Informed consent, respect for personal autonomy

Informed consent plays a significant part for ethics in research and in today’s world it is needed for an abundance of tasks. Consent is most commonly known as giving permission for something. Personal Autonomy is the ability to self-govern what you do in research. With informed consent comes respect for personal autonomy. When you involve human subjects into research, consent becomes crucial because it is the subjects’ choice to say what they are comfortable with. The standard for informed consent was acknowledged after the Belmont Report was released in 1979. Informed consent is necessary as a right of the participants in research because it is seen as a way of respecting the patients and their ability to have a choice. 

But why is informed consent in research so important? Well, it is a key component to assure that a study is ethical. Although crucial to medical and research studies, informed consent only became an issue of law in 1972. However, there is a bit of a backstory: “The ideal of ‘informed consent’ is a hallmark of Western medical ethics that came about following the horrors recounted in the Nuremberg trials and was codified in American law through Canterbury v. Spence in 1972.” (Sedig, 2016)  The Belmont report set the stage for informed consent in future research. Written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report included three ethical principles that should underlie any research involving human research subjects, one of them being respect for persons. Respect for persons incorporates two principles: autonomy and informed consent. According to the youtube video Part 3 – The Belmont Report: Basic Ethical Principles and their Application by youtube channel U.S. Department of Health and Human Services, individuals should be treated as autonomous agents meaning that he or she is able to make their choices after hearing all information. Besides the Belmont Report, The Principle of Respect for persons (PRP) demands that “ persons with a capacity for self determination should (1) enjoy liberty to the extent that they do not harm others; and (2) be informed as needed so that they can exercise their deliberative capacity to form a considered judgment concerning how to act.”(Kristinsson, 2007, Page 254) The Principle of Respect for persons acknowledges that there are influences to the subject whether it be family or friends. On most occasions, subjects consult their family members before coming up with a definite decision. In some eyes it is seen that the “PRP apparently requires that others ‘give weight to’ the considered opinions of autonomous persons in their own deliberations. (Kristinsson, 2007, Page 262)

Being a research subject in experiments can be a lot to handle which is why it is important that they be able to choose what they are comfortable with doing. Informed consent does not just mean that subjects give permission to do something; there are qualities that must be satisfied when it comes to consent. Giving people the choice to decide what they partake in is not enough, they must also be given enough information. Why is it important to be given the right information? The research subject bases their decision on the information they are given; without being given all the information needed, a subject might agree to a task they are not fully comfortable with. There are three aspects to informed consent: information, comprehension, and voluntariness. Research subjects are to be given all information about the upcoming experiment and after conscious thinking, they must voluntarily choose which parts of the trial they want to be included in. Comprehension and voluntariness mean that “Subjects must understand the extent of the risk they are taking; they must know that participation is voluntary, they can withdraw from the research at any point, if they chose.” (USGOVHHS, 2021, Minute 7:23-35) 

It is important that informed consent is given to human subjects rather than broad consent. Broad consent is sometimes used as a faster way of getting information to the subject but under legal demand informed consent is needed. Broad consent and informed consent are two branches of consent that have different features but in the topic of research studies “informed consent justified by the value of the autonomy of the participants excludes both the use of general consent.” (Ursin, 2008, Page 23) Another reason broad or general consent is used is because it is seen “as a way to facilitate research by avoiding the time and money spent on the administration of specific consent forms for every new research project.” (Ursin, 2008, Page 17) Informed consent has to go into specifics on risks, benefits, side effects, what the study is for, and what the procedure(s) will be. For informed consent to be executed correctly, sufficient information must be given to the subject: “no consent is informed unless the consenting person is allowed to arrive at an adequately informed decision.” (Ursin, 2008, Page 20) Informed consent deals with both ethical and legal aspects of research. 

Autonomy, in research, is required as a way to respect human subjects; it gives them the ability to be self-determining throughout the whole research process. At times, autonomy is confused with freedom, even though they are two distinct terms. Freedom, according to google, is the power or right to act, speak, or think as one wants without hindrance or restraint. Autonomy, in research, is the ability to choose what they would like to partake in. These can conflict as, “Autonomy is about actually steering the course of one’s life, while freedom is about having the possibility to do whatever you like. A person can be independent without using or valuing her independence—out of a specific conception of her own well-being.” (Ursin, 2008, Page 19) In research autonomy cannot be considered freedom because experiments can for a period of time ask you to give up your freedom. 

Both autonomy and informed consent are indisputably necessary for the sake of the human research subjects. Like I said in my introduction, with informed consent comes autonomy. It is important that researchers are specific and tell all details surrounding the experiments. Researchers should also be open to any questions a subject may have about anything surrounding the study. The information must be given in a conversation with the subject, “researchers and research participants should engage in a dialogue to understand the specific considerations associated with contributing genomic data.”(NIH, 2022) The human subject must completely understand everything about the experiment so that they are definite about their decisions. If a researcher were to deny a subject any information about the tests, it would be considered as a form of neglect and it would not comply with the requirements of respecting the subject. 

