Evaluating the ethical and legal challenges of using Biobanks
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This Blog is written by Anish Bachchan from Amity Law School, Noida. Edited by Karan Dutt.
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INTRODUCTION
Biology is very funny because it can be looked at as a double-edged sword subject. It can save lives and find discoveries of the world and the solar system while at the same time, it can take lives and destroy everything. When penicillin was discovered in 1928, it became a huge medical player alongside morphine during World War II. I must remind you that this is the same war that saw the human experimentation at the hands of Unit 731[1] and Joseph Mengele[2], the Nazi Scientists. What’s worse, Imperial Japan would go on biological warfare against the United States by sending infected insects to the US West Coast to kill the population. The main reason was to prevent them to reach the home island because, after the Battle of Okinawa, Japan was at the American Bald Eagle’s sight. But the atomic bombs and the Soviet’s declaration of war stopped those plans from coming to fruition[3].
The concept of controversial biology has reached the footsteps of pop culture. Hideo Kojima who was revered in the video game world tried to bring some horrors of biology in his video game franchise- Metal Gear Solid. The game dealt with serious subject matters like human exploitation, torture, viruses as WMDs, and an army based on genes that sound like sci-fi but can become a reality if human nature doesn’t learn its lesson[4][5].
As of this writing, new biological concepts are on the rise alongside new dangers and controversies. These concepts have fair intentions but it’s the flawed execution that speaks louder than intentions. By the time the questions regarding its legality and morality are raised, it will be already too late. And with the ongoing pandemic going on, things are very bleak right now. So without any delay, let’s talk about one of the recent controversial biological concepts- Biobank.
WHAT IS BIOBANK?[6]
Think of a biobank as an actual bank. Imagine you want to put your savings in a secure location. You’re saving a lot of money to go to say, Poland. So you’ll go to a bank and put all your savings there so that you could go to Poland. I hope the Poland trip would be worth it.
Do the same thing with the biobank. Instead of saving up money, you save up biological samples. Those samples could be resourceful shortly when you research them. Imagine that research ends up becoming medicines or a way to understand genomes. That’s how we understand the biobanks.
The use and advantage of biobanks in the times of Covid-19[7]
Biobanks will be a bastion of hope in a time like Covid. Scientists are using the samples of the victims to understand more about the virus. Through rigorous and tiring studies, they’re doing their very best to find the best course of action to tackle the diseases. Studying the Covid cells will help them gain more knowledge about the nature of the virus. It will be advantageous for the Covid war effort and finding a vaccine.
The long term process has its perks:
1. People are not required to give surveys and their samples every time.
2. The acquired snippets will pay off the hard work of the scientists. They will be a huge aid in creating better treatment and medication.
3. When Pharmaceutical companies give a helping hand to them, their contributions will be extensive in creating better medical drugs and treatment.
Like all definitions, biobanks have 2 types:
1. Human Genetics Research
2. Conservation, Geoengineering, and the restoration of the ecosystem.
THE ETHICAL QUESTIONS OF BIOBANKING[8]
1. Before I progress any further. I want to talk about the flawed capitalist system we are living in right now. Just because socialism is a paper tiger system doesn’t mean capitalism is all sunshine and rainbows. It’s quite the opposite. With all their big talk about the free market, capitalism sure is an expensive ideology. After all, it is the same system, that led to the global recession from 2007-09. This system also talks big about liberal ideas when they don’t practice it in the Middle East and China. These are the regions with a lack of respect for human rights. And the corporations invest it to get some Middle Eastern oil and Communist gold. Let’s not forget that their greed causes scandals like the Star Wars Battlefront 2 (2017) scandal and the Blizzard-Blitzchung controversy[9]. In other words, they pretend to be altruistic but in reality, they seek private gains[10]. Pharma corporations are so greedy that their greed will hinder the progress of biobanking. Let’s take the example of the property in samples. The UK Biobank says that once it detaches from one’s body it becomes “no one else’s thing”. The property of the participant’s sample remains in question.
2. Confidentiality in the modern world is like a penny. No one in this world values it until it is gone entirely. The internet and the world governments are becoming more authoritative like the Patriot Act. Words like confidentiality and privacy are just words that have lost their meaning. People are being conscious and fearful about their information being sold to a country or an organization. Genetics is a different story though. It is because it can reveal the identity of the person to the whole world. So people are raising concerns about confidentiality and privacy regarding their genes and identities.
