Ethics in Research & the Application Process - Ms Janet Cohen

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Part of the HDR Development Seminar Series, Ms Janet Cohen presented the following lecture focusing on: What is Research?; What is Ethical Research?; What is Human Research? – Research involving human participants includes; Purpose of the National Statement; National Health and Medical Research Council (NHMRC) requirements; What are the roles of the HREC?; Human Ethics at Monash University; Types of review; Types of harm – Not Low Risk; Applications; When do I need ethics approval?; Exemptions; After approval; Causes of delays in approval; Privacy and research ethics; Privacy legislation; Issues to be addressed in applications.

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Ethics in Research & the Application Process - Ms Janet Cohen

  1. 1. Ethics in Research & the Application Process Janet Cohen Executive Officer Human Ethics Monash Research Office September 2012
  2. 2. What is Research? “the systematic study of materials and sources in order to establish facts and reach new conclusions ” “includes work of direct relevance to the needs of commerce, industry, and to the public and voluntary sectors; scholarship; the invention and generation of ideas, images, performances, artifacts including design, where these lead to new or substantially improved insights; and the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products an processes, including design and construction.” NS 2007 2
  3. 3. What is Ethical Research?“ethical research is more than just doingthe right thing. It involves acting in theright spirit, out of an abiding respect andconcern for one’s fellow creatures” 3
  4. 4. What is Human Research? – Researchinvolving human participants includes • surveys, interviews or focus groups • undergoing psychological, physiological or medical testing or treatment • being observed by researchers • researchers having access to their personal documents or other materials • the collection and use of their body organs, tissues or fluids or exhaled breath • access to their information (in individually identifiable, re- identifiable or non-identifiable form) as part of an existing published or unpublished source or database 4
  5. 5. National Statement on Ethical Conduct inHuman Research (2007)Developed jointly by National Health and Medical Research Council, AustralianResearch Council and Australian Vice-Chancellors’ Committee 5
  6. 6. Purpose of the National StatementTo promote ethically good human researchThe National Statement clarifies theresponsibilities of-institutions and researchers for the design,conduct and dissemination of results of humanresearch (Monash University)-review bodies (MUHREC) 6
  7. 7. National Health and Medical ResearchCouncil (NHMRC) requirementsAll institutions/organisations that receiveNHMRC funding for research – Establish a Human Research Ethics Committee (HREC) – Review any research involving humans whether relating to health or not and whether funded by the NHMRC or not 7
  8. 8. What are the roles of the HREC?• Review applications• Provide advice• Education• Protection 8
  9. 9. Merit and RespectIntegrity Core research valuesBeneficence Justice 9
  10. 10. Research merit and integrityResearch should• be justifiable by its potential benefit• use methods suitable to achieve its aim• be based on current literature• ensure that respect for participants is not compromised• be supervised by persons with suitable experience, qualifications and competence• be conducted using appropriate facilities and resources 10
  11. 11. JusticeJust research requires• fair exclusion and inclusion of participants• fair recruiting processes• no unfair burden on participants• fair distribution of benefits of participation• no exploitation of participants• fair access to the benefits of research 11
  12. 12. BeneficenceThe likely benefits of the research must justify any risks of harmor discomfort to participants – Design research to minimise risks of harm or discomfort to participants – Clarify potential risks and benefits to participants – Researchers are responsible for participants’ welfare 12
  13. 13. Respect Respect for human beings is a recognition of their intrinsic value. Respect includes •Regard for the welfare, rights, beliefs, perceptions, customs and cultural heritage •Respect for the privacy, confidentiality and cultural sensitivities of participants •Respect for human beings making their own decisions •Protection of vulnerable persons 13
  14. 14. Theme: Consent• Voluntary participation• Consent must be obtained except in specific circumstances Consent may be expressed orally, in writing or some other means depending on –the nature, complexity and risk of research –the participants’ personal and cultural circumstances• Informed decision Participants must have sufficient information to understand the purpose, demands, risks and potential benefits. 14
  15. 15. Human Ethics at Monash University• Monash University Human Research Ethics Committee (MUHREC) – Human Ethics Office, Research Office• MUHREC reports to – Australian Health Ethics Committee (AHEC) – Monash Academic Board – Health Services Commissioner 15
  16. 16. Constitution of MUHREC Counseling Care Lay people Pastoral Care Chair Research Lawyer expertise 16
