Hindi English Translation || Editorial || Welcome development: On the ICMR and Controlled Human Infection Studies

Welcome development: On the ICMR and Controlled Human Infection Studies

Robust (मजबूत, शक्तिशाली) institutional (संस्थागत, संगठित) mechanisms (तंत्र) must be in place for human challenge studies

With the Bioethics (जैवनीति) Unit of the Indian Council of Medical Research (ICMR) (भारतीय चिकित्सा अनुसंधान परिषद) placing a consensus (सर्वसम्मति) policy statement on Controlled Human Infection Studies (CHIS) (CHIS, also called human challenge studies, where healthy volunteers are intentionally exposed to a disease-causing microbe in a highly controlled and monitored environment. it is used in many countries for vaccine and treatment development. Outside of India, this relatively new research model which involves intentionally exposing healthy volunteers to pathogens in a controlled environment, has been used to study malaria, typhoid, dengue, etc. (pathogen is a bacteria/virus that causes disease)) for comments (टिप्पणी, अवलोकन), India has taken the first step in clearing the deck for such studies to be undertaken (start, begin, initiate, commence, attempt, engage in, embark on) here. CHIS, also called human challenge studies, where healthy volunteers (स्वयंसेवक) are intentionally (जानबूझकर) exposed (come into contact with (the disease causing virus); bring into contact with, subject, lay open, put at risk of) to a disease-causing microbe (जीवाणु, सूक्ष्म जीव) in a highly controlled and monitored environment (पर्यावरण, वातावरण), has been carried out for hundreds of years, an example being the yellow fever (an acute viral haemorrhagic disease transmitted by infected mosquitoes. The “yellow” in the name refers to the jaundice that affects some patients) study in the early 1900s to establish (स्थापित करना) that mosquitoes transmit the virus. Typically, a less virulent (deadly, fatal, lethal, life-threatening, dangerous) strain (different variant or form or version or mutant of something (virus); variety, kind, type) of the microbe is used to study less deadly diseases that have proven drugs for treatment. They are more often undertaken on a small number of volunteers to understand the various facets (पहलू, विशेषता) of infection and disease, and, occasionally (कभी-कभी), to accelerate (increase, rise, expedite, step up, speed up) the development (विकास, प्रगति) process of a medical intervention ((In medicine) it is a treatment, procedure, or other action taken to prevent or treat disease, or improve health in other ways). When used as part of vaccine development, these studies are initiated only when safety and immune (resistant to, protected from, unaffected by (an infectious disease)) responses of the candidate vaccines (a biological preparation that improves immunity to a particular disease) are known through early phases of clinical testing. Importantly, human challenge studies are not done as an alternative to phase-3 efficacy trials (test, pilot study, experiment (phase 1, 2,3, and or human/clinical trial)), but to help select the best candidate for testing in a conventional (normal, regular, typical, traditional/standard) phase-3 clinical trial. Phase-3 clinical trials that follow human challenge studies often require fewer volunteers, speeding up the development process. In the last 50 years, CHIS studies have been carried out with thousands to accelerate vaccine development against typhoid and cholera. During the COVID-19 pandemic (the worldwide spread of a new disease; The illness spreads around the world and typically affects a large number of people across a wide area), the Imperial College London used 36 volunteers to study facets of the SARS-CoV-2 infection. In 2020, the World Health Organization (Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable - so everyone, everywhere can attain the highest level of health) approved using CHIS for accelerating COVID-19 vaccine development.

