1. Nuremberg Code, Guideline 1 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No 10 vol 2 (Washington, DC: US Government Printing Office, 1949) pp 181–182 Google Scholar, online: http://www.nihtraining.com/ohsrsite/guidelines/nuremberg.html; at 235–236.

2. World Medical Association Helsinki Declaration Ethical Principles for Medical Research Involving Human Subjects (October 2000) Part B, paras 20, 22, online: http://www.wma.net/e/policy/b3.htm (hereafter Helsinki Declaration); Council for International Organisations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 2002)Google ScholarPubMedGuideline 4 and Commentary, online: http://www.cioms.ch/frame_guidelines_nov_2002.htm (hereafter CIOMS Guidelines); UNESCO Universal Declaration on Bioethics and Human Rights (19 October 2005) Art 6(2), online: http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html (hereafter UNESCO Declaration).

3. Levine, R Children as Research Subjects’ in Kopelman, L and Moskop, J (eds) Children and Health Care: Moral and Social Issues (Boston: Kluwer Academic Publishers, 1989) p 73 CrossRefGoogle Scholar at pp 73–76.

4. Kauffman, R Scientific Issues in Biomedical Research with Children’ in Grodin, M and Glantz, L (eds) Children as Research Subjects: Science, Ethics, and Law (New York: Oxford University Press, 1994)Google Scholarch 1 at pp 34–37.

5. Caldwell, P et al Clinical trials in children’ (2004) 364 Lancet 803 CrossRefGoogle ScholarPubMed; ch 3 at pp 52–56.

6. Murphy and Goldkind, ibid.

7. Society for Adolescent Medicine ‘Guidelines for Adolescent Health Research’ (2003) 33 Journal of Adolescent Health 396 Google ScholarPubMed at 396–397.

8. Nelson, R Children as Research Subjects’ in Kahn, J, Mastroianni, A and Sugarman, J (eds) Beyond Consent: Seeking Justice in Research (New York: Oxford University Press, 1998) p 62 Google Scholar, citing the US National Institutes of Health and American Academy of Pediatrics policy statements.

9. R Nelson ‘Including Children in Research: Participation or Exploitation’ in Santoro and Gorrie, above n 5, ch 4 at pp 69–70.

10. UK Medical Research Council Medical research involving children (London: Medical Research Council, 2004)Google ScholarPubMedat 25, online: http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430.

11. Still, Jg The Pediatric Research Initiative in the United States: Implications for Global Pediatric Research’ (2000) 34 Drug Information Journal 207 CrossRefGoogle Scholar at 208–210; D Murphy ‘Pediatric Drug Development: What have we learned?’ FDA Office of Pediatric Therapeutics presentation to the Institute of Medicine (13 June 2006), online: http://www.fda.gov/oc/opt/presentations/IOM2006.html (hereafter FDA OTP).

12. ICH Harmonised Tripartite Guideline Clinical Investigation of Medicinal Products in the Pediatric Population: E11 (20 July 2000), online: http://www.ich.org/cache/compo/276-254-1.html.

13. Simar, Mr Pediatric Drug Development: the International Conference on Harmonization Focus on Clinical Investigations in Children’ (2000) 34 Drug Information Journal 809 CrossRefGoogle Scholar at 810.

14. See generally, Singapore: The Biopolis of Asia, online: http://www.biomed-singapore.com/bms/sg/en_uk/index.html.

15. Chen Huifen ‘Singapore well cut out to be clinical trial hub’ The Business Times 5 April 2006.

16. Ministry of Health, Singapore Funding and Medical Research, online: http://www.moh.gov.sg/mohcorp/fundings.aspx?id=112.

17. CIOMS Guidelines, above n 2, Guideline 9; UNESCO Declaration, above n 2, Art 7(b).

18. ICH Harmonised Tripartite Guideline Guideline for Good Clinical Practice E6(R1) (10 June 1996), para 4.8.14, online: http://www.ich.org/cache/compo/276-254-1.html.

19. See CIOMS Guidelines, above n 2, Guideline 14; cf Helsinki Declaration, above n 2, para 24, which refers to the ‘informed consent’ of a legally authorised representative of the incompetent subject.

