New RAMSeS Enhancement rolled out 06/22/2018
In the RAMSeS IPF, four questions have been added to the Human Subjects section of the Research Subjects screen that are required if the project involves Human Subjects research.
The four YES / No questions are 鈥�
- Does the research include 鈥渉uman subjects research鈥� as defined by federal regulations, including exempt research where data is identifiable?
- Does the research involve the collection or use of biospecimens that are individually identifiable or for which there is at least a very small risk that there is some way to deduce the identity of an individual?
- Does the research generate individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is 鈥渋dentifiable鈥� per the Common Rule?
- Does the research involve information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that the subject鈥檚 identity could be deduced?
On funded proposals involving Human Subjects research whose sponsor/prime sponsor is the National Institutes of Health (NIH), a new Certificate of Confidentiality (CoC) notification email will be sent to the
- Lead PI
- departmental PS Project ID Managers
- IPF Owner
- Primary Award Contact (designated via the proposal’s General Info screen)
- Sponsored Projects Specialist
- Office of Human Research Ethics (OHRE)
This notification email is informational only and will outline that a CoC will be issued automatically for any NIH-funded project using identifiable, sensitive information that was ongoing on or after December 13, 2016. The CoC is now issued as a term and condition of the award per the recent NIH Certificate of Confidentiality policy update.