3. The alarming issue of informed consent plays a role in questioning the ethics of the biobank. Critics say that it ignores the rights of the person connected to the sample. It has the potential to create problems regarding the autonomy of the individuals. Biobanks lack recognition as a research project. Rather they are considered as research libraries. The governments also face the criteria to meet the right to withdraw. The biobanks in the UK and Finland allow the right to withdraw without any penalties and reasons. Some researchers suggest that broad consent should serve as a solution to informed consent. However, the main critique of this consent is that it lacks guarantees and protection for the participants.
4. When there are mass withdrawals of participants then it could lead to the end of the biobanks. Critics say that the participation and representation of the participants must matter. The maintenance of trust must not be broken to prevent any more withdrawals.
5. The lack of feedback policies has been raised by various people. Let’s take the example of the MRI Scans. MRI scans play a profound role to find out any health problems. And the participants are given a little option for their feedback. Then it could create problems as no one would know if there is any problem with the MRI Scans.
6. Another issue raised by the critics is re-contact. Although there is little written about it, the critics say that there must be a balanced and healthy relationship with the participants. To put it in layman’s terms, the participants must be informed and included. They should not face a burden on their shoulders.
LEGAL CHALLENGES WITH CASE LAWS
The European Union has grave concerns regarding the legal position of biobanks. They fear that medical researchers would be jeopardized without any proper legal regulations. It is essential that the handling of human tissue must be done in a proper legal manner. There were 9 international workshops and 3 conferences to bring out the strengths and weaknesses of the biobanks.
1. Moore v. Regents of University of California[11]
John Moore went to UCLA Medical Center for his treatment of leukemia. His hairy cell was taken by a doctor named David Golde. When Moore’s cell develops into a cell line, Golde and UCLA decided to commercialize it. This made Moore file a lawsuit against the Regents of UCLA and Golde. The California Supreme Court stated that Moore neither have any right to claim his discarded cells nor could use it to make profits. The court also added that the doctor must reveal his financial intention to Moore. If he fails to do so then the latter can claim for injury.
2. Greenberg v. Miami Children’s Hospital Research Institute[12]
The claims of the plaintiffs’ were rejected in the court for various reasons-
1) No informed consent was provided.
2) Fidiciuary duties were breached.
3) Patents were concealed
4) Trade Secrets were misappropriated.
The plaintiffs’ claim regarding the unjust enrichment which came at a cost of the donors were upheld by the court.
CONCLUSION WITH INDIAN CONTEXT[13]
By now the Tata Memorial Hospital is the only biobank that currently exists in India. The biobank serves the billion people in the country. In the West, biobanks are abundant whereas in countries like India, Malaysia, Thailand, etc. The primary reasons for the lack of biobanks in India are-
1. No proper budgeting and infrastructure.
2. Barriers in social, ethical, and political realms.
3. Lack of awareness among the masses.
This serves as a reason for the need for biobanks in India because it could help the weakest sections of society. At the same time, proper legal regulations should be imposed so that biobanks could work properly. It should be moral and altruistic. It is hoped that the government should bring proper implementations to help the society’s weakest section.
