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Thursday, October 18, 2018
experiments, lead to the formulation of new guidelines for ethical conduct, with the Nuremberg
code being the first, most prominent example; the declaration of Helsinki followed, broader than
the first. The National Research Act was the milestone for medical research itself, leading to
Belmont Report; this one is statin respect for people (treating people as autonomous creatures
and not means to an end), beneficence (minimize harm and maximize benefits), justice (treat all
people fairly, and make sure that treatments are equally distributed). A joint regulatory project
was also issued, ???.
Ethical norms for clinical trials came up with Institutional review boards (IRB), and informed
consent; the former is protecting participant’s rights, and usually provides the participants with
the informed consent before they take part in the study. The IRB is any board committee or other
groups formally designated by an institution to review, approve the invitation of biomedical
research involving human subjects; they are responsible for many procedures, including issuing
written notes of approval or disapproval of the study, as well as providing informed consent.
The IRB in Italy is made of at least three clinicians, a pediatrician, a biostatistics, a
pharmacologist, a general territory physician, then depending on the type of studies, we have
other entities involved, related to the specialty that is involved.
Informed consent is the process through which the patients is informed and learns key facts
about the research study, and makes voluntary adhesion to it; the consent must include
statements that the study is involving research, explanation of purposes, expected duration,
description of procedures involved in the sett, risks or discomforts, benefits, alternatives to the
research study, statements about medical care and compensation in case of injury, alternative
therapies. We have vulnerable populations to think about as well, including children, mentally
impaired or dementia affected individuals, prisoners; others might be unduly influenced to
participate, like students, subordinates, pregnant women (there is debate for this, as there are still
drugs that need to be taken also in pregnancy, but it is borderline ethical to involve pregnant
women in studies), patients (when the caregiver is the researcher).
Transparency is also important; it is necessary that all trials are published, as also negative
outcomes are good for future reference, and are informative. FDA in the ‘90 established a
website, ClinicalTrials.gov, with informations about all ongoing trials, and the drugs tested; on
site, we have stated conditions, intervention, outcome measures, sponsors, locations, phases,
dates and results (all should be clearly stated); in USA, it is mandatory by law to fill in this
registry. Not all trials need to be registered, for example phase 1 trials, as these are poorly
informative, especially for the general population, so in general we only have phases 2 to 4.
Another reason to publish the trial on the site is because we do want the results published, and
this would not happen, in some journals, if the trial is not published first in the site (editors do
not care about ethical issues themselves, but only about reputation, as they need only clinical
trials that are registered, so we have convergence of interests); nowadays, also preclinical trials
are registered and published, obtaining ethical committee approbation, to guard also animal
rights.
In Italy, most of the times pharmaceutical marketing and development are generally in the hands
of pharmaceutical companies, starting as familiar, private organizations, and generally grown
over time (we do not have a national, state owned company); we have sites for multi-centrical
international experimentations, and all sites need approval from their ethical committees, but in
general we have a coordinator site, that gives first approval and it is difficult not to obtain
approval once the coordinator has given it.