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Introducing ETHICS and approval processes (Part 1)

Introducing ETHICS and approval processes (Part 1). Dr Vivien Rolfe v ivrolfe.com CC BY SA unless images otherwise stated. PART 1 of 2 Introduction to ethics. Learning outcomes. This resource will help you understand: What ethics are and why they are important.

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Introducing ETHICS and approval processes (Part 1)

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  1. Introducing ETHICS and approval processes (Part 1) Dr Vivien Rolfe vivrolfe.com CC BY SA unless images otherwise stated

  2. PART 1 of 2Introduction to ethics

  3. Learning outcomes • This resource will help you understand: • What ethics are and why they are important. • Some historical principles and how ethics originated. • How ethics might be important for typical university research projects. • Flow diagrams for university and NHS ethical approval. • Where ethics fits into our research planning and dissemination. • Resources and documents you might find useful.

  4. What is /are ethics? http://www.youtube.com/watch?v=ZIaHxC7BT0A

  5. What to expect from this resource? • It will not discuss the theories underpinning the subject of ethics. • Is intended as a basic introduction for undergraduate students embarking on research for the first time. • You may or may not need to gain ethical approval for your dissertations in your university, but it is important to understand ethical principles.

  6. Ethics are all around us! CC BY NC SAhttp://www.flickr.com/photos/gravitywave/7715395/ CC BY SAhttp://www.flickr.com/photos/bluesquarething/6563788523/ CC BY NC SAhttp://www.flickr.com/photos/victoriabernal/6294851265/ CC BY NC SAhttp://www.flickr.com/photos/francesbell/4655827551/ CC BY NDhttp://www.flickr.com/photos/illuminating9_11/3553723626/

  7. Early professional standards… • Hippocrate’s writings give mention to some of the principles we comply with today. (Public domain image)

  8. “I will not give a lethal drug to anyone if I am asked, nor will I advise such a plan; and similarly I will not give a woman a pessary to cause an abortion”. “Whatever I see or hear in the lives of my patients, whether in connection with my professional practice or not, which ought not to be spoken of outside, I will keep secret, as considering all such things to be private”. Translated by Michael North, 2002.

  9. …and lack of standards • Henrietta Lacks. • Born 1920 in Virginia USA. • Died of cervical cancer in 1951 (31 years). • Few hospitals for black patients (went to John Hopkins). Radium treatment applied to cervix. Tissue taken for culture. • There was no code of ethics. No system for gaining permission. Her family had initially said no, yet none of her body organs remained after autopsy. (Public domain image)

  10. The disaster continued • HeLa cells. Cells grew so rapidly and not confined by the space of the vessel. Used to test polio vaccine. • Cells used to develop cell culture techniques (media, freezing, handling). • Hela cells became mass produced and big industry around the world. • Early research used prisoner volunteers injecting Hela. No consent taken. Not informed it was cancer. • Henry Beecher talked about consent for medical research (Henry Beecher 1966).

  11. Nuremberg Code • Following 1947 Nuremberg war trials, a 10 point code of ethics was set up to govern human experimentation “the voluntary consent of the human subject is absolutely essential”. • The term “informed consent” didn’t appear in law courts until 1957.

  12. Declaration of Helsinki • Adopted by the World Medical Association in Helsinski in June 1964 and subsequently updated. • Governing “human subjects, includingresearch on identifiable human material and data”. • Establishing ethical review processes.

  13. Other acts • Human Tissue Act • Data Protection Act • Nuffield Council on Bioethics • Home Office Animal License / Project and Personal

  14. Introducing ETHICS and approval processes (Part 2) Dr Vivien Rolfe vivrolfe.com CC BY SA unless images otherwise stated

  15. PART 2 of 2Typical universityundergraduateresearch projects?

  16. Healthy human volunteers (students!) e.g. physiology laboratory Human tissue e.g. blood samples, human biopsies, cell culture Animalexperimentse.g. in vitro / in vivo testing Children / patients / NHS / clinical settings e.g. clinical studies. Human opinions – qualitative research e.g. questionnaires or interviews HIGH RISK Literature review e.g. biased review, plagiarism, misleading recommendations. Human data analysis e.g. pre-existing medical data, audit, service or technical evaluation LOW RISK

  17. Typical university process Ethical review form Ethical Review Panel / InternalAppraisal Feedback YES MODIFICATIONNO Research proposal; CVs of student and supervisor; research paperwork (informationsheet, informed consent, surveys).

  18. Typical university / NHS process Ethical review form Ethical Review Panel / InternalAppraisal Hospital Research and Development Office Input Feedback YES MODIFICATIONNO NHS Ethics (NRES) Weeks / months Months / years

  19. Informed consent • Be of the same mind – trust / cooperation between researcher / clinician and participant / subject. • Requires the participant information sheet and a consent form to sign. • The validity of consent is based on the following: • The provision of accurate information sheets to make a decision. • The participant understands the information. • Is competent to give consent. • Is not coerced.

  20. Confidentiality • Found within the Hippocratic Oath “I will not divulge, reckoning that all such should be kept secret”. • Research must comply with the UK 1998 Data Protection Act governing the use of personal data (name, age, date of birth) and its collection, use, disclosure and storage. • Data should be anonymised.

  21. Other research requirements • Includes ethics and items such as safe working and good practice. • Health and safety: • Risk assessments for laboratory working • COSHH for safe use of chemicals

  22. Where in our research pipeline? Ethical review form Ethical review form Ethical Review Panel / InternalAppraisal Ethical Review Panel / InternalAppraisal Feedback YES MODIFICATIONNO Feedback YES MODIFICATIONNO Research proposalCVs of student / supervisor All research paperworkPatient information sheetInformed consent sheet Questionnaires / interviewquestions Research proposalCVs of student / supervisor All research paperworkPatient information sheetInformed consent sheet Questionnaires / interviewquestions

  23. Learning outcomes • This resource will help you understand: • What ethics are and why they are important. • Some historical principles and how ethics originated. • How ethics might be important for typical university research projects. • Flow diagrams for university and NHS ethics. • Where ethics fits into our planning and dissemination. • Further reading.

  24. Resources • Henry Beecher (1966). (Available: http://www.nejm.org/doi/full/10.1056/NEJM199707243370419) • Michael North (2002). Hippocratic Writings. The National Library of Medicine, (Available: http://www.nlm.nih.gov/hmd/greek/greek_oath.html ) • MOCK ethicalreviewchecklist: Open educationalresource(Availablehttp://vivrolfe.com/research-projects/introduction-to-ethics-for-university-undergraduate-students/). • MOCK consent form: Open educationalresource (Availablehttp://vivrolfe.com/research-projects/introduction-to-ethics-for-university-undergraduate-students/). • MOCK patientinformationsheet: Open educational (Availablehttp://vivrolfe.com/research-projects/introduction-to-ethics-for-university-undergraduate-students/).

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