Re: Ancillary care in Clinical Trials

[Guest guest]

Dear Dr Kiran,

Although I am not a clinician but during devising of informed consent form I came across Declaration of Helsinki which clearly states " Health of my

patient will be my first consideration" but surely this concept can be difficult to extrapolate if the participants are from underprivileged area and the

researcher being with limited funding resources. Point of care testing or appropriate treatment in these predicaments is a tricky decision to make and

especially in developing countries where I suppose there are no clear cut guidelines for this.

Shazia Jamshed

Ancillary care in Clinical Trials

Dear all, I first came across to the concept of ancillary care during ICMR/NIH funded training programme in “Bioethics” at NARI Pune. Dr HS Rchardson from NIH introduced us about this concept. Let me ask you the same question that was asked to us, A participant in a trial on “AIDS Vaccine”, who was free from HIV infection previously, develops HIV infection during the course of Trial. HIV infection was not due to the vaccine but by other reasons. What next? You will keep him/her in study? Exclude from trial? What care will be given for HIV infection? (Say for trial period OR full life span with HIV infection).

What is to be done ideally? AND What is done routinely?

Regards, Dr Kiran Chaudhari (MD) Lecturer, Dept of Pharmacology, Govt. Medical College , Nagpur-44003

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[Guest guest]

Dear Dr Shazia,

Yes, it’s true for the developing and underdeveloped countries. But developing countries are HUBs for Clinical Trials. As far as we consider the Funding constraint in this set up, it’s not the sole responsibility of the Researcher and he is not accountable to the participant care alone. But the major players like institute where the research is going on, the local and central governmental bodies catering health care needs must play a major role.

Whenever we get approval from EC for any particular trial, the obligation on the part of institute for providing its facilities for participant care can not be ignored.

The most important concept behind Ancillary care is that “The participant’s permission for letting the researcher to use his body parts (samples, or as a whole) can never be fully compensated by any means.â€

Here comes ethics. What I personally feel about Ehtics is, “Putting ourselves in the shoe of the participant†at any stage during the trial will help us make a conscious decision and direct our efforts for betterment of participants as well as our trial.

Regards,

Dr Kiran Chaudhari (MD) Lecturer, Dept of Pharmacology, Govt. Medical College , Nagpur-44003

From: shazia jamshed <shazia_12@...>Subject: Re: Ancillary care in Clinical Trialsnetrum Date: Monday, 13 October, 2008, 7:41 AM

Dear Dr Kiran,

Although I am not a clinician but during devising of informed consent form I came across Declaration of Helsinki which clearly states " Health of my

patient will be my first consideration" but surely this concept can be difficult to extrapolate if the participants are from underprivileged area and the

researcher being with limited funding resources. Point of care testing or appropriate treatment in these predicaments is a tricky decision to make and

especially in developing countries where I suppose there are no clear cut guidelines for this.

Shazia Jamshed

Ancillary care in Clinical Trials

Dear all, I first came across to the concept of ancillary care during ICMR/NIH funded training programme in “Bioethics†at NARI Pune. Dr HS Rchardson from NIH introduced us about this concept. Let me ask you the same question that was asked to us, A participant in a trial on “AIDS Vaccineâ€, who was free from HIV infection previously, develops HIV infection during the course of Trial. HIV infection was not due to the vaccine but by other reasons. What next? You will keep him/her in study? Exclude from trial? What care will be given for HIV infection? (Say for trial period OR full life span with HIV infection).

What is to be done ideally? AND What is done routinely?

Regards, Dr Kiran Chaudhari (MD) Lecturer, Dept of Pharmacology, Govt. Medical College , Nagpur-44003

Add more friends to your messenger and enjoy! Invite them now.

From Chandigarh to Chennai - find friends all over India. Click here.

[Guest guest]

Dear All,

First of all i would like congratulate Dr.Kiran for

selecting such an apt topic for discussion.It is a main concern

faced in all sorts of research.

The question asked by Dr.Kiran

A participant in a trial on " AIDS Vaccine " , who was free from HIV

infection previously, develops HIV infection during the course of

Trial. HIV infection was not due to the vaccine but by other

reasons. What next? You will keep him/her in study? Exclude from

trial? What care will be given for HIV infection? (Say for trial

period OR full life span with HIV infection).

Ideally the that partcular patient should be provided antiretroviral

treatment,but this may not be stipulated in the trails protocol.So

most often such cases are dropped from the study saying that they

doesnt meet the said criteria

I would like to add an article from BMJ that highlights Medical

researchers' ancillary clinical care responsibilities

Researchers testing a new treatment for tuberculosis in a developing

country discover some patients have HIV infection. Do they have a

responsibility to provide antiretroviral drugs? In general, when do

researchers have a responsibility to provide clinical care to

participants that is not stipulated in the trial's protocol? This

question arises regularly, especially in developing countries, yet

(with rare exceptions1) existing literature and guidelines on

research ethics do not consider ancillary clinical care. We propose

an ethical framework that will help delineate researchers'

responsibilities.

