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Research Ethics, Information and Consent

Research Ethics, Information and Consent. Dr Sue Chetwynd Associate Fellow Warwick University. Session outline. Issues in conduct of research Information on Warwick websites Research on human subjects History Consent Information. Issues in conduct of research.

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Research Ethics, Information and Consent

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  1. Research Ethics, Information and Consent Dr Sue Chetwynd Associate Fellow Warwick University S B Chetwynd – Research ethics, Information and Consent

  2. Session outline • Issues in conduct of research • Information on Warwick websites • Research on human subjects • History • Consent • Information S B Chetwynd – Research ethics, Information and Consent

  3. Issues in conduct of research • respect for principles of integrity, honesty and openness • commitment to intellectual honesty and personal responsibility • Research involving participants must be undertaken to gain knowledge and understanding • avoid unnecessary repetition of existing knowledge. S B Chetwynd – Research ethics, Information and Consent

  4. Misconduct • NSF: “fabrication, falsification, plagiarism, or other serious deviation from accepted practice in proposing, carrying out, or reporting results from activities funded by NSF; or retaliation of any kind against a person who reported or provided information about suspected or alleged misconduct and who has not acted in bad faith.” [http://www.nsf.gov/od/ogc/regulation.jsp downloaded 29/03/2011] S B Chetwynd – Research Issues

  5. Warwick University Misconduct Includes: • the fabrication or falsification of research data; • the use of another person’s ideas, work or research data without appropriate acknowledgement; • misleading ascription of authorship to a publication. Members and employees of the University have a duty to report misconduct Any failure to comply with this code or proved allegation of misconduct could lead to disciplinary action [http://www2.warwick.ac.uk/services/rss/services/ethics/governance/codeofconduct/#intro, downloaded 10/03/2009} S B Chetwynd – Research Issues

  6. Warwick websites Research Support Services • Ethics and Governance • Research code of conduct • Guidelines on Ethical Practice • HSSREC guidelines • BioMedical research application details S B Chetwynd – Research ethics, Information and Consent

  7. Research on Human Subjects • Post Nuremberg • Importance of consent • Components of consent • Information • Capacity • Freedom from coercion • Need to minimise harm • Confidentiality S B Chetwynd – Research ethics, Information and Consent

  8. Use of tissue • Regulated by Human Tissue Act 2004 • Regulates removal, storage and use of human tissue • Lists the purposes for which consent is required (the Scheduled Purposes). • Specifies who may give consent for the Scheduled Purposes. • Creates a new offence of DNA theft • Makes it lawful to take minimum steps to preserve the organs of a deceased person • Tissue is still part of our bodies, so we have right to decide S B Chetwynd – Research ethics, Information and Consent

  9. Use of data • Similarly information about us is under our control • Should therefore reassure participants about who should have access to it • How it will be stored • How it will be included in publications • If data is received from another researcher, it will probably already be anonymous • But you should still assure yourself that consent has been given for it to be used in your research • You cannot pass on data to another researcher without the participants’ consent S B Chetwynd – Research ethics, Information and Consent

  10. Information • the nature and objectives of the project • the methodology of the project and conditions under which it is to be conducted • who is undertaking and who is funding the project • the potential risks and inconveniences that may arise • the potential benefits that may result • what participation in the research will require • Consent is not consent if they don’t understand the information – even if a form has been signed S B Chetwynd – Research ethics, Information and Consent

  11. Coercion • Where a relationship exists between the researcher and participant (e.g. employees, patients, students) careful consideration as to the nature of consent is required. • Willingness to volunteer may be unduly influenced by the expectation of benefits or rewards S B Chetwynd – Research ethics, Information and Consent

  12. Confidentiality • Secure storage • Publication • Anonymity • Details that would allow individuals to be identified must not be published or made available to anybody not involved in the research unless explicit consent is given by the individuals concerned. • You must inform prior to consent of any potential risks that might mean that the confidentiality or anonymity of personal data may not be guaranteed; S B Chetwynd – Research ethics, Information and Consent

  13. Conclusion • Research has the potential to harm participants • The researcher needs to minimise the risk of harm • And to inform the participant about the likely harms • So that they have the information they need to make decisions • You need to try and put yourself in their place • What do they know? • What might they want to know? • What might worry them? • And they must be free to refuse. S B Chetwynd – Research ethics, Information and Consent

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