|NIH Staff FAQs|
If the study is considered human subjects’ research and meets the NIH definition of clinical research, then it is subject to the NIH inclusion policy. For more details about working with existing datasets or resources involving human subjects see the specific FAQ on existing datasets and resources in inclusion (or Section II in the overall inclusion FAQ).
An existing dataset may be constructed of different types of data including but not limited to survey data, demographic information, health information, genomic information, etc. Also included would be data to be derived from existing samples of cells, tissues, or other types of materials that may have been previously collected for a different purpose or research question but will now be used to answer a new research question. In general, these will be studies meeting the NIH definition for clinical research with a prospective plan to analyze existing data and/or derive data from an existing resource and where no ongoing or future contact with participants is anticipated.
Yes. You can propose a study or analyses of an existing dataset where the cohort is limited in sex/gender, racial, and/or ethnic participation. However, you should justify why this dataset is useful in the proposed scientific context, particularly if the dataset does not reflect the population of the disease or condition under study. Some factors that can be considered as part of the justification include the nature of the scientific question, a requirement for data provided by the cohort, or addressing a gap in knowledge.
If you are proposing a study that will include both an existing dataset and recruitment of new participants, you should provide separate inclusion forms for the existing dataset and the participants to be prospectively recruited. The existing dataset sample can be provided on the Cumulative Inclusion Enrollment Report as described above. The participants to be prospectively recruited should be accounted for on a Planned Enrollment Report with the competing application/proposal and actual recruitment numbers will be reported to the NIH at least annually on the Cumulative Inclusion Enrollment Report.