When new participants are recruited by current participants to become part of a study sample, it is called “snowball sampling.” This is a non-probability sampling technique that can be a practical way to identify and recruit individuals with certain characteristics to...
On October 8, 2020, Office for Human Research Protections (OHRP), on behalf of the Department of Health and Human Services (DHHS), issued an exception determination as permitted by 45 CFR 46.114(b)(2)(ii) stating that certain categories of cooperative research...
The 21st Century Cures Act mandated that the Department of Health and Human Services (“DHHS”) “revise the DHHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules to reduce regulatory duplication and unnecessary delays;...
This happens quite often: a researcher would like to apply to a funding agency for a grant to perform a human subjects research study before they can finalize the study methods. But, the agency needs proof of IRB approval as part of the grant application. Can a...
In Vitro Diagnostics (IVDs) are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, to cure, mitigate, treat, or prevent disease. Such products are intended for use in...
