Genomic Research with the Newly Dead: A Crossroads for Ethics and Policy

Walker, Rebecca; Juengst, Eric T.; Whipple, Warren; Davis, Arlene M.

doi:10.1111/jlme.12137

Cited by 8 publications

(4 citation statements)

References 19 publications

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“…While ethical frameworks inform clinical research with living human participants, ethical guidelines for research on the recently dead remain limited [ 34 , 35 ]. The Last Gift study protocol involves a rapid research autopsy that must occur within 6 hours of death.…”

Section: Ethical Principles For Clinical Research At the Eolmentioning

confidence: 99%

“…The U.S. Federal regulations for the protection of human research participants classify children, pregnant women/fetuses/neonates, prisoners and persons with mental disabilities as vulnerable [ 77 ]. The NIH has also adopted a broader definition of vulnerability in which terminally ill individuals are also considered a “special class of research subjects [ 78 ].” Interestingly, research with deceased humans does not fall under the technical definition of research with human participants [ 34 , 77 ] and the U.S. Office for Human Research Protections (OHRP) remains conflicted whether research with the newly dead meets the technical definition of human research [ 79 ].…”

Section: Ethical Principles For Clinical Research At the Eolmentioning

confidence: 99%

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Ethical considerations for HIV cure-related research at the end of life

et al. 2018

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BackgroundThe U.S. National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) have a new research priority: inclusion of terminally ill persons living with HIV (PLWHIV) in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego (UCSD) for PLWHIV who have a terminal illness, with a prognosis of less than 6 months.DiscussionAs end-of-life (EOL) HIV cure research is relatively new, the scientific community has a timely opportunity to examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders (biomedical researchers, PLWHIV, bioethicists, and socio-behavioral scientists) and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders.ConclusionEOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable.

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Section: Ethical Principles For Clinical Research At the Eolmentioning

confidence: 99%

Section: Ethical Principles For Clinical Research At the Eolmentioning

confidence: 99%

Ethical considerations for HIV cure-related research at the end of life

et al. 2018

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“…However, the sheer amount of data generated by genomics studies can be overwhelming, and analysis and interpretation can be challenging [ 71 , 72 , 73 , 74 ]. In addition, in the era of data exchange and strict laws about privacy, there may be ethical concerns around the collection and use of genetic data, particularly when it comes to human subjects without informed consent [ 75 , 76 , 77 ].…”

Section: Discussionmentioning

confidence: 99%

“…In addition, in the era of data exchange and strict laws about privacy, there may be ethical concerns around the collection and use of genetic data, particularly when it comes to human subjects without informed consent [75][76][77].…”

Section: Genomicsmentioning

confidence: 99%

New Challenges for Anatomists in the Era of Omics

Stabile,

Pistilli,

Mariangela

et al. 2023

Diagnostics

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Anatomic studies have traditionally relied on macroscopic, microscopic, and histological techniques to investigate the structure of tissues and organs. Anatomic studies are essential in many fields, including medicine, biology, and veterinary science. Advances in technology, such as imaging techniques and molecular biology, continue to provide new insights into the anatomy of living organisms. Therefore, anatomy remains an active and important area in the scientific field. The consolidation in recent years of some omics technologies such as genomics, transcriptomics, proteomics, and metabolomics allows for a more complete and detailed understanding of the structure and function of cells, tissues, and organs. These have been joined more recently by “omics” such as radiomics, pathomics, and connectomics, supported by computer-assisted technologies such as neural networks, 3D bioprinting, and artificial intelligence. All these new tools, although some are still in the early stages of development, have the potential to strongly contribute to the macroscopic and microscopic characterization in medicine. For anatomists, it is time to hitch a ride and get on board omics technologies to sail to new frontiers and to explore novel scenarios in anatomy.

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Authorization of tissues from deceased patients for genetic research

et al. 2017

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Tissues from deceased donors provide important data for genomic research and Organ Procurement Organizations (OPOs) play a significant role. To understand the decisions of families who donated for transplantation and made decisions about donation to the Genotype-Tissue Expression Project (GTEx), we examined donation decisions of family decision makers (FDMs). 413 families were interviewed by telephone. The OPO staff who made the transplant and research requests completed self-administered surveys; a total of 309 matching surveys from 99 OPO staff were obtained. 76.8% of families donated to the GTEx project. Logistic regression analysis found that FDM consent to GTEx donation was associated with endorsement of policies to promote biobanking (OR = 1.35), positive attitudes about medical research (OR = 1.1), lack of concern regarding a breach of confidentiality (OR = 1.54), comfort with tissue donation (OR = 1.24), and prior authorization to solid organ donation (OR = 3.17). OPO staff characteristics associated with GTEx donation included being female (OR = 3.57), White (OR = 4.97), comfort with hospital staff role in donation (OR = 1.61), and number of topics discussed with families (OR = 57.9). Donor type, FDM attitudes, OPO staff sociodemographics, OPO comfort with the GTEx authorization process, and intensity of discussing research-specific issues were significantly associated with GTEx donation decisions.

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Genomic Research with the Newly Dead: A Crossroads for Ethics and Policy

Cited by 8 publications

References 19 publications

Ethical considerations for HIV cure-related research at the end of life

Ethical considerations for HIV cure-related research at the end of life

New Challenges for Anatomists in the Era of Omics

Authorization of tissues from deceased patients for genetic research

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