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Business & Regulation Business Practice, Standards & Regulation, Drug Discovery, COVID-19

What’s Fueling Your Research Engine?

Certain events – the COVID-19 pandemic being a very good (or bad) example – can shift research from steady and paced to a sprint. As a researcher running that sprint (and proudly donning the corporate branded apparel), there is no time for a mis-step; the whole world is watching this high-stakes race (1, 2).  Additionally, thousands in society will join in as research participants testing new vaccines and therapies. 

It’s no secret that the word “ethics” can result in rolling eyes, as well as visuals of hurdles, red tape, and barricades. Admittedly, the good of ethics is tarnished by too many negative experiences with research ethics committees or institutional review boards – who may move at a snail’s pace, staffed by volunteers who are sometimes working beyond their scope. And though that area of ethics surely needs remedying, let us turn to another area of ethics that researchers and corporations can control: their own ethics and integrity.

Robust research is more than a green light from a regional research ethics committee. The pharma industry is responsible for its organizational ethics – this means ensuring that they operationalize their mission, vision, and values in the research setting. The “corporate branded apparel” mentioned earlier is akin to the set of values internalized and functioning in each researcher (and each corporate leader) every day; these must align to qualities of robust research (for example, honest and truthful data collection, analysis, and reporting; admission of errors; protection of research participants). Without this operationalization, ethics is merely an affirmation poster or Code of Ethics – documents that “tick the box” for the compliance team.

Robust research must be viewed with a lens that is focused on more than compliance. This is because a company/employee can be legally compliant but still be behaving unethically. The results of unethical behavior can be harmful to research data, research participants, employees, shareholders, the organization, and the public. Ask yourself, as a researcher, and as a company, what have you poured into your research engine? A few policies? Some checklists? An on-line training quiz with too-obvious answers? Are you compliant or are you ethical?

The stakes are high and compliance is not enough for robust research. Society wants ethical research and, if you can provide it, you are providing value in your research outputs and setting the tone of trustworthiness for your brand and image.

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  1. KA Bramstedt, “The carnage of substandard research during the COVID-19 pandemic: a call for quality,” J Med Ethics, 46, 803-807 (2020). DOI: 10.1136/medethics-2020-106494.
  2. KA Bramstedt, “Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters,” Ther Innov Regul Sci., Oct 1:1-6 (2020). DOI: 10.1007/s43441-020-00224-1.
About the Author
Katrina A. Bramstedt

Katrina Bramstedt is a researcher and bioethicist and Head of Advisory and Training for Your Call Whistleblowing Solutions (Melbourne, AU) and also Adjunct Professor at Bond University Medical School (Gold Coast, AU). Disclosure: She is an ethics consultant for Novartis and Megeno via her firm, AskTheEthicist, LLC.

Katrina Bramstedt is a researcher and bioethicist and Head of Advisory and Training for Your Call Whistleblowing Solutions (Melbourne, AU) and also Adjunct Professor at Bond University Medical School (Gold Coast, AU). Disclosure: She is an ethics consultant for Novartis and Megeno via her firm, AskTheEthicist, LLC.

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