[The Committee for the Protection of Human Subjects in biomedical research, crossroads of misunderstandings].

The conditions for carrying out clinical experiments involved numerous and serious breaches of Hippocratic morality and of the rights of people subjected to research situations. The World Medical Association has recommended the prior intervention of an independent committee "for advice and guidance" to the medical researcher. This recommendation has been taken into consideration by the competent authorities of industrially developed countries, which have incorporated structures of this type into their legislation, each having their own dispositions in this domain.

[Legal aspects of consent in children (Part 1)].

In pediatric research, the patient is legally a minor and therefore protected by law. Research can only be conducted after parental consent and patient assent have been obtained. In this context, this review discusses the historical events and documents related to all ethical precautions and obligations.

[Consent in children: Practical situations (part 2)].

Ethical and regulatory documents frame informed consent in pediatric research; their application is obligatory but may be complex. In this specific context, pediatric investigators have a central ethical role to play to ensure the strict respect of regulatory and ethical requirements adapted to the French legal, social, and cultural context as well as good clinical practices. This article attempts to shed light on the considerations that can allow researchers to come to terms with industrial and institutional demands while responding to the needs of patients, particularly in the domain of pediatric research.

How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?

The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies).

Conflicts of interests in the area of healthcare products and technology. Current state of affairs and recommendations.

The handling of conflicts of interest in the area of healthcare products and technology has become a major issue for all of those involved in healthcare. Round Table N°4 at the Giens Workshops 2011 has put forward concrete proposals to clarify and optimise the handling of conflicts of interest. Conflicts of interest cannot be defined by the individuals consulted or applying for funds since each institution, whether public or private, that puts out a call for projects or that requests advice, analyses or expert testimony in the healthcare field has different degrees of what it defines as a conflict of interest, depending on the context of the proposal or specific request that it puts out.

Generics and substitution modalities: proposed methods for the evaluation of equivalence, traceability and pharmacovigilance reporting.

The use of generics results in savings for the budget of the health insurance, and no player of health could question seriously the principle. The generic drug of a reference medicinal product defines itself as a drug having the same qualitative and quantitative composition in active ingredients, the same dosage form and the bioequivalence with this reference medicinal product was demonstrated by appropriate studies of bioavailability. It is the right to switch granted to the pharmacists in 1999 that is at the origin of the real development of these specialties on the French pharmaceutical market.

[From Nuremberg to the ethics committees in human experimentation].

During the Nuremberg trials, the accusation prompted the creation of an ad hoc committee to advise on human experiments carried out on prisoners during wartime in the USA. Precisely a charge that had been brought against Karl Brandt and his colleagues. This committee was the forerunner of the Independent Committees, to which the Declaration of Helsinki assigned a role in analysing the ethics of research projects in humans.

Committee for the protection of persons.

The transposition into French law of Directive 2001/20/CE, which relates to good clinical practice in the conduction of trials on drugs for human use, has required the modification of certain provisions that concern the protection of persons participating in biomedical research, in particular those provisions concerning the conditions for the authorisation of biomedical research. Declaration to the competent authorities now comes prior to authorisation and, henceforth, the prior opinion of a Committee for the Protection of Persons (CPP) must be expressly favourable in order for a trial to be undertaken. Proposals are put forward by this Round Table in order to promote the stability and professionalism of the CPPs.

[Good clinical practice in clinical trials: training clinicians,incentives to apply good clinical practice and assessment of compliance].

Fourteen years after the concept was created, it seemed important to assess how well investigators actually apply Good Clinical Practice. Various sources of information have revealed a general deficiency in their application: "investigation by the working group, Afssaps (French Agency for the Safety of Health-Care Products) inspections, industrial data". The deficiencies identified stem from different factors: lack of professionalization, lack of training, lack of motivation, the large numbers of poorly conducted studies.

[ Legal aspects of advice provided by an institutional pharmacovigilance specialist to health-care professionals. Consequences in the field of teratology ].

An institutional pharmacovigilance specialist gives advice only when consulted by a prescribing physician about a pregnant woman. The situation may involve a pregnant woman for whom a prescription may be considered or a pregnant woman for whom a prescription has been given. The aim is to evaluate the risk for the fetus, both before and after the fact.

[Women in clinical trials].

In a workshop held in Giens in September 1994, representatives of drug companies and scientists met to discuss the place of women in clinical trials. They recommend that, in phase II and III studies, men and women should be included in a proportion equivalent to that observed for the condition studied. They also recommend that the impact of the gender on the results should be systematically studied.

Remuneration, freedom of choice, professional guinea pig.

The law of December 20, 1988 states that a participant in a clinical test without direct therapeutic benefit is not entitled to receive remuneration. Professionalism may be the strongest reason for participating. The law prohibits some participants from receiving an indemnity, not on the basis of healthy vs sick discrimination but when a situation of particular vulnerability or dependence has been established.

Double-blind placebo-controlled study of milnacipran in hospitalized patients with major depressive disorders.

Fifty-eight inpatients with a DSM-III diagnosis of major depressive disorder participated in a 5-week double-blind trial of milnacipran and placebo. Milnacipran was superior to placebo on all measures of depression. The first index of milnacipran superiority was the difference of dropouts due to treatment failure between milnacipran (10.