The principles of consent, with respect to diagnosis and treatment, apply equally to the field of obstetrics as to other areas of medicine. However, several complexities arise where pathological examination of the fetus or products of conception are concerned. This article focuses primarily on the stillborn fetus and associated umbilical cord, membranes, placenta and amniotic fluid, where some of the consent issues are governed by the various legal requirements and laboratory accreditation standards.
For early termination or miscarriage (less than 20 weeks gestation) the fetus and fetal tissue are regularly referred to pathology services for examination. While written consent is not usually legally required, it is good practice to obtain the consent of the mother using a fit-for-purpose consent form. This form should include clear descriptions of the options in terms of the extent of examination to which consent is being given, ancillary testing (such as genetic testing and its implications), and options for return of organs to the body and return of the body to the family. Queensland Health provides such a form.1
The clinician obtaining consent should have an understanding of the legal requirements in their own jurisdiction. For stillbirths of 20 weeks gestation and beyond, Coronial Act requirements apply in most jurisdictions and if the newborn has shown signs of life, birth and death certificates are required.
In some jurisdictions, consent for a fetal autopsy can be encompassed within the usual autopsy consent form. The Stillbirth and Neonatal Death Alliance of the Perinatal Society of Australia and New Zealand is developing an update of the Perinatal Mortality Guidelines, which include matters such as the consent required for an autopsy. One difficulty is that the various consent forms for the jurisdictions differ and attempts to harmonise them have been deemed too difficult. In addition, the Guthrie card collection that is performed for all newborns is now almost routinely done for all stillbirths. However, if parents do not consent to an autopsy, consideration may be given to not performing the Guthrie card tests.
Recent developments in diagnostic genetics, such as comparative genomic hybridisation (CGH), exome or whole genome testing, require particular care in the area of consent. Increasingly, incidental findings may arise with implications for living relatives that are unrelated to the cause of the fetal death. For example, the cause of death in a stillborn may be placental abruption, however CGH microarray may reveal copy number variants unrelated to the stillbirth, but known to cause intellectual disability or other serious conditions. This is especially important to consider as almost all perinatal units have moved to routine CGH array testing rather than cytogenetics. The Royal College of Pathologists of Australasia provides guidance relating to incidental genetic findings.2 If an abnormality is discovered upon testing of the fetal tissue, genetic testing may be carried out, preferably following counselling by clinical geneticists.
In the case of stillbirth or perinatal death, all products of conception should be sent to the pathology service with the fetus/body and included within the above consent procedure. Where the baby is living, but there are other indications such as prematurity, maternal or fetal/neonatal complications or abnormalities, placental pathology should be requested, although no specific written consent procedure is required. Where fetal cells are to be stored or propagated in tissue culture, or tissues or cells are to be used in human transplantation, specific consent is required.
Storage/disposal/return to family
Fetal tissue derived from pregnancies of less than 20 weeks gestation is subject to the same storage and disposal requirements as other human tissue under National Pathology Accreditation Advisory Council Guidelines;3 that is, unused wet tissue is retained by the laboratory for a minimum of one month and paraffin-embedded tissue in blocks and histological slides for ten years. If the infant has lived, retention requirements extend to paediatric requirements, which are once again one month for wet tissue, but 25 years for blocks and slides. Nevertheless, good practice is for both the perinatal autopsy consent process and the pathology service to provide options where physically possible. This includes return of organs to the body and return of the body to the family and some jurisdictions also allow for various combinations of tissues, blocks and slides to be returned to the parents at any stage following an autopsy (although the limitations on future diagnostic possibilities should be pointed out to the family if this is to occur). It is also good practice for the pathology service to have a means to respectfully dispose of all human tissue, in particular, fetuses at less than 20 weeks, and many provide cremation services in which families can participate. Fetuses over 20 weeks gestation are subject to all legal requirements for burial or cremation in each jurisdiction, although blocks and slides will generally be retained as mentioned above.
The National Health and Medical Research Council (NHMRC) developed the National Statement on Ethical Conduct in Human Research 4 which provides extensive guidance on this topic with respect to pregnancy. It has separate guidance on gametes, embryos and/or participants in assisted reproductive treatments,5 while conduct around embryos excess to the needs of those for whom they were created using assisted reproductive technology is covered by Australian legislation.6
The NHMRC Statement describes potential conflicts of interest between research and clinical care and makes particular reference to terminations of pregnancy, where the possibility of research must not be considered until a decision to terminate has been made. It also advises having separate consent forms and processes for clinical care versus research, suggesting that different (qualified) individuals obtain these consents.
Researchers are advised to discuss with the woman the possibility of involving others for whom the research may have implications and appropriate counselling and support should be available. Any storage of the fetus or fetal tissue for later use in research should comply with the principles outlined above and be specifically consented to. If there is any potential for commercial application of outcomes of the research, including the development of stem cells or cell lines, this should be pointed out along with the advice that the mother will receive no benefit. All commercial trade in human tissue is illegal and use for education, quality and training is governed by the various jurisdictional Acts.
Access to perinatal autopsy is a vital part of any obstetric service and is a complex area in terms of consent, particularly in a situation of great distress for mothers and families and the workload-pressured environment of an obstetric unit. Despite the complexity, it is vital to follow some general principles for legal, clinical and compassionate reasons. The pathology service may be able to assist in decision-making and should be consulted where there are concerns. The service will most likely have options to conserve the tissue while these important issues are being clarified and is accustomed to assisting clinicians in these difficult situations.
- www.rcpa.edu.au/getattachment/ 7d264a73-938f-45b5-912f-272872661aaa/Massively-Parallel-Sequencing-Implementation.aspx.
- www.health.gov.au/internet/main/publishing.nsf/Content/B8562E2C3D131ED8CA257BF00019153C/$File/V0.24%20 Retention.pdf.
- www.nhmrc.gov.au/guidelines-publications/e72 (2007) (Updated May 2015).
- Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (NHMRC 2004).