A Confidentiality Disclosure Agreement (CDA) is designed to protect the confidential information that may be released between a project Sponsor and the faculty and staff of UAB for the purposes of determining whether or not to enter into a subsequent agreement for either a clinical trial (CTA) or research agreement. Sometimes these agreements are called Non-Disclosure Agreement (NDA’s). CDA’s are generally requested by Sponsors before disclosing a study protocol or other information that the Sponsor considers proprietary. CDA’s can be one-way (UAB is only receiving information) or mutual (UAB is receiving and disclosing information). Not all Sponsors require a CDA prior to disclosing confidential information.
The Office of Sponsored Programs (OSP), in cooperation with the Office of Counsel, negotiates and processes all of the CDA’s for UAB pertaining to disclosures in regard to prospective work involving UAB faculty, staff or resources. UAB faculty and staff are not listed as parties to a CDA. UAB enters into these agreement on behalf of our employees.
Upon receipt of a CDA from a Sponsor, complete an Expedited Checklist found at the OSP website. Send the Expedited Checklist and an editable version of the document to:
This email address is being protected from spambots. You need JavaScript enabled to view it. (for non-Federal CDAs)
This email address is being protected from spambots. You need JavaScript enabled to view it. (for Federal CDAs)
so that it can be negotiated with terms consistent with UAB policies and procedures. The OSP will obtain an institutional signature on the fully negotiated CDA. Principal Investigators and Departmental staff are not parties to the agreement and are not authorized to sign a CDA on behalf of UAB.
The OSP is available to answer any question you may have about Confidentiality or Non-Disclosure Agreements. Contact Eloise Gooden by email
Forms
- Expedited Checklist
- UAB Unilateral Confidentiality Agreement
- UAB Unilateral Confidentiality Agreement - UAB Disclosing
- UAB Mutual Confidential Disclosure Agreement
For answers to Frequently Asked Questions regarding CDAs, please visit the OSP FAQ page.
Data Use Agreements (DUA) are non-funded contracts which define the terms and conditions of non-public data that is subject to restricted use. A DUA is normally used to assist parties wishing to share data to better understand important information regarding the data being exchanged, such as privacy rights that are associated with transfers of confidential or protected data, obligations to safeguard the data, limitations on use of the data, and any liabilities related to the use of the data.
A DUA should not be used if a funding agreement is in place between UAB and the other entity for the same project. The project’s funding agreement should address data sharing.
If the agreement being submitted is a research collaboration agreement for ongoing collection of data or retrospective collection of data, or an agreement for a departmentally funded project in which the sponsor requires the agreement to cover extended terms and conditions, please submit an editable version of the agreement to OSP with a UAB Extramural Support Checklist, Scope of Work, Cost Sharing Commitment Form (as applicable), and an Original/New RPL.
Types of Data
There are typically three types of data that can be shared by UAB and other institutions.
De-identified Data
De-identified data is data that has been “stripped of all HIPAA defined identifiers” – a DUA is not normally required however some institutions may require a DUA just to cover their transmission of the data to another entity.
Limited Data Set (LDS) Data
A limited data set (LDS) is data that has been “stripped of all HIPAA identifiers, except age/dates and city/state/zip” - a LDS DUA is required when HIPAA authorization for the data sharing has not been obtained from the participants. If participants have signed a HIPAA authorization that allows for the data sharing, a DUA referencing a LDS is not appropriate.
Protected Health Information (PHI)
Protected Health Information is data “beyond that which would qualify as a LDS” – Sharing PHI data requires a BAA (Business Associate Agreement) if the participants have not signed a HIPAA authorization for the data sharing.
Submitting a DUA to OSP (excluding dbGaP DUA requests)
To submit a data use agreement to the UAB Office of Sponsored Programs, please include the following forms to
- UAB Data Use Agreement (DUA) Checklist - is required for DUA submissions. Additional required documents are described within this form.
- Editable Version of DUA Agreement - provide a Word version of the DUA agreement provided by the institution sending data. If an agreement needs to be drafted, please indicate in the body of the email.
- Project Description - details the work to be done by the recipient with the Data (if UAB is the Provider of Data), or details the work to be done by UAB (if UAB is the Receiver of Data).
- Submit to the IRB. If your DUA includes human subjects research information, IRB approval is required. If you have an existing approval, submit a revision/amendment form to link to the DUA OSP number. See ePortfolio Initiated Applications: How to Create an Amendment. If the DUA is not related to an existing IRB protocol, follow the instructions for submitting an initial application here, providing the OSP Assigned Number on Page 7 of the ePortfolio. See How To Create an Initial Application Submission Using the ePortfolio.
Submitting dbGaP DUA Requests
Developed and operated by the National Library of Medicine’s National Center for Biotechnology Information (NCBI), dbGaP archives and distributes data from studies that have investigated the relationship between phenotype and genotype, such as genome-wide association studies (GWAS).
