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Biomedical Research in Developing Countries - UNICRI

Biomedical Research in Developing Countries - UNICRI

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Transparency is important both <strong>in</strong> the carry<strong>in</strong>g out and the report<strong>in</strong>g of cl<strong>in</strong>ical<br />

trials. To this purpose, a s<strong>in</strong>gle cl<strong>in</strong>ical trials register should be ma<strong>in</strong>ta<strong>in</strong>ed by an<br />

<strong>in</strong>tergovernmental body, conta<strong>in</strong><strong>in</strong>g all results of all cl<strong>in</strong>ical trials data, full trials<br />

<strong>in</strong>formation at launch as a condition to obta<strong>in</strong> the market<strong>in</strong>g licence.<br />

Cl<strong>in</strong>ical research with human participants has to be tailored to the therapeutic needs<br />

and expectations of the country <strong>in</strong> which it is carried out. This is a conditio s<strong>in</strong>e qua<br />

non to re<strong>in</strong>force the scientific validity of research, the ethical values related to the<br />

susta<strong>in</strong>ability and acceptability of research and to avoid misconduct or illegal acts.<br />

Ethical Committees need to be fully equipped to work <strong>in</strong> a susta<strong>in</strong>able environment,<br />

where their members can ensure a valid scientific and ethical review of cl<strong>in</strong>ical<br />

research and appropriate decision mak<strong>in</strong>g. Ethical Committees should receive<br />

cont<strong>in</strong>uous education and tra<strong>in</strong><strong>in</strong>g and particular attention should be posed on their<br />

composition, that should be as much diversified as possible both <strong>in</strong> terms of gender<br />

and professional figures. These should always <strong>in</strong>clude not only scientists but also<br />

law enforcement professionals (such as police officers, judges and lawyers) and lay<br />

members.<br />

59

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