20. See Glantz, L Research with Children’ (1998) 24 Am J of Law & Med 213 Google ScholarPubMed at 219–220.

21. See Weisstub, D et al Biomedical Experimentation with Children: Balancing the Need for Protective Measures with the Need to Respect Children's Developing Ability to Make Significant Life Decisions for Themselves’ in Weisstub, D (ed) Research on Human Subjects: Ethics, Law and Social Policy (Oxford: Pergamon, 1998)Google Scholarch 19 at pp 392–394.

22. CIOMS Guidelines, above n 2, Guideline 14; Helsinki Declaration, above n 2, para 25.

23. CIOMS Guidelines, ibid, Guideline 14.

24. See Wendler, D and Shah, S Should Children Decide Whether They Are Enrolled in Nonbeneficial Research’ (2003) 3(4) American Journal of Bioethics 1.CrossRefGoogle ScholarPubMed

25. Helsinki Declaration, above n 2, Part B, para 13; CIOMS Guidelines, above n 2, Guideline 2.

26. 2000 Rev Ed Sing, reg 3 (hereafter CTR).

27. Singapore: Ministry of Health, 1999 (hereafter SGGCP).

28. See above n 26, reg 11(1) and (2).

29. Ibid, reg 11(6).

30. Ibid, reg 11(2).

31. Ibid, reg 11(9).

32. King, N Defining and describing benefit appropriately in clinical trials’ (2000) 28 Journal of Law Medicine and Ethics 332 CrossRefGoogle ScholarPubMed at 333.

33. SI 2004/1031 (hereafter MHUCTR).

34. Ibid, Sch 1, Part 4, para 10 (emphasis added).

35. Ibid, para 13.

36. Weizing, L et al Consequences of Directive 2001/20/Ec for investigator-initiated trials in the paediatric population-a field report’ (2007) 166 Eur J Pediatrics 1169 CrossRefGoogle Scholar at 1174.

37. Hagger, L and Woods, S Children and Research: A Risk of Double Jeopardy’ in Freeman, M (ed) Children's Health and Children's Rights (Leiden: Martinus Nijhoff, 2006) pp 54–55.Google Scholar

38. Directive 2001/20/EC (4 April 2001) [2001] OJ L121/34 (hereafter ECTD).

39. Recommendations of the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric Population (2008), online: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/ethical_considerations.pdf (hereafter EC Guidelines).

40. Ibid, at 19, para 12.

41. Ibid, at 20, para 12.1.

42. ETS No 164 (1 December 1999), online: http://conventions.coe.int/Treaty/en/Summaries/Html/164.htm (hereafter Biomedicine Convention).

43. Above n 39, at 17, para 11.1.

44. Above n 42, at paras 111–114.

45. Above n 33, at para 7.

46. UK Department of Health Draft Guidance on Consent by a Legal Representative on Behalf of a Person Not Able to Consent under the Medicines for Human Use (Clinical Trials) Regulations 2003 (London: Department of Health, March 2003).Google Scholar

47. Above n 39, at 18, para 11.1.

48. Singapore: Bioethics Advisory Committee, 2004; online: http://www.bioethics-singapore.org/resources/reports3.html (hereafter BAC, Guidelines for IRBs).

49. Ministry of Health, Director of Medical Services Directive 1A/2006 (18 January 2006) at para 3, which states ‘The Singapore Medical Council would, in evaluating the appropriateness of a doctor's actions in research involving human subjects, rely on the BAC's recommendations as the standard for ethical conduct. Doctors are therefore expected to familiarize themselves with the BAC's recommendations and to comply with them’.

50. National Medical Ethics Committee, Ministry of Health Ethical Guidelines on Research involving Human Subjects (1997) at para 2.5.5, online: http://www.moh.gov.sg/mohcorp/uploadedFiles/Publications/Guidelines/human_bmr.pdf (hereafter NMEC Ethical Guidelines).

51. Ibid.

52. Royal College of Paediatrics and Child Health Ethics Committee ‘Guidelines for the ethical conduct of medical research involving children’ (2000) 82 Archives of Disease in Childhood 177 CrossRefGoogle ScholarPubMed at 179 (hereafter RCPCH Guidelines).

