People with disability may no longer be allowed to join as research participants, thereby adversely affecting new findings.
The new research rules in the Draft Delhi Rights of Persons with Disabilities Rules, 2017 uploaded by the Delhi government for public comments made no changes to the Central rules, thereby allowing only “medical research” and not academic research on participants with disabilities.
This marginalises the world’s largest minority community further. This will prevent the gathering of data and research on participants with disabilities, which is crucial for fund allocation in all government schemes and fulfilling Sustainable Development Goals (SDGs).
According to section 4 of the “Draft Delhi Rights of Persons with Disabilities Rules, 2017”, “Person with disability not to be a subject of research: No person with disability shall be considered to be a subject of research except when the research involves physical impact on his body.”
As a disability rights activist, I call for amendment on the research clause as such stringent criteria will curb academic research and lack of data will affect funding for all national schemes. The Rights of Persons with Disabilities Act, 2016, now has 21 disabilities, including the newer hematological disabilities like thalassemia, hemophilia and sickle cell anemia. So, this “controversial” rule on research needs to be deleted. The rules are problematic as they focuses on the medical model of disability and excludes qualitative research. The same rule has been copied in Telangana, West Bengal, and now in the draft Delhi Rights of Persons with Disabilities Rules, 2017.
The draft rules must incorporate section 99 of Mental Health Care Act 2017 (MHC Act) which are very clear on ethical research. To quote the relevant portions:
“99. (1) The professionals conducting research shall obtain free and informed consent from all persons with mental illness for participation in any research involving interviewing the person or psychological, physical, chemical or medicinal interventions.
(2) In case of research involving any psychological, physical, chemical or medicinal interventions to be conducted on person who is unable to give free and informed consent but does not resist participation in such research, permission to conduct such research shall be obtained from concerned State Authority.
(3) The State Authority may allow the research to proceed based on informed consent being obtained from the nominated representative of persons with mental illness, if the State Authority is satisfied that––
(a) the proposed research cannot be performed on persons who are capable of giving free and informed consent;
(b) the proposed research is necessary to promote the mental health of the population represented by the person;
(c) the purpose of the proposed research is to obtain knowledge relevant to the particular mental health needs of persons with mental illness;
(d) a full disclosure of the interests of persons and organisations conducting the proposed research is made and there is no conflict of interest involved; and
(e) the proposed research follows all the national and international guidelines and regulations concerning the conduct of such research and ethical approval has been obtained from the institutional ethics committee where such research is to be conducted.
(4) The provisions of this section shall not restrict research based study of the case notes of a person who is unable to give informed consent, so long as the anonymity of the persons is secured.
(5) The person with mental illness or the nominated representative who gives informed consent for participation in any research under this Act may withdraw the consent at any time during the period of research.”
Neither the Indian Council of Medical Research (ICMR) nor the Delhi rules safeguard the rights of PwDs in research. After 11 years, the ICMR has come up with a newly revised “National Ethical Guidelines for Biomedical and Health Research Involving Human Participants”.
Though these ethical guidelines mention disabled people among the vulnerable population, unfortunately, it only covers individuals with mental illnesses or those who are cognitively impaired. Despite being two different things, they have clubbed them together in Section 6.8. Moreover, they have not mentioned RPwD Act 2016 passed last year, although they mention about the MHC Act, 2017 passed this year. Many of the terminologies used in the ICMR ethical guidelines are in contravention of the provisions of both RPD and MHC Acts.