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February 5, 2016

Common Rule

Please read the Op Ed, "Your Cells. Their Research. Your Permission?," on tissue based research and the importance of informed consent in the context of the common rule.

The author, who wrote a book about HELA cells is certainly qualified and has given considerable thought to her balanced assessment of the issues.

For those of us who consent, respect the need to know on the part of our patients. For those who conduct research with discarded tissue, be attentive to the potential for loss of privacy and the always present potential for abuse of the luxury of the conduct of research on humans.  And for institutional leaders, respect the incredible impact this research can have advancing science and uncovering the next discovery leading to the next improvement in treatment. Having the infrastructure in place for efficient dialogue with patients and their giving of informed consent, for practical SOPs for tissue collection and storage, and for adjudication of the access and use of tissues across our campuses, is one of our major priorities for 2016.

AACI/AACR/ASCO/ASTRO Letter to HHS on "Common Rule"

Message from Barbara Duffy Stewart, MPH, Executive Director, Association of American Cancer Institutes (AACI)

On January 4, AACI, along with the American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO), and the American Society for Radiation Oncology (ASTRO), submitted comments to the Department of Health and Human Services Office of Human Research Protections (OHRP) on the Notice of Proposed Rulemaking (NPRM) for the Human Subjects Research Protections "Common Rule".

Included in the letter are three areas of concern in the proposed rule:

  • The proposed classification of all biospecimens as "human subjects," regardless of whether the biospecimens contain identifiable information. Obtaining additional consent for storage and future use of biospecimens would add significant time and resources to comply with this proposed regulation. AACI, AACR, ASCO and ASTRO are concerned that the requirement for more informed consent would negatively impact institutions serving minority populations.  Administrative costs to implement such procedures and track responses could directly impact minority institutions and ultimately limit the participation of minority patients in clinical trials. Additionally, our organizations note that the proposed 10-year timeframe/collection limit for biospecimens or information collected in non-research settings is arbitrary and would impede the ongoing research efforts in many cancers.
  • The lack of clear and consistent privacy standards across all research, including possible confusion between HIPAA Privacy Rule and the Common Rule. Clarification is needed in order to eliminate confusion and promote efficiencies in regard to research subject to the Common Rule regulations and those subject to HIPAA regulations.  AACI, AACR, ASCO, and ASTRO ask that the Common Rule Agencies work closely with our organizations to develop clarification and examples. 
  • The absence of harmonized guidelines for reporting unanticipated problems and adverse events and the decision to abandon a harmonized electronic database for reporting. A system that uses standardized data elements to simplify and consolidate the reporting of information that is already required has the potential to improve safety among research participants, decrease reporting requirement confusion, and promote the efficient use of the limited resources available for research.  AACI, AACR, ASCO, and ASTRO ask that the Common Rule Agencies reassess stakeholder comments on the implementation of a harmonized electronic database to report unanticipated problems and adverse events.