Indian Council of Medical Research

For the first time, ICMR issues national ethical guidelines for biomedical research involving children

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For the first time, the Indian Council of Medical Research (ICMR) has come out with the national ethical guidelines separately for biomedical research involving children. These guidelines cover the ethical and legal issues that researchers need to consider when carrying out biomedical research in neonates and children.

The aim of the guidelines is to set out general principles that can be applied in most situations rather than to cover every possible situation. These guidelines need to be used in conjunction with the current National Ethical Guidelines for Biomedical Research involving Human Participants issued recently by the ICMR, and are meant for use by researchers, ethics committees and other involved stakeholders. While these guidelines cover general biomedical research involving children, the definition of ‘child’ has been variable according to various legal and social contexts. As per the National Commission for Protection of Child Rights, a child is defined as a person from 0 to 18 years of age.

As per the document, for research in children certain guidelines should be followed when conducting research in children. They include research proposals should be scientifically sound; the equation between the potential benefit and the risk or potential harm should be at least as favourable for the proposed research procedure as for the alternatives available to the children; there should be benefit to children in general and, in most cases, to the individual child subject; the need for the study should be justified by a thorough review of literature; and the research should be conducted by a team of investigators who have the requisite expertise.

Besides, one or more members of the team should be a paediatrician and/or have prior experience of conducting research involving children; research involving children should take into consideration the unique physiology, anatomy, psychology, pharmacology, social situation and special needs of children and their families; and research involving children must be conducted in a child-friendly environment, as far as possible. In general, drugs should be tested for safety, pharmacokinetics, and at least initial indications of efficacy in adults established before they are tested in children. It may often be appropriate to defer paediatric testing until adult testing has reached phase III or beyond, when substantial data are available on the safety and efficacy of a drug in adults. However, there may be situations where studies involving children would be needed without prior adult studies, for example, surfactant use in premature babies with respiratory distress syndrome.

According to senior ICMR officials, biomedical research involving children is needed for the benefit of future generations of humanity. It leads to advances in medical care which can potentially improve the health and quality of life of children. As we near the end of the second decade of the 21st century, we have numerous opportunities to develop interventions to promote health, and prevent and treat diseases that affect children. This can only be achieved through experimentation. Research and innovation is therefore the core of the endeavour to generate and translate knowledge into clinical care. However, at the same time, we cannot expose children to undue harm by participating in research studies.

In 2006, ICMR had developed an updated, third version entitled “Ethical Guidelines for Biomedical Research on Human Participants”. These guidelines contain only a small section pertaining to research in children, which does not address in detail several ethical perspectives of conducting biomedical research in neonates and children. This monograph is intended to accomplish this important task and serve as the reference manual for ethical committees in the national context. These consensus recommendations were formulated through a rigorous and robust methodology including review of pertinent national and international guidelines, multiple stakeholders’ input and public scrutiny.

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ICMR releases revised national guidelines for biomedical research involving human participants

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The Indian Council of Medical Research (ICMR) has released the revised national guidelines for biomedical research involving human participants which are aimed at protecting and safeguarding the interests of individuals, communities and society as a whole.

This document is expected to address the ethical challenges involved in a variety of biomedical and health research areas and will be a useful document for the researchers, ethics committees, institution and sponsors engaged in the conduct of biomedical and health research involving human participants across the country.

These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data. The purpose of such research should be directed towards enhancing knowledge about the human condition while maintaining sensitivity to the Indian cultural, social and natural environment; conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.

The new guidelines have many new sections added up and many changes incorporated in the existing sections. There are now a total of 12 sections including Responsible Conduct of Research, Informed Consent Process, Vulnerability, Public Health Research, Social and Behavioural Sciences Research for Health, Biological materials, Biobanking and Datasets and Research during Humanitarian Emergencies and Disasters. Many new issues have been added up as subsections e.g. sexual minorities (LGBT), multicentric studies, research using datasets etc. The section on ethics review process has been elaborated to help the many ethics committees who have doubt about the various procedures to be followed.

