budget justification or narrative Timeline Bios Appendices all to CAH Research 5 days prior to submission deadline for: CAH review Formatting per agency guidelines Entry into agency forms and/or application NSF is the exception PI must set up FastLane application PI or ORC can enter application CAH Research will final package to ORC Proposal Package

When to Use a PTF Are you committing UCF resources? Letter of Intent Do you want to submit as an individual? NO YES General Call Prelim Proposal Invited Proposal Type of Submission PTF Required NO YES Self Submit Is a detailed budget required? YES ORC budget review Do you want a record of the proposal submission through UCF? YES NO

Questions? What else can the CAH Research Office do to help you? Additional Needs

UCF’s Office of Research and Commercialization (ORC) Proposal, budget, submission guidelines CAH Research Website Proposal, funded grants, ECRT ORC Compliance COI, RCR, export control, ECRT, IRB Websites

Madhavi Chokshi, Internal & limited Marysol Ortega-Perez, GrantForward and PIVOT Joan Jarvis, Proposal Cira Mathis, Contract Barbara Ward, Compliance and Maxine Zimmerman, ORC Contacts Dr. Rudy McDaniel, Research Kristin Wetherbee, Assoc Director Grace Nicholl, Research Assistant CAH Contacts