ICMR releases new draft guidelines on bio-medical research involving children

ICMR releases new draft guidelines on bio-medical research involving children

Author(s): Kundan Pandey

Children’s nod would be compulsory for making them part of any clinical trials, say guidelines

Children’s assent would be compulsory to make them part of any clinical trial in the country, according to the recently-released new draft guidelines published by Indian Council of Medical Research (ICMR), an arm of the Union Ministry of Health and Family Welfare.

The ICMR released the guidelines in the form of a 23-page document titled “National Ethics Guidelines for Bio-Medical Research involving Children”.

The guidelines say that the authority to allow a child’s participation in research rests with the parents or guardians because children usually lack the requisite legal and intellectual capacity. “However, with respect for children’s emerging maturity and independence, investigators must seek to involve children in discussions about research and obtain their assent for participation,” it says.

The guidelines use different terms to describe permission of the child and the guardian. While the child’s permission is termed “assent”, the guardian’s permission is termed as “consent”.

The guidelines further state that for children between 7 (84 months and above) to 12 years of age, oral assent must be obtained in the presence of the parent/ legally acceptable representative. For children between 13 and 18 years of age, written assent must be obtained. If a child turns 13 during the course of the study, then written assent must be obtained. In cases of verbal assent, the parent’s counter-signature must be obtained to certify that the child’s verbal assent has been taken.

The guidelines further propose the establishment of a Data Monitoring Committee (DMC), which should have members with appropriate expertise in the evaluation of clinical studies in children.

Because children are less likely to challenge records about themselves, there is an additional duty of the investigator in protecting children’s data and ensuring confidentiality. “All documents of a research involving children should be archived for a duration that takes into account the potential need for long-term review of data. This primarily pertains to long-term safety,” the guidelines add.

The guidelines stipulate that there are certain situations when an ethics committee can waive off taking children’s assent. These situations include the prospect of the research directly benefitting the child and the child being differently-abled.

The ICMR has asked for comments by November 15.

US consumers buying more from mass marketers than grocery stores: study

US consumers buying more from mass marketers than grocery stores: study

Author(s): chinmayis

This could pose a potential health concern to the country, it warns

A new study published in the United States has found that American consumers are increasingly buying food from mass marketers like giant warehouse clubs, convenience stores and retailers instead of grocery stores. The study has warned that this could pose a potential health risk to the country.

The study was spearheaded by eminent nutrition scientist and professor of nutrition at the University of North Carolina at Chapel Hill, Barry Popkin and published in the American Journal of Preventive Medicine.

Popkin and his team studied the buying habits of 652,023 households in 52 metropolitan and 24 non-metropolitan areas between 2000 and 2012. The data was recorded through self-reporting by consumers who scanned bar codes of the packaged foods they purchased and reported the name of the outlet they purchased the products from. The study divided stores into seven categories—warehouse clubs, mass merchandise, grocery chains, non-chain grocery, convenience stores, ethnic specialty stores and others.

The research revealed that the proportion of total volume of packaged foods purchase (PFP) has been growing in the last 11 years (between 2000-2012) at mass merchandise and convenience stores and warehouse clubs. The proportion of PFP from mass merchandisers jumped from about 13 per cent to 30 per cent between 2000-2012. A hike in PFP from 3.6 per cent to about 6 per cent was also recorded at convenience stores. Warehouse clubs recorded a hike from 6.2 per cent to 9.8 per cent.

The share of PFP, on the other hand, dipped by about 12 per cent at grocery stores and almost halved at non-chain grocery stores.

The study warns that this could pose a potential health threat to the US. “Grocery chains account for the majority of household PFPs. However, growing volume trends of household PFPs from store types with poorer nutrient density (more energy, total sugar, sodium, and saturated fat-dense), such as warehouse clubs, mass merchandisers, and convenience stores, could pose a potential U.S. public health concern,” it states.

Typhoon Koppu brings severe floods to Philippines

Typhoon Koppu brings severe floods to Philippines

Till now, the slow-moving typhoon has killed two people and forced tens of thousands to flee from their homes

Around a dozen villages were affected after Typhoon Koppu swept through the northern part of Philippines on Sunday and brought in its wake heavy rainfall and floods, media reports say.

Till now, the slow-moving typhoon has killed two people and forced tens of thousands to flee from their homes. The entire town of San Antonio in central Luzon province has been engulfed by flood water. Flood water has also wreaked havoc in several other towns in Nueva Ecija province, according to reports.

At present, Koppu has been downgraded to a severe tropical storm by the Japanese Meteorological Agency, which is responsible for naming and tracking it. However, the Philippines’ weather agency, which calls the weather system Lando, is still calling it typhoon, the BBC reported.

According to media reports, Koppu is expected to cause rainfall in the country for a considerable time. Some forecasts suggest it may not be until Wednesday that it moves on to Taiwan. 

Heavy rainfall

Unlike other tropical cyclones, the threat from Koppu is the massive amount of rainfall.

