When research ethics fall through the cracks

Research is defined by the American sociologist Earl Robert Babbie as "a systematic inquiry to describe, explain, predict and control the observed phenomenon. It involves inductive and deductive methods." But is such a systematic investigation into the study of materials and sources to reach new conclusions then at all bound by any ethics?

Dr Amar Jesani, an independent consultant researcher and teacher in bioethics and public health (a founder of the Forum for Medical Ethics Society and its journal Indian Journal of Medical Ethics) says this is absolutely necessary. "When it comes to ethics of research, stringent standards are implemented all over the world, but in India we don't seem to fully adhere to these with exceptions to new drug/clinical treatment trials," he laments. The expert added that the record isn't any good in humanities and social sciences. "Often they don't even have protocols set in place before commencing study."

Underlining how there is no single body to uphold ethical standards at the government level, Dr Jesani says, "Even where institutions have set up mechanisms to look at research ethics, many resist approaching the review panel for approval since they are aware there is no uniform mandatory enforcement. A convenient way of wriggling out is always found."

Consider, for instance, Tata Institute of Social Sciences' study, which blew the lid off the rampant child sexual abuse in Bihar's childcare institutions and triggered a political storm, prompting the Nitish Kumar government to ask for a Central Bureau of Investigation (CBI) probe. Dr Jesani told this writer that the study never came up for review with the board at TISS, where he is a member. "I would've clearly remembered if that was the case," he avers.

(Clockwise from top left: 1. Indian activists protest against recent incidents of rape in shelter homes of Bihar and Uttar Pradesh, in Ahmadabad; 2. Police personnel during a raid at the Aasra Home in Bihar following the expose from the TISS study; 3. A file photo of a venepuncture in process from the Tuskegee syphilis experiment (1935-1972) conducted in the US; 4. The Deoria Balika Ghar in Bihar, which was one of the shelter houses in Bihar where children were sexually abused)

Questions have been raised by several child rights' activists about why TISS' study did not report the abuse to authorities as soon as they found out. Commissioned in July last year under the Koshish Project, the seven-member team began their study in October 2017. By January, the team had found out about the widespread sexual abuse of children, but this was made public only in May this year when the report was submitted to the government. Little was done to contain the situation till news reports made it a raging issue.

Anti-trafficking expert Dr Pravin Patkar (who has decades worth of experience working with children in abusive situations) told DNA last week how this is a violation of Protection of Children from Sexual Offences Act, 2012 (POCSO Act).

In fact, Dr Patkar earlier said children escaped or rescued from abusive situations require urgent medical and psychiatric intervention. Pointing out how this was the spirit behind the provision of mandatory reporting in POCSO, he underlines how Section 19(5) places the responsibility on the police to make immediate arrangements to give a child such care and protection reporting the incident to the Child Welfare Committee within 24 hours of the report.

In an earlier interview, Muhammad Tarique Qureishi, who headed the TISS study, has defended his study, brushing off the criticisms with "shooting the messenger." He had also complained of his team being singled out for attack.

Sadiya Pagarkar, a freelancing dietician from the satellite town of Navi Mumbai, points out how there are problems surrounding research ethics in food and nutrition as well. She cites a study by Dr Karin Michels, a professor at the Harvard T H Chan School of Public Health, that claimed coconut oil is 'pure poison,' even calling it "worse than lard."

While the study made headlines globally last week, Pagarkar says, "One appreciates new research in nutrition, but this particular one only raises questions about its basis. Coconut oil has been used across South India and many parts of South and South East Asia for centuries. If it was indeed harmful, many would have been affected by now. Similarly, there was a time when eggs were given a bad name. But now, it is being said that they help reduce cholesterol."

But research and ethics have a history of not sharing the best relationship in the US. The Tuskegee Study of Untreated Syphilis in the N egro Male – an unscrupulous, underhand and spiteful clinical study conducted between 1932-72 in the US to observe the natural progression of untreated syphilis in abject poor rural African-American men in Alabama under the guise of receiving free health care – stands as a perfect example of this.

Lured with free medical care, meals, and free burial insurance for participating in the study, all of the 622 (431 with previously contracted syphilis) impoverished, African-American participants were told that the study would last six months – when it actually lasted 480 (40 years). No infected participant was told they had the disease, and none was treated with penicillin, which was being used to treat syphilis. It took a whole 25 years more before then-President Bill Clinton formally apologised on behalf of the country to the victims whose descendants have still not been given any compensation.

Lok Sabha MP and physician Dr Sanjay Jaiswal, who has often raised the issue of "people being treated as guinea pigs, lack of informed consent and unattributed deaths during trials," in the Parliament reminded this writer how doctors at the Bhopal Memorial Hospital and Research Centre (BMHRC) – an entity that was established exclusively for treating the victims of the 1984 gas leak, recruited unsuspecting survivors for clinical trials without their knowledge/consent and 14 of them died during trials in 2004. "This highlighted irregularities and ethical violations in trials by clinical research firms and pharmaceutical companies in India," he says and adds, "While one can understand that clinical trials are needed, the real issue is how this is done flouting the already weak rules. Our ethnically diverse pool, low overall costs and lax enforcement of laws has only contributed in many firms preferring India for their research and clinical trials."

He admits other poor countries would be "only too willing" to have these pharma and biotech majors go to them instead. "This needs to be tackled at a global level. A mere country-specific approach might not work when it comes to ethics."

Research is increasingly being determined by political agendas, corporate interests and market forces putting a question mark on its veracity, rues Dr A L Sharada, a Sociology doctorate who heads Population First – a communication and advocacy initiative for a balanced, planned and stable population. "As researchers, we need to make decisions based on human values and rights rather than our professional protocols. Since notification of child sexual abuse is mandatory, it should take precedence over other confidentiality clauses that are built into the research protocol. I feel the ultimate purpose of research should be based on human values, rights and the greater good."

BREAKING DOWN THE POCSO ACT, 2012

Chapter V Section 19 of the Protection of Children from Sexual Offenses Act (POCSO Act) states: Any person (including the child), who has apprehension that an offence under this Act is likely to be committed or has knowledge that such an offence has been committed, he shall provide such information to, a) the Special Juvenile Police Unit, or b) the local police. This mandate is regardless of what is stated in the Code of Criminal Procedure (1973)
The responsibility for mandatory reporting is on all persons with no exceptions of the 'professional communication' between a priest, lawyer, and a psychiatrist or psychotherapist and their clients
POSCO Act prescribes stringent punishment for failure to report/record a case:

1. Any person, who fails to report the commission of an offence under sub-section (1) of Section 19 or Section 20 or sub-section (2) of Section 19 shall be punished with imprisonment of either description which may extend to six months or with fine or with both

2. Any person, being in-charge of any company or an institution (by whatever name called) who fails to report the commission of an offence under sub-section (1) of Section 19 in respect of a subordinate under his control, shall be punished with imprisonment for a term which may extend to one year and with fine