BETHESDA, Md., Dec. 20, 2011 — Awards for Excellence in Human Research Protection for 2011 were announced today by Dr. Peter G. Goldschmidt, President and Founder of the Health Improvement Institute.
Winner of the Annual Award for Best Practice was:
Harvard Catalyst | The Harvard Clinical and Translational Science Center, Harvard Medical School (Boston, MA) for its best practice, Harvard Catalyst Master Common Reciprocal Institutional Review Board (IRB) Reliance Agreement. The agreement supports a framework that smoothes the review of proposed multicenter human studies by reducing the administrative burden on IRBs, increasing the efficiency of review, and, when utilized, facilitates best practices for research participants by preventing disparities among protocols and informed consent forms that often occur in multi-IRB reviews.
Recipients of an Award of Excellence for Best Practice included:
- Cedars-Sinai Medical Center (Beverly Hills, CA), IRB Educational Initiatives. The initiatives aim to ensure that criteria for IRB approval are appropriately addressed in submissions, to reduce or eliminate requests for edits, and to minimize the time needed to process them.
- Mount Sinai School of Medicine (New York, NY), Flexible IRB. This additional IRB relies on consultants (who are primarily members of other IRBs) for the scientific/scholarly review of research. It supports the functioning of all IRBs, decreases turnaround time for investigators, and increases efficiency of the office.
- Medical Research Management, Inc./CRA Solutions, Inc. (Coral Springs, FL), Monitoring. This best practice standardizes monitoring of clinical studies. A monitor verifies that the rights and well-being of the subjects are being protected. The method involves analyzing FDA warning letters and performing monitoring assessments.
- Quality Assurance Office for Clinical Trials (QACT), Dana-Farber/Harvard Cancer Center, Dana-Farber Cancer Institute (Boston, MA), Quality Assurance Office for Clinical Trails (QACT) audit team. The team ensures that Academic Research Consortium members are performing research of the highest quality while mitigating the inherent risks associated with clinical trials research. Internal auditing provides an added level of human subjects protection.
"The Award program offers positive recognition for excellence in the field of human research protection," said Dr. Goldschmidt. "This year's awards continue the high standard that we have seen since the program began. We congratulate the winners."
Awards are given for demonstrated excellence in promoting the well being of people who participate in research. The Health Improvement Institute created this Award program. This year's judges were drawn from academic, compliance, consulting, health services, legal, and research review organizations.
About Health Improvement Institute:
Health Improvement Institute is a non-profit, tax-exempt, 501(c)(3), charitable organization dedicated to improving the quality and productivity of America's health care. The Institute's principal program objective is to provide information to enable people to make informed health care choices. The Institute conducts projects and workshops, and sponsors national awards programs to recognize excellence, including the Award for Excellence in Human Research Protection. For more information, visit http://www.hii.org.
For information about the 2012 Award for Excellence in Human Research Protection, please contact the Award Coordinator at 301-320-0965 or by email at Email.
Contact: Yanan Ye
Email: Email
Phone: 301-320-0965
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