Observational research with adolescents: a framework for the management of the parental permission

BMC Medical Ethics

Jokin de Irala²  Alfonso Osorio³  Carlos Beltramo⁴  Maria Calatrava⁴  Silvia Carlos²  Cristina Lopez-del Burgo²  Miguel Ruiz-Canela¹ 

[1] Department of Biomedical Humanities, University of Navarra, Pamplona, Spain;Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain;Department of Education, University of Navarra, Pamplona, Spain;Institute for Culture and Society, University of Navarra, Pamplona, Spain

关键词: Research subjects;    Health surveys;    Observational research;    Research ethics;    Parental consent;    Adolescents;   

Others  :  799996
DOI  :  10.1186/1472-6939-14-2

 received in 2012-09-14, accepted in 2012-12-31,  发布年份 2013

【 摘 要 】

Background

Waiving parent permission can be an option in some epidemiological and social research with adolescents. However, exemptions have not been uniformly considered or applied. Our aim is to critically assess the different factors that could be taken into account when making decisions about waiving active parental permission in observational research with adolescents.

Discussion

In some cases alternatives to parental permission could be applied to protect the rights of both adolescents and parents and also to assure the benefits to adolescents as a group that can come from appropriately conducted studies. However, the criteria of ensuring minimal risk can be difficult to define and apply and a distinction between harm and discomfort is reviewed. Waiving active parental permission could be acceptable when the risk of harm is minimal; when the research questions are related to an activity for which adolescents are not legally considered to be children; when the risk of harm or discomfort may increase if parental permission is required; and when risk of discomfort is low because the questionnaire is not potentially offensive for some adolescents and/or for some parents.

Summary

Stringent rules concerning parental permission in some studies could be detrimental to adolescents. A framework and a decision tree guide are proposed to help researchers and Research Ethics Committees in their decisions on whether active parental permission must be obtained.