53. Medical Research Council Ethics Guide: Medical research involving children (2004) at para 4.3, online: http://www.mrc.ac.uk (hereafter MRC Guidelines).

54. Royal College of Physicians Guidelines on the practice of ethics committees in medical research with human participants (London: Royal College of Physicians, 4th edn, 2007)Google ScholarPubMedat paras 5.11–5.14 (hereafter RCP Guidelines).

55. This test is taken from the House of Lords' decision in S v S [1972] AC 24.

56. Above n 52 at 180; n 53 at para 5.1.4a. See also, Department of Health Seeking Consent: working with children (London: Department of Health, November 2001)Google ScholarPubMedat 25–26.

57. Above n 52.

58. Above n 53 and RCP Guidelines, above n 54, at para 5.13.

59. RCPCH Guidelines, above n 52, MRC Guidelines, above n 53.

60. RCPCH Guidelines, above n 52. See also section (d) (iii) below.

61. Ibid. See also RCP Guidelines, above n 54, at paras 5.13–5.20.

62. Nicholson, R (ed) Medical Research with Children: Ethics, Law & Practice (Oxford: Oxford University Press, 1986)Google Scholarch 5 at pp 118–119.

63. See above n 49.

64. Medical Registration Act (Cap 174, 2004 Rev Ed Sing) Part VII.

65. Ibid, s 2; above n 48, at paras 2.30–2.35.

66. Above n 48, at paras 3.25–3.26.

67. See for example Secretary, Department of Health and Community Services v JWB and SMB (1992) 175 CLR 218 at 269–272, 278–280, per Brennan J (hereafter Marion's case). In Singapore, the parens patriae jurisdiction in respect of minors is explicitly reserved for the High Court by s 17(d) of the Supreme Court of Judicature Act (Cap 322, 2007 Rev Ed Sing). See also, Laurie, G Parens Patriae Jurisdiction in the Medico-Legal Context: the Vagaries of Judicial Activism’ (1999) 3 Edinburgh Law Review 95 CrossRefGoogle Scholar at 98.

68. Marion's case, ibid, at 239–240, 258–259, per Mason CJ, Dawson, Toohey and Gaudron JJ.

69. Ibid, at 280–281, per Brennan J.

70. Ibid, at 259, per Mason CJ, Dawson, Toohey and Gaudron JJ. Cf Brennan J at 270–272.

71. Nicholson, above n 62, ch 6 at pp 134–135.

72. Re Eve (1987) 31 DLR (4th) 1 (SCC).

73. Ibid, at para 86, per La Forest J.

74. See for example Williams, R Pediatric Research and the Parens Patriae Jurisdiction in Canada and England’ (1999) 18 Medicine & Law 525 Google ScholarPubMed at 539, 545–546. These views raised concerns amongst many commentators uncomfortable with the implications for the advancement of knowledge and therapies for paediatric conditions and diseases: see for example at 198–199. For further obstacles in the Canadian context, see at 132–136.

75. Hart v Brown (1972) 289 A2d 386 at 373–375 (SC, Connecticut).

76. Curran v Bosze (1990) 566 NE2d 1319 (SC Illinois),

77. Ibid, at 1343–1344.

78. Ibid. Apart from this psychological benefit, it was clear that the bone marrow donation was of no physical benefit to the child donor.

79. In the Marriage of GWW and CMW (1997) 21 Fam LR 612 (Fam Ct, Aus).

80. See also In re Y (adult patient) (bone marrow transplant) [1997] 2 WLR 556, where the court was prepared to infer ‘benefit’ from the improvement of the incompetent's relationship with her mother who very much desired the procedure and the eternal gratefulness of the donee sister.

81. Simms v Simms [2003] Fam 83.

82. Ibid, at [64]. See also J Harrington ‘Deciding Best Interests: Medical Progress, Clinical Judgment and the ‘Good Family’ [2003] 3 Web JCLI, online: http://webjcli.ncl.ac.uk/2003/contents3.html, who argues that the court took a relational view of best interests.

83. Mason, K and Laurie, G Law and Medical Ethics (Oxford: Oxford University Press, 2006)Google Scholarch 18 at para 18.5.

