Discussion responses- NOT an essay – AMA format
Do you think that design of the SUPPORT study was ethical, why or why not?
In your opinion, did the SUPPORT study team deviate from the ethical principles during the informed consent process?
As pre-mature babies are a vulnerable population, and despite the lack of data and the classification of these treatments as standard of care, do you think researchers should have emphasized these risks to parents? Why or why not? Some neonatologists were noted to have had concerns about the use of low oxygen support, and study investigators should have been aware of these risks. What reasons do you think could have swayed the research team to leave this risk off of the consent form? explain.
Based on the information we have covered so far in this course; do you agree that deception in this type of research is vital in analyzing the “placebo effect”? Why or why not?
Do you personally believe in the “placebo effect”? Why or why not?
Can the “placebo effect” be achieved and analyzed without withholding or misleading participants with respect to the nature of the trial? Explain.
Do you think that the formation of the working group will be the solution to the countless ethical dilemmas that exist in developing countries?
What further measures or regulations would you suggest to ensure that researchers in developing countries are held to the same standards as the rest of the world?
How Do International Regulations Work in Practice?) by Halila R. it is explained that informed consent or authorization for conducting research in emergency can be waived after the approval of an ethics committee as long this emergency trial brings significant benefit for the patient.
Do you agree/disagree that human subjects are not able to give consent in all emergency trials? Why? Or Why not? Explain any differences you identify, if applicable.
In your opinion, what other challenges or barriers exist when conducting clinical trials during emergencies?
Covid-19
Did your opinion(s) regarding challenges or barriers in clinical trials during emergencies change after viewing Equity and Ethics video we just watched? (https://www.youtube.com/watch?v=jsD-1pBeGEw) Explain.
If you were a principal investigator overseeing a clinical trial during the current Covid-19 Pandemic,
How would you balance autonomy and informed consent while waiving certain requirements in order to expedite the trial due to the current emergency?
How would you ensure justice throughout the trial?
Has the COVID-19 pandemic affected the way the clinical research community shares data and knowledge?
In what ways has it hindered data and knowledge sharing?
What are the hurdles to sharing data and knowledge in clinical research?
The scientific/technological hurdles? The societal/investment hurdles?
What is needed to make data and knowledge sharing more effective and more the norm?