Get resources and template language on obtaining informed consent for secondary research with data and biospecimens and for genomic research activities.
In the resource Informed Consent for Secondary Research with Data and Biospecimens, NIH provides points to consider, instructions for use, and optional sample language. The above are designed for informed consent documents in the context of research studies that include plans to store and share collected data and biospecimens for future use. Use of this resource is optional. This resource only addresses consent for the storage and sharing of data and biospecimens collected during a primary research protocol, for the purposes of future secondary research. This resource is not a comprehensive informed consent document.
As an example, below is a selection of sample language that introduces a study and describes what samples will be collected, as well as what will be done with the samples, during the study. The language can be adjusted as needed. This excerpt, as well as additional sample language for other parts of an informed consent document, can be found on pages 4-7 of Informed Consent for Secondary Research with Data and Biospecimens.
Additional considerations may be applicable for research studies that include the storage and sharing of genomic data. The NHGRI Informed Consent Resource, originally created in 2010 and continuously maintained, provides sample language for informed consent forms and additional information about the required elements for informed consent and special considerations for genomics research.
