If You Plan to Write a Children’s Book, Here’s Some Great Information – Book1Blog

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1327736381 90 If You Plan to Write a Childrens Book, Heres Some Great Information Book1Blog

Some beginning writers think writing for children will be easier than writing for adults. Children are pretty sharp – and their attention span is usually much shorter. If you are planning to write a children's book, here are some things you need to consider.

Women buy 82% of all children's books, and half of those books are bought as gifts. Nearly 40% of the books are bought by mothers. Hardcover children's books currently are priced between $14-15.00  (if your book has a dust jacket, you will need to charge more), while softcovers are priced between $7-8.00.

According to Publisher's Weekly, children's books fall into the following categories: 27% are picture books, 17% are books for babies and toddlers, 20% are for younger readers, 19% are for middle readers and 17% are for young-adult readers. It's important that you decide which category your work falls into.

Generally speaking, children's books are considered 50% text and 50% illustration, so any royalties received will likely be split between the writer and illustrator. For example, if the royalty is 10% , then the writer and illustrator would each get 5 percent.

Children's books tend to have a longer life than books written for adults. Sales of children's books tend to start off slow and build over time. According to USA Today, October marks the beginning of a steady climb in the sales of children's books toward the holidays.

And finally, in writing your children's book , be upbeat and send a positive message. So often, children's stories center around mistakes and punishment, which sends a subtle message to a child about not taking risks for fear of harm.

[This post was created from excerpts taken, with permission, from Successful Nonfiction, written by Dan Poynter.]

Israel Fishman Non-Fiction Award given to “Hide/Seek: Difference and Desire in American Portraiture” by Jonathan D. Katz and David C. Ward

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1327735217 39 Israel Fishman Non Fiction Award given to “Hide/Seek: Difference and Desire in American Portraiture” by Jonathan D. Katz and David C. Ward

DALLAS – The 2012 Stonewall Book Awards were announced today by the Gay, Lesbian, Bisexual and Transgender Round Table (GLBTRT) of the American Library Association (ALA), during the ALA Midwinter Meeting in Dallas.

The Stonewall Book Awards are given annually to English-language works of exceptional merit relating to the gay, lesbian, bisexual and transgender experience and will be presented to the winning authors or editors at the American Library Association Annual Conference in Anaheim in June.

“The awards and honor books reflects an amazing breadth and depth in writing and publishing materials for gay, lesbian, bisexual, and transgender readers, allies, families, and friends,” said Stonewall Book Awards Committee Chair Lewis Day.  “The creativity, curiosity, and courage of these works is profound, and we feel privileged to be in the midst of these writers and their characters and creations.”

The Stonewall Book Awards – Israel Fishman Non-Fiction Award was given to both Hide/Seek: Difference and Desire in American Portraiture (written by Jonathan D. Katz and David C. Ward and published by Smithsonian Books) and A Queer History of the United States (Revisioning American History) written by Michael Bronski and published by Beacon Press. This is the first tie in this category since 1995.

The members of the 2012 Stonewall Book Awards Committee are: Chair Lewis Day, Houghton Library, Harvard University, Cambridge, Mass.; Robert Bittner, University of British Columbia, Vancouver; W. Stephen Breedlove, La Salle University, Philadelphia; Amanda Clay, Lakeview Elementary School, Norman, Okla.; Dave Combe, Ventura (Calif.) County Library; Sarah Dahlen, California State University-Monterey Bay, Seaside, Calif.; Joanna Fu, Harvard College Library, Cambridge, Mass.; Tess Goldwasser, St. Mary’s County Library, Lexington Park, Md.; Roland Hansen, Columbia College Library, Chicago; Rebecca D. Hunt, Northern Illinois University, DeKalb, Ill.; Lisa Johnston, Sweet Briar (Va.) College; Laurie Spurling, Denver (Colo.) Public Library; Stephen Stratton, California State University-Channel Islands, Camarillo, Calif.; and Rose Nagle-Yndigoyen, City of New York, Brooklyn, N.Y.

The Gay, Lesbian, Bisexual and Transgender Round Table of the American Library Association is committed to serving the information needs of the gay, lesbian, bisexual and transgender professional library community and the gay, lesbian, bisexual and transgender information and access needs of individuals at large. GLBTRT is committed to encouraging and supporting the free and necessary access to all information, as reflected by the missions of the American Library Association and democratic institutions.

For more information about the Stonewall Book Awards, please visit ala.org/stonewall.