In the south of Luzon province, Koppu has caused severe flooding with whole villages going under water. There is also the danger of landslides. The fear is that with the ground already saturated with water, whole hillsides can collapse, news reports say.

Typhoon Koppu made its landfall near the town of Casiguran on the main island of Luzon on Sunday morning, bringing winds of close to 200km/hour and cutting power supply to vast areas.

Troops have been deployed to rescue people trapped on rooftops, but accessing remote areas remains a struggle.

A teenager was killed by a fallen tree in Manila, which also injured four others. A concrete wall collapsed in the town of Subic, northwest of Manila, killing a 62-year-old woman, news reports say.

Roads and communication links have been cut off by floods and landslides in three towns in Aurora province.

The heavily-populated region around Manila, the Philippine capital, is also receiving rainfall, though it does not lie in Koppu’s direct path.

Warning note

President Benigno Aquino III and disaster-response agencies have warned that Koppu’s rain and winds may potentially bring more damage with its slow speed. However, government forecasters said there was less heavy rainfall than expected initially in some areas, including in Manila, though fierce winds lashed several regions.

Koppu is the 12th storm to hit the Philippines this year. An average of 20 storms and typhoons each year batter the archipelago, one of the world’s most disaster-prone countries, media reports say.

In 2013, Typhoon Haiyan, one of the most ferocious storms on record to hit land, barrelled through the central Philippines, levelling entire towns and leaving more than 7,300 people either dead or missing.

Over 100 cities pledge to make food systems sustainable in urban areas

Over 100 cities pledge to make food systems sustainable in urban areas

Author(s): DTE Staff

Urban centres will be key actors in achieving Sustainable Development Goals, including eradication of hunger by 2030:FAO chief

Food and Agriculture Organization Director General José Graziano da Silva welcomed a commitment by more than 100 cities to make food systems in urban areas sustainable.

Addressing a mayors' summit in Milan on Thursday, the FAO chief applauded city Mayor Giuliano Pisapia and his counterparts from other cities for signing the Urban Food Policy Pact and said cities had a major role to play in ending hunger and improving nutrition.

Through this agreement, cities will adhere to four principles: guaranteeing healthy food for all, promoting sustainability in food systems, educating the public about healthy eating and reducing waste.

Urban centres will be key actors in achieving the globally-agreed Sustainable Development Goals, including the eradication of hunger by 2030, Graziano da Silva said.

"A majority of the  population of the world already lives in cities and the urban population is going to increase, particularly in developing countries. Unfortunately, many cities cannot ensure regular and stable access to adequate food and water for all, nevertheless food security and nutrition remains overlooked in urban planning and development," he added.

He also referred to the need to address unhealthy and wasteful practices. "Obesity grows at alarming rates, particularly in urban areas of middle and upper income countries, where diet changes are driven by people's lifestyles," the FAO Director General said.

He cited innovative solutions such as an increase in small-scale urban and peri-urban agriculture that can produce food which will help to diversify and foster healthier diets in families living in cities.

About 60 per cent OECD population exposed to dangerous PM2.5 pollution levels: report

About 60 per cent OECD population exposed to dangerous PM2.5 pollution levels: report

Author(s): DTE Staff

Nearly half of all the countries from the group were found to have an annual PM10 concentration above WHO-recommended levels

Air pollution is becoming a threat to more and more countries. In a recent report, The Organisation for Economic Co-operation and Development (OECD) has highlighted that only 40 per cent of the residents of countries under the group have average PM2.5 exposure that is below the threshold that has been recommended by the World Health Organization (WHO).

Titled "How's life 2015: measuring well-being", the report documents latest evidence-based data on well-being, as well as changes over time, and the distribution of well-being outcomes among different groups of the population. The Green Growth Indicators initiative of the OECD (a group of 34 countries across the world) is one of the parameters factored in the report.

According to the report, in 2010-12, while only about 40 per cent of the OECD residents had an average annual exposure below the WHO-recommended threshold of 10 micrograms per cubic metre, about 42 million residents were exposed to PM2.5 levels of 25 micrograms per cubic metre or above, during the same time period. Annual exposure here refers to the population-wide exposure to fine particulate matter that is less than 2.5 microns in diameter, as well as the share of the population exposed at different levels of PM2.5. Other major components of particulate matter include sulphate, nitrates, ammonia, socium chloride and black carbon, among others.

A 2014 report by the group had stated that the cost of the health impact of air pollution in OECD countries (including deaths and illness) was about US $1.7 trillion in 2010. Another recent report by OECD stated that India and China suffer over US $1.89 trillion annually in terms of the value of lives lost and ill health caused from air pollution.   

Exposure to PM10 is another threat for the OECD economies. The report suggests that in 2009, nearly half of all the countries from the group had an annual urban PM10 concentration above WHO-recommended 30 micrograms per cubic metre.