84. Ibid, at para 19.12.

85. Above, n 55.

86. Ibid, at 44, per Lord Reid (emphasis added).

87. Ibid, at 44, per Lord Reid; at 58, per Lord Hodson.

88. See the typology offered by Kopelman, L The Best Interests Standard as Threshold, Ideal, and Standard of Reasonableness’ (1997) 22 Journal of Medicine and Philosophy 271 CrossRefGoogle ScholarPubMed at 279–281. Kopelman articulates three senses of ‘best interests’: as a threshold for intervention in child abuse and neglect cases, an ideal to promote the good of children or establish prima facie duties, and as a standard of reasonableness based on what most informed rational people would do to maximise net benefits and minimise net harms.

89. Above, n 55, at 43.

90. Dworkin, above n 74, Nicholson, above n 62, at p 135, Kennedy, I and Grubb, A Principles of Medical Law (New York: Oxford University Press, 1998)Google Scholarch 13 at p 730, para 13.40.

91. Above n 55, at 57, per Lord Hodson.

92. B Dickens ‘The Use of Children in Medical Experimentation’ (1975) Medico-Legal Journal 166 at 168–169.

93. Grimes v Kennedy Krieger Institute (2002) 782 A2d 807.

94. Ibid, at 852–853 (emphasis added). In doing so, the court affirmed an earlier decision in TD et al v New York State Office of Mental Health (1996) 228 AD2d 95 at 124 (SC App Div, New York), which held that ‘a parent or guardian…may not consent to have a child submit to painful and/or potentially life-threatening [greater than minimal risk] research procedures that hold no prospect of benefit for the child and that may have the same result as a denial of necessary medical treatment…’.

95. Grimes, ibid, at 858.

96. Ibid, at 862.

97. Ibid, at 853.

98. Ibid, at 855–856, citing TD v NYSOMH (1995) 626 NYS2d 1015 (trial court) at 1017–21, which in turn cited Prince v Massachusetts (1944) 321 US 158 (SC) at 170.

99. Grimes, ibid, at 856 fn 41.

100. 45 CFR §46.102(i) (2006).

101. Kopelman, L Minimal Risk as an International Ethical Standard in Research’ (2004) 29(3) Journal of Medicine and Philosophy 351 CrossRefGoogle ScholarPubMed at 360–365; at 38.

102. See Ackerman, T Moral Duties of Parents and Nontherapeutic Clinical Research Procedures Involving Children’ (1980) 2(2) Bioethics Quarterly 94 CrossRefGoogle ScholarPubMed at 105–106.

103. Wendler, above n 101 at 38.

104. K McDonnell ‘Medical Research and Dependent People’ in Proceedings of the Twentieth World Congress of Philosophy (1998), reproduced in Robinson, J et al A Health Law Reader: An Interdisciplinary Approach (Durham: Carolina Academic Press, 1999) p 218.Google Scholar

105. See Kopelman, above n 88.

106. L Glantz ‘The Law of Experimentation with Children’ in Grodin and Glantz, above n 4, ch 4 at pp 104–111.

107. Ibid, p 105.

108. D Brock ‘Children's Competence for Health Care Decisionmaking’ in Kopelman and Moskop, above n 3, p 181 at pp 196–197.

109. Marion's case, above n 67, at 280, per Brennan J. Cf Brock, ibid, at p 197.

110. See Ross, L Phase I Research and the Meaning of Direct Benefit’ (2006) 149 Journal of Pediatrics S20 CrossRefGoogle ScholarPubMed at S22.

111. On the difficulties associated with judicial resolution or clarification, see Dickens, above n 74, at 146–147.

112. Ackerman, above n 102, at 95–96. See also Dickens, above n 92.

113. S v S, above n 55, at 45, per Lord Reid.

114. See Marion's case, above n 67.

115. Above n 50.

116. See Kopelman, above n 101.

117. Freedman, B et al In Loco Parentis: Minimal Risk as an Ethical Threshold for Research upon Children’ (1993) 23(2) Hastings Center Report 13 CrossRefGoogle ScholarPubMed at 16.

118. Ibid, at 17.

119. Ibid, at 16.

120. 45 CFR §46.405 and §46.406 (2006) respectively.

