On January 4, ASCO submitted a joint comment letter with the American Association for Cancer Research (AACR), Association of American Cancer Institutes (AACI), and American Society of Radiation Oncology (ASTRO) to the U.S. Department of Health and Human Services on proposed changes to the Common Rule for the protection of human subjects in biomedical research.
Although the letter expressed support for several reforms outlined in the proposal, including streamlining informed consent and imposing mandatory data security standards, the letter raised concerns with certain aspects of the proposal, including the proposal to classify all biospecimens as “human subjects,” regardless of whether the biospecimens contain identifiable information. The organizations asserted that, since the lack of publicly available genomic data makes it highly unlikely that subjects could be identified from nonidentified biospecimens, the proposed regulation is “not appropriate for the very low level of risk inherent in this type of research.” Such an approach would impose a substantial administrative burden, jeopardizing biospecimen research that has been crucial in making progress against cancer, according to the organizations.
The comment letter also noted the following additional concerns with the proposal:
- The lack of clear, uniform privacy standards across all research, including guidance to eliminate confusion between the HIPAA Privacy Rule and Common Rule regulation.
- The absence of harmonized guidelines for adverse events and unanticipated problems reporting, as well as plans to develop a harmonized electronic database for reporting as suggested in the 2011 Advanced Notice of Proposed Rulemaking.
The organizations urged the Common Rule Agencies to address these areas of concern before finalizing changes to the rule.
To read the full comment letter go to www.asco.org/sites/www.asco.org/files/common_rule_comment_letter_1.11.16.pdf. ■
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