- What are Research Records?
- What points should I consider when managing my data?
- What am I responsible for?
- Who can help?
- What are the relevant policies and procedures?
Typically, research records refer to any type of records or materials that document your research effort. These can be electronic or hard copy as in various forms of logs, notebooks, correspondence, videos, computer databases, audio or digital records, or even the actual products of experiments.
In addition to maintaining accurate and complete research records for data analysis, all records relating to the conduct of the project are important including those that document the management of the research funds and the intellectual property.
Although not an inclusive list, research records typically include:
- Laboratory research: lab notes, notebooks, computer databases, microscopic slides, gels, images, photos, videos, laboratory equipment printouts, and records of statistical and other data analysis.
- Animal research: protocol binders with IACUC- approved protocols with all approved modifications, animal health records, surgical or treatment records, breeding records, drug records, research data files.
- Clinical trials: regulatory binders which include CHR approvals, protocols, informed consent documents, monitoring reports, adverse event reports, and other documents pertaining to sponsors, drugs and devices. Other clinical records can include records for research data, data analysis, audio and video tapes of subjects, images of subjects and any other type of record that can identify persons that data were collected from.
- Funding: records and correspondence relating to the grant financial records, purchasing records, scope of work, budgets, and service records.
- All correspondence with granting agencies, institutions, and collaborators.
The University of Iowa Operations Manual includes description of UI’s Records Management Program which provides definitions for different types of UI documents and records.
The integrity of your data is dependent upon having and using a system of data management. When determining how data will be collected, recorded, and stored, you should consider the following:
- Are the research records legible, accurate, and complete? Are they in sequence and dated? Is the researcher identified in the records?
- Are there reasonable plans for retention, retrieval and storage of the data?
- Have you managed the data so it can be shared if required by funding agencies?
- Would an audit of the research records support your claims in your publications?
- Could co-investigators confirm the accuracy of the manuscript from the laboratory or research notebooks?
Your research records are the source documents for verification of your research by governmental or University investigations and audits. Clear, permanent records of research are crucial for clarifying any challenges to your data authenticity, authorship and intellectual property.
As the PI, you should observe sound practices for the maintenance, oversight, and storage of data as you have the final responsibility for the following:
- Validity and quality of the data and manuscripts.
- Fulfilling all departmental and University research standards, policies, and procedures.
- Training and monitoring the performance of your students, research fellows, residents, and staff to assure that each has the knowledge, information, and skills necessary to meet these standards.
At Iowa, researchers are encouraged to retain research data and records for a period of at least five years following publication to provide verification of the validity of the reported results, according to 27.6 c of the University of Iowa Operations Manual.
In addition to institutional responsibilities, a growing number of U.S. funding agencies such as the National Science Foundation, the National Institutes of Health, and National Endowment for the Humanities-Office of Digital Humanities require researchers to supply detailed, cost-effective plans for managing research data, called Data Management Plans. These plans typically detail:
- What data will be kept and for how long
- How data will be formatted and described for reuse and interpretation
- Policies around data access, use, and attribution/copyright, and preservation
UI researchers can seek assistance in developing data management plans from various sources. The DMP Tool helps researchers create and manage data management plans. The University of Iowa Libraries subject liaisons and its Digital Research & Publishing unit also provide advice on developing data management plans and long-term archiving and preservation for small sets through Iowa Research Online.
University of Iowa Policy, Procedures, and Resources:
- The University of Iowa Operations Manual 17.3 Records Management Program
- The University of Iowa Guidebook on Records Management
- Guide for Human Subjects Research at the University of Iowa (guidance on records management can be found in Section F. Record Keeping)
- UI Information Technology Services – Research Services
- The Iowa Social Science Research Center offers data access and management services to UI social science researchers.
Partial list of Federal Policies, Procedures, and Resources:
- NIH Data Sharing Policy/Data Safety Monitoring Plans
- U.S. Department of Health and Human Services Office of Research Integrity Data Management Resources
- National Science Foundation Data Management Policy
- National Science Foundation Data Archiving Policy
- Centers for Disease Control and Prevention Policy on Releasing and Sharing Data