Monday, August 29, 2011

New Opportunities for Patients to Engage

Patients are the most underutilized resource in medical research – and they have the most to gain. Two things this past month struck us as truly promising in the effort to build a research culture that encourages and inspires broader public participation.

1) The National Institutes of Health (NIH) invited patient advocacy and disease research organizations to partake in the strategic planning process for the NIH Common Fund. The NIH Common Fund was enacted into law by Congress through the 2006 NIH Reform Act to support cross-cutting, trans-NIH programs that require participation by at least two NIH institutes or centers and that can be achieved over a 5-10 year period. This program supported NIH initiatives in nanomedicine, molecular libraries and imaging, the Clinical and Translational Science Awards, and the newly formed Center for Regenerative Medicine.

With this request for input, NIH is seeking innovative and transformative ideas from the outside community to drive the formation of new programs to be funded in 2013. This provides an opportunity for patients to help NIH clinical researchers prioritize novel research ideas and collaborations likely to drive new solutions to medical challenges. NIH lists a host of concepts on which they are seeking input, from artificial organs to Big Data initiatives to mobile health technologies. With this announcement, NIH is providing the public with an opportunity to peruse its strategic planning site and share its thoughts on the Nation’s biomedical research plans for the future. It is NIH’s hope that public input will help drive innovative new ideas through the Common Fund.

2) The Department of Health and Human Services (HHS) recently slated an update of the requirements for protecting human subjects in research – referred to as the Common Rule. This update, the first major overhaul in the 20 years since the regulations were enacted, is designed to enhance protection for research subjects while and reducing administrative burdens, delays, and ambiguity for researchers. The Common Rule covers a number of areas specific to Institutional Review Boards (IRBs), which review the ethics of research, and the need to obtain informed consent from research subjects.

HHS is requesting input on a number of key provisions. The department is proposing to simplify the informed consent process and allow consent on biospecimen research to extend broadly to future new studies. Stored biospecimens are an important source of information and material for researchers, and the reuse of existing data and materials can be an efficient resource for a new research study. If appropriately modified, this rule would respect patients’ contribution to science, as well as their rights and welfare, while removing unnecessary timely and costly administrative burdens to researchers.

In addition, in terms of oversight, HHS is proposing to restructure the missions of IRBs by prioritizing their workload based on the risks posed to subjects. The department also is evaluating the use of a single IRB of record to oversee studies conducted at multiple sites. Such modifications could greatly improve efficiency in coordinating research studies.

In this new era of transparency, patients and the broader public have an opportunity to redefine their role in research by sharing their ideas for innovative models of research and sharing perspectives on how to improve the informed consent process. These two opportunities are opening the door to more meaningful public input in the medical research enterprise.

At FasterCures, we are strong proponents of working to improve our medical research system to better work for patients. Similarly, we urge the public, and especially patients, to become engaged, proactive participants in the process.

A few months ago, we released the report Back to Basics: HIV/AIDS Advocacy as a Model for Catalyzing Change, which highlights how people affected by HIV/AIDS rallied together and created an advocacy movement that demanded change and got results. We have much to learn from HIV/AIDS activists, how they redefined patient engagement in the medical research process, and changed the drug development paradigm. Thanks in large part to the groundwork they laid, the public is increasingly viewed as an essential ally and partner in advancing medical research.


REGISTER NOW for a free FasterCures webinar Bits and Bytes: Making Patient Information Available and Meaningful to Researchers
September 16, 2011
1:00 - 2:30 p.m. (Eastern)

Three distinguished leaders will discuss opportunities for accelerating research through improvements in biobanking, the use of electronic medical records, and the release of personal health information for research. Don't miss this important discussion!


  • David Blumenthal, M.D., Director, Institute for Health Policy, Massachusetts General Hospital and Partners Health System; former National Coordinator for Health Information Technology

  • Carolyn Compton, M.D., Ph.D., Director, Office of Biorepositories and Biospecimen Research at the National Cancer Institute

  • Sharon F. Terry, President and CEO, Genetic Alliance

  • Moderator: Margaret Anderson, Executive Director, FasterCures

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