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1. M ODULE 4 P ART I C ONFLICT OF I NTEREST (COI) & Part 2 Research Integrity (RCR & RM) Griselle Báez-Muñoz Assistant Director/Ethics & Compliance July. - ppt download
1. M ODULE 4 P ART I C ONFLICT OF I NTEREST (COI) & Part 2 Research Integrity (RCR & RM) Griselle Báez-Muñoz Assistant Director/Ethics & Compliance July.
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Presentation on theme: "1. M ODULE 4 P ART I C ONFLICT OF I NTEREST (COI) & Part 2 Research Integrity (RCR & RM) Griselle Báez-Muñoz Assistant Director/Ethics & Compliance July."— Presentation transcript:
2 M ODULE 4 P ART I C ONFLICT OF I NTEREST (COI) & Part 2 Research Integrity (RCR & RM) Griselle Báez-Muñoz Assistant Director/Ethics & Compliance July 2013 Exploring Research Administration…for CONCEPT to COMMERCIALIZATION
3  Part I: Conflict of Interest (COI) AGENDA  Authority & Historical Facts  “Final Rule” requirements (Effective Aug 24, 2012)  Applicability (Policies & Regulations)  Relevant Definitions  COI Review Process at UCF  COI Training by Investigators  Summary  Case Study  COI & COC “Crossword” Exercise Conflict of Interest (COI) & Research Integrity (RCR & RM) 3
4 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  Authority Federal Financial Conflict of Interest Regulations : “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought” 42 CFR Part 50 Subpart F [Applicable to Grants and Cooperative Agreements] http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf (Pages 53283- 53288) 45 CFR Part 94 [Applicable to Contracts] http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf (Pages 53288-53293) 4
5 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  State of Florida Laws Code of Ethics for Public Officers and Employees, Title X, Part III, F. S. Chapter 112 (Sections 112. 311 to 112-326) http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute& URL=Ch0112/part03.htm&StatuteYear=2009&%20Title=%2D%3E2009% 2D%3EChapter%20112%2D%3EPart%20III State of Florida statutes requires that no employee shall have any interest, financial or otherwise, direct or indirect; engage in any business transaction or professional activity; or incur any obligation of any nature which is in substantial conflict with the proper discharge of his or her duties in the public interest. However, in some cases, an exemption can be granted by the university consistent with categories defined by the State of Florida under this Chapter.* * At UCF- COI supplemental form: Request for an Exemption/Disclosure 5
6 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  UCF Reporting a Potential Conflict of Interest or Conflict of Commitment in Research (Policy Number 4.504-2) http://policies.ucf.edu/documents/4-504.2ReportingaPotentialConflictofInterest orConflictofCommitmentinReseachFinalonLetterhead08-20-12.pdf Financial conflict of interest Guidelines/ORC (August 24, 2012) http://www.coi.ucf.edu/Documents/Financial%20Conflict%20of%20Interest%20Guidelines.pdf UCF Institutional Review Board (IRB) HRP-080-SPO, Conflicting Interest of IRB Members and Consultants http://www.coi.ucf.edu/Documents/HRP-080%20-%20SOP%20- %20Conflicting%20Interests%20of%20IRB%20Members%20and%20Consultants.pdf UCF Animal Research Protection Office (IACUC) IACUC-excerpt Policy Manual. III.8 http://www.coi.ucf.edu/Documents/IACUC-excerptPolicyManual_III.8.pdf 6
7 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) Continuation: UCF IACUC-excerpt Policy Manual_Appendix 7_III D.6 http://www.coi.ucf.edu/Documents/IACUC-excerptPolicyManual_Appendix%207_III_D.6.pdf UCF College of Medicine http://med.ucf.edu/media/2011/08/UCF-COM-Industry-Relations-Policy-and-Guidelines.pdf UCF Collective Bargaining Agreement Article 19-Conflict of Interest or Commitment/Outside Activity http://www.coi.ucf.edu/Documents/CBA_Article%2019_Conflict%20of%20Interest%20or%20Commitment_ Outside%20Activity.pdf College of Graduate Studies Graduate Catalogue/College of Graduate Studies/ Section Graduate Faculty and Graduate Faculty Scholars/ University-Wide Qualifications for Participation in Graduate Education http://www.coi.ucf.edu/Documents/Excerpts_20122013_GraduateCatalogFacultyAndGraduateFacultyScholars.pdf 7
8 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  Historical Facts The initial regulation was effective Oct 1 st 1995: http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm The revised regulation (“Final Rule”) was published in the Federal Register on Aug 25 th 2011 with an effective implementation date as of Aug 24 th 2012: http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf In addition to DHHS/PHS & NIH units, other sponsoring agencies have adopted the “Final Rule” http://sites.nationalacademies.org/PGA/fdp/PGA_070596 8
