Research Project Data Request

Research Project Data

Mission and goals of the CASCADE Consortium

The CASCADE Consortium is a working association of researchers, clinicians, community professionals, project personnel, and students from various health-oriented disciplines, such as, but not limited to anthropology, biostatistics, communication, epidemiology, ethics, genetics, health services research, medicine, nursing, psychology, public health, and sociology, who are committed to the mission of the Consortium.

The mission of the CASCADE Consortium is to develop a collaborative group of researchers, clinicians, and educators across institutions, committed to fostering the design and implementation of research related to cancer predisposition cascade genetic screening in Switzerland.

The goal of the CASCADE Consortium is to create an interactive environment that:

Supports research related to cancer predisposition genetic screening and related cancer care continuum.
Fosters collaboration among professionals involved in cancer predisposition research and clinical care.
Disseminates scientific advancements and new knowledge to scientists, practitioners, patients, families, healthcare institutions, and involved stakeholders.
Fosters the development of cancer predisposition researchers and clinicians through mentorship, access to existing datasets, and collaborative studies.

Collaboration with the CASCADE Consortium for a Research Project

The CASCADE Consortium invites collaborations with individuals who are committed to promoting cancer predisposition cascade genetic testing in Switzerland through research, education, collaboration in clinical care, and dissemination of scientific advancements. The collaboration entails the conduct of research projects, which require access to resources from the CASCADE study. Resources are decoded/anonymized data and/or (biological) samples. The requesting Investigator is a physical person who assumes scientific and administrative responsibility of the research project and is the primary contact with the CASCADE Consortium.

A collaborative research project may be based solely on data and/or samples and raw data analyses results specific to the CASCADE study, or require additional data and/or samples. If a research project requires the collection of additional and complementary data and/or samples, these data and samples will be used to enrich the CASCADE database.

Requests for access to data and/or samples can be made any time using the forms available from the Chairperson of the CASCADE Consortium and the CASCADE website.

Requests for research projects whose objectives have been defined in the original protocol of the CASCADE study must complete the Request Form for Data and/or Samples.

Requests for research projects NOT defined in the original protocol of the CASCADE study, the requesting investigator(s) must complete and submit the Research Project Form and the Request Form for Data and/or Samples in order to receive data and/or access to samples from the CASCADE study. The Research Project Form asks that the investigator describes scientific and methodological aspects (research question, data and/or samples requested, data analyses plan), implications regarding confidentiality, ethics and professional conduct, a budget estimate and its financing, and a provisional timetable for carrying out the investigations from the initiation of the project.
A list of variables and amount of data/samples collected through the CASCADE Consortium is available from the Chairperson of the Executive Committee on request.

Procedures for access to data and/or (biological) samples from the CASCADE study

The articulation of the following steps is summarized in Appendix 1.

The Research Project Form and/or the Request Form for Data and/or Samples will first be examined by the Scientific Review Committee, which will provide a recommendation to the Executive Committee.
The Scientific Review Committee will examine if the application is complete within a maximum of sixty (60) calendar days. During this period, the requesting investigator(s) may be asked to provide additional information in order to complete the application.
The requesting investigator(s) will be given a maximum of thirty (30) days to respond to the request for additional information. If the requesting investigator(s) does not respond within the specified time frame, the Scientific Review Committee will conclude that the request has been withdrawn. An acknowledgment that the application file is complete will be sent to the requesting investigator(s).
The Scientific Review Committee will disseminate a summary and an interim recommendation to the Executive Committee. The Executive Committee will provide a final decision.
The Executive Committee will decide for the collaboration with the requesting investigator(s) when the research project has NOT been defined in the CASCADE study protocol or when is not part of the research priorities of the CASCADE Consortium.
The review procedure will be completed within a maximum of six (6) months after receiving a complete application.

Access to data and/or (biological) samples and access conditions

All data and/or (biological) samples collected by the CASCADE study or from an analysis included in the study database can be used for a selected project.
The data and/or samples provided is all anonymous/coded – no extraction of the CASCADE study databases and no direct access to the study database will be granted to project proponents.
The codebook of data and samples including the initial data and samples of the CASCADE study is generated by the Clinical Trial Unit, University Hospital Basel and is distributed by the Chairperson.
Results of each research project are available by the Chairperson.
The Scientific Review Committee and/or the Executive Committee, after reviewing the project may decide to:
- Approve the research project;
- Provide a Conditional Approval;
- Reject the research project in the form in which it was presented; in this case, the research project may be revised and resubmitted;
- Reject the research project.
Access to resources (includes ONLY decoded/anonymized data and/or samples) by the requesting investigator(s) and/or the project manager is subject to the prior conclusion of an agreement defining the variable(s), the timetable, the budget, and the intellectual and sample property aspects.