  17. 17. Committee Review Expedited Review Low Risk Form Form 1 Ethics Review Multicentre (NLR) Process MOU with major hospitals 18
  18. 18. Low Risk Form Allocate tosubmitted to HE experienced Office Committee member Issues emailed to researchers Reader No issues Issues decides it’s not LR Researcher Researchers may be Project email response required to resubmit on Approved/Research Form 1 can start 2 weeks Proceed as Form 1 19
  19. 19. Allocate hard copiesForm 1 (NLR) Form to members for submitted to HE Committee meeting Office Committee meeting Issues emailed to researchers About 6 weeks No Issues issues Researchers email response Project Approved/Research can start 20
  20. 20. Types of review • Low risk projects (LR forms) – The foreseeable risk is no more than discomfort – Reviewed by the Chairs/experienced members within 2 week of receipt – Can be submitted at any time • Full review (Form 1) – used for all research where the foreseeable risk to participants is more serious than discomfort – Reviewed by the full committee MUHREC – Discussed at a meeting – Can be submitted at any time and allocated to the next available meeting • Multicentre projects – Where MUHREC is not the primary HREC – Reviewed by the Chairs within 2 week of receipt 21
  21. 21. Discomfort – Low Risk • The only foreseeable risk to participants (including researchers) is one of discomfort • Can involve body &/or mind – anxiety induced by an interview – Minor side effects of medication – minor discomfort associated with procedures eg blood pressure 22
  22. 22. Types of harm – Not Low Risk • Physical &/or psychological harms – pain, distress • Devaluation of personal worth – humiliated, manipulated, treated disrespectfully or unjustly • Social harms – discrimination in access to benefits, services • Economic harms – imposition of direct or indirect costs on participants • Legal harms – discovery and prosecution of criminal conduct 23
  23. 23. Applications on Form 1 – Not Low Risk• Interventions/therapies, including clinical and non- clinical trials, and innovations• Human genetics• Human stem cells• Women who are pregnant and the human foetus• People highly dependent on medical care who may be unable to give consent• People with a cognitive impairment, an intellectual disability, or a mental illness• Aboriginal and Torres Strait Islander Peoples• Research studying or exposing illegal activities 24
  24. 24. When do I need ethics approval? • Interview • Survey • Questionnaire • Psychological testing • Collecting and / or using tissues / body fluids • Using data already collected (database) • Photography and audio/videotaping 25
  25. 25. Exemptions from ethical reviewMUHREC can exempt from ethical review research that• involves no more than negligible risk to participants (no foreseeable risk of harm or discomfort and any foreseeable risk is no more than an inconvenience) and• involves the use of existing data or records that contain only de-identifiable data about human beings (eg publicly available reports, literature) 26
  26. 26. After approval • Any change to research project – Request for Amendments form – Approval from MUHREC • Annual Reports and Final Report – Annual/Final Report form 27
  27. 27. Causes of delays in approval • Misclassifying the research category • Incomplete forms • Insufficient information in explanatory statements • Missing permission letters, attachments, signatures • Privacy issues • Delays in responding to issues raised by MUHREC • UAs (unexplained acronyms) 28
  28. 28. Privacy and research ethics• Protect the privacy of individuals – Collection – Use – Disclosure• Personal information• Health information• Sensitive information 29
  29. 29. Privacy legislation • Privacy Act 1988 (Cth) • Information Privacy Act 2000 (Vic) – regulates all personal information (except health information) that is collected or held by – the Victorian public sector; and – organisations funded by the public sector • Health Records Act 2001 (Vic) – regulates both public and private sector organisations that handle personal health information 30
  30. 30. Use and Disclosure of information – IPP2• Only use or disclose information for the primary purpose for which it was collected or a directly related secondary purpose• Use for secondary purposes should have the consent of the person. – some use/disclosure may be allowed in certain circumstances 31
  31. 31. Issues to be addressed in applications • What data are to be collected • How identifiable is the data • How the data is to be collected used and disclosed • Compliance with privacy legislation 32
  32. 32. Data can be • Identified allows the identification of a specific individual name, date of birth or address • Potentially identifiable (coded, re-identifiable) has identifiers removed and replaced by a code possible to use the code to re-identify the person • De-identified, (not re-identifiable, anonymous) identifiers have been removed permanently or if the data have never been identified 33
  33. 33. Do I need to complete the privacyprovisions in Form 1? project involves the collection use disclosure Identifiable health information, personal information or sensitive information 34
  34. 34. Low Risk Form• How to complete a low risk form 35
  35. 35. Human Ethics OfficeBuilding 3EClayton CampusTel 9905 5490Fax 9905 3831 muhrec@monash.edu http://www.monash.edu.au/researchoffice/human/ 60

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