Growing Up in Ireland –the national longitudinal study of children in Ireland

Securing Informed Consent

EUCCONET Meeting

17-18th February 2009

Government funded study, carried out as part of National Statistical System

Study is being carried out by a consortium of researchers led by the Economic and Social Research Institute (ESRI) and Trinity College, Dublin (TCD)

Background

to study the lives of children in Ireland

to establish what is typical and normal as well as what is atypical and problematic

to identify the key factors that most help or hinder children’s development

to establish the effects of early child experiences on later life

to obtain children’s views and opinions on their lives

Policy focus - to provide evidence for the creation of effective and responsive policies and services for children and families

Objectives

Two cohorts of children.

• 8,500 9-year old children – the children themselves and their parent(s) / guardian(s) and other carers (if relevant)

• 10,000 9-month old infants – parent(s) / guardian(s) and other carers (if relevant)

• 120 households for in-depth qualitative assessment for both cohorts

• The 9-year-old children is being interviewed twice within initial phase of project – at 9 and 13 years.

• The family of the 9-month old cohort is being interviewed at9 months and 3 years.

• Envisaged study will run for seven years

Nature and Scale of Growing Up in Ireland

The Nine-Year Cohort – Overview

• School Component:– Principal– Teacher– Academic assessment tests in English and Maths

School had pivotal role in securing initial informed consent / assent

• Home Component Interviews with:– Primary caregiver – usually Mother – Spouse / Partner Primary (where relevant) – usually father– Study Child– Measurements – height and weight– Carer / non-resident parent where relevant (postal)

Main variable domains in home-based questionnaire

1. Child’s health and physical development – health, lifestyle, exercise, diet

2. Child’s Emotional, Social and Cognitive Functioning

3. Child’s education

4. Parenting/Family context – family structure, parenting style,parent’s lifestyle

5. Community/Neighbourhood

6. Socio-demographics

The Nine-Year Cohort - Variable Domains

Qualitative Component, 9 year cohort

120 families selected from main quantitative sample.

• In the course of main quantitative study families consent to be included in selection for qualitative study.

• Semi-structured interviews with the child and parent(s) / guardian(s).

• Multi-method participatory approach – range of techniques and activities. Photo diaries, structured interviews, letter to the minister, time capsule, drawings etc. Fun experience for child.

• Domains explored map onto those covered by quantitative study.

Quantitative Component, 9-month cohort

• Families of 10,000 infants

• Selected randomly from Child Benefit Register

• Primary and secondary caregiver (where relevant) interviewed

• Self completion questionnaires for non-resident parents and other care givers (crèche, baby minder etc)

• Fieldwork 70 per cent completed – complete by end March

Variable Domains, 9-month Cohort

• Temperament

• Attachment to parent(s) / guardian(s)

• Child’s physical, emotional, cognitive development

• Health from birth

• Habits – crying, sleeping, feeding etc.

• Childcare arrangements Prenatal care and mother’s lifestyle during pregnancy

• Birth and delivery

• Family context – parental stress, supports,

• Work-life, quality of parental relationship

• Parental lifestyles

• Neighbourhood and socio-demographic characteristics

Qualitative Component, 9-month cohort

• Semi-structured interview with parents – maps to domains of quantitative component

• Vignettes – parental attitudes and behaviours to discipline, emergencies, attachment and sensitivity

• Infant / toddler HOME

• Bayley scale of infant development

Study Team

Children’s Advisory ForumScientific and Policy Advisory Forum

Parents of 9-year-olds

Multi-disciplinary panel of experts

Interdepartmental Steering Group

Research Ethics Committee

Inputs to Consent Protocols, Forms and Leaflets

Stakeholder groups

Securing consent in the 9-year cohort

• School of pivotal importance. Random sample of 850 schools used as Primary Sampling Units

• Children within age scope selected within schools

• Information pack sent home to parents by the schools– Introductory letter - multilingual– Children’s information sheet– Parent information sheet– Parents consent form – signed by parent(s) / guardian(s)– Child’s assent form– Duplicate copies for parents and children

• Work in the schools commenced with children only after consent / assent forms signed

Informed consent in the 9-year cohort – the information leaflet to the families

• Background to the study

• Purpose of the study

• Funders

• How the family was selected

• What is involved in participation

• Confidentiality

• Flavour of questions asked

• Longitudinal nature of study – return visit

• Right to withdraw from study

• Respondent’s information provided only to donor – not to third parties – very important for children & teacher questionnaires.

• Contact numbers and addresses

Informed consent in the 9-year cohort – additional consents in the home

• Follow up / tracing information – alternative contact address

• Personal Public Service Number

• Permission to be considered for inclusion in Qualitative Study

• Permission to be included in nested studies

Informed consent in the 9-year cohort – qualitative component

• Sample selected from families who had already consented to have names included for qualitative component

• Introductory letter and information leaflet on qualitative component – phone follow up

• Child and parent / guardian information sheets comparable to those in quantitative component

• Child / Parent consent / assent forms signed prior to interview

Informed consent in the 9-month cohort

• Introductory letter with information leaflet from the Study Team

– Background and nature of the study– What participation involves– Who is funding and running the study– Confidentiality– How child / family was selected– Flavour of questions to be asked– Longitudinal nature of study and follow up at age 3 years– Respondents rights– Contact information

Consent form – the 9-month cohort

• Interviewer visits the household

• Interviewer explains the background to the study and goes through information sheet

• Interviewer explains consent form

• Generally arranges for subsequent visit for interview or to allow the parent(s) / guardian(s) time to consider.

• Consent form signed before interviewing or measurements take place

The 9-month cohort – consent to access related datasets

Permission for access at micro level to:

• National Perinatal Recording System (NPRS) – • details on birth, weight, gestation period, child’s health, child’s

feeding, mother’s health, mother’s ante-care,

• National Immunisation Database – immunisations received

• Nested Studies – none planned as yet but possibility of future studies

• Personal Public Service Number for tracing and potential future linkage

• 2 alternative contact addresses for tracing

Informed consent in the 9-month cohort – qualitative component

• Families already consented to have names included for qualitative component

• Introductory letter and information leaflet on qualitative component – phone follow up

• Child and parent / guardian information sheets comparable to those in quantitative component

• Child / Parent consent / assent forms signed prior to interview

Underlying legislation

• Carried out as part of National Statistical System

• Role of Irish National Statistics Institute very important

• Statistics Act 1993

• Same guarantee of confidentiality as in, e.g., Census of Population

• Confidentiality – statistical compilation and analysis purposes only

• No third party release – especially important for children and teachers