Independent Oversight of Vaccine Safety Data Program Needed to Ensure Greater Transparency and Enhance Public Trust

According to this press release, the Institute of Medicine of the National Academies suggests that two new oversight groups are needed as a way
of ensuring that the policies and procedures of the Vaccine Safety Datalink (VSD) and its Data Sharing Program are implemented fairly and with open
access to patient data. John C. Bailar III, chair of the committee who wrote the report stated, "Concerns about access and transparency have accompanied the development and functioning of the Vaccine Safety Datalink data sharing program, and consequently some people's trust in the reliability of findings from VSD studies has eroded..."

The report states that The Centers for Disease Control and Prevention (CDC), which oversees VSD and the Data Sharing Program, should create a
new, independent committee to "review researchers' proposals to use VSD data, monitor adherence to protocols, and advise the agency and its
partners on when and how to release preliminary findings based on the data."

The press release describes VSD as a large, linked database of patient information that was developed jointly by CDC and several private managed
care organizations in 1991. In 2002, the VSD Data Sharing Program was launched "to allow independent, external researchers access to information in the database linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991.

The VSD Data Sharing Program is described as unique from other data sharing programmes in the way it functions. It is characterised as offering "protections accorded to patient information by privacy laws...-... in addition to participating managed care organizations maintaining
proprietary control over data they have supplied from 2001 onward. Thus these data are not available to external researchers working independently on most types of studies. The report contends that "because the VSD is a tax-supported public resource used to inform health policy decisions, the public deserves access to the data that influence such decisions" Further the report states "the public also is entitled
to transparency and independence in the processes that permit or restrict access." In the end, the committee determined that it is possible to
facilitate public access and transparency while also protecting patient privacy.

The press release describes a number of key functions of the independent review committee. The report suggests that in the interest of fairness and openness, a wide group of stakeholder's views should be included; the criteria and the technical feasibility of proposals needs to be very clear; committee oversight should oversee changes in research protocols for VSD studies; members of this committee should be chosen on the basis of their scientific and technical expertise as well as their lack of conflicts of interest or biases; and VSD scientists and officials are counseled on when and how to release preliminary findings from studies based on VSD data.

Click here for the 20-page Executive Summary in PDF format.