Table 2 Comparative table of Ethical Approval Form required information

From: Towards a common European ethical and legal framework for conducting clinical research: the GATEKEEPER experience

Pilot

Aragon

Basque Country

Cyprus

Greece

Poland

Puglia

Saxony

UK

Partners

1

1

1

1

2

3

1

1

2

3

1

1

2

Directed to

Research Participants

+

+

+

Literature Review

-

-

-

-

-

-

-

-

-

-

-

Research classification (Clinical trial, Research, Study etc)

+

Research description, duration and participants’ characteristics for recruitment

-

+

+

+

+

Number of research participants mentioned

-

-

-

-

-

-

-

Use of Health products/ Medical devices/ Medical Intervention

-

-

-

-

+

-

-

Methodology of data collection and analysis description

-

-

-

Personal data and protection measures

+

+

+

+

+

Consent procedure

-

-

-

-

-

Risk Analysis and Assessment

-

-

-

-

-

-

-

Benefits Assessment

-

-

-

-

-

 

Funding Sources

-

-

+