Contract and Contract Negotiation
The RF routinely negotiates, on behalf of Downstate Health Sciences University, contracts related to industry research, including some DUAs that relate to non-industry partnerships. All contracts must be signed by an Authorized Organizational Representative (AOR) of the RF and not by the researcher themselves, including Data Use Agreements.
These agreements include CDA/NDAs, Clinical Trial Agreements (CTAs), Business Associate Agreements (BAAs), Data Use Agreements (DUAs) and in collaboration with RFSUNY Technology team, Material Transfer Agreements (MTAs). In addition, this team reviews and negotiates Purchase Service Agreements (PSAs), as well as Collaboration Agreements and other types where no money is exchanged.
Business Associate Agreement (BAA)
A Business Associate Agreement (BAA) is a crucial legal contract under HIPAA requiring organizations (Covered Entities) to ensure third-party vendors (Business Associates) properly protect sensitive patient data (Protected Health Informaration or PHI) they handle, detailing responsibilities, data safeguards, breach notification, and limits on use to maintain compliance with federal privacy rules. It clarifies what the Associate can and cannot do with PHI, ensuring data security.
Confidentiality Disclosure Agreements (CDAs)/Non-Disclosure Agreement (NDAs)
An agreement whereby party A (“Discloser”) agrees to give party B (“Receiver”) confidential information about its business practices or products for a particular purpose, such as an evaluation of a future research/business opportunity such as a collaborative research engagement. An NDA/CDA may be mutual, providing for the exchange of information by both parties (“bilateral”), or specify that only one party will be providing information (“unilateral”). The Receiver of the CI agrees to hold the CI in confidence, for a specified period of time, and agrees to use it only for the stated purpose outlined in the agreement. Traditionally, no funds are exchanged between or amongst the parties under an NDA/CDA.
Clinical Trial Agreements
An agreement under which one party (“Sponsor”) provides funding to a second party ("institution") to support the performance of a specified human subject research project or related activity (e.g. clinical trial agreement). Other than federal clinical trials, these sponsors have developed and hold the protocol and reporting is the responsibility of the sponsor. The sponsor may be a for profit corporation such as a pharmaceutical corporation, a not for profit foundation, a government agency such as the NIH, or another academic institution. A CTA must contain a budget, statement of work, period of performance, internal and external reporting requirements to regulatory agencies, IP ownership rights, and any other terms and conditions applicable to the funding such as enrollment and the reporting of adverse events. Please note: funds regardless of the source must be spent in accordance with the budget affixed to the CTA.
Data Use Agreements
An agreement under which an organization (“Data Provider”) agrees to give access to its proprietary or confidential data for a specified research or academic purpose to a second party (“Data User”). A DUA will provide a description of data to be disclosed (de-identified), the access requirements and non-disclosure obligations, the scope and purpose for which the data is to be used and the names and titles of those who will have access to the data. Please note: If human subjects' data is to be disclosed, the data use agreement may require IRB approval and/or any other internal regulatory requirement. The data is provided at no cost but a Data Provider may charge for data access.
Available sources for data sets can be found below:
dbGaP (NIH) - The database of Genotypes and Phenotypes (dbGaP) was developed to archive and distribute the data and results from studies that have investigated the interaction of genotype and phenotype in humans.
AllofUS Research hub (in collaboration with NIH) - Browse aggregate-level data contributed by All of Us research participants. Data are derived from multiple data sources. To protect participant privacy, personal identifers have been removed, rounded aggregate data to counts of 20, and only included summary demographic information. Individual-level data are available for analysis in the Researcher Workbench.
TriNetX - Operates the world's broadest federated network of real-world data in partnership with healthcare providers and apply intelligence that accelerates innovation across the healthcare ecosystem.
In order to access aggregate TriNetX datasets, please email clinicaltrials@downstate.edu.
In order to access individual-level data (currently available for non-funded research only), and if you already have TriNetX access, please follow the steps outlined below.
1. Sign in and create a query / cohort of interest
2. Utilize Summary Statistics and Query Design Assistance
3. Select the “Request Dataset” button from the Query History Panel for desired cohorts
4. User must request dataset with following info in “User Message”: PI Name, Email & Description of research
The complete process and helpful resources can be found here.
Independent Contractor Agreement (ICA)
A legally binding agreement between an entity and a self-employed worker that defines the scope of work, payment terms and project timeline. It clarifies the worker is not an employee, which is crucial for tax purposes, legal liability and compliance. Key components of this this agreement include: Scope of Work (a detailed description of services, deliverables and deadlines); Payment Terms (compensation rate (hourly or flat fee), payment schedule, and invoicing procedures); Relationship status (explicit statement confirming the worker is an independent contractor, not an employee, and is responsible for their own taxes and benefits); Intellectual Property/Ownership (clarification on who owns the final work product); Confidentiality (clause to protect proprietary business information); and a Termination clause (procedures for ending the contract by either party). Researchers mustn't engage an Independent Contractor until the review process has been met and approved by the RF HR division. See process here.
Investigator Initiated Study Agreement (“IISA”)
An agreement where typically the PI is the sponsor and the company is solely the funder. The protocol is developed by the researcher and the researcher holds the protocol and is responsible for all regulatory reporting. In many instances, these are unfunded. An IISA typically contains a statement of work, period of performance (“term”), confidentiality and IP rights, and may provide for the commitment of effort, provision of resources, visiting researchers, or other exchange of value in support of the collaboration. Please note: Under an IISA, each party may be responsible for its own costs in connection with the research project.
Professional or Purchase Service Agreement (PSA)
These are agreements where a party (“Purchaser”) procures the services of another party (“Service Provider”, “Vendor” or “Independent Contractor”) to complete a specific scope of work. The services procured are generally of the type provided by the Service Provider to a range of customers in its normal course of business. Payment is contingent on the Service Provider’s performance. Work is conducted pursuant to the specifications of the Purchaser, and the Purchaser typically will own all outputs delivered by the Service Provider, Vendor or Independent Contractor in performance of the agreement.
Material Transfer Agreement (MTAs)
An agreement where the provider of a material agrees to give a second party aka the recipient materials for use for a specified research and /or academic purpose. The MTA defines the rights, obligations, and restrictions for both the provider and recipient with respect to the materials being exchanged under the MTA. Please note: MTAs are not used for the purchase of commercially available materials that would require a purchases service agreement. MTAs at RFSUNY Downstate are handled by Intellectual Property and Licensing department and can be requested at Commercialization@rfsuny.org
Subawards / Consortium Agreements
These agreements are formal agreements where a primary grant recipient (pass-through entity) passes a portion of a larger sponsored project's funds and work to another organization (subrecipient) to perform specific tasks, involving shared decision-making, programmatic work and adherence to the prime awardee's terms and conditions. This differs from a simple vendor service (see PSA above) by the level of collabortion and responsibility. They enable complex research collaboration, require detailed scope of work, budgets and compliance with federal regulations like the Uniform Guidance, and are essential for federal funding projects. Contact the Office of Sponsored Programs (OSP) for assistance with subawards.