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Note: Respond To All Questions Below rite 200 words for this questions): one of

ID: 192717 • Letter: N

Question

Note: Respond To All Questions Below

rite 200 words for this questions): one of the big issues with biomedical research that involves human objects or tissues taken from human objects is the principle of informed consent wherebythe subject involved must be informed of the research, includingthe risks and potential benefits to medical understanding(including potential profits). What are some of the issues or complications associated with 'informed'consent that can make difficult? Fully describe and explain at least one complication or issue he etical quandanies rased by these HIV vaccine efficay trials w'll be at least as complex as, an roebly re difficut thr ay that have been faced by raccine rsearches inthe past. The Nazi cors did n erous acc ne t als n Bu em a an Nar e r concen a on camps 1 ea r 1940, an the es of ese es e ment as con tu r sm le an tra mor mect 100 s ects wr an e metal n us vacate e for some weeks or mue sesponse to deel After te weeks hare passed, assemble all 100 expenimental subjects,as well asnaitional 100cntrol sahjects, and then dinectly challenge(e, iniect) all 200 of them with rirulesct typkas.Li the expeimental taccine works, then most of those mbo secerred i wl be pootected adwtot cact pus, u the concols wall IE the expeimental vaccin does tot work, tnall 200 subjects ger ryps, and most of tem die This method of testing by daect chailenge, te mehod ot testing also used by Edard Jener in hs first accination expeninents, was clearly taetrocal o an least twasuiethazidt The Nuremberg Code, ooe of the earlest statesens of the etcs of medical research vlin ha su e s, was dere o ed as result ofthe c ors als a Nuremberg.d has ser ed as a basis r medica e cal decisg-m ng e er su e T e ecent T O MS Int ma onal E cal Guidelines r Biomedical Researca mol n man su ects, published by the World Heath Oenization in Norembeof19, as traces its history back to The Nuremberg Code. A brief smpling of someof the dafticlt questhions entailed in the lanting and design of these HIV accine trials would icluthollwing o wa researc ers ea etoesecutee aca are m rme corse proce ize en en unt om o maton necess or su ectstou em sso e can the a reo n so com bate o wilresearc ersbeabe o ov en ma ona o z ena re o esan maresponses toerosin deloçingnatios)ho ny bold concepticns of disease and disease-causality that requite dferent fromn the coaceptions o disease beld by the researchersHow can reseach sponsos properly assess whetes prospective subjects have udestod enougt nfcematica so tathey a able tome asequrely inomed coasear How canesearch counselors efecoively counsel subjects to notenzage nisk behaiors when they themseres, at soe level,realize thtthe research peotocolereuies hat sutjects do engage intose risk behamos? h are some cf the potentl hams tht might reasorably be expected to accrue to subjects who participate in these trials, andha are some benefitsthey mighr theoreicaly ewich coold cunterbalance the risks thery could be takngWh is so be done about protecting olnteers oery, ad how can dhese Tolacteers be protected against unfair Eiscnimication based on their nem sesostatus ntch l (offen) sesuit from thei garscipation in die studies? Ani ehinz althese specific questions is the deeper met2-qpestio:Shouls the main cperative ehical prnciples in tis intematiocal vaccine cesearch be Berent in diferet cosries, ing accocdung to the diferet oes rd diferest cunwal standars ineach country, or should there be a sete common, a ee-u on ernationa e cal standends o e protection o research si ects,cable to a researtsponsorsre a esso the coat mw ch the esearch s conducted? hesequestices, andes orhers relaredo tlbeeasy o dealwithor mill the ansersotem be simple subjects This earliest This book does not dal dectly with these questioas about AIDS vaccine(o thsee yrecebook, Ethicall IssesnHIVVaccie Trals) b will be quite instructite to look instead asom of the finst (scientifically designed) medicalresearchee don nh research too ras built on the onceqt of testing tre etficacy of a prevetive vaccine, aneerimental inoculation thart would, Edmard Jener hoged, peotect peopie against teost deraed pague of the age smallpox Inma res ects edisease o sma ormilt motto e t u alog nestanan tors ADS a HIN disease, or a least run sta ng so ease soforbattle agunthem ma isa most ce ar rabe rno e orun erst n ngADS an 5the some mes suggested) Black Des,whichwas selion endenic, ut in great blows, struck dawn upon a peogle by to-cne knewagncy (the word parue being fiors the Greek plege, mearngke, or bio)AIDS, ty cast, looks a it will be mce endenix, and probably for scme years peobably even some generations) to cone.If Professor Alan Brandt sboweds that the1th century epidemcs of tGretPoxphiliab ntuing and frutful as an analog for understanding our ato coatrol the spread of AIDS, itis study we will cascor tha heSmall Pox, as ananalog, wll alsobe able to groide us with inigsito tos sesearchonpevetica technlogies for AlDS.

Explanation / Answer

It is quite obvious that for biomedical research we need to take samples from the patients. It is very essential that the patient must agree for the giving the sample and permission for doing research on his/her sample. This falls under the category of human ethics and is legal requirement for performing research on humans. However there are many challenges or obstacles which a biomedical researcher faces while taking such consent from the subjects. These include language barriers, religious perspectives, false expectations and patient perceptions.

Language Barriers

Patients usually fill in the consent form and sign on their own will, however many of the times they are enable to understand what they have agreed in the consent form and later remove the such filled forms. Sometimes they don’t know what type of research is going to be done afterwards because they are unaware of the field and later make hue and cry. Instead of giving the motivation and making them understand they feel somehow insecure.

Religious Influence

To sign and agree the terms and conditions of the consent form is a free willingness of the patient. However, at some point some communities feel it religiously uncomfortable to allow for the same.

False Expectations

If the above two are corrected there are still some misunderstandings like patients fear they are taken mere as model animals and don’t have any benefit for doing the same research on his samples. They also fear that the results may be published which will create havoc for him

Patient Perceptions

Some patients think that the new research and therapies done thereafter may be not safe for him and believe that conventional treatment may be more benefial for them.

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