Statutes / Fees
Overview
Overview
Overview
Statutes of the Ethics Committee of the Faculty of Medicine of the University of Cologne
Overview of the schedule of fees
§1 Collection of fees
Fees for the evaluation of clinical trials and consultation on research projects are charged in accordance with Section 29 (4) HG NRW. The fees are payable in accordance with these regulations, unless other legal provisions apply.
§2 Fee reduction and fee exemption
(1) For reasons of equity, a reduction in fees or expenses or an exemption from fees or expenses may be granted upon written request.
(2) Reasons for equity and the prerequisites thereof are specified in Section 7 of § 5 of the Schedule of Fees.
(3) Applicants are obliged to disclose the financing of the research project.
§3 Fee debtor
Applicants are responsible for paying the fee, although third parties may assume responsibility for paying the fee by submitting a written declaration to the Ethics Committee.
§4 Origin and due date of the payment obligation
(1) The fee is due upon submission of the application. If a specific amount must be determined for a fee or if a fee reduction is to be granted, the fee becomes due upon determination.
(2) If an application is withdrawn prematurely, the fee charged will be refunded to the applicant on a pro rata basis, depending on the expenses already incurred by the Ethics Committee.
(3) The obligation to reimburse the Ethics Committee for expenses incurred for translations and expert opinions (see point 6.1 of the schedule of fees) arises upon determination of the costs for the service provided. Payment must be made before the Ethics Committee has completed its work.
§ 5 Directory of fees
| 1. | Clinical drug trials: Assessment pursuant to § 42 AMG (before the entry into force of Articles 2, 4, 5, 6, 8, and 10 of the Fourth Act Amending Pharmaceutical and Other Regulations of December 20, 2016) (this includes monitoring of the study with regard to reports pursuant to§ 13 GCP-V (3) – (5) and (8) – (9)) | |
| 1.1. | leading (monocentric) | 3.000 € |
| 1.2. | leading (multicenter) | |
| 1.2.1. |
| 3.500 € |
| 1.2.2. |
| 4.500 € |
| 1.2.3. |
| 1.000 € |
| 1.3. | involved (this includes monitoring the study with regard to subsequent changes in accordance with § 10 (1) GCP-V) | 2.000 € |
| 1.4. | Clinical drug trials: Evaluation of subsequent changes (§ 10(2) in conjunction with § 10(1) GCP-V) as the lead ethics committee | |
| 1.4.1. |
| 400 € |
| 1.4.2. |
| 600 € |
| 1.4.3. |
| 200 € |
| 1.5. | Clinical drug trials: Evaluation of additional trial sites (§ 10 (4) GCP-V) as the lead ethics committee, per center | 100 € |
| 1.6. | Evaluation of annual safety reports/DSUR | 500 € |
| 1.7. | Clinical drug trials: Evaluation of additional trial sites (§ 10 (4) GCP-V) as participating ethics committee (for a study not yet discussed by the ethics committee) | 2.000 € |
| 2. | For clinical trials in accordance with EU Regulation 536/2014, fees are charged in accordance with § 40(6) of the German Medicines Act (Arzneimittelgesetz) in conjunction with the annex to § 12 of the Clinical Trial Assessment Procedure Regulation (Klinische Prüfungen-Bewertungsverfahren-Verordnung, KPBV). | |
| 3. | For consulting services related to clinical trials of medical devices and performance evaluation tests, fees are set in accordance with the General Administrative Fees Regulations of the State of North Rhine-Westphalia. | |
| 4. | Assessments pursuant to § 36 StrlSchG and §§ 8 and 9 TFG | 2.000 € |
| 4.1. | Assessments of subsequent changes if the Ethics Committee of the Medical Faculty of the University of Cologne has carried out an assessment in accordance with § 36 of the German Radiation Protection Act (StrlSchG) and §§ 8 and 9 of the German Therapeutic Products Act (TFG) | 300 € |
| 5. | Professional legal advice pursuant to § 15 (1) of the Professional Code of Conduct for Physicians in North Rhine-Westphalia and advice pursuant to § 2 (1) of the Articles of Association, provided that clauses 1–3 do not apply. | 1.200 € |
| 5.1. | Consultation on subsequent changes or if consultation has already been provided by the Ethics Committee of the Medical Faculty of the University of Cologne in the same project | 200 € |
| 6. | Other fees | |
| 6.1. | Involvement of an external expert For studies that require expert opinions, the fee is increased by the expert's fee. | |
| 6.2. | Special work expenses Expenses that exceed the usual amount will be invoiced separately. Per hour of work commenced in accordance with the guidelines for taking administrative expenses into account when determining the administrative fees to be charged under the Fees Act for the State of North Rhine-Westphalia. | Reimbursement of expenses and costs |
| 7. | Reasons of equity:
Prerequisite:
|
Note on consulting fees
Please note that consultation fees are generally charged. The applicant is liable for the fees.
In your own interest, we therefore ask you to take the consultation fees into account when submitting funding proposals.
In the case of DFG funding, the consultancy costs of the Ethics Committee must always be requested from the funding body. The DFG will cover the consultation costs if they have been applied for and the corresponding application is approved. Further information on this can be found on the DFG website https://www.dfg.de/foerderung/faq/lebenswissenschaften_faq/index.html (here under the question "In which cases do I have to submit an ethics vote?").
According to the information provided there, the consultation fees can currently also be charged as an exception if the legal basis for the payment arose before the date of approval.
The fees can be applied for in the DFG proposal form under "Other funds".
Updated on 18.01.2023
Here you will find a form for the declaration of assumption of costs by the Ethics Committee, which must be downloaded, completed and signed accordingly. Please note that a signature of the account holder is mandatory for payments of fees from accounts of the University Hospital of Cologne. Please then attach the completed form in PDF format to the application documents.
Please note our information on consultation fees under News