121. A study by Ong, Meh et al A Review of 2,517 Childhood Injuries seen in a Singapore Emergency Department in 1999 – Mechanisms and Injury Prevention Suggestions’ (2003) 44(1) Singapore Medical Journal 12 Google Scholar at 12–19, found that a majority (56.4%) of observed injuries occurred in the home, while 14.4% were road, 8.2% sport and 7.4% playground related.

122. Thein, Mm et al Childhood injuries in Singapore: a community nationwide study’ (2005) 46(3) Singapore Medical Journal 116.Google ScholarPubMed

123. Above n 117.

124. Freedman et al above n 117, adopt a subjective interpretation.

125. See for example Field, M and Berman, R (eds) Ethical Conduct of Clinical Research Involving Children (Washington: National Academies Press, 2004)Google Scholarch 4 at p 126, which rejected a subjective interpretation in favour of a standard indexed to the experiences of average, healthy, normal children.

126. Kopelman, L, ‘Children as Research Subjects: a Dilemma’ (2000) 25(6) Journal of Medicine and Philosophy 745 CrossRefGoogle ScholarPubMed at 753–755.

127. Ackerman, above n 102, at 106–107 (emphasis added).

128. Ibid.

129. See E Wender ‘Assessment of Risk to Children’ in Grodin and Glantz, above n 4, ch 6.

130. Ackerman, above n 102. See also Wendler, above n 101, at 39–41.

131. For the Singapore Centre for Transfusion Medicine's guidelines on blood donation by minors, see Health Sciences Authority, online: http://www.hsa.gov.sg/publish/hsaportal/en/health_services/blood_donation/can_i_donate/who_can_donate.html.

132. See also Murray, T The Worth of a Child (Berkeley: University of California Press, 1996)Google Scholarch 4 at pp 86–87.

133. See, for example the assessment of the risks associated with blood sampling in Nicholson, above n 62, at 90–92, 120; Wendler, above n 101, at 38–39.

134. See, for example CIOMS Guidelines, above n 2, commentary on Guideline 9; Hull, D Guidelines for the ethical conduct of medical research involving children: Royal College of Paediatrics and Child Health’ (2000) 82 Arch Dis Child 177 Google Scholar at 179.

135. Wendler, above n 101, at 38–39.

136. Dan Brock ‘Ethical Issues in Exposing Children to Risks in Research’, in Grodin and Glantz, above n 4, ch 3 at pp 91–93.

137. Harris, J and Holm, S Should We Presume Moral Turpitude in Our Children? – Small Children and Consent to Medical Research’ (2003) 24 Theoretical Medicine and Bioethics 121 CrossRefGoogle ScholarPubMed at 123–124.

138. US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Research Involving Children DHEW Publication No (OS) 77-0004 (Washington: US Government Printing Office, 1977) ch 8 at pp 116–117.

139. Non-voluntary adult contribution to biomedical research is recommended in limited situations involving human tissue and personal information. See Bioethics Advisory Committee Human Tissue Research (Singapore: Bioethics Advisory Committee, 2002)Google ScholarPubMedat paras 8.1–9.6; at paras 5.16–5.33; online: http://www.bioethics-singapore.org/resources/reports.html.

140. Weisstub et al, above n 21, at pp 400–402 and Nicholson, above n 62, at pp 150–151.

141. Nelson, above n 8, at pp 61–62, citing Tauer, C The Nih Trials of Growth Hormone for Short Stature’ (1994) 16(3) IRB: A Review of Human Subjects Research 1 CrossRefGoogle ScholarPubMed, and

142. Ackerman, T Fooling Ourselves with Child Autonomy and Assent in Nontherapeutic Clinical Research’ (1979) 27 Clinical Research 345 Google ScholarPubMed at 346.

143. Weisstub et al, above n 21; Wendler, D Assent in paediatric research: theoretical and practical considerations’ (2006) 32 Journal of Medical Ethics 229 CrossRefGoogle ScholarPubMed at 230–231.

144. See, for example Baylis, F and Downie, J The Limits of Altruism and Arbitrary Age Limits’ (2003) 3(4) American Journal of Bioethics 19 CrossRefGoogle ScholarPubMed at 21.

