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Several different federal laws and regulations govern how research is conducted at federally funded research institutions. These regulate many different activities, from the use of animals and human beings in research to intellectual property rights and conflicts of interests.

The Office of Research Compliance in Bloomington is responsible for ensuring that the research conducted on the IU campuses (other than IUPUI and the regional Medical Education Centers) is conducted in a responsible manner, consistent with federal and state law and University Policies.

The following are brief descriptions of the research compliance areas and contact information.

Human Subjects Protection

All research (funded and unfunded) that involves humans must be approved by the institutional review board (IRB) on the appropriate campus prior to the commencement of recruitment of subjects and data collection. There is an IRB on each of the Bloomington and Regional Campuses. Each IRB's website contains application forms, sample consent forms and other information to assist researchers in the application process.

Animal Care and Use

The Institutional Animal Care and Use Committee (IACUC) has responsibility for assuring all research using animals at IU facilities complies with the extensive body of federal law governing the use of laboratory animals. As required by federal law, the IACUC reviews and approves all protocols, inspects all facilities used to house animals, and assures compliance with health regulations that apply to animal care personnel (e.g., TB tests, immunizations). On the Bloomington campus, Laboratory Animals Resources provides animal care and training for investigators and other personnel involved in the care of animals, as well as the administrative support for the IACUC. Bloomington, Kokomo, South Bend, and Southeast have campus IACUCs.

Research Safety

Biosafety

The Biosafety Officer and the Bloomington Institutional Biosafety Committee (IBC) assure that recombinant DNA molecules, pathogenic microorganisms and other infectious agents and toxins are used in compliance with federal regulations, and safely with appropriate environmental protections. The Biosafety Officer provides training, workshops, and written materials for researchers and lab personnel. All protocol reviews, training, and inspections for all campuses (other than IUPUI and the regional Medical Education Centers) are conducted by the Bloomington Biosafety Officer and Bloomington Institutional Biosafety Committee.

Radiological Health and Safety

The Radiological Health and Safety program ensures that: (1) hazards associated with the use of radioactive materials, x-ray devices, particle accelerators, and lasers are minimized; and that (2) all uses of these materials and devices are in compliance with applicable regulatory requirements. Research protocols involving the use of these materials and devices must be reviewed and approved by the Director/Radiation Safety Officer. The staff of Radiological Health and Safety provides consultations, onsite reviews, audits, and training to research staff at IUB and Regional Campuses on any issues pertaining to use of radioactive materials, radiation-producing devices, and lasers. For information or requests for service, contact the Director of Radiological Health and Safety.

Export Controls

There are a number of federal laws related to national security that may have an impact on researchers. This is particularly the case with respect to “dual” use equipment and technologies, i.e. items and technologies which can be used for civil applications as well as military or terrorism purposes. Researchers need to know the basics of the regulations in order to avoid inadvertent violations, with significant negative consequences. The Office of Research Compliance offers workshops and individual consultation to assist faculty, students, and staff.

Intellectual Property Policy

This policy governs both copyright and patent rights for work done by faculty, students, and staff at Indiana University. As a general matter, under the policy, intellectual property rights to articles, books, and monographs published by faculty (“traditional works”) are given to the individual faculty members. The intellectual property rights to inventions, devices, and other patentable items and institutional works belong to the University. A major exception to this rule with respect to “traditional works” is if the work was a sponsored project, meaning it received external financial support such as a federal grant or an internally funded campus grant. In those cases, the intellectual property rights remain with the University. Day-to-day administration of the policy is handled by the Office of Research Compliance. The Office of Technology Transfer in IU Research & Technology Corporation provides IU researchers with assistance in licensing and marketing new technology.

Research Ethics

Much effort in this area is to provide education to IU researchers on the ethical conduct of research. This is done primarily through workshops, training programs and lecture series. The research integrity officer (RIO) for the Bloomington and Regional campuses has primary responsibility for assuring compliance with the policy and procedures as well as the federal regulations. The RIO is assisted by a Standing Committee on Research Integrity, composed of faculty members.

Conflict of Interest

This University Policy on Financial Conflicts of Interest in Research provides a framework of principles for identifying, reporting, evaluating, and managing financial conflicts related to research endeavors or sponsored projects. Assistance is available from the Office of Research Compliance to determine if a conflict exists and, if so, how to deal with it.

Administrative Compliance

The Office of Research Compliance, Sponsored Research Services, and Contract and Grant Administration also provide services and support in complying with federal, state, institutional, and sponsor policies and procedures.

Contact Information

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Office of Research Compliance

Executive Director of Research Compliance, Eric D. Swank
(812) 856-1229

Human Subjects Office
Institutional Review Board

Director, Carey L.Conover

Assistant Director, Senta Baker
(812) 855-3067

www.research.iu.edu/rschcomp/human.html

Institutional Animal Care and use Committee

IACUC Administrator, Jo Anne Tracy
(812) 855-5138

www.research.indiana.edu/rschcomp/animals.html

Biological Safety Office
Institutional Biosafety Committee

Biosafety Officer, Beth Reeves
(812) 856-3638

www.research.indiana.edu/rschcomp/biosafety.html

Radiation Safety Office
Radiation Safety Committee

Radiation Safety Officer, Greg Crouch
(812) 855-3230

www.research.iu.edu/rschcomp/radiation.html

Intellectual Property/IURTC

(317) 274-5905
http://iurtc.iu.edu//ott/inventors/index.html

Intellectual Property Policy can be found at:
www.research.indiana.edu/respol/intprop.html

Research Ethics

Office of Research Compliance
(812) 855-7807

Research Integrity Officer, Jeffrey R. White
(812) 855-3931

Research Integrity Policy can be found at: www.research.indiana.edu/rschcomp/pdf/PolicyResInteg.doc

Procedures for Bloomington and Regional Campuses can be found at: www.research.indiana.edu/rschcomp/pdf/ProcedRespond.doc

Export Controls

Office of Research Compliance
Executive Director of Research Compliance, Eric D. Swank
(812) 856-1229

Conflicts of Interest

Office of Research Compliance
Executive Director of Research Compliance, Eric D. Swank
(812) 856-1229

Financial Conflicts of Interest in Research Policy can be found at: www.indiana.edu/~rschinfo/rschcomp/coi/coi_intro.html

Sponsored Research Services

(812) 855-0516
www.research.iu.edu/leadership/offices.html#srs

Contract and Grant Administration

(812) 855-6538
Director, Jim Becker

For questions on the regional campuses related to research compliance: the IU South Bend campus has a designated research officer, Erika Zynda (574) 520-4181 or at sbirb@iusb.edu. At IU Southeast, research affairs is located in the office of the Associate Vice Chancellor, Deborah Finkel (812) 941-2210). At IU Northwest, IU Kokomo, and IU East, the offices of the Vice Chancellor of Academic Affairs handle issues of research compliance(219) 980-6966, (765) 455-9227 and (765) 973-8230, respectively.

 
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