Food for healthy life and for thought, too

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1327734009 57 Food for healthy life and for thought, too

After saluting the national flag at his school in Old Washermenpet, Dhilly Ganesh, a class VIII student, wasted no time to get to the Madras Medical College. He was eager to find out how he fared in the essay competition on the topic – ‘Food for healthy life’ organised by MMC’s Surgical Gastroenterology Department. The prize distribution took place as part of the Republic Day celebrations on Thursday.

“I wrote about consuming nutritious food, reducing oil intake and not eating too many chocolates,” he said, before quickly adding that he has not been very successful in cutting back on the sweets. He, however, had to wait patiently for the results, as the audience was involved in an animated interactive session with two nutritionists, Varsha and Gomathy Sivaji, who helped clear all their doubts about healthy diets.

“Can you please tell us if there are any ill-effects of re-heating old food stored in the fridge?”, “What constitutes a balanced meal”, and “Is a size zero figure healthy?” For that last question, Dr.Varsha, said: “Size zero is like the dimensions of a Barbie doll. Her body structure makes her a non-functional woman who cannot menstruate or produce babies. No one should aspire to be size zero.”

V.Palani, medical superintendent, Rajiv Gandhi Government General Hospital, spoke about the ill-effects of junk food and urged the audience not to let their children consume such foods. “Eat at the right time by keeping a routine for yourself,” he said.

S.M. Chandramohan, head of the Surgical Gastroenterology department, who coined the title for the essay competition, said 410 participants enrolled from across the State.

In previous years, the department announced the top three prizes but this year all participants were given a certificate and medal, he added. “This year, it was a common topic that was open to all categories in both Tamil and English,” said Dr.Chandramohan.

V.Kanagasabai, Dean, MMC, Anand Prathap and Ponnu Rajeswari, resident medical officers of the RGGGH, participated.

Internet creates a rise in cut-and-paste plagiarism

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1327733950 68 Internet creates a rise in cut and paste plagiarism

“I’m not an idiot,” Danae Brentzel-Martina tells her high-school English students. “So don’t try to play me for one by plagiarizing on your papers.”

Plagiarizing — claiming someone else’s words as your own without proper credits — may be shameful, but not uncommon. In a Pew Research Center study released in August, 55 percent of college presidents said plagiarism had increased in the past decade; 89 percent of those who thought plagiarizing was on the increase cited the Internet was a major reason.

According to surveys of students and faculty by Rutgers Business School in Newark, N.J., about 33 to 40 percent of high-school and college students admit to having done some kind of cut-and-paste plagiarism.

Academic integrity is important, as is respecting people’s intellectual property, says Brentzel-Martina, who teaches her students to value their own ideas and work and to give credit to other people’s.

“My goal is that they know how to do it (credit) properly by the time they leave my classroom,” she says. “One of the biggest things that I work on in my classrooms is encouraging them to have their own ideas, so they don’t feel the need to … fall back on cheating.”

When the Norwin High School teacher sees something suspicious — often caught through the computer program called Turnitin — she will meet with the student privately. Sometimes, the student admits to cheating by copying someone’s else’s work, often from the Internet. Brentzel-Martina might will give students a chance to fix it, if they simply failed to cite their sources properly.

But in clear-cut, deliberate cases of plagiarism, the students will fail the assignment. A second offense could lead to the principal’s office and failing the course.

Plagiarizing is easier than ever for students, who can just copy something from a website, change the font and electronically paste it into their papers. Yet, the same technology that makes plagiarism easier for students to do makes it easier for teachers to catch. Many schools use anti-plagiarism computer programs. Turnitin, which 10,000 educational institutions use in 126 countries, scans papers and the Internet and reports on text matches.

The Turnitin software has helped numerous high-school teachers and college professors enforce academic integrity in the electronic age, says Chris Harrick of the Oakland, Calif.-based Turnitin.com.

“The means to commit plagiarism is much easier,” says Harrick, a native of Peters. “It’s definitely a growing concern among educators.”

Turnitin isn’t intended to be punitive, Harrick says. It may catch cheaters, but it, ultimately, aims to teach kids how to paraphrase and cite sources properly.

“We look at Turnitin not as a policing tool, but more as an educational tool for engaging students and helping instructors,” he says.

Brentzel-Martina calls Turnitin her first line of defense. After that, she catches plagiarism the old-fashioned way: watching for writing that just looks fishy. The writing may be above the student’s ability level, or it may shift in voice and tone in parts of the paper. Often, if she Googles something that looks suspicious, she will find it online.