ICMR first brought out the ‘Policy Statement on Ethical Considerations Involved in Research on Human Subjects’ in 1980 under the chairmanship of Justice H R Khanna. These guidelines were revised in 2000 as the ‘Ethical Guidelines for Biomedical Research on Human Subjects’ under the chairmanship of Justice M N Venkatachaliah. In view of the new developments in the field of science and technology, another revision was carried out as Ethical Guidelines for Biomedical Research on Human Participants in 2006. Bioethics is a dynamic area and over the last 10 years many new concerns and issues have evolved internationally over the ethical dilemmas faced by the scientific and ethics committees in the conduct and review of biomedical research. Hence, an exercise was taken up over a period of one year with national and international consultation to come up with this new set of state of art guidelines.

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ICMR and Forte to begin collaborative research projects in field of ageing & health

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The Indian Council for Medical Research (ICMR) and Forte, the Swedish Research Council for Health Working Life and Welfare, will soon begin collaborative research projects in the field of ageing and health, focusing on developing affordable and appropriate innovative assistive technology for the disabled elderly and methods of home based care interventions for the elderly.

The collaborative research projects will stimulate interdisciplinary, innovative, close to practice research in the field of ageing and health. The main theme of these projects will be Innovative and assistive technology studies; and Models of home-based care. All studies should aim to enhance the understanding of the theme of the call for proposals and should demonstrate potential benefits to Sweden and India. The ICMR and Forte have invited research proposals from eligible scientists for the projects and will deliver significant 2-3 years research funding for internationally competitive and innovative projects.

Proposals could include the development of innovative and assistive technology and services that are affordable and appropriate (culture, gender, age specific) for the elderly. It will include Projects on development of visual assistance, mobility assistance and cognitive assistance of the elderly; Design and provision of technology applicable to working with older adults; and Identify barriers and strategies on older adults’ acceptance of technology and perceptions of learning how to use new tools.

In the area of models of home-based care, proposals could include how the design of housing, living arrangements, effective supportive technologies for functional abilities, and the availability of local communities affect elderly people’s participation, activities and independence. Proposals should address how interventions could prevent or reduce the severity of functional impairment, especially impairments secondary to cognitive decline. It will include interventions aimed at the prevention of functional impairment as well as health promotion in order to reduce the incidence of functional impairment in the elderly; Systems of integrated care designed to address the set of health, social and functional needs of the frail elderly; and community based care models.

Proposals must demonstrate collaboration and include both Swedish and Indian Principal Investigators. Indian applicants must be working in a permanent position in a medical college, research institute or university, anywhere in the country including government, semi-government and registered bodies. Applications from non-governmental agencies and private organizations should provide documentary evidence of registration certificate for research with the Department of Scientific and Industrial Research (DSIR), government of India, previous track record etc.

This call for proposal is open for joint proposals from research teams based in India and Sweden. A Memorandum of Intent (MoI) between ICMR and Forte for cooperation in the field of ageing research and health was signed during the visit of the President of India to Sweden in June 2015. The MoI is based on a planning workshop that was partnered by ICMR and Forte in November 2014 to identify key areas for bilateral cooperation.

With declining fertility and rising life expectancy, there is a rapid increase in the number of elderly persons worldwide. Currently, persons aged 60 years or over comprise 11.5 per cent of the world’s population. This number is expected to surpass the 2 billion mark in 2050 from 841 million in 2013.

India stands to witness 100 million persons aged 60 and above currently as per the latest report from Helpage India. The need for elderly care in India is similar to the global scenario with some factors pertinent to India like a changing family system, a rural urban divide, gender based beliefs, and a lack of facilities that needs to be addressed.

