Research Integrity TU Delft, CESAER, Paris

‘TRUST’
Human Research Ethics and Research Integrity:
institutional embedding TU Delft
Joost Groot Kormelink, secretary HREC/TF RRI
CESAER Paris October 16, 2019

This presentation is about
Technology
Research
Universities
Society
Transparency
TRUST

Content
I. Framework: Research Integrity policies TU Delft
Zoom in
II. Human Research Ethics
III. Ethics in Education Ba/Ma
IV. Responsible Innovation
V. Doctorate Education (Viola)
VI. Questions for pondering
Discussions on policies, norms/standards and challenges

Content
Zoom in:
V. Doctorate Education IDEA-League (summer school: slides Viola Schiaffonati,
Polytechnic University of Milan)

‘Integrity as guiding
value in the
organization’
Policy document TU Delft
2018

DIVERSITY
INTEGRITY
RESPECT
ENGAGEMENT
COURAGE
TRUST
But
Norms
??
Impli-
cations
??

Integrity: institutional embedding
– A focus on integrity for new employees
– Facilitating discussions about integrity (breaches)
– Website TU Delft over integrity: www.integrity.tudelft.nl
Research integrity is emphasized by:
– Institutional embedding (Integrity office /3 fte) and arrangements
– HREC
– (Mandatory) courses for PhD candidates
– Teaching ethics at TU Delft: http://tudelft.nl/ethics/
– Responsible Research Innovation (RRI) concept
But: Requires a lot of effort

3 pillars
Academic Integrity Social Integrity Organizational Integrity
• Research Ethics
• Research Integrity
• Educational Integrity
• Responsible research
cooperation
• Research Data
management
• Open Science
• Diversity& Inclusion
• Work pressure
• Interactions between
staff and/or students
• Undesirable behaviour
• Managerial Integrity
• Responsible cooperation
• Ancillary activities
• Responsible operational
management
• Fair treatment/ assessment of
students and staff members
• Data management

10
As also reflected in the integrity roadmap

Let’s start with a bit of history of HRE..

Nuremberg
trials 1945/46
Nazi
medical
experiments
Human research ethics has developed in both
theory and practice from experiences in medical
research

But history if full of other examples….

See this video: https://youtu.be/x-Y2t9FjHGQ

Helsinki declaration 1964
The subject's welfare must always take
precedence over the interests of science
and society and ethical considerations must
always take precedence over laws and
regulations

Principles Helsinki Declaration
(medical research)
• Protect the life, health, privacy, and dignity of the human subject.
• The right of research subjects to safeguard their integrity must always be
respected.
• Informed consent by research participants is necessary.
• Risks should not exceed benefits.
• Vulnerable groups: special procedures.
• Research protocols should be reviewed by an independent committee prior to
the research.
Committees oversee most governmentally-funded medical
research around the world.
The voluntary consent of the human subject is
absolutely essential, making it clear that subjects
should give consent and that the benefits of the
research must outweigh the risks

Gradual shift: From medical human research
ethics to general principle
‘Basic ethical principles and guidelines that should assist in
resolving the ethical problems that surround the conduct of
research with human subjects (also non-medical)’ .
Always ensure approval by IRB

Important milestone: Belmont report (USA):
fundamental principles for human research
• Respect for persons
• Beneficence
• Justice.

Over the last decades…
Increasing awareness that all
human research needs
institutional review, also
because of regulations from
funding agencies and journals.

Since 2012 the TU Delft has its own
independent and formal human
research ethics committee.
www.hrec.tudelft.nl

Task and responsibilities of HREC

Mandate HREC (IRB) TU Delft
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
 Safety equipment (certification)
Additional safeguards:
 Participation vulnerable group's (including children)
 Medical experiments
 Experiments which involve own students
 Experiments with are based on deception
 Sensitive data
Starting point is the interest/welfare of the participant, not
TU Delft
Any engineer: this is bad
design!

What do we check: IC
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 and procedures
for data withdrawal
• Clearly state that participation is voluntary and that withdrawal will not
result in any negative consequences.
• (IC-procedure depends on type of research. Also think of proxy consent )
So, we do not mean consent but INFORMED consent!

Data collection:
• Convert methods?
• Access?
• Anonymization?
• Safe Storage?
• Privacy and alignment with GDPR, i.e. when sensitive info is
involved
• Rules far sharing data (default: no raw data)
• Opt-out
(Must be clear from IC-forms)
What do we check: Protection Personal Data

Important for HRE:
• Whether any personal information about the participant will be collected,
processed and stored and how long this will be stored;
• Right to of the participant to request access, rectification or erasure of personal
data
• Procedures for safeguarding personal information, maintaining confidentiality and
de-identifying (anonymising) data, especially in relation to data archiving and
reuse maintaining confidentiality of information
• Future publishing, archiving and reuse of the data
• Compliance with GDPR and the rationale behind this regulation
What do we check: personal data

What do we check: Safety issues
Is equipment/device used for the experiment CE-certified
or checked by a safety expert from the TU Delft
otherwise? Is the whole set-up safe?

