Self-declaration for AU’s Research Ethics Committee

Self-declaration for AU's Research Ethics Committee

Study manager

Name, study responsible*

Title*

Department/school*

Telephone no.*

Email*

Who requires ethical approval for research?*

a) Journal

b) ERC

c) Other, please state:

c) Other:

My supervisor has seen and approved this application*

Yes

I am not a PhD student

Alternative contact, if applicable

Title

Department/school

Telephone no.

Study information

Study title*

Main objective of the study*

Will data be collected in other countries? If yes, which?*

Will a recruitment bureau or any other external data processor be used? If yes, which?*

Study participants*

a) Legally competent adults

b) Minors

c) Legally incompetent adults

c) Same limitation as in the Danish Act on Research Ethics Review of Health Sciences Research Projects ( komitéloven om videnskabsetisk behandling af sundhedsvidenskabelige forskningsprojekter), that is to say the medical definition in section 5(1) of the Danish Guardianship Act (værgemålsloven): “a person who is not capable of managing their own affairs on account of mental illness, including severe dementia, or mental retardation or other forms of severe ill health".

Participant information contains the following information

a. The name of the primary investigator

b. The purpose of the study

c. Financing

d. The process for recruiting study participants

e. The methodology of the study

f. Expected risks/inconveniences

g. Who will benefit from the results of the study

h. How the study results will be communicated (including participant feedback)

i. How data will be protected

j. Opportunities for leaving the study

k. Opportunities to view and, if applicable, comment on transcriptions of interviews and quotes, if relevant

l. Debriefing opportunities, if relevant

c. The research study's funding sources*

Study information (cont.)

Purpose and risks (please describe the balance between benefit and risks/inconveniences)*

The declaration must demonstrate that the beneficial outcome of the study is balanced against the human resources involved in the project and the risks/inconvenineces (including inconveniences of a mental or social nature) that participants may be exposed to in connection with recruitment, study and reporting. The declaration must also demonstrate that the social group represented by the study participants will benefit from the outcome of the study.

Methods for anonymised data collection and publication (in brief)*

Is the study a health sciences study?*

Yes

The purpose of the question is to clarify whether the evaluation of the study’s ethical viability falls under the remit of the health research ethics committee system governing health research projects.
A health research project is defined as a project involving experiments on live-born human individuals, human gametes intended for fertilisation, fertilised human eggs,embryos and fetuses, tissues, cells and genetic material from humans or deceased persons. Health research projects also include clinical trials of medicines on humans and clinical evaluation of medical devices.
A health data research project is defined as a project involving the use of sensitive bioinformatic data in which there may be a risk of significant secondary health findings, including projects with genome data.

If yes: Has the study been submitted to the health research ethics committee system?

Yes

If no: Explanation...

Any other permits (please state)

Will the study participants be remunerated?*

Yes

Data collection period (from)*

Data collection period (to)*

All processing of personal data is compliant with GDPR and the Danish data protection legislation, including registration on Aarhus University’s list of research projects in which personal data is processed.*

Yes

Will the information be stored securely and in accordance with AU’s guidelines?*

Yes

Comments

Appendices

Appendices*

Protocol in Danish or English (mandatory template, max 5 pages)

Participant information

Declaration of consent

Questionnaire

Recruitment material

Study responsible’s CV (1 page max)

Other, please state:

Other

Attach protocol in compulsory template (max. five pages)

Attach participant information

Attach declaration of consent

Attach project manager’s CV (max. one page)

Attach Appendices

Final step before going over and submitting declaration

Submit to*

Don't fill this field!

Self-declaration for AU’s Research Ethics Committee

Self-declaration for AU's Research Ethics Committee

Do you have any questions?