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Use of an Investigational Drug or Device in a Limited Number of Patients:  When a physician wishes to use a drug or device in an individual patient for whom no other treatment has been efficacious, and which drug or device is under investigation elsewhere and which may offer therapeutic effect to the patient (often called “compassionate” use of investigational drug or device), the investigation-sponsoring agency may require IRB expedited approval to use the agent in an individual patient not recruited into the research project.   The local physician seeking this approval should submit IRB Form C-01, “Request for ‘Compassionate’ Use of Investigational Drug or Device in Limited Number of Patients.”  The IRB Chair will act on this request.

Emergency Use of a Non-Approved Drug or Device:  Federal regulations require that the treating physician who uses an investigational drug or device in an emergency situation which is not part of an approved research project shall provide a report of such use to the appropriate IRB within five working days.  The procedure for such emergency use and rules for reporting are in the Appendix.

But note:  Federal regulations do not permit research activities to be started, even in an emergency, without prior IRB review and approval (45 CFR 46.103(b) and 46.116(f).  When emergency medical care is initiated without prior IRB review and approval, the patient may not be considered a research subject.  Such emergency care may not be claimed as research, nor may any data regarding such care be included in any report of a prospectively conceived research activity.

IRB Reports:  In all cases the IRB will report its findings and actions to the appropriate investigator(s) by letter, memorandum (using electronic means where possible and appropriate), or the return of one of the IRB’s forms.  Copies of such notifications will be kept in the files with the relevant protocols, and these files will be updated accordingly.

The Medical Director of the Heart and Vascular Center, acting as the Human Protections Administrator, is responsible for oversight of the IRB activities and for reporting findings and actions to senior Health System Administration and Governing Board when appropriate, as well as for reporting findings and actions to OHRP and other Federal offices as necessary.

An Annual Report is prepared for the IRB, which summarizes the year’s activity including the number of new protocols reviewed, the number of expedited and other reviews, the number of renewals, and other relevant information.

The Cone Health IRB will be the IRB of record for any clinical research that involves Cone Health employees and or patients who are recruited, enrolled or treated at Cone Heath as an in-patient or outpatient."

"Waiver of Authority to a Central IRB:

Clinical research that involves subjects who are recruited, enrolled or treated exclusively as an outpatient in a physician’s private practice will not be subject to review by the Cone Health IRB.  Investigators involved in clinical research of this nature may chose to use an independent IRB instead of the Cone Health IRB; however the investigator may request the Cone Health IRB be the IRB of record for clinical research involving their own outpatients and we will accommodate that request.

In the event that an Independent IRB requests documentation from the Cone Health IRB affirming willingness to relinquish IRB review from the local level to the independent IRB, the Cone Health IRB Chair, (or the Co-Chair in the absence of the Chair), has the authority to sign any document waiving review authority to an independent IRB. 

Although investigators who enroll subjects in the outpatient setting may choose to use an independent IRB, it is strongly encouraged that Cone Health IRB review any studies that will involve patients who may be admitted to Cone Health during the course of the research study.