Guidance on genomic research with deceased patients

Question:

Could you provide guidance regarding genomic sequencing of deceased patient’s DNA for a research study? Does the protocol need to specify that deceased patient DNA can be used? Who signs the consent form- the parent of deceased patient; what if deceased patient is an adult, who would sign consent?

Response:

According to the federal regulations on human research protections (the Common Rule), a “human subject is a living individual about whom an investigator obtains data through an intervention or interaction or identifiable information.” 

While research involving deceased individuals is not subject to the federal regulations on human research protections and, therefore, not under the regulatory purview of the IRB, other regulatory and ethical issues should be considered in the design and conduct of the research.

For example, the Health Insurance Portability and Accountability Act (HIPAA) applies to an individual’s protected health information for 50 years after death. Uses and disclosures of PHI requires either authorization by family or a legally authorized executor of the individual’s estate or, the researcher has to document that use or disclosure is sought solely for research on the protected health information of decedents; be able to provide, at the request of the covered entity, evidence of death of the individual; and, representation that the use or disclosure of the protected health information is necessary for the research purposes. Many covered entities have delegated the oversight of the HIPAA Privacy Rule to their IRBs. Be sure to check with the IRB or privacy board within your organization for guidance on how to adhere to their policies and procedures.

Some federal funding agencies, notably the National Institutes of Health have in place data sharing policies that require informed consent for future research uses of data and specimens. The NIH website is a rich source of information on the topic of informed consent for genomics research.

Other ethical issues for consideration are how the analysis of DNA could be important clinically to the next-of-kin.  Careful consideration should be given to whether the family should be informed about ongoing research, whether the family members should give proxy consent for use of post-mortem data and specimens, and if results should be shared with the family.