Many people may assume that students plagiarize deliberately because they are lazy and just want to avoid doing their own work by stealing someone else’s. Yet, these cases are the minority, Harrick and Brentzel-Martina say. She had a student who plagiarized on a personal-reflection essay years ago. When confronted, he told her, “I thought you’d rather have it be right than what I think.”

“It’s rarely that they’re lazy,” Brentzel-Martina says. “They’re so afraid to be wrong.”

Wendy Skinner, dean of students at Shady Side Academy in Fox Chapel, agrees. Students usually don’t intend to steal someone else’s work. Often, Skinner will hear students say that they were up until 1 a.m. working on a writing assignment, ran out of energy, and copied some work into the paper as a last resort.

“They rarely plagiarize when they are well rested and when they have plenty of time to do the assignment,” Skinner says.

Plagiarism contains some gray areas and can be confusing, Skinner says. For instance, maybe a student will repeat a paragraph almost word-for-word from another source, but the paragraph contains mostly factual information and isn’t easily rephrased. Maybe students gave proper attributions and citations in their papers, but only changed a few words here and there.

Sometimes, a highly gifted student may raise suspicions because his or her writing is so good, Skinner says, but after a few assignments, the teacher will know and recognize the student’s ability.

More Family headlines

Teach Writing in the Science Classroom Using NSTA’s Science the “Write” Way

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ARLINGTON, Va.–(BUSINESS WIRE)– Writing skills are high on the list of real-world requirements for all students—including science students. Every scientific discipline needs professionals who can ably communicate in writing. Scientists must be able to describe their proposed studies for funding considerations, track their observations and results in their own notes, describe their experimental protocols for their peers to replicate, and synthesize their work to the wider world community. Yet setting aside time to develop these important skills in an already jam-packed science curriculum is often difficult. And even when teachers can carve out such moments, what do science writing lessons look like?

This valuable compendium of articles originally published in the award-winning journals Science and Children and Science Scope, highlights the importance of science writing and attempts to help elementary and middle school teachers of science tackle the topic with confidence and ease. Outlining both the process and the methods for teaching science writing, articles cover lab reports, science journals, field guides, interactive science notebooks, blogs, and even creative nonfiction and environmental poetry. Practical—and time-efficient—assessment ideas are also covered.

Volume editor Jodi Wheeler-Toppen, herself well-versed in the art of combining writing and science instruction, sums up the case for teaching science writing best: “There are many reasons to have our students write, but the one that is most powerful for me is simple: Writing helps students learn.”

About the Editor

Jodi Wheeler-Toppen received her PhD in science education from the University of GA. She is a science writer for children’s books and magazine articles and is also a former science teacher.

You can browse sample pages of this new book free at the NSTA Science Store website at nsta.org/store.

For additional information or to purchase Science the “Write” Way and other books from NSTA Press, visit the NSTA Science Store at nsta.org/store. To order by phone, call 800-277-5300 between 9 a.m. and 5 p.m. ET weekdays. The 291-page book is priced at $25.95 and discount-priced for NSTA members at $20.76.

The Arlington, Va.-based National Science Teachers Association is the largest professional organization in the world promoting excellence and innovation in science teaching and learning for all. NSTA's current membership includes more than 55,000 science teachers, science supervisors, administrators, scientists, business and industry representatives, and others involved in science education.

NSTA Press produces 20–25 new books each year. Focused on the PreK–college market and specifically aimed at teachers of science, NSTA Press titles offer a unique blend of accurate scientific content and sound teaching strategies.

Teach Writing in the Science Classroom Using NSTA’s Science the “Write” Way

Lessons learned from slavery math questions in Gwinnett

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1327732753 77 Lessons learned from slavery math questions in Gwinnett

4:46 am January 16, 2012, by Maureen Downey

Christopher Emdin teaches at Columbia University and writes the “Emdin Five Series” for the Huffington Post where this essay on the slavery debate in Gwinnett originally appeared.

The “slavery math problems” assigned to 8-year-olds in Norcross has left the entire country in disbelief. I am perturbed by the fact that these questions were posed by a school system that prides itself on valuing “the important role education plays in building a thriving, global community” and having “the finest teachers in the profession.”

The homework assignment was part of a longer narrative that led to specific homework questions like, “Each tree had 56 oranges. If eight slaves pick them equally, then how much would each slave pick?” and “If Frederick got two beatings per day, how many beatings did he get in one week?”