145. Collogan, L and Fleischmann, A Adolescent Research and Parental Permission’ in Kodish, E (ed) Ethics and Research with Children: A Case-based Approach (New York: Oxford University Press, 2005)Google Scholarch 5 at p 86; at 551.

146. See Ramsey, B Appropriate Compensation of Pediatric Research Participants’ (2006) 149 Journal of Pediatrics S15.CrossRefGoogle ScholarPubMed

147. Dunn, L et al Assessing Decisional Capacity for Clinical Research or Treatment: a Review of Instruments’ (2006) 163(8) American Journal of Psychiatry 1323 CrossRefGoogle ScholarPubMed at 1324–26;

148. Brown, P Human Independence and Parental Proxy Consent’ in Gaylin, W and Macklin, R (eds) Who Speaks For The Child: The Problem of Proxy Consent (New York: Plenum Press, 1982)Google Scholarch 7 at pp 212–214.

149. Ross, L Children as Research Subjects: a Proposal to Revise the Current Federal Regulations Using a Moral Framework’ (1997) 8 Stanford Law & Policy Review 159 Google ScholarPubMed at 164–166.

150. Above n 28. The default age of majority in Singapore at common law is 21 years: Rai Bahadur Singh and Another v Bank of India [1993] 1 SLR 634 (HC); affirmed on the point by Bank of India v Rai Bahadur Singh and Anor [1994] 1 SLR 328 (CA).

151. Above n 28.

152. See Gillick v West Norfolk and Wisbech AHA and Anor [1986] AC 112 (HL).

153. See Glantz, above n 20, at 225–226.

154. Above n 26, reg 11(2).

155. See, for example CIOMS Guidelines, above n 2, Commentary to Guideline 14. The US National Commission, above n 138, at p 16, distinguished ‘assent’ from a legally valid consent. The former represents a child's ability to understand the purposes and procedures of research and indicate her wish regarding participation. The US Federal Regulations define assent to mean a child's ‘affirmative agreement to participate in research’: 45 CFR §46.402 (2006).

156. Above n 152, at 189, per Lord Scarman.

157. Above n 27, para 4.8.12 read with para 4.8.5, which together provide that where a minor cannot give ‘informed consent’, ‘the subject should be informed about the trial to the extent compatible with the subject's understanding and, if capable, the subject should sign and personally date the written informed consent’.

158. Above n 50.

159. Above n 33, Part 4, para 4. The MRC view this measure as additional protection device in that it disallows even competent minors (under 16 years of age) from consenting to participation in clinical trials: MRC Guidelines, above n 53, at para 25.

160. Ibid, at paras 6 and 7.

161. Above n 33, reg 2.

162. Ibid, Sch I, Part 3.

163. See RCPCH Guidelines, above n 52, at 180; MRC Guidelines, above n 53, at paras 5.1.3–5.1.3a, which also notes the different position in Scotland, where individuals aged 16 and above may give consent of legal effect in any transaction: Age of Legal Capacity (Scotland) Act 1991, c 50, s 1.

164. MRC Guidelines, above n 53, at para 5.1.4.

165. RCPCH Guidelines, above n 52, at 180; MRC Guidelines, ibid, at para 5.1.4.a. See also, Department of Health Seeking Consent: Working with children (London: Department of Health, 2001)Google ScholarPubMedat 25.

166. The RCP Guidelines 2007, above n 54, at para 4.58, continue this advice, albeit in less absolute terms. In fact, the RCP's earlier Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (2nd edn, January 1990) advocated a dual consent approach for subjects below the age of 18 (at para 13.1). A similar recommendation was made by the Institute of Medical Ethics working group in respect of non-beneficial research: Nicholson, above n 62, at p 151.

167. Marion's case, above n 67, at 316, per McHugh J.

168. Above n 55, at 45.

169. Above n 156. See also Marion's case, above n 67, at 316, per McHugh J; cf Brennan J at 280–281.

170. Re R [1992] Fam 11 (CA).

171. Re W [1993] Fam 64 (CA).

172. Bonner v Moran 126 F2d 121 (1941) (USCA, DC). See also, Glantz, above n 20, at 227–229 and Re W, ibid, at 78–79, where Lord Donaldson observed obiter that it was inconceivable, in the context of organ donation, that doctors would proceed solely on the basis of the consent of a Gillick competent child without ‘supporting parental consent’ or a court order.