9 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  Among others, the “Final Rule” requires that Institutions receiving DHHS, PHS & NIH funding shall : Comply with revised FCOI regulations Revise their institutional COI policies accordingly. Require (and enforce) completion of COI training by their investigators (PIs & Co-PIs) and by any other project participant responsible for the design, conduct or reporting of research. Provide required certifications (included in proposal(s) being submitted to DHHS, PHS & NIH) for the existence of written FCOI policies & a process in place for the review of FCOI disclosures submitted by investigators; Submit an initial report to DHSS, PHS or NIH units (as applicable) prior to the expenditure of any PHS funds, detailing any investigator’s FCOI identified by the university relating to PHS funding which requires a management plan accepted by the university. An annual report is also required. Make FCOI policies publicly accessible, and/or available upon request. 9
10 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  Applicability  The new FCOI requirements apply to: Any institution applying for funding or receiving funding from any of the DHHS, PHS or NIH units [either Domestic (Public or Private) & Foreign] All SBIR & STTR Phase II recipients, HOWEVER, it does not apply to SBIR & STTR Phase I recipients Subrecipients (Compensated or uncompensated subcontractors, consultants, or other third-party entities (affiliates) performing research services for UCF under a written or verbal agreement). 10
11 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  RELEVANT DEFINITIONS Conflict of Interest Disclosure Financial Conflict of Interest (FCOI) Significant Financial Interest (SFI) SFI exclusions Outside Activity Conflicts of Commitment Consulting Investigator Institutional Responsibilities 11
12 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) UCF’s Collective Bargaining Agreement defines Conflicts of Interest as: (1) Any conflict between private interests of the employee and the public interests of the university, the Board of Governors, or the State of Florida, including conflicts of interest specified under Florida Statutes; or (2) Any activity which interferes with the full performance of the employee's professional or institutional responsibilities or obligations. UCF’s COI Policy in Research defines Conflict of Interest as: A divergence between an individual’s private interests and his or her employment obligations to the university such that an independent observer may reasonably question whether the individual’s actions or decisions are influenced or determined by considerations other than the best interest of the university. 12
13 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) Disclosure: A disclosure is a form used by an employee to disclose any actual or potential conflict of interest or conflicts of commitment any time that a personal or financial interest could potentially influence the employee’s objectivity and performance of his/her institutional responsibilities. Disclosure is required on an annual basis and/or within 30 days of discovering, acquiring, or committing to a new financial interest or commitment. The “Final Rule” requires submission of a COI disclosure by investigators and any other project participant identified by the PI as responsible for the design, conduct or reporting of research prior to proposal submission to any of the DHHS/PHS/NIH units. The ORC’s Pre- Award Staff verifies completion of this requirement. This requirement also applies to disclosure actions initiated by subrecipients and other affiliates. Financial Conflict of Interest (FCOI) : A significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS- funded research. Significant Financial Interest (SFI): Consists of one or more of the following interests of the investigator (and those of the investigator's spouse and dependent children) that reasonably appears to be related to the investigator's university (institutional) responsibilities: 13
14 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) (Continuation: SFI) 1. with regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure and the value of any equity interest or fixed asset value of the entity as of the date of disclosure, when aggregated, equals or exceeds $5,000; 2. with regard to any non-publically traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, equals or exceeds $5,000 or when the investigator (or the investigator's spouse and dependent children) holds any equity interest (e.g., stock, stock options, or other ownership interest); or intellectual property rights and interests (e.g., patents, copyrights, trademarks) upon receipt of income related to such rights and interests. 14