Evaluation criteria for Research Projects

The Scientific Review Committee will evaluate the feasibility of the research project, particularly in relation to data and/or samples requested. Special attention will also be given to the data analyses plan and whether a statistician/data analyst is included.
The evaluation criteria will take into account the consistency of the project with the CASCADE study and the priority research topics set by the CASCADE Consortium, the submission of other projects on the same thematic areas, the proposed methodology and the innovative aspect of the project.
Consistency of the estimated budget with the proposed project.
Possible collaboration of the requesting investigator(s) with the CASCADE Consortium. A written recommendation from a Consortium member, or plans for active collaboration with the Consortium will be viewed favorably.
Depending on the complexity of the research project, the Scientific Review Committee will call on external experts for reviewing the project. This may affect the time frame of the scientific review, which will be communicated to the requesting investigator(s).
In case the Scientific Review Committee or the Executive Committee reject the application, the decision will be accompanied by a summary of the reports; if the decision is “revise and resubmit” the decision will be accompanied by suggestions for amendments

Budget preparation

The research project budget is provided in the submission package.
The requesting investigator(s) will be asked to contribute a fee depending on the amount of data and/or samples requested, which will be counted towards the general budget of the CASCADE study. The fee involves the hourly rate of the biostatistician who will extract and clean the requested data and/or (biological) samples.
The requesting investigator(s) is responsible for making the necessary funding requests for the realization of the research project.

Formalization of the agreement

When a research project has been selected in principle by the Executive Committee, the specific modalities of the collaboration between the CASCADE Consortium and the requesting investigator(s) must be formalized in an agreement.
The Chairperson of the Executive Committee will draft this agreement with the institution of the requesting investigator(s). The agreement will specify in particular the following points:
- Definition of resources; access will be provided only to anonymized/decoded data and/or samples;
- Methods of realization of the research project;
- Accessibility time to resources;
- Frequency and methods of transfer, including name and contact details of the recipients;
- Communication of the project’s results to the CASCADE Consortium in a suitable format;
- Confidentiality clause and project monitoring procedures;
- Publication and communication rules, including intellectual and sample property;
- The responsibility for the transport, storage and use of data and/or samples will be defined in the agreement between the CASCADE Consortium, represented by the Chairperson, and the institution of the requesting investigator(s);
- Financial clauses;
Data and/ or samples will not be transferred abroad, to another individual and/or institution without the explicit written consent of the Executive Committee, and will be managed according to the Swiss legislation of the Federal Act on Research involving Human Beings (Human Research Act, HRA) of 30 September 2011, RS 810.30 and the Federal Act on Data Protection (FADP) of 19 June 1992, RS 235.1.

Monitoring of research projects

The requesting investigator(s) is responsible for the appropriate use and safe keeping of the data and/or samples. This includes not transferring the data and/or samples abroad and/or sharing resources with any other individual not affiliated with the project, the CASCADE study, or any other institution.
Further use of data and/or samples, not defined in the agreement and the objectives of the research project needs to be approved by the Scientific Review and the Executive Committees.
Newly collected data and/or samples will be transmitted to enrich the CASCADE database.
Progress reports, including status of data and/or samples that will be used to enrich the CASCADE dataset, must be submitted annually to the Executive Committee.
The Executive Committee maintains the right to terminate the collaboration with a requesting investigator(s) in cases of not fulfilling the agreement and/or the objectives of the research project.
Any violation of the collaboration agreement and use of data and/or samples that does not follow the above described procedures will be examined according to the Swiss legislation of the Federal Act on Research involving Human Beings (Human Research Act, HRA) of 30 September 2011, RS 810.30 and the Federal Act on Data Protection (FADP) of 19 June 1992, RS 235.1

Scientific publications and communications

The results of analyses using data and/or samples from the CASCADE study must be disseminated in the form of scientific publications, reports, theses, abstracts, dissertations, etc. The methods of publication and communication are defined in the agreement between the Executive Committee and the requesting investigator.
The requesting investigator(s) is required to provide the Executive Committee with a copy of the publications or reports from their project.

Authorship guidelines

The CASCADE Consortium follows the Swiss Academies of Arts and Sciences guidelines regarding Authorship in Scientific Publications. This document will guide procedures for determining authorship, order of listing, and authors’ responsibilities.
“CASCADE Consortium” should appear in the title or in the list of authors of all articles using data and/or samples from the CASCADE study.
Authorship is discussed during formalization of the agreement. The requesting investigator(s) can propose authors in the junior and senior positions.
Full members of the CASCADE Consortium and Site Investigators will be co-authors in all publications based on the CASCADE dataset. These names will be forwarded to the requesting investigator(s) at the time of the agreement.

Acknowledgments

The authors of the publication must mention that the research project was conducted within the CASCADE study framework.
The following wording must be used in all published manuscripts and presentation. Additional grants will also be cited accordingly:

“This study was supported by:
Swiss Cancer League – KLS-4294-08-2017 to Katapodi, MC; Chappuis, PO; Erlanger, TE; Pagani, O; Rabaglio, M; Viassolo, V. and the CASCADE Consortium Co-Investigators.
University of Basel – Office of the Vice Rector of Research Forschungsfonds to Katapodi, MC”

Nominative acknowledgments for researchers who have contributed to the development of the research project, have made a particular contribution to the data analyses, or have enriched the CASCADE database may also be added.
All publications should refer to the methodological publication presenting the protocol of the CASCADE study. The reference of the article will be specified in the agreement established between the institution of the requesting investigator(s) and the Executive Committee.