The referral process begins with a Duke physician (or physician from a collaborating program) who encounters a patient who could meet the inclusion criteria:
- With parental consent, the treating physician refers the patient to the Task Force for Neonatal Genomics for consideration.
- The TFNG genetic counselor reviews the patient’s medical records and previous clinical testing.
- The TFNG decides by consensus that (a) the child qualifies for the study; (b) the child does not qualify for the study; or (c) to continue to monitor the prospective patient and family via the treating physician. In such cases, the TFNG may monitor until there is sufficient information with which to make a recruitment decision.
- For families that are both eligible and interested, the genetic counselor and referring physician discuss participation.
- If the family agrees to proceed, the genetic counselor meets with the patient and family to begin the informed consent process. The consent process allows for family members to have any and all questions answered to their satisfaction. The consent process informs prospective families:
- what is involved in participating
- the attendant risks
- the possible benefits
- procedures for withdrawal at any time
- clear explanation of the fate of participants’ samples and information during and after the study
For additional information, please read more about how the research study works.