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  • Writer's pictureVedant Parikh

Lab Notes on: Informed Consent in Research

Anika Ajgaonkar's notes on informed consent in research— the pros vs. the cons.

 

Research is a field committed to the discovery of knowledge that can help society at large, but the waters get murky when human participation is required to facilitate the success of a study.


Although research academia has progressed leaps and bounds from the past, some issues remain the same, such as that of informed consent of participants in research.


By definition, informed consent is more than having participants sign on a paper. The FDA also considers it to encompass these other parameters:

  • Providing sufficient information about the experiment so participants can make their own informed decision

  • Helping them understand the information provided and answering questions or doubts

  • Granting enough time for the participant to discuss their participation in the study with family and friends

  • Obtaining voluntary, not coerced, participation

  • Providing information throughout the procedure as necessary or as the circumstances and the investigation progress

Pro


Informing research participants of what they will be subject to in the experiment is an ethical necessity, no matter what potential findings could be lost in the process.


If participants could be exposed to certain risks, discomforts, or side effects as a result of testing, they have a right to be aware of this knowledge and opt out if they so choose. Ultimately, no knowledge or research question is worth sacrificing our moral obligations to, because, from that point onwards, there is no clear indication of when to stop. Certain demographics are at a higher risk of being taken advantage of, such as prisoners, those suffering from life-threatening diseases, children, the educationally or socioeconomically disadvantaged, and the cognitively impaired. Without informed consent, they are more likely to be coerced into research or clinical trials without full understanding or willingness to participate. Additionally, a lack of required participant consent could easily be taken advantage of by the creators of the study to do as they please, even crossing the acceptable boundaries of what is permitted in a research or medical setting.


Transgressions in medical or research protocol regarding informed consent reflect poorly on other researchers and clinicians as well. For the sake of the bodily autonomy and dignity of patients, informed consent is absolutely mandatory to ensure upright practices in research and medicine.


Con


Consent is important, but in the case of research, it is better omitted. After all, researchers would not knowingly harm their participants, would they?


Some research or medical operations are more likely to have participants be opposed to them if given the chance to express their opposition, but this data has no way of being collected otherwise. For the sake of science and the greater good, and as long as patients are not harmed, it is better to do what needs to be done whether the participant agrees or not. Henrietta Lacks, for instance, had a sample of the cells from her cancerous cervical tumor removed without her knowledge or consent. These cells, however, were unlike any seen before, and had the miraculous ability to replicate indefinitely. Countless numbers of these cells, known as HeLa cells, have been used for medical testing of new drugs and treatments and also saved many lives in the process. If Lacks had chosen not to provide her cells, is there any guarantee that similar cells would have been found soon enough to create the life-saving medications we have today? Radiation and poison research, understanding the human genome, studying viruses, and the development of polio and Covid-19 vaccines are just a few of the applications that HeLa cells were used for that benefited countless individuals.


Informed consent becomes especially tricky in the realm of psychological or behavioral studies, where informing participants what they are being studied for beforehand could prime them to act differently than they normally do. In cases like these, the verity of the data collected may even be compromised by providing informed consent and impact our understanding of the human body.


Readers, what do you think? Are the downsides to informed consent worth jeopardizing medical ethics, or should a participant’s right to knowledge override any potential losses in discovery?

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