Biobanks are collections of human biological material and related information stored for research purposes. They are valuable to scientists because they help them learn more about human health and disease. Biobanks don’t always do the actual research, but they give samples to scientists who do. These samples are often donated voluntarily or taken after death. They can also be stored in case they are needed later. The research objectives may not be determined at the time of sample collection. Biospecimens might also be collected with future applications in mind.


India doesn’t have specific laws for biobanks. Instead, they follow the 2017 National Ethical Guidelines by ICMR. These guidelines define biobanks and set standards for biospecimen identifiability and donor consent, and there are other guidelines, such as stem cell research and gene therapy. In 2019-2020, the Indian Association for Assisted Reproduction formulated guidelines for assisted reproductive technologies (ART). Although efforts were made in 2006-07 to set up a national repository of human genetic material, it has not been approved. The Transplantation of Human Organs and Tissues Act of 2014 regulates the preservation of organs and tissues but lacks detailed provisions. The proposed Personal Data Protection Bill of 2019 seeks to protect personal data, including health information.


Biobanking raises fundamental ethical concerns due to factors like limited knowledge, the sensitive nature of data, unpredictable outcomes, and socioeconomic disparities.

In the context of biobanks, informed consent presents a difficult challenge. Samples collected for biobanks may not be used immediately but may be retained for future research purposes, making it harder for donors to understand their implications fully. Socioeconomic factors influence biobanking ethics more significantly because low-income and middle-income countries with greater genetic diversity tend to sample despite solid regulatory frameworks. 

Despite guidelines such as the ICMR Guidelines for the Modification of Human Organisms for Medical Research Purposes, widespread application is still lacking. Lack of clarity in the process of implementing guidelines and non-enforcement contribute to non-compliance. Even leading agencies like ICMR, CSIR, ICAR, DBT, and DST do not follow these guidelines consistently. There have been cases of unauthorized export of biospecimens, again highlighting the challenges of ensuring compliance.

CONSENT MODELS IN BIOBANKING: Biobank research is future-focused, informed consent is a more complicated concept in biobanking than it is in traditional research. Various consent approaches are employed in biobanking, contingent on the study’s specific needs.

(i) BROAD CONSENT:  Consent enables the biobank to collect, store and generally use samples upon registration. Donors approve in advance, guaranteeing that the model will be used to the extent that they do not have to request approval multiple times for each research project.

(ii) STUDY-SPECIFIC CONSENT: Here, consent is obtained for a specific research project, where information is sought from the participants whenever a sample is used for another purpose.

(iii) TIERED CONSENT: Participants are presented with a list of study groups to be used in sampling, allowing for consensus on relevant groups. This approach gives stakeholders the control while reducing administrative tasks, improving the efficiency of biobanking practices.


Various sample identity levels have been designed to preserve data confidentiality. 

  1. TOTAL ANONYMIZATION: In this scenario, no connection is made between the donor and the sample. All identifiers connecting the sample to the donor have been eliminated. Opposition to the right to withdraw from research is the opposite of this. Once the sample is fully anonymized, the donor forfeits ownership and, with it, the ability to remove the sample. 
  2. IDENTIFIABLE: There is a clear connection between the participant’s identity and the sample. 
  3. CODED:The sample is devoid of a direct identifier. However, the identifying information is coded, and a coding key can be used to decode it.


Biobanking is used for research and commercial purposes. It is also essential to understand the commercial value of biobanks and their potential to improve public health. If used for commercial purposes, biobanking can lead to the exploitation of vulnerable people. It is important to be aware of this potential problem.

i) PHARMACEUTICAL INDUSTRY: The pharmaceutical industry is based on research to evaluate the efficacy of drugs before manufacture. Biobank specimens are essential for clinical trials and complement pharmacogenomic research to test new drugs and detect potential side effects. By accessing genetic patterns, researchers can gain insight into disease profiles and community vulnerabilities and improve treatments and vaccines.

ii) HEALTHCARE INDUSTRY:New technologies make it more efficient while reducing the use of biodiversity. Biotechnology enables detailed analysis of bio samples and comprehensive data processing. Access to biobank samples can help biotechnology companies discover medical biomarkers.


M Shanthish Kumar, 5th year B.A, LL. B(Hons.), Veltech School of Law, Chennai


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