Abstract

Session presented on Thursday, July 21, 2016 and Friday, July 22, 2016:

Background: The past twenty years have seen distinct shifts in the way the participation of children and adolescents in research is viewed. This has been emphasized by the growing pediatric research enterprise. Additional information on children's and adolescents' experiences during research participation is needed to better inform researchers on the ethical conduct of research with this vulnerable population.

Aims: The objective of this analysis was to examine ethical issues in research with children and adolescents from their perspective as participants, including: assent, parental consent, risk perception, impact of research participation, and incentives.

Methods: This systematic review was conducted per the Long et al. framework by means of an iterative searching process. Using the key words 'research ethics' and 'child or pediatric or adolescent', PubMed, CINAHL, and EBSCOhost databases were searched to identify articles. Limitations placed on the original searches were: English language, year of publication between 2003-2014, humans, abstract available, and age birth-18 years.

Findings: Twenty-three empiric studies were identified and formed the sample. Included studies represented a diverse range of areas of research, methods, settings, sample demographics, authors, and journals.

Discussion: Even young children demonstrated the ability to understand essential elements of research, although there is variability in children's level of understanding. Trust was a significant contributing factor to children's and adolescents' participation in research, and also shaped their assessments of risk. Research participation was mainly beneficial for children and adolescents. Incentives were mainly viewed positively, although concerns of possible undue influence were expressed.

Conclusions: This systematic review highlights the importance of including the perspectives of children and adolescents and provides researchers and nurse clinicians with best practices for involving children in research. Key conclusions included that: Assent processes and instruments need to be created with the assistance of child development specialists and piloted with children before being used. A priori consultation with representative adolescents and parents can provide guidance for developing consent and assent procedures within challenging contexts. All research with children and adolescents could benefit from inclusion of a short, formative, off-study interview or survey with participants to gauge their experience in the study. An important gap in the literature is consideration of whether children and adolescents, beyond simply understanding their research rights, are capable of applying this knowledge and of actually exerting their research rights.

Author Details

Stacey Crane, RN, CPON and Marion E. Broome, RN, FAAN

Sigma Membership

Alpha

Lead Author Affiliation

Indiana University, Indianapolis, Indiana, USA||Duke University, Durham, North Carolina, USA

Type

Poster

Format Type

Text-based Document

Study Design/Type

N/A

Research Approach

N/A

Keywords:

Research Ethics, Children and Adolescents, Participant Perspective

Conference Name

27th International Nursing Research Congress

Conference Host

Sigma Theta Tau International

Conference Location

Cape Town, South Africa

Conference Year

2016

Rights Holder

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All permission requests should be directed accordingly and not to the Sigma Repository.

All submitting authors or publishers have affirmed that when using material in their work where they do not own copyright, they have obtained permission of the copyright holder prior to submission and the rights holder has been acknowledged as necessary.

Review Type

0 1

Acquisition

Proxy-submission

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Understanding ethical issues of research participation from the perspective of participating children and adolescents

Cape Town, South Africa

Session presented on Thursday, July 21, 2016 and Friday, July 22, 2016:

Background: The past twenty years have seen distinct shifts in the way the participation of children and adolescents in research is viewed. This has been emphasized by the growing pediatric research enterprise. Additional information on children's and adolescents' experiences during research participation is needed to better inform researchers on the ethical conduct of research with this vulnerable population.

Aims: The objective of this analysis was to examine ethical issues in research with children and adolescents from their perspective as participants, including: assent, parental consent, risk perception, impact of research participation, and incentives.

Methods: This systematic review was conducted per the Long et al. framework by means of an iterative searching process. Using the key words 'research ethics' and 'child or pediatric or adolescent', PubMed, CINAHL, and EBSCOhost databases were searched to identify articles. Limitations placed on the original searches were: English language, year of publication between 2003-2014, humans, abstract available, and age birth-18 years.

Findings: Twenty-three empiric studies were identified and formed the sample. Included studies represented a diverse range of areas of research, methods, settings, sample demographics, authors, and journals.

Discussion: Even young children demonstrated the ability to understand essential elements of research, although there is variability in children's level of understanding. Trust was a significant contributing factor to children's and adolescents' participation in research, and also shaped their assessments of risk. Research participation was mainly beneficial for children and adolescents. Incentives were mainly viewed positively, although concerns of possible undue influence were expressed.

Conclusions: This systematic review highlights the importance of including the perspectives of children and adolescents and provides researchers and nurse clinicians with best practices for involving children in research. Key conclusions included that: Assent processes and instruments need to be created with the assistance of child development specialists and piloted with children before being used. A priori consultation with representative adolescents and parents can provide guidance for developing consent and assent procedures within challenging contexts. All research with children and adolescents could benefit from inclusion of a short, formative, off-study interview or survey with participants to gauge their experience in the study. An important gap in the literature is consideration of whether children and adolescents, beyond simply understanding their research rights, are capable of applying this knowledge and of actually exerting their research rights.