Gwinnett spokeswoman Sloan Roach said the questions were an attempt by the teacher to “incorporate social studies lessons into the math problems.” She then mentioned that the problem was that the assignment “lacked an appropriate historical context.” Unfortunately, that assessment of the situation barely scratches the surface of the complexity of the issue.

There are five messages that we can take away from this case — to arm ourselves to address the larger issue of race and education in schools across the country.

Connect Issues of Race: Parents must recognize that this story is not an anomaly. These issues may only emerge in national media in cases like this one — where an alert parent paid attention. However, for every scenario where a race-based education issue emerges in the form of a youth arrest in school, nooses being hung on cartoon characters in school newsletters , or a scenario like this one, there are many others that never see the light of the mainstream news. It is important for us to be able to link seemingly separate incidents related to race, class, and gender, and connect them for the school and the public so that they can be addressed

Address racial history: The school spokeswoman’s use of the district’s effort to incorporate social studies into math lessons as a way to justify or explain the slavery references in math problems is problematic. Furthermore, it is an example of how the language of teaching and buzzwords in education simply serve as a way to explain away poor teaching and offensive practices.

In this case, and in many others cases, teaching across subject areas, using vivid examples in teaching, and even using imagery in constructing questions, simply masks larger issues in the school that are not being addressed. Parents and the public must be aware of this fact and push for more focus on the causes for race issues in classrooms.

Get To the root of the problem: In this case, the school district agreed to shred the assignment and offered an apology for its insensitivity. For many people this is sufficient. I argue that the shredding of the assignment is inconsequential if the reason why a teacher finds it appropriate to pose such questions to begin with has not been addressed. There must be a push to shred the root of the problem and not just the assignment.

Review your child’s schoolwork for hidden agenda: The most powerful thing about this case are the vigilant parents that saw the math problems as they were going over homework with their children. In particular, two African-American fathers discovered the questions and contacted the school district. These parents serve as an example and provide us all with an additional reason to be involved with what our children are learning in school, what assignments they are bringing home, and what messages they may be receiving from their assignments.

Demand cultural sensitivity in teacher training: The teacher who gave this assignment is touted by the district as being part of the “finest in the profession,” but may not be aware of the implications of racial ignorance on students. Teacher hiring focuses solely on the degrees teachers have earned, their GPA’s, and their knowledge of their content areas, but do not evaluate or prepare them on race, class and urban issues. In many cases, these teachers lack ongoing professional development on race, class and gender issues in schools.

To be the “finest teacher in the profession” one must have ongoing training beyond math, science or subject area. Schools, parents, and the public must demand more from the people who teach our children.

–From Maureen Downey, for the AJC Get Schooled blog

Greece hopeful as debt talks resume

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1327731549 44 Greece hopeful as debt talks resume

By Renee Maltezou

ATHENS – Greece hoped on Wednesday it could wrap up tortuous negotiations on a debt swap as early as this week when private creditors return to Athens for a fresh round of talks to avert a chaotic default.

After weeks of bargaining, deadlocks and an intervention by eurozone ministers, Greece and its bondholders find themselves back at the drawing board as they search for a compromise needed to clinch a bailout for Athens before it runs out of money.

With time slipping away ahead of a March deadline when Greece faces major bond redemptions, the top negotiator for private creditors, Charles Dallara, returns to Athens on Thursday to resume talks with officials, the government said.

“We are now in the most delicate phase of the negotiations to complete the debt swap,” government spokesman Pantelis Kapsis told reporters.

“It is clear that what happens in the coming days will affect the country’s course for years.”

The focus is expected to be on whether Dallara budges from what the creditors’ billed as their “final offer” of a 4% coupon on new bonds that Greece will swap out for existing debt after eurozone finance ministers rejected that proposal.

Dallara, who is chief of the International Institute of Finance, left Athens over the weekend after the last round of talks proved inconclusive. He has pleaded for a quick resolution before time runs out but has not disclosed whether his group is willing to change its stance on the coupon, or interest rate.

Greece has insisted on a coupon of not more than 3.5% at the behest of its European partners worried that the debt swap will otherwise not do enough to rein in the country’s massive debt burden.

Without a deal, Greece would tumble into a “hard” default that risks setting off panic in the financial system and pulling bigger euro zone members like Italy and Spain closer to the brink, though the ECB has helped to assuage those fears by flooding the banking sector with nearly half a trillion euros of three-year money.