Ancillary care is that which is not required to make a study

scientifically valid, to ensure a trial's safety, or to redress

research injuries. Thus, stabilising patients to enrol them in a

research protocol, monitoring drug interactions, or treating adverse

reactions to experimental drugs are not ancillary care. By contrast,

following up on diagnoses found by protocol tests or treating

ailments that are unrelated to the study's aims would be ancillary

care.

When asked how much ancillary care they should provide to

participants, the first reaction of many clinical researchers,

especially those working in developing countries, is that they must

provide whatever ancillary care their participants need. From an

ethical perspective, this response makes sense. Research

participants in trials in the developing world are typically

desperately poor and ill, and everyone arguably has a duty to rescue

those in need, at least when they can do so at minimal cost to

themselves.2 3 Yet this response fails to acknowledge that the goal

of research is to generate knowledge not care for patients.4 5 When

researchers consider that offering ancillary care this broadly may

drain limited human and financial resources and confound study

results, they tend to retreat from this position.

Some researchers veer to the opposite extreme. " We may be doctors, "

they note, " but these are our research participants, not our

patients, so we owe them nothing beyond what is needed to complete

the study safely and successfully—that is, we owe them no ancillary

care. " But this extreme position is ethically questionable. Consider

the case of researchers studying a rare disease. It is ethically

unacceptable to say to a participant, " We are going to monitor the

toxicity and effectiveness of this experimental drug, and we will

make sure it does not kill you, but we are not going to provide any

palliative care for your condition. " Closely monitoring a

participant's disease without being willing to treat it in any way

amounts to treating him or her as a mere means to the end of

research.

Hypothetical case: trial of antimicrobials for sexually transmitted

diseases in a developing country

While performing clinical examinations on female patients to check

for sexually transmitted diseases or side effects of the

antimicrobial drug, researchers are likely to discover many women

with vaginal candidiasis.8 More than half are likely to be suffering

from the results of poor dental care and hygiene. What care should

be provided for these problems?

Vaginal candidiasis

This is clearly within the scope of entrustment because the

diagnosis results from examinations essential to the research. The

underlying duty of care also seems strong because untreated

candidiasis will greatly affect their wellbeing and treating it is

relatively cheap and easy

Decision: Researchers ought to treat vaginal candidiasis

Dental problems

These are not within the scope of entrustment. If we assume that the

poor dental hygiene is apparent on casual observation, its diagnosis

would not result from exercising the permission participants granted

on entering the study. The question of strength thus does not arise.

Decision: Dental care falls outside the scope of ancillary care

responsibilities

We propose a model of the researcher-participant relationship that

lies between these two views. It rests the special responsibilities

of researchers on the idea that the relationship involves a partial

and limited entrustment of participants' health to researchers.6

When participants join research trials, they implicitly or

explicitly give researchers permission to access confidential

medical information, to perform procedures and treatments, or to

take samples. With this permission, researchers have discretionary

power over how to respond to any collected medical information and

potential diagnostic insights. Because researchers' responses to

these needs will greatly affect participants' health and wellbeing,

participants are vulnerable to the researchers. Participants thus

tacitly entrust aspects of their health to researchers through the

permission they give when joining a study.

The participants' entrustment is limited and partial. The permission

entrusts only specific aspects of their health to researchers, not

their health in general. Furthermore, how far researchers must go in

caring for entrusted aspects of health will differ from case to

case. In order to identify the depth and breadth of researchers'

ancillary care responsibilities, we distinguish between the scope of

entrustment (what is entrusted) and the strength of the duty of

care.

In the partial entrustment model, the scope of entrustment depends

on the study. The research protocol, which specifies the

information, interventions, tests, and sample required, will

determine what permission needs to be obtained. A protocol that

collects only a single magnetic resonance image from each

participant yields a limited scope of entrustment, pertaining mainly

to the researchers' collection and use of the image. A study

involving an extended inpatient stay, by contrast, will yield a far

broader scope of entrustment.

Although the scope of this partial entrustment will vary, it is

possible to generalise. Since a participant typically gives

permission for a disease under study to be monitored, the scope of

entrustment typically includes caring, as needed, for that disease.

Since participants' permission is needed for doing tests or

collecting confidential medical information, the scope of

entrustment typically includes following up on any clinically

relevant information or diagnoses generated.

Researchers do not automatically have a responsibility to provide

complete care for all aspects of health that fall within the scope

of entrustment. Rather, the responsibility to provide ancillary care

depends on the strength of the underlying, relationship based duty

of care. This is influenced by at least four factors:

Participants' vulnerability

Participants' uncompensated risks or burdens

Depth (intensity and duration) of the researcher-participant

relationship7

Participants' dependence on the researchers. These four factors can

vary independently.

