Table 1

Summary of legal requirements in Europe for research in neonates

Country Legislation on research Ethical review system Consent Benefit of the child requirement Research of no direct benefit in minors permitted
DenmarkAct 503 of 24 June 1992 as amended by Act 499 of 12 June 1996Regional RECs review all biomedical research projects on liveborn human subjectsWith proxy consent risk evaluation is stringent. (Report 1335 of April 1997 by commission of Minister of Research and Minister of Health).YesYes, when only minimal risk involved
Consent from both parents required where custody is shared. If one parent withholds consent, research cannot proceed
FinlandFinnish Medical Research Act 1999Medical Research Act regulates RECs. Each of the 20 hospital districts to have at least one REC. Duties and composition regulatedWritten proxy consent by guardian or legal representative following information (Medical Research Act 8(3) and 6(2)). Both parents to consent unless health care procedure is “routine” or welfare of child demands immediate decision (Child Custody and Right of Access Act 1983). Research Act permits research without consent in situations of “urgency” and expectation of “immediate benefit to the patient's health”.Research should directly benefit child's health or be of special benefit to other children or those with the same state of health and not possible to use other research subjects.Yes, provided only minimal risk of harm or distress, benefit to similar groups, and if unable to use other research subjects.
France1988 specific legislation on researchRegional RECsWritten proxy consent by those legally responsible (usually both parents). Research can be commenced without consent in cases of emergency; then consent from “members of the family” should be soughtResearch must aim to provide a direct benefit to the health of the minor. However, placebo-controlled trials permitted (guidebook of Department of Health)Yes, provided there is only minimal risk expected and research will benefit other children with the same disease, handicap and age or there is no alternative solution
GermanyLaw governing clinical trials of drugs and medicinal products provides rules for involvement of minorsSubmission of research protocols to RECs required by law for clinical trials of drugs and medicinal products. Declaration of Helsinki and professional rules for physicians require submission to RECs for other research projectsProxy consent for minors from both parents (if share custody). Presumed consent permitted in cases of clinical emergencyYes. Child must be expected to derive therapeutic, diagnostic or prophylactic advantage. There is some question of whether placebo controlled clinical trials are legal for neonatesNo
GreeceSpecific legislation on clinical drug trialsScientific committees instead of RECs. RECs only function in a few hospitals. In clinical drug trials, control by the National Drugs Organisation.Proxy consent required (by legal representative)Not specifically mentioned for research but stated in general legislationYes, for diagnosis or prevention of diseases applicable to the child
IrelandAll pharmacological research controlled by the Clinical Trials and Drugs Acts 1987–1990, as amended by the Irish Medicines Board Act 1995. Non-pharmacological research regulated by common law principles, the constitution and professional canons.Yes, RECs review medical research. Competence of RECs for clinical trials must be approved by the Irish Medicines Board. Clinical trials need permission (including approval of investigators' indemnity arrangements) from the Irish Medicines Board (prior to REC approval). The statutory requirements only relate to clinical trials involving pharmacologically active preparations. Medical Practitioners bound by “A Guide to Ethical Conduct and Behaviour and to Fitness to Practise of the Medical Council”Proxy consent by person independent of investigator. A six day period must elapse after patient or patient's legal representative has been given information about a trial before the start of the trial. This provision can be amended with the permission of the Irish Medicines Board. “Therapeutic privilege” has no role in obtaining consent to participation in research. Consent to participation in research is required even in a clinical emergency.YesNot clear. Lawyers have divided views. It may be permitted if interventions are minor with negligible risk and if increase in scientific knowledge gained which may benefit other children
NorwaySpecific legislation on clinical drug trials (4 Dec 1992, no 132). Legal obligations governed by general principles of law, specifically individual autonomy. Penal Code offers protection against bodily harm and mental coercion. Courts apply provisions of the Declaration of HelsinkiFive regional RECs cover the country. No statutory status but their mandate imposes review by one of these committees on all research involving humans. No local hospital or other committee acknowledged in the system. Small country and research community said to be surveyable.Proxy consent for minors (aged less than 18 years)Yes, in Act on Children and Parents and Act on Legal GuardianshipNot clear. Lawyers have divided views. It may be permitted if interventions are minor with negligible risk and if increase in scientific knowledge gained which may benefit other children
SwedenNo specific legislation. Patients right to self determination governed by Act on Professional Activities in Health and Medical Services (1998:531) and Health and Medical Services Act (1982:763). Medical Products Act (1992:859) regulates pharmaceutical clinical trialsNo statutory regulation for RECs; however, ten regional RECs connected to six faculties of medicine covers biomedical research on humans. However, there is no explicit legal demand for REC approval for non-pharmaceutical regulatory research. REC status is only advisory. Coordination of the independent RECs is provided by the Medical Research Council's National Board for Research Ethics. No appeal can be made to the latter for an individual case. For clinical trials on drugs, the permission of the Medical Products Agency is required by lawOral consent is allowed. Parents and Children Code regulates rights and duties of custodians of minors. Both custody holders to consent unless health care procedure is minor or best interest of the child demands immediate decision. Sometimes unclear whether or not consent of one parent sufficient. In extraordinary situations, patients unable to give consent may be included if trial is linked to treatment of patient's illness, has REC approval and may benefit the patientYes, following Sweden's ratification of the UN Convention on the Rights of the Child (1989); Article 3.1 states that the best interest of the child must be a primary consideration in all decisions concerning children.Yes, provided no more than minimal risk involved
SpainSpecific laws of 1990 and 1993 regulate clinical trials on drugs and these stipulate requirements for minorsEthics committees for clinical research in all hospitals where research is carried outProxy consent by legal representatives (Royal Decree, art.12.1 stipulates requirements of proxy informed consent). Before research starts, the proxy consent by the legal representative is communicated to the Public Attorney (Royal Decree, art.12.5).Yes, within general legislationYes, provided there is adoption of measures to guarantee that risk will be minimal and relevant knowledge about the illness will be obtained
Consent may be dispensed with in an emergency when research concerns the specific interest of the health of the child and if there is REC approval. Retrospective consent of the legal representative is then requested as soon as possible (Royal Decree, art.12.6).
United KingdomNo specific legislation and no specific case law. Legal rights and duties based on common law principles governing medical treatment and general principles in the Children Act 1989.No statutory basis for ethical review but approval of (local RECs and medical RECs) required for research which is publicly funded or conducted on NHS premises.Consent of person legally responsible for the child required. Consent in writing not legally required.Yes. Welfare and best interests of child must be protected.Probably not permitted.
  • REC, research ethics committee.