Patients also want to be: Respected for their contributions to science and medical advances. Those contributions include samples from their bodies (biospecimens), information (data), experiences (input), and sometimes their very lives. Protected from harm and misuse of sensitive data about themselves, their family, and/or their culture or ethnicity. As long as we are respected and protected, … Continue reading Patients Want Their Data Shared
Something horrible happened - a clinical trial failed, causing one unexpected death and seriously injuring 5 people. And instead of dealing with a dysfunctional research system, “experts” are spouting off on their own. The few articles written to date focus on the drug (aka the money), not on what people want to know. My Initial Thoughts ClinicalTrialsArena asked … Continue reading A Clinical Trial Failed Patients
Looks like 1,772 of us posted public comments about medical research informed consents to the NPRM docket! I realize this sounds obtuse, but bear with me through this post - please! So, What's the Big Deal? The final regulation will affect millions of patients, researchers, institutions, and companies. These rules last changed in 1991. You know, before the … Continue reading A Plan for Real Research Improvements
I posted "Informed about Changes to Research Consents?" on 11/15/15. You now have until 1/6/2016 at 11:58pm EST to send your comments about the changes that will affect hundreds of thousands of patients, researchers and institutions (at least). PLEASE send in your comments! Here's how: Read my blog post on 11/15/15 to refresh yourself, and feel free … Continue reading Last Chance to Say Your Word on NPRM
Click here for useful tips on making public comments about the changes to informed consent before 12/7/15. EDIT: the public comment period has been extended - post your comments before 1/5/2016. More information in this blog post and at this website.
If not, you'll be surprised soon. The Common Rule is changing - 1st time since 1991. The US NIH NINR says, "The Common Rule contains regulations that protect individuals who participate in research and is followed by 18 federal agencies." Translation: these are the rules that apply to informed consent forms that patients sign to join research studies. Your … Continue reading Informed about Changes to Research Consents?