The vulnerability of participants is assessed by looking at how much

their wellbeing would be affected by researchers exercising their

discretion—this is the vulnerability resulting from the

participants' consent to participate. Participants' pre-existing

vulnerabilities, such as those caused by illness, oppression, or

poverty must also be taken into account. The researchers' debt of

gratitude to participants depends on whether participants have

accepted uncompensated risks and burdens or offered researchers a

hard to come by scientific opportunity. The depth of the

relationship between a researcher and participant will vary from

study to study because different protocols demand interactions of

varying intensity, duration, and longevity. Researchers have a

stronger moral responsibility to engage with the full range of

participants' needs when the relationship is deeper. Finally,

dependence matters because it may indicate that the research team is

in a unique position to help participants. Participants may become

dependent on researchers because they are impoverished, lack

insurance, or have an otherwise untreatable disease and join a trial

because it is their last hope. In each case, these strength factors

need to be judged against the competition for limited financial and

human resources and the danger of confounding study results. These

considerations generate a decision tree, which can be used to

determine when researchers have a responsibility to provide

ancillary care .

Researchers and ethics committees should attempt to anticipate the

ancillary care responsibilities that will arise in a given protocol.

Funding to cover researchers' ancillary care responsibilities must

be included in research budgets. Many major research sponsors have

been hesitant to fund medical care that is not necessary for the

scientific success of a trial. Our hope is that the partial

entrustment framework will encourage ethics committees, researchers,

and sponsors to regard fulfilling ancillary care responsibilities as

an essential part of ethical research.

Hypothetical case: HIV treatment in tuberculosis treatment trial

The trial calls for screening out patients who are HIV positive and

dropping participants who seroconvert during the trial. The local

standard of care for HIV and AIDS includes only palliative care. Do

the researchers have a responsibility to help provide antiretroviral

drugs to people they find to be HIV positive?

People screened out because they are HIV positive

Such people are within the scope of entrustment because the study

calls for checking HIV status; but the strength of the duty of care

is questionable. Although vulnerability and dependence are high

(since HIV infection is deadly and other sources of antiretroviral

drugs do not exist), engagement and gratitude are weak because these

are not yet research participants.

Decision: Researchers probably do not have a responsibility to

provide drugs

Participants dropped mid-trial because they seroconvert Treatment is

within the scope of entrustment because the study design calls for

monitoring HIV status, and the strength of the duty of care is high.

Vulnerability and dependence remain high and with enrolled

participants engagement and gratitude are greater.

Decision: Researchers probably have a responsibility to provide

antiretroviral drugs

Summary points

Researchers need ethical guidance regarding their responsibilities

for providing ancillary care to participants

An ethically acceptable approach would recognise a partial

entrustment of participants' health to researchers

The scope of this entrustment is determined by the permission

researchers need to do the study safely and validly

Whether ancillary care should be provided then depends on the

strength of the duty of care

The strength of the duty of care depends on participants'

vulnerability, dependence, and uncompensated risks or burdens and

the depth of the researcher-participant relationship

( copied form BMJ 19 JUNE 2004)

Dr.Santosh

>

> Dear all,

>  

> I first came across to the concept of ancillary care during

ICMR/NIH funded training programme in “Bioethics†at NARI Pune.

Dr HS Rchardson from NIH introduced us about this concept.

>  

> Let me ask you the same question that was asked to us,

>  

> A participant in a trial on “AIDS Vaccineâ€, who was free from

HIV infection previously, develops HIV infection during the course

of Trial. HIV infection was not due to the vaccine but by other

reasons. What next? You will keep him/her in study? Exclude from

trial? What care will be given for HIV infection? (Say for trial

period OR full life span with HIV infection).

>  

> What is to be done ideally?

>  

> AND

>  

> What is done routinely?

>  

> Regards,

> Dr Kiran Chaudhari (MD)

> Lecturer,

> Dept of Pharmacology,

> Govt. Medical College,

> Nagpur-44003

>  

>

>

> Download prohibited? No problem. CHAT from any browser,

without download. Go to http://in.webmessenger./

>

[Guest guest]

Dear friends,

Details relating to ancillary care and the criteria for providing it should be reported in protocol. Some studies stipulate that,except for the intervention under investigation, all other patient care is left to the discretion of the attending clinician. As ancillary care varies depending on the study centre, clinician preferences and patient comorbidities, key

details should be documented. Ancillary care may also be specified in the protocol. For example, antiemetics may be used routinely in an oncology trial to allow for a planned

fixed dose of a chemotherapy regimen for all patients. Many interventions are used with specified “rescue or salvage options†in the event of treatment failure

