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Evaluate the Ethical and legal challenges of using Biobank

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This article wis written by Meenakshi Asthana, an intern under Legal Vidhiya

Abstract

‘The study of law , medicine and the arts in each of these instances , the developed mindset is very helpful to one who is practising medication’

A law student who’s art is to debate the legality of a procedure is uncanny, but with medicine normalcy is seeked so a medical student doesn’t debate they just listen and provide a solution that will not ignite a debate and a person who seeks a legal help knows they are in for a lot of questionnaire but a medical student is all about answers ,

Lets check , how the two so distinct things come together and joins so that protects our medical and legal rights

This whole topic we are going to discuss today is the evaluation of ethical and legal challenges of using biobanks :

Firstly , what is a Biobank?

A Biobank is generally defined as a collection of human biological samples and associated information organized in a systematic way for research purposes, often the samples are kept indefinitely , or for several years , depending on the study , so that long term further future research can be carried out. The researchers may track the health of the participants , by looking at their past and future medical records , but only  if people have given them  permission to. The Human Tissue Authority has useful information for people interested in donating for research and the Nuffield council on Bioethics has also recently issued a useful report called ‘Human Bodies’ donation for medicine and research

Introduction:

What is Biobank?

A normal bank is used to save money for future, but instead of saving money , you save up biological samples. The sample 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

If i visualize it let’s say Vinnie and Micky got engaged and Micky started saving up money to go to New York , now where will this money be saved? Obviously Bank now if we feel it in today’s world , saving money has been a boon for future, but if Vinnie and Mickey are planning to get married and travel together they need to work also , so after all this there’s a possibility their biological clock for having a kid running , but should one just have kid because their biological clock is ticking or when they feel that now they are ready to be parents and they are ready to take care of a baby, in this scenerio biobanks can play a major role. If Vinnie and Mickey save up their Pregnancy hormone and got through the procedure at a later time it will come in as saviour so Vinnie and Mickey can get pregnant through artificial insemination , sperm donation and surrogacy if not normally

Background

Aree chirtra tribunal institute for medical sciences and technology is the first ever India’s national heart failure biobanks (NHFB) in the country that would collect blood , biopsies and clinical data as a guide to future therapies and was inaugurated at the same it is also called biological resource centres . Biobanks will be a bastion hope in a time like covid. The virus can be detected and researched about the studying the samples 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 whole procedure of saving and testing samples has its own perks:-

Now let’s Decode the biobanks types

Th use and exchange of human genetic material and the information derivaled from it, is not without some controversy. Within the scientific community, there is consensus that progress in understanding disease will depend on the establishment , harmonisation and broad use of human biobanks and genetic research databases

Human biobanks and genetic research databases which bring together and allow the sharing of human biological material and information derived from its analysis , are a key element of the scientific infrastructure underpinning such research. In October 2009, the OCED Council adopted a Recommendation on Human biobanks and Genetics Research Databases (HBGRD)

However , the number of species currently represented in biobanks remains extremely low relative to the conservation need and the availability of suitable material , especially in zoos and aquariums . To realise biobankings conservation potential it needs to become a normalised component of the ONE PLAN APPROACH   for species conservation.

Issues

  1. The pharmaceutical corporation are so greedy and selfish for money that their lust for money will hinder the progress and main motive and intention behind the biobanking system, it loses its respect for Human senstivity and rights, they are all bark and this system wholly talks about being about liberal ideas , but in reality they don’t preach , for example. The UK Biobank samples as it terms of property. As the UK Biobanks says that once it detaches from one’s body it becomes ‘No one else’s thing’. The property bodily fluid samples still remains a question mark in the whole thing
  2. Confidentiality in modern world is as dormant as the letter ‘EA’ in the word of ‘Tea’ , it’s ethically wrong to be revealed at world level more exposure than one expects . For instance if a surrogate who have someone’s child in her womb is doing a job for charity or for her needs for money (exemplary) she would and the parents would not want that secrecy to be revealed to the world , even if the kids are born and it’s been years of that the kids also have a right to privacy for their identity prevention it’s such a blatant abuse of their privacy and confidentiality , let’s take an example if a baby is born through artificial insemination , sperm donation or egg or through a test tube process they are being born to parents who may or may not be biologically connected to them , revelation of their procedure of being born anyone can claim parentage over their sperm or egg , or the woman’s egg is claimed it can generate and give meaning to so many baseless claims.
  3. The alarming issues of informed consent plays a role in questioning the ethics of the biobanks.  Critics say that it ignores the rights of a person connected to the sample. It has potential to create problems regarding the autonomy of the individuals.  Biobanks lacks recognition as a research project. rather they are considered as research libraries
  4. Biobanks are banks overall, so the withdraws matter through regular donations are suggested, no one could or can force anyone for donation of bodily fluid such as blood , sperm, egg or other samples
  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 as no one would know if there is any problem WITH MRI Scans.
  6. The donation should not be mandatory rather it should be voluntarily it should be balanced and healthy relationship with the donor , in layman’s terms , the donor must not just be informed but also included. Any kind of body organ or fluid donation should not create a burden on donor

