Ethics review and other approval review of research

involving humans

(Chapter 3) Group 2

Ethics of technology and science: Seminar I

2015-09-17

Outline

• Introduction• Highlights• Conclusion

Ethics Committee

• Research on humans requires approval from an ethical review board

• The ethics review boardFor research involving humans, other approval can be required, eg if the effects of a new drug should be studied

• Withdraw of consent

Research on Animals

• “Use animals (non human) in experiments, because they are sufficiently like humans, - and - since they are sufficiently different from us (to motivate the suffering caused).”

• Minimum and maximum levels of Animal Welfare in EU. • Swedish legislation is only applicable on Swedish

territory.

Application for ethics review

• Up to the researcher to justify the importance of the study and whether animals are necessary

• Conflict of interest…?– Scientific clarity vs laymen description– Honesty vs scientific drive– Assigning levels of suffering caused to the animals

– Circumvent ethical pitfalls on paper?

What counts as an aminal?• Ethics review in Sweden required for experiments on vertebrates… and squid

• Classification by phylogeny somewhat arbitrary for this purpose?• How to estimate pain in animals?

"Fried calamari" by Chensiyuan at the English language Wikipedia.

"Nacktmull" by Roman Klementschitz, Wien - Own work. CC BY-SA 3.0

Animal use – ethics vs scientific rigor

• What animals should a scientist use and how relevant will this be to the eventual scientific results?

– Eg. Human disease– Always aim at vertebrates?– “Golden standard” experiment perhaps not always

right?

• 1 macaque = 10 mouse = 100 chickens… = X worms?

Ethics of raw materials

• Ethical permit required only for experiment itself, not antibodies or serum

• Antigen+adjuvant injection • Inducing immune response• Repeated bleeding of animal for harvesting antibody

• Ethical responsibility on manufacturer, no longer on researchers (yay!)

Research involving Humans• Have to be ethical approved if biological material

can be traced to an specific individual– How should studies on HeLa cells be treated?– Organs from dead patients or operations

• Sensitive personal data can be processed scientifically without consent (but always requires ethical review)

• An removal of consent requires only the researcher to remove the trace to the individual

GMO• Genetically modified organisms

– Inserting/removing/manipulate genetic material in organisms

• Not black and white– The term is too wide that it looses meanongin talking in

those terms• Are the regulations too strict or too loose?

– Department wide regulations which enables everyone to handle such kinds of organisms (low scale, low taxanomy)

– Open culture batches but retained inside the walls of the department.

– Shipping (=spreading) an issue or advantage?

Different ethical standards, rules and regulations in different

countries

”Ethical standards that are self-evident in Sweden can be difficult to find support for in international research environments.”

• Too strict laws in your country – collaborate with groups in countries with more relaxed ethical standards

• Conversely, if Swedish regulations are more relaxed, it may cause difficulties in collaborations

• But! In our global research community, collaborations is necessary and expected!

Responsibilities of journals and funding agencies?

• Should unethical high impact work be rewarded by e.g. publication and/or funding?

• Gene editing in human embryos rejected by Nature and Science partly due to ethical reasons

• How much influence should journals and funding agencies exert?

• Some requirements already in place by journals and funding agencies – should there be more? Less?