Research Essay

Renique Sands 

Brenna Crowe

11/2/2022

FIQWS 1011: Thoughtful Choices, 

Composition for Scientific World

The Research Essay

When you hear the term “consent,” you think about asking for permission to do something. It is something that is all around us and deals with a lot of things that affect our daily lives. That’s why they matter so much for our lives.There are many different types of consent, like informed consent, implied consent, explicit consent, active consent, passive consent, and opt-out consent. The one I’ll go more in depth about is informed consent, which is usually a conversation held between a physician and a patient when patients receive crucial information about a medical procedure or therapy. Consent is a crucial component of our health care system as In the patient-physician relationship, effective communication promotes trust and supports shared decision-making.

For research involving human subjects, informed consent is a moral and legal requirement. It is a procedure in which a participant is informed of all trial-related matters that are relevant to his or her decision-making, and after carefully examining all trial-related matters, the participant voluntarily affirms his or her willingness to take part in a particular clinical trial and the importance of the research for the advancement of medical knowledge and social welfare. The Belmont Report, the Declaration of Helsinki, and the Nuremberg Code all contain principles that include informed consent. Before conducting any research using humans as subjects for study, informed consent is a necessary requirement.In order to ensure that subjects’ participation in the study is entirely voluntary, obtaining consent entails providing the subject with information about his or her rights, the goal of the study, the procedures to be followed, the potential risks and benefits of participation, the anticipated length of the study, and the extent of confidentiality of personal identification and demographic data. An overview of the topics in informed consent is given in this article. Protecting the rights and welfare of human research subjects is the responsibility of the researcher, sponsor, and institutional review board. It covers the fundamental components of informed consent as well as the steps that must be taken to obtain informed consent. An article also highlights some of the situations in which informed consent can be waived and the moral difficulties doctors encounter when asking subjects for their informed consent. People’s values, attitudes, and beliefs also influence their decision to be involved in a study. 

According to the author Rachel Lee(2022) There are 4 principles to be followed: The patient must be able to make a decision, meaning that those that are of lesser understanding, who cannot understand the possible effects of a medical treatment, will need to have consent from a legal guardian. There must be an explanation of information before a decision is made,meaning If you are conducting clinical research, you must outline and detail everything that will happen as a result of the procedure. Additionally, you are required to explain all the possible outcomes and side effects of your trial. If you miss anything, informed consent cannot be given in full faith.The patient must understand the medical information given meaning It is crucial that the patient comprehends what has been communicated once you have covered all the bases regarding a medical procedure or clinical trial. They must understand the medical information conveyed in particular. This is done to ensure that they completely understand the potential outcomes, and The patient must understand their decision is voluntary meaning Legal informed consent cannot ever be given if a patient provides it willingly. They must have the autonomy to accept or reject the course of therapy or research that is suggested to them. Legal informed consent cannot be provided if someone is subjected to any sort of coercion.

Informed Consent Dealing with medical situations have 5 categories starting with letting the patient know about the nature of the treatment, The benefits of the treatment, The risks of having the treatment, Any alternatives in case the patient doesn’t want to deal with the risks and the opportunity to ask any questions on things they are confused about.  Informed Consent is not only used in medical situations it can also be used during an experiment. During an experiment the participant may be asked to sign a form that states something like I have read and I understand the provided information and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost.

As mentioned earlier with Rachel Lee(2022) article four informed consent principles can be distilled into the following four points with reference to clinical trials and human research in particular:The patient must receive a thorough explanation of the study’s goals and methods.The patient must get all pertinent information on the study. This needs to cover any benefits or drawbacks that the study might have.All of the information provided to the patient must be understood by them.The patient must be given the option of participating or not. According to the authors Amy L.McGuire and Laura M.Beskow (2010) “ Genetic and genomic research requires access to human DNA from biological specimens, which can be stored and used in multiple research studies.” Meaning that your DNA is being used for a lot of different studies and trials, and knowing what those trials and what your DNA is being used for is something everyone is entitled to know.

