Informed consent is crucial in clinical trials and medical research. Like stated in the question, this could end up being a disservice to the larger scientific field in the instance that a person such as Henrietta Lacks were to check "No" for research use.
However, in medical research, clinical trials, and overall in all aspects of life, a persons privacy, and feeling of safety is essential. If a person knows that by going to the doctors office, they are unsafe, and do not have the opportunity to decide what happens to them, their bodies, or their samples that could be used for research, they are much less likely to go. Personally, if something about me could be researched to help other people, I would be all for it, and for a similar reason, I sign my life away on all papers at the doctor's office without reading them. However, some people who are more particular, and don't want any of their information used in research, like to have this choice and informed consent.
Overall, if informed consent is taken away, and it becomes a free-for-all of anything can happen in a medical setting, people will be much less likely to go, and it will cause more of a detrimental effect on the scientific field than the 1 out of 1000 people who check "No" to be used fro research use.
In my opinion, I believe it is very important for patients to be given the decision to determine whether data or samples pertaining to them can be used for research or other purposes. For starters, the creation of untold unknowns about how ones data or samples could or could not be used could deter some individuals from visiting medical care providers. For example, in situations where a patient feels uncomfortable about telling others of any medical impairment their hope is that what they shared with their doctor is solely between the two of them. On the contrary, if the doctor could use their data or samples without allowing for refusal, the patient would have increased reservations about sharing any medical ailment with their health care provider. Furthermore in scenarios in which surgeries are involved, the patient may already have fears in relation to the procedure and the addition of unknowns pertaining to data collected would only add to this. As a result, I believe it is important for the individuals being clinically tested to have a say on how they would like their data to be handled and collected. Nonetheless, I believe if the doctor or other party would really like to collect samples or data from an individual then they could try persuading them to participate. Lastly in terms of monetary compensation, I believe that the promise of compensation or royalties should only be provided if they were agreed upon prior to the clinical study. Correspondingly such compensation could be used to convince patients to agree to clinical trials.
I think consent should by all means be secured from patient prior to using materials or data from patients. It is crucial people and therefore patient have complete control over THEIR being. At the core of slavery of African for several centuries was notion that they did not have right over their own bodies. Any assertion to suppress a person autonomy over their own body is a return to the same hideous subjugation of one human being to benefit others.
The question "Is patients saying NO a disservice to science" should be consider in the wider scope of human rights. Science should not be advanced by disregarding human rights.
I think if Henrietta had said NO, maybe she would have been treated better in an effort to influence her to participate.
This example still is a point of outrage to me, because it demonstrates what systemic racism in healthcare looks like. Henrietta Lacks is essentially a guinea pig to be profited from. Neither she nor her family have been treated like they matter. Not only was she disregarded as a human being, her family was denied any compensation for the commercialization of her cells. This is NOT ethical research practice; the law be damned. Much of the distrust of the pharmaceutical and biotech industries, especially when we broach the subject of limited participation in clinical trials by people of color, is a result of this attitude that they are not worthy to be treated like human beings. If commercialization always trumps being ethical then what a diabolical enterprise that we are a part of! We are supposed to do no harm. We are supposed to develop enterprises from science that improve the quality of life and abate the ravages of disease.
When I think of the Henrietta Lacks debacle or the cat-fighting over the CRISPR/Cas9 patents, I feel ashamed about our industry not proud. And by the way, for the vaunted CRISPR/Cas9 genomic technology, how many phase III clinical trials have been completed? How many new medicines have been developed that regular patients or citizens can get access to? I'll wait for the answers... So, hundreds of millions or perhaps billions of dollars can be thrown around and not ONE patient can be helped or restored? Is THAT who we want to be?
Lastly, let me address informed consent, since many of its advocates within this forum speak as if it is ironclad. Informed consent can also be a tool of manipulation if it is fulled with a preponderance of medical and scientific jargon that the layperson cannot truly understand, and I have observed shameless examples of these. At the Morehouse School of Medicine, our IRB is downright anal and vigilant about informed consent documents being written to a level where even a 5th grader can understand their contents. I fear and KNOW that this is NOT the case everywhere else.
I met a pastor friend who is only a couple of years older then me who was given a heart medication to help manage his congestive heart failure. That medication causes debilitating rheumatoid arthritis. When I last saw him, I almost cried; he couldn't manipulate his fingers to shake my hand. He can't walk anymore without a wheelchair; it's too painful for him to even attempt using a walker. Mind you this is after less than two years of the medication, I asked him, "Did your doctor recommend this? Did they fully explain the side effects and repercussions? Did you consent to this?" He answered that he guesses that he did, but his doctor had explained that this medication was the ONLY way for him to survive? What? Only one way to survive CHF, which is very survivable? He went from having fatigue and breathing issues prior to a pacemaker and this medication to now being a shell of him. He has the frailty of an 80 or 90 year old patient.
