One noticeable new aspect of the Revised Common Rule is the requirement to include a “concise and focused” presentation of key information that would help a subject decide whether or not to join a study in the consent process. Although guidance as to what form this summary should take is only trickling out, we have […]

The Revised Common Rule (RCR), slated to be implemented Jan. 19, 2019, will be here before you know it. IRB staff recently gave a talk on the (RCR) changes most likely to affect research teams. For those who couldn’t attend, the talk was recorded, and will be rebroadcast in a webinar format at the following […]

Continuing review forms include a query asking you to summarize study progress in a free-text response. Please use this space to provide a complete summary of the study’s status, including describing how many subjects have completed the study, what part of the study any that haven’t completed yet are in, whether any notable positive or negative issues […]

If you couldn’t make it to the IRB’s October 30th talk about the changes coming with the Revised Common Rule, here are a few ways to catch up on what you missed. Feeling sociable? Attend one of the upcoming webinar replays: There will be two showings on Friday Nov. 9, Cancer Institute 10th floor, Room […]

We’d tell you exactly how many days there between now and Thanksgiving, but knowing the exact figure might throw us into a panic. So we’ll just stick with the facts – the holiday season is just about upon us, which means feasts, presents, parties, and keeping any pressing research deadlines in mind. Both Christmas and New […]

Questions about the findings of earlier research (from the New York Times) have led to the pause of an NIH-funded trial testing stem cell therapy in heart failure patients, the Washington Post reported Oct. 29. These reports are significant for several reasons. As the Post’s article notes, subject safety is of primary importance, and a research […]

Can’t wait until the IRB’s Oct. 30th presentation to get familiar with the Revised Common Rule, slated to take effect in January? An online 10-module course on the Revised Common Rule is now available through citiprogram.org. Even better – you can earn Certified Research Specialist credit for successfully completing it. The exact credit amount is […]

While we worry about things such as how biological samples and paper data collection sheets are labeled, the world of genetic accessibility marches on. Recent articles in The New York Times and the journal Science point out that publicly available genealogy databases now allow the identification of about 60 percent of Americans of Northern European […]

The Revised Common Rule will bring some largely welcome changes to the Exempt categories of research. In general, the language changes expand the type of research to which exempt status review will apply. As a reminder, “exempt” does not mean the same thing in research-land as it does in real life. An “exempt” study is […]

The Revised Common Rule (RCR), slated to go into effect Jan. 21, 2019, will bring some changes* to informed consent requirements. And that asterisk by “changes” is intentional, as the federal Office for Human Research Protections (OHRP) has said that it may issue guidance regarding some RCR consent requirements. Well, here we are, a mere […]