Journal of Clinical Epidemiology
-
(2014)
-
LETTER TO THE EDITOR Obtaining informed consent in pediatric clinical trials To the Editor: Recruiting children for clinical studies remains a challenge [1]. For recruitment to be valid, the investigators must obtain signed parental informed consent in advance, after both oral and written information about the study has been given [2]. Unfortunately, participant refusal rates, which may introduce substantial selection bias and lead to study failure, are not well documented. In their article, Kaguelidou et al. [3] questioned parental refusal regarding the participation of their children in clinical research and also investigated the factors influencing pediatricians’ decisions to refer children to clinical research trials. The median refusal rate of the 36 studies evaluated in their survey was 12.5% (refusal rate ranges between 0% and 28%). The authors concluded that refusal to participate in clinical research was influenced by factors related to the characteristics and perceptions of the recruiting pediatricians. Moreover, the parents’ refusal rate was reduced by about three-quarters (74%) when families were invited to participate in trials by a pediatrician with teaching responsibilities [3]. A previous study [4] also demonstrated that the time that pediatricians spend in their own research activities might influence their decision to refer a child to a clinical research trial. Additionally, many subjective factors related to the investigators may also potentially influence their decision making in referring their patients to pediatric clinical research trials including concerns about the scientific merit of the study, patient benefit, and anticipated refusal to participate [5]. However, parents were more interested in enrolling their child into clinical research trials than practitioners anticipated [6] and merely needed adequate and sufficient information to make their decision [7]. In this regard, between March 2012 and April 2012, we examined the participation refusal rate of children’s families who had been asked to give consent for their children to take part in a prospective study being conducted at the pediatric emergency service of a university hospital. This study aimed to evaluate the prevalence of potential pathogens responsible for diarrheal disease in stool and saliva specimens collected from children younger than 5 years.
Funding: No funding was received for this study. Conflict of interest: The authors have declared no conflicts of interest. 0895-4356/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved.
The results of this study will be published elsewhere. The recruitment was performed by a dedicated clinical research assistant who was present at the pediatric emergency service during the study period. A total of 312 parents were approached for consent to enroll their children into the study. Among them, 34 (10.9%) refused to give their consent. Our refusal rate was comparable with that observed in the study by Kaguelidou et al. in which pediatricians with clinical research experience were involved in the recruitment process. In conclusion, although there is some evidence to support the importance of involving investigators who are active in research activities to improve child recruitment into clinical trials, dedicated clinical research assistants may also be required to better inform families about the research studies and to support pediatricians in obtaining informed consent in light of their time constraints. Samir Benkouiten Aix Marseille Universite, URMITE UM63, CNRS 7278, IRD 198, Inserm 1095 27 bd Jean Moulin, 13005 Marseille, France Institut Hospitalo-Universitaire Mediterranee Infection 13005 Marseille, France
Philippe Minodier Urgences Pediatriques, CHU Nord 265 chemin des Bourrely, 13015 Marseille, France
Didier Raoult Philippe Brouqui* Aix Marseille Universite, URMITE, UM63 CNRS 7278, IRD 198, Inserm 1095 27 bd Jean Moulin, 13005 Marseille, France Institut Hospitalo-Universitaire Mediterranee Infection 13005 Marseille, France *Corresponding author. Tel.: þ33-(0)491-32-43-75; fax: þ33-(0)491-38-77-72. E-mail address: [email protected] (P. Brouqui)
References [1] Menson EN, Walker AS, Gibb DM. Clinical trials in children. Lancet 2004;364:2176e7. [2] Smyth RL, Weindling AM. Research in children: ethical and scientific aspects. Lancet 1999;354(Suppl 2):SII21e4. [3] Kaguelidou F, Amiel P, Blachier A, Iliescu C, Roze JC, Tsimaratos M, et al. Recruitment in pediatric clinical research was influenced by study characteristics and pediatricians’ perceptions: a multicenter survey. J Clin Epidemiol 2013;66:1151e7.
2
Letter to the Editor / Journal of Clinical Epidemiology
[4] Dalen J, Annett RD, Brody JL, Perryman ML. Influences upon pediatricians’ willingness to refer patients to clinical research. Open Access J Clin Trials 2010;2:23e8. [5] Amiel P, Moreau D, Vincent-Genod C, Alberti C, Hankard R, Ravaud P, et al. Noninvitation of eligible individuals to participate in pediatric studies: a qualitative study. Arch Pediatr Adolesc Med 2007;161(5):446e50. [6] Shilling V, Williamson PR, Hickey H, Sowden E, Beresford MW, Smyth RL, et al. Communication about children’s clinical trials
-
(2014)
-
as observed and experienced: qualitative study of parents and practitioners. PLoS One 2011;6(7):e21604. [7] Tait AR, Voepel-Lewis T, Malviya S. Participation of children in clinical research: factors that influence a parent’s decision to consent. Anesthesiology 2003;99:819e25.
