Clinical 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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This Simple Blood Test Can Predict Cancer Years Before Symptoms Appear

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A new type of non-invasive cancer test has just delivered promising results in an early-stage feasibility study, paving the way for a future when we’ll be able to get highly accurate cancer screening with a simple blood test.

The technology, which involves scanning the blood for bits of DNA shed by tumours, is also referred to as a ‘liquid biopsy’, and these new results are getting us one step closer to a major upgrade in cancer diagnostics.

Right now, our best method for detecting cancer is a biopsy – cutting out a small piece of the tumour tissue for lab analysis. But biopsies are often painful and invasive, and you need to already have a tumour or at least a suspect tumour to cut something out of it.

That’s why scientists have been working on devising blood tests that can do the same thing without any surgery, and with the promise of delivering a diagnosis much earlier.

Finding cancer in the blood is possible when scientists focus on DNA fragments shed into the bloodstream by tumours. This is called circulating tumour DNA (ctDNA).

In recent years, scientists have been working on finding the best method for detecting ctDNA, using samples from patients who already have diagnosed cancer.

The latest study, which was just presented at the 2017 meeting of the American Society of Clinical Oncology (ASCO), has turned up the dial on what scientists can find when they scan for ctDNA.

“Our findings show that high-intensity circulating tumour DNA sequencing is possible and may provide invaluable information for clinical decision-making, potentially without any need for tumour tissue samples,” says lead researcher Pedram Razavi from Memorial Sloan Kettering centre.

The team used blood and tissue samples from 124 metastatic breast cancer, lung cancer, and advanced prostate cancer patients.

They scanned the samples for 508 different gene mutations, going over the specific regions of the genome up to 60,000 times. According to the scientists, this method generates 100 times more data than other sequencing approaches.

To see whether the method could catch any tumour DNA floating around in the blood, the team compared the results with those from tissue samples and genetic material from the patients’ own white blood cells.

“Our combined analysis of cell-free DNA and white blood cell DNA allows for identification of tumour DNA with much higher sensitivity, and deep sequencing also helps us find those rare tumour DNA fragments,” says Razavi.

The researchers detected 864 genetic changes across all three types of cancers in the tissue samples, and found 73 percent of those in the blood tests as well.

In 89 percent of the patients, they found at least one mutation in both tumour tissue and in blood. For breast cancer, for which liquid biopsies are more established, the success rate was 97 percent.

A huge benefit of having sensitive ctDNA tests is the chance of finding cancer years earlier than is possible with a biopsy, catching it before it has time to spread through the body.

The new method was developed with researchers from Grail, a genomics company dedicated to early cancer detection, backed by philanthropic funding from people like Jeff Bezos and Bill Gates.

Grail’s Mark Lee, who was one of the study co-authors, told Reuters that the company is now planning to use this new test to gather large-scale data from hundreds of thousands of people, both with and without cancer.

While the results are promising so far, the team will be needing a lot more research before this technology becomes an early detection tool that we all can benefit from in a routine check-up.

“It’s an important first step. We show that what we call a high-intensity approach works,” Razavi told Reuters.

The results were presented at the ASCO Annual Meeting, and have been accepted for publication in the Journal of Clinical Oncology.

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Sitting down all day ‘may accelerate DNA ageing’

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Image result for sitting down all day

“Women who lead a sedentary lifestyle have faster-ageing cells than those who exercise every day,” BBC News reports.

This research looked at telomeres – often likened to the caps at the end of shoelaces, they are made up of molecules that protect strands of chromosomes from “fraying”.

Telomeres shorten every time the genetic information in cells is duplicated. It’s believed that this leads to cell ageing and death.

In a sample of older women, the researchers looked at whether there was an association between time spent sitting down and telomere length.

Telomeres are measured in the small sections of nucleic acids that make up DNA, known as base pairs.

Among women in the study who did less than about 40 minutes of physical activity a day, those who sat longest had shorter telomeres by an average 170 base pairs.

The researchers say telomeres shorten at a rate of 21 base pairs a year – using a rough “back of a fag packet” calculation, 170 equals about eight years.

