Research

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Office of Research

The mission of the Office of Research is to provide a departmental environment where research and intellectual inquiry will flourish.

To accomplish this goal the office provides pre and post grant award management including assistance with grant budgets, post- award financial management for faculty and fellows. The office also provides career guidance, grant writing skills, up to date information regarding federal and state regulations.

The Office of Research also houses the Obstetrics and Gynecology Site-Based Research Group that provides support to all clinical research studies in general Obstetrics and Gynecology, Maternal-Fetal Medicine, Reproductive Endocrinology and Fertility and Urogynecology.

Administration

Phyllis C. Leppert MD,PhD, Vice Chair of Research, Director Site Based Research Group

Beverly Thorpe, Research Administrator, Financial Manager for Site Based Research Group

William Hackney, Administrative Assistant to Vice Chair, Administrative Support for Site Based Research Group

Research Proposal Submission Procedures (PDF)

The intent of this protocol is to streamline the research process and insure that all grant applications are completed in an accurate and timely manner.

If your proposal involves:

· Human Subjects, refer to Steps 1-4 and 6-10.

· Animal Subjects, refer to Steps 1-3 and 5-10.

· Human and Animal Subjects, refer to Steps 1-10.

· Neither Human nor Animal Subjects, refer to Steps 1-3 and 6-10.

Step 1: At least two months prior to the sponsor deadline, the PI should notify Beverly Thorpe (the departmental Research Administrator) in the department’s Office of Research at 668-3854 or thorp027@mc.duke.edu of his or her intent to submit a research proposal. A copy of the RFA or the proposal application should be provided to Ms. Thorpe at that time. In addition, your specific aims, hypothesis, and abstract should be emailed to Dr. Phyllis Leppert (department’s Vice-Chair of Research) for her review and input (and copy Beverly Thorpe) at least two months prior to the sponsor deadline.

Note: It is also departmental policy that all non-federal proposals (i.e. clinical trials, foundation grants, etc.) are to be routed to the “Department of OB/GYN’s Research Committee” for internal peer review. The PI and/or Study Coordinator should email the following forms to Beverly Thorpe who, in turn, will submit these forms to the Research Committee for review:

(1) Completed e-IRB Protocol Application (Please do not route in eIRB for approval until the departmental research committee has approved the study. A hardcopy of the eIRB information needs to be sent to Beverly Thorpe).
https://eirb.mc.duke.edu/eirb/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5BAC482809EC03C442A46F2C8EEC4D75D3%5D%5D

(2) Completed IACUC Protocol Application (if applicable)
http://vetmed.duhs.duke.edu/index_of_protocol_development.htm

(3) Itemized internal budget

(4) Copy of the sponsor’s protocol

(5) Copy of the consent form

The Research Committee will have at least one week to review the documents and determine whether or not the PI should proceed with submitting the proposal to the sponsor.

Step 2: The Office of Research will notify the PI, via email, of the deadline dates for proposal submission. The email will include deadline dates for both the department’s Office of Research and the Office of Research Administration (ORA) formerly known as the Office of Grants & Contracts.

Note: The department’s Office of Research requires at least 5 business days to review the proposal and the ORA requires at least 7 business days to review and approve the proposal prior to the deadline date to submit to the funding agency.

Step 3: Office of Research will review the appropriate agency forms (i.e. budget detail, budget justification, resources page, abstract, etc.) for completeness and accuracy and will enter the proposal data into the Sponsored Projects System (SPS).

Step 4: Effective January 1, 2007, “new” human subjects research protocols are required to be submitted online to the IRB Office via the following website http://eirb.mc.duke.edu/eirb. Renewal applications for existing protocols should continue to be submitted to Bill Hackney in the Office of Research who will obtain the Chairman’s signature and then forward to the IRB Office as a hardcopy until further notice.

A. After the Study Coordinator enters the protocol online into eIRB, Bill Hackney in the Office of Research will electronically identify which departmental IRB representative will be responsible for reviewing a particular protocol. Departmental IRB reviewers will be assigned based on a rotating schedule. A listing of all current departmental IRB reviewers will be maintained in the Office of Research.

B. Once the departmental IRB reviewer approves the protocol, it will be electronically routed to the department Chairman for review. After the Chairman approves the protocol, it will be electronically routed to the IRB Office for final review and approval.

C. The IRB Office must review and approve the IRB protocol and your research proposal
      together for concordance. Please note that it is ORA policy that all “new” research proposals
      involving human subjects are to be submitted to the sponsor with the IRB approval date as
      “pending”.

D. The PI and/or Study Coordinator will need to submit a copy of the IRB approval to the Office of Research.

E. All research personnel must complete web-based basic training in research ethics before conducting research involving human subjects and key research personnel must receive additional web-based ethics training each year to remain credentialed. For information on these educational modules and training requirements go to http://irb.mc.duke.edu/certification.htm.

Step 5: Any animal subjects involvement with a proposal will require that the PI complete the IACUC Protocol Application which is available online (http://www2.mc.duke.edu/depts/iacuc/dumc.htm#IACUC_Forms). The PI may seek assistance in completing the application with the departmental IACUC representative (currently Dr. Tom Price).

A. The completed form should be emailed to the IACUC Office (iacuc@duke.edu). Send/deliver signature page separately.

B. If the grant is to be funded by NIH, MOD, NSF, American Heart Foundation or any other foundation - following NIH guidelines, the proposals and applications are reviewed for concordance and an electronic (emailed) copy of the grant should also be sent to the IACUC Office.

C. The “Animal Handlers Online Training” course (parts 1 and 2) is required to

be taken by the PI and all other research personnel who are working on the protocol (http://www.safety.duke.edu/OnlineTraining/Default.asp). CO₂ euthanasia training is also required and the contact person is Thelma Christ in the IACUC Office and she can be emailed at thelma.christ@duke.edu.

Step 6: The Office of Research will obtain the appropriate departmental approval signatures and will forward the grant application to the ORA for review.

Step 7: ORA will notify the Office of Research of any discrepancies, which will be relayed to and clarified with the PI and then revised as appropriate.

Step 8: ORA will review, approve, obtain the appropriate institutional signatures, and return the proposal to the Office of Research for submission to the sponsor.

Step 9: The PI should submit the full proposal (including the research plan and any another attachments) to the Office of Research at least 1 business day prior to the sponsor’s deadline for submission. The Office of Research will make the appropriate copies and forward the completed proposal to the funding agency.

Step 10: For all NIH grant applications, please email all NIH Summary Statements which includes the critiques and recommendations of your grant applications and your priority score, directly to Dr. Phyllis Leppert and Dr. Haywood Brown for review and copy Beverly Thorpe as well. The Summary Statements serve as a tool for departmental budgeting purposes as well as a way to assist the Vice-Chair of Research in providing valuable input to faculty members in securing future grant and bridge funding. In addition, the Summary Statements are useful tools when updating your pending research listed on your NIH Other Support Page.