There are several ethical (moral) challenges with human challenge studies, which require well-trained and robust systems in place. While collaborations (agreement, alliance, partnership, participation, association) with institutions and scientists well versed in conducting such studies are a must, navigating (guide, direct, handle; negotiate) the ethical minefield (a situation with unknown dangers) is a challenge. Several clinical trials, including those by or involving the ICMR, have been mired (involve in a tough situation; entangle, enmesh, mix up, embroil, catch up, bog down) in ethical violations (breach, infringement, breaking, non-observance, dereliction), such as the Human papillomavirus (HPV) (the most common viral infection of the reproductive tract. Human papillomavirus (HPV) is the most common sexually transmitted infection (STI)) vaccine trial in Andhra Pradesh, in 2010. The ethical challenges while conducting CHIS are of a higher magnitude (size/value, extent, degree, measure, proportion), the scope (chance, possibility) for misuse (wrong use, abuse, exploitation, misemployment, misapplication) vast (huge, extremely big), and the repercussions (consequences, effect, aftermath, after-effects, reverberation; result, outcome) severe. There is potential (possibility) for exploitation (misuse, manipulation, taking advantage, unfair treatment, cheating), given (considering, taking into account, bearing in mind) the monetary (relating to money; financial) dimension (aspect, feature, side, element, facet) involving volunteers. If it becomes a reality, India should use CHIS only to study diseases with safe and effective treatment. Using CHIS to study novel microbes/disease with limited medical intervention should wait till Indian scientists gain expertise (skill, knowledge, competence, proficiency, mastery), and robust institutional structures and mechanisms are in place.

Courtesy: The Hindu

Important Word List With Meaning

1.development (noun)

Hindi Meaning - विकास, प्रगति
English Meaning - progress, progression, advancement, improvement, growth.

2.Indian Council of Medical Research (ICMR) (noun)

Hindi Meaning - भारतीय चिकित्सा अनुसंधान परिषद
English Meaning - the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. As early as in 1911, the Government of India set up the Indian Research Fund Association (IRFA) with the specific objective of sponsoring and coordinating medical research in the country. It was redesignated in 1949 as the Indian Council of Medical Research (ICMR). The ICMR is funded by the Government of India through the Ministry of Health & Family Welfare.

3.robust (adjective)

Hindi Meaning - मजबूत, शक्तिशाली
English Meaning - strong, powerful.

4.institutional (adjective)

Hindi Meaning - संस्थागत, संगठित
English Meaning - organised, established, systematic, regulated, methodical, structured.

5.mechanism (noun)

Hindi Meaning - तंत्र
English Meaning - system, arrangement, scheme, policy, regime; apparatus, medium, agency, instrument, channel.

6.bioethics (noun)

Hindi Meaning - जैवनीति
English Meaning - the branch of ethics that studies moral values in medical and biological research.

7.consensus (noun)

Hindi Meaning - सर्वसम्मति
English Meaning - an idea or opinion that is shared by all the people in a group; general agreement.

8.comment (noun)

Hindi Meaning - टिप्पणी, अवलोकन
English Meaning - remark, observation, opinion, view.

9.volunteer (noun)

Hindi Meaning - स्वयंसेवक
English Meaning - participant (who is interested in a clinical trial study to aid in the advancement of drug development).

10.intentionally (noun)

Hindi Meaning - जानबूझकर
English Meaning - deliberately, purposely, purposefully, knowingly.

11.microbe (noun)

Hindi Meaning - जीवाणु, सूक्ष्म जीव
English Meaning - microorganism/microbe is an organism that is so small & microscopic (invisible to the naked eye). (bacteria, fungi, viruses & etc).

12.environment (noun)

Hindi Meaning - पर्यावरण, वातावरण
English Meaning - situation, setting, medium, scenario, atmosphere.

13.establish (verb)

Hindi Meaning - स्थापित करना
English Meaning - prove, demonstrate, show, indicate, validate, verify, determine.

14.facet (noun)

Hindi Meaning - पहलू, विशेषता
English Meaning - aspect, feature, characteristic, nuance.

15.occasionally (adverb)

Hindi Meaning - कभी-कभी
English Meaning - sometimes, at times, now and then.

16.carry out (phrasal verb)

English Meaning - conduct, perform, implement, execute, bring about.

17.in place (phrase)

English Meaning - ready, set up, established, arranged.

18.welcome (adjective)

English Meaning - pleasing, agreeable, favourable, promising, much needed.

19.controlled human infection studies (CHIS) (noun)

English Meaning - CHIS, also called human challenge studies, where healthy volunteers are intentionally exposed to a disease-causing microbe in a highly controlled and monitored environment. it is used in many countries for vaccine and treatment development. Outside of India, this relatively new research model which involves intentionally exposing healthy volunteers to pathogens in a controlled environment, has been used to study malaria, typhoid, dengue, etc. (pathogen is a bacteria/virus that causes disease).

