Legal jurisdictions in most Western countries have legislation that allows a coroner or medical examiner to mandate an autopsy without consent by the next of kin in certain situations (e.g., suspected foul play, unexpected death, or when the cause of death is not clear). If these conditions are not met, consent by the next of kin is mandatory (1). Medicolegal autopsies usually allow for the retention of specimens, including whole organs, when necessary for pathological study. Investigations of (possible) homicide will typically take priority over family objections. Hospital autopsies were traditionally requested by physicians to understand the death of a patient under their care. For many decades, the standard autopsy consent form typically stated that it is customary practice to remove and retain some organs, tissues, and other parts as appropriate for diagnostic, research, or teaching purposes. However, legal precedent in American law indicates that it is advisable to secure extended consent if specimens are to be retained for dedicated research purposes (1). More explicit disclosure is necessary when the anticipated research might have diagnostic significance to living family members (2). Although DNA analysis on collected tissues offers major opportunities for understanding sudden death in the young, DNA sample collection also has particular ethical requirements (2).

In 1997, autopsy pathologists in North America expressed varied opinions concerning the ethical acceptability of using autopsy tissues for research and education (3). Perceived questionable autopsy practices, including the retention of brains, was the subject of a government inquiry that resulted in numerous regulations in Australia in the 1990s (4). In 2001, Japan instituted a law, the Ethics Guidelines for Human Genome/Genetic Analysis Research, which provided some oversight of the use of forensic autopsy material (5). In the early 2000s, the pediatric organ retention scandal in Britain brought world-wide attention to the matter. Parents were distressed that their children were not buried whole, that organs from medicolegal cases had been retained for reasons beyond those necessary to establish the cause of death, that organ retention had occurred without explicit consent in family-permission autopsies, and that they had no control of the situation, which had been hidden from them (6, 7). The upshot was ratification of the Human Tissue Act (2004). Unfortunately, tissue from autopsy is treated more strictly than that obtained from living individuals (6). A consequence of these new laws has been a decline in fetal, perinatal, and infant autopsies (8–11).

Alternatives to organ retention have been sought. It has become widely customary to discuss the value of a complete brain examination with the family. When necessary (e.g., for religious beliefs), a compromise such as fixation of brains for <48 hours is possible (12). Virtual autopsies using magnetic resonance imaging can give fairly good morphologic information about malformations (13–17). In the immediate future, however, imaging advances cannot replace the resolution and specificity of the tissue autopsy. Autopsy remains an essential part of investigating fetal loss, stillbirths, and neonatal deaths associated with non-chromosomal fetal anomalies (18).

Consent forms often use complex language that adhere to legal principles, but do not necessarily ensure that the proposed autopsy is understood. Because autopsy consent is obtained at an emotionally stressful time and because not all parents will be highly educated, some authors advocate “restructuring [consent forms] as educational materials that adhere to current health literacy guidelines” (19). Comprehension of biobank consent forms was tested in a low stress test situation. Shorter forms were not necessarily understood better, but the long forms were considered by all participants to have too much information. Overall comprehension by those who had not completed high school was significantly lower (20, 21). Medical staff must therefore be trained to develop a team strategy for consent taking, potentially with the assistance of a bereavement counsellor (22–27). It is incumbent on the medical profession to be sensitive and adaptive to parents’ wishes so that they can make an informed and comfortable choice (28, 29).

If a brief consent form is agreed upon within an institution, it should define and explain the purposes of the autopsy and include clear direction regarding the scope, tissue use, and eventual disposal of unused tissue (see example in Figure 4.1). Educational material such as that offered by the College of American Pathologists can be very useful for instructing families (https://cap.objects.frb.io/documents/2017-autopsy-brochure.pdf). The permission form must be accompanied by a summary of clinical information and contact details (30). Ideally, the consent process should include the possibility for retaining reasonable tissue samples when they hold unexpected findings or to accommodate future retrospective research (31). More detailed consent forms and explanations might be necessary when the autopsy includes a prospective study that requires atypical promptness or tissue sampling, e.g., in cancer deaths (32, 33). Planned research (e.g., developmental neurobiology on relatively normal brain tissue) or investigation of specific disease processes should be justifiable. Risks and benefits to living subjects including relatives must be balanced. The information potentially gained should be translatable to living humans. The research must be feasible and it must not conflict with possible organ donation or the main goals of the autopsy (34).

Figure 4.1 Example of a generic autopsy consent with sections highlighted in red font. The consent outlines the purpose of the autopsy with Definitions and Explanations. Note that it refers to a “preferred claimant” because the next of kin is not necessarily the legal guardian. The Limits section briefly deals with the extent to which the body may be examined and which organ(s) may be retained. The Research Use section explicitly deals with use of the tissue beyond the diagnostic purpose of the autopsy. The Retention/Disposal section directs the institution on the handling of tissue after the autopsy is complete.

Most fetal and perinatal autopsies are non-medicolegal. Circumstances where the medical examiner or coroner might become involved include in utero deaths associated with maternal trauma, at home deaths when a known natural cause is not present (see Chapter 66) and deaths associated with trauma to the infant. In these situations, the parents will not have a choice about the decision to conduct an autopsy. Nevertheless, they still deserve complete transparency about the goals and the possible need for retention of the brain (or another organ).

Tissue archives are an invaluable resource for medical research. Pathology departments and other institutions that house archived tissue samples must accept the ethical and legal responsibilities of doing so. The oversight and “ownership” of retained tissues vary by country according to local laws (35). In most jurisdictions, evolving law does not directly impact archived tissue retention. If the tissues were obtained legally, the fact that the old ethical standards do not meet current standards does not preclude their use (36). Most research ethics boards accept this principle when it pertains to retrospective studies so long as confidentiality is maintained. Some ethicists have argued convincingly that we have “a moral obligation to participate in medical research in certain contexts … [including] participation in biobanks, provided safeguards against wrongful use are in place” (37, 38).