What do we check in: special cases
• Medical experiment? other route!
• Deception?
• ‘Vulnerable’ people (for example children, can they
real give IC considering the experiment?)?
• Do we know of any conflict of interests?

Big data research: when do we consider this as
human research as well?

DNA research: when is this privacy sensitive?

Data Protection? Informed Consent? Withdraw?

When do we speak of medical research = NOT
our mandate

Implications of new Legislation: GDPR and MDR
How do we deal with conflicting requirement and new policies?
• GDPR (May 2018) versus Open Access data/FAIR/Privacy
• Medical Devices Regulation (MDR/’ formal’ in May 2020)
versus accelerating innovation

MDR-implications
• More transparency
• New risks categories (walking stick can be risky!)
• Much more detailed risks assessment
• More monitoring
• High fines
• Closer collaboration with METCs required
• More expertise in-house required
• Bureaucracy
• Nobody understands the implications

Content
Zoom in :

Teaching Ethics at TU Delft
Since ca 20 years provided by the
Ethics and Philosophy of Technology
Section (TPM) at TU Delft.
Tailor-made courses (per program),
containing lectures, tutorials, essay
and written exams.

National Society of Professional Engineers
(NSPE/USA)
Engineering is an important and learned profession. As members
of this profession, engineers are expected to exhibit the highest
standards of honesty and integrity. Engineering has a direct and
vital impact on the quality of life for all people. Accordingly, the
services provided by engineers require honesty, impartiality,
fairness, and equity, and must be dedicated to the protection of
the public health, safety, and welfare. Engineers must perform
under a standard of professional behavior that requires adherence
to the highest principles of ethical conduct.

National Society of Professional Engineers
(NSPE)
Engineering is an important and learned profession. As members
of this profession, engineers are expected to exhibit the highest
standards of honesty and integrity. Engineering has a direct and
vital impact on the quality of life for all people. Accordingly, the
services provided by engineers require honesty, impartiality,
fairness, and equity, and must be dedicated to the protection of
the public health, safety, and welfare. Engineers must perform
under a standard of professional behavior that requires adherence
to the highest principles of ethical conduct.

Ethics education TU Delft
Purpose: TU Delft would like to educate engineers with a broad,
‘comprehensive’ perspective
For this reason, TU Delft would like to see to it that all students
are offered training in ethics.

New setup for teaching Ethics
BSc: Basic competencies in ethics (and philosophy of science,
scientific integrity and diversity) preferably through teaching
lines, possibly by stand-alone course.
MSc: Specialized master course for students of all Faculties, not
necessarily organized by program, but instead create a palette of
more thematic courses,

Thematic ethics courses
Geoengineering and Space ethics
Climate ethics
Water ethics
Energy ethics
Risk and safety ethics
Computer ethics
Robotics/AI and ethics
Science ethics
Biotechnology and ethics
Health technology and ethics
(Urban) design ethics
Ethics of transportation technology and logistics
Environmental ethics
Responsible Innovation and Value Sensitive Design
Engineering Ethics (general)

Content
Zoom in
IV. Responsible Research and Innovation

Responsible Innovation: ‘think ‘design’
• Identify serious problems to solve
• Think in advance about consequences of and alternatives re
proposed solutions
• Evaluate solutions in terms of moral values
• With help from a broad range of stakeholders
• Use the resulting moral considerations as requirements for
Design

Technology has to be an expression of
our shared values
Technology is never ‘value neutral’
No false excuses, we are responsible

Balancing multiple values…
Design for privacy
Design for security
Design for inclusion
Design for sustainability
Design for democracy
Design for safety
Design for transparency
Design for accountability
Design for human capabilities

Example: Safety for the driver or the
pedestrian?

Example: Energy Sector transition is
more than sustainability

Example: Energy Transition and Values
• Well-being
• Distributive
justice
• Procedural justice
• Justice as
recognition
• Trust
• Sustainability
• Energy
autarky
• Efficiency
• Safety
• Security
• Resilience
• Privacy

Responsible
Example: Entrepreneurship

The Collingridge dilemma
“In the early phases of technological development, technology can
still be changed, but the effects of technology can be hard to
predict. In the later phases, we see the opposite, where the
effects are clear, but technology is already embedded in society
and therefore much harder to change”.