【 授权许可】

   
2013 Ruiz-Canela et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Coughlin SS, Beauchamp TL: Ethics and epidemiology. New York: Oxford University Press; 1996.
• [2]CIOMS: International ethical guidelines for epidemiological studies. Geneva: CIOMS; 2009.
• [3]Rothman KJ: Commentary: epidemiology still ascendant. Int J Epidemiol 2007, 36:710-711.
• [4]Rahu M, McKee M: Epidemiological research labelled as a violation of privacy: the case of Estonia. Int J Epidemiol 2008, 37:678-682.
• [5]Ness RB, Joint Policy Committee: Influence of the HIPAA privacy rule on health research. JAMA 2007, 298:2164-2170.
• [6]Kho ME, Duffett M, Willison DJ, Cook DJ, Brouwers MC: Written informed consent and selection bias in observational studies using medical records: systematic review. BMJ 2009, 338:b866.
• [7]Wartenberg D, Thompson WD: Privacy versus public health: the impact of current confidentiality rules. Am J Public Health 2010, 100:407-412.
• [8]Hansson MG: Need for a wider view of autonomy in epidemiological research. BMJ 2010, 340:c2335.
• [9]Hakulinen T, Arbyn M, Brewster DH, Coebergh JW, Coleman MP, Crocetti E, Forman D, Gissler M, Katalinic A, Luostarinen T, Pukkala E, Rahu M, Storm H, Sund R, Tornberg S, Tryggvadottir L: Harmonization may be counterproductive-at least for parts of Europe where public health research operates effectively. Eur J Public Health 2011, 21:686-687.
• [10]Emanuel EJ, Menikoff J: Reforming the regulations governing research with human subjects. N Engl J Med 2011, 365:1145-1150.
• [11]Santelli JS, Smith Rogers A, Rosenfeld WD, DuRant RH, Dubler N, Morreale M, English A, Lyss S, Wimberly Y, Schissel A, Society for Adolescent Medicine: Guidelines for adolescent health research. A position paper of the Society for Adolescent Medicine. J Adolesc Health 2003, 33:396-409.
• [12]Chartier M, Stoep AV, McCauley E, Herting JR, Tracy M, Lymp J: Passive versus active parental permission: implications for the ability of school-based depression screening to reach youth at risk. J Sch Health 2008, 78:157-164. quiz 184-6
• [13]Sammons H: Ethical issues of clinical trials in children: a European perspective. Arch Dis Child 2009, 94:474-477.
• [14]Olds RS: Informed-consent issues with adolescent health behavior research. Am J Health Behav 2003, 27(Suppl 3):S248-S263.
• [15]Piercy H, Hargate M: Social research on the under-16s: a consideration of the issues from a UK perspective. J Child Health Care 2004, 8:253-263.
• [16]Kelly AB, Halford WK: Responses to ethical challenges in conducting research with Australian adolescents. Aust J Psychol 2007, 59:24-33.
• [17]Helweg-Larsen K, Boving-Larsen H: Ethical issues in youth surveys: potentials for conducting a national questionnaire study on adolescent schoolchildren's sexual experiences with adults. Am J Public Health 2003, 93:1878-1882.
• [18]Risjord M, Greenberg J: When IRBs disagree: waiving parental consent for sexual health research on adolescents. IRB 2002, 24:8-14.
• [19]English A, Santelli JS, Rogers AS: Legal and ethical issues in adolescent health care and research. In Adolescent health. Understanding and preventing risk behaviors. Edited by DiClemente RJ, Sanelli JS, Crosby RA. Hoboken, NJ: Jossey-Bass; 2009:531-547.
• [20]Lothen-Kline C, Howard DE, Hamburger EK, Worrell KD, Boekeloo BO: Truth and consequences: ethics, confidentiality, and disclosure in adolescent longitudinal prevention research. J Adolesc Health 2003, 33:385-394.
• [21]Caskey JD, Rosenthal SL: Conducting research on sensitive topics with adolescents: ethical and developmental considerations. J Dev Behav Pediatr 2005, 26:61-67.
• [22]The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont Report. Ethical Principles and Guidelines for the protection of human subjects of research. 1979. April 18. [http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html webcite]
• [23]United Nations: Convention on the rights of the child. 1989. http://www2.ohchr.org/english/law/crc.htm webcite
• [24]World Health Organization: Adolescent Health. [http://www.who.int/topics/adolescent_health/en/ webcite]
• [25]Breinbauer C, Maddaleno HM: Youth: choices and change: promoting healthy behaviors in adolescents. Washington D.C.: Paho; 2005.
• [26]Hunfeld JA, Passchier J: Participation in medical research; a systematic review of the understanding and experience of children and adolescents. Patient Educ Couns 2011, 87:268-276.
• [27]Bruzzese J, Fisher CB: Assessing and enhancing the research consent capacity of children and youth. Appl Dev Sci 2003, 7:13-26.
• [28]Flicker S, Guta A: Ethical approaches to adolescent participation in sexual health research. J Adolesc Health 2008, 42:3-10.