So, please spare me the praises of informed consent, because if implemented with the wrong motives or selfish intent from the medical practitioner, we can easily have Henrietta Lacks all over again. I do applaud informed consent and other proactive regulations enacted by the FDA, but let's NOT forget that the more important thing is for us to be ETHICAL RESEARCHERS AND CLINICIANS.
The interesting thing about Henriatta Lacks case is that it occurred prior to legislation that now exists to inform and protect patients. (As well as occurring before legislation regarding the ownership of tissues was created. Fun fact: If you consent to donate tissues any products made with such or money made with such does not belong to you since the tissue used is defined as "waste" and thus you have no ownership of it after it is removed from your body).
It's hard to imagine what it would have been like if Henriatta Lacks had been informed of what her tissues were being used for. I imagine if she had been informed, then very likely it would be due to the fact that someone before her had experienced something similar that resulted in a court case thus setting a precedent that patients should receive informed consent.
It's also hard to imagine what would have happened if she had said no to donating her cervical tissue. She was not the only person to have their tissues used without their consent at the time; she was just the only one tested to have cervical cancer so virulent that it was able to be cultured. Maybe someone else would have come along with similar cancer cells, maybe not.
Ultimately, it's hard to make any distinct conclusions about what could or could not have happened if the precedents during her lifetime had been different. What really matters though is the consequences that occurred after such including legislation that requires informed consent, America's history of using African Americans as, "Lab rats" coming to light, and the continued issues surrounding medical research, ownership, and consent in regards to clinical testing.
My opinion is that humans have a right to decide what they want to do with their body including whatever is removed during a surgery. Some people do not want their tissues/specimen to be part of research and to me that is fine because it's theirs and they are at liberty to decide. While I understand the point of view that we would be missing out on an opportunity to greatly advance science, it is unethical to force someone to do so. There is a reason that all these laws and checks were created. To respect, honor, and behave ethically towards human life.
To jwashin3's point, it's crucial to properly convey information in a manner that patients/ research subjects will understand. Many times patients will blindly accept medication because their doctor recommended it to them and doctor's are supposed to have the patient's best interest in mind. While this might be the case in most, there are always exceptions. This is the importance in having a robust review process and the ability to explain things plainly. While many ethical questions arise around clinical trials, I do think we have controls (though improvements might be needed) in place aimed to fight the manipulation and deception that can arise.
This topic is near and dear to my heart, Ms. Lacks and her family endeavored and are still processing through the legalities of her cells being taken without her consent while she was alive. The fact that her cells are still used for medical research. No consent was obtained to culture her cells, nor were she or her family compensated for their extraction or use. As of recent, her family has been given “limited rights” but I am still unclear as too how much. It is my belief that patients should have the right to chose what can and cannot be done, it is their body and if they are not psychological capable of making the decision then they should not be allowed to participate. What would have happened with science if Ms. Lacks would have been given the option and she selected “no” the science and medical progression may have been slowed down a tad bit. HeLa Cells are an invaluable part of laboratory and various specialties in science. The government should bestow some type of back pay to the Lacks family as well and put stipulations on the uses and accessibility of HeLa cells and allow the family to have a larger voice in the utilization of HeLa cells.
Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research. Lacks was the unknowing source of these cells from a tumor biopsied during treatment for cervical cancer at Johns Hopkins Hospital in 1951. These cells were then cultured by George Otto Gey who created the cell line known as HeLa, which is still used for medical research. No consent was obtained to culture her cells, nor were she or her family compensated for their extraction or use.
Today's clinical trials require patients to sign informed consent forms as Dr. Simon mentions and showed in lecture. Informed consents allow hospitals to use patient data/materials for internal research use if the patient elects to do so. What if Henrietta lacks was in a clinical trial and checked "No" on her informed consent to not allow Johns Hopkins to use her samples for research use? Her samples created one of the most valuable cell lines ever created, and has helped advance medical research as we know it. Should patients have the option to elect "No" for research use or is that doing a disservice to the larger scientific community trying to find cures?
I believe that patients should have right to choose what can and cannot be done with their data/samples. I personally think it should be explained to the patient the benefits of providing their data/samples for research use, but that its ultimately up to them if they don't want to provide it for research use. I also believe the Lacks family should have received some type of royalty or compensation for the commercialization of the HeLa cells.
Henrietta Lacks was an African American woman who died from cancer in 1951. Her cancer cells were the source of the HeLa cell line, the first immortalized human cell line and one of the most important cell lines in medical research. These cells were taken without her knowledge and consent. Additionally, her family was not made aware of their use until 1975 and were compensated even though they have led to considerable medical advancements. This case brings up the issues of patient rights as well as the historical exploitation of minorities for medical advancement. Similarly, the Tuskegee Syphilis Study followed 600 African American men over a period of 40 years to study the natural course of syphilis. The participants were not informed of the true nature of the study, they were not allowed to leave the study, and they were not told when treatment became available. Many of the men died from causes related to syphilis. The true nature of the study was not revealed until a journalist published an exposé in 1972. It is wrong and it is my hope that this pervasive overt racism in clinical trials does not continue.