173. Medical Research Council of Canada Guidelines for Research Involving Human Subjects (Ottawa: Minister of Supply and Services Canada, 1987)Google ScholarPubMedat 29.

174. Collogan and Fleischman, above n 145, at pp 84–86.

175. Weisstub et al, above n 21, at p 394.

176. See section 2 (d) (iii) above.

177. Brody, J et al Voluntary Assent in Biomedical Research with Adolescents: a Comparison of Parent and Adolescent Views’ (2003) 13(1) Ethics & Behavior 79 CrossRefGoogle ScholarPubMed at 93.

178. As recognised in the CTR, above n 26, reg 14.

179. As recognised in the NMEC Ethical Guidelines, above n 50, para 2.5.5.1.

180. Beyleveld, D and Brownsword, R Consent in the law (Oxford: Hart Publishing, 2007)Google ScholarPubMedch 1 at pp 5–7.

181. In re C (Adult: Refusal of Treatment) [1994] 1 WLR 290 (Fam). This test was applied to a minor in Wolverhampton Metropolitan Borough Council v DB [1997] 1 FLR 767 (Fam).

182. Cf CIOMS Guidelines, above n 2, which appears to conceive of assent as agreement to participate which falls short of legally valid consent solely on the score of the chronological age of majority.

183. See Weithorn, L, ‘Children's Capacities to Decide about Participation in Research’ (1983) 5(2) Hastings Center Report 1 Google ScholarPubMed at 2.

184. S Leikin ‘An Ethical Issue in Biomedical Research: The Involvement of Minors in Informed and Third Party Consent’ (1983) Clinical Research 34 at 39.

185. Ackerman, above n 142. Cf NMEC Ethical Guidelines, above n 50.

186. See generally, Collogan and Fleischmann, above n 145, at pp 83–85.

187. Ibid.

188. Weisstub et al, above n 21, at pp 399–403.

189. W Rossi et al ‘Child Assent and Parental Permission in Pediatric Research’ (2003) Theoretical Medicine and Bioethics 131 at 142–143; V Miller and R Nelson, ‘A Developmental Approach To Child Assent For Nontherapeutic Research’ (2006) Journal of Pediatrics S25 at S29.

190. Wendler, above n 143.

191. See Nicholson, above n 62, ch 7 at p 148.

192. See W Bartholome ‘Parents, Children and the Moral Benefits of Research’ (1976) Hastings Center Report 44 at 45.

193. Above n 144.

194. Scott, E et al Evaluating Adolescent Decision Making in Legal Contexts’ (1995) 19(3) Law and Human Behavior 221 CrossRefGoogle Scholar at 224–229.

195. Above nn 170 and 171 respectively. In Ney v Canada (Attorney General) (1993) 79 BCLR (2d) 47 (BC SC) the court noted that it was still uncertain at common law whether parental control yields to the child's independence or whether there are concurrent powers of consent.

196. Cap 347, 1985 Rev Ed Sing, s 3(2)(c).

197. Smoking (Control of Advertisements and Sale of Tobacco) Act (Cap 309, 2003 Rev Ed Sing), s 10.

198. Scott et al, above n 194, at 228.

199. Ibid.

200. J Santelli et al ‘Recruitment of Pregnant, Minor Adolescents at Risk of Pregnancy into Longitudinal Observational Research’ in Kodish, above n 145, at p 110.

201. Steinberg, L and Cauffman, E Maturity of Judgment in Adolescence: Psychosocial Factors in Adolescent Decision Making’ (1996) 20(3) Law and Human Behavior 249.CrossRefGoogle Scholar

202. See for example Brazier and Bridge, ‘Coercion or caring: analyzing adolescent autonomy’ (1996) 16 Legal Studies 84 CrossRefGoogle Scholar at 89–93, who advocate a test based on a maximally autonomous choice free from defects in control, reasoning and information/experience, but not defects in stability of values and preferences.