Sinking further into recession and gloom, Greece is finding itself in an increasingly precarious state yet again as it confronts difficult debt talks, political dithering and snail-paced reforms that have exasperated lenders.

STRUGGLING REFORMS

On top of its list of tasks is the debt swap that must be wrapped up quickly in order to seal a 130-billion rescue plan that European partners and the International Monetary Fund drew up in October.

There could be trouble even if there is a quick conclusion of the swap, which is aimed at chopping 100-billion euros off Greece’s 350-billion-euro debt load by getting bondholders to accept a 50% nominal writedown on their holdings.

Public sector holders of Greek debt, like the European Central Bank, may end up having to write down their holdings if the private sector restructuring is unable to make Greece’s debt burden sustainable, IMF chief Christine Lagarde warned.

Greece has already threatened to include a clause enforcing losses on investors if fewer than expected bondholders sign up to the deal voluntarily.

Even with a successful debt swap, Greece faces trouble on other fronts. Beset with squabbling politicians and entrenched special interests, the country has made little headway in pushing through a host of labor and economic reforms demanded by lenders as a condition for bailout funds.

Underscoring lenders’ fears that Greece cannot come to grips with the reforms it has promised, dissenting lawmakers overnight defeated a clause to deregulate working hours for pharmacies in a liberalization package passed by parliament.

The measures had been demanded by the “troika” lenders, whose inspectors were in the Greek capital as parliament voted down the clause and came close to scrapping other provisions of the law.

Greek authorities on Wednesday morning dispersed a protest by a few hundred Communists who had gathered outside a hotel where EU and IMF officials were staying. The demonstrators had shouted slogans and held up banners reading “Out with the troika.”

“This was a symbolic action to show our opposition to the troika’s presence in Greece and to the government’s proposals … that mutilate workers’ rights,” said Communist KKE party lawmaker Nikos Karathanassopoulos.

European partners like paymaster Germany have already warned that Greece must follow through on its reform pledges or put its second bailout at risk. They have demanded that all political party leaders must commit in writing to back reforms.

© Thomson Reuters 2012

Tutor Demystifies Test-Taking for Students

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1327730426 32 Tutor Demystifies Test Taking for Students Vigee Droesch has used her own unique teaching formula to help students improve their standardized test scores. Photo credit: Jim Gerweck

DARIEN, Conn. – Vigee Droesch has a deep education – fine arts, journalism, even some MBA work – and that eclectic background has enabled her to teach in a way that might not be “by the book” but has proven to be extremely effective.

“I have ‘cooked up’ a recipe for my personal teaching philosophy,” she said. “Learning, besides advancing knowledge, should be fun. I love to see the delight on my students’ faces when the light bulb goes on, or they have made that metaphorical leap.”

Droesch has been switching on mental light bulbs in many venues. She co-taught the AIM (Achievement, Interest, Motivation) program at Middlesex Middle School in Darien, which increased classroom success, grade promotion and the ability to function in a mainstream high school setting for failing and emotionally disturbed students.

For the past six years, she has been at Darien Sylvan Learning Center, working as an in-house specialist in college and prep school applications and essay writing, and providing guided test prep for the alphabet soup of standardized tests, including ACT, SAT, PSAT, ISEE, SSAT and HSPT.

“When I work with students, I try to ‘de-mystify’ the tests for them, since they are already usually whipped up into a frenzy about their performance,” she said. “We go through sample tests, one question at a time, so I can teach them strategies about how to attack every type of question. It’s a slow and thorough process, and it requires a strong work ethic on their part.

“Part of being successful on standardized tests is being familiar with the format and style,” Droesch continued. “Of course, along the way I drill them on vocabulary, vocabulary, vocabulary, so by the time they have finished our course they get the extra added bonus of gaining a handsome vocabulary.”

Droesch has many success stories through this method, including most recently a senior at a local high school who doubled his ACT scores, enabling him to get into his first choice college.

“Children really are thirsty for knowledge,” Droesch said. “My students and I are on a mission together to help them be successful through knowledge and work ethic. I consider my students and I to be partners in the learning process – it’s a symbiotic relationship.”

Criminal trials

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print2 Criminal trials friend Criminal trials PUBLIC HEALTH Criminal trials T.K. RAJALAKSHMI Questionable drug trials on mentally challenged persons by doctors in Indore emphasise the need for strict enforcement of medical ethics.

