Applicants proposing to use established key biological and/or chemical resources are expected to include an authentication plan in the “Authentication of Key Biological and/or Chemical Resources” attachment, even if the key resources were purchased or obtained from an outside source that provided data on prior authentication. The authentication plan must include only a description of the methods proposed to authenticate key resources prior to use and at regular intervals, if appropriate. The plan should be no more than one page. Key resources and the methods for authentication will vary by research field.
For example, applicants proposing to use cell lines should describe the method they plan to use to verify the identity and purity of the lines, which might include short tandem repeat (STR) profiling and mycoplasma testing. Applicants proposing to use chemicals that are key to the research should describe the method used to validate the chemical, which might include liquid or gas chromatography or mass spectrometry. Applicants proposing to use genetically modified animals or cells should describe the method used to confirm the genome modification, which might include PCR amplification or Southern blot. When published consensus standards exist, these may be cited in this section as the procedure(s) that will be used for validation.
Authentication data should not be included in the plan.
NIH recently issued a reminder, highlighting this and other aspects of resource authentication: read NIH Guide Notice NOT-OD-17-068 for details.