ISO 26000 – Framework (essentials)
Seven SR
principles
1. Accountability
2. Transparency
3. Ethical behaviour
4. Respect for
stakeholder
interests
5. Respect for
rule of law
6. Respect for
international
norms of
behaviour
7. Respect for
human rights
Clause 4
Integrating practices
Review organization’s
characteristics to SR
Reviewing
and
improving
Communication
and reporting
Determining relevance,
significance, priority,
due diligence,
exercising influence
Annex SR
initiatives
Clause 7
Enhancing
credibility
Selecting
Voluntary
initiatives
Awareness, competency,
setting direction,
integrating into systems
Human
Rights
Labour
Practices
The
Environ-
ment
Fair
Operating
Practices
Consumer
issues
Community
involvement
and
development
Seven SR Core
Subjects
Related actions and expectations
Clause 6
Organizational Governance
Recognizing SR
(value chain and
sphere of influence)
Stakeholder identification
and engagement
Clause 5Two fundamental
practices of SR

https://www.rri-prisma.eu/road-map-rri-for-companies/

Content
Zoom in
V. Doctorate Education (Example IDEA-L)

Scientific integrity
Fraud
• Intentional deception
Misconduct
• Also non-intentional breaches of
scientific integrity (e.g. negligence)
Sloppiness
• May not (always) be misconduct
but may still be bad science

Highly recommended: Dilemma game

Video: on being a scientist
(developed for discussions on Integrity among
students)
Video was made to stimulate discussion by University Leiden
Setting:
• Professor claims to be inventor of a major breakthrough
• However, his PhD-student is the main researcher but he
accuses her of plagiarism

Ethics in Engineering Education
Projects and challenges of the IDEA League
Ethics WG
Viola Schiaffonati
Artificial Intelligence and Robotics Lab
Dipartimento di Elettronica, Informazione e Bioingegneria

What IDEA League does
 It contributes to making Europe a world leader in science
and technology by sharing academic resources and
knowledge
 It promotes activities in education, research and
quality assurance, as well as joint participation in EU
programs and initiatives
 It creates added value by pooling resources for
collaborative and complementary programs for
students, researchers and staff

Summer school Doctorate
 Each week consisting of 3 full and 2 half days
 Monday afternoon Friday Morning
 Each day no more than 2 lectures
 Morning lectures followed by case-study discussions
and exercises connected to the lecture
 Afternoon sessions starting with group work and
continuing with a lecture followed by a general discussion
 Remarkable attention for the group work
 Participants incentivized to critically think about their
own field of research while engaging with the relevant
literature
 Week coordinators in charge of the group work

Learning objectives for students
 Be acquainted with established ethical norms and
concepts
 Be able to identify ethical issues in their domain of
research
 Develop the ability to argue about ethical issues in science
and technology drawing on specialized literature and
ethical frameworks
 Learn about challenges, opportunities and criticalities
of addressing ethical issues through design

How to render your
research societally relevant
 Learnings from transdisciplinary
research
 Increasing need for researchers to
demonstrate the practical value of
their research for society
 10-step approach to better link
research to societal problem solving
 Reflections and discussions around
research issues, the societal
problems addressed, relevant
actors and disciplines, and the
purpose and form of the interaction
with them
Michael Stauffacher (Zurich)

Social construction of S&T:
Gendered perspectives
 Gender as dimension to be
integrated and reflected within
Responsible Research and
Innovation (RRI)
 Social construction of gender
and its implications for science,
technology and innovation
 Gendering of scientific
knowledge and knowledge
production as well as its
implications for technologies
 Case studies of “gendered
innovations”
Carmen Leicht (Aachen)

Brain engineering? Human
Enhancement – promises and
perils
 Concept of Human Enhancement
 Potential of a variety of
neurotechnologies and ethical
implications
 Ongoing ethical debate and key
moral values
 Moral deliberation on emerging
technologies that have a strong
impact on human self-
understanding
Saskia Nagel (Aachen)

The ethics of health technology
 Improving quality of life with
health technology as not
only a technical but also an
ethical endeavor
 Analysis of concrete cases
and different ethical
theories
 Ethical issues associated with
health technologies and
challenging questions that
could arise from this
perspective
Janna van Grunsven (Delft)

Ethics of risk
 How the Fukushima accidents
fell through the cracks of risk
assessments
 Review of the nuclear accident of
the Fukushima Daiichi, focusing
on how the accident fell through
the cracks of risk assessments
 Several limitations of
assessments, specifically
reviewing important societal and
ethical aspects of risksBehnam Taebi (Delft)

Science, technology, and public policy
 Complex relationship between
science and policy-making
 Selected case studies and established
scholarship in science policy
 Role of knowledge in policy
formation
 Role of public policy in regulating
scientific research and
technological innovation
 Prospects for democratic
deliberation around the governance
of science and technology
Alessandro Blasimme (Zurich)