The Swedish national objectives for the policy for the elderly are focused on individual care and treatment. India on the other hand has to put greater stress on the healthcare system to cater to the needs of its elderly population. There is a need to understand and strengthen the mechanisms of provision of care for the elderly and address them through appropriate delivery mechanisms. For this we need to turn to global models of home-based services and remote healthcare delivery through mHealth or telemedicine to understand the nuances of designing and implementing public and private models of elderly care. This will provide an insight into critical success factors as well as challenges in managing elderly care. Through cross national studies, lessons can be learnt on the need for collaboration amongst various stakeholders that can change India’s elderly care landscape, and bring it to a level that is comparable with global standards.

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Government looks to fast-track approvals for clinical trials

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As the government reviews an overhaul of the drug regulatory process, rules related to clinical trials may be further eased and timelines for approvals shortened to four to six months from around six to eight months now.

The central drug regulator plans to fast track the approval process for clinical trials while ensuring that the contract research organisations (CROs) involved in the tests comply with stricter quality and compliance checks.

This comes two months after the drug regulatory agency eased rules related to clinical research — a move that was frowned upon by patient rights groups. These rules let investigators undertake as many trials as approved under the watch of the designated ethics committee and could risk patient lives, groups like Swasthya Adhikaar Manch earlier told ET.

“(There will be) changes to the (regulations) to make it both easy and stringent,” a senior health ministry official told ET, speaking about the government’s upcoming move on the condition of anonymity.

According to the official, the changes include a reduction in processing and approval time for clinical trials here while ensuring that companies adhere to higher quality standards.
The government has so far halved the clinical trial processing and approval timeline which previously would, in some cases, take up to a year and half, said the official. “The target is to reduce (the entire process) further by 30-40%.” Clinical trial regulations will also be tightened on quality parameters, focusing on aspects like the profile of the recruited patients and the CROs enrolling them, said the official. For this purpose, CROs across the country will be inspected for compliance withGood Clinical Practice (GCP) standards, the official added.

The government has reduced the timeline by measures like increasing the frequency of meetings of the committees granting the approvals and waivers, said another senior ministry official who also preferred to remain anonymous. The Subject Expert Committee, for instance, now meets once a month as compared to once every three months.

It has also introduced an online system to receive and process clinical trial applications faster.

Clinical trial sites currently also have to comply with strong quality measures like GCP standards and the Indian Council of Medical Research ethical guidelines, said the official. “There is no compromise in the quality requirements.” The industry feels the government’s latest decision is much needed to spur pharmaceutical research.

According to Indian Society for Clinical Research president Suneela Thatte, the process can be made more efficient by restricting certain requirements like a three-tiered review process of new drug applications to only special cases. Training and orientation of experts overseeing the entire process would also help speed up the process, she added.
“Other countries don’t have multi-tiered reviews like India does,” she said. Additional investment in governance and infrastructure is also required to ensure compliance with the new regulations, said Naz Haji, Quintiles IMS’ CRO head for India, Singapore, Malaysia and Indonesia.

India’s approval timeline is much longer than timelines of leading clinical research hubs, according to Meir Perez Pugatch, managing director of research consultancy Pugatch Consilium. “In Singapore, for instance, clinical trial applications are usually processed within a timeframe of 30 days, and small-scale clinical trials … are processed within a timeframe of only 15 days.”
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TB epidemic in India larger than what was previously estimated: WHO

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Tuberculosis epidemic in India is “larger” than what was previously estimated, the World Health Organisation (WHO) today said while asserting that the country was one of six nations which accounted for 60 per cent of the new cases in 2015.

The Global Tuberculosis Report 2016 which was released today, however, said the number of TB deaths and incidences rate continue to fall globally as well as in India.

“The TB epidemic is larger than previously estimated, reflecting new surveillance and survey data from India. However, the number of TB deaths and the TB incidence rate continue to fall globally and in India,” WHO said.

It said that in 2015, there were an estimated 10.4 million new (incident) TB cases worldwide, of which 5.9 million (56 per cent) were among men, 3.5 million (34 per cent) among women and 1.0 million (10 per cent) among children while people living with HIV accounted for 1.2 million (11 per cent) of all new TB cases.

