Compliance

Regulatory Compliance & University Review

All research projects affiliated with the University are subject to federal regulations and university policies. Compliance with these regulations and policies is monitored through University review processes. The extent of the internal review depends on the type of research proposed. Any elements of your proposed research that require special review must be addressed before you submit a proposal to a sponsor.

Compliance is the responsibility of each investigator and SPA staff will assist an investigator in making sure his or her research proposal is approved by all of the appropriate individuals and institutional review committees.

Make sure to consult the Checklist of Project Elements Requiring Special Review & Approval


Human Subjects

Drake University is guided by federal regulations and ethical principles regarding all research involving humans subjects or private information of human subjects. All research conducted at Drake University and/or associated clinics that involves physical, behavioral, or social welfare of humans, including educational research, is subject to review by the Institutional Review Board (IRB). This review is conducted without regard to the source of financial, physical (facilities), or logistical support. This review must be conducted and approval granted before a project can be started.


Animals

The University is guided by federal regulations and ethical principles intended to ensure the humane care and use of animals in research. All research involving vertebrate animals that is conducted or authorized under the jurisdiction of Drake University is subject to review by the Institutional Animal Care and Use Committee (IACUC). This review must be conducted and approval granted before a project can be started.

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Biohazardous Materials

The University is guided by federal guidelines regarding the safe use and containment of biohazardous materials, including recombinant DNA and infectious biological agents. The Hazardous Waste Advisory Committee is responsible for reviewing and approving any possession of and/or activity involving known or potential biohazardous materials that is not otherwise exempt under its policies. This review must be conducted and approval granted before a project can be started.

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Radioactive Materials

Drake University is guided by state and federal regulations governing safe use, transport, and disposal of radioactive materials, radiation-generating equipment, and lasers. The IRB reviews and approves the use of radioactive materials for clinical, research and educational purposes when used on human subjects. The Hazardous Waste Advisory Committee works to ensure appropriate training of personnel, to monitor personnel exposure to radiation and to document use of radioactive materials and radiation-generating equipment according to regulations. The Hazardous Waste Advisory Committee reviews research protocols that involve exposure of human subjects to radiation from radiation-generating equipment or lasers in excess of that which is considered within the standard of clinical care.

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General Health & Safety Issues

In addition to the specific areas of review identified above, Drake University follows federal, state and local regulations regarding general health and safety issues. The Campus Safety and Security Committee oversees a variety of general health and safety issues including fire hazards; personal protective equipment and employee exposure to hazards. The Hazardous Waste Committee oversees chemical procurement, use, safety, storage and abandonment; and appropriate chemical and biohazardous waste disposal. Approval from the Campus Safety and Security Committee and the Hazardous Waste Committee is needed to ensure that hazards to employees involved in this research are identified. If you have questions about general health and safety issues related to your proposed research or need review forms, please contact the Environmental Health and Safety Specialist.

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Research Integrity

The guidelines that govern research integrity are applicable to all stages of grants and contracts management from proposal preparation to project completion. It is your responsibility to review and follow sponsor guidelines and university policies related to research integrity.

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Fiscal Responsibility

As the Principal Investigator or Project Director you are responsible for all aspects of the research project or sponsored program, including the proper stewardship of research or sponsored program funds and avoiding any conflicts of interest--See Drake University Conflict of Interest Policy.

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Intellectual Property

SPA reviews proposals to ensure that necessary agreements are established regarding the ownership, liscensing and control of any intellectual property that may result from the proposed research. If you or any of your co-investigators foresee developing potential investions, patents or other intellectual property during the proposed project, contact SPA to inform us of the proposed project and determine how best to address issues related to intellectual property. You are expected to comply with the University's policy regarding the conditions for ownership, legal protection, liscensing and development of any intellectual property conceived of or first reduced to practice by any university-associated personnel. (See Drake University Copyright Policy and Rules, Drake University Statement of Policy and Rules Relating to Patents.

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Commitment of Time

Investigators are responsible for keeping track of how much time they have committed to grant and contract work in terms of percent of effort and for informing their chairs of such commitments of time. The total percent of effort committed to grants or contracts (including research and service projects), teaching and administration must not exceed 100%. This "after-the-fact" record-keeping is accomplished by completing monthly Rate of Effort forms and submitting them to SPA.

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Material Transfer Agreements

Material transfer agreements define the terms of use for research materials exchanged with industry sponsors or academic colleagues at other institutions. If your proposed research involves the exchange of proprietary research materials--such as biological materials, chemical compounds, or animals--SPA staff will assist you in the negotiation of a material transfer agreement to ensure that both parties have a common understanding of how the materials can be used. Such agreements are intended to protect the interests of both parties, including commercial, intellectual property and academic interests. Material transfer agreements are binding contracts and all such agreements must be reviewed and approved by a University Authorized Representative to ensure appropriate protection of investigator and University interests.

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Confidentiality Agreements

Confidentiality agreements define the terms of use of confidential information exchanged with industry sponsors or academic colleagues at other institutions. Confidentiality agreements may be stand-alone agreements or may be included in a contract or material transfer agreement. Such agreements define the nature of the confidential information and the limits of how such information can be used. Confidentiality agreements are intended to protect the interests of both parties, including commerical, intellectual property and academic interests. If the sponsor requires the signature of an authorized university official, contact SPA.


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