Research Ethical Clearance 2010
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This document discusses ethical clearance for research at Zayed University. It provides examples of issues that have come up in the past regarding obtaining proper ethical approval. It outlines the importance of ethical clearance in ensuring respect for participants, doing no harm, and fair inclusion in research. It introduces ZU's Research Ethics Committee and new procedures for obtaining ethical approval, including forms and informed consent. It addresses some recent feedback from faculty and stresses the importance of ethical training, which will soon be provided through an online training program.
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Research Ethical Clearance 2010
- 1. Ethical clearance for Research at Zayed University March 2010 Brigitte Howarth: Chair ZU Committee on the use of Human Subjects in Research Janet Martin: Office of Research
- 2. How do you feel about “ethical clearance”?
- 3. January 29 2010 “acted dishonestly and irresponsibly in carrying out research on children against their best interests and without official permission”
- 4. January 29 2010 “did not have the ethical approval or qualifications to oversee the study, which involved children undergoing colonoscopies, lumbar punctures, barium meals and brain scans.”
- 5. January 29 2010 “he received 55,000 UKP to carry out the research on behalf of solicitors acting for parents who believed that their children had been harmed by MMR… He did not declare any conflict of interest to the Lancet medical journal.”
- 6. January 29 2010 “The study prompted a massive drop in the number of children being vaccinated against measles, mumps and rubella. Subsequent studies involving millions of children found no evidence of a link between MMR and autism.”
- 7. UN apology after flawed climate study Times Online January 21, 2010
- 8. 21 January 2010 “The IPPC said that the prediction in its landmark 2007 report was ‘poorly substantiated’ and resulted from a lapse in standards”
- 9. 21 January 2010 “The UN’s top climate change body issued an unprecedented apology yesterday over its flawed prediction that Himalayan glaciers were likely to disappear by 2035.”
- 10. ZU investigators would know all about ethical clearance … … this is straightforward stuff that hardly needs to be covered! “I’m only doing a pilot study”
- 11. ZU investigators would know all about ethical clearance … … this is straightforward stuff that hardly needs to be covered! “I don’t need clearance because I’m only surveying ZU students”
- 12. ZU investigators would know all about ethical clearance … … this is straightforward stuff that hardly needs to be covered! “my supervisor said that not to worry. It’s ok.”
- 13. ZU investigators would know all about ethical clearance … … this is straightforward stuff that hardly needs to be covered! “I already have ethical clearance from another collaborative institution”
- 14. ZU investigators would know all about ethical clearance … … this is straightforward stuff that hardly needs to be covered! “I received my research grant before this ethics committee got going”
- 15. Recent examples from faculty have assisted the Committee in determining what is not recommended for the quality of ethics consideration at ZU: Obtaining informed consent: “a relevant statement will be included in the instructions given prior to data collection” “Questionnaire aimed to know your opinion on the [subject] in terms of the level of satisfaction, as well as in terms of information and since I … would like to know”
- 16. So what is “ethical clearance” all about?
- 17. Ethical clearance is part of Research Integrity: This embodies a range of good research practice and conduct which can include •intellectual honesty •accuracy •fairness •intellectual property •protection of human and animal subjects involved in the conduct of research. Responsibilities for research integrity are shared by individual researchers and the institution.
- 18. Ethical clearance in Research The ‘Belmont’ ethical principles are to ensure: • Respect for persons (the research consent process ensures autonomy for individuals – “informed” consent, confidentiality of data etc) • Beneficence (the intention to do no harm – to maximize possible benefits and minimize possible risks to people involved in research) • Justice (fairness in distribution of research inclusion and exclusion)
- 19. What should we do about understanding ethical clearance in research?
- 23. http://www.zu.ac.ae/research/aspx/ResearchIntegrity.aspx New procedures and forms mean that you will need: 1.Criteria for referral of Proposed research 2.Application for Research Ethical Approval 3.Checklist and Coversheet 4.Informed Consent of Human Subjects
- 24. Who is your Research Ethics Committee? Dr. Brigitte Howarth (Chair) Dr. Eric Breton Dr. Usama AlAlami Dr. Gaelle Duthler Dr. Sharon Parker Dr. Grant Regan (ex-officio for ICE) Dr. Chet Jablonski Janet Martin (ex-officio for the Office of Research) External representative (yet to appoint)
- 25. Recent feedback from faculty: Considering the Committee responses: “…don’t you and your committee think that I will be able to present a professional research study” “This is not the first time I’m working on research that requires ethical clearance…. You are underestimating my skills and potential as a researcher openly and very rudely.” “I am a highly educated person, and I don’t need another person to speak to me about conducting research professionally.” “I should have received a quick reply from you”
- 26. Recent feedback from faculty: Considering the Committee responses: “Thank you very much for your prompt reply and considerations. I greatly appreciate it!” “Thank you very much to the Committee for processing my application in such an efficient manner.” “I do hope this clarifies some of our statements and I thank you again for your valuable help.” “Thanks for this feedback, will make changes as recommended and pre test.”
