Participation of the incarcerated in Clinical Trials in India: Need for a road map -Albina Arjuman
At present evidence-based medicine is guided by the rules and regulations particularly of ethics and moral rights given which Clinical Trials (CTs) have evolved into a more lucrative study design for involving vulnerable populations. Engagement of the incarcerated population in trials (CTs) can provide valuable information particularly from a longitudinal follow up point of view. However, being guided by ethical norms and regulatory processes particularly for this group which is susceptible to coercion and the fear of involving them merely as a sample of convenience often leads to a conservative representation in trials, amounting to inequitable exclusion. There is an undeniable gap in understanding the barriers which prevent researchers to include prison inmates as a study population in the Indian context. Hence, there is an unmet need for undertaking an in depth qualitative inquiry from key informants including the incarcerated as well as various other stakeholders around the prison framework, which may in turn provide a clear cut road map based on participant perceptions. Such data will provide the basis of guideline formulation by informing policy to facilitate their participation, which is urgently needed especially in the Indian context.
Introduction
Incarcerated individuals comprise a particularly vulnerable population for various reasons including disadvantaged social satire, adverse living conditions such as overcrowding leading to high disease burden, susceptibility to coercion, restricted-to-lack of adequate access to healthcare, etc. Of these the crucial factor which is thought to contribute toward their considerable disadvantage is hesitancy amounting to inequitable exclusion particularly in the aspect of access to healthcare. This hesitancy especially in a country such as India with over 5 Lakh incarcerated individuals constituting the fourth highest prisoner population in the world (Prison Statistics of India, 2021) is of concern and is a topic of current debate from social, ethical, legal as well as scientific angles.1
The premise of duty of care for incarcerated populations rests on the equation of what prison health would equate to the overall public health in a country. High disease burden among prison inmates is prevalent due to various reasons starting from low socioeconomic background, incidental non-communicable diseases and overcrowding conditions in the prison environment catering to transmission of infectious diseases such as TB, HIV, hepatitis B and C which may also be life threatening. For instance as per the Prison Statistics of India, 2021, of the 2116 prisoners that died in judicial custody, about 88.7% died of natural causes. Of these around 95.6% died of an illness including 27.4% heart related, 16.4% lung related, around 4.34% kidney related, 5.73% of cancer, 4.23% liver related, 3.17% brain hemorrhage,2.43% of HIV and around 4.62% of TB. Furthermore, the deaths due to illness figures among prison inmates are also consistently comparable to the figures in 2022 at 94.19%.2
Given this statistic, the chances of some of these transmissible diseases being carried back into the community when the incarcerated are released may also be high. Hence, the need to provide first hand access to beneficial healthcare options to this group is compelling. Furthermore, In India, the penal law permits incarcerated individuals to retain all the fundamental rights including access to healthcare, similar to that of any other citizen except for the ones they lose in lieu of their incarceration.3
Contribution of Ethics towards the evolution of safety parameters and reliability of clinical trials
History has recorded a series of Clinical Trials (CTs) of spurious and unethical nature such as the infamous Tuskegee syphilis (1932) and Guatemala (1946) experiments, various experiments under the Nazi regime (starting 1940s; experiments with twins, Dachau hypothermia, sulphonamide, mustard gas, high altitude, sea water, etc), the sulphanilamide disaster (1937), the thalidomide tragedy (1957-61), the propulsid, acutance and permax tragedies in the 80s, so on and so forth.4
In India, one of the oldest trials was probably conducted in 1821, however, the one formal report on the use of plasma infusion for treating diarrhea due to cholera was published in 1945.5 In 1946, a new treatment for malaria was tested in a controlled trial.5 Notable trial tragedies in India include the unethical CTs involving survivors of the Bhopal gas tragedy (2005-2008) among several others.5,6
Although these trials are true to be remembered for their immoral accounts, the lessons learnt from these, however, have paved way for stringent guidelines which regulate the conduction of these with the integration of ethics, morality, safety and drug efficacy perspectives, and scientific validation. Today, CTs are bound by various rules and guidelines with a particular emphasis on ethics involving human participants.
Of the various landmarks where corrective measures were implemented in this context since the 1820s, some of the most notable ones include, the Nuremberg code which provided guidelines for informed consent, preclinical experimentation, voluntary participation, withdrawal, social advantage, etc; the Belmont report which was release in 1979 after a four year deliberation by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research; the FDA Good Clinical Practices (GCP) of 1976, the Declaration of Helsinki of 1975 (revised in 1982, 1989, 1996 & 2000), the CIOMS International Ethics for Biomedical Research involving human subjects, the National Pharmacovigilance Programme India in 2002, the Schedule Y which was added to the Drug & Cosmetics Act of 1945, India and its subsequent amendment in 2005, are few to name.5
The argument
Today, CTs are a highly sought after research type which provide valuable information for innovative, safe and efficacious drug development and are highly regulated. For instance, in India human experimentation is guided predominantly by the permission of New Drug Advisory Committee (NDAC) and the ethics committee formed under the Drugs and Cosmetics Act and rules. Approval for human experimentation is granted summarily by the Drug Controller General of India (DCGI).