“Six countries accounted for 60 per cent of the new cases – India, Indonesia, China, Nigeria, Pakistan and South Africa. Global progress depends on major advances in TB prevention and care in these countries,” the global health body said in its report.

It said worldwide, the rate of decline in TB incidence remained at only 1.5 per cent from 2014 to 2015 and stressed the need for it to accelerate to a 4–5 per cent annual decline by 2020 to reach the first milestones of the End TB Strategy.

“In 2015, there were an estimated 480000 new cases of multidrug-resistant TB (MDR-TB) and an additional 100000 people with rifampicin-resistant TB (RR-TB) who were also newly eligible for MDR-TB treatment.

“India, China and the Russian Federation accounted for 45 per cent of the combined total of 580000 cases. There were an estimated 1.4 million TB deaths in 2015, and an additional 0.4 million deaths resulting from TB disease among people living with HIV. Although the number of TB deaths fell by 22 per cent between 2000 and 2015, TB remained one of the top 10 causes of death worldwide in 2015,” it said.

WHO said that in 2015, 6.1 million new TB cases were notified to national authorities and reported to WHO while notified TB cases increased from 2013–2015, mostly due to a 34 per cent increase in notifications in India.

“However, globally there was a 4. 3 million gap between incident and notified cases, with India, Indonesia and Nigeria accounting for almost half of this gap. The crisis of MDR-TB detection and treatment continues.

“In 2015, of the estimated 580000 people newly eligible for MDR-TB treatment, only 125000 (20 per cent) were enrolled.

Five countries accounted for more than 60 per cent of the gap – India, China, the Russian Federation, Indonesia and Nigeria,” it said.

WHO said that the upward revisions to estimates of the burden of TB disease in India for the period 2000–2015 follow accumulating evidence that previous estimates were “too low”.

“This evidence includes household surveys, a state-wide TB prevalence survey, studies of anti-TB drug sales in the private sector, notification data and new analysis of mortality data.

“Since India accounts for more than one quarter of the world’s TB cases and deaths, these revisions have had a major impact on global estimates. Estimates for India are considered interim, pending a national TB prevalence survey scheduled for 2017/2018,” WHO said.

It said that in the African Region where the burden of HIV-associated TB is highest, 81 per cent of notified TB patients had a documented HIV test result.

“The proportion of known HIV-positive TB patients on ART was above 90 per cent in India, Kenya, Malawi, Mozambique, Namibia and Swaziland,” it said.

Giving out details about India, WHO said mortality (HIV+TB only) was 37 per thousand while incidence (HIV+TB only) was 113 per thousand.

Estimated TB incidence in India in 2015 in the age group of 0-14 years for both males and females was 255 per thousand.

Commenting on the report and the disease in the South East Asian Region which also includes India, WHO Regional Director (SEARO) Poonam Khetrapal Singh said TB remains a serious problem across the region and requires the fullest attention and strongest commitment of governments.

“As outlined in WHO’s new global report on TB, a number of countries in the region are among the world’s highest TB burden countries, while revised estimates based on increased case-reporting and enhanced surveillance show that the TB caseload is higher than previously projected.

“TB is the single largest cause of death of any infectious disease in the region, and remains responsible for incalculable suffering, premature mortality, impoverishment and foregone development,” she said.

She said though countries have been making efforts to end TB and the number of TB deaths and its incidence rate continues to fall, at the current trend the region would not be able to achieve the SDG targets.

“A newer and bolder approach is needed to bend the curve faster and sharper to achieve the global targets. This means intensifying measures to ensure early diagnosis and treatment, such as active case-finding and enhancing access to cutting-edge diagnostic tools.

“Adopting newer approaches of case diagnosis, community based treatment and treatment of latent infection. It means integrating TB programmes with existing health systems, thereby amplifying the effect these interventions have,” she said.

Singh also said that funds must be allocated accordingly, while political commitment must be fortified and both must occur at national and international levels.

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