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Research Integrity and Regulatory Affairs

Introduction

When a researcher initiates a research project, whether supported by an external sponsor or through Purdue funds, he or she must comply with an array of federal, state and University regulations. The following highlights key regulations and policies affecting research.

The Office of Research Integrity and Regulatory Affairs, which is part of the Office of the Vice President for Research (OVPR), and Radiological and Environmental Management (REM), which is part of the Office of the Vice President for Physical Facilities, assist researchers in complying with federal and state statutes and regulations affecting research, and certifying to sponsoring agencies that Principal Investigators (PIs) and Purdue University have satisfied applicable requirements.

PIs should identify regulated activities associated with proposed projects and report their status on the Proposal Submission Form (PSF) created in the COEUS system, a research grant management tool. The Office of Research Integrity and Regulatory Affairs works with Sponsored Program Services (SPS) and institutional regulatory committees to ensure that all regulated activities are identified on the PSF. For more information, see www.purdue.edu/research/vpr/rschadmin.

Regulatory Approvals

PIs must obtain regulatory approval for the use of human subjects, vertebrate animals, recombinant DNA and potentially biohazardous materials, radioactive materials and radiation-producing devices, and Class 3b and Class 4 lasers. All necessary approvals must be in place before initiating research involving human or vertebrate animal subjects or bringing to campus regulated materials such as recombinant DNA, infectious agents, radioisotopes or radiation-producing materials, Class 3b or Class 4 lasers, pesticides, certain drugs or controlled substances, and hazardous chemicals.

See the following Web pages for more information on regulatory approvals:
• Human subjects: www.purdue.edu/research/vpr/rschadmin/rschoversight/humans
• Vertebrate animals: www.purdue.edu/research/vpr/rschadmin/rschoversight/animals
• Biohazards and rDNA: www.purdue.edu/research/vpr/rschadmin/rschoversight/rdna
• Radioactive materials and radiation-producing devices: www.purdue.edu/rem/rs/rs.htm
• Class 3b and Class 4 lasers: www.purdue.edu/rem/laser/laser.htm

Research Integrity

Each PI is responsible for ensuring the integrity of research conducted under his or her leadership and guidance. Researchers concerned with potential violations of research integrity should contact Purdue’s research integrity officer or the provost. See the Policy on Research Misconduct at www.purdue.edu/policies/pages/teach_res_outreach/viii_3_1.html.

Financial Conflict of Interest

On the Proposal Submission Form, the PI certifies that he or she will assist SPS in identifying all individuals who are investigators on the project and that the PI will disclose whether or not they have a Significant Financial Interest (SFI) in the project or sponsor that could reasonably be anticipated to create a potential or real conflict of interest threatening the objectivity of the proposed research. When SFIs are identified, the PI and other Investigators with such financial interests are required to disclose the details of these SFIs to the University’s conflict of interest officer. Read more at www.purdue.edu/research/vpr/rschadmin/coi.

Export Controls

U.S. federal statutes restrict access to certain technologies by foreign persons both within and outside of the United States. When terms and conditions associated with a sponsor award impose export restrictions, the Office of Research Integrity and Regulatory Affairs contacts the PI to explain what restrictions apply to the project and to collaborate with the PI in developing a Technology Control Plan to ensure that controls are observed. For more information, visit www.purdue.edu/research/vpr/rschadmin/rschoversight/export.

Controlled Substances Program

Generally, in research, controlled substances (drugs or chemicals that have the potential for illegal use) are used for anesthesia, tranquilizing or euthanasia. They also may be used in pharmacological studies or other related chemical processes.

A PI who needs to use a controlled substance in a research protocol or project must have a licensed individual identified with the protocol to obtain and use the controlled substance. REM assists researchers with the registration and licensing procedures for controlled substances for Indiana and with the federal Drug Enforcement Administration. REM also assists with assuring compliance once licenses have been obtained. For more information, see www.purdue.edu/rem/eh/dea.htm.

Laboratory and Chemical Safety

REM staff members can assist PIs in conducting risk assessments and developing procedures to ensure general lab safety, and the identification, safe use and disposal of hazardous chemicals. For more information, see www.purdue.edu/rem.

Intellectual Property

Policy VIII.4.1, administered by the Office of Research Integrity and Regulatory Affairs, establishes the principles that determine ownership of intellectual property developed through use of University resources by Purdue faculty, staff, students and others involved with Purdue programs. The policy also establishes the obligation to disclose Purdue intellectual property to the Purdue Research Foundation Office of Technology Commercialization, which has the sole authority to manage Purdue intellectual property and distribute income derived from licensing Purdue intellectual property. For more information, see www.purdue.edu/policies/pages/teach_res_outreach/viii.4.1.htm.