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By Jaime Marach

Jaime Marach-finalThe National Institutes of Health (NIH), Nature, and Science gathered editors, ultimately representing over 30 major journals, at the American Association for the Advancement of Science (AAAS) headquarters earlier in 2014. Their goal was to discuss reproducibility and documentation of scientific studies in journals, what was already being done, and additional solutions. The group agreed upon and published common Principles and Guidelines in Reporting Preclinical Research.

The main points covered are statistical analysis, transparency in reporting (including setting “no limit” or “generous limits” on methods sections to encourage sharing of experimental details), data and material sharing (including making available all data sets upon request and deposition of data in public repositories), consideration of publishing refutations against a manuscript, and consideration of best practices (for image data and unique identification/descriptions of biological materials such as cell lines).

researchers looking at computer screen in the laboratoryThe first thought that crossed my mind was, “Are journals becoming more ‘good manufacturing practice (GMP)’ or ‘good laboratory practice (GLP)?’” Let me explain. GMPs are used by pharmaceutical industry folks to support FDA regulations that ensure the identity, strength, quality, and purity of drug products. A key reference document is the Code of Federal Regulations (CFR) Title 21, which includes, among other things, rules on proper documentation of experiments. I’m thinking of part 58, “Good Laboratory Practice for Nonclinical Laboratory Studies,” which describes similar requirements regarding documentation, record storage, and methodology as the journals are recommending. In addition, requirements are found in part 211, which reviews “Current Good Manufacturing Practice for Finished Pharmaceuticals,” and part 11, which reviews “Electronic Records; Electronic Signatures.” These CFR regulations have spawned the common catchphrase, “if it isn’t documented, it didn’t happen,” that GMP workers live by. We use this catchphrase and regulatory guidances to instill a drive for documentation and information sharing of details like experimental design, reagent lot numbers used, and location of audit-trail enabled data.

What do you think? Does the new research reporting Principles and Guidelines for journals sound like they are heading in the direction of GMP/GLP? What thoughts do you have regarding the Principles and Guidelines? Perhaps the academic and industrial worlds are slowly converging. One thing is clear: no matter the job or industry, there will continue to be an increase in the amount of documentation and transparency required. Could we even see a future day in which scientists also document by wearing GoPro cameras in the lab…?

Jaime Marach, Ph.D. develops small molecule and peptide medicines, emphasizing analytical method development/validation and formulation activities. She volunteers as chair of the AAPS Chemical and Biological API Focus Group.