VI. ALTERNATIVE REVIEW TYPES
6.1 Collaborative Research Projects
When research is part of a collaborative program, the IRB may agree to establish a joint review process or may agree to rely upon the review of another qualified Institutional Review Board. Documentation of a collaborative agreement will be kept in the IRB files.
6.2 Investigational New Drug (IND)
Researches involving Investigational New Drugs (IND) require IRB approval. IND research does not qualify for expedited review. The Principal Investigator is responsible for submitting a consent form that identifies the drug (s) as "experimental". Investigators or their study sponsors must have an IND application on file with the FDA and have received an IND number. FDA IND applications may be obtained from the FDA. Copies of the forms are also available from the IRB coordinator.
Investigators proposing to conduct IND research must specify on the "Request for Project Review Form" the drug name, IND number, and specify the sponsor company name. It is recommended that the investigator submit the investigators' brochure or clinical protocol provided by the sponsor as part of the original submission material.
6.3 Investigational Device Exemption
Research studies involving Investigational Device Exemption (IDE) require IRB approval. IDE research does not qualify for expedited review. The Principal Investigator is responsible for submitting a consent form that identifies the device (s) as "experimental". Investigators or their study sponsors must have an IDE application on file with the FDA and have received an IDE number. FDA IDE applications may be obtained from the FDA. Copies of the forms are also available from the IRB coordinator.
Investigators proposing to conduct IDE research must specify on the "Request for Project Review Form" the drug name, IDE number, and specify the sponsor company name. It is recommended that the investigator submit the investigators' brochure or clinical protocol provided by the sponsor as part of the original submission material.
6.4 Emergency or Humanitarian Use of An Investigative Drug, Technique or Device
In all cases involving the use of an investigative drug, technique, or device in emergency situations or isolated humanitarian patient care cases, the IRB's policy is:
6.4.1. Application
The attending physician shall make a written request for the emergency use of an investigational drug, technique or device or for isolated humanitarian patient care to his/her department chair. The request shall 1) name and describe the investigational drug, technique, or device proposed; 2) a copy of the research protocol shall certify that the case is an emergency situation or isolated humanitarian patient care case; and 3) specify the reason why the proposed investigative care is recommended.
6.4.2. Approvals
The department chair or in his/her absence, the designee, shall at his/her discretion approve the proposed investigative care if the potential risks are outweighed by the potential benefits to the patients. The attending physician shall document in the patient's medical record that the approval was obtained.
6.4.3. Notice to the IRB
Within twenty-for (24) hours of giving approval for the investigative use of a drug, technique, or device, the department chair or designee, shall notify the IRB chair in writing of the permission granted and attach all documents concerning the investigative care. The Chair shall send the attending physician a statement that any subsequent use of the investigative care at SHS will require prior approval from the Board under the "Full Review" protocols.
6.4.4 Emergency Use
In emergency cases where, in the opinion of the attending physician, time will not allow for such reporting and approval process, the attending physician shall notify in writing within five (5) working days to the department chair and IRB chair of the investigative care utilized. A statement of that describes the results of the investigative care utilized shall be forwarded to the IRB Chair.
6.4.5. No Research Use
Any individual treated under these Emergency provisions and without prior IRB approval, may not be considered as a research subject. The outcome or data of the patient may not be included in any report of research activities. (21 CFR 312.34)
6.4.6. FDA Follow-up
The IRB Chair with the assistance of the IRB coordinator will ensure that the sponsor and SHS entity files the appropriate IND documentation with the FDA.
