Ethics protocol EEMCS

Reference: Ethics Committee Protocol EEMCS 120820.doc

EWI12/B:Vne/611

Date: 20 August 2012

Preliminary version

Protocol for assessing the ethical permissibility

of proposed research by the Faculty of

Electrical Engineering, Mathematics and Computer Science

at the University of Twente

Established on dd mm 20yy by the

Dean of the Faculty of

Electrical Engineering, Mathematics and Computer Science

Table of contents

1. Principles and background: the Ethics Committee (EC) of the Faculty of Electrical Engineering, Mathematics and Computer Science and the responsibilities of the department chairs and researchers 4

2. Procedure to apply for an assessment by the Ethics Committee of the ethical permissibility of the proposed research 6

2.1 Procedure 6

2.2 Waiving signed informed consent forms 6

2.3 Personally Identifiable Information (PII) 7

2.4 Essential information in order to assess the ethical permissibility of the proposed research 7

3. Checklist for the principal researcher when submitting a request to the EC or the EC member for an assessment of the ethical permissibility of the proposed research 9

3.1 General 9

3.2 Questions about fulfilled general requirements and conditions 9

3.3 Questions regarding specific types of standard research 11

4. Assessment of the ethical permissibility of proposed research by the Medical Ethics Committee (MEC) or Ethics Committee (CE) 12

4.1 Introduction 12

4.2 Primary Selection Criteria 12

4.3 Secondary selection criterion: Nature of the Research: Medical or Non-Medical 12

4.4 Secondary selection criterion: Degree of Risk, negligible or non-negligible 13

4.5 Nature of the Research & Degree of Risk: Assessment Table 13

4.6 Tertiary selection criterion: legal incapability and persons younger than 18 years old 13

4.7 Summary of the rules for the assessment of the ethical permissibility of research by the Medical Ethics Committee (MEC) or the Ethics Committee (EC) 14

4.8 Flowchart for assessment of the ethical permissibility of the proposed research 15

5. Standardized research within the Faculty of Electrical Engineering,Mathematics and Computer Science 16

5.1 Introduction 16

5.2 Standardized research: general requirements and conditions which should be fulfilled 16

5.2.1 Authorization EC: assessment of ethical permissibility by EC or by MEC 16

5.2.2 Selection of adult, competent subjects 16

5.2.3 Voluntariness of participation 17

5.2.4 Screening of subjects 17

5.2.5 Accidental discoveries 18

5.2.6 Informed consent and minimum content of the Information brochure 18

5.2.7 Anonymity 19

5.2.8 Deception and debriefing 20

5.2.9 Recruitment of subjects 20

5.3 Specific types of standard research per department 20

5.3.1 Department of Design and Analysis of Communication Systems (DACS) 21

5.3.2 Department of Distributed and Embedded Security (DIES) 21

5.3.3 Department Human Media Interaction (HMI) 23

5.3.4 Department of Information Systems (IS) 24

5.3.5 Department of Signals and Systems (SAS) 24

6. Lists of names and information samples for the EC and (human) subjects 26

6.1 Names and addresses of the EC members 26

6.2 Standard examples of the Information Brochure, Informed Consent Form and PII 26

6.2.1 Sample Information Brochure from the CPE department (Behavioural Sciences) 26

6.2.2 Informed Consent forms 27

6.2.2.1 Informed Consent for standard research 27

6.2.2.2 Informed parental consent for research involving children 28

6.2.2.3 Passive Informed Consent, children 28

6.2.2.4 Informed Consent Department XXX, 29

6.3 Example of statement concerning the use of Personally Identifiable Information (PII), Department DIES 29