Solutions

Statute and case laws: Worldwide Including European union

The EU has grave concerns regarding the legal position of biobanks. They fear that medical researcher would be jeopardized without any proper legal regulations . It is essential that the handling of human tissues must be done in a proper legal Manner

1 .Moore Vs. regents of University of California

Moore John went to UCLA medical center for his treatment of leukemia. His hairy cell was taken by a doctor names David Golde. When Moore’s cells developed into a cell line, Golde and UCLA decided to commercialize it. This made John Moore file a lawsuit against UCLA and Golde.  The California supreme court stated that Moore neither had 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 Vs Miami Children’s Hospital Research institute

  1. The claims of the plaintiff’s were rejected
  2. No informed consent was provided
  3. Fiduciary duties were breached
  4. Patents were concealed .
  5. Trade secrets were misappropriate

The plaintiff’s claim regarding the unjust enrichment which come at a cost of the donors were upheld by the court

3.Lamaritata v. Lucas (823 So.2d 316 (2002)) The donor and the recipient entered into a contract whereby the donor provided sperm to the recipient with the expectation that she would become pregnant through artificial insemination. The agreement provided that if childbirth resulted, the donor would have no parental rights and obligations associated with the child. The donor, in an attempt gain parental rights of the twin boys who were born to Ms. Lamaritata argued that he was not a sperm donor but instead the biological father, and thus should be afforded parental rights. Issue is does a sperm donor have any legal parental rights. Court held that In an attempt to avoid the enforcement of the contract, Mr. Lucas argued that he was not a sperm donor. Instead, he argued that he was part of a commissioning couple with the mother. A commissioning couple is defined as the intended mother and father of a child who will be conceived by means of assisted reproductive technology using the eggs or sperm of at least one of the intended parents. There were no facts to establish this, and the intent of the parties was established by contract. A person who provides sperm for a woman to conceive a child by artificial insemination is not a parent. Thus, the sperm donor here has no legal parental rights.

Reference:- -https://www.legalserviceindia.com/articles/art_ins.htm

Keywords- Biobank, Sperm , egg , bodily fluid , biopsies , parentage , artificial insemination , test tube babies

Future of biobanks development

Conclusion:

Considering TATA MEMORIAL is India’s only Biobank that exist , serving billions whereas other European union countries have million biobanks, and there are some major reasons why India is far fetched in this process :-

With certain legalities and blatant abuse of ethical values it is possible to establish biobanks but India supercede in maintaining ethics before development

Future perspective:

One of the major challenges for long term sustenance faced by biobanks is financial support , financial support from multiple sources like the commercialization of research results or derived products , cost recovery related to access to samples , funding from private for profit entities such as biotech companies and finding through government institutions or agencies night ensure long term financial viability

The material stored in the Biobank is a treasure as it can be utilized in personalized medicines tackling aspects of prevention , diagnosis ,  t , and monitoring specific characteristics of an individual patient using omics technologies .standardization The material stored in the biobank is a treasure as it can be utilized in personalized medicine tackling aspects of prevention, diagnosis, treatment, and monitoring specific characteristics of an individual patient using omics technologies. Standardized protocols and SOPs for the collection and storing of the biospecimen were used to ensure high-quality biospecimen samples. Long term storage of biospecimens continuously demands capital cost and recurring cost. However, preservation science has progressed considerably in preserving therapeutic proteins and drugs. Integrating the preservation science from other fields to the biospecimen preservation to improve quality and cost is an unmet need.

New technologies can be developed to reduce time and labor involved in processing of biospecimen and improve the quality.32 Technologies have improved in data collection as well, as there are potentials to enter the data from multiple digital sources. Leveraging the data sources and integrating them with the biorepository can increase the knowledge base and utility of sample.33

Biorepositories do not generate profits; however, sustaining itself with quality and cost is challenging. Models of international and interdisciplinary collaboration and sample sharing and better preserving technologies may address some of the challenges in long term sustainability. Disseminating experimental lessons learned and scientific data across the scientific community and society might be a model where people will willingly come forward to donate their samples and personal information. Important to have private agencies permitted to create such biobanks for future research. Databases located only within regional and academic institutes have a drawback—there is no commercial goal to translate research into action. There is no value in creating large amounts of data that is converted into publications without a go-to-market drive to transform the lives of people suffering from the disease. Hence, the goals of any database must be to translate knowledge to practice.

In conclusion, reduction of health care cost is only possible with development of long-standing well-characterized biobanks with constantly developing new approaches and ideas.

Footnotes and references

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