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Examples of problems that are still unsolved

In document GOOD RESEARCH PRACTICE (Page 38-41)

A highly central issue in animal ethics concerns the fact that humans are traditionally regarded as something special – as having a special dignity and integrity – and therefore enjoy an elevated level of protection. It is unrealistic to believe that we can arrive at one single reason that is valid for everybody why humans hold this exceptional position. Perhaps the philosophers are right when they say it is impossible to justify it in any other way than to say that someone born by a human thereby has the right to a certain moral protection that is not extended to other living beings. If this is indeed the case, then we have just as great a responsibility to contemplate what we should do with this special position.

Our rationality and knowledge allow us to exercise power over other animals. But with power comes responsibility – power over the animals’ situation and power over what issues we choose to research, for both the sake of the people who put their hopes in science and the sake of the animals whose lives are used to this end.

What would you do in the following situation?

Millions of people today have HIV and risk contracting AIDS if they do not receive effective inhibitor medications. A great deal of research is being conducted to find a cure for HIV/AIDS using chimpanzees which, besides humans, are the only animals that can get HIV/AIDS.

You are a member of an ethics committee on animal experiments that is to ethically evaluate a research project aiming to test the effectiveness of a potential vaccine. The researchers inform the committee that the vaccine’s effect needs to be tested on advanced AIDS, which means that the chimpanzees will be in very poor health when the actual experimenting begins.

What ethically significant aspects to you feel should be considered to ethically evaluate whether this experiment should be approved? Consider the issue from both a researcher’s and a layman’s evaluation perspective.

Sweden participate and Swedish funding bodies contribute money. Ethical standards that appear self-evident in Sweden can then be difficult to find support for in international research environments.

It is especially worrying if researchers perform their work in countries with lower ethical standards, just to take advantage of this. It can, for example, be easier to find research subjects, easier to get permission to use primates in research, cheaper to conduct studies, or involve less extensive application procedures. If these advantages come at the cost of the integrity of the research, it will in many cases involve a breach of the standards in the Declaration of Helsinki:

Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

It is unacceptable for studies to violate this principle. The Norwegian National Committee for Research Ethics in Science and Technology states precise and necessary requirements, namely that

a researcher is not to conduct parts of his or her research in another country simply because it has lower ethical or safety standards than at home;

and that researchers shall inform funding bodies of divergent ethical or safety standards in the country or countries where their research is being conducted.

Another problem is that the most fundamental protection for research subjects – that the research project must be ethically reviewed before it can begin – is not always self-evident in other countries. The Declaration of Helsinki requires this review for all medical research performed on humans, and this requirement is held by many funding bodies and journals.

Here, the Swedish legal requirement of ethics review is less comprehensive. However, as mentioned earlier, in Sweden there is the option to request an advisory statement from an ethics review board regarding a project that does not formally need to be reviewed. It is good research practice to request a statement in the event research collaborations in other countries are expected to present ethical difficulties for the researchers.

The ethics review boards have no obligation to issue these advisory statements however, just the right to do so. If the regional ethics review board refuses to issue such a statement, however, this may cause profound consequences for the researchers’ chances of obtaining further funding and being published.

There are issues concerning the withdrawal of consent that are problematic for research ethics. In biobank research, the research subject has the option of withdrawing consent. If this happens, it is the responsible party at the biobank who determines whether the biological material should be destroyed – which is likely to be the research subject’s wish – or only de-identified. In the latter case, the research subject can feel tricked. In research projects using video or audio recording, the research subject is often told he or she can withdraw consent after the recording and that the tape will be destroyed. However, this is in conflict with the regulations governing archiving and storage of research material, as well as with the rules regarding withdrawal of consent in the Act concerning the Ethical Review of Research Involving Humans.

References

1. Alexius Borgström, Katarina, Djuren, läkarna och lagen: en rättslig studie om djurförsöksetik. Uppsala, Iustus förlag, 2009. Arkivlag (SFS 1990:782).

2. Brambell, Rogers, F.W. (Chairman), Report of the Technical Committee to enquire into the Welfare of Animals kept under Intensive Livestock Husbandry Systems, London, HMSO, 1965. This states five freedoms for farm animals: freedom from hunger and thirst, from discomfort in housing, from pain and injury, from fear and worry and the opportunity to exhibit natural behaviour.