15 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) SFI exclusions: The term significant financial interest does not include the following: (i) salary, royalties, or other remuneration paid by the university, (ii) income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with the university, (iii) income from service on advisory committees, review panels for a federal, state, or local government agency, institution of higher education, an academic teaching hospital, medical center, or research institute affiliated with the university. 15
16 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) Outside Activity or Employment: UCF’s COI Policy in Research defines Outside Activity or Employment as: Any compensated or uncompensated secondary employment or activity, private practice, private consulting, teaching, research, or other activity that is not part of the employee's assigned duties at the university. If the amount of time spent on paid or unpaid activities outside the university interferes with one's teaching, research, or service work for UCF, it is a potential conflict of commitment. Potential Conflicts of Commitment (COC): UCF’s COI Policy in Research defines Conflicts of Commitment as: An employee’s devotion of time to activities that adversely affect his or her capability to meet their primary university responsibilities. Examples may include but are not limited to outside employment, pro bono or volunteer work, and government service in the public interest. 16
17 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) Consulting: The use of scholarly and scientific expertise for the benefit of organizations outside of the university in return for compensation. Investigator: [FINAL RULE]: The Project Director (PD) or Principal Investigator (PI) and any other person, regardless of title or position who is responsible for the design, conduct, or reporting of research (funded by PHS) or proposed for such funding, which may include, for example, collaborators or consultants. [UCF]: Expanded the definition to also include non-sponsored research. 17
18 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) Institutional Responsibilities: Refer to an investigator's professional responsibilities on behalf of the university. The activities outlined in an employee’s annual assignment or position description may include: administration, teaching, research and creative activities, course preparation, curriculum development, lectures, evaluation of student efforts, academic advising, committee meetings and memberships, service on panels such as university review boards or data and safety monitoring boards, public service to include service on advisory committees or review panels, and any other activity assigned by the employee’s supervisor in accordance with university policies. 18
19  UCF’ s On-line Disclosure [internal review/approval routing] Employee completes disclosure using the PCOI system/ARGIS ↓ Review by employee’s supervisor or Dept Chair (as applicable) is conducted ↓ Review by College Dean or Ctr/Institute Director is conducted ↓ If a “Yes” response is provided to Questions # 1, 2, 3, 9 or 10, record will be routed for ↓ Review by ORC’s Director of Compliance or delegate ↓ ↑ [Determines if there is “ No Conflict” or if a conflict is identified and /or if COI supplemental forms* are required from Employee/Discloser in order to mitigate and/or manage the identified conflict] [If responses are “No” to these questions, record will not be routed to ORC but to the Office of Faculty Relations for review] ↓ Review by Office of Faculty Relations as the last reviewer/approver *Monitoring Plan for PCOI or a Request for an Exemption/ Disclosure Forms. As needed, ORC shall report to the sponsoring agency any identified COI relating to PHS funding. 19
