European Research Area

 

		EDCTP
The EDCTP initiative The European Commission's role Press room Conferences in 2002: Barcelona & Brussels (Heysel)

Ethical dimension of the EDCTP programme

Because clinical trials involve human participants, highest ethical standards should be applied when setting up and conducting clinical trials.

International conventions, declarations and ethical guidelines such as the Opinion 17 (PDF: 207 kB) of the European Group on Ethics on Ethical aspects of clinical research in developing countries (4 February 2003) and Declaration of Helsinki ⁽¹⁾ should be applied.

A. Setting up a clinical trial

A number of safeguards must be in place before a clinical trial can take place:

• Addressing the health needs of the country: The research envisaged should address the specific needs of the country where the clinical trial is performed.

• Local, regional and national ethics committees: The clinical trials should be examined by a local, regional or national ethics committee in the countries where the trial will be performed. The creation of ethics committees and the training of ethics committee members in countries should be encouraged.

• National Authorities: The authorities and the local community should be fully informed and should agree before the start of the clinical trials.

• Local research institutions: The research teams of the country where the trial is performed should be involved. Clinical trials being conducted with the involvement of local research teams ensure a better representation and knowledge transfer to the local communities and a better protection of the rights of participants.

B. Undertaking a clinical trial

When undertaking a clinical trial, the following issues should be addressed on a case by case basis, respecting the fundamental ethical principles as defined in international declarations and in dialogue with local, regional or national ethics committees and national authorities.

It is required to obtain the consent of each persons participating in a clinical trial. First, information must be provided to participants in a way that these persons can understand. This requires also trained staff able to communicate the objectives of the research and the risks and benefits such research may entail for the participants.

• Protection of confidentiality

The researchers must keep personal medical information confidential.

• Level of care for the trial participants

The level of care, which will be offered to the participants should be specified and conform requirements set by the local, regional or national ethics committee and the national authorities. The level of care includes also appropriate provision of effective alternative prevention and the non-exposure of participants to undue risks.

• Use of placebo

The use of placebo in randomised clinical trials has raised in the past important ethical concerns, especially when the disease is life threatening or severely debilitating.

The European Group on Ethics in its opinion 17 recommends that (section 2.10) the use of placebo should be regulated by the same rules as in EU countries. "Any exception must be justified: an obvious one is when the primary goal of the clinical trials is to try to decrease the costs of treatment for countries where the standard treatment is not available for logistic reason or inaccessible because of the cost".

• Benefits for the population after the end of the trial:

At the beginning of each clinical trial, the benefits for the local community where the trial takes place should be specified. Special attention should be given to the possibility of a future access to the new treatment. But other possible benefits should be examined such as: improvement of access to health care or capacity building.

European Group on Ethics
http://ec.europa.eu/european_group_ethics/index_en.htm

World Medical Association - Declaration of Helsinki
http://www.wma.net/e/index.htm

CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects
http://www.cioms.ch/

SARETI
SARETI is a joint effort by the University of Pretoria and the University of Natal (South Africa) to offer advanced learning in bioethics and health research ethics. http://shsph.up.ac.za/sareti/sareti.htm

Laurence.Cordier@ec.europa.eu

(1) Declaration of Helsinki on "Ethical Principles for Medical Research Involving Human Subjects" - World Medical Association – (adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and revised by the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000)

Background information

On-going research funded by the EC