Continuation
 Continuation of the network
 IDEA League Ethics Working Group already established
but further strengthened
 Making continuation stronger among students and
between students and instructors: support from the
instructors after the end of the school in view of a
publication
 Academic ambitions for the participants from engineering &
design to be prepared to contribute to ethics of technology
as a field

What about the future?
 Doctoral School only the beginning of more collaborations
 Ethics hub approach and teaching ethics at other
universities than IDEA partners
 Possibility to open our graduate courses on ethics to
other IDEA League students
 Organizational and credits issues
 Possible guidelines for teaching ethics in technical
universities
 From our best practices and the adopted working strategies

Ethics hub
 Doctoral School as the starting point to create this hub
 Expertise in teaching ethics of science, technology and
engineering proposed to other universities than IDEA
partners
 Genuine interest in exchange with China and the Middle
East

To conclude
 Learning from each other, benchmarking and sharing
intelligence
 Strengthening the peculiarities of each member and the
common efforts
 Opening to other communities and groups
 Sharing the best practices at all levels

Content
Zoom in
V. Doctorate Education (Example IDEA-L)
VI. Questions for pondering/discussions

Observation of traffic: how do we deal with
privacy?Living labs cities…
Data collection:
restrictions?

Emotions: ignore them as scientist or value them?

GitHub
Code
Leave it
to
scientist?

Content
Zoom in

Allowed? Conditions?
• Equipment CE-certified for
the purpose for which it is
used?
• Data/privacy?
• Informed Consent? Who?
• Is this medical research?
• What if some children
cannot participate?
Inclusion/exclusion
• Unknown risks?

Allowed? Conditions
• Ethical
hacking
allowed?
• Data/privacy?
• Deception
allowed?

• Equipment CE-
certified for the
purpose for
which it is used?
• Data/privacy?
• Informed
Consent? Who?
• Is this medical
research?

• Equipment
CE-certified
for the
purpose for
which it is
used
• Data/privacy?
• Conflict of
interests if this
commercial?
• Is this medical
research?

• Equipment CE-certified for the
purpose for which it is used?
• Data/privacy?
• Informed Consent? Who?
• Is this medical research?
• Unknown risks?

Safety/safety
measures ?
Insurance?
Unknown risks?
Exceptional payment
for students who
participate?

Big Data: Purpose?
Anonymization? Consent?
Also in the future GDPR-proof?

Observation of traffic: how do we deal with
privacy?

Research Integrity: Dilemmas of peer-review
You receive a request to review an article from a peer. You know
this colleague; you worked together last year on a project and
will regularly discuss this project during the coming time. But
there is no other scientist with the same expertise to review this
article.
What do you do?

Research integrity: dilemma of funding
You get invited to comment in the media on a recently published
scientific report to which someone from your group has
contributed. Continuation of the funding for this research
partially depends on how well the preliminary results published
in this report will be received.
What do you do?

Discussions
• What is needed to deal with dilemmas ‘ as an organization?’
• Responsibilities: central, faculty,?
• What are best way to include ethics in education?
• Who are key persons within your organization for the debate?
• Compulsory courses RI for Doctorate students?

How to recognize an integrity issue?
Tips to help you determine a possible integrity issue:
– Ask yourself: could I explain this to society?
– And: What if everyone were to do this?
– Golden Rule: treating others as you would wish to be
treated
– Critically reflect on your conduct, also by using moral
emotions such as imagination, compassion, sympathy,
feelings of responsibility

Key references
• WHO/Helsinki declaration and updates: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-
for-medical-research-involving-human-subjects/
• Belmont report 1978 : https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
• Roadmap for responsible framework by Companies: https://www.rri-prisma.eu/road-map-rri-for-companies/
• Textbook on Responsible Innovation: https://textbooks.open.tudelft.nl/index.php/textbooks/catalog/book/24
• Applying Ethical Principles to Information and Communication Technology Research: A Companion to the Department of
Homeland Security Menlo Report (2012): https://www.dhs.gov/sites/default/files/publications/CSD-
MenloPrinciplesCOMPANION-20120103-r731.pdf
• Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee, 2014 ( David Koepsell, Willem-Paul
Brinkman Sylvia Pont - HREC TU Delft): https://www.ncbi.nlm.nih.gov/pubmed/24938695
• https://www.tudelft.nl/en/about-tu-delft/strategy/strategy-documents-tu-delft/integrity-policy/
• https://www.delftdesignforvalues.nl/
• https://www.vsnu.nl/en_GB/research-integrity
• On being a scientist: https://youtu.be/tCgZSjoxF7c
• Dilemma game: https://www.eur.nl/sites/corporate/files/24708_integriteitsspel_interactief_2016.pdf
• Human Research Ethics Committee of the TU Delft: www.hrec.tudelft.nl

Thank you!
j.b.j.grootkormelink@tudelft.nl

Research Integrity TU Delft, CESAER, Paris

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