New Discussion : ICH-GCP & Schedule Y

[Guest guest]

I am very thankful to Dr. Vijay Thawani Sir for giving me an opportunity to moderate this e-discussion on this segment of our e-workshop on RESEARCH METHODOLOGY on NetRUM. Dear Members, I welcome

you all for the discussion on "International Conference of Hormonization (ICH)-Good Clinical Practices (GCP) guidelines & Schedule Y"

The ethical justification of biomedical research

involving human subjects is the prospect of discovering new ways of benefiting

people's health. Such research can be ethically justifiable only if it is

carried out in ways that respect and protect, and are fair to, the subjects of

that research and are morally acceptable within the communities in which the

research is carried out. Moreover, because scientifically invalid research is

unethical in that it exposes research subjects to risks without possible benefit,

investigators and sponsors must ensure that proposed studies involving human

subjects conform to generally accept scientific principles and are based on

adequate knowledge of the pertinent scientific literature.

As each country possesses its own ethical guideline,

there should be few international guidelines to ensure that the universal

ethical values and international scientific standards are uniform. International ethical

guidelines are required to indicate how the ethical principles that should

guide the conduct of biomedical research involving human participants, as set

forth in the International Conference of Harmonization (ICH)- Good Clinical Practices (GCP), could be effectively applied unvaryingly

in all countries and also needed for conducting multinational or

transnational medical research. Regards,Dr. Vijaya Chaudhari.JR-3,Dept. of Pharmacology,Government Medical College, Nagpur.

[Guest guest]

Hi,

Please replace the term " subject " with " participant " as the use of the term

" subject " subjugates the participants, is derogatory, is outdated and no more

liked in ethics.

Vijay

>

> I am very thankful to Dr. Vijay Thawani Sir for giving me an opportunity to

> moderate this e-discussion on this segment of our e-workshop on RESEARCH

> METHODOLOGY on NetRUM.

>

> Dear Members,

>

> I welcome you all for the discussion on " International Conference of

> Hormonization (ICH)-Good Clinical Practices (GCP) guidelines & Schedule Y "

>

>

>

> The ethical justification of biomedical research involving human subjects is

the

> prospect of discovering new ways of benefiting people's health. Such research

> can be ethically justifiable only if it is carried out in ways that respect

and

> protect, and are fair to, the subjects of that research and are morally

> acceptable within the communities in which the research is carried out.

> Moreover, because scientifically invalid research is unethical in that it

> exposes research subjects to risks without possible benefit, investigators and

> sponsors must ensure that proposed studies involving human subjects conform to

> generally accept scientific principles and are based on adequate knowledge of

> the pertinent scientific literature.As eachcountry possesses its own ethical

> guideline, there should be few international guidelines to ensure that the

> universal ethical values and international scientific standards are uniform.

> International ethical guidelines are required to indicate how the ethical

> principles that should guide the conduct of biomedical research involving

human

> participants, as set forth in the International Conference of Harmonization

> (ICH)- Good Clinical Practices (GCP), could be effectively applied unvaryingly

> in all countries andalso needed for conducting multinational or transnational

> medical research. Regards,

> Dr. Vijaya Chaudhari.

> JR-3,Dept. of Pharmacology,

> Government Medical College, Nagpur.

>