Human Research Ethics Committee (HREC) Sabine Roeser, chairJoost Groot Kormelink, secretary

What is HREC?

• Established in 2012 by CvB• Interfaculty committee• Check all research by staff and students that

includes involvement of Humans (during experiments and/or data collection) for ethical issues, e.g.:

Informed consent Data & privacy issues Participation vulnerable group's Safety equipment (certification)

Members of the committee

• Sabine Roeser (Chair, TPM)• Willem-Paul Brinkman (Vice-chair, EEMCS)• Ruth Mugge (IDE)• John van den Dobbelsteen (3mE)• Daan Pool (AE)• Clarine van Oel (Arch)• Joost Groot Kormelink (TPM, Secretary)

A bit of background

• Ethics committees common practice for medical experiments since famous Helsinki declaration in 1964

• Common practice Anglophone countries• However, not yet common practice for technical universities: 62%

of European universities outside the United Kingdom do not have an HREC at university level(Source: http://www.ncbi.nlm.nih.gov/pubmed/25746787, 2014)

How does it work (process)

Applicants fill in checklist

• (see HREC.TUDelft.nL)

If minimal risk (MR) :

chair approves

• Takes about one week

If not MR: decision by committee

• Additional info required, committee meets every 4-6 weeks)

Note: HREC is not authorized to review medical experiments

Some remarks

• Awareness existence HREC needs to be improved (according to the rules: we have to give consent before experiment may start)

• Number of applications per year: steady increase (this year we expect around 120 applications compared with 50 in 2014).

• But still: top of the iceberg • As from this year: applications in order to get EU-funding

What do we check: Safety issues

Is all specific equipment certified or checked by ARBO?

Data collection:

• Convert methods• Access• Anonymization• Storage• Privacy

What do we check: Data

What do we check: Informed consent (IC) participants

IC-form must:• Clearly state the purpose and benefits of the

research/study without jargon• Include any foreseeable risk and discomfort • Describe how data will be secured, including

privacy issues • Clearly state that participation is voluntary

and that withdrawal will not result in any negative consequences.

NB: Special regulations for vulnerable groups

Examples of applications

• AE: air traffic controllers experiments• Bio-mechanical engineering: new equipment• TPM: Data collection for cybersecurity• IDE: Devices for the deaf • EEMCS: Sensors during festivals• EEMCS: Virtual reality tests• CITG: Monitoring behaviour people at railway stations• CITG:Driving automated vehicles• TPM: Data gathering MOOCs

In most cases: approved but under conditions and/or recommendations.

Important

• Funding agencies like EU and NWO pay more and more attention to ethical issues (screening)

• Same goes for publishers

Training

• All PhD students have mandatory training in scientific integrity, which also covers human research ethics.

• Some faculties pay attention to HRE in their curriculum (i.e. IDE)

Where do we go from here?

• Web based application (under development)• Awareness campaign• Faculties assess applications by students (Ba/Ma):

IDE will hit the ground first, other faculties to follow in 2016. • Faculties decide on their structure/procedures • Online teaching materials (web lectures)