Information

It is the responsibility of the sponsor to follow their institution’s guidelines and abide by federal, state and local laws.  When filing IND or IDE, please submit FDA approval letter to IRBCo.  It is the sponsors’ responsibility to determine the needs of data safety using data safety monitoring boards, data monitoring committees or safety monitoring committees.  Sponsors are expected to submit findings of the data safety monitoring boards or committees to IRB Co, especially if it may affect research subjects’ safety.

Sponsors are expected to maintain safeguards to maintain research subjects’ privacy and confidentiality as outlined in HIPAA (http://www.hhs.gov/ocr/hipaa/).

Electronic Submission

IRB Co is using a state of the art 100% web based solution for IRB submissions, tracking and communication.  This system reduces errors and time while enhancing communication between IRB staff, Reviewers and Investigators.  If you have any questions about our protocol submission system, please feel free to contact us by phone or email.