20 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  ORC’ s Hard-Copy disclosure form Applicable to (a) project participants responsible for the design, conduct or reporting of research (as identified by the PI or Co-PI), and (b) any PI or Co-PI not classified as Faculty or Post-Doc assigned under a sponsored project. Employee completes disclosure using the ORC’s Hard-Copy disclosure pdf fillable form ↓ http://www.coi.ucf.edu/Forms/COI/COI_COC_2013.pdfhttp://www.coi.ucf.edu/Forms/COI/COI_COC_2013.pdf ↓ Review by Employee’s supervisor or Dept Chair (as applicable) is conducted ↓ Review by College Dean or Ctr/Institute Director is conducted ↓ If a “Yes” response is provided to Questions # 1, 2, 3, 9 or 10, the record will be routed for ↓ Review by ORC’s Director of Compliance or delegate ↓ ↑ [Determines if there is “ No Conflict” or if a conflict is identified and COI supplemental forms* are required from Employee/Discloser in order to mitigate and/or manage the identified conflict] ↓ ORC is last reviewer/approver *Monitoring Plan for PCOI or Request for an Exemption/ Disclosure Forms 20
21 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  ORC’ s Hard-Copy disclosures for use by Subrecipients & Other Affiliates participating in projects to be sponsored by any of the DHHS/PHS or NIH units and/or by any other agency that adopted the revised FCOI guidelines Completion of disclosures by Subrecipients or Other Affiliates is required by UCF. Use of the ORC’s hard-copy Subrecipients & Other Affiliates disclosure form is required if no PCOI disclosure reporting process exists at their contractually-affiliated institution(s), if they are not affiliated to any entity or they are acting as individual consultants. ↓ Review by UCF’ s Principal Investigator is conducted↓ Review by ORC’s Director of Compliance or delegate is conducted ↑ [Determines if there is “ No Conflict” or if a conflict is identified and/or if COI supplementalforms are required from Subrecipient or Other Affiliate in order to mitigate and/or manage any identified conflict] ORC is final reviewer/approver. As applicable, ORC shall report to the sponsoring agency any identified FCOI relating to PHS funding. 21
22 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  COI TRAINING REQUIREMENTS Effective August 24, 2012, COI training must be completed by investigators (PIs & Co-PIs) and by any other project participant responsible for the design, conduct and reporting of research under sponsored projects. Training must be completed prior to set-up of a new project account number by the ORC’s Post-Award Staff, or any incremental funding action processed by UCF in/or after August 24, 2012. The Post-Award Staff monitors completion of this requirement. The UCF’CITI Program–COI Training Course can be accessed at: https://www.citiprogram.org/default.asp?language=english https://www.citiprogram.org/default.asp?language=english 22
23 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  SUMMARY Effective August 24, 2012: Disclosure of potential COI & COC by investigators and any other person responsible for the design, conduct or reporting of research is required PRIOR to proposal submission to any DHHS/PHS & NIH units, as well as other selected agencies. Reporting to the sponsor of any financial conflict of interest of an investigator identified by the university is required, including a description of any mitigation effort and/or monitoring plans established by the university to address such conflict(s). COI Training by investigators and any other person responsible for the design, conduct or reporting of research is required PRIOR to set-up of a new project account and/or the processing of an incremental funding action at UCF. __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________  As a standard, ORC is involved in the review process of on-line disclosures with positive answers to Questions # 1, 2, 3, 9 or 10.  Submission of COI supplemental forms may be required from an employee/investigator, if the identified conflict of interest is found to require the processing (and approval) of a Monitoring Plan for Conflict of Interest, a Request for an Exemption/Disclosure (or both), consistent with federal, state and/or university requirements, as applicable. 23
24 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) Case Study & COI & COC “Crossword” Exercise 24
26 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  Part 2: Responsible Conduct of Research (RCR & RM) AGENDA  Relevant Definitions  Applicability (Policies & Regulations)  RCR Training (CITI & Individualized)  9 Instructional Cores of RCR  RM Review Process at UCF  iThenticate  Case Study 26
