Research Guidelines and Research Goals:

General Principles:

The SCMR Registry is established under the auspices of the Society of Cardiovascular Magnetic Resonance, and the steering committee (SC) is a formal SCMR committee. The registry policies should conform to existing SCMR policies and bylaws where possible.

All data must be contributed in accordance with HIPAA and other privacy legislation in place in the countries of contributing sites. All data are de-identified before being stored in the repository. No attempt will be made to identify individuals. All users with data access must endeavor to protect the privacy of the individuals from who the data were obtained.

Participants (those who contribute data to the SCMR Registry) should be recognized and acknowledged appropriately on the SCMR Registry website and this Web site should be referenced in publications in the acknowledgement.

ICMJE recommendations regarding authorship and non-authorship will be followed to the extent possible. If journals allow, the registry participants should be listed following the authors using the phrase “on behalf of the SCMR Registry contributors” (www.icmje.org).

Grant Proposals and Sub-Studies:

Researchers (which may include non-participants) requesting data access for either grant proposals or sub-studies will be required to submit a proposal to the SC for approval.

If approved, data access will be given to the researchers for a specific time period determined by the magnitude of the work involved, and only for the purposes of the grant proposal or sub-study. At the time of the sub-study submission, a publication plan is also required detailing hypotheses, authorship, intellectual property created and timelines. Amendments and additions to the publications associated with a sub-study can be requested subject to the approval of the SC. As part of the approval process, the SC may invite participants to collaborate with researchers and become co-authors on eventual publications.

Sub-studies can be approved even if there are existing overlapping studies already approved however the SC may reject studies with substantial overlap (similar aims and methodology) to existing studies. Researchers will be informed if their proposal overlaps with an existing study, and may wish to modify their proposal accordingly. Multiple groups may work on similar or overlapping topics, particularly if the methodology differs or if confirmation of results by an independent group seems warranted. In some cases this may lead to conflicting reports, but this is part of the open scientific process.

Data Access:

By contributing data to the SCMR registry, participants are giving permission for the data to be used in ongoing and future SC-approved research studies including meta-analyses. Data access is approved by the SC for approved sub-studies and grant applications.

Data access is granted only for the purposes of the specific research project detailed in the approved grant proposal or sub-study and publication plan, and under the terms and conditions specified below:

  1. The Data will be used solely for the purposes outlined in the study, and will not be used for any other purpose.
  2. Data access is not transferable to another investigator. Substantive changes made to study, and/or appointment of another Investigator to complete the study, should require execution of a new study proposal.
  3. Researchers must comply with the SCMR Registry publication policy.
  4. Researchers must acknowledge the SCMR Registry and its funding sources and cite the main SCMR Registry paper, in any oral and written presentations, disclosures and publications resulting from data access.
  5. Researchers agree that the Data will not be used, either alone or in conjunction with any other information, in any effort to determine the individual identities of any of the individuals from whom Data were obtained.
  6. Researchers will retain control over the Data, in a secure environment, and not transfer Data, to any other entity or any individual in a manner not previously approved by the the SCMR Registry. When the study is completed, the Data will delete from the researchers’ computers, unless other arrangements are agreed upon or an extension is obtained.
  7. Derived results and modifications of the data, including data cleaning, should be contributed to the SCMR Registry for the benefit of future research.
  8. To the maximum extent allowed by law, researchers should hold the SCMR, the SC and associated personnel harmless and to defend and indemnify all such parties for all liabilities, demands, damages, expenses, and losses arising out of their use of registry data for any purpose.
  9. Cost for data distribution of Data should be borne by the researcher. No warranties express or implied, are offered as to the merchantability or fitness for any purpose of the Data provided by the SCMR Registry, or that the Data may be exploited without infringing the intellectual property or proprietary rights of any third parties. SCMR is not responsible for the accuracy of Data provided.
  10. Amendments to the study should be made in writing and signed by authorized representatives of all parties.
  11. The SCMR Registry SC has the rights to examine the methods of data analysis (e.g. statistical analysis codes and post processed data files) by the researchers, should any issue relating to data integrity arises.
  12. SCMR or the SC may terminate access at any time.
  13. Researchers must comply with any licensing arrangements or protection of existing intellectual property agreements under which data were contributed to the SCMR Registry. Rights to any inventions or new information arising from the study, not relating to any existing agreements, will remain the property of the researcher.
  14. The Data cannot be used for commercial purposes without the permission of the the SCMR Registry SC.
  15. Failure to comply with these conditions could result in denial of further access to the SCMR Registry.

Publications:

Penultimate drafts should be submitted to the SC for approval at least one month prior to submission to a journal.  Abstracts for conferences, and extended abstracts for conference publication, should be submitted to the SC at least two weeks before the due date of the conference.  
Criteria for approval include consistency with the goals of the SCMR Registry, quality of the research, soundness of the methodology and interpretation of the results. The SC may require specific investigators or participants to be given the opportunity to become co-authors. However, all authors must have substantial contribution within an agreed time frame, not unreasonably impede publication timelines, and be accountable for all aspects of the work. Established guidelines for authorship of papers will be followed (http://www.icmje.org/ethical_1author.html). Where journals permit, registry participants should be listed in the author list with “on behalf of the SCMR Registry contributors”. All publications should acknowledge any funding supporting the SCMR Registry and cite the main SCMR Registry paper (when available). SCMR requires that any publications include the following credit, which credit shall be incorporated with the so-called “abstract” of such publications: “This research has been conducted using the SCMR Registry Resource”

While every effort is be made to foster high quality research outputs, the SCMR Registry cannot guarantee the integrity of every study published

Intellectual Property:

The SCMR Registry seeks to promote the development of valuable discoveries and inventions beneficial to public health based upon use of the registry repository. In some cases, intellectual property agreements may be entered into as part of the contribution of data to the registry. These should be designed to protect specific existing IP and ensure participant rights to any IP generated in these specific areas by third party researchers. IP generated by researcher which does not pertain to these specific areas, should remain the property of the researcher.