Indiana University Guidance for the Management of Research Data

About This Guidance

Effective Date: May 22, 2019
Last Updated: May 21, 2019
Contact: Heather Coates, Data Steward for Research Data, hcoates@iu.edu

Scope

This guidance applies to all individuals who hold University appointments and all graduate students who are engaged in the design, conduct, or reporting of research, whether or not the research is funded; and to anyone engaged in the design, conduct, or reporting or research through a Sponsored Program at Indiana University, to the extent of that research.

This guidance adopts the definition of Research Record from ACA-30 (provided below), with two modifications: Research Record: 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 that constitutes the subject of an allegation of research misconduct. A research record 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.

• Principal or Lead Investigator(s) are not responsible for duplicating information that is captured in University enterprise information systems (e.g., Kuali Coeus Grants, Kuali Coeus IRB, etc.).
• In addition to the types of information described above, this guidance applies to the scholarly products derived from research data, including data analyses and reports (including, but not limited to, abstracts, posters, presentations, articles, and other publications).

Reason

Research rests on a foundation of intellectual honesty. Scholars must be able to trust their peers, students must be able to trust their teachers, and both sponsors and the public must be able to trust the integrity of the results of research performed in institutions of higher education. The integrity of research is the subject of widely shared professional norms and legal requirements that place specific obligations on the University and all members of the University community.

Maintaining accurate and appropriate records of research is an essential component of the process for any research project. Such records are necessary to support and substantiate findings, to protect intellectual property rights, to facilitate management of the research program by the University, and to ensure compliance with federal regulations and University policies. Additionally, many funders and publishers require that the data which underlie published findings are made publicly available, when appropriate.

The University holds responsibilities and rights with respect to research records and data. These responsibilities influence University policy and procedure and, thus, have bearing on the responsibilities of University personnel engaged in research activities. These responsibilities include, but are not limited to:

• Complying with federal grant requirements with respect to the retention of research data and records to support grant payments;
• Complying with the terms of sponsored project agreements, including clinical trial agreements;
• Ensuring the appropriate use of animals, human subjects, recombinant DNA, biological agents or toxins, etiological agents, radioactive materials, and the like;
• Protecting the rights of students, postdoctoral appointees, staff and other collaborators, including, but not limited to, their rights to access data from research in which they participated;
• Securing intellectual property rights;
• Facilitating potential investigations, such as allegations of research misconduct or conflict of interest; and,
• Complying with applicable state and federal laws and regulations.

Procedures

As custodians of research records and data, the Principal or Lead Investigator(s) hold primary responsibility for the collection, management, and disposal of research records and data. The Lead or Principal Investigator(s) is responsible for educating all research personnel of their obligations regarding research records and data, and for protection of the University’s rights and ability to meet obligations related to the research records and data. Investigators should adopt an orderly system of data organization and should communicate the chosen system to all research personnel and to the appropriate administrative personnel, where applicable. Particularly for long-term research projects, Principal or Lead Investigators should establish and maintain procedures for the protection of essential records in the event of a natural disaster or other emergency.

The Principal or Lead Investigator(s) should adopt the following recommendations, with customization as appropriate to their discipline, field, school, and departmental practices:

1. Each research project should have an operational Data Management Plan (DMP) that is prepared during project development, maintained throughout the life of the project, and retained with key project documentation until the research records and data can be discarded.
   1. The purposes for this tool are to:
      1. enable planning all key activities related to the data before project initiation;
      2. facilitate communication and a shared understanding of the project among the team;
      3. identify and address the data management issues most relevant to the research project;
      4. provide a record that describes how the data were gathered, managed, analyzed, reported, archived, and disposed of throughout the lifespan of the project.
   2.  The core sections of an operational DMP include:
      1. Roles & Responsibilities: Document all project personnel throughout a project, including a brief description of their assigned work for the project. See the IU Data Management Plan template for examples.
      2. Onboarding and Exit Procedures: Describe the onboarding and exit procedures specific to the project, with references to team, departmental, school, and university procedures as appropriate. (see item 3 below for additional details).
      3. File Storage & Organization: Document a list of all systems used to manage or store data related to the project, both digital and non-digital. Describe which techniques (e.g., participant ID, common folder structures, file naming conventions, etc.) will be used to support information retrieval when files are stored on multiple systems.
      4. Documentation: Describe the documentation created to demonstrate the validity and origins of the data.
      5. Data & Metadata Standards: Describe and reference all relevant standards that apply to the data and metadata generated for the research project.
      6. Sharing & Dissemination: Describe what data, the rationale for doing so (or not), when, and how data will be made available for publication, validation of published findings, or reuse.
      7. Retention, Archiving, & Disposal: Describe procedures for retention, archiving, and disposal of data generated by this project, referencing relevant regulations or policies.
2. Monitor the performance of personnel and provide feedback throughout the project to ensure data quality and integrity. This should include review of research records, such as lab notebooks, as well as data dictionaries. Additionally, Investigators should compare data to defined project standards for data quality.
3. Each team should have basic onboarding, training, supervision and mentoring, and exit processes in place. These processes should be documented and kept current.
   1. Each team should have a documented process for onboarding new personnel, in addition to any processes for new hires to the University, a school, or department.
   2. All training provided to personnel throughout the project should be documented, including details about the trainees, trainer, date of training, and any testing or auditing results.
   3. Exit procedures when research personnel leave a research team. These are in addition to any processes for leaving Indiana University or a particular school.
      1. Transfer of research records and data to the possession of the Principal or Lead Investigator
      2. Documentation of the above procedures.
4. For every research project resulting in a presentation, poster, manuscript, or other scholarly product disseminated beyond the institution, the research records and data should be retained for a minimum of five years after completion of the project, submission of final financial report, or dissemination of the final product, whatever duration is longer. Research records and data should be retained on the Indiana University campuses, or in facilities under the auspices of Indiana University, unless specific permission to do otherwise is granted by General Counsel and the appropriate Data Stewards.

Tools & Templates

• Operational Data Management Plan (DMP) template
• SecureMyResearch

Related Information

• DM-01 Management of Institutional Data
  • DM-01-Standards
• DM-02 Disclosing Institutional Information to Third Parties
• UA-05 Intellectual Property Policy
• IU Policy on Research Misconduct
• Indiana University Release of Student Information Policy
• Family Education Rights and Privacy Act
• Proposal and award policies and guidelines

Using electronic Personal Health Information (ePHI) in your research project

• Indiana University HIPAA Privacy and Security Compliance
• Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
• Health Insurance Portability and Accountability Act (HIPAA) Security Rule
• Health Information Technology Economic and Clinical Health Act (HITECH)

History

This guidance was created in consultation with the University Information Policy Office, Research Compliance, Data Stewards, as well as others engaged in and supporting research at IU.