T. VIJAYA KUMAR Criminal trials SOME WOMEN BELONGING to Piduguralla of Guntur district in Andhra Pradesh, who underwent clinical trials by a pharmaceutical company in Hyderabad, at the Government General Hospital in Guntur. A June 2011 picture.

IN what appears to be a page out of Robin Cook’s medical thriller, government and private doctors in Indore, Madhya Pradesh, reportedly carried out clinical trials of various medicines on some 233 patients who had gone to them seeking psychiatric treatment. As in Cook’s famous book Coma, in which a medical student uncovers the unethical practices in a hospital and is targeted, a resident doctor with a prominent government hospital in Indore attempted to expose the unethical trials and was removed from service. The trials, using humans as guinea pigs to test medicines produced by pharmaceutical companies, were conducted between January 2008 and October 2010 without following proper guidelines.

Following a huge public and media uproar over the trials and the related deaths, 12 doctors, including six involved in the trials on mentally ill patients, were fined just Rs.5,000 each for not informing the parent hospital about the conduct of the trials and for ignoring protocols. The doctors had apparently obtained the approval from independent ethics committees attached to private hospitals. Five doctors were hauled up by the Economic Offences Wing (EOW) of the State government in 2011. But no action was taken against them. On January 1, the State government imposed a small fine on the 12 doctors. Responding to media reports on the trials conducted on mentally ill patients, the National Human Rights Commission (NHRC), which addresses matters concerning morality relating to clinical trials, issued a notice to the State government on December 23, 2011, and demanded a report within four weeks.

The matter pertaining to the drug trials on mental patients in contravention of Schedule Y of the Drugs and Cosmetics Act, which has explicit guidelines for clinical trials involving the mentally ill, and the Indian Council of Medical Research’s (ICMR) Ethical Guidelines for Biomedical Research on Human Participants, was raised by Anand Rai, a former resident doctor of MGM Memorial Medical College in January 2011. Anand Rai wrote to the NHRC, which in turn referred his complaint to the State Human Rights Commission. Even after several months, no action was taken. The media then began to report the issue, following which the NHRC took suo motu cognisance of the trials.

No one took notice of his complaint, Anand Rai told Frontline. Things were moving but not fast enough.

In the third week of November 2011, the Union Ministry of Health and Family Welfare proposed amendments to the Drugs and Cosmetics Rules, 1945, relating to regulations in clinical trials. The amendments, it said, had been approved by the Drug Technical Advisory Board, a statutory committee under the Drugs and Cosmetics Act, 1940. The notification dated November 18, 2011, pertaining to the draft rules called the Drugs and Cosmetics (3rd Amendment) Rules, 2011, seeks to strengthen the regulations in favour of trial subjects but has many loopholes. Moreover, it was not given adequate publicity to elicit responses.

Public health experts noticed only recently the notification, posted on the website of the Central Drugs Standard Control Organisation (CDSCO), seeking comments from the public within 45 days. “ Not everyone visits the website regularly. More time should be given for responses as the proposal is beset with problems,” said Anand Rai. The deadline of 45 days for sending responses has expired, but given the concerns raised, the government could consider extending the deadline in order to get more feedback on the rules.

The draft rules claim to have incorporated effective provisions to provide financial compensation to trial subjects in case of trial-related injury or death; enhance the responsibilities of the ethics committees, the sponsor and the investigator to ensure financial compensation and medical care to trial subjects who suffer injury or death; and amend the format for obtaining consent to include details such as address and occupation, and annual income of the subject so as to have information of the socio-economic status of the trial subjects.

Public health groups such as the Low Cost Standard Therapeutics (LOCOST) and Sama have criticised the proposed amendments. They have requested more time from the government so that all concerned groups can articulate their views. Under the proposal, the ethics committees have been given the responsibility of deciding the clinical trial relatedness of an injury as well as the quantum of compensation. Sama representative N.B. Sarojini and LOCOST spokesperson S. Srinivasan argued that it was not correct to hand over both issues to the ethics committees. At present there are no clear guidelines about the constitution of the ethics committees and their monitoring. Members of the ethics committees were found to be biased as they themselves conducted the trials. The so-called independent ethics committees looked into issues of protocol instead of assessing them objectively, they said. They were not part of any hospital but were often owned and operated by powerful private commercial interests, the critics pointed out.

A.M. FARUQUI Criminal trials A DEMONSTRATION IN February 2011 in front of the Bhopal Memorial Hospital & Research Centre against unethical drug trials on victims of the 1984 gas leak.