The database provides two levels of access: open (available to anyone with no restrictions), and controlled (requiring preauthorization). The controlled-access portion of the database provides for downloads of individual-level genotype and phenotype data that have been de-identified (i.e., no personal identifiers, such as name, etc.).
Please review both Starting Point to Applying for dbGaP Data and dbGaP Request Procedures to Access Individual-Level Data for detailed guidance from NCBI for requesting access to data.
- The Principal Investigator (PI) and institutional Signing Official (SO) must have existing eRA Commons accounts. If you not have an existing account, please see the eRA Commons account registration page.
- The PI must login to the dbGaP controlled-access data request login page using the PI's eRA Commons username and password. The login page also includes information on who can apply for access, how to apply for access, and why access is controlled.
- If this is the PI's first dbGaP request, the PI will be prompted to provide contact information.
- The PI clicks on the "my projects" tab where a link is provided for new data request.
- The PI follows the provided directions for completing the SF 424 (R&R) to request data access.
- Notable information provided in these forms:
- Select your OSP Federal Grants Officer as the SO.
- Provide a statement summarizing the proposed research use for requested data.
- Provide a list of collaborating investigators at the same institution. Collaborators at other institutions must submit separate requests for co-submissions with their local SOs.
- Submitting a data access request will constitute agreement and acknowledgement by both the PI and SO to the terms of use for the specific dataset(s) requested. Data Use Certification (DUC) outline policies and procedures for data use (e.g., distribution controls, confidentiality protections).
- After the PI completes the electronic data request process, the SO will be notified by email that a request has been submitted and is awaiting signoff.
- The PI should separately complete and submit a UAB Expedited Checklist to
This email address is being protected from spambots. You need JavaScript enabled to view it. for routing to the appropriate OSP Federal Grants Officer.
- The PI should separately complete and submit a UAB Expedited Checklist to
- The SO will login to the dbGaP authorized access system to review the PI's application. The SO has the ability to edit the forms, return the forms to the PI for revision, or sign off that the submitted application is valid.
- The PI and SO will receive emails updating them on the status of a request or any required actions.
- Once submitted, the Data access request is reviewed by the appropriate Data Access Committee(s) at NIH.
- Both the PI and SO will be notified by email of approval or disapproval for the data access request.
Overview
The term “Non Sponsor Funded” Research is most often used to describe a research project in which a UAB researcher is collaborating with an external entity who is providing product, equipment or materials in lieu of financial support (see criteria set forth below). Often the external entity is directing or requesting that a research agreement be used, rather than a material transfer agreement (“MTA”), because of the level of anticipated collaboration or scope of the project. Non sponsor funded research agreements necessitate negotiation of terms and conditions and are required to be handled by the Office of Sponsored Programs (OSP). The criteria of “Non-Sponsor Funded” Research Projects are set forth below along with submission requirements. Please note that a cost sharing commitment form is required for costs, such as effort and supplies, that are associated with the project but are not being charged to the project account.
“Non Sponsor Funded” Research Project Criteria
- You are receiving a product, equipment or research material (cell lines, compounds, etc) from an external entity.
- The external entity supplying the product, equipment, material is NOT providing you with any financial support to conduct the work.
- Any financial support used to conduct the work is provided from another unrestricted source. If the product, equipment or materials provided by the external entity will be used in a project funded by another award, please see below.
- The data you supply to the external entity is more than just a listing of the raw data, but includes analysis of the results.
- There is some level of collaboration on the research project, where you are not the sole determiner of how the donated item is used in the project but the external entity providing the item has some input into how the project is conducted.
- Some of the criteria alone or a combination of the criteria will eliminate the use of a material transfer agreement (MTA) or a data use agreement (DUA).
Submission Requirements
Please ensure that you provide the following documents/information when submitting a “Non-Sponsor Funded” Research Project to OSP:
- UAB Extramural Support Checklist
- Responsible Personnel List (RPL)
- A contract/agreement with the external entity providing the product/equipment/materials
- Scope of Work
- Budget
- Cost Sharing Form
Federal and Other Awards Involving “Non Sponsor Funded” Research
If you intend to use the product, equipment or material provided by an external entity in a research project which is funded by a federal award, the federal funding agency’s approval is required. Approval will be deemed to have been given by the federal funding agency if the use of the product, equipment or material is identified and commitment is provided in the proposal resulting in the award. Alternatively, approval may be given under separate cover (email or letter) by the funding agency Grants Management Specialist (GMS) or equivalent grants or contracts officer. Please note: approval from a Program Official is not sufficient. Please do not hesitate to contact your OSP Officer for assistance with obtaining needed approvals.
You should also notify the external entity providing the product, equipment or material that it will be used in a project that will be funded by the federal government. Some for profit companies do not want and will not agree to the use of their developmental materials in federally funded projects because of the march in rights the federal government may exercise and which are granted to it by virtue of the Bayh-Dole Act. Please contact your OSP officer, the UABRF or the Office of Counsel if you need information or assistance on this issue.
