Content Requirements for Documents
The checklists provide information on the content requirements that apply when you need to report your scientific trial.
If you need to report a research project with adults over 18 years old who have the capacity to act, you can find guidance here (also projects with biological material or medical equipment).
Document requirements
Requirements for protocol
Requirements for protocol summary
Requirements for participant information
Standards for consent declarations.
If you need to report a research project on individuals without the capacity to act, such as persons under 18 years old or adults without the capacity to act, you can find guidance here (also projects with biological material or medical equipment).
I. Special requirements - Persons without the legal capacity
If you need to report a research project on previously extracted biological material, for which you are seeking an exemption from consent, you can find guidance here.
II. Special requirements - Research in biological material with exemption from consent
If you need to report a research project taking place in emergency situations where informed or proxy consent is not possible, you can find guidance here.
III. Special requirements - Research in emergency situations without prior consent
Researcher checklist - declarations of consent final January 2023
If you need to report a research project where you conduct extensive mapping of the genetic material, you can find guidance here (also projects involving children and projects with exemption from consent).
IV. Special requirements - Research in genomes
Standards for Consent Statements
If you need to report a research project with biological material taken during autopsy (under the Health Act Chapter 56) or a research project involving a minor procedure on the deceased, you can find guidance here.
V. Special requirements - Research on the deceased
If you need to report a change to an already approved research project, you can find instructions here.
Addendums to an Ongoing Research Project
Here you will find an overview of other guidelines and support documents for notification:
Appendix 1: Guidelines for Remuneration and Other Benefits for Volunteer Subjects (PDF)
Appendix 2: Guidelines on the Use of Ionizing Radiation (PDF)
Guidelines for submitting oral participant information
Parental power of attorney
Template for good participant information
Front page for participant information
Writing good participant information (PDF)
Information for 15-17-year-olds (PDF)
Guidelines on reporting and mandatory reporting, etc., of medical research projects may still apply to previously reported projects.
Guidelines on reporting (January 6, 2014)
Guidelines on reporting (January 2012)
Please note that the text on this page has been translated with the help of AI. If you find any errors in the text or something is unclear, please contact us for clarification.
Find answers on how to report electronically and which committee you should report to, etc.
Overview
Here you can download the consolidated researcher checklists:
Researcher checklist (non-drugs)
Standards for consent declarations
Are you looking for more comprehensive guidelines on topics such as Biobanks and Research on the Deceased?
See Guidelines.
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