Investigators

When a protocol, amendment, or continuing review is approved, investigators will receive an email notification. A rich text version of the approval is included as an attachment so that investigators can generate an approval document.

Sponsors

Many sponsors will accept a copy of the rich text notice sent to the investigator by the IRB.

If a sponsor requires notification of approval in the form of a signed letter, the investigator should contact IRB staff, providing the name and address of the individual who requested the notification.

A letter will be prepared and forwarded according to the sponsor's specifications. Typically, the notification is both faxed and mailed.

If the sponsor is the one of the National Institutes of Health investigators may also be asked to certify that all key personnel have received training in the conduct of research with human subjects.

At this time, Duke investigators must be certified to conduct research with human subjects. The Duke certification requirement is used to meet the NIH education requirement. IRB staff will prepare a letter describing the process to be forwarded to NIH. Investigators simply need to provide the IRB staff with the name and address of the program officer requesting confirmation that key personnel have been educated.