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The Personalized/Precision Medicine Blog

The official blog of the Annual Personalized and Precision Medicine Conference provides readers with information, insight and analysis regarding the field of personalized and precision medicine, genomics, genomic interpretation and the evolution of healthcare in the post-genomic era.

Proposed Changes to the Common Rule: Protection to Participation in Action

Guest Blogger: Christopher Ianelli, MD, Ph.D., CEO, iSpecimen (Dr. Ianelli will be giving a presentation entitled "Protection to Participation in Action: Engaging Patients for the Use of Their Clinical Remnants in Research" at the 7th Annual Personalized and Precision Medicine Conference in Baltimore on October 5-6, 2015.
On September 2, the government announced a proposal to update the Federal Policy for the Protection of Human Subjects, also known as the “Common Rule”. According to the Department of Health & Human Services (HHS) the proposed changes are intended to strengthen human subjects’ protection while facilitating important research. Since the volume and landscape of research have changed substantially since the rule was first published, particularly with the rise of precision medicine, HHS determined that a review and upgrade may be in order. The proposed changes are a real-time example of the shift that has been occurring in healthcare privacy: the shift from patient protection to protection and participation.
Untouched since its publication in 1991, the Common Rule ensures that all individuals enrolled in biomedical and behavioral research studies are treated ethically. It consists of several sub-parts and dictates that informed consent and Institutional Review Board (IRB) approval be secured when human subjects (i.e. living people) interact with principal investigators as part of a study or when researchers obtain private information from them. One portion of the Rule very significant to precision medicine research is the portion that governs the use of de-identified, remnant human biospecimens in research.
The Common Rule currently says that the use of de-identified remnant specimens for research is “non Human Subjects Research” because individuals a) have no interaction with researchers and b) data are de-identified so there is no private information transfer. Therefore, under the Common Rule, de-identified remnant biospecimens can be used for research purposes without IRB approval and informed consent. As personalized medicine continues to surge forward, the need for human biospecimens has proliferated. And with the proliferation has come the emergence of many new types of research, particularly genomic research, shining a light on the ethics of using patient specimens without their consent and the very definition of what’s protected information.
While current law does not require consent or IRB approval, iSpecimen feels it is best practice that consent be obtained whenever possible. As patient-centricity and consumer-directed care have continued to move to the forefront of care paradigms, consent is the best way to ensure that the ethical principles detailed in the Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research, namely beneficence (“the goal of maximizing possible benefits of research and minimizing possible harms”), respect for persons (“treating people as autonomous agents, and allowing them to make choices based on their own judgments and opinions”), and justice (“fairness in terms of who receives the benefits from research and who bears its burdens, especially when dealing with vulnerable populations) are followed.
These three principles have been the impetus behind the proposed changes to the Common Rule that would affect the use of de-identified remnant biospecimens.  The proposal would require that a patient give informed consent and that an IRB review and approve the use of de-identified remnant specimens for most types of research. It would also make it more difficult for researchers to get a waiver of consent for the secondary use of biospecimens.
The proposed changes are open for comments through December 7, 2015. If approved and subsequently published to the Federal Register, there would be a compliance period of three years. While it would be closer to the end of the decade before these changes would fully go into effect, the fact that today, after nearly 25 years we are collectively re-evaluating their merit, is indicative of the healthcare revolution known as precision medicine, which has indeed arrived and must be pursued with as much focus on the interests of the patients as the outcomes of the research.
To further your understanding of the proposed Common Rule changes, and the shift from protection to participation in action, please visit the following resources and attend Dr. Ianelli’s session at the the 7th Annual Personalized and Precision Medicine Conference. The presentation starts at 2:05 p.m. on Oct. 6, at the Sheraton Inner Harbor Hotel in Baltimore, MD.
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