Ethics

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Justice is based on the concept of fairness, where all benefits, costs and risks are evenly and fairly distributed. Justice/fairness in participant selection in research is where the selection parameters are based on science, rather than discrimination (eg. vulnerability, easy to access within a population, availability, privilege). Justice is also where all of the participants accept the risks of the research and have adequate access to the benefits of it<ref name="UKCEN: Ethical Issues - Ethical Frameworks">http://www.ukcen.net/ethical_issues/ethical_frameworks/the_four_principles_of_biomedical_ethics</ref><ref>https://www.avac.org/principles-research-ethics</ref><ref>https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research</ref>.  
 
Justice is based on the concept of fairness, where all benefits, costs and risks are evenly and fairly distributed. Justice/fairness in participant selection in research is where the selection parameters are based on science, rather than discrimination (eg. vulnerability, easy to access within a population, availability, privilege). Justice is also where all of the participants accept the risks of the research and have adequate access to the benefits of it<ref name="UKCEN: Ethical Issues - Ethical Frameworks">http://www.ukcen.net/ethical_issues/ethical_frameworks/the_four_principles_of_biomedical_ethics</ref><ref>https://www.avac.org/principles-research-ethics</ref><ref>https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research</ref>.  
  
=== Ethics in human subject genetics<br> ===
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=== Ethics in human subject genetics  ===
  
Human subjects are arguably the most representative model organisms in helping scientists learn about human health<ref>National Institute of Allergy and Infectious Diseases. Research using human subjects. 2018 [cited 6/12/18] Available from: https://www.niaid.nih.gov/grants-contracts/human-subjects</ref>.&nbsp;Using human subjects for research purposes is a complicated process as many rules and regulations must be followed.&nbsp;This mainly focuses on protecting confidentiality, as well as preventing discrimination against an individual. This can be deemed as an important factor in encouraging individuals to seek health care access, as people are more likely to trust the purpose of the research<ref>Andrews L.B, Fullarton J.E, Holtzman N.A. Assessing Genetic Risks: Implications for health and social policy. Washington (DC): National Academies Press (US); 1994. Pg 252.</ref>. Furthermore, with more research being carried out on human subjects, scientists are more likely to tailor treatment methods to better fit the human population.&nbsp;<br>
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Human subjects are arguably the most representative model organisms in helping scientists learn about human health<ref>National Institute of Allergy and Infectious Diseases. Research using human subjects. 2018 [cited 6/12/18] Available from: https://www.niaid.nih.gov/grants-contracts/human-subjects</ref>. Using human subjects for research purposes is a complicated process as many rules and regulations must be followed. This mainly focuses on protecting confidentiality, as well as preventing discrimination against an individual. This can be deemed as an important factor in encouraging individuals to seek health care access, as people are more likely to trust the purpose of the research<ref>Andrews L.B, Fullarton J.E, Holtzman N.A. Assessing Genetic Risks: Implications for health and social policy. Washington (DC): National Academies Press (US); 1994. Pg 252.</ref>. Furthermore, with more research being carried out on human subjects, scientists are more likely to tailor treatment methods to better fit the human population.  
  
=== Laws<br> ===
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=== Laws  ===
  