http://dx.doi.org/10.1016/j.jclinepi.2014.02.004
-
(2014)
-
LETTER TO THE EDITOR Obtaining informed consent in pediatric clinical trials To the Editor: Recruiting children for clinical studies remains a challenge [1]. For recruitment to be valid, the investigators must obtain signed parental informed consent in advance, after both oral and written information about the study has been given [2]. Unfortunately, participant refusal rates, which may introduce substantial selection bias and lead to study failure, are not well documented. In their article, Kaguelidou et al. [3] questioned parental refusal regarding the participation of their children in clinical research and also investigated the factors influencing pediatricians’ decisions to refer children to clinical research trials. The median refusal rate of the 36 studies evaluated in their survey was 12.5% (refusal rate ranges between 0% and 28%). The authors concluded that refusal to participate in clinical research was influenced by factors related to the characteristics and perceptions of the recruiting pediatricians. Moreover, the parents’ refusal rate was reduced by about three-quarters (74%) when families were invited to participate in trials by a pediatrician with teaching responsibilities [3]. A previous study [4] also demonstrated that the time that pediatricians spend in their own research activities might influence their decision to refer a child to a clinical research trial. Additionally, many subjective factors related to the investigators may also potentially influence their decision making in referring their patients to pediatric clinical research trials including concerns about the scientific merit of the study, patient benefit, and anticipated refusal to participate [5]. However, parents were more interested in enrolling their child into clinical research trials than practitioners anticipated [6] and merely needed adequate and sufficient information to make their decision [7]. In this regard, between March 2012 and April 2012, we examined the participation refusal rate of children’s families who had been asked to give consent for their children to take part in a prospective study being conducted at the pediatric emergency service of a university hospital. This study aimed to evaluate the prevalence of potential pathogens responsible for diarrheal disease in stool and saliva specimens collected from children younger than 5 years.
Funding: No funding was received for this study. Conflict of interest: The authors have declared no conflicts of interest. 0895-4356/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved.
The results of this study will be published elsewhere. The recruitment was performed by a dedicated clinical research assistant who was present at the pediatric emergency service during the study period. A total of 312 parents were approached for consent to enroll their children into the study. Among them, 34 (10.9%) refused to give their consent. Our refusal rate was comparable with that observed in the study by Kaguelidou et al. in which pediatricians with clinical research experience were involved in the recruitment process. In conclusion, although there is some evidence to support the importance of involving investigators who are active in research activities to improve child recruitment into clinical trials, dedicated clinical research assistants may also be required to better inform families about the research studies and to support pediatricians in obtaining informed consent in light of their time constraints. Samir Benkouiten Aix Marseille Universite, URMITE UM63, CNRS 7278, IRD 198, Inserm 1095 27 bd Jean Moulin, 13005 Marseille, France Institut Hospitalo-Universitaire Mediterranee Infection 13005 Marseille, France
Philippe Minodier Urgences Pediatriques, CHU Nord 265 chemin des Bourrely, 13015 Marseille, France
Didier Raoult Philippe Brouqui* Aix Marseille Universite, URMITE, UM63 CNRS 7278, IRD 198, Inserm 1095 27 bd Jean Moulin, 13005 Marseille, France Institut Hospitalo-Universitaire Mediterranee Infection 13005 Marseille, France *Corresponding author. Tel.: þ33-(0)491-32-43-75; fax: þ33-(0)491-38-77-72. E-mail address: [email protected] (P. Brouqui)
References [1] Menson EN, Walker AS, Gibb DM. Clinical trials in children. Lancet 2004;364:2176e7. [2] Smyth RL, Weindling AM. Research in children: ethical and scientific aspects. Lancet 1999;354(Suppl 2):SII21e4. [3] Kaguelidou F, Amiel P, Blachier A, Iliescu C, Roze JC, Tsimaratos M, et al. Recruitment in pediatric clinical research was influenced by study characteristics and pediatricians’ perceptions: a multicenter survey. J Clin Epidemiol 2013;66:1151e7.
2
Letter to the Editor / Journal of Clinical Epidemiology
[4] Dalen J, Annett RD, Brody JL, Perryman ML. Influences upon pediatricians’ willingness to refer patients to clinical research. Open Access J Clin Trials 2010;2:23e8. [5] Amiel P, Moreau D, Vincent-Genod C, Alberti C, Hankard R, Ravaud P, et al. Noninvitation of eligible individuals to participate in pediatric studies: a qualitative study. Arch Pediatr Adolesc Med 2007;161(5):446e50. [6] Shilling V, Williamson PR, Hickey H, Sowden E, Beresford MW, Smyth RL, et al. Communication about children’s clinical trials
-
(2014)
-
as observed and experienced: qualitative study of parents and practitioners. PLoS One 2011;6(7):e21604. [7] Tait AR, Voepel-Lewis T, Malviya S. Participation of children in clinical research: factors that influence a parent’s decision to consent. Anesthesiology 2003;99:819e25.
http://dx.doi.org/10.1016/j.jclinepi.2014.02.004
