Duke Clearances and Protocols

In addition to the required departmental and central office approvals a variety of additional clearances may be required at the time of submission or at the time of award depending on the type of sponsor or the nature of the work.

Proposals to corporations and foundations must be cleared by either Duke's Office of Corporate Relations or Foundation Relations. ORS will confirm that the proposal has been cleared for submission but faculty are encouraged to seek clearance early in the proposal preparation process.

If needed, ORS will secure Presidential and/or Vice-President for Research authorization.

Also, when preparing proposals to corporations, bear in mind that the University's relationship with industry is governed by several policies, including:

  • University Industry Guidelines
  • Patents and Technology Transfer Policies Governing Research
  • Policy on Conflict of Interest

To a potential corporate sponsor, the proposal represents a formal offer to conduct a specific project. The proposal should not contain promises or language which are incompatible with Duke policies and guidelines because these may be difficult to change when the award comes in.

The use of animals and human subjects in research is governed by the University in strict compliance with federal regulations. Upon submitting a proposal for a project which uses animals, the PI should prepare a protocol for the Institutional Animal Care & Use Committee IACUC. Any necessary protocols for the use of human subjects should be submitted for review to the appropriate Campus IRB: Human Subjects in Non-medical Research or Human Subjects in Medical Research.
Information Required by Sponsors:

  1. The date the IRB or IACUC approved the protocol
  2. The Human Subjects Federal-wide Assurance number
  • Human subjects in non-medical research: FWA 00000265
  • Human subjects in medical research: FWA 00009025
  1. The Animal Welfare Assurance of Compliance number
  • Animal Welfare (General) Assurance No. D16-00123 (old # A3195-01)

If the approval of a protocol is pending at the time of proposal submission, it must be approved before an award is made. Most sponsors will allow the University to submit a notice of approval of a human or animal subjects protocol after the submission of a proposal, but before receipt of award. Some federal agencies specify a 60-day period after submission in which to provide a notice of approval from the University. NIH policy now allows protocol approvals to wait until a proposal has been scored. The required approvals can be submitted as part of the "just-in-time" documentation sent in when it appears likely that a proposal will be funded.

International programs which require large scale and multi-unit efforts may require a pre-submission review. If an international program or research proposal will involve the commitment of funds, space, resources, or faculty effort from more than one school or major unit, including Perkins Library it must be reviewed by the Vice Provost for International Affairs early in the proposal preparation process. Letters of approval or commitment will be provided to ORS for final institutional endorsement.

For guidance in planning international programs and/or visits by foreign nationals, contact the International House (684-3585) and the Office of Export Controls (668-2711).

Hazardous Materials include infectious, radioactive, carcinogenic, teratogenic, mutagenic, corrosive, and combustible substances. Handling, shipping, and disposition of hazardous materials and waste are federally regulated. Departments affected by the regulations have guidelines available. The institutional contact is:

Hazardous materials shipped to a foreign destination are also regulated by federal export controls. For these activities the institutional contact is: Office of Export Controls, or contact the director of the Occupational and Environmental Safety Office.

Use of Class 3b and 4 Lasers require an approved fail safe system and written standard operating procedures prior to their activation and use in a research project. The institutional contact for obtaining approval is:

  • OESO, Radiation Safety: 684-6320

Use of the Duke Forest: Contact Sara Childs, Director of the Office of the Duke Forest (613-8115) for information about using this research and teaching facility. There are NO fees for using the Forest. http://dukeforest.duke.edu/

Housing needs for summer residential programs should be discussed with Jim Hodges of Conference Services, 660-1760; he administers housing, classroom space, and dining services for summer programs.
Every summer Duke sponsors camps and special programs for high school students. Residential space for other projects may be limited. Not all proposals for summer programs will be funded; therefore, exact planning for the use of available summer space is not possible. However, promises to sponsors that Duke will provide housing must be cleared with Conference Services.

Recombinant DNA : The use of recombinant DNA is strictly regulated by the federal government. Departments affected by the regulations have guidelines available. See the Institutional Biosafety Committee's home page http://www.safety.duke.edu/biological-safety.