Ref: http://www.mja.com.au/public/issues/176_06_180302/bri10036_fm.pdf

-Anupama

From: drsantosh74 <drsantosh74>Subject: Re: Ancillary care in Clinical Trialsnetrumgroups (DOT) comDate: Monday, October 13, 2008, 10:39 AM

Dear All,First of all i would like congratulate Dr.Kiran for selecting such an apt topic for discussion.It is a main concern faced in all sorts of research.The question asked by Dr.KiranA participant in a trial on "AIDS Vaccine", who was free from HIV infection previously, develops HIV infection during the course of Trial. HIV infection was not due to the vaccine but by other reasons. What next? You will keep him/her in study? Exclude from trial? What care will be given for HIV infection? (Say for trial period OR full life span with HIV infection). Ideally the that partcular patient should be provided antiretroviral treatment,but this may not be stipulated in the trails protocol.So most often such cases are dropped from the study saying that they doesnt meet the said criteriaI would like to add an article from BMJ that highlights Medical researchers' ancillary clinical care

responsibilities Researchers testing a new treatment for tuberculosis in a developing country discover some patients have HIV infection. Do they have a responsibility to provide antiretroviral drugs? In general, when do researchers have a responsibility to provide clinical care to participants that is not stipulated in the trial's protocol? This question arises regularly, especially in developing countries, yet (with rare exceptions1) existing literature and guidelines on research ethics do not consider ancillary clinical care. We propose an ethical framework that will help delineate researchers' responsibilities. Ancillary care is that which is not required to make a study scientifically valid, to ensure a trial's safety, or to redress research injuries. Thus, stabilising patients to enrol them in a research protocol, monitoring drug interactions, or treating adverse reactions to

experimental drugs are not ancillary care. By contrast, following up on diagnoses found by protocol tests or treating ailments that are unrelated to the study's aims would be ancillary care. When asked how much ancillary care they should provide to participants, the first reaction of many clinical researchers, especially those working in developing countries, is that they must provide whatever ancillary care their participants need. From an ethical perspective, this response makes sense. Research participants in trials in the developing world are typically desperately poor and ill, and everyone arguably has a duty to rescue those in need, at least when they can do so at minimal cost to themselves.2 3 Yet this response fails to acknowledge that the goal of research is to generate knowledge not care for patients.4 5 When researchers consider that offering ancillary care this broadly may drain

limited human and financial resources and confound study results, they tend to retreat from this position. Some researchers veer to the opposite extreme. "We may be doctors," they note, "but these are our research participants, not our patients, so we owe them nothing beyond what is needed to complete the study safely and successfully— that is, we owe them no ancillary care." But this extreme position is ethically questionable. Consider the case of researchers studying a rare disease. It is ethically unacceptable to say to a participant, "We are going to monitor the toxicity and effectiveness of this experimental drug, and we will make sure it does not kill you, but we are not going to provide any palliative care for your condition." Closely monitoring a participant' s disease without being willing to treat it in any way amounts to treating him or her as a mere means to the end of research.

Hypothetical case: trial of antimicrobials for sexually transmitted diseases in a developing countryWhile performing clinical examinations on female patients to check for sexually transmitted diseases or side effects of the antimicrobial drug, researchers are likely to discover many women with vaginal candidiasis. 8 More than half are likely to be suffering from the results of poor dental care and hygiene. What care should be provided for these problems?Vaginal candidiasisThis is clearly within the scope of entrustment because the diagnosis results from examinations essential to the research. The underlying duty of care also seems strong because untreated candidiasis will greatly affect their wellbeing and treating it is relatively cheap and easyDecision: Researchers ought to treat vaginal candidiasisDental problemsThese are not within the scope of entrustment.

If we assume that the poor dental hygiene is apparent on casual observation, its diagnosis would not result from exercising the permission participants granted on entering the study. The question of strength thus does not arise.Decision: Dental care falls outside the scope of ancillary care responsibilitiesWe propose a model of the researcher-particip ant relationship that lies between these two views. It rests the special responsibilities of researchers on the idea that the relationship involves a partial and limited entrustment of participants' health to researchers. 6 When participants join research trials, they implicitly or explicitly give researchers permission to access confidential medical information, to perform procedures and treatments, or to take samples. With this permission, researchers have discretionary power over how to respond to any collected medical information and

potential diagnostic insights. Because researchers' responses to these needs will greatly affect participants' health and wellbeing, participants are vulnerable to the researchers. Participants thus tacitly entrust aspects of their health to researchers through the permission they give when joining a study. The participants' entrustment is limited and partial. The permission entrusts only specific aspects of their health to researchers, not their health in general. Furthermore, how far researchers must go in caring for entrusted aspects of health will differ from case to case. In order to identify the depth and breadth of researchers' ancillary care responsibilities, we distinguish between the scope of entrustment (what is entrusted) and the strength of the duty of care. In the partial entrustment model, the scope of entrustment depends on the study. The research protocol, which

