What Kind of Information Should I Include in the “Authentication of Key Biological and/or Chemical Resources” Attachment?

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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.

Learn more about rigor and transparency in your application from the grants.nih.gov page on rigor and reproducibility, and related resources, including more answers to frequently asked questions.

9 Comments

  1. Do I need to authenticate primers that I use for PCR and order from the outside source?
    I tried to send this comment and received reply that I already sent it. I didn’t.

    1. Key biological and/or chemical resources are established resources considered integral to the proposed research, as determined by the investigator. Applicants proposing to use key biological and/or chemical resources are expected to include an authentication plan in the “Authentication of Key Biological and/or Chemical Resources” attachment. Applicants proposing to generate a new key biological and/or chemical resource must describe the development and authentication of the resource in the Approach section of the Research Strategy, not in the “Authentication of Key Biological and/or Chemical Resources” attachment. Thus, you should determine whether the primers are integral to the proposed research and whether they are considered an established resource.

      Please refer to NOT-OD-17-068 for more information.

  2. “The plan should be no more than one page”
    Does this mean more than 1 page is still fine if necessary?

    1. Applications should include an authentication plan for established key biological and/or chemical resources or reagents that may differ from laboratory to laboratory, or over time, or may vary in qualities or qualifications that could influence the research data. If tissues are obtained from an established source, a plan for authenticating the tissues should be included.

  3. All reagents and resources in our proposal are commercially available, including animals. Do we need to authenticate them (e.g. antibodies, animals)?

    1. Purchased or established resources may have been authenticated prior to receipt, and the vendor may have included a specification sheet with the product. If the authentication data provided by the vendor meets your needs in terms of how the product will be used, this may be mentioned in the plan, but you should also include a plan to independently verify the identity and activity of the product before use. If the product will be used long-term, consider the stability of the product and how the validity of the product will be assessed over time. For more, see: https://nexus.od.nih.gov/all/2016/01/29/authentication-of-key-biological-andor-chemical-resources-in-nih-grant-applications/

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