We recently received word from NIH about policy changes that people who conducted NIH-funded human subject research, or who seek to apply for NIH support for such research, need to know about it. The correspondence is below. Please contact the Office of Research and Sponsored Programs for more information about these changes. If you are […]
Two sure-fire — and avoidable — contingencies
Since we all – research teams and IRB alike – like to see research proposals get approved quickly, we thought we’d point out a couple of issues we’ve been seeing a lot of lately that will get you a contingency. — Incorrectly stacked documents. If your clean and tracked-changes copies of documents are not stacked correctly, […]
Lessons from the Tuskegee study still felt today
The news about the Tuskegee study became public 45 years ago this summer. The federally funded study, which involved leaving syphilis untreated in African-American men for decades to follow its course, even after effective treatment became available, is one of the seminal events leading to the development of human subject protection regulations, policy, and best […]
At long last — Draft FDA guidance on Part 11 compliance
The Food and Drug Administration, continuing its long tradition of issuing timely guidance, has issued a draft guidance about 21 CFR Part 11 – the regulation pertaining to the use of electronic records and electronic signatures in clinical investigations. A summary of the draft guidance is available here. The comment about “timely guidance” should be […]
What kind of enticement will prompt people to relinquish privacy?
In IRB-land, we use a variation of what might be called “Notice and Choice” regarding subjects’ allowing access to their private information. We tell people up front what their private information might be used for, including in the future as well as for the current project, and then give them the choice to opt in […]
Two simple fixes that will get things through the IRB faster
We at the IRB really hate to have to send submissions back due to minor little slip-ups, but we’ve been seeing a few little problems crop up lately. Since we’re a little short-staffed, we don’t really have time to sort through submissions that need some minor fixes to get them ready to review, so we’ve […]
Overcoming barriers to clinical trial enrollment
In a perfect world, clinical trial participant populations would perfectly reflect the population from which they’re drawn. Those of us living in the real world, however, know that attracting and retaining a truly representative can be difficult. Different populations face different barriers to joining clinical trials, and UAMS and ACH researchers encounter people of a […]
We’re not the only ones wondering about new informed consent regulations
As noted in a recent IRB Research News and Tips blog item, the revised Common Rule will require some changes to the current way we present and document key elements of informed consent information. We have yet to hear specifics about how those new requirements, slated to take effect in January 2018, are to be […]
We’re still thinking about informed consent processes and forms here
As we gear up for the implementation of the revised Common Rule, slated for January 2018, we’re still thinking about ways to make the informed consent process more meaningful for and understandable to potential subjects. The revised rule includes a requirement that the informed consent “begin with a concise and focused presentation of the key […]
Closure form enrollment tips
We’ve noticed a few trends on reporting enrollment on study closure forms that we’re hoping to nip in the bud: – When listing the total number of people who enrolled in your study, please be sure to include everybody who signed a consent form, even if they failed screening or didn’t actually participate in the […]