Essay Sample on Informed Consent Process: Benefits, Risks & Changes

The process of getting informed consent from clients is neither easy nor hard. It depends on how you handle your customer. Your first impression to the client makes him or her understand how the information is essential to you and that his or participation is voluntary having gone through the benefits and risks of the study (Lokesh, 2013). The changes that I might make to my informed consent is the size of the subjects. The maximum sample size is 100 cancer patients, for a more conclusive decision, the sample size should be bigger than a hundred, in fact, the minimum sample size should be 200 cancer patients to capture the most probable outcome as the conclusion.

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For the approval and implementation of the drug, its efficacy and safety have to be proved in clinical trials (DeMets, 2010). Since no person has the right to infringe the fundamental rights of the other in the fulfilment of his study purpose, informed consent is a vital tool used in such situations. This is the primary ethical guideline influencing my informed consent. The informed consent is described in regulations and ethical codes for research using human subject. The goal is to provide adequate information to the participant in a way that is easily understood by her or him so she or he can voluntarily decide to or not take part in the research (Ofer, 2018).

The privacy practices do not go beyond the procedure in the consent form. The multiple dosages comprising of subtherapeutic and ascending doses are administered to the cancer patient and results recorded in a questionnaire. The client is assured of confidentiality during and after the study. The only change that can be made for the privacy discussion is the setting of the procedure. To maintain full privacy, the setting can be made private, for instance, at a person's residence instead of a hospital or health care setting.

The patient asked about the management of the risks to the patient during and after the end of the study concerning patient monitoring. The risks of the drug to be tested have minimal possible side effects on the subject, but in case the patients show serious and prove outcomes due to the drug testing, then compensation for the same is guaranteed in addition to the appreciation fund. The clarification was done face to face before appending of the signatures.

DeMets, D., Friedman, L. & Furberg, C. (2010). Fundamentals of Clinical Trials (4th ed). Springer. Retrieved from https://www.edx.org/course/fundamentals-of-clinical-trials

Lokesh, P., Muddukrishna, B., Bhat, K., Udupa, N., & Prashant, B. (2013). Informed consent: Issues and challenges. Journal of Advanced Pharmaceutical Technology & Research. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3777303/

Maria, Z. (2015). 5.1 IRB Informed Consent Checklist. Center for Innovation in Research and Teaching. Retrieved from https://cirt.gcu.edu/irb_documents/5irbinformedconsentchecklistdocx

Ofer, Z. (2018). Professional Association Codes of Ethics and Guidelines on Informed Consent. Zur Institute. Retrieved from https://www.zurinstitute.com/ethics-of-informedconsent/