- 27. Ethical Training for Research All faculty and students will soon have access to an internationally recognized online training resource: CITI: Collaborative Institutional Training Initiative https://www.citiprogram.org Committee members will also hopefully have access to SRA certification from the US, such as “Human Research Protections Certificate Program”
Editor's Notes
- Is it a MAZE to you?
- A HELPFUL process? HITTING your head against a wall … or something!!? What are your past experiences?
- Is it still needed? … examples Nuremberg Trials (1947); Milgram Study (1974); Thalidomide Study (late 1950’s); untreated syphilis in negro males (1952-)
- Is it still needed? … examples Nuremberg Trials (1947); Milgram Study (1974); Thalidomide Study (late 1950’s); untreated syphilis in negro males (1952-)
- Is it still needed? … examples Nuremberg Trials (1947); Milgram Study (1974); Thalidomide Study (late 1950’s); untreated syphilis in negro males (1952-)
- Is it still needed? … examples Nuremberg Trials (1947); Milgram Study (1974); Thalidomide Study (late 1950’s); untreated syphilis in negro males (1952-)
- Is it needed at ZU now? International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects Anyone “surveyed out” here sometimes? When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
- Is it needed at ZU now? International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects Anyone “surveyed out” here sometimes? When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
- Is it needed at ZU now? International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects Anyone “surveyed out” here sometimes? When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
- Is it needed at ZU now? International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects Anyone “surveyed out” here sometimes? When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
- Is it needed at ZU now? International protocol dictates that quality research all over the world undergoes a systematic evaluation of ethical appropriateness of research involving either human or animal subjects Anyone “surveyed out” here sometimes? When research which is not well designed (and likely to not deliver sound outcomes) but widely circulated to avoid the hassle of good sampling design, everyone is more likely to delete quality research requests when they come along. Not in anyone’s interest.
- Examples of what not to do… These were the TOTAL information responses provided to the Committee at ZU. University of Arizona example with permission from Sarah Trainer, Fulbright student at ZU undertaking research in 2009/10
- Ethical consideration for human or animal subjects used in research
- The Belmont Report” (http://en.wikipedia.org/wiki/Belmont_Report) – shapes research principles world-wide It is in the interests of both the institution and all researchers that research projects are reviewed and conducted ethically, both to protect the right and welfare of research subjects, as well as to enable international recognition for creditable institutional procedures in research being supported and followed at ZU. Society entrusts investigators with the privilege of using other humans to advance knowledge, but the research community as a whole suffers when even a few investigators ignore basic principles of ethics.
- Many options …
- It is no time to HIDE and IGNORE research ethics! Future grants will depend on it. UAE organizations like HAAD and the EF will insist on it. Our research credibility depends on it.
- This Committee will: Establish protocol and procedures during 2009/10 Review and approve all applications for ethical clearance during 2009/10 Communicate with faculty and students undertaking research to educate, learn and develop 4. Review all policies, procedures and committee structures for future recommendation…. Live and learn! Comparison to the past – thanks to Richard Mapstone Is it an easy/fun job? Road to popularity? No. The Committee is simply working within principles that we believe in to do the best by the researcher AND the institution. The process for ethical clearance should improve research design, not hinder the research process.
- Examples of what not to do… The Committee have and will make every attempt to support all research applications with constructive and diplomatic feedback. Don’t take issues personally. In truth many of us do not like criticism or interference with our work. The Committee would greatly appreciate support of less experienced researchers by more experienced people in such situations, and a mob of volunteers next time the call for Committee membership (and the heavy workload involved) comes up from those unhappy with the current arrangements! The Committee is attempting to ensure that the respect, beneficence and justice is upheld for all ZU research, for the benefit of researchers and the institution. That’s all.
- A philosophy to work together. The spirit of our decisions … Discuss and debate, rather than become offended or offensive
- Membership for CITI in progress Certification or course completion will become a pre-requisite for grant funding and ethical clearances
- Sometimes learning new things seems daunting.
- As Stephen Abrams said: “Learning is incremental and you can grow a little bit at a time and suddenly realize that you’re competent in something new.” At ZU we have the beginnings of policies and procedures We have a hard-working and very positive team (our ZU Committee) working together with a solid philosophical view We have new training initiatives imminent – available to everyone We are listening and learning We are establishing a credible ethical research clearance procedure at ZU, one-step-at-a-time!
- Questions?