Responsible Conduct of Research & Research Compliance Adam J. Rubenstein, Ph.D. Director of Research Compliance Old Dominion University Office of Research

Responsible Conduct of Research (RCR) “The responsible conduct of research means the functioning of the research process meets the professional obligations of scientists and contributes to the perpetuation of science as a social institution held in high regard.” Lawrence Rhodes, Office of Research Integrity

RCR Core Elements Human subjects Animal subjects Data acquisition, management, sharing, ownership Publication practices/responsible authorship Peer review Mentor/trainee responsibilities Conflict of interest/commitment Collaborative science Research misconduct

AMERICA Competes Act, signed into law in 2007 SEC RESPONSIBLE CONDUCT OF RESEARCH. The Director shall require that each institution that applies for financial assistance from the Foundation 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 undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project.

New NSF Requirements Effective January 4, 2010 all new proposal submissions must certify that the institution has in place an RCR training & oversight plan for undergraduates, graduate students and postdoctoral researchers supported by NSF. Training plans need not be submitted with the proposal, however, they must be provided for review upon request.

New NSF Requirements Institutions are responsible for verifying that their undergraduate students, graduate students and postdoctoral scholars receive training. Institutions are provided maximum flexibility in creating and implementing RCR programs to meet this new requirement. These requirements do not apply to existing NSF awards.

New ODU Requirements On January 7, 2010 President Broderick approved an Institutional RCR Program requiring all graduate students to complete the Collaborative Institutional Training Initiative (CITI) seven core RCR training modules within twelve months of enrollment.

Tracking RCR Completion Grant requirement PIs are responsible for submitting documentation of completion to ODURF ODU graduate student requirement Tracking done via Registrar’s Office Failure to complete requirement by the end of the student’s first 12 months will result in a registration hold

Research Compliance Conformance with Federal, State, and Local Regulations and University Policies Protection of human subjects Institutional Review Board Welfare of laboratory animals Institutional Animal Care and Use Committee Safe use of radioactive material and radiation-producing machines Radiation Safety Committee Safe conduct of recombinant DNA research Institutional Biosafety Committee Attention to safety and integrity issues

Human Subjects Research ODU policy is guided by federal regulations requiring the review of federally-supported research Institutional Review Board – meets monthly All research if a university chooses to apply 45CFR46 to research (ODU does)

Is the study federally-supported? Submit to IRB (There is 1 IRB at ODU) Does the study meet exemption criteria? (See 45CFR46) Submit to College Committee (There are 6 college committees at ODU) yes no yes ODU Human Subjects Review Research must be reviewed & approved prior to data collection

Human Subjects Training All Responsible Project Investigators (RPIs), proposing non-exempt research must document on-line training within the past 12 months from: A copy of the completion certificate must accompany proposal applications to the IRB (and NIH) RPIs must ensure training of all personnel

Reviews proposed teaching and research protocols involving the use of live animals IACUC

Review Process Two Mechanisms Designated Member Review Utilized for simple studies with “non-inspectable” animals (e.g. mice, rats, reptiles, amphibians) Full Board Review – reviewed at monthly meetings Utilized for “inspectable” animals (e.g. rabbits, hamsters) and complex procedures

Training Multiple paths for satisfying training requirements Laboratory Animal Training Association (LATA) online modules Documentation of expert training (consultant; faculty training student) Training by animal facility manager Training by attending veterinarian

RSC Reviews all applications for the possession and use of sources of ionizing radiation Establishes the policies and procedures for conduct of the Radiation Protection Program

Radiation Safety Training Required for faculty or students who have little or no experience with radioactive materials Radiation Safety Officer (RSO) teaches a 6-hour course Users are required to pass test There is a shorter course for those using radiation producing machines

IBC Reviews teaching and research protocols involving recombinant DNA that are considered non-exempt under the NIH “Guidelines for Research Involving Recombinant DNA Molecules.”

Training Less standardized than other areas Training plan is coordinated with ODU Biological Safety Officer

Other Compliance Issues Activities are strictly regulated and may require review by EHSO or the Office of Research Specialized waste disposal Controlled Substances Bloodborne Pathogens Laser Safety Hazardous Materials Electrical Safety

Contact info Adam J. Rubenstein, Ph.D. Director of Research Compliance