If you intend to use the product, equipment or material provided by an external entity in conjunction with a research project for which any other party is providing external funding, then all entities should be made aware of the involvement of the other parties and each party should consent in writing (email is acceptable) that they are willing for the research to proceed. As with federal awards, if the involvement of all of the parties is referenced in the scope of work then additional approvals may not be required.
On notice of approval, the product, equipment or material provided by the external entity is considered in-kind cost sharing. UAB’s in-kind cost sharing commitment form is required only if the award terms and conditions or funding agency determines or requires reporting of the in-kind cost sharing.
Overview
UAB, as a receiver of federal contract funds, is compliant with federal contract regulations, and UAB requires the same of its subcontractors. The requirements for a prime contractor as well as a subcontractor are listed below.
SAM.gov
SAM.gov, the primary registrant database for the U.S. Federal Government, collects, validates, stores, and disseminates data in support of agency acquisition missions. UAB is registered in SAM.gov as is any institution or entity conducting business with the U.S. Federal Government.
DUNS / UEI Number
The Data Universal Numbering System (DUNS) number is a unique nine digit identification number provided to a registered entity by Dun & Bradstreet. The federal government requires that all applicants for grants and contracts have a DUNS number. The federal government will use the DUNS number to better identify related organizations that are receiving federal funding. UAB has ONLY one DUNS number for sponsored activities – 063690705.
Important Note (Source):
By April of 2022, the federal government will stop using the DUNS number to uniquely identify entities registered in the System for Award Management (SAM). At that point, entities doing business with the federal government will use a Unique Entity Identifier (UEI) created in SAM.gov. They will no longer have to go to a third-party website to obtain their identifier. Active registrants will have their UEI assigned and viewable within SAM.gov; there is no action for registered entities to take at this time. This transition allows GSA to streamline the entity identification and validation process, making it easier and less burdensome for entities to do business with the federal government.
The UEI for UAB is YND4PLMC9AN7.
Representations and Certifications
Representations & Certifications from subcontractors and suppliers are necessary to help assure that the UAB and the Federal Governments interests are protected, laws relating to ethical conduct are adhered to, cost or pricing data are properly disclosed, and socioeconomic and environmental programs are initiated and maintained by the prime contractors and their subcontractors.
Representations & Certifications are also required to ensure the necessary information is obtained to adequately establish a business relationship, i.e. TIN/EIN, business type and classifications, and addresses.
UAB must ensure that the appropriate Representations and Certifications of subcontractors are filed in SAM.gov.
Overview
The contract award is considered the “official authorization” to implement the contract and to obligate federal funds. This authorization becomes effective on the date that the Contracting Officer signs the contract on behalf of the Government. Federal contract “Post Award Administration” begins when the contract is awarded and ends after all close-out functions, procedures and deliverables have been performed and delivered, and any open issues between UAB and the Government have been resolved.
Role of the Government’s Contracting Officer
This individual is the Government’s authorized agent in dealing with the Contractor (UAB). He / she has the ultimate authority to interpret the provisions of the contract, approve any actions requiring Government approval, negotiate, authorize payments, award and amend contracts, and formally evaluate the Contractor’s performance on behalf of the government and will deal almost exclusively with the OSP Officer assigned to be the contact for that particular contract. The Contracting Officer obtains advice from other Government staff, particularly the Project Officer, who serves as the Government’s technical (science) expert.
Financial and Administrative Reports
The contract will provide a listing of all technical deliverables, the delivery schedule, and identification of administrative and financial reports. Most cost reimbursement contracts will require the submission of quarterly and annual technical progress reports, financial reports, patient testing reports, patient refusal reports, etc. on either a monthly or quarterly basis as well as final close-out reports. These details will be specified in the solicitation.
Modification / Amendment
By definition, a Contract modification means any written alteration in the specification, delivery point, rate of delivery, contract period, price, quantity, or any other contract provision of an existing contract, whether accomplished by unilateral action or by mutual action of the parties to the contract.
Contracting Officer Approval (COA’s)
These authorizations come in the form of a COA (Contracting Officer’s Approval) which is a signed formal letter from the sponsor’s Contracting Officer. The letter requesting COA is written by the PI, forwarded to OSP for review and countersigned. The letter is then forwarded to the Contracts Officer at the sponsor for approval. If approved, the COA is issued by the Sponsor.
Examples: Request permission to change budget, to subcontract, to change the PI.
Contract Close Out
The contract closeout process includes, but is not limited to, such things as final invoice, reports and other closeout documents. After all reports have been submitted, all administrative actions completed, all disputes settled and final payment has been made…then the contract closeout process is essentially complete. Closeout can however include audits, on-site visits, and other activities to ensure the Government’s satisfaction. For all federal contracts exceeding $100,000 a final evaluation is prepared by the Contracting Officer and the Project Officer and the Contractor is given 30 days to review it and submit additional information or a rebutting statement. This evaluation may be considered by NIH and other federal agencies in future contract competitions.