The document presents a comprehensive summary of stakeholder feedback regarding proposed regulatory changes, particularly concerning the definition of "human subjects" and associated consent and oversight mechanisms in biomedical research. Across a sample size of 2,000 valid responses (excluding non-applicable and extension request submissions), the overall trend demonstrates substantial opposition to the proposed expansion in the definition of human subjects, with 74% of respondents opposing compared to 26% in support. This pattern holds consistently across most respondent groups, including researchers, universities, industry, and patients, with opposition rates frequently exceeding 90%. Notably, substantial support is seen in some subgroups, such as Tribal Nations and Advocacy Groups, particularly for provisions relating to consent and community safeguarding.
Respondents were extensively surveyed on alternatives to the primary proposal, notice for broad consent, opt-out mechanisms, single Institutional Review Board (IRB) requirements, extension of Common Rule protections, and posting of consent documents. While support for alternative regulatory approaches ('Alternative A' or, less often, 'Alternative B') tended to be higher in qualitative feedback, most of these alternatives were nonetheless less preferred than maintaining the status quo. On issues such as broad consent notice and opt-out provisions, support rates varied widely by stakeholder type, with the general public and advocacy groups expressing notably higher rates of approval. Conversely, requirements such as single IRB review and expanding Common Rule safeguards encountered pronounced resistance, especially from institutional and researcher respondents. In summary, although the call for greater human subject protections is recognized and select measures received moderate support, the dominant view across constituents is cautionary, especially regarding broad regulatory expansion, with many stakeholders explicitly preferring limited or strictly qualified adjustments to the existing framework.
