Duke Clearances

In addition to the departmental and central office approvals required for a proposal, depending on the type of sponsor or nature of the work being proposed a variety of additional clearances may be required.

Use of Animals & Human Subjects in Research

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 IACUC [1]. Any necessary protocols for the use of human subjects should be submitted for review to the appropriate University IRB: Human Subjects in Non-medical Research [2] or Human Subjects in Medical Research [3].

Information Required by Sponsors:

1. The date the IRB or IACUC approved the protocol
2. The Human Subjects Federal-wide Assurance number or
3. The Animal Welfare Assurance of Compliance number

• Human subjects in non-medical research: FWA 00000265
• Human subjects in medical research: FWA 00009025
• Animal Welfare (General) Assurance No. A3195-01
• Animal Welfare (Lemur Center) Assurance No. A3947-01

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.



Corporate and Foundation Proposals

Proposals to corporations and foundations must be cleared by Duke's Office of Corporate and Foundation Relations (919-681-0468). (ORS will confirm that the proposal has been cleared for submission but faculty are encouraged to seek clearance early in the proposal preparation process).



NOTE: The University has development strategies which include seeking support from foundation and corporate sponsors, and it is important that individuals do not send proposals which would conflict with, or jeopardize, these strategies. Also, the development staff have cultivated relationships with potential sponsors, know what their expectations are, and seek to facilitate these relationships by sending only appropriate submissions. OCFR advice can be very helpful in the preparation and presentation of proposals to many foundation or corporate sponsors.



In addition to clearance, foundation and corporate proposals require levels of institutional review above that of ORS.

• Proposals under $50,000 per year or $250,000 in total costs must be reviewed by Dr. James N. Siedow, Vice Provost for Research and Professor of Biology
• Proposals meeting or exceeding these dollar limits must be reviewed by Dr. Siedow and by President Brodhead.

If needed, ORS will secure Presidential and/or Vice-Provost 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

As a formal offer, which may be difficult to change, a proposal should not contain promises or language which are incompatible with the guidelines.



International Programs

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 Academic and International Affairs, Professor Gilbert Merkx (684-5830) 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

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:

• Occupational and Environmental Safety Office
• Wayne Thomann, Director of OESO, 684-6320

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 [4]

Mark Stomski [5], Director of OEC, 668-2711



Use of Class 3b and 4 Lasers

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
• Ben Edwards, Laser Safety Officer

Use of the Duke Forest

Contact Judson Edeburn, Resource Manager in the Office of the Duke Forest (613-8013) for information about using this research and teaching facility. There are NO fees for using the Forest.



Summer Residential Programs

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.



Conflict of Interest

Duke's conflict of interest (COI) policy requires that all individuals with faculty status, all postdoctoral scholars and associates, and certain salaried employees submit a COI disclosure form [6] annually through Duke's online interface. The purpose of this form is to provide the necessary information for the evaluation of outside activities that could be perceived as or lead to a potential conflict of interest. This online form can be updated at any time and must be updated anytime a significant change has occurred relating to your outside activities.



Before a sponsored research proposal can be approved for submission, the PI and any co-PI(s) must certify that he or she is in compliance with the policy. Assurance of compliance is obtained by answering the COI question and signing in the space provided on the 3rd page of the DPAF as printed from SPS, or by submission of the proposal in Grants.Duke.



Furthermore, if the PI has any relationship with the sponsor or with any consultants or subcontractors included in the proposal which might constitute a real or apparent conflict of interest as defined by the policy, at the time of the proposal the online form must be updated. If you have any questions regarding this policy or the procedures, please contact the ORS Assistant Director for Compliance (681-8540).

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 [7].