Publication Policy for Data

The following is the policy for publication of aggregate data obtained from the Gaucher Registry. Physicians participating in the Gaucher Registry may request data analyses for the purpose of publication. This policy will be administered by an International Review Committee which is comprised of physicians from the Gaucher medical community who are participating in the Gaucher Registry. The Medical Directors from Genzyme's U.S. and European offices will also be members of the International Review Committee.

• Any health care provider in the Gaucher medical community may generate proposals to publish aggregate data. The publication policy does not apply to site-specific data and as such physicians are free to publish their own data at any time.
• Health care providers interested in publishing Registry data must submit their proposal for publication and request for data analyses on the Publication Proposal Form.
• The ICGG Publication Subcommittee will coordinate the publication policy and review and approve publication proposals.
• Proposals submitted by ICGG physicians actively participating in the Gaucher Registry will generally be approved by the Publications Subcommittee unless the proposal lacks scientific merit, duplicates other previously proposed projects, raises serious legal, regulatory, or ethical questions, or poses significant limitations on resources due to the scope of the work requested. Proposals submitted from non-participants in the Gaucher Registry will be evaluated on a case-by-case basis.
• Abstracts and manuscripts generated from pooled Registry data must be reviewed and approved by the Publications Subcommittee prior to submission to the meeting/congress or journal.
• The requesting health care provider (principal author) will be required to liaison with a member of the Publications Subcommittee to review results and interpretation of the data analyses.
• If the data set used for the analysis is comprised of more than 20% of patients from a single contributing physician, that contributing physician should consent to the publication and/or be invited to co-author. The principal author will discuss the project and authorship directly with the contributing physician. The contributing physician will have the option to withdraw his or her data from this publication.
• The ICGG Gaucher Registry must be appropriately acknowledged as the source of the data. In addition, proper acknowledgement must also be given to those physicians (non-authors) who contributed to the data analyzed.
• This policy does not apply to requests for Registry data for the purposes of clinical interest and patient care.

For additional information regarding this policy, please contact the Gaucher Registry.