Ethics review and other approval review of research involving humans

1. Ethics review and other approval review of research involving humans (Chapter 3) Group 2 Ethics of technology and science: Seminar I 2015-09-17

2. Outline • Introduction • Highlights • Conclusion

3. 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

4. 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.

5. 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?

6. Whatcounts 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

7. 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?

8. 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!)

9. Research involving Humans • Haveto be ethicalapprovedifbiological material can be tracedto an specificindividual • Howshould studies on HeLa cells be treated? • Organs from dead patients or operations • Sensitive personal data can be processedscientificallywithoutconsent (butalwaysrequiresethicalreview) • An removalofconsentrequiresonly the researcher toremove the traceto the individual

10. GMO • Geneticallymodified organisms • Inserting/removing/manipulategenetic material in organisms • Not black and white • The term is toowidethat it loosesmeanongintalking in those terms • Are the regulationstoostrict or tooloose? • Departmentwideregulationswhichenableseveryonetohandlesuch kinds of organisms (lowscale, lowtaxanomy) • Openculturebatchesbutretained inside the wallsof the department. • Shipping (=spreading) an issue or advantage?

11. 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!

12. 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?