Exemption from Informed Consent

[briangow]

Researchers using MIMIC can be asked to provide proof from an IRB that the data is exempt from informed consent. We should add information that indicates this to the website.

@lceli suggested that this statement would be helpful:

MIMIC is de-identified, and the institutional review boards of the Massachusetts Institute of Technology (Protocol No. 0403000206) and Beth Israel Deaconess Medical Center ( Protocol No. 2001-P-001699/14) both approved the use of the database for research.

@rgmark provides this statement from the IRB approval:

This research study is approved for continuation for a period of up to one year, ongoing collections. The protocol is approved under expedited category 5 with a waiver of informed consent and authorization. The research staffing form is dated 01/07/2022.

We need to decide exactly what to put on the website and where, @tompollard , @alistairewj , @SichengH .

[alistairewj]

I think including a date is too much and will become obsolete soon.

I would suggest the following:

The creation of the deidentified database was approved by the Massachusetts Institute of Technology (Protocol No. 0403000206) and the institutional review boards of the Beth Israel Deaconess Medical Center (Protocol No. 2001-P-001699/14).

This is specific, as it is the creation of the database that requires IRB approval. Once deidentified, the dataset can be used for research without IRB oversight, as it does not constitute human subject research.