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Project submission & guidelines

GUIDELINES AND OPERATIONAL RULES FOR SCIENTIFIC PROJECTS

I. Introduction

The Swiss HIV Cohort Study (SHCS) welcomes all types of research projects linked to patients with HIV infection. However preference will be given to projects likely to benefit from the SHCS infrastructure and including at least two of the seven SHCS centers (research on large number of patients and/or necessitating recruitment from more than one center). The same rules are also valid for submission of MoCHiV projects.

II. Submission of a research project

1. General principles

All grant submissions and communication with the Scientific Board has to occur in English.

Any use of the SHCS/MoCHiV data for research purpose has to be submitted to the Scientific Board. This applies even if no funding is requested, to avoid duplication and potential conflicts with other projects. Submission is required prior to the initiation of a project. Ongoing or finalized projects cannot be submitted for retroactive funding.

In case of simultaneous submission to the Swiss National Science Foundation (SNSF) and the SHCS, the Scientific Board has to give a first opinion/advice, which will be transmitted to the investigator and to the SNSF.

If a submitted SHCS project is nested within a research project financed by the SNSF, the two experts designated by the SB must have the possibility to read the grant submitted to the SNSF and have full knowledge of its decision. In order for the experts to gather  this information and study the documents, such a project has to be submitted 2 weeks earlier than the usual deadline.

2. Who can submit

Researchers who are formally involved and actively participate in the SHCS may submit research projects.

Any project which is submitted by a non SHCS researcher has to be endorsed by a SHCS member who will supervise the project scientifically and will have the financial responsibility (responsible investigator).

3. Deadline and addresses

Letter of intent and full proposals have to be submitted at least 3 weeks before the Scientific Board meeting. See agenda on the SHCS web site.

All proposals need to be submitted electronically to shcs-submission©hospvd.ch, from where they are automatically forwarded to the Chair of the Scientific board and the administrative office of the SHCS.

For the submission of MoCHiV projects, please send a preliminary copy of your proposal to :

• Chairperson : PD Dr. Christoph Rudin Universitäts-Kinderspital beider Basel (UKBB), Römergasse 8, 4058 Basel christoph.rudin©unibas.ch

After an internal discussion among the MoCHiV Board, the submission follows the same procedure as for SHCS projects (shcs-submission©hospvd.ch).

4. Types of Proposals

In order to simplify the procedure of application for research projects, the Scientific Board (SB) supports the following two steps in research proposals:

• Letter of Intent (1-3 pages)
• Full Proposal

At each step, the Scientific Board will get back to the investigators in order to avoid unnecessary efforts if a project is not felt to be worth pursuing or if coordination with other projects is necessary.

4.1. Letter of Intent

The purpose of a letter of intent is to inform the Sc-Board about a plan for a Scientific project. A preliminary discussion of such a proposal will help the investigators to finalize their project within a major scope of the scientific agenda of the SHCS. The Sc Board will also make suggestions for additional study aims or research groups to be included in the final project.

The letter of intent 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

For a project which needs only data sets and no financial support, the decision can be taken on the basis of a letter of intent. For funding, a full proposal has to be elaborated.

4.2. Full Proposal

The detailed description of the study should concisely present all the information necessary to permit a complete assessment of the proposal. In general, it should consist of 10 pages or less. For proposals that only require the use of SHCS data but no financial support, 1-3 pages will usually suffice. The following information is required.

Download of template for full proposal

4.2.1. Administrative information

The name of all investigators of each center involved in the project should be mentioned. It is understood that they have all agreed to participate actively in the submitted proposal. The chief of the unit/lab has to approve the proposal.

For each project, a responsible investigator has to be identified (see point 2)

4.2.2. Summary

1 page maximum. The author should provide a running title (or the complete title) for announcement on the WEB site of the SHCS in case of acceptance

4.2.3. Background

• Present state of knowledge in the area of the proposed research with key references
• Objectives of the project in relation to state of knowledge

4.2.4.  Own research in the field

• Including relevant experience and a list of publications
• Relevant background information on the other investigators

4.2.5. Study aims and objectives

• The hypothesis which this project proposes to test
• The scientific and practical significance of the proposed research

4.2.6. Study design and research plan

• Investigations and tests to be performed in patients
• Laboratory methods
• Follow-up evaluation; patient management issues
• Biostatistical methods
• Time-frame for the project (the research tasks to be performed within the credit and the duration of the projects should be explicitly mentioned)

4.2.7. Study budget

• Indicate infrastructure and manpower already available for the study
• Indicate what funds you expect to obtain from other sources (Industry, AIDS-Hilfe, etc...)
• 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 budget of the study should take into account only costs not already covered by the core research project of the SHCS :

Note the 4 phases of a project : preparation, operation, data analysis, manuscript writing. Specify the following costs : personnel, laboratory tests, specimen retrieval, reimbursement to the participating centers, special tasks requested from the Data Center, diverse.

Sample retrieval is paid according to the number of samples and not the number of aliquots:

• • 1-6 samples flat rate Fr. 50
  • for more than 6 samples Fr. 8 per sample
  • add costs for packaging, dry ice and shipment (usually about Fr 50 per shipment)
• The budget may be modified by the Scientific Board and has to be approved by the Executive Board. If the authors do not agree with the allocated budget, they should immediately notify the President of the SHCS, particularly if they think that the whole project cannot be fully carried out with the allocated funds. In principle, supplement funding at a later stage will not be possible.
• The budget must comply with the rules of the Swiss National Science Foundation (www.snf.ch)

4.2.8. Other information

• Ethical committee to contact
• Interim analysis (if applicable)
• How you imagine to disseminate your results (publication in scientific journal, thesis, internal report, conference, etc.)
• A proposal for authorship should be part of each submitted project.

