Imagine being told that a new medicine, vaccine or medical intervention is safe and effective, only to discover that people like you were quietly kept out of the clinical trial that produced that evidence. For millions of persons with disabilities, this is not a hypothetical concern. A person with a neurological disability may be screened out. Someone with a speech or language impairment may be considered too difficult to enrol.A person with a cognitive disability may be presumed incapable of providing informed consent. A person with a locomotor disability may be excluded because researchers assume that their disability will somehow interfere with participation. The exclusion may appear as a seemingly innocuous sentence buried deep within a clinical trial protocol, but behind that sentence is a person being told that the research is not meant for them.A recent study examining 271 fully published clinical trial protocols relevant to India between January 2017 and December 2024 should make the research community pause. This period is particularly significant because it follows the enactment of the Rights of Persons with Disabilities Act, 2016 (RPDA), India’s landmark disability rights legislation. Yet 117 protocols, or 43.2%, contained 126 instances of disability-related exclusionary language in their eligibility criteria. Neurological disabilities accounted for the overwhelming majority of these exclusions at 69.8%, followed by speech and language impairments at 16.6%, blood disorders at 9.5%, locomotor disabilities at 3.1%, and hearing- and vision-related disabilities at 1%.The problem was not confined to early-stage or small studies. Disability-related exclusionary language appeared in 49.2% of Phase III trials and 54.7% of international or multicentric trials, compared with 44.4% of trials conducted exclusively in India. Even more revealing was the treatment of informed consent. 5.9% of the protocols required enhanced cognitive ability to provide informed consent, yet none described mechanisms for supported decision-making or other accommodations that could facilitate participation. In other words, when faced with cognitive difference, the research system appears more comfortable with exclusion than with asking what support might enable participation.When the law speaks, but the system remains silent This is precisely the mindset that the RPDA was intended to challenge. The Act places dignity, autonomy, equality, non-discrimination, participation and accessibility at the centre of the rights of persons with disabilities. More importantly, parliament did not leave research ethics to general principles alone. Section 6(2) specifically provides that no person with disability shall be subjected to research without the prior permission of the Committee for Research on Disability constituted by the Central Government.There is, however, a glaring problem. We are now in the tenth year since the enactment of the RPDA, and the Central Committee for Research on Disability (CCRD) has still not been constituted. This can no longer be dismissed as an ordinary administrative delay. It represents a significant regulatory and ethical vacuum in disability research in India.Since 2019, and subsequently in 2023, 2024, 2025 and 2026, Doctors with Disabilities: Agents of Change has sent repeated representations to the secretary, Department of Empowerment of Persons with Disabilities, and more recently to the secretary, Ministry of Health and Family Welfare, seeking the urgent constitution of the CCRD. These representations have specifically drawn attention to the statutory mandate under Section 6 of the RPDA and Rule 4(v) of the Rights of Persons with Disabilities Rules, 2017. There has, however, been no response.Meanwhile, research has not stopped. Some of India’s most prestigious institutions, including AIIMS, JIPMER, NIMHANS and PGIMER, along with institutions under the Indian Council of Medical Research, continue to undertake research involving persons with disabilities. This is not an argument against research at these institutions; indeed, much of this research is essential. The question is whether the statutory safeguards created specifically for persons with disabilities are being implemented alongside it.Institutional Ethics Committee approval is indispensable, but it cannot substitute for a specific statutory mechanism enacted by Parliament. Section 6 was not written because parliament believed that existing ethics committees were inadequate for every research question. It was written because disability raises questions of autonomy, representation, vulnerability and participation that require specific safeguards.Nothing about us without us, even in researchThe composition mandated for the CCRD makes the intention of the law even clearer. At least half of its members are required to be persons with disabilities or members of organisations of persons with disabilities. This is not merely a demand for symbolic representation. It reflects a fundamental principle: research about a population cannot be governed entirely without meaningful participation from that population.A researcher may bring methodological expertise, a clinician disease-specific knowledge, a statistician expertise in study design and an ethicist knowledge of research ethics. But persons with disabilities bring something that cannot be acquired from a textbook: lived experience. They understand the consequences of inaccessible healthcare, assumptions about incapacity, dependence, stigma and medical decision-making in ways that can fundamentally change how a research question is framed and how participation is enabled.This principle is not merely aspirational. Delhi has already demonstrated that the statutory architecture can work. The Delhi State Committee for Research on Disability (DSCRD) was constituted through a notification dated 21 November 2019, and I have had the privilege of serving as a nominated member. The Committee has examined research proposals involving persons with disabilities from an ethical and rights-based perspective. Its existence demonstrates that such a mechanism is both feasible and operationalisable.The continuing absence of the CCRD is therefore difficult to reconcile with India’s broader disability-rights commitments. It is particularly difficult to understand in the context of the intervention of the Supreme Court in the Seema Girija Lal PIL, following which states were directed to constitute State Committees for Research on Disability. The Department has also published a status report on the constitution of these committees. Yet the central statutory body remains conspicuously absent.This is also about the quality of science There is a tendency to treat disability inclusion in research as an issue of charity or compliance. It is neither. It is fundamentally an issue of scientific validity.When substantial sections of a population are excluded from clinical research, the resulting evidence may not adequately represent the people who will eventually receive the intervention. The consequences extend beyond disability. An intervention may demonstrate efficacy under controlled trial conditions while its applicability to people with different impairments, comorbidities, communication needs or treatment dependencies remains poorly understood.Exclusion also creates a vicious cycle. If persons with disabilities are routinely excluded from research, researchers have less evidence about how interventions work for them. The absence of evidence then becomes the justification for continued exclusion, and the resulting knowledge gap is mistaken for scientific inevitability.The same problem applies to informed consent. Requiring a particular cognitive profile without considering supported decision-making risks confusing communication difficulty or disability with lack of decision-making capacity. The ethical response should be to determine what support is required for meaningful participation, not to assume that exclusion is the safest option.The responsibility therefore rests with everyone involved in clinical research: investigators, sponsors, ethics committees, regulators, institutions and funders. Eligibility criteria should be based on scientifically and ethically justified requirements rather than assumptions about disability. Where reasonable accommodation or supported decision-making can enable participation, those possibilities should be actively considered.India has rightly positioned itself as a global advocate for disability rights. It has enacted progressive legislation and created statutory mechanisms intended to ensure that persons with disabilities participate not merely as recipients of services but as rights-holders and decision-makers.Yet legislation has meaning only when implemented.The question before the Government is no longer whether a Committee for Research on Disability is desirable. Parliament has already answered that question. Section 6 requires it. The Rules provide the institutional framework. A State-level example exists. The Supreme Court has intervened on the broader issue. Civil society has repeatedly asked for action.What remains is implementation. The tenth year of the RPDA should not become another year in which persons with disabilities have to remind the Government of a statutory obligation enacted a decade ago. If India wants its clinical research to be ethical, representative and relevant to the real world, it must ensure that the people whose lives are being studied have a meaningful voice in determining how that research is conducted.The government should constitute the Central Committee for Research on Disability without further delay. Not as another bureaucratic addition, but as a long-overdue fulfilment of parliament’s promise of dignity, autonomy, participation and equality in research.Dr Satendra Singh teaches at University College of Medical Sciences, Delhi, is the founder of Doctors with Disabilities: Agents of Change, and is a disability justice activist. Views are personal.