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Executive Summary
Pages 1-12

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From page 1...
... The opportunities offered by the VSD for thorough investigations of vaccine safety concerns and well-designed, planned, retrospective vaccine studies have led to heightened interest in the results of VSD studies and sometimes in the VSD data themselves. A few researchers interested in particular vaccine safety hypotheses also have shown interest in accessing and analyzing VSD data.
From page 2...
... review the design and the implementation to date of the new Vac cine Safety Datalink Data Sharing Program to assess compliance with the current standards of practice for data sharing in the scientific community and (1b) make recommendations to the National Immunization Program and the National Center for Health Statistics for any needed modifica tions that would facilitate use, ensure appropriate utilization, and protect confidentiality; and (2a)
From page 3...
... The principles can be described as common themes inherent in the committee's recommendations and thus principles that should be considered in any modifications of the VSD data sharing program or any determinations about whether, when, and how to release VSD preliminary findings. The four overarching principles that emerged from the committee's recommendations are these: · Independence.
From page 4...
... The committee's recommendations are related to four main topics: the VSD data sharing program; the release of preliminary findings based on VSD data; independent review of VSD activities; and the applicability of the Shelby Amendment and Information Quality Act to VSD data and VSD preliminary findings. THE VACCINE SAFETY DATALINK DATA SHARING PROGRAM Reflecting on all the information gathered throughout its study, the committee finds that the VSD data sharing program has three short-term goals:
From page 5...
... On the basis of those three goals, the committee developed its recommendations related to the VSD data sharing program in the following framework: · The NIP should support the broadest feasible use of the VSD for vaccine safety research within the constraints of law, protection of confidentiality, and VSD contract provisions; · Bureaucratic and technical barriers to accessing the VSD should be minimized, although some types of studies may require collaboration with or facilitation by data custodians; · Guidelines for proposals from independent external researchers should be developed and publicized to facilitate access; · Responses to proposals should be timely; · Criteria for the independent review of proposals should be publicly accessible; · Costs to researchers should approximate the incremental costs of access; · Descriptions of the objectives and methods of current and published studies should be made publicly available; · All VSD users should provide a timely and detailed public report of their results to the NIP; and · All completed VSD studies should be subjected to scientific peer review before any public release. LIMITATIONS OF THE VACCINE SAFETY DATALINK DATA SHARING PROGRAM AND THE NEED FOR COLLABORATION The VSD and the VSD data sharing program have a number of limitations.
From page 6...
... All the committee's recommendations related to the VSD data sharing program can be found in Box ES-1 at the end of this executive summary. RELEASE OF PRELIMINARY FINDINGS BASED ON VACCINE SAFETY DATALINK DATA Solely internal peer-review processes may be needed when preliminary findings could have a substantial impact on public health.
From page 7...
... with minimal and balanced biases and conflicts of interest should be established to review various aspects of VSD research activities and of the VSD data sharing program. The committee recommends that an independent review committee with minimal and balanced biases and conflicts of interest be created to: · Review independent external researchers' proposals to use VSD data through the data sharing program; · Review research proposals from internal researchers and provide oversight of changes in or deviations from research protocols for internal VSD studies; and · Provide advice on when and how preliminary findings based on VSD data should be made public.
From page 8...
... BOX ES-1 Committee Recommendations Chapter 2: DESCRIPTION OF THE VACCINE SAFETY DATALINK Recommendation 2.1: The committee recommends that the NIP and NCHS seek legal advice to clarify the applicability of the Shelby Amend ment and the Information Quality Act to VSD data and VSD preliminary findings. Chapter 3: THE VACCINE SAFETY DATALINK DATA SHARING PROGRAM Recommendation 3.1: The committee recommends that future revisions of the VSD data sharing guidelines clearly and explicitly describe the VSD data that are and are not available to independent external re searchers for new vaccine studies through the VSD data sharing program.
From page 9...
... Recommendation 3.8: To assist independent external researchers who want to use VSD data through the data sharing program, the committee recommends that the NIP and NCHS add to the VSD data sharing program guidelines a list of recommended competencies for VSD data analysis. Recommendation 3.9: To facilitate use of the VSD data sharing program, the committee recommends that the NIP work with the VSD-participat ing MCOs to determine the feasibility of using IRB authorization agree ments for VSD research proposals.
From page 10...
... Recommendation 3.12: The committee concludes that it is reasonable to expect researchers who request access to VSD data to have their own funding and it therefore recommends that RDC costs not be waived for independent external researchers. Recommendation 3.13: The committee recommends that, as a condition of accessing VSD data, all independent external researchers that use the VSD data sharing program be required to submit a report to the NIP (with a copy to NCHS)
From page 11...
... Recommendation 4.7: The committee recommends that preliminary findings from VSD data be shared with the public whenever the findings are presented to anyone other than collaborators in the research, fed eral employees responsible for research activities, MCO-affiliated VSD researchers, scientific journals, peer reviewers for scientific journals, and people responsible for oversight of the research. Recommendation 4.8: The committee recommends that preliminary findings from VSD data be shared with the public whenever these find ings contribute to the basis of a policy decision or are used to change guidelines on vaccine administration.
From page 12...
... Recommendation 5.3: The committee recommends that an independent review committee with minimal and balanced biases and conflicts of in terest be created to: · Review independent external researchers' proposals to use VSD data through the data sharing program; · Review research proposals from internal researchers and provide oversight of changes in or deviations from research protocols for inter nal VSD studies; and · Provide advice on when and how preliminary findings based on VSD data should be made public.


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