Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate (BRAGGSS): DATA AND SAMPLE ACCESS AND OWNERSHIP POLICY February 2007

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1 Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate (BRAGGSS): DATA AND SAMPLE ACCESS AND OWNERSHIP POLICY February Summary This paper covers the procedures that should be followed in relation to the use of the laboratory material gathered as part of the BRAGGSS study. It considers the relationship between those involved in gathering the data and materials in the BRAGGSS clinical centres and those involved in analyzing and exploiting the data (both internal and external collaborators). It also outlines the policy for recognition of the contribution made by investigators in relation to grants acquired for BRAGGSS and publications and related outputs from BRAGGSS. 2. Description of BRAGGSS BRAGGSS is a multicentre study involving the collection of laboratory materials on patients with rheumatoid arthritis (RA) who are currently or who have been treated with a biologic drug. The funding of the data collection comes as part of the block grant from the Arthritis Research Campaign (ARC) to the Epidemiology Unit (EU) in Manchester and that institution is the custodian of the materials collected. 3. Participating Centre Commitment to BRAGGSS For the duration of the recruitment period of BRAGGSS (currently, 2 years from which a participating centre joins the study), the aim is to collect samples from all patients from each participating center treated currently or in the past with a biologic drug. Suitable patients from each participating centre are identified following a search of the British Society of Rheumatology Biologics Register (BSRBR). One of the aims of BRAGGSS is to provide a central resource of DNA and biologic material for genetic studies. To meet this aim a sample for DNA (an EDTA blood sample), serum (clotted sample) and RNA (for a limited subsample of the total, collected into an RNAeasy tube) is taken at a time when bloods are being taken for routine clinical purposes. 4. Scientific Exploitation of BRAGGSS Material The BRAGGSS material can be used to address the primary question of whether predictors of treatment response can be identified. In addition the study can be used as a springboard for a number of possible add on studies which will give added value to the BRAGGSS endeavour. A BRAGGSS Scientific Steering Committee has been established whose remit is to take responsibility for these aspects in relation to BRAGGSS. All applicants (internal and external) wishing to use BRAGGSS

2 data/samples must follow the application process established by the Scientific Steering committee. a. Membership of Scientific Committee The Committee comprises one representative each from Newcastle, Sheffield, Leeds and the ARC-EU (a deputy may attend if the main representative is unable to do so). The chair of the committee is a representative of the BSRBR. The Committee would for the most part be a virtual committee, working electronically in responding to requests for work but would meet a minimum of twice per year. b. Review of Proposed Clinical Data Analyses The clinical data has been collected as a separate study, the BSRBR, and this is held on a secure database within the ARC-EU. Analyses of the clinical data would only be undertaken on datasets provided by the BRAGGSS team to ensure quality and consistency. Statistical analyses would typically, but not exclusively, be undertaken by scientists working within the EU. Proposals for planned analyses will be distributed to the Scientific Committee for comment and the resulting outputs circulated or discussed at scientific steering committee meetings. All PI s or staff working under their direction may have access to the entire BRAGGSS dataset for analyses. Such proposals would be submitted in advance to the scientific steering committee as with proposals from the EU, to ensure scientific appropriateness and lack of duplication. The resulting statistical analyses could either be undertaken between the collaborating centre and the statistical staff at the EU or be undertaken entirely within one of the collaborating centres. c. Review of Proposed Access to Biological Materials i. DNA: BRAGGSS has established a centralised DNA bank from the BRAGGSS participants which is available for genotyping studies. Typically, but not exclusively, genotyping will take place in the EU s laboratories, or those of the major collaborators (Sheffield, Leeds Newcastle). DNA can be made available for genotyping (and subsequent linkage to anaonymised clinical data) at other institutions or could be undertaken in the EU, with scientific collaboration with the relevant PI. The resource is finite and proposals to use the DNA must all be approved by the Scientific steering Committee as with the clinical data above. The steering committee will ensure that proposals represent an appropriate use of the resource with evidence that the amount of DNA requested was justified Additional funding may need to be secured for undertaking extensive