4.2.9. References

4.2.10. Attachments

Please attach whatever information you feel would help support the submission. Such information includes :

• A covering letter
• CRF if relevant (i.e. key investigators not known to the Sc Board)
• The curriculum vitae of the principal investigator (if not already sent before)
• An informed consent form for drug trials
• Approval of the sponsoring institution's and/or the university's ethics review board

5. Evaluation and decision process :

• The Scientific Board has to evaluate all submitted projects. It's President will appoint one or two members as "expert" for each submitted project.
• The experts review the project and send a written structured comment to the Chairman of the Scientific Board. They must verify that there is no overlap with an ongoing project. Should this be the case, the expert must inform the SB Chairman who will contact the investigator.
• The responsible investigator is invited to attend the Scientific Board meeting during the discussion of his project A project is accepted with the approval of 2/3 of the members attending the meeting. The Chairman may request a secret vote if the opinions among the members diverge considerably.
• The Executive Board ratifies the Scientific Board decision The responsible investigator will be informed about the decision within three weeks following the Scientific Board meeting
• Authors, who do not agree with the rejection of a project can appeal to the Executive Board within one month. The Executive Board will then take a final decision.

Submission of a modified project :

A project for which modifications have been required by the Scientific Board may be resubmitted :

• A point by point reply to all comments of the Scientific Board is requested from the investigators (like for publications)
• The modified protocol, with relevant changes highlighted in yellow, and the point by point reply (filled into the specific text box of the full proposal template) have to be sent to the usual address (shcs-submission©hospvd.ch)
• The modified protocol is sent to the experts who have initially reviewed the project
• The project is discussed at the next Scientific Board meeting

Urgent decision needed :

• Rapid decisions may be taken by e-mail but they are limited to very special circumstances :
  • Temporal delay of the decision to the next Scientific Board meeting would jeopardize the timely publication of the work (e.g. late breaker abstract, important publication in a very competitive situation)
  • The suggested budget for the proposed work is less than CHF 5'000.-
• Submissions have to be done as usual through the SHCS submission e-mail with request for rapid evaluation (shcs-submission©hospvd.ch)
• The Chairman of the Scientific Board will decide whether special circumstances are met
• If accepted, the proposal is sent to all members of the SB by e-mail.
• The proposal is first discussed by e-mail by all SB members using the SB address (shcs-sb©hospvd.ch) during 7-10 days. The deadline is given by the SB Chairman.
• After the discussion period, the SB Chairman will ask all SB members to vote by direct mail to  (shcs-submission©hospvd.ch) : 7 days turnaround time. The decision is final if all voting members accept the proposal. If this is not the case, the project will automatically be put on the agenda of the next Scientific Board meeting

6. Progress report

6 to 8 months after having initiated the project, the responsible investigator has to send a short progress report to the Coordination Center. It should contain :

Quantitative figures if appropriate (% of objectives reached) Delay in the initial time schedule should be explained and a revised time schedule has to be presented (termination, manuscript, publication).

7. Allocation of the funds

The following rules will be applied for the allocation of the funds:

• 20 % of the budget on approval
• 30 % of the budget on receipt of a scientific intermediate report and of the expense proofs corresponding to 50%
• The remaining amount but not more than 50% of the approved budget on receipt of the required documents :
  • a financial report including original expense proofs
  • a publication or a manuscript accepted for publication. In case of repeated rejections, a scientific report must be sent
  • a CD Rom including the final study protocol, the raw data and the statistical programs used for the analysis
  • a list of the requested blood samples with mention of their quality and availability.

If the allocated budget does not exceed CHF 10'000.- 50% of the amount is paid on approval.

A bonus will be allocated for publication :

• Articles (full/concise) CHF 1500.- + I.F. x 500.- Max. 10'000
• Letters if IF >5                            I.F. x 250.- Max    7'500

Each publication of a research project is considered. If > 1 publication, only article(s) with I.F. is/are to be considered

Paid ½ to center of first author and ½ to center of last author. In case of controversy, the EB will decide. Only centers belonging to the SHCS can receive a bonus.

IF : Impact Factor

8. Publications

8.1. Authorship

• The wording to be used is "XYZ.. and the Swiss HIV Cohort Study".
• Alternative wordings like".. for the SHCS" can only be used with the approval of the Scientific Board. If a rapid decision is needed, the request has to be submitted to the SB Chairman or to the SHCS President. Alternative wordings can be justified in the following situations:
  
  • For a study taking place in one or two centers only or for a study including less than 100 patients.
  • For a study where the involvement of the SHCS regarding data, blood samples and budget is minor.
  • For international collaborations where the SHCS contributes less than half of the included patients.
• A local project, from a single center, that has used SHCS data and that was not funded by the SHCS has to mention the SHCS in the acknowledgment and not in the title. No bonus will be paid

8.2. Footnote

The SHCS or MoCHiV member list has to be included as a footnote.

8.3. Reporting of Observational data

Please refer to the recommendations made by STROBE

8.4. Any submitted or published manuscript

with mention of the project number, should be sent by e-mail to: M.-C. Francioli,
E-mail : marie-christine.francioli-volz©chuv.ch

Update : October 2007