Guidelines for authors

I. INTRODUCTION

The Swiss Hepatitis C Cohort Study (SCCS) welcomes all research in the form of Scientific Nested Projects (SNP) involving the SCCS infrastructure.
Applicants are invited, before submitting a project, especially when this is requiring the use of biosamples, to verify the feasibility of the proposed work by contacting the Data Center at the e-mail address hcvBiosampleRequest@clinicaltrialunit.ch.
The corresponding SOP is detailed in the attached PDF file.
II. SUBMISSION OF A RESEARCH PROJECT

1. General principles
Any use of the SCCS data for research purposes has to be submitted to the SCCS Scientific Committee. This should be done before initiating the project, to avoid duplication and potential conflicts. SNP must be reviewed by the SCCS Scientific Committee also when they are going to be submitted to the Swiss National Science Foundation (SNSF) for funding: in this case, the prior approval by the SCCS Scientific Committee is a prerequisite for submission to the SNSF. In case of SNP not necessitating funding or SNP already funded by sources other than the SNSF, the positive decision of the SCCS Scientific Committee is sufficient for starting the work. If a SNP is nested within another research project already financed by the SNSF, the SCCS Scientific Committee must have the possibility to read the grant previously submitted to the SNSF and have full knowledge of its relative decision.
2. Who can submit
SNPs may be submitted by all researchers who are formally involved and actively participate in the SCCS or – if not members of the SCCS - committed to actively collaborate with the SCCS.
3. Deadline and addresses
There are no fixed deadlines for submission. However, whenever a request is planned to be submitted to the SNSF, it is strongly advised to request a prior approval from the SCCS Scientific Committee at least 4 (four) weeks before the deadlines established for grant applications to the SNSF (i.e. September 30 and March 31).

All documents have to be submitted electronically (as pdf files)) to the Chairperson of the Scientific Board,
Dr David Semela, Bereich Gastroenterologie und Hepatologie, Kantonsspital, St. Gallen, e-mail: David.Semela@kssg.ch
4. Types of Proposals
In order to simplify the procedure of application for research projects, the Scientific Committee supports the following types of SNP:
  • Letter of Intent (LOI) (max. 3 pages)
  • Full Proposal (with the detailed budget requirements, collaborations, other sources of funding)

4.1 Letter of Intent
The LOI has the role of providing the submitting investigators with a preliminary assessment of the feasibility and scientific merit of a project nested within the SCCS and that can be later submitted as a Full Proposal. The LOI will include a short general description of the research question, the rationale and the resources likely to be needed. Minimum requirements include:
  • a short introduction with 1 - 5 key references
  • the study objectives
  • the study design
  • a preliminary budget
4.2 Full Proposal
The detailed description of the study should concisely present all the information necessary to allow a complete assessment of the proposal. It must be typed on no more than 10 pages. The following information is required:

4.2.1 Abstract
(max. one page)
4.2.2 Research Plan
4.2.2.1 State of the Art
  • present state of knowledge in the area of the proposed research with key references
  • objectives of the project in relation to state of knowledge
4.2.2.2 Own Research in the Field
  • including relevant experience and a list of publications
  • relevant background information on the other investigators
4.2.2.3 Detailed Research Plan (only pertinent items to be filled)
  • the hypothesis to be tested
  • study design, endpoints, inclusion/exclusion criteria
  • investigations and tests to be performed in patients
  • laboratory methods
  • drug information (if applicable)
  • follow-up evaluation; patient management issues
  • ethical committee evaluation
  • biostatistical methods
4.2.2.4 Significance of the Project

The scientific and practical significance of the proposed research

4.2.2.5 Time Frame for the Project

The research tasks to be performed within the credit and the duration of the projects should be explicitly mentioned.

4.2.3 Available Means and other sources of Funding
  • Indicate infrastructure and manpower already available for the study
  • Indicate what funds you expect to obtain from other sources
4.2.4 Detailed Budget
  • The budget should include appropriate details as well as external funded expenses
  • For personnel, the requested position(s) and duration should be justified by a description of the tasks
  • The keys of the financial distribution between the different participating centers should be presented
  • The budget of the study should take into the following costs: personnel, laboratory tests, specimen retrieval from the SCCS repositories (9 CHF per each sample), special tasks requested from the Data Center (data extraction and analysis), other expenses
4.2.5 Investigators and Authorship
A proposal for authorship should be part of each submitted project. It is understood that they have all agreed to participate actively in the submitted proposal. For each project, the financial responsibility should be explicitly mentioned and the project should be approved by the chief of the unit / lab / etc. who is ultimately responsible for the advancement of the project.
The SCCS is listed as author in all papers made with the contribution of at least two centers, using the quote: *and the Swiss Hepatitis C Cohort Study Group*, followed by an index that refers to a footnote providing the full list of SCCS members.
4.2.6 Attachments
Please attach whatever information you feel would help support the submission. Such information may include:
  • a cover letter
  • the curriculum vitae of the principal investigator
  • an informed consent form/patients' information form for all clinical trials
  • Case Record Forms for clinical trials
  • approval of the sponsoring institution's and/or the university's ethics review board
  • list of potential reviewers (positive and negative, with reasons to exclude some of them)
  • statement concerning the dissemination of results (see paragraph 8).
5. Evaluation and decision process
The SCCS Scientific Committee has to evaluate all submitted projects. The detailed procedure is decided internally by the Chairperson. The latter may appoint one or two external referees (including experts from abroad) in case of controversy among the internal members of the Scientific Committee about the decision to be taken. After the Scientific Committee has made its decision, this is notified by the Chairperson to the responsible investigator in a written and detailed form.
Authors who do not agree with the rejection of a project can appeal to the Scientific Committee within one month of the decision with a letter detailing the reasons for the rebuttal. The SCCS Scientific Committee will decide whether a further evaluation is warranted, but the following decision – in this case – has to be considered as definitive.
A grant application to the SNSF requires a prior approval by the SCCS Scientific Committee: the latter approval must be submitted together with the application. In this case, it is understood that (i) a preapproval by the SCCS Scientific Committee by no means constitutes a guarantee that the SNP will be fully or partially accepted by the SNSF, and that (ii) the submitting investigator is fully responsible – from both the administrative and scientific point of view – of his/her project vis-à-vis the SNSF, and accepts to adhere to the guidelines established by this same institution concerning the grant allocation and subsequent evaluation.
6. Progress reports
A copy of the scientific report of each SNP must be made available upon request to the SCCS Scientific Committee, who will include a summary of the most relevant results on the SCCS website. The SCCS Scientific Committee reserves the right to issue recommendations in case the scientific work does not proceed as planned.
7. Special funding requirements
The SCCS Scientific Committee reserves the right to modify the SNP budget concerning (i) the SCCS clinical samples retrieval, and (ii) the costs for involving the Data Center personnel (data extraction, analysis), if deemed insufficiently covered at the time of submission.
8. Dissemination of results
The responsible investigator for each SNP has to state how he/she plans to disseminate the results of his research in a publicly available format (publication in scientific journal, thesis, communication at a scientific meeting), and this at the time of the initial submission of the SNP.