specifies the information, interventions, tests, and sample required, will determine what permission needs to be obtained. A protocol that collects only a single magnetic resonance image from each participant yields a limited scope of entrustment, pertaining mainly to the researchers' collection and use of the image. A study involving an extended inpatient stay, by contrast, will yield a far broader scope of entrustment. Although the scope of this partial entrustment will vary, it is possible to generalise. Since a participant typically gives permission for a disease under study to be monitored, the scope of entrustment typically includes caring, as needed, for that disease. Since participants' permission is needed for doing tests or collecting confidential medical information, the scope of entrustment typically includes following up on any clinically relevant information or diagnoses

generated. Researchers do not automatically have a responsibility to provide complete care for all aspects of health that fall within the scope of entrustment. Rather, the responsibility to provide ancillary care depends on the strength of the underlying, relationship based duty of care. This is influenced by at least four factors: Participants' vulnerability Participants' uncompensated risks or burdens Depth (intensity and duration) of the researcher-particip ant relationship7 Participants' dependence on the researchers. These four factors can vary independently. The vulnerability of participants is assessed by looking at how much their wellbeing would be affected by researchers exercising their discretion—this is the vulnerability resulting from the participants' consent to participate. Participants' pre-existing vulnerabilities, such as those caused by illness,

oppression, or poverty must also be taken into account. The researchers' debt of gratitude to participants depends on whether participants have accepted uncompensated risks and burdens or offered researchers a hard to come by scientific opportunity. The depth of the relationship between a researcher and participant will vary from study to study because different protocols demand interactions of varying intensity, duration, and longevity. Researchers have a stronger moral responsibility to engage with the full range of participants' needs when the relationship is deeper. Finally, dependence matters because it may indicate that the research team is in a unique position to help participants. Participants may become dependent on researchers because they are impoverished, lack insurance, or have an otherwise untreatable disease and join a trial because it is their last hope. In each case, these strength

factors need to be judged against the competition for limited financial and human resources and the danger of confounding study results. These considerations generate a decision tree, which can be used to determine when researchers have a responsibility to provide ancillary care .Researchers and ethics committees should attempt to anticipate the ancillary care responsibilities that will arise in a given protocol. Funding to cover researchers' ancillary care responsibilities must be included in research budgets. Many major research sponsors have been hesitant to fund medical care that is not necessary for the scientific success of a trial. Our hope is that the partial entrustment framework will encourage ethics committees, researchers, and sponsors to regard fulfilling ancillary care responsibilities as an essential part of ethical research. Hypothetical case: HIV treatment in

tuberculosis treatment trialThe trial calls for screening out patients who are HIV positive and dropping participants who seroconvert during the trial. The local standard of care for HIV and AIDS includes only palliative care. Do the researchers have a responsibility to help provide antiretroviral drugs to people they find to be HIV positive?People screened out because they are HIV positiveSuch people are within the scope of entrustment because the study calls for checking HIV status; but the strength of the duty of care is questionable. Although vulnerability and dependence are high (since HIV infection is deadly and other sources of antiretroviral drugs do not exist), engagement and gratitude are weak because these are not yet research participants.Decision: Researchers probably do not have a responsibility to provide drugsParticipants dropped mid-trial because they

seroconvert Treatment is within the scope of entrustment because the study design calls for monitoring HIV status, and the strength of the duty of care is high. Vulnerability and dependence remain high and with enrolled participants engagement and gratitude are greater.Decision: Researchers probably have a responsibility to provide antiretroviral drugsSummary pointsResearchers need ethical guidance regarding their responsibilities for providing ancillary care to participantsAn ethically acceptable approach would recognise a partial entrustment of participants' health to researchersThe scope of this entrustment is determined by the permission researchers need to do the study safely and validlyWhether ancillary care should be provided then depends on the strength of the duty of careThe strength of the duty of care depends on participants' vulnerability, dependence,

and uncompensated risks or burdens and the depth of the researcher-particip ant relationship( copied form BMJ 19 JUNE 2004)Dr.Santosh>> Dear all,>  > I first came across to the concept of ancillary care during ICMR/NIH funded training programme in “Bioethics� at NARI Pune. Dr HS Rchardson from NIH introduced us about this concept.>  > Let me ask you the same question that was asked to us,>  > A participant in a trial on “AIDS Vaccine�, who was free from HIV infection previously, develops HIV infection during the course of Trial. HIV infection was not due to the vaccine but by other reasons. What next? You will keep him/her in study?