In this context, this article intends throw some light on the discussion on how prisoner participation in research particularly CTs can be increased by facilitating a guideline to provide administrative and ethical clarity for undertaking prison research on the one hand, while on the other, facilitating an environment for prison administration to either identify potential inmates for participation in CTs or record their health-seeking behavior to make the turf conducive from both ends of the spectrum.
Given the lucrative environment for conduction of CTs at present with various ethical guidelines on conducting research on human participants in place involving the incarcerated population on the one hand offers a contained environment with a feasibility for a longitudinal follow up appropriate for CTs adding value to the research premise and on the other increasing the access to healthcare among the same group. However, there are several challenges in engaging this group in research including CTs.
Barriers in conduction of prison research in India
In India, although many studies have been undertaken on prison populations,7,8,9 still due to limited access to this population, the cumbersome nature of including this group as research participants along with the associated ethical dilemmas around their participation, this group has been largely underrepresented in clinical trials, same is, however, true for the world over.10 There are presumably various barriers which deter researchers from intensely undertaking research on the incarcerated including:
Vulnerability11,12 in being susceptible to coercion due to constrained autonomy
Tendency for inclusion of prison participants as a sample of convenience
Perception exploitation among these participants, even in the absence of any such factors due to fear11
Lack of a clear cut roadmap for seeking requisite permissions from the authorities and data collection13
Ethical issues pertaining to data collection, including procuring informed consent13
Witnessed interviews in the presence of a chaperone assigned by the prison, again subjecting the participant to coercion13
Although the debate regarding inclusion of prisoners in research in very much alive, but fears of exploitation may deter one from considering how their participation in research, particularly CTs may benefit this group. 14,15,16 More so, it is important to understand how this population perceives their participation in the CTs, whether the paternalism shown by the State in restricting them from participating in research in general and CTs in particular is perceived as a protection of their own interests, or merely as constraining autonomy preventing them from accessing newer vaccines and treatment which otherwise may not be available to them on priority needs an in-depth assessment. Furthermore, how the system, which comprises of administrators, legal advisors, ethics committees as well as healthcare workers perceive this dilemma against the backdrop of various technical and moral difficulties in engaging them in CTs also requires detailed documentation based on their perceptions.
Potential steps that may increase prisoner participation in CTs in India
Health seeking behaviour among prison inmates could in part be indicative of a potential willingness among inmates to participate in CTs. This may be primarily to access quality health care. Participation can be further made lucrative by increasing infrastructure in nodal hospitals and treatment facilities associated with prisons to house inmates who are actively participating in CTs.
Committees can be set up including health care representatives and public attorneys from conglomerations such as NALSA (National Legal Services Authorities) along with concerned Prison authorities who have access to prison management softwares (e-Prison) with demographic history of all the inmates and care givers for reviewing and recommending potential cases of inmates for participating in CTs based on their willingness as well as the need. For instance, if there is willingness of an inmate to participate in a TB vaccine trial, however, he/she is suffering from an untreated urinary tract infection which was neglected then such a willing candidate may receive preferential treatment in lieu of recruitment in CTs. On the other hand, prevalent awareness among inmates regarding such an arrangement may also induce a willingness among inmates to volunteer themselves for participation in CTs.
Need for a roadmap for undertaking prison research in India
Overall, considering that the incidence of several infectious diseases such as TB, HIV, etc in a cohort of individuals do not occur without an incubation period there is an unmet need in understanding the prisoner perceptions. This may provide an insight into the health-seeking behavior of the inmates and also to understand the gaps related to the participation of this group in CTs while also preserving their respective ethical as well as legal rights. This can be done through in depth qualitative inquiries to record prisoner perceptions. Studies for generating primary evidence by analyzing multi-stakeholder perceptions around the said context need to be undertaken. Such data will have policy implications and will then provide a potential roadmap for researchers in the country to decide upon undertaking more CTs involving prisoner populations in India. Lastly, there is an unmet need for a clear roadmap for encouraging researchers to undertake prison research more. Such a roadmap will require administrative as well as ethical input so as to provide clear channels for administrative permissions to undertake prison research and the ethical boundaries and leniencies which will go hand-in-hand with for the conduction of the same. Having such guidelines may reduce the hesitancy among researchers in undertaking prison research to a large extent.
References
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Disclaimer: The views expressed in this article are the author’s personal views and do not represent the views of their affiliated organization or of Medical Dialogues. The Editorial/Content team of Medical Dialogues has not contributed to the writing/editing/packaging of this article.
