Medical technologies-drug testing Module Number: HSO4001 Module Name: Legal and Ethical Issues

Drug testing involves four stages: Discovery and Development, Preclinical Research,
Clinical Research, and Official Body Review (Abadie, 2022).
When a new drug develops, testing is needed to find the effectiveness and safety
features.
Drug testing refers to ingesting an active drug substance that has a measurable effect
on the body of humans and animals to the possible reaction within a population
(Corrigan, 2018).

1. BSC (Hons) Health and Social Care HSO4001 Legal and Ethical Issues

2. Assessment 2: Individual Presentation Topic : Medical technologies-drug testing Name: Oana Dediu ID:

3. Contents Introduction Description Medical technologies Ethical Dilemma in HSC Advantages Disadvantages Ethical theories on Drug testing Synergy Proposed questions Conclusion References

4. Introduction

5. Description of drug testing Drug testing measures the efficacy and risk It is also called a clinical trial FDA requires three trial phases to get approval Testing new drugs starts with computer analysis The next stage of drugs testing on the human body The last clinical stage conducts clinical trials

6. Medical technologies for drug testing

7. How Drug Testing Can Cause Ethical Dilemma in HSC (cont.) Drug testing plays a significant role in health and social care (HSC) Drug testing is ethically necessary Integrity is a must for drug testing They need to ensure no harm or Ethical dilemmas can occur

8. How Drug Testing Can Cause Ethical Dilemma in HSC

9. Advantages of drug testing Drugs can assure the pharmacist of safe use The rigorous testing process helps to find efficacy The drug test has several stages to ensure the safety and efficacy When a drug gets approved it is considered safe Drugs are tested in labs, computer tests, animal bodies, and the human body

10. Disadvantages of drug testing

11. Ethical theories on Drug testing Deontology This ethical theory uses rules to differentiate wrong from Right Pharmacists must be honest by telling the truth to the They don't deserve the credit for drug test success. They need to give credit to the proper authority who deserves it. researchers should give full credit to the participants

12. Ethical theories on Drug testing Right-based and virtue-based theory P eople’s rights need to be upheld in the drug testing procedure Virtue-based ethics are concerned with displaying good actions such as loyalty, courage, and wisdom Drug testing researchers need to be ethical

13. Synergy between law and ethical theories of drug testing UK follows the EU Clinical Trail Directive (2001/20/EC) UK Medicines for Human Use Regulations in 2004. These regulations protect the rights, well-being, and safety Deontology theory concurs with the laws and regulations (MRC) of the UK is concerned with the rights of human participants (MHRA) concurs with virtue-based ethics

14. Proposed questions to the audience for group discussion 1. Are organizations following ethical codes of conduct while testing drugs on human and animal participants? 2. What ethical codes of conduct should be followed during the clinical trial process of drug testing? 3. How should researchers avoid ethical dilemmas in health and social care (HSC)?

15. Conclusion Drug testing is necessary to find the efficacy and safety features Drug testing has become a common phenomenon Drug testing can cause ethical dilemmas Participants face injustice, dishonesty, and potential harm Drug testing has advantages Deontology ethics is supported by drug regulation of the UK Legal authorities also support right-based and virtue-based authority

16. Reference List Abadie, R. (2022). The Ethics Debate on Compensating Drug Trial Volunteers. Anthropology News , 49(2), pp.24–24. doi:https ://doi.org/10.1525/an.2008.49.2.24.1. Corrigan, O.P. (2018). 'First in man': the politics and ethics of women in clinical drug trials. Feminist Review , 72(1), pp.40–52. doi:https ://doi.org/10.1057/palgrave.fr.9400055. Enserink , M. (2022). Fraud and Ethics Charges Hit Stroke Drug Trial. Science , 274(5295), pp.2004–2005. doi:https ://doi.org/10.1126/science.274.5295.2004. Gyawali , B. and West, H. (Jack) (2021). Lessons From ADAURA on Adjuvant Cancer Drug Trials: Evidence, Ethics, and Economics. Journal of Clinical Oncology , 39(3), pp.175–177. doi:https ://doi.org/10.1200/jco.20.01762. Heemskerk, J., Tobin, A.J. and Ravina, B. (2020). From chemical to drug: neurodegeneration drug screening and the ethics of clinical trials. Nature Neuroscience , 5(S11), pp.1027–1029. doi:https ://doi.org/10.1038/nn931. Hulsey, T. (2015). Prenatal Drug Use: The Ethics of Testing and Incarcerating Pregnant Women. Newborn and Infant Nursing Reviews , [online] 5(2), pp.93–96. doi:https ://doi.org/10.1053/j.nainr.2005.03.004. Kimmelman, J., Weijer , C. and Meslin, E.M. (2019). Helsinki discords: FDA, ethics, and international drug trials. The Lancet , [online] 373(9657), pp.13–14. doi:https ://doi.org/10.1016/s0140-6736(08)61936-4. London, A.J. and Kimmelman, J. (2019). Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy. Hastings Center Report , 49(4), pp.31–41. doi:https ://doi.org/10.1002/hast.1034. Lurie, P. and Wolfe, S.M. (2017). Unethical Trials of Interventions to Reduce Perinatal Transmission of the Human Immunodeficiency Virus in Developing Countries. New England Journal of Medicine , 337(12), pp.853–856. doi:https ://doi.org/10.1056/nejm199709183371212. Schipper, I. and Weyzig, F. (2018). Ethics for Drug Testing in Low and Middle Income Countries: Considerations for European Market Authorisation . Social Science Research Network . Suñé , P., Suñé , J.M. and Montoro, J.B. (2013). Positive Outcomes Influence the Rate and Time to Publication, but Not the Impact Factor of Publications of Clinical Trial Results. PLoS ONE , 8(1), p.e54583. doi:https ://doi.org/10.1371/journal.pone.0054583. van Lent, M., Rongen , G.A. and Out, H.J. (2014). Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review. BMC Medical Ethics , 15(1). doi:https ://doi.org/10.1186/1472-6939-15-83.    

17. Questions ?

18. Thank You