Exclude from trial? What care will be given for HIV infection? (Say for trial period OR full life span with HIV infection). > Â > What is to be done ideally?> Â > AND> Â > What is done routinely? > Â > Regards,> Dr Kiran Chaudhari (MD)> Lecturer,> Dept of Pharmacology,> Govt. Medical College,> Nagpur-44003> Â > > > Download prohibited? No problem. CHAT from any browser, without download. Go to http://in.webmessen ger.. com/>

Add more friends to your messenger and enjoy! Invite them now.

[Guest guest]

Hi,

Pleasure to have Henry in the grid. He is the expert in the field.

I feel that if ancillary care is a confounding factor, the

participant may be excluded from the trial so that the results are

not affected. However ethically participant deserves the " care "

since it is duty of the medical doctor to extend that first rather

than continue with the untreated patient or ignore the disease

status of the participant for the sake of the trial

completion.Particpant is human first rather than a case for study or

a number for completion of " n " .

The members of the ethics committee need to realise the humane

aspect in handling humans.

Vijay Thawani

> > > > >

> > > > > Dear all,

> > > > >

> > > > > We are all talking about Ancillary care in clinical

trial.

> > > > >

> > > > > Can any one suggest about the responsible / accountable

> > > authority for

> > > > > ancillary care.

> > > > >

> > > > > If there is no one currently, who shall be in that

position to

> > > control it.

> > > > >

> > > > >

> > > > > Regards,

> > > > >

> > > > > Dr kiran Chaudhari

> > > > >

> > > > > ------------ --------- ---------

> > > > > Download prohibited? No problem.

> > > CHAT<http://in.rd. <http://in.rd./> /

> > <http:///> tagline_webmesse

> > nger_1/*http: //in.webmess

> > > enger.. com/>from any browser, without download.

> > > > >

> > > > >

> > > > >

> > > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > > Add more friends to your messenger and enjoy! Go to

> > http://messenger./invite/

> > <http://messenger./invite/>

> > >

> >

> >

> >

>

[Guest guest]

Vijay puts it well, here.

Best,

Henry

Vijay wrote:

>

> Hi,

>

> Pleasure to have Henry in the grid. He is the expert in the field.

>

> I feel that if ancillary care is a confounding factor, the

> participant may be excluded from the trial so that the results are

> not affected. However ethically participant deserves the " care "

> since it is duty of the medical doctor to extend that first rather

> than continue with the untreated patient or ignore the disease

> status of the participant for the sake of the trial

> completion.Particpant is human first rather than a case for study or

> a number for completion of " n " .

>

> The members of the ethics committee need to realise the humane

> aspect in handling humans.

>

> Vijay Thawani

>

> > > > > >

> > > > > > Dear all,

> > > > > >

> > > > > > We are all talking about Ancillary care in clinical

> trial.

> > > > > >

> > > > > > Can any one suggest about the responsible / accountable

> > > > authority for

> > > > > > ancillary care.

> > > > > >

> > > > > > If there is no one currently, who shall be in that

> position to

> > > > control it.

> > > > > >

> > > > > >

> > > > > > Regards,

> > > > > >

> > > > > > Dr kiran Chaudhari

> > > > > >

> > > > > > ------------ --------- ---------

> > > > > > Download prohibited? No problem.

> > > > CHAT<http://in.rd. <http://in.rd./ <http://in.rd./>> /

> > > <http:/// <http:///>> tagline_webmesse

> > > nger_1/*http: //in.webmess

> > > > enger.. com/>from any browser, without download.

> > > > > >

> > > > > >

> > > > > >

> > > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > > Add more friends to your messenger and enjoy! Go to

> > > http://messenger./invite/

> <http://messenger./invite/>

> > > <http://messenger./invite/

> <http://messenger./invite/>>

> > > >

> > >

> > >

> > >

> >

>

>

[Guest guest]

Dear Sir,

Even I agree. But from practical point of view this may not always be feasible, the reasons for which I have already mentioned in my post.

Clinical trials usually have some specified human and financial resources, offering ancillary care may drain these limited resources.

One solution to this problem could be that funding to cover researchers' ancillary care responsibilities should be included in research budgets. But, many major research sponsors are even hesitant to fund medical care that is not necessary for the scientific success of a trial.

Another problem is that acceptance of ancillary care responsibilities for research subjects from economically poor countries might coerce them into participating in the study and induce a strong element of volunteer bias.

Whatever the arguments, we finally have to agree that it is the moral duty of those involved in clinical research, whether individual or collective, to rescue those in need. Availability of some defined guidelines for the same may be helpful.

