Consent and Opt-out

 

It is essential that parents are informed fully of the benefits of the newborn-screening programme.  They should be given the Parent Information Leaflet during the third trimester of pregnancy and again at the time of obtaining consent. They should be told:

  • about the nature of the conditions which are being screened for;
  • If these conditions are detected soon after birth, treatment can be instituted and significant handicap and possibly premature death can be prevented.  Treatment is essentially by modification of the diet under careful medical supervision or by drugs, as for congenital hypothyroidism.
  • that a further sample may be required, either to check the first result or because of an equivocal result or a technical problem in the first analysis, such as a borderline result, an insufficient quantity of blood collected or assay interference;
  • that the newborn screening card will be retained for 10 years for the future benefit of the baby, if required;
  • that parents of an infant with a positive result will be contacted directly, usually by the maternity unit; clear instructions will be given.

 NB        Parents must be reassured that with early detection and treatment of most of the conditions their baby will develop essentially normally provided that the parents and then the child/adolescent adheres to the medical advice given.  For those with Cystic Fibrosis, early detection and management significantly improved the nutritional state of the child and reduced the number of admissions to hospital.

When parents consent to their baby being screened, one parent should sign the Newborn Screening card, preferably the mother (Guardianship of Infants Act, 1964) as she has automatic parental responsibility for the newborn.  The mother signs the Newborn Screening Card to:

  1. confirm that her baby’s details mare correct
  2. confirm that she has read the Parent Information Leaflet
  3. consent to her baby being screening

The appropriate leaflet from the Newborn Screening Card should be given to the parents and the Nurse Copy filed in the baby’s clinical notes as a record that consent for newborn screening has been given.

If the parent has literacy difficulties he/she can be asked to make a mark on the form – this mark must be witnessed by an adult other than the sample taker.

Right to Opt-out of Newborn Screening

Download and Print Opt-Out Form

Parents do have the right to opt-out from the programme on behalf of their baby.  However, parents should be actively discouraged from so doing in the best interest of their baby’s well-being. PHNs should consider seeking the support of the General Practitioner and the midwives or children’s nurses or the support of a consultant paediatrician in persuading parents to consent to the programme. If parents do decide to opt-out, it is essential that they are fully informed of the potential clinical consequences to their baby.  The benefits of screening are explained in the Parent Information Leaflet and the consequences of not detecting a case summarised on the Opt-out Form.

Parents must sign the HSE Opt-out Form; this must be witnessed and signed by all parties. A copy of the Opt-out Form must be given to the parents and a copies sent to the Directors of Public Health Nursing and Midwifery or Nursing and to the National Newborn Bloodspot Screening Laboratory.  A copy must also be sent to the infant’s General Practitioner.

Parents should be informed that they may change their mind in the future. However, it is their responsibility to make their change of mind known either to the PHN or to their General Practitioner.