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Human Research Ethics
Committee (HREC)
Sabine Roeser, chair
Joost 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)

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Human Research Ethics Commitee TU Delft: procedures and criteria

  • 1. Human Research Ethics Committee (HREC) Sabine Roeser, chair Joost Groot Kormelink, secretary
  • 2. 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)
  • 3. 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)
  • 4. 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)
  • 5. 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
  • 6. 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
  • 7. What do we check: Safety issues Is all specific equipment certified or checked by ARBO?
  • 8. Data collection: • Convert methods • Access • Anonymization • Storage • Privacy What do we check: Data
  • 9. 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
  • 10. 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.
  • 11. Important • Funding agencies like EU and NWO pay more and more attention to ethical issues (screening) • Same goes for publishers
  • 12. 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)
  • 13. 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)

Editor's Notes

  1. https://www.flickr.com/photos/desiitaly/2201907500/
  2. https://www.flickr.com/photos/desiitaly/2201907500/
  3. https://www.flickr.com/photos/desiitaly/2201907500/
  4. https://www.flickr.com/photos/desiitaly/2201907500/
  5. http://en.wikipedia.org/wiki/Closed-circuit_television#mediaviewer/File:Three_Surveillance_cameras.jpg