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OGC Guidelines for Access to and Use of Research Data

The following are guidelines from the Office of the General Counsel (“OGC”) concerning access to and use of research data created by University of Michigan (“University”) employees using resources controlled by the University (“Research Data”). These guidelines relate to intangible research data and do not cover tangible property such as specimens or samples.

  1. General Principle: The University may access, retain a copy of, and use all Research Data unless otherwise provided by law, University policy, or a written agreement to which the University is a party.

    1. Relevant University Policy - University policy supports this general principle, providing that Research Data “is a University asset” and “is not owned by a particular individual, unit, department, or system of the University.” SPG 601.12. University policy further provides that in certain circumstances:

      • the University has the right to access and use Research Data;

      • the University has the right to share Research Data; and

      • holders of Research Data will share Research Data with the University.
        SPG 601.11, 601.12.

    2. Authorities Superseding or Supplementing the General Principle:
      • Agreements - Sponsored activity, data use, confidentiality, material transfer, or other similar agreements will often have language concerning control of or access to Research Data.

      • IRBs - Institutional Review Boards and informed consents may limit the access to and use of Research Data obtained through or about research subjects.

      • Other Laws, Consents, or Regulations - Federal and state laws and regulations, and other research subject consents, may further restrict the use and dissemination of specific types of Research Data. For example, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) regulates the use and disclosure of personal health information.

    3. Circumstances Requiring University Access to or Use of Research Data - The following are examples of circumstances in which the University would access and use Research Data:

      • To comply with agreements, such as sponsored activity, non-disclosure, data use, or material transfer agreements;

      • To ensure the appropriate use and maintenance of research subjects and materials (e.g., Research Data related to animals or radioactive materials);

      • To protect the rights of students, faculty and staff (e.g., their rights to access Research Data in which they participated);

      • To perform or satisfy University and third party compliance and audit functions;

      • To secure and protect intellectual property rights;

      • To investigate charges of misconduct or conflict of interest;

      • To respond to questions about the accuracy, authenticity, provenance, or primacy of Research Data;

      • To comply with legal or regulatory obligations (e.g., responding to a subpoena).
  1. Responsible Management of Research Data - Responsible management of Research Data is essential to: (1) prevent loss of data; (2) prevent security breaches; (3) comply with applicable research contracts; (4) preserve data quality and integrity; (5) facilitate the sharing of data; etc.

    1. Data Management Practices and Plans - Researchers, such as principal investigators, and administrators responsible for research oversight, such as research associate deans, should establish responsible management practices for Research Data within their units or projects consistent with the data stewardship provisions of the Standard Practice Guide. SPG 601.12 (sec. III). Standards and best practices within a particular scientific discipline should also inform these plans on the following aspects of data management:

      • acquiring data;

      • labeling data and managing metadata;

      • archiving and data curation;

      • disseminating data;

      • using / re-using data and implementing back-up procedures;

      • ensuring data quality; and

      • identifying individuals responsible for data management for a particular project.

    2. Exit Strategies Concerning Research Data - Issues concerning Research Data frequently arise when a researcher leaves a particular project. As part of any researcher leaving a project (such as through cessation of employment, graduation of students, or other termination of involvement with a project), the unit should consult the departing researcher concerning: (a) the existence and location of Research Data with which the researcher has been involved; and (b) whether and to what extent the departing researcher may access Research Data after leaving the University or project. Under the University’s general principle (see Section I above), the University should generally retain a copy of any Research Data when a researcher involved with that Data leaves University employment.
  1. Finding Assistance With Research Data Issues at the University
    A variety of resources are available as starting points to assist you with questions concerning Research Data:

Issue Resource
Questions about Research Data collected or generated as part of a sponsored activity DRDA
Questions about HIPAA compliance concerning Research Data. Health System Legal Office Research Attorney
Questions about Research Data supporting an invention reportable to the Office of Technology Transfer. Office of Technology Transfer
Legal disputes with a third party concerning Research Data. Office of the General Counsel
Research misconduct questions concerning Research Data. OVPR - Research Misconduct
Questions about an employee leaving the University and Research Data generated or possessed by that employee. Academic HR (Faculty)

Staff HR (Staff)

Also, DRDA Project Rep if the Research Data was generated under a sponsored project.
Other general questions concerning Research Data DRDA Data Sharing Resource Center

 


 

 
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