Scope

This Policy applies to:

1. All individuals who hold Indiana University School of Medicine (IUSM) appointments, IUSM staff and temporary employees, volunteers, and all IUSM learners (medical students, graduate students, residents, and fellows) who are engaged in the design, conduct, or reporting of research, whether or not the research is funded; and
2. Anyone engaged in the design, conduct, or reporting of research through a sponsored program at IUSM, which includes research, training, and instructional projects and other activities involving funds, materials, gifts, or other compensation from external entities (including any individuals or government agencies) under agreements with IUSM, to the extent of that research.

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Policy Statement

Data Retention

Research Data must be retained for a minimum of seven years after any publication based on the data in question, with original data retained wherever possible. Individual departments or centers may establish a longer, but not a shorter, period of retention. Any of the following circumstances may justify a longer period of retention:

1. the terms of a sponsored research agreement require a longer retention period;
2. Research Data must be kept for as long as is necessary to protect any intellectual property resulting from the work;
3. if any charge, audit, claim or litigation regarding the research arises, such as allegations of misconduct or conflict of interest, Research Data must be retained until such charge, audit, claim or litigation is fully resolved;
4. if a learner is involved in collecting the Research Data, it must be retained at least until the learner’s degree is awarded or it is clear that the learner has abandoned the work.

Beyond the period of retention specified here, or other applicable retention period, the destruction of the Research Record is at the discretion of the PI and his or her department or laboratory. The destruction of any Research Data should be documented by the department or laboratory and conform to the secure data removal techniques outlined in IU’s guidelines.

In circumstances that do not permit the orderly execution of the provisions of this policy (e.g., death of the Principal Investigator), the applicable department chair or his or her delegate shall assume the PI’s responsibilities for the Research Data or shall appoint a successor investigator to carry out the obligations.

Data Security

Research Data that contains confidential information, such as personally identifiable information, protected health information, proprietary university information, trade secrets, or export controlled information, must have adequate security protections in place. It is the PI’s responsibility to properly identify the classification of the data according to Indiana University’s Management of Institutional Data Policy and to determine appropriate security protections, including any additional protections specifically required under a Sponsored Program agreement.

It is the PI’s responsibility to immediately report any suspected or proven disclosure or exposure of confidential or otherwise restricted data to the University Information Policy Office. The PI should also report any suspected or proven disclosure of any personally identifiable HIPAA information to the University HIPAA Privacy Officer.

Access to Research Data

IUSM has the right of access to data arising from all research conducted at or under the auspices of IUSM, whether or not the research is funded. IUSM’s right of unfettered access to data shall continue regardless of the location or employment of the individuals responsible for or involved in collecting the data.

IUSM reserves the right to audit research studies, including research data, data collection procedures, data retention, training completion, and compliance with study protocols, and compliance with this Policy at any time. All IUSM Research Community Members are responsible to cooperate fully with any such audit.

Transfer in the Event an Investigator or Researcher Leaves the University

When an individual involved in a research study other than the PI leaves IUSM, he or she may request to take a copy of data gathered in studies on which the individual has worked. Such requests will be reviewed to determine whether there are restrictions on transfer of data (e.g. sponsor restrictions, IRB-approved informed consent restrictions, etc.) as well as whether the requesting individual is proposing to transfer the data to another research institution that will agree to assume responsibility for the security, privacy and integrity of the data.  If transfer is approved, an IUSM data transfer agreement will be entered into with the requesting individual and co-signed by the transferee institution. Original data must remain with IUSM.

If a PI leaves IUSM and a research study is to be moved to another institution, original data may be transferred with the approval of the IUSM Executive Associate Dean for Research Affairs and with written assurance from the transferee institution guaranteeing: 1) its acceptance of custodial responsibilities for the data; 2) a complete copy of the original data will remain with IUSM; and 3) IUSM will have an ongoing right to access the original data. IU reserves the right to decline a PI’s request to transfer original IU data, including where there are sponsor restrictions, IRB restrictions, or other restrictions. If transfer of original data is approved, an IUSM data transfer agreement will be entered into with the requesting individual and co-signed by the transferee institution.

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Reason for Policy

The purpose of this policy is to describe the rights and responsibilities of IUSM and its faculty, staff, and students in the collection, use, retention, and maintenance of data produced as part of Indiana University’s research enterprise.

Indiana University is the owner of research data for all projects conducted at the University, under the auspices of the University, or with University resources.

This Research Data Ownership Policy is not intended to supersede or contradict any portion of the IU Intellectual Property Policy (the “IP Policy”). In the event this policy conflicts with the IP Policy, the IP Policy shall control.

Indiana University’s responsibilities with respect to Research Data include, but are not limited to:

1. Complying with regulatory requirements with respect to the retention of Research Data to support grant or contract payments;
2. Complying with the terms of sponsored project awards or agreements;
3. Protecting the ability of students, postdoctoral appointees, staff and other collaborators to access Research Data from research in which they participated;
4. Securing and protecting the University’s intellectual property rights in accordance with its IP Policy; and
5. Sequestering or otherwise obtaining access to Research Data for a required investigation pursuant to University policy, including its Research Misconduct Policy and/or regulatory or sponsor requirements.

The PI’s responsibilities with respect to Research Data include, but are not limited to: 

1. Identifying, collecting, managing and retaining Research Data as data manager for the University;
2. Ensuring that sufficient records are kept to document the experimental methods and accuracy of data collection as well as the methods and accuracy of data interpretation;
3. Adopting an orderly and dated system of Research Data organization;
4. Communicating the chosen system of data organization to all members of his/her research team, including appropriate administrative personnel;
5. Complying with sponsor requirements regarding Research Data access and retention; and
6. Complying with the University’s policies, rules, and expectations on the ownership of Research Data associated with inventions or tangible research property that the University wishes to commercialize.

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Definitions

Research Data: Any data, document, computer file, digital medium, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research performed or conducted at or under the auspices of IUSM. Research Data includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; printed or electronic correspondence; memoranda of telephone calls; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files. Research Data also includes intangible data, including statistics, findings, conclusions, etc.

Principal Investigator (PIs): researcher with the primary responsibility for the design, conduct, and reporting of research.

Sponsored Programs: Research, training, and instructional projects involving funds, materials, gifts, or other compensation from external entities (including any individual and government agencies) under agreements with the University.

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Sanctions

Violations of this Policy may result in disciplinary action up to and including immediate termination, pursuant to applicable university policy.

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History

1. IUSM ra-adm-0001, pre-June 2021, first known draft of policy.
2. Policy given final approval on 01 July 2021.
3. Policy migrated and published 08 October 2021.

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