This is covered in a SOM policy. Generally, any faculty member in the School of Medicine and senior administrative staff are granted PI status. This status is available to faculty on tenure tracks I through III and to other regular rank faculty on the Research Professor, Clinical Professor, and Professor of the Practice of tracks.
Other training is based on the roles carried out in the conduct of the study. This may include Obtaining Informed Consent, Investigator Responsibilities and Study Documentation. These classes are developed by DOCR, and registration is available on the Learning Management System (LMS) website.
a. Types of contracts-managed by ORC
i.Confidential Disclosure Agreement (CDA): also referred to as a Non-Disclosure Agreement (“NDA”), is an agreement between two or more parties that outlines the terms under which the parties will exchange information for a specified purpose. Duke researchers should generally not sign CDAs in their own name and are not authorized to sign CDAs on behalf of Duke – all CDAs should be submitted to ORC to obtain the proper review and signature.
ii. Data Transfer Agreement (DTA): The transfer and use of human subject data is a complicated issue. Duke researchers wishing to transfer or use human subject data must contact ORC to initiate a discussion on the proposed data transfer or use.
iii. Material Transfer Agreement (MTA): an agreement entered into by the parties to govern the provision or receipt of research material.
iv. Clinical Trial Agreement (CTA) or Research Agreement (RA): a contract that establishes the relationship between Duke and another party (the “External Entity”) under which Duke receives funding and/or a study drug or device to support the research project. The research may be non-clinical, preclinical, or clinical. The RA defines the terms under which the research will be conducted, such as the specific research scope of work, the budget and payment terms, and the research timeline.
b. ORA manages federal and foundation agreements
a. Any time a researcher would like to transfer data from Duke or use data coming from outside of Duke, a DTA should be negotiated through ORC.
b. A Materials Transfer Agreement (MTA) is necessary to define the terms for the exchange of material between Duke and another party.
Note: These agreements cover the transfer of material or data for research purposes. However, the IRB must approve any use of material or data for research. The IRB must also be notified of any research data or material being moved outside of Duke.
An individual signing a contract creates an agreement between the sponsor and that individual. Duke has no requirement to honor a contract signed by an individual employee. A non-Duke signatory who signs a contract, can be held personally responsible for the terms of the contract.
Any time services are provided through Duke Medical Center, there is a potential for a bill to be generated. For example, billing risk occurs when a clinical phlebotomist draws blood from a research participant, even though the test may be sent out to a non-Duke lab.
The Internal Cost Assessment (ICA) is a tool to assist in the development of an acceptable budget. It is meant to help the study team assess the actual cost of all study procedures as well as staff and faculty effort necessary to conduct the research. The FPM and the CRU staff can help in creating the required ICA.
We recognize the importance of pilot projects that may lead to funding, or the need to do unfunded research for multiple reasons. Divisions must provide approval for all unfunded research. Despite the lack of funding, an ICA is still required, so that the division understands and agrees to cover the cost of the unfunded project. A fund-code is required as Duke policy, in the event there is a charge related to the research.
It is the responsibility of the PI to manage the financial health of each project. Monthly reports are supplied by the CRU financial staff. Information includes earned revenue and expenses for the current month and year-to-date. Investigators are encouraged to meet with the FPM and Lead CRC on a monthly basis to review these reports. Around the eighth or ninth of each month you will receive an email from FIBATCH email@example.com. Upon notification, go to your Duke's Box: https://box.duke.edu/, click on your Home Folder, click on your Monthly Financial Reports, open the files that were most recently added. Open those files in Excel.
A conflict of interest occurs when there is a personal or financial relationship between the PI and the sponsor or anyone else who might profit from the study. Relationships are reported to the COI committee. The committee will develop a management plan, which must be approved by the IRB. Full policy regarding COI can be found on the IRB website.
All research data collected at Duke must remain at Duke. Contracts can be executed for the transfer of data and/or samples if the research study is to be moved to another institution. Funds can also be transferred with an appropriate contract. Note that investigators with an adjunct Duke faculty position will not be able to serve as PI at Duke.
Research coordinators are skilled professionals with specific abilities in the clinical and administrative areas. The CRU RPM will help in assessing what level of coordinator or research assistant is needed. All research positions must be approved by the RPM and the Departmental Vice Chair for Administration. Please contact the Medicine RPM for information.
The Medicine CRU strives to assist investigators in all aspects of conducting human research. We develop and monitor training, conduct quality reviews for early correction of errors, are well versed in GCP guidelines and federal regulations so that we can help to ensure the quality of research. We are available to answer questions, can help in providing adequate staffing, and participate in all aspects of financial management. We strive to relieve the PI from the administrative burden of conducting human research.
Duke University and School of Medicine shared resources offer state-of-the-art research support services and facilities to Duke investigators. Over 70 shared resources provide expertise in a broad range of research needs. Housed and administered by the School’s departments, institutes, and centers, these shared resources are staffed by experts in their fields and are available to the Duke research community.
Office of Research Resources
Jennifer Foreman, Research Resources Manager
Duke University and Duke University School of Medicine offer state-of-the-art shared research facilities that are available for use by all Duke investigators. Core facilities are physically housed and administered by Duke research institutes and centers, including the Duke Cancer Institute and the Duke Human Vaccine Institute. Cores with an asterisk (*) are live on CoreResearch@Duke.
The Medicine CRU team can help you identify additional resources specific to your research.