Does My Clinical Research Involve an Existing Dataset or Resource

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If you are proposing a clinical research study to NIH, you will need to specify whether your research involves an existing dataset or resource as part of the PHS Human Subjects and Clinical Trials Information Form Inclusion Enrollment Report. But what is an existing dataset or resource?

NIH has updated its FAQ and the OER Glossary to clarify that an existing dataset or resource consists entirely of data that has been or is being collected for a different purpose or research question but will now be used to answer a new research question or replicate scientific findings. An existing dataset may be constructed of different types of data including but not limited to survey data, demographic information, test results, health records, genomic information, as well as data to be derived from existing samples of cells, tissues, or other types of materials. It would not be an existing dataset if the new research study will have ongoing or future contact with participants in the original study.

For example, a study examining data from electronic health records (EHRs) may be considered to involve an existing dataset or resource, even if the collection of data in the electronic health records will continue after the study begins. However, if the study team will be contacting the participants, it would not be considered an existing dataset or resource. Check out the FAQs on Working with Existing Datasets or Resources on the Inclusion of Women and Minorities FAQs and the Inclusion Across the Lifespan FAQs webpages for more details on reporting inclusion information for these studies.