Reconceptualizing the Standard of Consent for Stem Cell Research in India

by | Oct 19, 2021

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About Philip Alexander

Philip Alexander is a law student at the West Bengal National University of Juridical Sciences, Kolkata.

Human stem cell research involves the extraction of clusters of undifferentiated cells, derived from the human embryo, bone marrow, or blood in the umbilical cord, which are capable of multiplying into specialized tissue. Its clinical application focuses on regenerative medicine in which damaged cells caused by diseases such as Parkinson’s, Alzheimer’s, type I diabetes, osteoarthritis, and cancer are replaced by stem cells. Stem cell research has led to polarising debates on ethical and legal issues across several jurisdictions and regulation varies accordingly. Without a policy framework, stem cell research remains unregulated, which could have dire ramifications on the rights of the research participants involved. This is a problem in India, which has taken a laissez-faire approach to stem cell research which is not regulated by specific legislation, creating a “governance vacuum” in India’s drug policy. 

The Indian Council of Medical Research has issued The National Guidelines for Stem Cell Research in 2017, which state that it is mandatory to obtain informed consent from the voluntary donor. However, without a binding legal framework and grievance redressal mechanism, the consent process can become heavily skewed. Two factors could undermine consent in stem cell research: remunerative packages for patient recruitment and false advertising.

First, there is correlation between the number of patients a Doctor recruits for stem cell research and their income. Infertility clinics obtain embryonic stem cells by in vitro fertilization (IVF). When the treating physician is also conducting stem cell research, the consent process may become compromised because the physician’s remuneration is directly proportional to patient recruitment. Remuneration packages could encourage physicians to place subtle pressure on the subjects to join stem cell procedures, violating the subject’s right to withdrawal of consent and reproductive autonomy.  Even without remuneration, a treating physician who is conducting stem cell research could exert undue influence on the patient because those receiving infertility treatment heavily depend on their physician and may agree to anything the doctor presents to them.

Second, there is an issue with advertising using clinically unproven research. The Drug and Cosmetics Act, 1940 and the Drug and Cosmetics Rules, 1945 form the governing authority on the sale and distribution of prescription drugs in India. To conform with the growing popularity of stem cell research, the Law was amended in 2018 to include stem-cell derived products within the scope of “New Drugs.” However, “minimally manipulated cells,” which are types of cells that require minimal external manipulation, were excluded from this classification, exempting stem cell therapy utilizing such cells from clinical trials. This creates a market driven by inaccurate claims and certification.  For example, Stromal Vascular Fraction (SVF) is a type of therapy that is falsely advertised as minimally manipulated stem cells.

Many clinics have built similar false narratives of “revolutionary” stem cell therapy that has not undergone clinical trials. A clinic in Delhi, which published a study on the treatment of Down’s Syndrome with stem cells was heavily criticized by several experts as inaccurate and baseless. Additionally, several journals issued editorial objections over the questionable ethical standards employed in the study and the failure to mention the development of teratoma, a rare form of cancer, as a potential side effect. Another hospital falsely stated that stem cells improve nerve function after spinal cord injury even though no clinical evidence supports this. Presently, treatment for spinal cord injury relies on supportive care. Such statements that lack medical backing place unrealistic expectations on the treatment, which influence the donor’s decision.

Stem cell research must adopt stricter standards of consent by framing enforceable procedural rules accompanying specific stem cell legislation. Failure to do so will have significant implications on the ethical standards for scientific research in developing countries across the world. First, patients of IVF must be notified before the onset of treatment that the treatment has no relationship with their decision to participate in research. Second, the relationship between the clinic and the research organization must be disclosed to the non-parenting gamete donor as well as the couple undergoing IVF. Third, treating physicians cannot serve as investigators in stem cell studies and must not be allowed to participate in the consent process or research protocol.

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