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«ETHICAL CONSIDERATIONS FOR CLINICAL TRIALS PERFORMED IN CHILDREN Recommendations of the Ad hoc group for the development of implementing guidelines ...»

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What is the requirement from at national level:

–  –  –

In case of disagreement between the 2 parents, do you have specific provisions (law or guidelines) to deal with such disagreement?

What are these provisions?

2) Specific national provisions for child’ s assent Do you have a law, addressing assent from a child participating in a trial?

Do you have national guidelines addressing assent from a child participating in a trial?

Consent refers to legal representatives, as opposed to assent which refers to minors Guideline means implemented at national level, excludes local recommendations.

–  –  –

If yes, from which age?

In relation to development milestone (eg, from school age)?

Is there a need for written child’s assent?

If yes, from which age?

3) Neonates Do you have laws or national guidelines to confer additional protection to neonates?

4) Adolescents Do you have a law stating that adolescents can consent independently?

Do you have a national guideline stating that adolescents can consent independently?

If yes, from which age?

Is there a possibility for adolescents to overrule their parents’s decisions (or legal representatives’s decision) Is the investigator obliged to follow the parent(s)’s decision?

Is the investigator obliged to follow the adolescent’s decision?

Do they have the right to privacy vis-à-vis parents (or legal representatives) in a clinical trial (e.g., for contraceptive use, Sexually Transmitted Diseases)?

5) Emergency trials Do you have a law on consent in emergency trials?

Do you have a guideline on consent in emergency trials?

–  –  –

6) Other questions:

Can parents contact directly Ethics Committees to obtain information?

Is there a role for national authorities when there is disagreement between parents and investigators?

Is an investigator required to provide information to parents in case of a negative opinion of Ethics Committee during trial?

–  –  –

Special conditions (trial characteristics) for consent from only one parent Special conditions for consent from only one parent

–  –  –

Agreement between parents and adolescents should be reached if parents negative and adolescent positive This was understood in most cases as respect of refusal from adolescent to participate (and not the possibility for an adolescent to consent when parents don’t)

–  –  –

List of issues to be taken into consideration for planning a paediatric study:

Identification and scientific validity of the study question to be answered Justification of the study to be performed in children and in the proposed age groups

–  –  –

The potential risks (real and theoretical) have been weighed against the expected benefits for the children enrolled in the clinical trial. The balance of risks versus expected benefits should be positive for the clinical trial.

The competence of the responsible study investigator and his/her team and the infrastructure of the institution or primary care practice that should be experienced in paediatric research in general and in particular in the field of the applied project.

The pre-clinical safety and efficacy data (investigator's brochure, available literature) that are preconditions for a paediatric clinical trial The clinical results of adult studies (literature, investigator's brochure), if any.

–  –  –

Comprehensive, understandable Informed Consent and Information sheets for legal representatives Understandable age specific Informed Assent and Information sheet for children

–  –  –

World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Revision 2002.

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.

European Treaty Series – No 164.Oviedo, 4 IV 1997.

Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research Strasbourg, 25.I.2005 Clinical investigation of medicinal products in the paediatric population. ICH E11.

CPMP/ICH/2711/99. http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf CIOMS guidelines (CIOMS IV Working group)

–  –  –

CESP Guidelines

-. Gill D. Ethical principles and operational guidelines for good clinical practice in paediatric research.

Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr 2004; 163: 53-57.

- De Lourdes Levy M, Larcher V, Kurz R: Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr 2003;162:629-633.

- Mason S, Megone C. European Neonatal Research Consent Ethics Committtees and law. Ashgate, Aldershot 2001.

- MRC Ethics Guide. Medical research involving children. November 2004 27.2 North America guidance

- FDA. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biologicals products in pediatric patients. Fed Reg 1998;63:66631-72

- FDA. Additional safeguards for children in clinical investigation of FDA-regulated products (21 CFR 50.53). Federal Register 2001; 66: 20589-20600.

- American Academy of Pediatrics. Committee on Drugs. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 1995; 95: 286-294.

- Ethical conduct of clinical research involving Children. MJ Field and R Behrman Ed. Institute of Medicine. 2004. The National Academies Press.

- Health Canada Therapeutic products Directorate. Draft Guideline on “Inclusion of pediatric subjects in clinical trials”. http://www.hc-sc.gc.ca

–  –  –


- Royal College of Paediatrics and Child Health: Ethics Advisory Committee. Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 2000; 82: 177-182.


- Perspectives on medical research conducted in children. Final report on the Working Group appointed by the National Advisory Board on Health care Ethics.

http://www.etene.org/dokumentit/ChresEN3.pdf Lötjönen S. The regulation of Neonatal Research in Finland.

27.4 Relevant Publications on research and CTs in children

- Steinbrook R. Testing medications in children. N Engl J Med 2002; 347: 1462-1470.

- Steinbrook R. Registration of clinical trials – Voluntary or Mandatory. N Engl J Med.2004;351:1820-2.

- Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-145.

- Koski G, Nightingale SL. Research involving human subjects in developing countries. N Engl J Med 2001;345:136-138.

- Phillips B. Towards evidence based medicine for paediatricians. Arch Dis Child 2004;89:286-290

- Schreiner M. Paediatric clinical trials: redressing the imbalance. Nature Reviews 2003; 2:949-961.

- Emmanuel E J, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000; 283: 2701Smyth R L, Weindling A M. Research in children: ethical and scientific aspects. Lancet 1999; 354 S2: 2124.

- Thompson L. Human gene therapy. Harsh lessons, high hopes. FDA consumer magazine.

www.fda.gov/fdac/features/2000/500_gene.html. Accessed 26/9/2004

- Glantz LH Research with children. Am J Law 1998;24:213-44

- Wendler D. Forster H. Why we need legal standards for pediatric research. J Pediatr 2004;150-3.

- Kopelman L. Pediatric research regulations under legal scrutiny L Law Med Ethics 2002;30:38-49.

- Helms P J. ‘Real world’ pragmatic clinical trials: what are they and what do they tell us. Pediatr Allergy Immunol 2002; 13: 4-9.

- Braunholtz D A, Edwards S J, Lilford R J. Are randomized clinical trials good for us (in the short term)? Evidence of a “trial effect”. J Clin Epidemiol 2001; 54: 217-224.

- Ware J H, Antmann E M. Equivalence trials. N Engl J Med 1997; 337: 1159-1161.

- Coppola G. Treatment of partial seizures in childhood: an overview. CNS Drugs 2004;18:133-156.

–  –  –

- Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet. 2004;364 :365-367.

- Shah S. Globalization of clinical research by the pharmaceutical industry. Int J Health Serv 2003; 33:


- Shirkey HC. Therapeutic orphans. J Pediatr1968;72:119-20.

27.5 Consent and assent – Parental decisions

- Susman EJ, Dorn LD, Fletcher JC. Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians. J Pediatr 1992;121:547-552.

- Rossi WC, Reynolds W, Nelson RM. Child assent and parental permission in pediatric research.

Theor Med Bioeth 2003;24:131-148.

- Harth S C, Thong Y H. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med 1995; 41: 1647-1651.

- Singhal N, Oberle K, Burgess E, Huber-Okrainec J. Parents’ perception of research with newborns. J Perinatol 2002; 22: 57-63.

- Van Stuijvenberg M, Suur M H, de Vos S et al. Informed consent, parental awareness and reasons for participating in a randomised controlled study. Arch Dis Child 1998; 79: 120-125.

- Rothmier J D, Lasley M V, Shapiro G G. Factors influencing parental consent in pediatric clinical research. Pediatrics 2003; 111: 1037-1041.

- Zupancic JA, Gillie P, Streiner DL, Watts JL, Schmidt B. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics 1997;99:E6.

- Coulibaly-Traore D, Msellati P, Vidal L, Ekra CW, Dabis F. The Ditrame (ANRS049) clinical trial aimed at reducing the mother-child transmission of HIV in Abidjan. Participants’ understanding of the trial principles. Presse Med 2003;32:343-350.

- Devereux JA, Jones DP, Dickenson DL. Can children withhold consent to treatment? BMJ 1993;


- Tait AR, Voepel-Lewis T, Malviya S. Factors that influence parents’ assessments of the risks and benefits of research involving their children. Pediatrics 2004; 113:727-32

- Weithorn LA. Children’s capacities to decide about participation in research. IRB;1983;5:1-5.

- Leikin. An ethical issue in biomedical research: The involvement of minors in informed and third party consent. Clin Res 1983;31:34-40

- Weithorn LA, Scherer DG. Children involevement in research participation decisions: Psychological considerations. In: Grodin MA, Glanz LH (eds) Children as research subjects: Science Ethics and Law. New York: Oxford University Press 1994;133-79.

–  –  –

- Stenson B J, Becher J-C and McIntosh N. Neonatal research: the parental perspective. Arch. Dis.

Child. Fetal Neonatal Ed., Jul 2004; 89: F321 - F324

- Allmark P, Mason S, Gill AB, Megone C. Obtaining consent for neonatal research.

Arch Dis Child Fetal Neonatal Ed 2003 88:F166-7

- Allmark P, Mason S, Gill AB, Megone C. Is it in a neonate's best interest to enter a randomised controlled trial? J Med Ethics. 2001 Apr;27(2):110-3.

- Dalla-Vorgia P, Mason S, Megone C, Allmark P, Bratlid D, Gill AB, Morrogh P, Plomer A, ReiterTheil S. Overview of European legislation on informed consent for neonatal research. Arch Dis Child Fetal Neonatal Ed 2001;84:F70-3.

- Schmidt B, Gillie P, Cano C, Roberts J, Roberts R. do sick newborn infants benefit from participation in a randomized clinical trial? J Pediatr 1999;134:130-1

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