Dr. Smita

From: Vijay <drvijaythawani@...>Subject: Re: Ancillary care in clinical trialsnetrum Date: Saturday, 9 January, 2010, 10:24 PM

Hi,I personally feel that the health problems not related to CT also must be attended to by the CI during the CT. It is inhuman to refuse that.Vijay >> v    Researchers testing a new treatment for tuberculosis in a developing country discover some patients have HIV infection. Do they have a responsibility to provide antiretroviral drugs? >  > v    Malaria researchers may detect that their juvenile subjects are suffering from schistosomiasis, a serious parasitic disease common in many malarial areas. Do the researchers have a responsibility to treat the schistosomiasis?>  > Such questions about

researchers' responsibilities to provide ancillary clinical care arise pervasively, yet there is an almost total absence of guidance.>  >  > Ancillary care is that which is not required to make a study scientifically valid, to ensure a trial's safety, or to redress research injuries. Thus, stabilising patients to enroll them in a research protocol, monitoring drug interactions, or treating adverse reactions to experimental drugs are not a part of ancillary care.> >  > In general, when do researchers have a responsibility to provide clinical care to participants that is not stipulated in the trial's protocol? > >  >  There is a difference of opinion when answer to this question is concerned.>  > Some researchers feel  that they must provide whatever ancillary care their participants need. From an ethical perspective, this

response makes sense. Research participants in trials in the developing world are usually desperately poor and ill, and everyone arguably has a duty to rescue those in need, at least when they can do so at minimal cost to themselves. >  > When researchers consider that offering ancillary care this broadly may drain limited human and financial resources and confound study results, they tend to retreat from this position.>  > Some researchers veer to the opposite extreme.  They opine that the  research participants are not their patients, so they don’t  owe them anything beyond what is needed to complete the study safely and successfullyâ€"that is, they don’t owe them ancillary care. But this extreme position is ethically questionable.>  >  > Another problem is that acceptance of ancillary care responsibilities for research subjects from

economically poor countries might coerce them into participating in the study and induce a strong element of volunteer bias. This practice of offering medical care in exchange for study participation would be no different to the payment of research subjects (in fact, it could mean greater financial incentives for poorer subjects), and has ethical implications.> Â > Â > Keeping the arguments and controversy apart, let us understand that those involved in clinical research, whether individual or collective, have duties to rescue those in need. For instance, everyone has a duty to help a person who is in need and whom no one else can help, at least when one can provide the help without serious sacrifice or risk. (1) Even if one's ability to help is not strictly unique, an urgent need can generate a duty to help when it is predictable that no one else will. (2) These duties are quite general and generate moral demands not

only on individual researchers' medical skills but also on the collective financial resources of the research team and its sponsors.>  >  > Dr Smita> > > The INTERNET now has a personality. YOURS! See your Homepage. http://in.. com/>

The INTERNET now has a personality. YOURS! See your Homepage.

[Guest guest]

Dear madam

Even i agree with you and Vijay sir that provision of ancillary care services to the participants is a moral duty of the investigator in spite of scientific research. It is the prime responsibility of the investigator to respect the participation of participant in research with regard to right, well being, dignity and healthcare.

Thanks and Regards

Tarun Wadhwa

From: Vijay <drvijaythawani@ .co. in>Subject: Re: Ancillary care in clinical trialsnetrumgroups (DOT) comDate: Saturday, 9 January, 2010, 10:24 PM

Hi,I personally feel that the health problems not related to CT also must be attended to by the CI during the CT. It is inhuman to refuse that.Vijay >> v    Researchers testing a new treatment for tuberculosis in a developing country discover some patients have HIV infection. Do they have a responsibility to provide antiretroviral drugs? >  > v    Malaria researchers may detect that their juvenile subjects are suffering from schistosomiasis, a serious parasitic disease common in many malarial areas. Do the researchers have a responsibility to treat the schistosomiasis?>  > Such questions about researchers' responsibilities to provide

ancillary clinical care arise pervasively, yet there is an almost total absence of guidance.>  >  > Ancillary care is that which is not required to make a study scientifically valid, to ensure a trial's safety, or to redress research injuries. Thus, stabilising patients to enroll them in a research protocol, monitoring drug interactions, or treating adverse reactions to experimental drugs are not a part of ancillary care.> >  > In general, when do researchers have a responsibility to provide clinical care to participants that is not stipulated in the trial's protocol? > >  >  There is a difference of opinion when answer to this question is concerned.>  > Some researchers feel  that they must provide whatever ancillary care their participants need. From an ethical perspective, this response makes sense. Research participants in

trials in the developing world are usually desperately poor and ill, and everyone arguably has a duty to rescue those in need, at least when they can do so at minimal cost to themselves. >  > When researchers consider that offering ancillary care this broadly may drain limited human and financial resources and confound study results, they tend to retreat from this position.>  > Some researchers veer to the opposite extreme.  They opine that the  research participants are not their patients, so they don’t  owe them anything beyond what is needed to complete the study safely and successfullyâ€"that is, they don’t owe them ancillary care. But this extreme position is ethically questionable.>  >  > Another problem is that acceptance of ancillary care responsibilities for research subjects from economically poor countries might coerce them into