They said a very large number of trials took place in private clinics. The ethics committees did not have the expertise required to determine the quantum of compensation based on the extent of injury, the age of the sufferer, and liabilities in case of death and, overall, had very little training in issues of ethics. Conflict of interest issues as well as institutional biases were matters that were yet to be resolved, they said. The committees had a complete say over compensation issues, including a review of disputes relating to compensation. “The decision of the ethics committee after the review shall be final,” the draft rules state.

Registration of clinical trials was voluntary before November 17, 2008. But the ICMR made it mandatory to register such trials with full disclosure of trial data with its Clinical Trials Registry from June 15, 2009.

In response to a question in the Rajya Sabha in March 2011 relating to the total number of clinical trials and deaths caused by such trials between 2007 and 2011, the Health Ministry gave the following information: 1,622 clinical trials were conducted between July 2007 and February 2011, and there were 288 deaths in 2008, 637 in 2009, and 597 up to August 2010. They were definitely not insignificant numbers.

The matter of trials being conducted clandestinely was raised in the State Assembly more than once where an independent legislator claimed that 1,883 persons, including children and mentally challenged persons, were subjected to drug trials between 2006 and 2010. No action was taken against any doctor during all those years. No names came out. The matter came up in Parliament. On December 20, 2011, replying to a question in the Rajya Sabha on the regulation of clinical trials, the Minister of Health and Family Welfare spoke of six cases of violation of the Drugs and Cosmetics Rules in the context of clinical trials and the action taken during the last three years.

The Minister said that following news reports about drug trials in the MGM Memorial Medical College and Maharaja Yashwantrao Hospital involving the drug Tadalafil for pulmonary arterial hypertension, the CDSCO and the State Drugs Controlling Authority conducted investigations and found that two doctors had used the drug without permission from the Drugs Controller General of India (DCGI). The Minister informed the House that the study with the drug had been initiated on September 18, 2005, when the drug had not been approved for the said indication in the country. It was approved for another indication, male erectile dysfunction, on June 10, 2003. On November 2, 2011, the Ministry directed the two doctors to stop the clinical trial of Tadalafil in pulmonary arterial hypertension and restrained them from conducting any clinical trial for a period of six months.

That was all the punishment handed out. Barring the occasional warning or temporary suspension of permission to conduct trials, the Ministry did not cite a single instance where strict action had been taken against the doctors in the last three years. Consider this. Last year, a Hyderabad-based research firm was reported to have conducted clinical trials of an anti-cancer drug at a multi-speciality hospital on poor people without their informed consent. It transpired that it had conducted bio-equivalence study on an already approved anti-cancer drug and there were certain irregularities with respect to the process of informed consent, review and the decision-making process of the ethics committee.

The firm was punished by withdrawing the permission granted for equivalence on June 22, 2011. But when it submitted “corrective” actions for the subject recruitment process and other procedures, it was granted a no-objection certificate to conduct the bio-equivalence study, subject to the fulfilment of certain conditions such as informed consent process, including documentation of the process through audio-video means, and conditions about the functioning of the ethics committees and the investigators. It was business as usual again.

The Indore and Hyderabad episodes are not isolated ones. Issues of informed consent involving the poor and vulnerable sections of society have always posed a problem. The compensation paid by pharmaceutical majors in case of death during trials is paltry compared with the profits they make. It was not very long ago that post-licensure clinical trials on tribal girls in Khammam in Andhra Pradesh and Vadodara in Gujarat to test the efficacy of the human papillomavirus (HPV) vaccine came under severe criticism over consent-related issues. The ICMR and the two State governments were the collaborating partners in the trial. Following reports of the death of seven girls, the ICMR suspended the trials on April 7, 2010. An inquiry committee found certain discrepancies in the conduct of the trial.

In response to a Right to Information application on November 27, 2010, seeking information about drug trials conducted by the Chacha Nehru Children’s Hospital and Research Centre, Indore, over the last six years, doctors used the smokescreen of confidentiality between the sponsor and the principal investigator in order to evade an answer to the queries raised. A doctor in the medicine department of the MGM Memorial Medical College and Maharaja Yashwantrao Hospital, in response to an RTI application filed by Anand Rai, wrote that clinical trial agreements could not be publicised as that would affect scientific and business interests. He argued that the sponsoring pharmaceutical companies and the clinical research organisations (an individual or an organisation to which the sponsor may transfer or delegate some or all of the tasks and duties in a clinical trial provided such obligations are defined in writing) would be reluctant to undertake new research in the State and in the government hospitals if such information was made public.

