Ignoring substantial safety risks of the study to participants, workers or environment
From The Embassy of Good Science
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ThemesIgnoring substantial safety risks of the study to participants, workers or environment
What is this about?
Ignoring safety risks when planning and conducting a study is a questionable research practice in study design. Not considering potential physical, psychological, social, legal or economic risks can harm researchers, research participants, and wider community.
Why is this important?
Whether you carry out research in an academic setting or you are conducting a fieldwork, there is a variety of safety risks that could affect researchers and research participants. Depending on research areas, different kinds of safety risks may occur, ranging from physical (experiencing pain or other side effects from medication) to psychological harm (stress).[1] Furthermore, faculties at academic sites, such as chemical and microbiological laboratories, may pose hazardous risks.[2] Potential risks that can occur in social research are related to data or perspectives that impact on feelings, values and viewpoints of people involved in research.[3] Fieldwork particularly poses some risks, for example conducting interviews in high-risk locations, such as in war zones or in countries with authoritarian regimes.[4] Not considering safety risks in research can result in tragic events including death.
For whom is this important?
What are the best practices?
VIGOR (Vioxx Gastrointestinal Outcomes Research) study is one of the most known cases where researchers ignored safety risks. The study aimed to examine if a new drug Vioxx, produced by drug maker Merck, would cause fewer gastrointestinal side effects for the treatment of the rheumatoid arthritis than naproxen. Over 8,000 patients participated in the study, half of them taking Vioxx, and the other half naproxen. As it turned out, the risk of serious heart problems and death was twice as higher for patients using Vioxx, than for those using naproxen, however, the study decided to ignore the risks and obscure the results.[5][6] Five years after Vioxx’s launch, Merck withdrew the drug from the market, but by that time it had already sold billions of dollars of the drug[6]. Another study published in the medical journal Lancet estimates that 88,000 Americans had heart attacks from taking Vioxx, and 38,000 of them died.[6]
Andrijana Perković Paloš, Joshua Gualtieri contributed to this theme. Latest contribution was Jun 13, 2024
Other information
Virtues & Values
Good Practices & Misconduct
- ↑ Drew Clifford J, Hardman Michael L, Hosp Jon L. Designing and Conducting Research in Education. Thousand Oaks: Sage Publications, Inc.; 2008. Online publication date: 2014 Dec 22. [cited 2021 Sept 2]. Available from: https://methods.sagepub.com/Book/designing-and-conducting-research-in-education.
- ↑ Dehdashti A, Fatemi F, Jannati M, Asadi F, Kangarloo M B. Applying health, safety, and environmental risk assessment at academic settings. BMC Public Health. 2020;20(1328):1-7.
- ↑ McCosker H, Bernard A, Gerber R. Undertaking Sensitive Research: Issues and Strategies for Meeting the Safety Needs of All Participants. Forum Qual. Soc. Res. 2021;2(1).
- ↑ European Commission. Ethics in Social Science and Humanities. 2018 Oct. [cited 2021 Sept 2]. Available from: https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020_ethics-soc-science-humanities_en.pdf.
- ↑ Krumholz H M, Ross J S, Presler A H, Egilman D S. What have we learnt from Vioxx? BMJ. 2007;334(7585):120-123.
- ↑ 6.0 6.1 6.2 Prakash S, Valentine V. Timeline: The Rise and Fall of Vioxx. NPR. 2007 Nov 10. [cited 2021 Sept 2]. Available from: https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and-fall-of-vioxx?t=1630493248177&t=1630497533212.
