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Disclosures, Agreements and Approvals

Data Use Agreements
 
When do I need a Data Use Agreement and how to I obtain one?
  • Data use agreements are required when researchers want to access a limited data set.  The HIPAA Privacy Rule is a regulation that governs the way health information is collected, maintained, used, and disclosed.  Limited data sets may be used or disclosed for purposes of research with a data use agreement as described in the HIPAA Privacy Rule at 45 CFR Part 164.  See the Office of Responsible Research Practices (ORRP) Policy on Research Involving Human Subjects  for more information on the use of limited data sets.  The list of identifiers that must be removed from health information in a limited data set can be found on the ORRP website.  For more information, contact Frank White, HIPAA Privacy Officer in the College of Medicine.
Material Transfer Agreements (MTA)
 
When do I need a Material Transfer Agreement and what is the process to obtain one?
  • MTAs are used when a researcher at The Ohio State University wants to exchange materials with an outside party.  A MTA is needed whether the materials are being sent out or received from outside party and are facilitated by the Technology Commercialization Office (TCO).  The MTA defines the rights and responsibilities of both parties including use, ownership, publication, intellectual property, and liability. To begin the process of obtaining a MTA, complete the MTA-CDA Questionnaire.  Information on MTAs can be found on the TCO website.  Additionally you can contact the TCO at 614-247-6633 or by email with questions. Reminder - Only a representative from the TCO can sign a MTA, you cannot sign.

Confidentiality Disclosure Agreements (CDA) and Non-Disclosure Agreements (NDA)

When do I need a Confidentiality Disclosure Agreement (CDA) and what is the process to obtain one?
  • A CDA or NDA (Non-Disclosure Agreement) may be executed in order to protect the confidential information shared between OSU researchers and sponsors.  The information is shared to conduct research or evaluate a research opportunity.  For example, if a sponsor has approached a PI regarding participating in a potential study and the PI is interested, the sponsor will send the protocol to the PI for review.  In order for the PI to receive the protocol for review, they are asked to sign a CDA or NDA.  These would need to be reviewed and signed by the Technology Commercialization Office (TCO), they cannot be signed by the PI.  For more information on CDAs and NDAs, see the TCO website.

National Death Index 

Who can sign off on my National Death Index (NDI) Application?

  • The Office of Sponsor Programs (OSP) can sign off on the application if funding is involved.  If no funding is involved the Senior Vice President of Finance or a signatory authority for the university and defined as such by legal.  Reminder - You must send a draft application to the CDC first without signature.  The CDC typically has requirements that need to be included in the application prior to being signed by the university. 
How does the Center for Disease Control (CDC) define "Data Steward" in the NDI Application?
  • The "Data Steward" could be the Principal Investigator or their research associate working on the data collection and analysis.  The "custodian" and "steward" can be the same person.  The CDC needs someone involved in the project that is able to attest that the data has been safeguarded and destroyed appropriately when the time comes.