27 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  Relevant Definitions Research Integrity: I ncludes the use of honest and verifiable methods in proposing, performing, and evaluating research, reporting research results with particular attention to adherence to rules, regulations, guidelines, and following commonly accepted professional codes or norms. (DHHS, Grants & funding/ http://grants.nih.gov/grants/research_integrity/whatis.htm) http://grants.nih.gov/grants/research_integrity/whatis.htm Responsible Conduct of Research (RCR): Includes most of the professional activities that are part of a research career. RCR seeks t the highest level or ethical and scientific performance standards. Although not necessarily regulated, the federal government and the scientific community acknowledges that RCR encompasses nine (9) instructional cores which shall be of general knowledge to investigators (PIs & Co-PIs)/mentors of participants in projects funded by NSF (all programs) and NIH (selected programs only). Research Misconduct (RM): The fabrication, falsification or plagiarism in proposing, performing, or reviewing research, or in reporting research results. RM does not include honest error or differences of opinion. 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. 27
28 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) Plagiarism: the appropriation of another person’s ideas, processes, results or words without giving appropriate credit. Deciding Official: Final Institutional approver for results and recommendation of RM proceedings- all levels. (at UCF= VP for Research & Commercialization) RIO: Responsible Institutional Officer for the oversight of all RM institutional proceedings (at UCF=ORC’ s Director of Compliance) Complainant: Individual, agency or entity generating & releasing an allegation of research misconduct. Respondent: Individual being accused of an alleged research misconduct action(s). Levels of Intent: The NSF’s Office of Inspector General (OIG) has defined the levels of intent regarding an allegation of research misconduct to include the following criteria: Careless, Reckless; Knowing or Intentional. 28
29 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  Applicability (Policies & Regulations) 45 CFR Part 689 (National Science Foundation-Research Misconduct) http://www.nsf.gov/oig/resmisreg.pdf http://www.nsf.gov/oig/resmisreg.pdf 42 CFR Parts 50 and 93 (Department of Health and Human Services) Public Health Service Policies on Research Misconduct: Final rule (2005) http://ori.dhhs.gov/sites/default/files/42_cfr_parts_50_and_93_2005.pdf For a list of all other federal agencies having a RM Policy or Procedures in place access: http://ori.dhhs.gov/federal-policieshttp://ori.dhhs.gov/federal-policies UCF’s Research Misconduct Policy No. 4-211 (Effective 11-16-2011) http://policies.ucf.edu/documents/4-211ResearchMisconductFinalonLetterhead11-16-11.pdf 29
30  RCR Training (CITI Program & Individualized Training) UCF is a registered user of the CITI-RCR Training Courses Current courses in RCR include: RCR for Administrators, Arts & Humanities, Biomedical Sciences, Engineering, Social & Behavioral Sciences and Physical Sciences. RCR Training completion: Within 120 days of assignment to payroll. The ORC’s RCR Training Program staff monitors completion of RCR training under NSF & NIH awards. The CITI Program–RCR Training Course can be accessed at: https://www.citiprogram.org/default.asp?language=english https://www.citiprogram.org/default.asp?language=english CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) 30
31 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) NSF requires RCR training completion by undergraduate students, graduate students and post-doctoral researchers paid under any NSF award. The CITI-RCR Training Courses are acceptable to NSF as the sole means of RCR training. NIH also requires RCR training completion by undergraduate students, graduate students and post-doctoral researchers paid under selected NIH programs. The CITI-RCR Training Courses are acceptable to NIH, however, additional 8 hrs (minimum) one-to-one contact training is required between the PI (mentor) and project participants as defined above. Individualized RCR training is also acceptable by UCF. This type of training is used by a very small percentage of PIs who prefer to conduct their own RCR training session, either as a component of a course curriculum (research ethics & compliance) or via a specialized RCR designed training session. Documentation for completed training by project participants is required by ORC for accountability and audit purposes, as applicable. 31
32 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) RCR Training by doctoral students: The UCF’s Office of Graduate Studies requires completion of CITI Program RCR Training Courses by all enrolled doctoral students. Training must be completed in/or by the time of thesis presentation. Students select the RCR training course of their interest taking into consideration their field of study. 32
