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: jeff.busch@utoledo.edu