participating in the study and induce a strong element of volunteer bias. This practice of offering medical care in exchange for study participation would be no different to the payment of research subjects (in fact, it could mean greater financial incentives for poorer subjects), and has ethical implications.> Â > Â > Keeping the arguments and controversy apart, let us understand that those involved in clinical research, whether individual or collective, have duties to rescue those in need. For instance, everyone has a duty to help a person who is in need and whom no one else can help, at least when one can provide the help without serious sacrifice or risk. (1) Even if one's ability to help is not strictly unique, an urgent need can generate a duty to help when it is predictable that no one else will. (2) These duties are quite general and generate moral demands not only on individual researchers' medical skills but

also on the collective financial resources of the research team and its sponsors.>  >  > Dr Smita> > > The INTERNET now has a personality. YOURS! See your Homepage. http://in.. com/>

The INTERNET now has a personality. YOURS! See your Homepage.

The INTERNET now has a personality. YOURS! See your Homepage.

[Guest guest]

From: smita sontakke <smitaavanti@...>netrum Sent: Sun, 10 January, 2010 9:22:22 AMSubject: Re: Re: Ancillary care in clinical trials

Dear Sir, Even I agree. But from practical point of view this may not always be feasible, the reasons for which I have already mentioned in my post.

Clinical trials usually have some specified human and financial resources, offering ancillary care may drain these limited resources.

One solution to this problem could be that funding to cover researchers' ancillary care responsibilities should be included in research budgets. But, many major research sponsors are even hesitant to fund medical care that is not necessary for the scientific success of a trial.

Another problem is that acceptance of ancillary care responsibilities for research subjects from economically poor countries might coerce them into participating in the study and induce a strong element of volunteer bias.

Whatever the arguments, we finally have to agree that it is the moral duty of those involved in clinical research, whether individual or collective, to rescue those in need. Availability of some defined guidelines for the same may be helpful. Dr. Smita

From: Vijay <drvijaythawani@ .co. in>Subject: Re: Ancillary care in clinical trialsnetrumgroups (DOT) comDate: Saturday, 9 January, 2010, 10:24 PM

Hi,I personally feel that the health problems not related to CT also must be attended to by the CI during the CT. It is inhuman to refuse that.Vijay >> v    Researchers testing a new treatment for tuberculosis in a developing country discover some patients have HIV infection. Do they have a responsibility to provide antiretroviral drugs? >  > v    Malaria researchers may detect that their juvenile subjects are suffering from schistosomiasis, a serious parasitic disease common in many malarial areas. Do the researchers have a responsibility to treat the schistosomiasis?>  > Such questions about researchers' responsibilities to provide

ancillary clinical care arise pervasively, yet there is an almost total absence of guidance.>  >  > Ancillary care is that which is not required to make a study scientifically valid, to ensure a trial's safety, or to redress research injuries. Thus, stabilising patients to enroll them in a research protocol, monitoring drug interactions, or treating adverse reactions to experimental drugs are not a part of ancillary care.> >  > In general, when do researchers have a responsibility to provide clinical care to participants that is not stipulated in the trial's protocol? > >  >  There is a difference of opinion when answer to this question is concerned.>  > Some researchers feel  that they must provide whatever ancillary care their participants need. From an ethical perspective, this response makes sense. Research participants in

trials in the developing world are usually desperately poor and ill, and everyone arguably has a duty to rescue those in need, at least when they can do so at minimal cost to themselves. >  > When researchers consider that offering ancillary care this broadly may drain limited human and financial resources and confound study results, they tend to retreat from this position.>  > Some researchers veer to the opposite extreme.  They opine that the  research participants are not their patients, so they don’t  owe them anything beyond what is needed to complete the study safely and successfullyâ€"that is, they don’t owe them ancillary care. But this extreme position is ethically questionable.>  >  > Another problem is that acceptance of ancillary care responsibilities for research subjects from economically poor countries might coerce them into

participating in the study and induce a strong element of volunteer bias. This practice of offering medical care in exchange for study participation would be no different to the payment of research subjects (in fact, it could mean greater financial incentives for poorer subjects), and has ethical implications.> Â > Â > Keeping the arguments and controversy apart, let us understand that those involved in clinical research, whether individual or collective, have duties to rescue those in need. For instance, everyone has a duty to help a person who is in need and whom no one else can help, at least when one can provide the help without serious sacrifice or risk. (1) Even if one's ability to help is not strictly unique, an urgent need can generate a duty to help when it is predictable that no one else will. (2) These duties are quite general and generate moral demands not only on individual researchers' medical skills but

also on the collective financial resources of the research team and its sponsors.>  >  > Dr Smita> > > The INTERNET now has a personality. YOURS! See your Homepage. http://in.. com/>

The INTERNET now has a personality. YOURS! See your Homepage.

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