How to obtain ethical approval for a study involving deceased patients?

Obtaining Ethical Approval for Research Involving Deceased Patients

Obtain IRB approval by submitting a research protocol that addresses privacy protections, family notification procedures, and demonstrates scientific value, while recognizing that consent requirements differ based on whether you are using newly deceased patients for training/procedures versus conducting retrospective research on data from deceased patients. 1

Key Distinction: Type of Research Determines Approach

For Retrospective Research Using Data/Records from Deceased Patients

Submit your protocol to the Institutional Review Board (IRB) emphasizing that the research involves minimal risk and requesting a waiver of informed consent. 1

• The IRB can approve research on deceased patients' data without family consent if the study has scientific value and protects patient privacy. 1
• You must demonstrate compliance with HIPAA regulations for protecting health information and medical records, even for deceased patients. 1
• Minimize collection of personal health information and implement strict confidentiality protections in your protocol. 1
• Document that obtaining consent from families is impracticable and would not alter the minimal risk nature of the research. 1

For Research/Training Using Newly Deceased Bodies

Obtain consent from family members before using newly deceased patients for training or research purposes—this is the ethical standard that should prevail. 1

The American Heart Association guidelines are explicit on this point:

• "Ultimately, the respect for the individual should prevail over the need for healthcare providers to practice lifesaving techniques." 1
• Obtaining consent from family members shows respect for the newly dead patient and surviving family members. 1
• Arguments for presumed consent based on "greater good" fail to adequately weigh potential harm to surviving family members who may oppose such use. 1
• Cultural differences in acceptance of cadaver use in medical education must be respected. 1

Required IRB Application Components

Your IRB application must include these specific elements: 1

• Scientific rationale demonstrating social and scientific value of the research (i.e., does it matter and will it advance knowledge?) 1
• Risk-benefit analysis showing risks are minimized and reasonable 1
• Fair participant selection criteria 1
• Privacy and confidentiality protections, including HIPAA compliance 1
• Procedures for family notification if using newly deceased patients 1, 2
• Data safety and monitoring procedures 1

Special Considerations for Deceased Patient Research

Develop institutional protocols in advance that address: 2

• Processes for obtaining permission from families when applicable 2
• Guidelines for procurement of tissues or data 2
• Information about applicable laws and societal values 2
• Emotional support mechanisms for family members and healthcare providers 2

Common Pitfalls to Avoid

Do not assume deceased patients have no privacy rights—HIPAA protections continue after death. 1

Do not proceed with presumed consent for using newly deceased bodies without IRB approval and institutional protocols. 1

Do not conflate organ/tissue donation protocols with research protocols—while related, research requires separate IRB approval. 2

Ensure your IRB has appropriate expertise to evaluate your specific type of research involving deceased patients. 1

Timeline Expectations

Plan for IRB review to take weeks to months, with potential for multiple submissions. 1

• Emergency research protocols using exception from informed consent have taken up to 404 days (median 108 days) and up to 7 submissions for approval. 1
• Standard retrospective research typically requires less time but still plan for iterative review. 3, 4