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 ElementsHuman subjectsAnimal subjectsData acquisition, management, sharing,

ownershipPublication practices/responsible authorshipPeer reviewMentor/trainee responsibilities Conflict of interest/commitmentCollaborative scienceResearch misconduct

AMERICA Competes Act, signed into law in 2007 SEC. 7009. 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 RequirementsEffective 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 RequirementsInstitutions 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.

http://www.citiprogram.org

Tracking RCR CompletionGrant requirement

PIs are responsible for submitting documentation of completion to ODURF

ODU graduate student requirementTracking done via Registrar’s OfficeFailure 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 ResearchODU 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)

yesno

no

yes

ODU Human Subjects ReviewResearch 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:• http://www.citiprogram.org• 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 researchprotocols 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

TrainingMultiple paths for satisfying training

requirementsLaboratory Animal Training Association (LATA)

online modulesDocumentation of expert training (consultant;

faculty training student)Training by animal facility managerTraining 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

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

TrainingLess standardized than other areasTraining plan is coordinated with ODU

Biological Safety Officer

Other Compliance IssuesActivities 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 infoAdam J. Rubenstein, Ph.D.Director of Research Compliance683-3686arubenst@odu.edu

http://www.odu.edu/ao/research/compliance/index.shtml