The European Medicines Agency (EMA) has tightened up its rules on clinical trials in order to counter the damaging effects of globalisation.

From 1 May 2012, clinical trials used to support EU marketing authorisation applications will require the informed consent of participants.

The trial protocol will also need to be submitted to an independent ethics committee before the trial takes place.

According to the EMA’s reflection paper, a trial will be disqualified if non-compliance “significantly affects the rights, safety or well-being of the subjects or the quality and integrity of the data reported”.

The EMA said these measures were necessary to address the globalisation of clinical trials: “No matter where you stand today, most clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in a different cultural setting.”

The agency said it will work to improve international co-operation on trial regulation and help regulators to gain assurance that ethical and good clinical practice standards are applied.

In recent years the pharma industry has used 178 countries for clinical trials, with China, Russia, India, Brazil, Poland and South Africa becoming key locations.

While all trials used in EU marketing authorisation applications are expected to meet the same ethical standards as trials conducted in Europe, there have been a number of alleged breaches of standards.

The case of Pfizer’s 1996 trial in Nigeria of its meningitis drug Trovan, in which 11 children died, reflects the legal complexity of such cases. Pfizer finally reached a settlement with the families involved in 2009.

This year, GSK denied claims that it failed to secure consent from the parents of children enrolled in an Argentinian study of its pneumococcal vaccine Synflorix.

Unethical overseas drug trials were the subject of a high-profile film, The Constant Gardener, based on a novel by John le Carre – who claimed that the pharma industry was guilty of worse crimes than those he had depicted.

The Chartered Institute of Personnel and Development (CIPD) has issued a revised and strengthened Code of Professional Conduct for Human Resources professionals.

The revised Code is intended to shift the balance of responsibility away from the employer towards self-regulation within the HR profession.

For the first time, the CIPD will provide independent panels for the investigation of complaints and for disciplinary action.

The new Code, which comes into force on 1 July 2012, lists the CIPD’s requirements under four headings: professional competence and behaviour, ethical standards and integrity, representative of the profession, and stewardship.

The new complaints and disciplinary arrangements are intended to give CIPD members more ownership of the investigation process and open up disciplinary cases to a wider group of professionals.

Any valid complaint regarding an alleged breach of the Code will be handled first by an Investigation Panel of CIPD members. Where this panel determines that the Code has been breached, the case will be referred to a formal Disciplinary Panel of appropriately experienced and trained professionals.

Vicky Wright, Chair of the CIPD’s Nominations and Professional Conduct Committee, said: “Our new Code of Professional Conduct is an evolution of our existing Code. But it also marks a raising of the bar in terms of the maintenance and enforcement of clear, simple, rigorous standards in HR professional practice.

“Designed by the profession, and with responsibility for investigating and adjudicating complaints resting firmly with the Institute and a qualified body of professionals, this represents the establishment of modern, best practice self-regulation for the HR profession.”

The CIPD is the world’s largest organisation for chartered HR and development professionals, with over 135,000 members in 120 countries.