Animals and Human Subjects : Corporate & Foundation Proposals :
International Programs : Hazardous Materials : Duke Forest :
Residential Programs : Conflict of Interest : Recombinat DNA

Use of Animals & Human Subjects in Research

The use of animals and human subjects is governed by the University in strict compliance with federal regulations. Before submitting a proposal for a project which uses animals, the principal investigator should prepare a protocol for the Institutional Animal Care and Use Committee (IACUC). Any necessary protocols for the use of human subjects should be submitted for review by the appropriate University Institutional Review Board (IRB): Human Subjects in Non-medical Research or Human Subjects in Medical Research.

Committee, Policy and Contact Information:

• IACUC - Institutional Animal Care and Use Committee
• Contact: Mollie Sykes, Director, Medical Center Office of Research Administration, 684-5175
• Policy: See the Institutional Animal Care and Use Committee's home page.

• IRB - Institutional Review Board for Human Subjects in Non-medical Research
• Contact: Lorna Hicks, Human Subjects Administrator, 681-8773
• Policy: Duke University Principles and Procedures for Non-medical Research Involving Human Subjects
• Forms, meeting schedules, and other information

• IRB - Institutional Review Board for Human Subjects in Medical Research
• Contact: Laura Stewart, 668-0463
• Policy: See the Duke University Health System's Institutional Review Board (IRB) for Clinical Investigations home page.
  

Information Required by Sponsors:

• The date the IRB or IACUC approved the protocol
• The IRB or IACUC assurance of compliance number, assigned by the federal Department of Health and Human Services:
  • Human subjects in non-medical research: FWA 00000265
  • Human subjects in medical research: M1106
  • IACUC: A3195-01
  • The Primate Center has a unique IACUC number: 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

Corporate and foundation proposals require additional reviews and must be submitted seven days prior to the sponsor's deadline.
Proposals to corporations and foundations must be cleared by Corporate and Foundation Relations (CFR), 681-0405. (Research Support will confirm that the proposal has been cleared for submission. 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 submission.

In addition to clearance, foundation and corporate proposals require levels of institutional review beyond those in the Office of Research Support.

• 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, Research Support 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

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 a program involves 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 Research Support for final institutional endorsement.
For guidance in planning visits by foreign nationals, contact the International House, 684-3585

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 Occupational and Environmental Safety
  684-6320

Use of the Duke Forest

Contact the Judson Edeburn in the Office of the Duke Forest at 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 Proposal Approval Form
Duke Policy
NSF and PHS conflict of interest policies

Duke's conflict of interest policy requires that any faculty member engaged in an outside activity or possessing a personal interest that could lead to a conflict of interest file a disclosure with his or her dean.
Before a proposal can be approved for submission, the principal investigator must certify that he or she is in compliance with the policy by signing the Duke Proposal Approval Form (DPAF).
Furthermore, if the principal investigator has any relationship with the sponsor which might constitute a real or apparent conflict of interest as defined by the policy, a disclosure must be completed through the on-line disclosure document located at https://faculty.duke.edu/.

NSF and PHS have instituted conflict of interest policies which are more stringent than the University's and require an additional certification. Their policies require that Duke provide a certification for every proposal submitted to either agency which states that:

the principal investigator does not have a conflict of interest which could affect the design, conduct, or reporting of the specific proposed project.

Before Research Support can provide this certification to the agency, the principal investigator must provide it to Research Support by checking the appropriate box on the Duke Proposal Approval Form.
If a conflict, as described in NSF and PHS policy, does exist a disclosure must be submitted completed on-line at https://faculty.duke.edu/.

Recombinant DNA

The use of recombinant DNA is strictly regulated by the federal government. Departments affected by the regulations have guidelines available. The institutional contact is:

• The Institutional Biosafety Committee
• Mollie Sykes , Director Medical Center Office of Research Administration 684-5175
• Also see the Institutional Biosafety Committee's home page.