Sitting time did not seem linked to telomere length for women who did at least 30 minutes of physical activity a day.

We don’t know whether the results apply to men or younger people.

And, importantly, as the study only looked at the women’s activity levels and telomeres at one point in time, we don’t know whether activity levels or sitting causes telomeres to shorten.

Still, arguably, most of us would benefit from spending less time sitting down.

Image result for sitting down all day

Where did the story come from?

The study was carried out by researchers from the University of California, San Diego State University, the State University of New York at Buffalo, the University of Washington, the Fred Hutchinson Cancer Research Centre, George Washington University, the University of Florida and Northwestern University, all in the US.

It was funded by the US National Heart, Lung and Blood Institute.

The study was published in the peer-reviewed American Journal of Epidemiology on an open access basis, so it’s free to read online.

All of the UK media outlets that covered the study implied that a direct cause and effect relationship between sitting down and cell ageing had been proven.

For example, the Mail’s headline stated that, “Women who spend at least 10 hours on their backsides each day speed up their aging process.”

This is untrue. While there certainly seems to be an association worthy of further research, no causal link has been established.

What kind of research was this?

This cross-sectional study used data from women taking part in a much bigger study of health called the Women’s Health Initiative.

Cross-sectional studies can find correlations between different factors – in this case, sitting time and telomere length.

But because this type of study only looks at one point in time, researchers can’t say which factor happened first, so it’s not very useful for telling us whether one causes the other.

What did the research involve?

Researchers used information about 1,481 women aged over 65 who’d taken part in various sub-studies of the Women’s Health Initiative.

They used information from women who’d had their physical activity measured using accelerometers (devices that measure movement) and had also given DNA samples that had been tested for telomere length.

After accounting for other factors, they looked at whether telomere length was linked to the amount of time spent sitting.

The information about physical activity was measured over one week, during which time women wore their accelerometer all the time, except when bathing or swimming.

Women taking part also completed a questionnaire about their physical activity and kept a record of their sleep. Telomere length was measured from DNA in blood cells.

The researchers took account of the following possible confounding factors:

  • age and ethnic background
  • education level
  • marital status
  • smoking and alcohol consumption
  • body mass index
  • hours of moderate to vigorous physical activity each day
  • long-term diseases
  • use of hormone medicines

They also redid their calculations to divide the women into those who did more or less than the average amount of physical activity (about 40 minutes).

They then looked at the link between time spent sitting and telomere length for women who did more or less than 40 minutes physical activity a day.

They also looked at the link between sitting and telomere length for women who did 30 minutes or more a day, the recommended activity level for all adults.

It’s unclear whether these additional calculations were planned from the start of the study, or whether the researchers decided to do them because the initial findings did not show a link between time spent sitting and telomere length.

What were the basic results?

The length of time spent sitting was not linked to telomere length for women who did 30 minutes or more of moderate physical exercise a day.

For women who did less than the average amount of moderate physical activity each day, time spent sitting did show a link to telomere length.

Among these women, those who spent more than about 10 hours a day sitting had shorter telomeres than those who spent less than about eight hours a day sitting. The average difference was 170 base pairs (95% confidence interval [CI] 4 to 340).

Women who spent the most time sitting were more likely to be older, white, obese and have long-term illnesses.

How did the researchers interpret the results?

The researchers said their results suggest that, “Prolonged sedentary time and limited engagement in moderate to vigorous physical activity may act synergistically to shorten leukocyte telomere length among older women.”

In other words, being both sedentary for long periods and not getting much physical activity may act together to shorten telomeres in blood cells.

They speculated that causes of the link might include insulin resistance, lack of the anti-inflammatory responses the body has to exercise, or obesity.

They also acknowledged women who have long-term illnesses are more likely to have a sedentary lifestyle, and the illness rather than the lack of exercise may cause shortened telomeres.


It’s not news to anyone that being more physically active and spending less time sitting around is likely to keep people in better health.

But this study has many limitations that make it difficult for us to rely on its results.

