Office of Research & Sponsored Programs
Responsible Conduct of Research
Jeff Busch, Ph.D.Main CampusResearch Compliance Coordinator
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.
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
RESEARCH PROTOCOLS
Students MUST be Named Participants on Approved Protocols for Research Involving:
• Human Subjects
• Animals
• Environmental Safety
• Chemical, radiation & biohazards
GRAD Approval & Assurance Form
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
ANIMAL SUBJECTS RESEARCH
Use of LIVE, VERTEBRATE Animals for RESEARCH, RESEARCH TRAINING, or
BIOLOGICAL TESTING
Includes:• Lab Testing • Behavioral Testing • Field Collection• Field Observation
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
Responsible Conduct of Research
Students MUST be Named Participants on Approved Protocols for Research Involving:
• Human Subjects
• Animals
• Environmental Safety
• Chemical, radiation & biohazards
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)
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).
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
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
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
Summary
Practice Everything You Learned in Kindergarten
Work Hard and Do Things Right
Be Aware of Rules and Regulations That Effect You
Responsible Conduct of Research
Students MUST be Named Participants on Approved Protocols for Research Involving:
• Human Subjects
• Animals
• Environmental Safety
• Chemical, radiation & biohazards
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]