Informed consent, although seeming like a common or simple term, is actually complex and has a lot to consider. It can get complicated very quickly because one mess up can make a study illegal and unethical. A person can consent to a test but if he or she realizes that they were not given the right information, the subjects can rightly declare that their consent was invalid. However, it is not always the researchers fault. A subject cannot justify that their consent was invalid if the researchers did not purposely want to manipulate them into consenting. The inadequate information could be given if the subject is negligent because in that case the subject’s autonomy was not compromised. Since the researchers were not trying to persuade the subject by misinforming them nor did they control them, the subject was an autonomous individual at all times. With all of this in mind “a research participant might be autonomous even if he does not give a legitimate informed consent to his participation. The participant might be

autonomous even if he consented to participate in a study which involved risks he was unaware of, and where the researchers involved failed to inform him about these risks because they thought they were obvious to everyone.” (Ursin, 2008, Page 21)  Researchers are ethically at fault if they fail to get informed consent from each subject before conducting the study, the reason being that it could be putting their health at risk. Sometimes even with informed consent a subject might be allowing their health to be put at risk which although would not affect their autonomy, would affect their safety. 

 Informed consent is a crucial part of the legal and ethical features of research. Informed consent is only required with human subjects. Human subjects allow research to become more specific and achieve better results than with any other form of test subject. The subjects in the studies must fully volunteer and agree to all terms based on all the information they are given by the researchers. The subjects must fully comprehend all aspects of the trials before making their decision and giving their consent. With consent comes the term of autonomy which allows subjects to decide what parts of the study they would like to partake in. A study immediately becomes unethical if researchers purposely fail to give all information to a subject before getting their consent. Protecting subjects’ right to informed consent and autonomy is important because it lets them choose what they are comfortable with. We know ourselves more than anyone else so we know what is safe for us to partake in. With laws placed making it essential to get informed consent, research becomes a safer and better environment for the subjects. Subjects should be seen as autonomous agents because they are already letting themselves be tested on for the advancement of science, they should have the right to choose what experiments they agree to be in. 

References

USGOVHHS. (2021, June 16). Part 3 – The Belmont Report: Basic ethical principles and their application. Retrieved December 16, 2022, from https://www.youtube.com/watch?v=M6AKIIhoFn4 

Kristinsson, S. (2007, March 01). Autonomy and informed consent: A mistaken association? – medicine, health care and philosophy. Retrieved December 16, 2022, from https://link.springer.com/article/10.1007/s11019-007-9048-4

Ursin, L. (2008, June 10). Personal autonomy and informed consent – medicine, health care and philosophy. Retrieved December 16, 2022, from https://link.springer.com/article/10.1007/s11019-008-9144-0 

National Center for Biotechnology Information. (n.d.). Retrieved December 16, 2022, from https://www.ncbi.nlm.nih.gov/books/NBK556864/ 

 Sedig, L. (2016, January 01). What’s the role of autonomy in patient- and family-centered care when patients and family members don’t agree? Retrieved December 16, 2022, from https://journalofethics.ama-assn.org/article/whats-role-autonomy-patient-and-family-centered-care-when-patients-and-family-members-dont-agree/2016-01#:~:text=Patient%20Autonomy%20and%20Informed%20Consent,clinicians’%20recommendations%20%5B1%5D 

NIH (2022, January 04). Informed consent Retrieved December 16, 2022, from https://www.genome.gov/about-genomics/policy-issues/Informed-Consent 

Cover Letter

Phase three was the most challenging for me because I had never written a research paper on a biological topic before. There was definitely a lot of reading in this phase which was not terrible but I do tend to zone out which caused me to have to reread some of my sources. I felt like I learned a lot of useful information while writing my research essay. I am an intended biology major and I know that I will have to write research papers in the future so I saw this phase as good practice. 

My intended audience for this essay are people who are trying to get a simple and basic understanding of informed consent and respect for personal autonomy in the research on genomics. I appealed to my audience by trying to refrain from complicated terms in this essay and making it as simple as I could for this advanced topic. Text and evidence were the terms that impacted this research paper the most. I had to use evidence from the carefully gathered sources I chose to back up everything I was saying. The term text reminded me of in- text citations which I also had to use throughout my essay.  

I believe that my writing improved with this assignment. I learned how to cite and use APA style in my writing. Besides that I gained some confidence in starting papers. I often find myself struggling to start essays because I feel like introductions have always been my weakness. I also learned about my topic of choice, which prior to this essay, I knew little to nothing about. My topic was informed consent and respect for personal autonomy. I don’t think it’s the best research paper but I did try my best. While writing this essay, I had to really think of ways to phrase sentences to make the paragraph sound nice. I also had to think of ways to transition paragraphs into each other. This assignment was also the first one where I used a multimedia source. I didn’t even know that a youtube video could be used as a source for a research paper. 

In this phase I achieved quite a few of the learning course outcomes. I located research sources (including academic journal articles, magazine and newspaper articles) in the library’s databases or archives and on the Internet and evaluated them for credibility, accuracy, timeliness, and bias. Searching for sources was a bit of a hassle because I would skim through and find something I didn’t like so I would have to move on to another source. It was especially hard to find a good scholarly source because many that I found on google scholar required a payment to see the full document. I had to practice systematic application of citation conventions with my in-text citations. As with every prior phase, I developed strategies for reading, drafting, collaborating, revising, and editing. With writing this research essay came a lot of reading and editing my drafts. In conclusion, I think that phase three, the research essay taught me many valuable skills that I will use in the future.