Compared with other States, he wrote, Madhya Pradesh lagged behind in medical research. Particularly, government hospitals were far behind private clinics in this area. Delineating the benefits of medical research through drug trials, he said it encouraged foreign investment, improved scientific skill, generated employment and brought international contacts for the medical community. He stated that information could be given under limited conditions to the investigating authorities such as the EOW.

The State EOW launched an investigation only as the matter refused to die down. It found that 73 trials were carried out at the Maharaja Yashwantrao Hospital on nearly 3,300 patients, of whom 1,800-odd were children. The trials were carried out by six doctors who received pecuniary benefits from drug companies. Eighty-one trial subjects, including 18 children, suffered from serious side effects. Sixty trials were carried out in the private sector by some 40 doctors; the details of the patients were unknown. Eight Indian companies and 22 multinationals had sponsored the trials.

Anand Rai brought out some more interesting details. He said that the MGM Memorial Medical College had 27 members on its ethics committee, of whom 22 were professors in the college. The chairpersons of the committees of at least two government hospitals were veterinary doctors. The members of the ethics committee of the MGM Memorial Medical College were the principal investigators in many cases, he said. The secretary of the committee himself failed to follow the Good Clinical Practice (GCP) and ICMR guidelines, he said.

“At the moment, we are discussing drug trials sponsored by large pharmaceutical companies and conducted on vulnerable sections of the population. The research subject is typically less powerful than the sponsors and investigators conducting the research. Hence, any compensation should address this imbalance and not be directed to short-term harm or injury,” he said. All trial subjects should be given cashless health insurance for the rest of their lives, Anand Rai suggested. (He is now serving as a medical officer with the Health Department.)

On January 5, Brinda Karat, Communist Part of India (Marxist) leader and a former Rajya Sabha member, submitted a memorandum to V.G. Somani, the DGCI, requesting action against the clinical trials in Indore. She reminded him that it was more than a year since the trials and the violations had been exposed but the DCGI had failed to act against those involved. She said that an inquiry conducted by the EOW had found clear violations for which the licences of the doctors should have been cancelled. The State government’s inquiry report had specifically recommended that the DGCI and the ICMR conduct investigations into the violations of the Drugs and Cosmetics Act and the ICMR and Medical Council of India guidelines.

Barring certain weak and cosmetic changes to the Drugs and Cosmetics Rules, relating to compensation in case of injuries to and death of trial subjects, no measures have been taken to strengthen the system in favour of those undergoing trials. Notwithstanding the Ethical Guidelines for Biomedical Research on Human Participants framed by the ICMR in 2006, norms continue to be flouted by both the public and private sectors in health care. The framework to deal with issues of compensation, consent and transparency is considered very weak, leading to several allegations, many of which seem to be well-founded, of exploitation of the poorer sections. After all, it is not the well-to-do on whom the trials are conducted. And often on the grounds of confidentiality (clinical trial agreements), agreements between the pharmaceutical company, the principal investigator and the organisation, information regarding drug trials is not given out freely. It requires dogged efforts by people like Anand Rai to bring these aspects into the public domain.

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Work experience fee 'unfair' says Bristol students' leader

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1327729157 37 Work experience fee 'unfair' says Bristol students' leader20 January 2012 Last updated at 01:06 ET Share this page

A Somerset company which helps organise work experience has been criticised because applicants have to pay.

Web-based agency Etsio puts people who want experience or training in touch with small businesses, who usually charge a daily fee.

Gus Baker, president of the University of Bristol Students' Union, said it was "unfair" to poorer graduates.

Etsio director Kit Sadgrove said he provided opportunities with businesses that typically do not provide training.

‘Administration fee’

Mr Baker added: "It locks out huge swathes of the country who can't afford to work for free and certainly can't afford to pay for the opportunity to do so.

"The companies asking interns to work for free are cruelly exploiting young unemployed people's demand for work experience."

But Mr Sadgrove said he provided an opportunity for people who needed experience on their CVs from companies who would not normally be able to offer it.

Mr Sadgrove's company takes a small administration fee from the applicant, who can only undertake a placement for a maximum of 20 days.

He is involved in several companies and is offering a paid internship at one of them. Experience at his copywriting business costs £130 a day.

"We are cutting edge for copywriting and internet marketing which you can't really get anywhere else," he said.

"And I don't really think £130 is really frankly enough for someone to get the kind of experience they can get here to be honest."