Research Ethics

All experiments conducted at CIBIT must follow the Declaration of Helsinki. This declaration is a set of ethical principles, developed for the medical community by the World Medical Association (WMA).

Steps before starting a (clinical) study

  1. If you are conducting research on human participants, make sure you prepare an Informed Consent according to the Declaration of Helsinki and a protocol compliant with the ICH-GCP guidelines and the data protection applicable laws.
  2. You should then obtain the approval for conducting the study from the Competent Ethics Committee - CEC (check this link to find the appropriate Ethics Committee for your study).
  3. If the CEC for your study is the Ethics Commission (EC) of the Faculty of Medicine, University of Coimbra, check the documents below for existing Informed Consent examples, and the committe website for all the instructions and procedures to follow in order to submit a research project. These procedures have recently been updated in accordance to the latest update to the General Data Protection Regulation.

Notes

  • If you are integrating a project, please check if there is already an Ethics Commission approval or if you need to ask for an addendum for the existing one.
  • Check for detailed information and support at the Clinical Research Unit (CRU2C).

Useful Contacts

  • CE-FMUC: comissaoetica [at] fmed.uc.pt
  • Clinical Research Unit - CRU2C: cru2c [at] uc.pt
  • DPO @ICNAS: dpo [at] icnas.uc.pt

General Data Protection Regulation (GDPR)

The General Data Protection Regulation (GDPR) governs how any data (including research data) should be managed. All members are responsible to abide by the data protection guidelines/rules.

If you have any doubts regarding this topic, get in touch in #rgpd @Discord and/or contact the closest DPO (dpo [at] icnas.uc.pt).

Open Brain Consent

To facilitate neuroimaging data sharing, we provide an “out of the box” solution addressing aforementioned human research participants concerns and consisting of 1) widely acceptable consent forms (with various translations) allowing deposition of anonymized data to public data archives; and 2) collection of tools/pipelines to help anonymization of neuroimaging data making it ready for sharing.

Example documents

  • Informed consent for an fMRI experiment (healthy subjects) pdf

  • Informed consent for an imaging experiment (with clinical group) pdf

  • Data Use Agreement form for CIBIT docx

  • Personal data request form for CIBIT (in PT) docx

  • FMUC Ethics Commission specific form (in PT) docx


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Page last modified: Apr 28 2021 at 09:03 PM.

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