The Ministry of Health and Family Welfare (MoHFW) has published Indian Council of Medical Research’s (ICMR) Guidelines for Ethical use of Leftover De-identified/ Anonymous Samples for Commercial Purpose. These specimens include organs, parts of organs, cells, tissues, cell products such as blood, blood products (even positive for eHBsAG/HCV/HIV/Syphilis and expired blood), urine, saliva, DNA/RNA, hair, nail clippings, or any other cells, body fluids etc.

These guidelines were issued through an Office Memorandum dated December 15, 2023 and published on June 19, 2024.

Applicability: These guidelines are applicable to a wide range of stakeholders involved in the handling, processing, and utilization of biological samples. These stakeholders includes:

 

1. Healthcare Providers and Institutions

• Hospitals and Clinics: Medical facilities where biological samples are collected and may be retained as leftover samples.
• Pathology and Diagnostic Labs: Laboratories that process biological samples and may have access to de-identified or anonymous samples.

 

2. Research Institutions and Researchers

• Academic Institutions: Universities and colleges conducting research involving biological samples.
• Private Research Organizations: Companies and organizations engaging in biomedical and clinical research using leftover samples.

 

3. Biotech and Pharmaceutical Companies

• Biotechnology Firms: Companies involved in developing new technologies or products using biological samples.
• Pharmaceutical Companies: Firms conducting drug development and clinical trials that may use de-identified samples for research and development.

 

4. Healthcare and Research Personnel

• Doctors and Clinicians: Medical professionals who collect and handle biological samples from patients.
• Researchers and Scientists: Individuals conducting studies using leftover, de-identified, or anonymous samples.

 

Ethical consideration of  leftover samples for commercial purposes:

1. Donor rights in sample use

   –  Donors have the right to be fully informed about their samples’ collection, use, and potential commercial purposes.
   –  Donors can have their personal information protected and their samples de-identified.
   –  Donors can withdraw consent at any time.
   –  Donors can be informed about their samples’ commercial use.
   –  Donors can share benefits from commercial use.
   –  Donors can know their samples will be used in ethically reviewed research.
   –  Donors can have their cultural values and social norms respected.

 

2. Role of Hospitals in commercial use:                                                                                                                                                                                                                                                                                                                                                                                                                        –  Comprehensive Consent Process:

• Hospitals must ensure that patients are fully informed about how their leftover samples might be used, including potential commercial applications.
• The consent process should be transparent, detailing the specific types of research or commercial activities that may be conducted.
• Consent should not be a one-time event,  hospitals should have mechanisms in place for patients to withdraw their consent at any time.

    –   Privacy and Confidentiality

• Hospitals must implement robust procedures to anonymize or de-identify samples to protect patient privacy.
• Ensure that identifiable information is not linked to the samples when used for commercial purposes.
• Hospitals should use secure systems to store and manage samples and associated data, preventing unauthorized access.

         –   Transparency and Communication

• Establish clear channels for communicating with patients about how their samples are being used.
• Provide updates and disclosures about ongoing and new commercial uses of leftover samples.
• Hospitals should disclose partnerships with commercial entities and the nature of these relationships.
• Ensure that the community is informed about the benefits and risks associated with commercial uses of leftover samples.

          –   Contractual Agreements:

Establish clear contractual agreements with commercial partners that outline the ethical use of samples, compliance with regulations, and respect for patient rights.

 

3. Role of Commercial Companies Using Leftover De-Identified Samples :

Commercial companies play a significant role in the use of leftover de-identified samples, particularly in the fields of medical research and product development. Here are some key roles as-

• Clearly explain to patients how their leftover samples might be used, including any commercial purposes.
• Be open about how samples are used and provide regular public reports to maintain trust.
• Use strong methods to remove identifying information and follow data protection laws.
• Set up independent ethics committees and work with Institutional Review Boards (IRBs) to review the ethical aspects of using the samples.
• Ensure benefits from the research are shared fairly, acknowledge the contributors, and assess risks to minimize potential harms.
• Have systems in place to monitor and report any negative outcomes or ethical issues.
• Talk with the public and patient communities to understand their views and concerns.
• Companies must adhere to local, national, and international regulations governing the collection, storage, and secondary use of biological samples.

 

Dispute: In case of deviation, violation of regulations and disputes between parties, government regulatory agencies take action through appellate bodies like the High Court or Supreme court.

In conclusion, the MoHFW guidelines ensure that the ethical use of leftover, de-identified, and anonymous samples for commercial purposes is conducted with respect for privacy and consent. These measures aim to balance the advancement of medical research with the protection of individual rights.

 

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