The Lack of Global Standardisation in Life Sciences Research

By Dr. Priyom Bose, Ph.D.Reviewed by Emily Henderson, B.Sc.

Scientists stated that life science research is the foundation for biotechnological applications, which are growing rapidly. Biotechnology promises to be the greatest high-technological marketing industry worldwide. Owing to the lack of global standardization of the methodology, researchers face difficulties with the reproducibility of products. 

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Advancements in research and innovation (R&I) are deeply associated with high-quality data. High-quality research data is generated by following well-defined, validated, or standardized research methodologies. A standardized methodology ensures quality control (QC) of the data generated. QC procedures and a standardized methodology would aid in generating reproducible data that can be shared or reused effectively worldwide. 

Problems Associated with the Lack of Standardization in Life Science Research

The lack of standardization in life science has generated a “reproducibility crisis,” i.e., data generated cannot be reproduced. The Global Biological Standard Institutes have reported that the majority of published research related to cancer and preclinical studies is not reproducible. Irreproducible data implies that millions of dollars invested in scientific studies get wasted.

Scientists highlighted some of the reasons associated with the reproducibility crisis, including the lack of appropriate study design, insufficient documentation, and the absence of proper control. There is a need for a unifying quality control and assurance framework. The lack of quality life sciences data reduces public research investment. 

Another factor that limits the exchange or reuse of data from different sources is the lack of interoperability. Although this shortcoming in life science research was identified years ago, only recently has the scientific community been pushing to develop interoperable tools and implement standardized techniques.

There is a need for detailed metadata and comprehensive annotations to accelerate the desired innovation process. Life science research involves using various languages, formats, and methods, and the available standards or tools cannot facilitate the automatic conversion of these data to a uniform output.

The Role of the CHARME Community in Scientific Research

The CHARME community comprises a group of experts from thirty-two countries in Europe and beyond, belonging to different life science research and standardization sectors. This organization operated between 2016 and 2020, and its primary aim was to promote the importance and need for standardization in life science research. Additionally, it identified critical existing gaps in the research domain that required immediate attention.

After four years of extensive work, the CHARME members met in Brussels and reviewed their achievements and observations. They further discussed future perspectives and challenges associated with standardization in life sciences research. The group further presented strategies to accelerate the application of standard procedures in this research domain.

Challenges Linked to the Implementation of Standardization in Life Science Research

Scientists have identified some of the challenges that hold the key to improving the quality of life science research. One of the identified challenges is the lack of knowledge of standards and standardized methods. Hence, there is an urgent need to increase awareness of the importance of its implementation in research.

Incidentally, some scientists believe that using standard procedures limits their scientific freedom. Therefore, it is important to communicate the benefits of standards in the life sciences domain and the risks of not following them. 

The lack of appropriate study design has enhanced the reproducibility crisis. Standardized research procedures could reduce variance, improve reproducibility, and enhance the quality of the research. Accurate and reproducible data can be generated by following good laboratory practices (GLP) and data management plans (DMPs). As the use of standards requires the prior purchase of documents, most academic researchers find it unattractive.

The International Organization for Standardization (ISO) development is a time-consuming and cost-effective process. In life science research, the development of ISO standards requires a longer period that often exceeds the contract term of the project staff. Additionally, every five years, all ISO standards must be reviewed regarding their applicability in the marketplace.

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How to Improve the Implementation of Standard Procedures in Life Science Research?

Scientists have identified several methods to improve the applicability of standard procedures in research. For instance, there is a lack of suitable tools that enables transferability between different data formats. To rectify this problem, scientists are currently working at the metadata level, using and developing innovative tools that enable fast and easy data exchange amongst varied data platforms or laboratories.

Electronic lab notebooks have been considered an ideal instrument that aids the daily implementation of standard procedures in research facilities.

The CHARME members stated that as the topic of implementation of standard procedure is relatively new, it is important to raise awareness about quality management and standardization in research. Young researchers must be provided with basic training on standard operating procedures (SOPs) and how to document results properly.

Proper incentives must be awarded to academic or research institutions involved with high-quality research. All scientific communities are encouraged to publish their study on Open Access platforms like OpenAIRE. This could reduce redundancy and variability and accelerate quality research.

Some of the ongoing efforts by various scientific communities to enhance the reproducibility of data include the contribution of the American Society for Cell Biology (ASCB), which identifies optimal methods and practices associated with life science research. The American Type Culture Collection (ATCC) provides standardized and authentic cell lines and microorganisms that aid the reproducibility of assays. The National Institutes of Health (NIH) also helps improve reproducibility and transparency in scientific research.