Paramedics show the way

Paramedics show the way

Author(s): Kundan Pandey

How hundreds of villages in Bangladesh have overcome child and maternal mortality 10 years before the MDG deadline

Two girls, in their late 20s, knock on the door of Subhash Barman, a fisherman living in Gopinathpur Malopada village, about 35 km from Dhaka. The family welcomes them warmly. Shilpi Barman, wife of Subhash, is in her seventh month of pregnancy. These girls cut Shilpi’s nails and check her blood pressure. They then inspect her bedroom to check whether the bedsheets are clean and also collect her urine sample.

These girls are paramedics from Gonoshasthaya Kendra (GK), a non-profit, which provides community healthcare to the marginalised. Started in 1972, GK has today reached more than 1.5 million rural people in 647 villages through over 1,100 employees, 43 primary health centres (PHCS), five referral hospitals and one medical college.

Their efforts have helped achieve the targets under the Millennium Development Goals (MDGs) for child and maternal mortality in hundreds of villages in Bangladesh, 10 years before the MDG deadline of 2015. GK’s success was highlighted by a World Bank report, To the MDGs and Beyond: Accountability and Institutional Innovation in Bangladesh, in 2006. It says, “GK has already exceeded the MDG for infant mortality a decade ahead of time, while the rest of the country remains at a level two-thirds higher. On maternal mortality, GK has achieved a rate of 186 per 100,000 live births, 42 per cent lower than the national average in 2001 when the decline for country as a whole was much less.” Besides, GK provides multiple health facilities to vulnerable people.

Tracing the model

GK began as a field hospital for the wounded freedom fighters and refugees during the liberation war in 1971. Realising that millions of people in the rural areas had no access to any kind of healthcare facilities, these survivors established GK on April 27, 1972.

Graduating doctors serve in rural areas and get their certificates only after completing their internship period

The GK model relies primarily on paramedics who knock on the doors of poor people in villages providing healthcare. “We identify pregnant women, ailing children and the elderly in villages with the help of the bai (traditional midwife),” says Devi Haldar, one of the GK employees visiting Shilpi.

The paramedics at GK are mainly young girls, hailing from local communities, who are trained for a period of six months at GK’s medical college in Savar, around 30 km from Dhaka. And if Shilpi is to be believed, these paramedics help them a lot. “This is my third pregnancy and all deliveries have been normal so far. My kids are healthy too,” adds Shilpi (see ‘Networked model’).

Bangladesh has one paramedic for every 7,200 population, while GK has one paramedic for every 5,000-6,000 population. “The team of paramedics is the face of the organisation,” says Rezaul Haque, director, rural health and training, GK. They are trained to treat general illnesses like fever, headache, dehydration and diarrhoea. “If we receive a serious case, we refer it to the local PHC,” says Haldar. For every six paramedics, the organisation has one field supervisor, who reports to the health in-charge.

Similarly, the organisation has one intern for every 30,000-40,000 population who treats patients in PHCs or referral hospitals.

These interns are graduating doctors of GK’s medical college located in Savar. At present, the organisation has around 153 interns and 34 physiotherapists. These interns serve in the rural areas as mandated in their course. They get their certificates only after completing their internship period. “We are not a doctor-dependent organisation, but paramedics-driven. Here, doctors are only to assist,” says Manzur Kadir, coordinator of GK.

The organisation takes care of antenatal care and postnatal care of patients at the local PHC, and delivery, child care, immunisation, care for disabled, elderly and destitute at their homes. GK also organises health camps every month or two for patients who need special care. Such camps help reach poor people and minimise consultation fees, diagnostic costs, travel and hospital stay costs, making healthcare affordable.

Innovative insurance

When it began work, GK charged all income group households a flat rate of 2 Taka per year. Over the years, the organisation realised that this was a burden for poor households. After conducting a socio-economic survey to categorise the populations, GK devised an insurance model in which the premium varied depending on the categories: upper and middle class who pay a higher premium and ultra poor, poor and lower-middle class who pay very little, yet receive comprehensive healthcare coverage.

The insured families get inpatient coverage and discounts on medications. For specialised services, the cost varies depending on their categories. But poor households, whether insured or not, can access PHC services, including preventive and reproductive healthcare services free of cost. “People are willing to pay money, but they need proper and quality facilities,” says Kadir.

“We have decided to audit every birth and death,” says Zafrullah Chowdhury, founder of GK. “I see sustainability in terms of accessibility, irrespective of whether people use the services or not.” Organisations like GK are literally hand-holding the Bangladesh government’s rural health-care system.

 Networked model

The village traditional midwife or bai keeps a tab on the general health of people in the village, including pregnancies and childcare
They inform the visiting paramedics of GK on the status of cases
The paramedics visit the homes of ailing people to provide care and guide them about treatment and medications
If a paramedic feels a patient needs intense care or specialised treatment, he/she refers them to PHCs
Graduating doctors from GK's medical college are posted at every PHC. They provide basic treatment to patients
If patients need specialised treatment, they are guided to the health camps, where they are taken care of by specialists