Submission Form

1. Identification of the Project Administrator Researcher:

Name: *

Institutions and respective departments, laboratories or services where the project takes place: *

Telephone contact: *

Email: *

2. List of Collaborators, including researchers (Name, Title, Function, Place where the functions are performed, Tasks performed in the project): *

3. Project Identification (Title): *

4. Project funding source(s):

5. Authorizations / Opinions for the project:

Required:

Obtained:

INFARMED

National Data Protection Commission

Entities that own the files

Official Entities to which authorizations related to the project are due including the Directorate General of Veterinary

Animal Protection Entities

Not applicable

If you have requested an authorization / opinion for the project and selected at least one of the options in the previous question, please indicate the date(s) on which it was / were obtained:

6. Main objective of the study / project: *

7. Expected duration of the study / project: *

8. Brief description of the Research Program: *

9. Previous scientific knowledge to support the Project (including references): *

10. Ethical concerns, identification and characterization of the sample (Indication of the benefits in scientific knowledge that are expected from the studies and their meaning, risks of injuries and malaise that may reach the participants. What is the project proponent's assessment of the risk / benefit ratio resulting from the experimentation you intend to perform; Identification and characterization of the sample: a) animals - eg: species, sex, genetic changes or b) humans - healthy or sick): *

11. Indicate the documents, including legislation and guidelines on ethical principles, that were the reference in the experimental design of the study (e.g. WMA- Declaration of Helsinki): *

12. Experimental procedure and data collection (Description of the execution of the experiment, interventions, measurement methods, number of visits, time required for each act, doses and modes of administration for any drugs, size of samples collected, etc.): *

13. Possible complications (eg: pain, indisposition, integrity) and measures to avoid or correct them: *

14. Summary of previous results of investigations in animals relevant to the project or justification for doing direct experimentation on humans: *

15. Specify the previous experience (own and / or of the collaborators) of the use of the technique or treatment (In case the Project is the continuation of a previously approved project or that involves the same methodology and / or sample, identify it. Even in the case of exclusively animal experimentation, this information must be provided): *

16. Relationship between the Researcher and the study participant:

Relationship type(s):

Doctor-patient

Teacher-student

Employer-employee

Other(s)

In case you have selected as relationship type: "Other(s)" in the previous question, please specify:

17. Selection of participants (Indication if the participants are recruited from previous or ongoing studies. Indication of the selection criteria - inclusion / exclusion): *

18. Inclusion of participants in several studies simultaneously (Indication of project titles, names of administrator researchers and indication of approval of studies): *

19. Indication of the forms and records of the health controls of the people participating or excluded from the study (Previous exams before the selection, use and destination of the records of previous exams. Inclusion in the information given to obtain the “Informed Consent Statement”): *

20. Indication of the ways of recording the results and of any complications (Guarantee of confidentiality, for example, in the processing of the results by computer or video recordings. Data coding. Project personnel who have access to the records and obligations related to the guarantee of confidentiality): *

21. Forms of information for participants, intended for the “Informed Consent Statement”:

Forms of information:

Written (attached to the proposal)

Oral and written (attached to the proposal)

Oral (not attached to the proposal but stated)

Not applicable

Clear selection

22. Main responsibilities and duties, as well as potential benefits for participants: *

23. Compensation:

Forms of compensation for participants:

Monetary - attached receipt

Monetary - receipt not attached

None

Other(s)

Clear selection

If you selected the "Other(s)" option in the previous question, please specify:

24. Indication of the existence of insurance (The Investigator Administrator is responsible for controlling the existence and coverage of said insurance. Special insurance in case of need):

25. Other information considered relevant to the analysis of the project:

26. References:

27. Declaration:

Check the options:

I confirm all the information provided above .

I declare that there is no financial and / or personal relationship that could represent a potential conflict of interest.

I confirm the obligation to send the signed "Declaration of Submission" by email.

I confirm the obligation to send the "Informed Consent Statement" by email (if applicable).

Clear selection

Contacts - CE.ECTS

Comissão de Ética da Escola de Ciências e Tecnologias da Saúde (CE.ECTS)

Campo Grande, 376
1749 - 024 Lisboa

Tel.: 217 515 500

Email: ce.ects@ulusofona.pt