While they are used as a marker for ageing cells, telomeres are not a direct measure of ageing. Although shortened telomeres have been linked to certain diseases, everyone’s telomeres shorten over time.

Saying shorter telomeres make someone “biologically older” doesn’t mean much. This hasn’t stopped the emergence of private companies offering to measure your telomeres – but it’s unclear what exactly you could usefully do with that information.

And the only cells studied in this research were blood cells, so we don’t know whether the results would have held for brain cells, muscle cells or any other cells in the body.

Doctors have tried to disentangle the effects of physical activity from the effects of being sedentary before without much success.

Generally, as in this study, research seems to show that if you get plenty of moderate to vigorous physical exercise, the amount of time you spend sitting or lying down doesn’t make much difference.

The researchers carried out a lot of comparisons and used multiple models to try to show sedentary time was linked to telomere length.

In most of these models, once you take account of women’s age, ethnicity, body mass index and long-term illnesses, there was no link.

Only when the researchers stratified the results by how much physical activity women did could they show a link in one category: those who did the least physical activity.

That suggests sedentary behaviour is not the strongest factor to affect telomere length.

Another problem with the study is it only looked at telomere length and physical activity at one point in the women’s lives.

We don’t know how much physical activity they’d done throughout their lives, or whether their telomeres had shortened faster than other women recently or at an earlier stage in life.

The study doesn’t add much to what we already know: physical activity is likely to be beneficial for people at all stages of life, and everyone should aim to get at least the recommended level of 30 minutes of moderate to vigorous physical activity a day.

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Lifestyle Delivery Systems plans to conduct clinical trials of CannaStrips in Canada

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Lifestyle Delivery Systems Inc.(LDS) has begun outlining the protocols for clinical trials of its patent pending CannaStrips formula.

LDS’ chief medical officer, John Sanderson MD, having over 30 years of clinical research, clinical trial coordination and analysis experience, will oversee the protocols and operational aspects of the trials. The trials will be conducted in Canada with the specific goal of substantiating the efficacy of the CannaStrip delivery system. The company intends to submit the results of the clinical trials for consideration to Canadian health officials as an alternative delivery method for medicinal marijuana in Canada.

The clinical trials’ primary focus will be on three specific aspects of the delivery system. First, the time required from application onto the buccal membrane to the introduction of active ingredients into the blood stream. Second, the volume or percentage of active ingredients delivered into the blood stream and the length of time that those ingredients become bioavailable in the blood stream to the patient. Third, to determine the extent to which the ingredients can be directed to specific areas of the body and brain.

Brad Eckenweiler, CEO of Lifestyle Delivery Systems, states, “The value of these trials goes far beyond the Canadian marijuana market. The Company believes that clinical evidence supporting the goals for LDS technology will set regulatory expectations significantly higher for the control, effectiveness and safety of all marijuana products worldwide.”

The patent pending CannaStrips formula is unlike any other delivery method currently available. The current market has lookalike strips that in truth are simple sheeted material that act more like edibles and have little if any sublingual delivery capabilities. CannaStrips nano-engineered technology addresses the challenge of efficient transport of therapeutic molecules, including cannabis-derived bioactives, across the oral mucous barrier for systemic delivery into the bloodstream. Low viscosity pores or temporary channels are created which foster the rapid transfer of cannabis nanoparticles from the buccal surface into the circulation. Each particle is coated with a nano-envelope which chaperones its cargo to target tissues within the body. The net effect is improved bioavailability as well as enhanced efficacy.

Dr Sanderson, states, “While edibles overcome the health and safety issues of inhalation as a method of cannabis delivery, they are inherently far less efficient, as much of the therapeutic effect of the plant is lost to incomplete absorption and early liver disposal. These clinical investigations are an exciting next step that takes us from the laboratory trials to a more rigorous examination of the incremental benefits of this unique system of delivery which provides a third option that addresses concerns about both safety and efficacy.”

Lifestyle Delivery Systems Inc’s technology produces infused strips (similar to breath strips) that are not only a safer, healthier option to smoking but also a new way to accurately meter the dosage and assure the purity of the product.

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