33 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) The Nine (9) Cores of RCR Data Acquisition, Management, Sharing and Ownership Mentor/Trainee relationships Publications- Practices and Responsible Authorship Peer Review Collaborative Science Human Research Protections (Human Subjects) Laboratory Animal Welfare (Research Involving Animals) Research Misconduct Conflict of Interest and Conflicts of Commitment 33
34 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  SHARED VALUES IN SCIENTIFIC RESEARCH* HONESTY convey information truthfully and honoring commitments  ACCURACY report findings precisely and take care to avoid errors  EFFICIENCY use resources wisely and avoid waste  OBJECTIVITY let the facts speak for themselves and avoid improper bias * STENECK, N. H. 2007. ORI - Introduction to the Responsible Conduct of Research,Introduction to the Responsible Conduct of Research Washington D.C., U.S. Government Printing Office, p.3 34
35 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  Research Misconduct (RM) Review Process at UCF An allegation of research misconduct could be received at UCF/ORC from either an INTERNAL or an EXTERNAL source. ORC will accept responsibility to look into allegation facts and will notify the Deciding Official (UCF’s VP for Research & Commercialization) of the allegation receipt: If the allegation comes from an INTERNAL source, ORC: Initiates a “Assessment”. If results of the Assessment determines that the allegation is unjustified or mistaken, notification to the Deciding Official is processed for a determination to notify both the Complainant and the Respondent that no further RM proceedings will be conducted and that the allegation case will be closed. If the preponderance of the evidence resulting from the Assessment process is determined to warrant an “Inquiry”, the Inquiry process will be activated via a RM Inquiry Committee. If the RM Inquiry Committee determines that a full “investigation” is warranted, a RM Investigation will be activated via a RM Investigation Committee (consistent with federal and UCF RM policies & procedures). 35
36 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) If allegation comes from an EXTERNAL source, ORC: Must make a decision (on UCF’s behalf) to accept responsibility for conducting a formal investigation of the allegation of research misconduct [Otherwise, the Complainant will do it following its own RM guidelines]. Notifies the Deciding Official that an allegation of RM has been received. Requests appointment members from the Deciding Official for the composition of the RM Investigation Committee. Coordinates and facilitates the RM Investigation proceedings consistent with federal regulations and UCF’s RM Policy and Assurance. Coordinates preparation, internal review and submission of the “RM Investigation Final Report” to be submitted to the Complainant, which includes findings and recommendations of the completed investigation. Processes any post-RM Investigation Final Report submission actions through receipt of an official response from the Complainant of its determination regarding the content of the RM Final Report.. 36
37 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM)  iThenticate iThenticate is an online plagiarism detection technology that allows the uploading of documents (including among others, proposals, manuscripts, thesis, journals, etc.), and screens them against millions of published documents available through the Internet and multiple web-based databases. Effective September 2012, use of iThenticate is required for the review of proposals prior to submission to the sponsor, in order to protect investigators and UCF from the receipt of allegations of research misconduct. iThenticate can be accessed at https://app.ithenticate.com/en_us/loginhttps://app.ithenticate.com/en_us/login or via the ORC´s webpage at http://www.rcr.ucf.edu/.http://www.rcr.ucf.edu/ Registration to iThenticate is required and the RCR Training Program Office facilitates access by investigators to the system. Have a question about iThenticate: Send an e-mail to rcr-ucf@ucf.edurcr-ucf@ucf.edu 37
38 CONFLICT OF INTEREST (COI) & RESEARCH INTEGRITY (RCR & RM) CASE STUDY UCF received an allegation of Research Misconduct relating to your XXXX… (proposal/journal….) Relating to what? PLAGIARISM! What? … Am I in trouble? What’s next: for me, for UCF? We must now begin the RM proceedings… 38
40 THANKS FOR JOINING US! See you at the next session: Research Ethics &Compliance: IRB & IACUC on 7/31/2013
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