May 02, 2011
VIA ELECTRONIC SUBMISSION
Valerie H. Bonham
The Presidential Commission for the Study of Bioethical Issues
1425 New York Avenue, NW
Washington, DC 20005
RE: Request for Comments on Human Subject Protections in Scientific Studies
The Association of Academic Health Centers (AAHC) is pleased to provide comment to The Presidential Commission for the Study of Bioethical Issues in response to the March 2, 2011 request for comment on the Federal and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal government. The AAHC believes there is a fundamental need for all regulations governing the protection of human subjects to be harmonized. The Common Rule takes a relatively holistic approach to the protection of human subjects, but only applies to research that is funded by one of the federal agencies that have adopted the Rule. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is not restricted to government-funded research, but only applies to “covered entities” and the information they supply. The Food and Drug Administration (FDA) also has regulations related to human subject protection, but those regulations only apply to studies being done for market approval. This maze of regulations is only made more complex when research studies involving human participants are conducted overseas.
The AAHC believes that regulations governing the privacy of research participants, while certainly laudatory, have unfortunately had a significant negative impact on the type and pace of biomedical research conducted. We believe this negative impact can be reversed with a new regulatory framework to govern, protect, and enhance the privacy of research participants that will simultaneously advance the nation’s research enterprise. Many researchers are deterred from pursuing important lines of inquiry necessary to advance science, slowing the progress towards new cures and treatments for illness and disease, thus ultimately doing harm to patients both present and future. The AAHC believes that the chilling effect the Privacy Rule has had on research will only be magnified by the added provisions mandated in the Health Information Technology for Economic and Clinical Health (HITECH) Act, signed into law by President Obama in February 2009 as part of the American Recovery and Reinvestment Act (ARRA).
The AAHC recommends that Congress authorize the Secretary of Health and Human Services to create a new regulatory framework to protect the privacy of research participants. The framework should include the creation of a certification process for institutions to qualify as “safe harbor” entities, similar to that of Canada and the United Kingdom. In order to be certified, an institution must show evidence of sound data security practices as well as established criteria for researchers with respect to ethical research practices and protection of privacy and confidentiality. Academic health centers, where the vast majority of research is conducted in the United States, are in the vanguard, developing new methods for data security and the protection of patient privacy. The new framework should recognize the significant safeguards already in place at these institutions by allowing them to be certified as “safe harbors” while simultaneously providing institutions and researchers with the flexibility to pursue innovative lines of scientific inquiry. The AAHC recommends that once this new framework for privacy of research participants is established, research should be exempted from the Privacy Rule.
By its nature, the regulatory process does not move quickly enough to keep pace with technology; the technical knowledge necessary to bypass the safeguards in the HIPAA Privacy Rule is, unfortunately, already available. Adding more detailed and prescriptive regulations will neither deter those who are determined to breach the privacy of others nor keep pace with technologies designed to accomplish that goal. Thus, the new framework should establish significant penalties for the intentional and malicious breach of privacy as well as a solid mechanism to enforce such penalties.
The AAHC recognizes that the establishment of a new framework and the exemption of research from the Privacy Rule will take time. In the interim, the AAHC recommends that the U.S. Department of Health and Human Services take immediate action to harmonize the HIPAA Privacy Rule with the Common Rule and all other federal regulations governing research.
Furthermore, the Common Rule should be harmonized with FDA human subject protection regulations. Eliminating the areas of inconsistency would break down some of the existing barriers for institutions, researchers, and patients alike, and facilitate the transition to a framework that is compatible with the unique needs of the research environment.
Ultimately, the best way to protect the privacy and safety of human research participants is to ensure that all research conducted in the United States adheres to a uniform set of regulations. Thus, AAHC recommends that Congress develop legislation to ensure that the Common Rule and the new framework extend to all research conducted in the United States regardless of its funding, sponsor, or location.
The AAHC hopes that the Presidential Commission for the Study of Bioethical Issues will support these efforts to ensure that regulations governing the protection of human research participants are more efficient and effective, while enhancing safety, quality, and privacy.
Steven A. Wartman, MD, PhD, MACP
President and CEO
Association of Academic Health Centers