The Human Developmental Biology Resource 2023

• Research type

  Research Tissue Bank

• IRAS ID

  330783

• Research summary

  The Human Developmental Biology Resource (HDBR)

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  23/NE/0135

• Date of REC Opinion

  14 Jul 2023

• REC opinion

  Favourable Opinion

• Data collection arrangements

  Embryonic/fetal material will be collected from consenting women undergoing surgical and medical termination of pregnancy between 4 and 23+6 weeks. Anonymised samples will be transferred to the HTA licensed centre at Newcastle University.

  Women who are eligible to participate in the study will be approached by a member of the research team:
  - Inpatients: when they attend the ward/unit for a TOP;
  - Outpatients: over the telephone at a convenient time.

  Inpatients eligible to donate will be given a verbal explanation about the project by the research team member and the Patient Information Sheet (sent by email if consenting remotely). Women are then given a minimum of 1 hour to consider donation before being re-approached to take written consent from those wishing to participate.

  If an outpatient wishes to donate, liaising with the clinical team, an inpatient appointment will be booked and the woman will be provided with information about admission. On admission to the clinic, the research team member will attend the ward and check if the woman has any questions and whether she still wishes to donate. If the woman confirms that she still wishes to donate, written consent will be taken by the research nurse/midwife/approved team member.

• Research programme

  While animal models provide a useful starting point to understand how humans develop, there are clear differences between humans and other animals; higher cognitive function and language ability are two obvious examples. These differences are also seen at a molecular level. For example, some genes are only present in humans and the expression of shared genes varies substantially between species. These differences mean that to fully understand how humans develop, we need to look directly using human tissue. The HDBR provides both genetically normal and abnormal human embryonic and fetal tissue to researchers. The tissues provided are used to study the usual developmental process of tissue and organ development. This is vital research, as without knowing what the normal developmental process are we can’t appreciate what happens when these processes are perturbed, which in some case can ultimately result in a congenital anomaly at birth. The material is also used to study specific diseases, either by mimicking the aberration through the creation of a disease model, or through studies using the genetically abnormal tissue samples. The ultimate long-term goal of the research the HDBR tissue bank supports is to improve diagnostics and develop preventative measures and treatments for birth defects.

• Storage license

  12534

• RTBTitle

  The Human Developmental Biology Resource (HDBR)

• Establishment organisation

  Newcastle University

• Establishment organisation address

  International centre for Life

  Times Square

  Newcastle Upon Time

  NE1 3BZ