Laws in genetics have to be carefully managed by research companies to protect individuals against genetic discrimination. The Human Tissue Act 2006 creates a law which holds anyone accountable of DNA theft if they contain human tissue with the purpose of carrying out research on it without the person's consent<ref>Human Tissue Authority. Human Tissue Act 2004. 2016 [cited on 9/12/18] Available from:fckLRhttps://www.hta.gov.uk/policies/human-tissue-act-2004</ref>. This law aims to protect human tissue from unlawful removal, storage or use in research<ref>Human Tissue Authority. Human Tissue Act 2004. 2016 [cited on 9/12/18] Available from:fckLRhttps://www.hta.gov.uk/policies/human-tissue-act-2004</ref>. There are, however, acts which allow research to be carried out without being granted consent. For example, Section 251 NHS Act 2006 temporarily lifts the common law duty of confidentiality, meaning the discloser will not be prosecuted by breaching the Data Protection Act 1998<ref>Medical Research Council. Seeking Approvals: Section 251 approval. 2010 [cited on 9/12/18] Available from: fckLRhttp://www.dt-toolkit.ac.uk/routemaps/station.cfm?current_station_id=383</ref>. This is only permissible in certain scenarios, for example, where consent is not feasible<ref>Administrative Data Research Network. Legal Framework. 2018 [cited on 9/12/18] Available from:fckLRhttps://www.adrn.ac.uk/policies-procedures/legal/nhs2006/</ref>.&nbsp;
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Laws in genetics have to be carefully managed by research companies to protect individuals against genetic discrimination. The Human Tissue Act 2006 creates a law which holds anyone accountable of DNA theft if they contain human tissue with the purpose of carrying out research on it without the person's consent<ref>Human Tissue Authority. Human Tissue Act 2004. 2016 [cited on 9/12/18] Available from: https://www.hta.gov.uk/policies/human-tissue-act-2004</ref>. This law aims to protect human tissue from unlawful removal, storage or use in research<ref>Human Tissue Authority. Human Tissue Act 2004. 2016 [cited on 9/12/18] Available from: https://www.hta.gov.uk/policies/human-tissue-act-2004</ref>. There are, however, acts which allow research to be carried out without being granted consent. For example, Section 251 NHS Act 2006 temporarily lifts the common law duty of confidentiality, meaning the discloser will not be prosecuted by breaching the Data Protection Act 1998<ref>Medical Research Council. Seeking Approvals: Section 251 approval. 2010 [cited on 9/12/18] Available from: http://www.dt-toolkit.ac.uk/routemaps/station.cfm?current_station_id=383</ref>. This is only permissible in certain scenarios, for example, where consent is not feasible<ref>Administrative Data Research Network. Legal Framework. 2018 [cited on 9/12/18] Available from: https://www.adrn.ac.uk/policies-procedures/legal/nhs2006/</ref>.  
 
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=== References  ===
 
=== References  ===
  
 
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Latest revision as of 09:13, 10 December 2018

According to the Oxford Dictionary, 'ethics' are defined as:

'One's actions, behaviour or conduct as governed by moral principles'

In the context of biomedical research, ethics refer to the methods and practice of scientists in relation to the treatment and respect of their subjects (both human and non-human) in and outside the lab[1].

The use of humans and non-human animals in biomedical research is a highly controversial topic which has resulted in the introduction of many laws[2]. Animals are models used for studying human biology and disease with the aim of making advancements in human health. Scientists aim to replicate certain mutations/diseases that are present in humans into animals in the lab to then further research the causes and implications of the mutation and try potential treatments.

In any research projects, a subject or participant must give their informed consent to the researcher before they can partake. To give consent, a participant must have sufficient capacity and be fully informed of the aims and research methods, intended to be used during the research, in terms which they can understand and free from scientific jargon[3].

There are four principles of biomedical ethics:

  1. Respect for participants
  2. Beneficence
  3. Non-maleficence
  4. Justice

Contents

Respect for participants

Respect for participants encompasses their autonomy and confidentiality.

Respecting participants' autonomy relies on the researcher allowing the participant to formulate their own decisions free from coercion and penalties. Participants' decisions includes granting their consent to participate in a research project, changing their minds part-way through the research and withdrawing from the research[4][5].

Respecting participants' confidentiality relies on all of the data generated from the research and all personal/identifiable patient data are stored securely, in accordance to the responsible laws/regulations, and that only the data essential for the research is collected[6][7].

Beneficence

Beneficence is where the actions of the researcher/study are done for the benefit of the participant. In research, beneficence is to both minimise the risks posed to the participant and to maximise the benefits to them. In research, beneficence can be viewed as part of a risk-benefit ratio, where the predicted benefits equal or outweighs the risks[8][9][10].