203. Collogan and Fleischman, above n 145, at p 86, citing Leikin, Sl ‘Minors' assent or dissent to medical treatment’ (1983) 102(2) Journal of Pediatrics 169 CrossRefGoogle ScholarPubMed at 169–176; at 287–297; at 412–427.

204. Scott et al, above n 194, at 231, citing W Gardner and J Herman ‘Adolescent's risk taking: A rational choice perspective’ in Gardner, W, Millstein, S and Wilcox, B (eds) Adolescents in the AIDS Epidemic (San Francisco: Jossey-Bass, 1993) pp 17–34.Google Scholar

205. Ibid.

206. R Jagtiani, ‘I'm on a drug trial’ The Straits Times 24 September 2006, which noted a trend in Singapore of young adult and minor students enrolling in clinical trials and other biomedical research to make extra pocket money.

207. See text accompanying nn 106–109 above.

208. In respect of clinical trial participation: CTR, above n 26, reg 14.

209. See text accompanying n 192 above.

210. Brody, J et al ‘Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols’ (2005) 37 Journal of Adolescent Health 229 CrossRefGoogle ScholarPubMed at 234.

211. Snethen, J et al ‘Family Patterns of Decision-Making in Pediatric Clinical Trials’ (2006) 29 Research in Nursing & Health 223.CrossRefGoogle ScholarPubMed

212. See Joffee, S ‘Rethink “Affirmative Agreement” but Abandon “Assent”’ (2003) 3(4) American Journal of Bioethics 9 CrossRefGoogle Scholar at 10; S Leikin, above n 184; Miller and Nelson, above n 189, at S28–29.

213. For recommendations on appropriate practices in obtaining informed consent from parents and adolescents, see Broome, et al ‘Children in Research: New Perspectives and Practices for Informed Consent’ (2003) 5 IRB: Ethics & Human Research S20 CrossRefGoogle Scholar at S23.

214. As defined in section (d) (ii) above.

215. Collogan and Fleischman, above n 145, at p 91.

216. Cf Collogan and Fleischman, ibid, at p 94.

217. See, for example, the example given by 45 CFR §46.408(c) (2006).

218. Women's Charter (Cap 353, 1997 Rev Ed Sing), s 17.

219. Above n 197, s 10.

220. Medical (Therapy, Research and Education) Act (Cap 175, 1985 Rev Ed Sing), s 3.

221. Enlistment Act (Cap 93, 2001 Rev Ed Sing), s 10.

222. See above n 131.

223. See for example Appelbaum, P et al ‘False Hopes and Best Data: Consent to Research and the Therapeutic Misconception’ (1987) 17(2) The Hastings Center Report 20 CrossRefGoogle ScholarPubMed at 20–21.

224. Above n 25.

225. Miller, P and Kenny, N ‘Walking the Moral Tightrope: Respecting and Protecting Children in Health-Related Research’ (2002) 11 Cambridge Quarterly of Healthcare Ethics 217 CrossRefGoogle ScholarPubMed at 222.

226. SGGCP, above n 27, at 8, para 1.37.

227. BAC, Guidelines for IRBs, above n 48, at para 2.20.

228. Ibid, at para 2.25, citing a Singapore Ministry of Health Directive dated 25 June 1998.

229. Ibid, at paras 3.9 and 3.25 respectively.

230. Ibid, at para 4.17(d).

231. Ibid, at paras 5.12–5.17: although institutions may share IRBs or refer protocols to an IRB established by a parent organisation, these IRBs are still, by definition, principally institution-based.

232. See Wendler, above n 101, at 40–41.

233. See Scott et al above n 194; Steinberg and Cauffman, above n 201.

234. J Lantos ‘Children and Clinical Research’ (Transcript of presentation to the President's Council on Bioethics, 20 April 2006), online: http://www.bioethics.gov/transcripts/april06/session4.html.

235. Kopelman, above n 126, at 757.

236. Edgar, H and Rothman, D ‘The Institutional Review Board and beyond: Future Challenges to the Ethics of Human Experimentation’ (1995) 73(4) The Millbank Quarterly 489 CrossRefGoogle ScholarPubMed at 497–502.