office of research & sponsored programs responsible conduct of research jeff busch, ph.d. main...
TRANSCRIPT
![Page 1: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/1.jpg)
Office of Research & Sponsored Programs
Responsible Conduct of Research
Jeff Busch, Ph.D.Main CampusResearch Compliance Coordinator
![Page 2: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/2.jpg)
Don’t Let This Happen to You
Recent Cases
• Dr. J. Reece Roth, emeritus professor of electrical engineering at the University of Tennessee in Knoxville recently was sentenced to four years in prison for deemed export violations.
• Dr. Thomas Butler, professor at Texas Tech Health Sciences Center was sentenced to two years’ imprisonment, three years’ supervised release and criminal fines totaling $50,000 for exporting hazardous microorganisms to Tanzania without a license.
![Page 3: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/3.jpg)
RESPONSIBLE CONDUCT OF RESEARCH
• Data Management• Mentor/Trainee Relationships• Publication Practices• Peer Review• Collaborative Science• Human Subjects• Animal Welfare• Research Misconduct• Conflict of Interest and Commitment• Environmental Safety (chemical, radiation & biohazards)• Export Control Laws
![Page 4: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/4.jpg)
RESEARCH PROTOCOLS
Students MUST be Named Participants on Approved Protocols for Research Involving:
• Human Subjects
• Animals
• Environmental Safety
• Chemical, radiation & biohazards
![Page 5: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/5.jpg)
GRAD Approval & Assurance Form
![Page 6: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/6.jpg)
HUMAN SUBJECTS RESEARCH
HUMAN SUBJECTS refers to living individuals about whom an investigator conducting research obtains:
DEFINITION OF “HUMAN SUBJECTS”:
• Data through INTERVENTION or INTERACTION with the individual, OR
• IDENTIFIABLE PRIVATE INFORMATION
![Page 7: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/7.jpg)
ANIMAL SUBJECTS RESEARCH
Use of LIVE, VERTEBRATE Animals for RESEARCH, RESEARCH TRAINING, or
BIOLOGICAL TESTING
Includes:• Lab Testing • Behavioral Testing • Field Collection• Field Observation
![Page 8: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/8.jpg)
ENVIRONMENTAL SAFETY
Radiation Safety• Radioisotopes• Radiation Generating Devices
•Irradiators, Electron Microscopes, Particle Accelerators
Chemical Safety• Toxic, Carcinogenic, Caustic or Flammable Materials
Biohazard Safety• Recombinant DNA Research• Other Biohazardous Microorganisms
![Page 9: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/9.jpg)
Responsible Conduct of Research
Students MUST be Named Participants on Approved Protocols for Research Involving:
• Human Subjects
• Animals
• Environmental Safety
• Chemical, radiation & biohazards
![Page 10: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/10.jpg)
Export Control Laws
Violations of trade sanctions and export controls can result in criminal penalties:
• Heavy Institutional Fines (up to $1 M per violation)
• Individual Prison Terms (up to 20 years per violation)
![Page 11: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/11.jpg)
What is an Export?
Exports: The shipment or transfer of items, information, or software outside the U.S. or; the release or sharing of restricted technology or data
• Items – Tangible things, equipment or hardware• Information = “Technical Data” such as models, formulae, engineering designs or technical assistance such as training or instruction.• Software – Computer programs in either “Source Code” (programming statements) or “Object Code” (machine- readable instructions).
![Page 12: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/12.jpg)
Prohibited Countries
Commerce Sanctioned CountriesAfghanistan Liberia Armenia North KoreaAzerbaijan SyriaBelarus TajikistanCuba UkraineIran VietnamIraq
Arms Embargoed CountriesBurmaChina
Fed. Rep. of Yugoslavia Haiti
LiberiaSomaliaSudanZaire
Subject to U.S. Trade EmbargoesBurmaCubaIran
SyriaNorth Korea
Sudan
State Sanctioned CountriesBalkans
Cote D’IvoireIraq
LiberiaLibya
Palestinian AuthorityZimbabwe
![Page 13: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/13.jpg)
What is a Conflict of Interest?
• I am actually, or potentially, in a situation in
which it would be reasonable for others to
wonder whether certain interests of mine might
compromise my ability to exercise good
judgment • Can Be Both Positive or Negative• Types of COI
–Conflicts of the wallet–Conflicts of the heart–Conflicts of conscience
![Page 14: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/14.jpg)
COI Disclosure
• Researchers Have an Obligation to Fully Disclose• Formal Disclosure
– Annual disclosure to university– Disclosure submission with each new proposal
• Informal Disclosure– Document statement or recusing oneself from decision
• Positive Disclosures are not Necessarily Bad– Conflicts need to be managed
![Page 15: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/15.jpg)
Summary
Practice Everything You Learned in Kindergarten
Work Hard and Do Things Right
Be Aware of Rules and Regulations That Effect You
![Page 16: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/16.jpg)
Responsible Conduct of Research
Students MUST be Named Participants on Approved Protocols for Research Involving:
• Human Subjects
• Animals
• Environmental Safety
• Chemical, radiation & biohazards
![Page 17: Office of Research & Sponsored Programs Responsible Conduct of Research Jeff Busch, Ph.D. Main Campus Research Compliance Coordinator](https://reader030.vdocument.in/reader030/viewer/2022032803/56649e205503460f94b0b58c/html5/thumbnails/17.jpg)
Office of Research & Sponsored Programs
Main Campus (MC)2300 University HallMail Stop # 944Phone (419) 530-2844
Web: http://utoledo.edu/research/
E-mail: [email protected]