Consent for autopsy research for unexpected death in early life

Research in sudden death in fetuses (stillbirth) and infants (sudden infant death syndrome [SIDS]) is urgently needed, particularly in high-risk populations involving socioeconomic disadvantaged families. Essential to such research is the analysis of fetal and infant tissues at autopsy. Obtaining consent for donating autopsy tissues for research is especially problematic in socioeconomically disadvantaged populations in which mistrust of the medical establishment often exists. In this article, we present communication strategies for obtaining consent for research in autopsy tissues of stillbirth and SIDS cases in socioeconomically disadvantaged populations. Recommendations are provided about preparation for and the timing, setting, and content of the consent interview. The same lines of open and transparent communication delineated in this article are applicable to obtaining consent for the autopsy and autopsy research. Although the grief responses to the untimely death of the fetus or infant are universal and the recommendations of this essay are widely applicable to the general population, the expression of this grief and feelings toward autopsy-based research in socioeconomically disadvantaged populations may raise special issues that health care workers should be aware of when obtaining consent for research on autopsy-derived tissues.     

The stillbirth collaborative research network postmortem examination protocol

After reviewing the state of knowledge about the scope and causes of stillbirth (SB) in a special workshop sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the participants determined that there is little guidance regarding the best use of postmortem examination (PM) to address the pathogenesis of stillbirth. In this report, we describe the PM procedure designed and used in the NICHD-supported Stillbirth Cooperative Research Network (SCRN). Perinatal pathologists, clinicians, epidemiologists, and biostatisticians at four tertiary care centers, a data coordinating center, and NICHD developed a standardized approach to perinatal PM, which was applied to a population-based study of stillbirth as part of the SCRN. The SCRN PM protocol was successfully instituted and used at the four medical centers. A total of 663 women with stillbirth were included: 620 delivered a single stillborn infant, 42 delivered twins, and one delivered triplets for a total of 676 stillborn infants. Of these women, 560 (84.5%) consented to PM (572 stillborn infants) that was conducted according to the SCRN protocol. A standardized PM protocol was developed to evaluate stillbirth consistently across centers in the United States. Novel testing and approaches that increase the yield of the PM can be developed using this model.     

Stillbirth Collaborative Research Network: design, methods and recruitment experience

The Stillbirth Collaborative Research Network (SCRN) has conducted a multisite, population-based, case-control study, with prospective enrollment of stillbirths and livebirths at the time of delivery. This paper describes the general design, methods and recruitment experience. The SCRN attempted to enroll all stillbirths and a representative sample of livebirths occurring to residents of pre-defined geographical catchment areas delivering at 59 hospitals associated with five clinical sites. Livebirths <32 weeks gestation and women of African descent were oversampled. The recruitment hospitals were chosen to ensure access to at least 90% of all stillbirths and livebirths to residents of the catchment areas. Participants underwent a standardised protocol including maternal interview, medical record abstraction, placental pathology, biospecimen testing and, in stillbirths, post-mortem examination. Recruitment began in March 2006 and was completed in September 2008 with 663 women with a stillbirth and 1932 women with a livebirth enrolled, representing 69% and 63%, respectively, of the women identified. Additional surveillance for stillbirths continued until June 2009 and a follow-up of the case-control study participants was completed in December 2009. Among consenting women, there were high consent rates for the various study components. For the women with stillbirths, 95% agreed to a maternal interview, chart abstraction and a placental pathological examination; 91% of the women with a livebirth agreed to all of these components. Additionally, 84% of the women with stillbirths agreed to a fetal post-mortem examination. This comprehensive study is poised to systematically study a wide range of potential causes of, and risk factors for, stillbirths and to better understand the scope and incidence of the problem.     

International issues in stillbirth

The phenomenon of stillbirth has been poorly addressed in terms of reported statistics and as a clinical issue. A Study Group of the European Association of Perinatal Medicine reviewed the topic and highlighted specific issues. Such proposal was discussed in an open workshop held in Modena, Italy last year and this paper reports the final recommendations.

Briefly, at least 22 completed weeks of gestation was endorsed as definition for including SB in statistics and for clinical studies. A minimum diagnostic work-up was suggested together with the emphasis toward a local, multidisciplinary audit process, in order to comprehend causality. Attention for parents emotional support and appropriate counselling was believed as essential part of the clinical process. Finally, the need for funding comprehensive research programs in SB through international, multidisciplinary involvement was believed mandatory for developing effective preventative strategies to avert the devastating occurrence of stillbirth.