Safe-by-Design

Question 1

What is Safe-by-Design all about?

Answer 1

• Thinking before doing;
• Taking safety (in the broadest sense of the word) into account integrally in innovation trajectories
• Making doing the right thing standard practice, instead of merely doing what is right

Question 2

What are examples of unsafe innovations?

Answer 2

• X-rays
• Nuclear energy
• PFOAs: substance that helps with water resistance. It is in/on waterproof shoes, receipts, pans
• Chrome-6
• Fipronil

Question 3

Which innovations could also be unsafe, depending on how you look at it?

Answer 3

• Gene therapy
• Glycophosphate (“Roundup”)
• Facebook
• CRISPR-Cas9
• Nano-titanium dioxide

Question 4

What are examples of standardized ways of dealing with risks?

Answer 4

• REACH (for chemical substances)
• “Buro GGO” (for risk assessment of genetically modified organisms)
• CE (“Conformité Européene) certification
• ISO standards
• EMA guidelines

Question 5

What is the ethical problem with standardized ways of dealing with risks?

Answer 5

Complying with these standardized guidelines means that you “do things right”, but does that mean that you “do the right thing”?

Question 6

What is (the definition of) “ethics”?

Answer 6

The practical study of deciding how we ought to act. It is a systematic reflection on morality (values, norms, beliefs). With ethics, we provide reasons to justify
our decisions

Question 7

When do moral problems arise?

Answer 7

Moral problems arise when the values, rights, interests,

desires of “an other” are at stake or harmed.

Question 8

Why should safety be taken into account when looking at ethical problems regarding design?

Answer 8

Values are very important in ethics and safety is a very important value (“safety first”)

Question 9

What does it mean to be safe?

Answer 9

Being safe means being protected against harmful events, products, processes,…

Question 10

What is science?

Answer 10

The systematic study of the structure and
behaviour of the physical and natural world. Many different disciplines, studying virtually everything we know to exist, using a multitude of methodologies

Question 11

What is technology?

Answer 11

“The science of craft”
> Techniques, skills, methods, processes used to produce goods or services
> Knowledge ánd ”machinery”
Everything from bows and arrows to apps on your smartphone or CERN’s Large Hadron Collider

Question 12

What is innovation?

Answer 12

New idea, concept, product, process, technology,…extension
1. Regular
2. Niche
3. Revolutionary
4. Architectural
It is often characterized as:
-Aimed at impact on market and/or society
-Practical implementation of invention/knowledge/etc.
-Not necessarily NEW knowledge

Question 13

Do science and technology overlap?

Answer 13

Yes, in technoscience.
Technoscience is science, technology and social context. Science and technology are linked and grow together. Scientific knowledge is historically situated and socially constructed, and is made durable through material (non-human) networks. Scientific knowledge requires

Question 14

Is the course Ethics in Life Sciences interested in science, technology or innovation?

Answer 14

They are interested in the overlap between the three: (new) knowledge-intensive innovation.

Question 15

Where in the production process is safety considered right now?

Answer 15

Right now it is considered somewhere between step 4 (validation) and step 5 (production). Safety is often predominantly regarded as a regulatory requirement:
• safe-by-compliance
• “end-of-pipe”-type of interventions
We are currently witnessing (in several fields) a shift towards safety as a core value and a precondition for product development.

Question 16

What does safe-by-design do with safety?

Answer 16

Safe‐by‐Design expresses the move towards taking into account safety pro‐actively, early on, continuously and integrally in research and innovation trajectories

Question 17

What is the pacing problem?

Answer 17

The pacing problem:
“technology changes exponentially, but social, economic, and legal systems change incrementally” (Downes 2009)
• Technological innovation outpaces the ability of laws and regulations to keep up
• Hence, especially when working on emerging technologies, there will often be no relevant laws or regulations in place warranting safety and other public values

Question 18

What is the Collingridge dilemma?

Answer 18

The Collingridge dilemma:
“When change is easy, the need for it cannot be foreseen; when the need for change is apparent, change has become expensive, difficult, and time‐consuming.” (Collingridge 1981, p.11)

Question 19

What is the precautionary principle?

Answer 19

The precautionary principle:
• The introduction of new products or processes, the ultimate effects of which are disputed or unknown, should be resisted. (Or: better safe than sorry.)
• Application visible in EU rules and regulations in casu GMOs

Question 20

Is safe-by-design a barrier to innovation?

Answer 20

Safe‐by‐Design purports to be less a barrier to innovation, but a facilitator or even a driver of innovation

Question 21

What are the four types of innovation?

Answer 21

1. Regular (/ incremental) innovation:
   builds on existing knowledge and aims at existing
   customers. Example: new model of a mobile phone.
2. Niche innovation:
   builds on existing knowledge but reaches out to
   new customers or markets. Example: GPS device
   especially for cyclists.
3. Revolutionary (/ radical) innovation:
   aimed at existing customers but based on new
   knowledge. Example: electric cars.
4. Architectural (/ disruptive) innovation:
   based on new knowledge that opens up new
   markets for the innovator. Examples: the T‐Ford, the
   television, the first fighter jets, fertilizers, the Internet, smart grids and cities, nanotechnology — and so on. (Srivatsa et al. 2017)

Question 22

Is there always a big challenge in keeping the safety as high as possible?

Answer 22

Safety always pertinent (batteries can explode, privacy can be breached, et cetera…)
The challenge is not always as big:
• Risks can vary
• Uncertainty can vary

Question 23

What is scenario uncertainty?

Answer 23

“we know what might go wrong but cannot meaningfully attach a probability
to the occurrence of these consequences.”

Question 24

What is indeterminacy?

Answer 24

because the future is still open and undetermined, all sorts of actors might use
the technology differently than foreseen or expected by designers

Question 25

What is normative

ambiguity?

Answer 25

“uncertainty or disagreement about values and norms”

Question 26

What are the three types of safe-by-design?

Answer 26

a) analyzing risks in the design phase of innovation
[“upstream risk assessment”]
or
b) realizing safety through design practices [use
design‐thinking to eliminate risks]
or
c) the product of design practices in which risks and
safety have been taken into account [inherent or
absolute safety]

(b) implies (a), but (b) does not imply (c)
Safe-by-design can also be a combination of (a), (b) and (c)