Research

Thirteen women on being driven from the workforce.

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Woman alleges one of the posts was about her criticizing a murderer...

'''Viral Video Proves The FBI Are Unconstitutionally Spying On And Harassing Social Media Users'''Two videos have gone viral on Twitter X showing FBI agents visiting people’s houses to ask questions about offensive social media posts.The first clip shows three people who claim to be FBI agents visiting a woman called Rolla Abdeljawad at her home in Stillwater, Oklahoma. The woman asks them to identify themselves, but they refuse to do so while being filmed, before claiming they had already shown the woman their IDs."Wow. The FBI reportedly sent agents to a woman’s house in Stillwater, Oklahoma to question her over her political beliefs that she posted on Facebook. Unless these guys are impersonating federal agents, this is a very serious red line they’ve crossed."— Robby Starbuck (@robbystarbuck) March 29, 2024“What we’d like to do is have a conversation with you about some social media posts that you’ve made, would you be willing to talk to us about that?” asks one of the agents. The woman refuses to talk until she has a lawyer present, before the agent asks her for contact information. “No, I’ll get back to you,” states Abdeljawad. Another agent then asks the woman to have her attorney “contact the FBI office in Oklahoma City.” Abdeljawad is told by one of the agents that '''“Facebook gave us a couple of screenshots of your accounts.”'''“Well you can’t arrest me for freedom of speech, we live in America, so it’s kind of weird that you want to come talk to me about me exercising my freedom of speech,” responds the woman. “We do this every day, all day long we talk to people, it’s just an effort to keep everybody safe, make sure that nobody has any ill will or bad intent or anything like that,” responds one of the agents.“Just verified with local law enforcement that, the indivs who came to my home, really were FBI per their license plate. My lawyer will contact the OKC field office. The lawyer did inform me that, these instances are now common but, the lawyer doesn’t believe that FB sent them the screenshots of my posts. Rather, it seems like a fishing expedition. I do not fear them. My only concern as, I told the cop is that, someone in my state will do something or that they would and then use my posts in a malicious attempt to “smear” me. Just *remember, I am a Muslim, an obligated protector of creation. I enjoin what is good and forbid what is wrong.”Another X user called Kam St. Martin posted, “the FBI came to my house over a TWEET! Not cool. My pinned tweet that’s still up.”https://www.zerohedge.com/political/viral-videos-appear-show-fbi-agents-visiting-homes-over-social-media-posts

The rule allows an IRB responsible for review/approval/continuing review of clinical investigations to approve an informed consent procedure that does not include/alters certain informed consent elements, or to waive the informed consent requirement for certain minimal risk clinical investigations.

In certain cases, federal regulations allow the IRB to waive the requirement to obtain any informed consent. Most complete waivers of consent involve studies in which there are minimal risks to subjects, but complete waivers are also possible in emergency care and other limited circumstances.

Official websites use .gov A .gov website belongs to an official government organization in the United States.

Guidance on when consent is not required or elements of consent can be waived.

Describes when it may be appropriate for a U-M IRB to approve a waiver to document informed consent or a waiver of informed consent for human subjects research.

On December 21, 2023, the U.S. Food and Drug Administration (“FDA”) published a final rule to allow institutional review boards (“IRBs”) to waive or alter informed consent for certain clinical investigations that pose no more than minimal risk to human subjects and include appropriate safeguards to protect the rights, safety, and welfare of human subjects (the “Final Rule”).1 The Final Rule follows a proposed rule issued in November 2018,2 which we discussed in a previous Alert. It is one of several steps that FDA has taken to harmonize its requirements with those of the “Federal Policy for the Protection of Human Subjects,” known as the “Common Rule,”3 as required under the 21st Century Cures Act (the “Cures Act”) enacted in 2016.4 Other steps FDA has taken include publication of two proposed rules in September 2022 to harmonize FDA regulations pertaining to human subjects research and review of cooperative research by a single IRB with the Common Rule,5 which we discussed in an earlier Alert. To complete the harmonization process, which the Cures Act had required FDA to complete by December 13, 2019, FDA must still finalize these proposed rules. Additionally, FDA has said that it is also considering how certain other provisions in the Common Rule that are potentially relevant for FDA-regulated research, such as provisions on the posting of informed consent forms, broad consent, limited IRB review, exempt research, and public health surveillance activities, could be applied to FDA-regulated research.6

Northern Kentucky University, a growing metropolitan university on a thriving suburban campus near Cincinnati.

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued a new guidance document on informed consent (the “Final Guidance”).1 This guidance finalizes the draft “Informed Consent Information Sheet” from 2014 (the “Draft Guidance”) and supersedes FDA’s guidance from 1998, “A Guide to Informed Consent.”2 FDA’s issuance of the Final Guidance follows FDA’s continuing efforts in recent years to modernize and streamline the clinical trial enterprise.