Does the NIH inclusion policy apply to research using existing datasets or other types of existing resources involving human subjects?
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 Section II below.
For the purposes of inclusion policy, what is an existing dataset/resource?
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.
Is it acceptable to use existing datasets or resources that are limited to specific sex/gender, racial, and/or ethnic groups?
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 I am using an existing dataset or resource, what form(s) do I use when submitting my application/proposal?
The NIH provides forms with the different application packages for completing information on sex/gender, race, and ethnicity. We are transitioning to a modified layout of the forms starting with competing applications. For additional details see this Guide Notice. As noted above, if you are conducting research with an existing cohort or dataset, you would use the Cumulative Inclusion Enrollment Report rather than the Planned Enrollment Report.
What do I do if my proposed study involves both an existing dataset/resource AND recruitment of new participants? How do I address inclusion and complete the forms?
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.
What do I do if my proposed study involves multiple, different existing datasets or resources ? How do I address inclusion and complete the forms?
If you are proposing a study that will include multiple existing datasets/resources, you may submit the datasets/resources on separate Cumulative Inclusion Enrollment Reports or consolidate onto one Cumulative Inclusion Enrollment Report. The decision to use separate forms or one consolidated form should be considered in the context of the scientific goals of the study and whether there is value in providing separate forms to illustrate the breakdown of sex/gender, race, and ethnicity information for each dataset/resource. Also, please be sure to check with FOA (Funding Opportunity Announcement) you are applying to in case there is additional guidance on this issue.