伦理问题在儿童临床试验中的探讨与研究
摘要
伦理问题纳入到儿童临床试验中是一个需要引起重视的问题。在争取到家长及儿童的同意下进行临床研究， 防止出现在不需要儿童同意下引起他们真正参与的障碍。由于儿童的特殊性和临床试验的变化，无论参与临床试验的儿童 的年龄多大都需要赢得他们的同意，同时有必要做出正确的判断方法和过程，最大化地减少对孩子的伤害。参考
[1]Luchtenberg, M., Maeckelberghe, E., Locock, L., Powell,
L. and Verhagen, AAE,. Young People’s Experiences of
Participation in Clinical Trials: Reasons for Taking Part[J]. The
American Journal Of Bioethics: AJOB,2015, 15(11): 3–13.
[2]Baines, P. Let’s Be Clear About Children and Young
People[J]. American Journal of Bioethics,2015, 15(11):16–17.
[3]Navratil, J., McCauley, H.L., Marmol, M., Barone, J.
and Miller, E., . Involving Youth Voices in Research Protocol
Reviews[J]. American Journal of Bioethics, 2015,15(11): 33–34.
[4] 郭春彦，王晓玲，王天有，杜忠东 . 涉及儿童的药物
临床试验伦理审查要素 [J]. 中国临床药理学杂志，2016,(2)：
186-189.
[5]Rocchi, F. and Tomasi, P.. The development of
medicines for children[J]. Pharmacological Research,2011,
64(3):169–175.
[6] 郭春彦，张怡，丁倩，王谦，杨禹欣，冯晓萱，王天有 . 涉
及儿童的临床研究伦理审查指南 ( 北京 )[J]. 中国临床药理学
杂志，2021,37(11)：1476-1480.
[7]Jongsma, K., Bos, W. and Vathorst, S., . Morally Relevant
Similarities and Differences Between Children and Dementia
Patients as Research Subjects: Representation in Legal Documents
and Ethical Guidelines[J]. Bioethics, 2015,29(9):662–670.
[8]Crane, S. and Broome, M. E.,. Understanding Ethical
Issues of Research Participation From the Perspective of
Participating Children and Adolescents: A Systematic Review[J].
Worldviews on Evidence-Based Nursing, 2017,14(3):200–209.
[9]Phuhaibul, R.,. Ethical Issues in Research on Children[J].
Pacific Rim International Journal of Nursing Research,2016,
20(4):271-274.
[10] 张姝，卢仲毅，史文俊，甘芹，冉素娟 . 儿童临
床试验伦理要素与受试者保护机制研究 [J]. 医学与哲学，
2019,40(5)：43-44，60.
[11]JUNEJA, A., ADHIKARI, T. and RAO, M. V. V. , .
Some Objectivity to the Ethical Aspects in Conduct of Clinical
Research in Vulnerable Population[J]. Journal of Clinical and
Diagnostic Research, 2019,13(2): 1–2.
[12]Afhami, N., Nekuei, N., Bahadoran, P. and TaleghaniEsfahani, H., . Evaluation of ethical attitude approaches in
midwives and their relationship with their demographic
features[J]. Iranian Journal of Nursing and Midwifery
Research,2018, 23(3):193-197.
[13]Dabbagh, H. and Dabbagh, S., . Iranian Muslim
Reformists and Contemporary Ethics; Revival of
“Utilitarianism”[J]. Human and Society / nsan ve
Toplum,2018, 8(2):19–32.
[14]de Vries, M. C., . The Use of Dogmas in Pediatric
Research Ethics[J]. American Journal of Bioethics, 2015,15(11):
18–19.
[15]Brawner, B.M., Volpe, E.M., Stewart, J.M., and Gomes,
M.M., . Attitudes and beliefs toward biobehavioural research
participation: Voices and concerns of urban adolescent females
receiving outpatient mental health treatment[J]. Annals of Human
Biology, 2013,40(6): 485–495.