Informed consent is one of the founding pillars of the medical profession. Without it, patients are at risk of being subjected to medical treatments or human research without their consent. It is critical, too, to acknowledge the importance of the word informed. Patients must have all the information they need to make an informed decision. If all the information isn’t given, patients may be agreeing to a course of action that they do not fully comprehend. Making it a legal requirement to provide all the information to patients helps prevent negligent behavior. Additionally, it helps stop those in the world who would seek to take advantage of patients. If the legal requirement to have informed consent didn’t exist, they could do so. Informed consent was established to protect the most vulnerable in society. With respect to human research, informed consent is important to both the patient as well as the medical researchers. Firstly, it stops careless professionals having a cavalier attitude towards their patients and research. Secondly, it means that patients understand fully what they are letting themselves in for. Thirdly, and perhaps most importantly, it helps make results reliable so that they can be used.

They could do so if the informed consent requirement was not mandated by law. Informed consent was created to safeguard society’s most helpless members.Informed permission is crucial for both patients and medical researchers when it comes to human research. It first prevents negligent professionals from treating their patients and research with indifference. Second, it indicates that patients are completely aware of the risks they are taking. Thirdly, and possibly most significantly, it assists in making results trustworthy so that they can be applied.

From a human research standpoint, it is crucial to gain informed permission right from the beginning. Without it, any research done or information acquired can be disputed. Even if the trials or study yielded results that were medically beneficial, they may still be invalidated if they weren’t obtained legally. With that in mind, if you’re thinking about doing some study, be sure to take the time to get the laws right. If you don’t, you risk casting doubt on whatever conclusions you reach and opening yourself up to legal action from your patients. Put the appropriate agreements and consent forms in place to make sure you don’t expose yourself to any risk.

The patient’s protection is the process’ primary goal in obtaining informed consent. An official consent form guarantees continuing contact between you and your healthcare practitioner. This data may consist of:The label of your ailment,The title of the surgery or therapy that the healthcare professional suggests,Benefits and risks of the therapy or process,risks and advantages of alternative options, such as forgoing the procedure or therapy.The patient’s protection is the process’ primary goal in obtaining informed consent. An official consent form guarantees continuing contact between you and your healthcare practitioner. It suggests that you have used the information your doctor has given you about your disease and your alternatives for treatment to pick the one you think is best for you. Your state’s regulations may specify how, for instance verbally or in writing, you must be informed of your treatment options. Together, you and your healthcare professional will determine how to best provide you with the information you require.To aid with your understanding of the content, the provider may opt to employ techniques other than a verbal discussion or a written document, such as movies, interactive computer modules, audio files, or other techniques. Make sure you comprehend all the information provided, even if that requires reading it several times or requesting your provider to do so.

In conclusion it is very important that we are informed of whatever medication or experiment is sent our way , and that we also know that we have choices with whether or not we want to continue with said treatment or experiment. We do have the right to not accept treatment and even the information about treatment and we can also ask a trusted doctor to be in charge of the treatment while you ask for the minimal amount of information while at the same time informed consent does not allow health care providers to hide a diagnosis from a patient even at the family’s request .

 

References 

 

  • Nijhawan, L. P., Janodia, M. D., Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa, N., & Musmade, P. B. (2013). Informed consent: Issues and challenges. Journal of advanced pharmaceutical technology & research, 4(3), 134.

  • Cocanour CS. Informed consent-It’s more than a signature on a piece of paper. Am J Surg. 2017 Dec;214(6):993-997. doi: 10.1016/j.amjsurg.2017.09.015. Epub 2017 Sep 20. PMID: 28974311.

  • Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015 Feb 26;372(9):855-62. doi: 10.1056/NEJMra1411250. PMID: 25714163.


  • Katz AL, Webb SA, Committee on Bioethics. Informed consent in decision-making in pediatric practice. AAP News & Journals; 2016; 138(2):e1-e13.

  • Spruit SL, Van de Poel I, Doorn N. Informed consent in asymmetrical relationships: An investigation into relational factors that influence room for reflection. US National Library of Medicine National Institutes of Health; 2016;10:123-138.

  • The Joint Commission, Division of HealthCare Improvement. Informed consent: More than getting a signature. 2016. Accessed at https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-One_February_2016.pdf on February 19, 2019.

  • McGuire AL, Beskow LM. Informed consent in genomics and genetic research. Annu Rev Genomics Hum Genet. 2010;11:361-81. doi: 10.1146/annurev-genom-082509-141711. PMID: 20477535; PMCID: PMC3216676.