3. Cavalieri, Paola & Singer, Peter (red.), The Great Ape Project: Equality Beyond Humanity. New York, St.

Martin’s Press, 1994. A proclamation from 34 researchers and authors for three rights for certain primates: the right to life, the right to freedom and a prohibition against torture.

4. Centrala försöksdjursnämnden, Författningar, allmänna råd och anvisningar om användningen av djur för vetenskapliga ändamål. Stockholm, CFN:s skriftserie: 45, 2002.

5. Den nasjonale forskningsetiske komité for naturvitenskap og teknologi (NENT), Forsknings- etiske retningslinjer for naturvitenskap og teknologi. Oslo, 2007.

6. Djurförsöksetiska utredningen. Etisk prövning av djurförsök: delbetänkande (SOU 2002:86). Stockholm, Fritzes offentliga publikationer, 2002. Djurskyddslag (SFS 1988:534).

7. Egonsson, Dan, Filosofiska essäer om människovärde. Nora, Nya Doxa, 1999.

8. Förordning om etikprövning av forskning som avser människor (SFS 2003:615).

9. Förordning med instruktion för regionala etikprövningsnämnder (SFS 2007:1068) 10. Förordning med instruktion för Centrala etikprövningsnämnden (SFS 2007:1069).

11. Förordning om utsättning av genetiskt modifierade organismer i miljön (SFS 2002:1086).

12. Förordning om innesluten användning av genetiskt modifierade organismer (SFS 2000:271).

13. Jordbruksverket, Användningen av försöksdjur i Sverige under 2015. Rapport, Dnr: 5.2.17-5428/17.

14. Hug, K. and M. Johansson, The ethics of withdrawal: the case of follow-up from first-in-human clinical trials. Regen Med, 2017. 12(1): p. 25-36.

15. Hug, K., G. Hermeren, and M. Johansson, Withdrawal from biobank research: considerations and the way forward. Stem Cell Rev, 2012. 8(4): p. 1056-65.

16. Karlsson, Fredrik, Weighing Animal Lives – a Critical Assessment of Justification and Prioritization in Animal-Rights Theories. Uppsala, Acta Universitatis Upsaliensis, 2009.

17. Klareskog, Lars & Rönnelid, Johan & Lundberg, Karin & Padyukov, Leonid & Alfredsson, Lars

”Immunity to citrullinated proteins in rheumatoid arthritis.” Annual Review of Immunology, 2008, 26:651–675.

18. Lag om etikprövning av forskning som avser människor (SFS 2003:460).

19. Lag om biobanker i hälso- och sjukvården med mera (SFS 2002:297).

20. Läkemedelslag (SFS 2015:315).

21. Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor (LVFS 2011:19).

22. Perel, Pablo, & Roberts, Ian & Sena, Emily & Wheble, Philipa & Briscoe, Catherine & Sandercock, Peter

& Macleod, Malcolm & Mignini, Luciano E. & Jayaram, Pradeep & Khan Khalid S.,”Comparison of Treatment Effects between Animal Experiments and Clinical Trials: Systemic Review”. British Medical Journal, 2007, 334 (7586):197.

23. Personuppgiftslag (SFS 1998:204).

24. Personuppgiftsförordning (SFS 1998:1191).

25. Rodman, John, ”The Dolphin Papers”, The North American Review, spring 1974, 259:13-26 (page 18).

26. Statens Jordbruksverks författningssamling (SJVFS 2008:70).

27. Strålsäkerhetsmyndighetens föreskrifter om allmänna skyldigheter vid medicinsk och odontologisk verksamhet med joniserande strålning (SSMFS 2008:35).

28. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General Assembly, Seoul 2013. Ferney-Voltaire, France, World Medical Association, 2013.

4 HANDLING OF RESEARCH MATERIAL - THINK FIRST

This chapter, with the exception of Section 4.5, is the translation of a text that is virtually identical to that of Göran Hermerén’s article, “Hantering av integritetskänsligt material”.

In document GOOD RESEARCH PRACTICE (Page 38-41)

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