Published on February 5, 2014
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
How do you feel about “ethical clearance”?
January 29 2010 “acted dishonestly and irresponsibly in carrying out research on children against their best interests and without official permission”
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.”
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.”
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.”
UN apology after flawed climate study Times Online January 21, 2010
21 January 2010 “The IPPC said that the prediction in its landmark 2007 report was ‘poorly substantiated’ and resulted from a lapse in standards”
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.”
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”
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”
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.”
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”
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”
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”
So what is “ethical clearance” all about?
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.
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)
What should we do about understanding ethical clearance in research?
Change is happening at ZU
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
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)
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”
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.”
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”
Contact information: firstname.lastname@example.org
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