Objectives 1 Define and describe each of the

Objectives 1. Define and describe each of the Agreement types being discussed today; 2. Highlight specific questions to ask when determining the administrative process for each of the Agreements being discussed today; 3. Describe steps to take in partnership with CUNY Research Office in administering and processing the Agreements; 4. Final steps and recap…

Define and Describe 1. Data Transfer Agreements (“DTA”) 2. Data Use Agreements (“DUA”) 3. IRB Authorization Agreements (“IAA”) 4. Independent Researcher Agreements (“IRA”) 5. Collaborative Agreements 6. Other Agreements Defined: Nondisclosure and Confidentiality Agreements; Certificates of Confidentiality

Data Transfer Agreements (“DTA”) • Definition: DTAs are contracts that describe how CUNY data is being shared with a non-CUNY individual or organization and how that data can be used. • For example: • A non-CUNY researcher would like access to CUNY data; • A CUNY faculty member leaves CUNY and wishes to take data; • A CUNY faculty member is exchanging data with someone outside of CUNY • Questions to ask when determining the administrative process: 1. 2. 3. 4. Is the PI Leaving or is the Data Leaving? Is the PI a Faculty Member or is the PI a Student? Does the data belong to the Student or Faculty Member? Is Human Subjects Research (HSR) data being transferred?

Data Use Agreements (“DUA”) • Definition: Data Use Agreements are contracts that describe the receipt and use of non-CUNY data by CUNY researchers. • For Example: • Restricted Data Use Agreements – datasets that cannot be distributed to the general public, i. e. participant confidentiality and privacy concerns • Unrestricted Data Use Agreements – datasets that do NOT contain personally identifiable information or confidential or private information etc. • Questions to ask when determining the administrative process: 1. Is the DUA to be used as part of a Sponsored or not Sponsored Project? 2. Is the DUA for a Student or for a Faculty Member?

IRB Authorization Agreements (“IAA”) • Definition: An IAA is a formal document that provides a mechanism for an institution “engaged” in human subject research (HSR) to designate the IRB of another institution as the IRB of Record for one or more HSR protocols. • For Example: • It specifies which institution’s IRB will be the IRB of record • It defines the responsibilities for the IRB and each institution • Questions to ask when determining the administrative process: 1. 2. 3. 4. Why is an IRB Authorization being sought? Who determines whether CUNY &/or external Institution is engaged in HSR? Which institution will be the IRB of Record, CUNY or the external Institution? Who issues the IAA?

Independent Researcher Agreements (“IRA”) • Definition: An IRA is the mechanism by which an individual who is not affiliated with CUNY nor is acting as an employee or agent of another institution can be involved in research activities being conducted by or on behalf of CUNY. • Questions to ask when determining the administrative process: 1. Is the Independent Researcher getting paid by CUNY or RF CUNY? 2. What Research Activities are taking place? 3. Is Human Subject’s research taking place? 4. Is an Independent Researcher the same as a Volunteer? 5. Are Independent Researcher allowed to be under 18 years old?

Collaboration Agreements • Definition: Collaboration agreement means an agreement entered by two or more researchers engaged in a research project, and that describes the nature of their working relationship. It specifies the intent of the parties to share data, research materials and facilities, and to publish research findings. • Questions to ask to determine the Administrative Process 1. Is this a Sponsored Research Agreement? 2. Is this a Domestic or International Collaborative Agreement?

Other Agreement Types: 1. Nondisclosure and Confidentiality Agreements A Nondisclosure and Confidentiality Agreement is a contract between CUNY and an external organization. This agreement lays out binding terms and conditions that prohibit the disclosure of confidential proprietary information or materials. These agreements govern how the information or materials will be protected, used, and discarded, and protect the rights of the owners 2. Material Transfer Agreements (MTA) MTAs govern the exchange of commercially unavailable (proprietary) materials to-CUNY or from CUNY for use in research to be conducted by CUNY and/or the other organization. 3. Certificates of Confidentiality (Co. C) COCs are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure and subpoena. • These are issued only for research projects that are collecting subject names or other identifying characteristics, on a sensitive research topic.

Steps to take in partnership with CUNY Research Office Agreement Point Person: 1. Identify the Type of Agreement being requested 2. Review and follow the SOP associated with the type of Agreement as well as the Authorized Signatory for the Agreement Type: http: //www 2. cuny. edu/research-compliance/research-agreements/ 3. Provide all information requested from our CUNY Research Office, for example full name, title, institution, addresses for all parties in the agreement as well as name, title, address for the authorized signatory at other institution etc. 4. All agreements will list The City University of New York on behalf of the (insert College or School Name) as the party entering into the agreement.

Final steps and recap… • Final Steps: • All parties must sign the Agreement • If this is a CUNY drafted Agreement CUNY will be the last party to sign the Agreement • Retain a copy of the Agreement according to CUNY Record Retention Policy. • Recap: • Agreements defined • Questions to ask when determining the administrative process discussed • Steps to take in partnership with CUNY Office of Research discussed • If you need guidance. Contact me: pauline. gonen-smith@cuny. edu