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New National Institute of Health guidelines

NIH Guidelines - HOMEPAGE

New guidelines for grant funding, from the National Institute of Health (NIH), intended to enhance the reproducibility of research, came into effect on 25 January 2016.  

Scientific researchers applying for grants from the NIH must now include a PDF file entitled ‘Authentication of Key Resources Plan’, with their application. This file must describe the methods that will be used in the proposed study, to ensure the identity and validity of key biological and chemical resources; this includes cell lines. 

This information will be assessed by reviewers, and any questions that they may have regarding the plan for authentication of materials, will need to be addressed before a grant award can be made. Any applications not meeting these new requirements, which include authentication of cell lines, will be withdrawn from the grant application process.

These guidelines have been introduced in an attempt to address the issue of cell line misidentification, a long standing and continuing problem. Despite being recognised as an issue since the 1960s, many hundreds of scientific papers, describing the use of cell lines known to be misidentified, are still being published. The result is that valuable research funds are being wasted producing data of no, or questionable, value. In a recent publication in the journal 'Science' Christopher Korch calculated the financial impact of using just two cell lines, HEp-2 and Int-407, both known to be misidentified and actually Hela cells, in scientific research. Christopher estimated that there were over 7000 articles published articles describing research with these cell lines. The project costs associated with this, essentially worthless research, were estimated at over $700 million.

In fact, the problem of misidentified cell lines is part of a wider issue relating to the reliability and reproducibility of research. The broader aim of the new NIH guidelines is to ensure that all of the key reagents and biological materials used in a scientific project are validated, not just cell lines.

The more information that researchers can provide to qualify the materials that they are working with, the more likely it is that research will be able to be duplicated by others.


Full details of NIH grant application guidelines can be found in the link below:

Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications



Related Links

Authentication of cell lines available from ECACC

Mycoplasma testing of cell lines available from ECACC

Sterility testing of cell lines available from ECACC

Science article by Christoper Korch on the financial impact of cell line misidentification

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