3 genotyping. All genotype data, however gathered, would be returned to the central database at the EU. ii. Serum A serum bank from BRAGGSS has been established centrally. Similar arrangements would apply to serum as for DNA though it is recognised that the resource is finite. All proposals would be considered by the Scientific Committee to ensure they represented an appropriate use of the resource with evidence that the amount of serum requested was justified. iii. RNA An RNA bank from BRAGGSS has been established centrally. Similar arrangements would apply to serum as for DNA though it is recognised that the resource is finite and only available on a subset of the samples. All proposals would be considered by the Scientific Committee to ensure they represented an appropriate use of the resource with evidence that the amount of serum requested was justified. The samples in the central resource can be made available to any one of the other collaborating institutions. Proposals to use this material would be considered by the Scientific Committee. All proposals would be considered by the Scientific Committee to ensure they represented an appropriate use of the resource with evidence that the amount of material requested was justified. Additional funding may need to be secured for these studies. d. Review of all Proposed Grant Applications Given the above, it is likely that the work on BRAGGSS will involve submission for extra funding from a grant body. All proposals should be considered by the Scientific Steering Committee prior to submission to ensure they represent an appropriate use of the resource. Where the work involved required the data obtained from grant-funded work on the biological samples derived from BRAGGSS then the PI s would be offered the option (subject to the rules of the Grant body) of being listed as either a named applicant (without additional funding) or as a collaborator. The choice of collaboration or named applicant for other uses of the material would be discussed on a case by case basis with the final decision resting with the scientific steering committee. e. Review of Abstracts and Publications

4 The Scientific Steering Committee would consider, and advise on, topics and broad outlines for abstracts to be submitted in advance of any major rheumatology or other meeting. All abstracts subsequently submitted would be sent to the Scientific Committee. All draft publications would similarly be submitted to the Scientific Committee for comment and final copies distributed. All manuscripts arising from the use of the samples combined with response data to biologic treatments should be submitted to the pharmaceutical companies funding the BSRBR at least 30 days before submission to a journal. All abstracts to be submitted to a conference should similarly be submitted at least 20 days ahead of the submission deadline. This is to be coordinated centrally with all such manuscripts being sent to Mervyn Hogg at the BSR via Anne Barton at the ARC-EU. f. Review of Add-on Studies Exploitation of the BRAGGSS material will be enhanced by the additional collection of other information which for reasons of cost or feasibility is restricted to one or more centres. Where such add ons apply to the whole of BRAGGSS, arrangements for handling the data and materials as outlined above would also operate. However there may be situations where such data collection occurs in only one centre. The centre concerned in this situation should inform the Scientific Steering Committee of the proposal, to prevent duplication. The ownership of the resulting data would be vested with that centre but in any subsequent publication the role of BRAGGSS in the collection of the samples would be acknowledged. 5. Parallel Studies It is feasible that in some centres, patients may be enrolled in additional studies to their participation in BRAGGSS. Ethical Committees may not favour such multiple studies on the same patient but such studies may either already be underway or planned following the start of BRAGGSS. Such studies may involve collection for example of biological materials. It may not always be clear how distinct the parallel study is from BRAGGSS and hence whether any of the procedures listed above apply. It is considered judicious for PI s to inform the Scientific Committee of such parallel studies and how the information derived may relate to that collected by BRAGGSS. 6. Authorship a. The authorship of each paper emerging from BRAGGSS (including abstract) should be considered on a paper by paper basis and follow the general principles set out in the attached guidelines. (Feb 2007)

5 b. It may not always be appropriate for all BRAGGSS main investigators to be listed as authors on publications. As with many collaborative groups, papers may be published with several lead authors on behalf of the BRAGGSS group, with the names of those in the group listed separately. c. As a general rule, authorship/contributorship will be as inclusive as possible depending on the requirements of the journal. d. The final decision re authorship of a paper rests with the scientific steering committee. 7. External collaborations: External collaborators may apply to use to use BRAGGSS data and samples. There will be a formal process of application via the scientific steering committee and external collaborators are bound by the ownership and authorship guidelines for BRAGGSS as laid out here. All externally-led projects will be allocated a BRAGGSS liaison member of the steering committee. Data generated from work of an external collaborator using BRAGGSS data/samples will be returned to BRAGGSS at the end of the project.