• [29]Stablein T, Jacbos SH: Waiving parental consent when researching at-risk youth. In The Well-Being, Peer Cultures and Rights of Children. Volume 14. Edited by Bass LE, Kinney DA. Bingley: Emerald Group Pub Ltd; 2011:205-226.
• [30]Weithorn LA, Campbell SB: The competency of children and adolescents to make informed treatment decisions. Child Dev 1982, 53:1589-1598.
• [31]Mammel KA, Kaplan DW: Research consent by adolescent minors and Institutional Review Boards. J Adolesc Health 1995, 17:323-330.
• [32]Snider DE Jr, Stroup DF: Defining research when it comes to public health. Public Health Rep 1997, 112:29-32.
• [33]Dang MT: Let teens provide their own consent for the HPV vaccine. Am J Nurs 2012, 112:11.
• [34]Swinford S: Girls of 13 given birth control jab at school without parents’ knowledge. The Telegraph 2012. October 28. [http://www.telegraph.co.uk/education/educationnews/9639650/Girls-of-13-given-birth-control-jab-at-school-without-parents-knowledge.html webcite]
• [35]Guttmacher Institute: An overview of minors's consent law. States Policies in Brief 2012. January 1. [http://www.guttmacher.org/statecenter/spibs/spib_OMCL.pdf webcite]
• [36]Miller FG: Research on medical records without informed consent. J Law Med Ethics 2008, 36:560-566.
• [37]Dawson AJ: Methodological reasons for not gaining prior informed consent are sometimes justified. BMJ 2004, 329:87.
• [38]Rojas NL, Sherrit L, Harris S, Knight JR: The role of parental consent in adolescent substance use research. J Adolesc Health 2008, 42:192-197.
• [39]Lepine S, Smolla N: Ethical issues concerning participants in community surveys of child and adolescent mental disorders. Can J Psychiatry 2000, 45:48-54.
• [40]Eaton DK, Lowry R, Brener ND, Grunbaum JA, Kann L: Passive versus active parental permission in school-based survey research: does the type of permission affect prevalence estimates of risk behaviors? Eval Rev 2004, 28:564-577.
• [41]Geluda K, Bisaglia JB, Moreira V, Maldonado BM, Cunha AJ, Trajman A: Third-party informed consent in research with adolescents: the good, the bad and the ugly. Soc Sci Med 2005, 61:985-988.
• [42]Anonymous: European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Eur J Health Law 2008, 15:223-250.
• [43]Westra AE, Wit JM, Sukhai RN, de Beaufort ID: How best to define the concept of minimal risk. J Pediatr 2011, 159:496-500.
• [44]Bull SS, Breslin LT, Wright EE, Black SR, Levine D, Santelli JS: Case study: an ethics case study of HIV prevention research on facebook: the Just/Us Study. J Pediatr Psychol 2011, 36:1082-1092.
• [45]Tigges BB: Parental consent and adolescent risk behavior research. J Nurs Scholarsh 2003, 35:283-289.
• [46]Range L, Embry T, MacLeod T: Active and passive consent: a comparison of actual research with children. Ethical Hum Sci Serv 2001, 3:23-31.
• [47]Blom-Hoffman J, Leff SS, Franko DL, Weinstein E, Beakley K, Power TJ: Consent procedures and participation rates in school-based intervention and prevention research: using a multi-component, partnership-based approach to recruit participants. School Ment Health 2009, 1:3-15.
• [48]Bergstrom JP, Partington S, Murphy MK, Galvao L, Fayram E, Cisler RA: Active consent in urban elementary schools: an examination of demographic differences in consent rates. Eval Rev 2009, 33:481-496.
• [49]Esbensen FA, Melde C, Taylor TJ, Peterson D: Active parental consent in school-based research: how much is enough and how do we get it? Eval Rev 2008, 32:335-362.
• [50]Secor-Turner M, Sieving R, Widome R, Plowman S, Vanden Berk E: Active parent consent for health surveys with urban middle school students: processes and outcomes. J Sch Health 2010, 80:73-79. quiz 108-10
• [51]Wolfenden L, Kypri K, Freund M, Hodder R: Obtaining active parental consent for school-based research: a guide for researchers. Aust N Z J Public Health 2009, 33:270-275.
• [52]Dahl T: Surveys in America’s classrooms: how much do parents really know - some further perspectives. J Educ 2009, 38:473-497.
• [53]Dahl T: Surveys in America’s classrooms: how much do parents really know. J Educ 2008, 37:143-192.
• [54]Eichner M: School surveys and children’s education: the argument for shared authority between parents and the state. J Educ 2009, 38:459-471.
• [55]Conn K: Parents’ right to direct their children’s education and student sex surveys. J Educ 2009, 38:139-150.
• [56]Boddy J, Oliver C: Research governance in children’s services: the scope for new advice. DFE-RB072; 2010. [https://www.education.gov.uk/publications/eOrderingDownload/DFE-RR072.pdf webcite]