Non-maleficence

Non-maleficence is where the participants are protected from harm (ie. do no harm). In research, this is where the main aim is not to cause any undue/significant harm to participants or where there is no benefit to conducting the research but also has the risk of significant harm to them. Non-maleficence must also be considered when conducting research in order to prevent cumulative risks of harm to the patient (eg. cumulative X-ray damage over prolonged exposure before and during the study) and to prevent patients from volunteering for research more often than is advisable[11][12].

Justice

Justice is based on the concept of fairness, where all benefits, costs and risks are evenly and fairly distributed. Justice/fairness in participant selection in research is where the selection parameters are based on science, rather than discrimination (eg. vulnerability, easy to access within a population, availability, privilege). Justice is also where all of the participants accept the risks of the research and have adequate access to the benefits of it[13][14][15].

Ethics in human subject genetics

Human subjects are arguably the most representative model organisms in helping scientists learn about human health[16]. Using human subjects for research purposes is a complicated process as many rules and regulations must be followed. This mainly focuses on protecting confidentiality, as well as preventing discrimination against an individual. This can be deemed as an important factor in encouraging individuals to seek health care access, as people are more likely to trust the purpose of the research[17]. Furthermore, with more research being carried out on human subjects, scientists are more likely to tailor treatment methods to better fit the human population.

Laws

Laws in genetics have to be carefully managed by research companies to protect individuals against genetic discrimination. The Human Tissue Act 2006 creates a law which holds anyone accountable of DNA theft if they contain human tissue with the purpose of carrying out research on it without the person's consent[18]. This law aims to protect human tissue from unlawful removal, storage or use in research[19]. There are, however, acts which allow research to be carried out without being granted consent. For example, Section 251 NHS Act 2006 temporarily lifts the common law duty of confidentiality, meaning the discloser will not be prosecuted by breaching the Data Protection Act 1998[20]. This is only permissible in certain scenarios, for example, where consent is not feasible[21].

References

  1. Ethics definition, Oxford English Dictionaries © 2017 Oxford University Press [cited 19/10/17] available from: https://en.oxforddictionaries.com/definition/ethics
  2. Mental Capacity Act 2005
  3. https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/consent-to-research/consent-to-research
  4. https://www.avac.org/principles-research-ethics
  5. https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
  6. https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
  7. https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-practice-in-research/good-practice-in-research#paragraph-5
  8. https://www.avac.org/principles-research-ethics
  9. https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
  10. https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-practice-in-research/good-practice-in-research#paragraph-5
  11. https://www.avac.org/principles-research-ethics
  12. https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-practice-in-research/good-practice-in-research#paragraph-5
  13. http://www.ukcen.net/ethical_issues/ethical_frameworks/the_four_principles_of_biomedical_ethics
  14. https://www.avac.org/principles-research-ethics
  15. https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research
  16. National Institute of Allergy and Infectious Diseases. Research using human subjects. 2018 [cited 6/12/18] Available from: https://www.niaid.nih.gov/grants-contracts/human-subjects
  17. Andrews L.B, Fullarton J.E, Holtzman N.A. Assessing Genetic Risks: Implications for health and social policy. Washington (DC): National Academies Press (US); 1994. Pg 252.
  18. Human Tissue Authority. Human Tissue Act 2004. 2016 [cited on 9/12/18] Available from: https://www.hta.gov.uk/policies/human-tissue-act-2004
  19. Human Tissue Authority. Human Tissue Act 2004. 2016 [cited on 9/12/18] Available from: https://www.hta.gov.uk/policies/human-tissue-act-2004
  20. Medical Research Council. Seeking Approvals: Section 251 approval. 2010 [cited on 9/12/18] Available from: http://www.dt-toolkit.ac.uk/routemaps/station.cfm?current_station_id=383
  21. Administrative Data Research Network. Legal Framework. 2018 [cited on 9/12/18] Available from: https://www.adrn.ac.uk/policies-procedures/legal/nhs2006/
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