20.clear the decks (phrase)

English Meaning - get ready for a specific action/event (by getting rid of all other hindrances that may hamper the event/action).

21.undertake (verb)

English Meaning - start, begin, initiate, commence, attempt, engage in, embark on.

22.expose (verb)

English Meaning - come into contact with (the disease causing virus); bring into contact with, subject, lay open, put at risk of.

23.yellow fever (noun)

English Meaning - an acute viral haemorrhagic disease transmitted by infected mosquitoes. The “yellow” in the name refers to the jaundice that affects some patients.

24.virulent (adjective)

English Meaning - deadly, fatal, lethal, life-threatening, dangerous.

25.strain (noun)

English Meaning - different variant or form or version or mutant of something (virus); variety, kind, type.

26.drug (noun)

English Meaning - medicine, medication, medical drug.

27.accelerate (verb)

English Meaning - increase, rise, expedite, step up, speed up.

28.intervention (noun)

English Meaning - (In medicine) it is a treatment, procedure, or other action taken to prevent or treat disease, or improve health in other ways.

29.vaccine (noun)

English Meaning - a biological preparation that improves immunity to a particular disease.

30.immune (adjective)

English Meaning - resistant to, protected from, unaffected by (an infectious disease).

31.candidate vaccine or vaccine candidate (noun)

English Meaning - a “potential” vaccine prepared in the research and development (R&D) centres and it can be used in human clinical trials.

32.human trial/clinical trial (noun)

English Meaning - a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.

33.trial (noun)

English Meaning - test, pilot study, experiment (phase 1, 2,3, and or human/clinical trial).

34.phase 1 trial (noun)

English Meaning - In phase 1 trial of clinical testing, the vaccine is given to a small group of people to determine whether it is safe and to learn more about the immune response it provokes.

35.phase 2 trial (noun)

English Meaning - In phase 2 trial, the vaccine is given to hundreds of people so scientists can learn more about its safety and correct dosage.

36.phase-3 trial (noun)

English Meaning - In phase 3 trial, the vaccine is given to thousands of people to confirm its safety - including rare side effects - and effectiveness. These trials involve a control group which is given a placebo.

37.efficacy (noun)

English Meaning - In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect; effectiveness, efficiency, power.

38.conventional (adjective)

English Meaning - normal, regular, typical, traditional/standard.

39.pandemic (noun)

English Meaning - the worldwide spread of a new disease; The illness spreads around the world and typically affects a large number of people across a wide area.

40.novel coronavirus (nCoV) (SARS-CoV-2) (noun)

English Meaning - a new strain (type/variety) coronavirus that has not been previously identified in humans.

41.World Health Organization (WHO) (noun)

English Meaning - Founded in 1948, WHO is the United Nations agency that connects nations, partners and people to promote health, keep the world safe and serve the vulnerable - so everyone, everywhere can attain the highest level of health.

42.ethical (adjective)

English Meaning - moral.

43.collaboration (noun)

English Meaning - agreement, alliance, partnership, participation, association.

44.well-versed (adjective)

English Meaning - knowledgeable, experienced, competent, specialist, up-to-date, sophisticated, well informed, intelligent.

45.navigate (verb)

English Meaning - guide, direct, handle; negotiate.

46.minefield (noun)

English Meaning - a situation with unknown dangers.

47.mire (verb)

English Meaning - involve in a tough situation; entangle, enmesh, mix up, embroil, catch up, bog down.

48.violation (noun)

English Meaning - breach, infringement, breaking, non-observance, dereliction.

49.Human papillomavirus (HPV) (noun)

English Meaning - the most common viral infection of the reproductive tract. Human papillomavirus (HPV) is the most common sexually transmitted infection (STI).

50.magnitude (noun)

English Meaning - size/value, extent, degree, measure, proportion.

51.scope (noun)

English Meaning - chance, possibility.

52.misuse (noun)

English Meaning - wrong use, abuse, exploitation, misemployment, misapplication.

53.vast (adjective)

English Meaning - huge, extremely big.

54.repercussions (noun)

English Meaning - consequences, effect, aftermath, after-effects, reverberation; result, outcome.

55.potential (noun)

English Meaning - possibility.