REFERENCES
(1) Stockton, R. (2017, November 3). Inside Unit 731, World War II Japan’s Sickening Human Experiments Program. All That’s Interesting; All That’s Interesting. https://allthatsinteresting.com/unit-731
(2) Stockton, R. (2016, June 6). The Sickening Experiments Of Dr. Josef Mengele, The Nazi “Angel Of Death.”All That’s Interesting. https://allthatsinteresting.com/josef-mengele
(3) Geoghegan, J., & Geoghegan, 32;John. (2014). Operation Storm: Japan’s Top Secret Submarines and Its Plan to Change the Course of World War II. Broadway Books. https://military.wikia.org/wiki/Operation_Cherry_Blossoms_at_Night
(4) Metal Gear Solid: Learning Lessons Of War From Video Games. (2021, March 30). Youth Ki Awaaz. https://www.youthkiawaaz.com/2021/03/metal-gear-solid-the-lessons-of-war/
(5) Creating Superhumans Through Gene Manipulation and More. (2018, October 30). HowStuffWorks. https://science.howstuffworks.com/life/genetic/creating-superhumans-through-gene-manipulation-and-more.htm
(6) Biobank. (2021, May 31). Wikipedia. https://en.wikipedia.org/wiki/Biobank#Legal_cases
(7) What is a biobank?(n.d.). Biobank. Retrieved June 24, 2021, from https://www.biopankki.fi/en/what-is-a-biobank/
(8) Widdows, H., & Cordell, S. (2011). The Ethics of Biobanking: Key Issues and Controversies. Health Care Analysis, 19(3), 207–219. https://doi.org/10.1007/s10728-011-0184-x
(9) Bachchan, A. (2021, January 6). Current Issues that Plagued the Video Game Industry. Medium. https://anishbala147.medium.com/current-issues-that-plagued-the-video-game-industry-5067de7db0a9
(10) Metal Gear Solid: Learning Lessons Of War From Video Games. (2021, March 30). Youth Ki Awaaz. https://www.youthkiawaaz.com/2021/03/metal-gear-solid-the-lessons-of-war/
(11) Moore v. Regents of the University of California. (2021, April 4). Wikipedia. https://en.wikipedia.org/wiki/Moore_v._Regents_of_the_University_of_California#Issue
(12) Wikipedia Contributors. (2021, January 31). Greenberg v. Miami Children’s Hospital Research Institute. Wikipedia; Wikimedia Foundation. https://en.wikipedia.org/wiki/Greenberg_v._Miami_Children%27s_Hospital_Research_Institute
(13) India needs gen-next cancer biobank. (2013). Nature India. https://doi.org/10.1038/nindia.2013.103
In-text Citation(s):
[1] Stockton, R. (2017, November 3). Inside Unit 731, World War II Japan’s Sickening Human Experiments Program. All That’s Interesting; All That’s Interesting. https://allthatsinteresting.com/unit-731
[2] Stockton, R. (2016, June 6). The Sickening Experiments Of Dr. Josef Mengele, The Nazi “Angel Of Death.” All That’s Interesting. https://allthatsinteresting.com/josef-mengele
[3] Geoghegan, J., & Geoghegan, 32;John. (2014). Operation Storm: Japan’s Top Secret Submarines and Its Plan to Change the Course of World War II. Broadway Books. https://military.wikia.org/wiki/Operation_Cherry_Blossoms_at_Night
[4] Metal Gear Solid: Learning Lessons Of War From Video Games. (2021, March 30). Youth Ki Awaaz. https://www.youthkiawaaz.com/2021/03/metal-gear-solid-the-lessons-of-war/
[5] Creating Superhumans Through Gene Manipulation and More. (2018, October 30). HowStuffWorks. https://science.howstuffworks.com/life/genetic/creating-superhumans-through-gene-manipulation-and-more.htm
[6] Biobank. (2021, May 31). Wikipedia. https://en.wikipedia.org/wiki/Biobank#Legal_cases
[7] What is a biobank? (n.d.). Biobank. Retrieved June 24, 2021, from https://www.biopankki.fi/en/what-is-a-biobank/
[8] Widdows, H., & Cordell, S. (2011). The Ethics of Biobanking: Key Issues and Controversies. Health Care Analysis, 19(3), 207–219. https://doi.org/10.1007/s10728-011-0184-x
[9] Bachchan, A. (2021, January 6). Current Issues that Plagued the Video Game Industry. Medium. https://anishbala147.medium.com/current-issues-that-plagued-the-video-game-industry-5067de7db0a9
[10] Metal Gear Solid: Learning Lessons Of War From Video Games. (2021, March 30). Youth Ki Awaaz. https://www.youthkiawaaz.com/2021/03/metal-gear-solid-the-lessons-of-war/
[11] Moore v. Regents of the University of California. (2021, April 4). Wikipedia. https://en.wikipedia.org/wiki/Moore_v._Regents_of_the_University_of_California#Issue
[12] Wikipedia Contributors. (2021, January 31). Greenberg v. Miami Children’s Hospital Research Institute. Wikipedia; Wikimedia Foundation. https://en.wikipedia.org/wiki/Greenberg_v._Miami_Children%27s_Hospital_Research_Institute
[13] India needs gen-next cancer biobank. (2013). Nature India. https://doi.org/10.1038/nindia.2013.103