I can see both sides of this very controversial question. For the sake of ethics and basic human rights, I would support the enforcement of the Informed Consent Form if Henrietta had checked no for the research use of her cells. Patients have a right to privacy and a right to delegate what physician or researcher should use their biological samples for once they leave the body. However, on a microcosmic scale, the HeLa cells have been used to move forward the research of cancer and many forms of cancer treatment. Without these cells, the mortality rate of people living with cancer would be extremely high, along with a large list of other diseases. Although what happened to Henrietta Lacks was absolutely wrong and should never happen again, regardless of potential benefits, her cells were used for the greater good.
@alexandrabuga Great topic, a nice contrast to typical posts. I do believe that Henretta lics heirs were ultimately compensated – largely due the pubic cries of “foul”, which I believe appropriate. You made some interesting points; I am ignorant to the details of medical consent as you described. I am fortunate to never have needed a procedure of any sort. Either way, I disagree that a patient should lose all rights to matter removed from their body. My perspective is that just as an artist is compensated by royalty payments from others who use their copywritten work, biological matter of derived from unique DNA should belong to the human it was obtained. Any approved use should result in compensation. Still, I need to research this further, as your post suggest that consent is transferred by simply completing a routine medical procedure, but it would not surprise me if such small print is hidden in legal jargon.
This thread assuredly posses an ethical dilemma. My goodness, what to choose. At the end of the day, it is likely that the next Henrietta Lacks has, in fact, chosen to keep their tissues out of the hands of scientists. While this is most definitely going to make research move a little slower, it is also their right. How far are humans willing to go to make everyone think they are their own person but deceive them in the long run? It would be creating a false sense of control for everyone just to override their decisions in the name of science. That's not right. "My body, my rules" goes for every aspect of life. Even if science needs it.
Informed consent originates from the patient's right to direct what happens to their body, even though Henrietta Lacks cells have gone on to contribute greatly to science and make a lot of people rich. I still believe ethically that everybody including Henrietta have the right to choose what happens with their body and Informed consent is both an ethical and legal obligation of medical practitioners in the US to make sure that happens.
I agree that both sides of the argument have a complicated choice when it comes to what is ethically correct. An Informed Consent form is necessary for obtaining proper documentation of patient agreement. The cells of Henrietta Lacks have provided numerous advancements in medical solutions. Through all of the accomplishments, there is a dark past that accompanies these discoveries. Since the cells were stolen, Henrietta Lacks should have been allowed to check no on the informed consent form. Not getting proper recognition allowed the cells to be used countless times. The cells lead to a decrease in mortality for serious diseases like cancer. It is hard to say when these advancements would have happened if she was allowed to check no.
I live in a country where many people believe that we should have the right to choose. Choose to own a gun, choose to say what we want, choose to vote; the quote life, liberty, and the pursuit of happiness. It all sounds great. In reality the right to choose varies depending on whose rights we are talking about. Such was the case with Henrietta Lacks. She did not have the right to choose. Her right was taken, no everyone else is supposed to provide informed consent. Even the current system can be predatory and abusive to certain people. Any advances in medicine that originate from an individual should provide immediate financial compensation. Currently there is millions of people that have submitted there DNA to companies like 23andMe. 23andMe had around 80% of their customers opt in to providing their DNA for research. Research that will further our ability to move into personalized medicine and gene therapies. There is a definite balance that needs to be maintained. I believe people when properly educated want to be a part of the advancement of the human race.
Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research. Lacks was the unknowing source of these cells from a tumor biopsied during treatment for cervical cancer at Johns Hopkins Hospital in 1951. These cells were then cultured by George Otto Gey who created the cell line known as HeLa, which is still used for medical research. No consent was obtained to culture her cells, nor were she or her family compensated for their extraction or use.
Today's clinical trials require patients to sign informed consent forms as Dr. Simon mentions and showed in lecture. Informed consents allow hospitals to use patient data/materials for internal research use if the patient elects to do so. What if Henrietta lacks was in a clinical trial and checked "No" on her informed consent to not allow Johns Hopkins to use her samples for research use? Her samples created one of the most valuable cell lines ever created, and has helped advance medical research as we know it. Should patients have the option to elect "No" for research use or is that doing a disservice to the larger scientific community trying to find cures?
I believe that patients should have right to choose what can and cannot be done with their data/samples. I personally think it should be explained to the patient the benefits of providing their data/samples for research use, but that its ultimately up to them if they don't want to provide it for research use. I also believe the Lacks family should have received some type of royalty or compensation for the commercialization of the HeLa cells.
I also believe a person should have the right to choose. However, at the same time if the samples have already been taken and no hard has been done to the person. The samples should be disassociated from the person they came from and used.
