Integrity, risks, safety - keepin' it real for all of us
Feb 22, 2019 1:55:44 GMT -5
idoitforthepong likes this
Post by brat on Feb 22, 2019 1:55:44 GMT -5
This is not a risk-free endeavor. Be careful out there!
It's really important to know what you're agreeing to. Don't assume every study sponsor, PI and staff has your safety as their primary concern. It's
super important to consider the risks
involved for you, personally, with whatever is being studied and any
drugs/procedures you're allowing. It's YOUR quality of life, body,
and its the only one you get this time around. Please research and understand the study phase, the drug itself, what it is, how it works, why it was developed, by whom, is the drug FDA approved yet, has the study been properly approved, any previous results, whats the purpose, what it did previously, how it's supposed to be effective, why, and for what malady, context, study administration, purpose, # blood draws, sponsor info, IRB info, known side effects, risks, etc.
super important to consider the risks
involved for you, personally, with whatever is being studied and any
drugs/procedures you're allowing. It's YOUR quality of life, body,
and its the only one you get this time around. Please research and understand the study phase, the drug itself, what it is, how it works, why it was developed, by whom, is the drug FDA approved yet, has the study been properly approved, any previous results, whats the purpose, what it did previously, how it's supposed to be effective, why, and for what malady, context, study administration, purpose, # blood draws, sponsor info, IRB info, known side effects, risks, etc.
Please add your wisdom, research, experiences so we can know more. What are some of the AE's (adverse effects) you've experienced?
Importance/validity of "informed consent:" www.clinicalleader.com/doc/clinical-trial-deaths-will-clearer-informed-consent-documents-be-enough-0001
Trends, Charts, and Maps: clinicaltrials.gov/ct2/resources/trends
Did you know...there's issues with conflict of interest for universities doing studies which are also receiving program and endowment funding from the sponsors/affiliates? This creates a bias that can be deadly: chicago.suntimes.com/education/3-million-research-breakdown-at-uic-where-a-star-psychiatrist-put-kids-at-risk/
Textbook Overview: Responsible Conduct of Research in Humans: ori.hhs.gov/education/products/ucla/default.htm
What a find! I never expected to find this published in full online vie Google search. It's not everyday you get access to a UCLA textbook for future study professionals. So, now we know what they teach the peeps that oversee our health and safety...and what kinds things to look out for when screening, participating, and reading the results of studies as well.
About IRBs: acrpnet.org/2018/04/17/central-irb-vs-institutional-irb-advantages-disadvantages-multicenter-trials/
Commercial IRB's are now taking over Hospital Studies. Is this even ethical? www.statnews.com/2016/07/06/institutional-review-boards-commercial-irbs/
FDA Blah Blah Blah: (aka watered down advice) www.fda.gov/forpatients/clinicaltrials/ucm417961.htm
Know your study's IRB name and contact info in case there's an issue. It is supposed to be included in your informed consent, usually towards the end.Here's what can happen when things go wrong, why, and how (also see Chapter 8 in the above textbook link)
www.abc.net.au/radionational/programs/sciencefriction/the-drug-trial-that-went-wrong...very,-very,-very-wrong/9247388
www.sciencemag.org/news/2017/06/new-clues-why-french-drug-trial-went-horribly-wrong
www.sciencemag.org/news/2017/06/new-clues-why-french-drug-trial-went-horribly-wrong