Common Rule

Emerging Technologies, Human Subject Research, and the Common Rule: High level overview of the 2023 OHRP Research Community Forum

Earlier this month, WPF attended a joint conference focused on the shifting dynamics of how the Common Rule that governs human subject research in the US will be interpreted amidst new technological shifts such as AI. The department of Health and Human Services is seeking to define what the next steps and new policy frameworks should be to ensure the Common Rule protects individuals in current and future research environments. Details on the presentations, conversations, and key takeaways in the post.

WPF advises HHS on confidentiality of patient records re: alcohol and drug treatment records

The World Privacy Forum (WPF) submitted comments on an important Notice of Proposed Rulemaking that proposes modifications of the protection requirements for substance use disorder (SUD) treatment records. Currently, health records regarding treatment for Substance Use Disorders receive special protections under what is called Part 2 regulations, or,  42 CFR Part 2. The changes proposed

WPF urges National Institutes of Health to expand privacy guidance for researchers

WPF is urging the National Institutes of Health to do more to properly advise the research community and to protect data subjects in its draft guidance on data management and sharing. WPF is asking for changes to the NIH guidance because in the US, much health research data in the hands of researchers is not subject to the privacy or security rules in HIPAA.

WPF Files Comments on Federal Proposal for Human Subject Research (Common Rule)

The Nuremberg Code, an extraordinary document around ethics and research on human subjects written after the research abuses that took place during World War II, is akin to a global Emancipation Proclamation for human research subjects. The Nuremberg Code’s 10 principles remain a timeless rendering of thought on what should be in place prior to any entity conducting research on human subjects, and this code forms the philosophical foundation of a regulation in the US known as the Common Rule. We have written extensive comments on the US proposal that will update the Common Rule…

Public comments: WPF urges FTC to focus on providing statistical parity for consumers (Big Data workshop)

WPF urges FTC to focus on consumers’  ability to control their digital exhaust and statistical parity for big data era At the FTC workshop on Big Data September 15, Big Data: Tool for Inclusion or Exclusion?, panelists including the World Privacy Forum discussed legal and ethical frameworks that are applicable to large datasets and issues