Download Forms

Pdf-based smart forms are now available below for sending initial reviews, changes in research, promptly reportable information, and study closure information.
 
Please note the following about our smart forms:
  • The smart forms must be completed using either Adobe's free Reader or Adobe Acrobat (version 11 or newer). Use of a program other than Adobe (version 11 or newer) to view or complete the forms will result in missing questions and non-functional fields.  To download Adobe Reader for free, please visit https://get.adobe.com/reader/. (If you do not have access to Adobe's Reader or Acrobat, please contact us to obtain an alternate, Word submission form).   
  • Because these smart forms are dynamic (change based on your responses), they must be completed electronically; therefore, you cannot print them out and complete them on paper. However, at any time during their completion, you can edit, save, print, or share with your colleagues.
  • The forms have been adopted by WIRB, NEIRB, MLIRB, Aspire, and CGIRB. 

 

 
For questions or assistance, please see the WIRB Guide for Researchers available below, call 1-800-562-4789, or email clientservices@wirb.com.
About emergency and expanded access to investigational drugs, biologics, and devices

FDA has set up several methods for patients and their physicians to access investigational drugs, biologics, and devices when patients with life-threatening or serious disease have run out of options. There are four broad categories:


1. Emergency use of drugs and biologics: For situations where treatment cannot wait for IRB Chair concurrence.
2. Emergency use of devices: For situations where treatment cannot wait for IRB Chair concurrence.
3. Compassionate use of drugs and biologics: For situations where treatment can wait for IRB Chair concurrence.
4. Compassionate use of devices: For situations where treatment can wait for IRB Chair concurrence.

It usually takes no more than four days for IRB Chair concurrence. 

Compassionate use is also called Expanded Access or Single Patient Expanded Access.
 
The WCG IRBs do not charge for reviews related to emergency and expanded access to investigational drugs, biologics, and devices.
 
For questions about and requests for emergency use and expanded access for drugs, biologics, devices or to get an emergency IND or IDE, contact FDA at:
  • During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays):
    • Drugs: 301-796-3400 [CDER's Division of Drug Information]
    • Biologics: 800-835-4709 [CBER's Office of Communication, Outreach and Development]
    • Devices: 301-796-7100 [CDRH's Division of Industry and Consumer Education]
  • Nights/Weekends: (866) 300-4374 [Office of Crisis Management & Emergency Operations Center] 
 
Emergency use of drugs and biologics
 
You may use an unapproved drug or biologic without prior FDA authorization or IRB Chair concurrence if:
  • The patient has a life-threatening or severely debilitating situation.
Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do NOT require the condition to be immediately life-threatening or to immediately result in death. Rather, the patients must be in a life-threatening situation requiring intervention before a chair can concur with the use.
 
Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
  •  NO standard acceptable treatment is available.
  • There is insufficient time to obtain IRB approval
  • The unapproved investigational drug or biologic has been authorized by FDA.

For questions about and requests for emergency use and expanded access for drugs, biologics, devices or to get an emergency IND or IDE, contact FDA at:

  • During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays):
    • Drugs: 301-796-3400 [CDER's Division of Drug Information]
    • Biologics: 800-835-4709 [CBER's Office of Communication, Outreach and Development]
    • Devices: 301-796-7100 [CDRH's Division of Industry and Consumer Education]
  • Nights/Weekends: (866) 300-4374 [Office of Crisis Management & Emergency Operations Center] 
  • The treating physician will obtain written informed consent of the patient or the patient’s legally authorized representative (See the IRB’s Web Site for the Template for Informed consent for Emergency and Compassionate Use) or certify in writing that:
    • The patient is confronted by a life-threatening situation necessitating the use of the drug or biologic.
    •  Informed consent CANNOT be obtained from the patient because of an inability to communicate with, or obtain legally effective consent.
    • There is insufficient time to obtain consent from the patient’s LAR.
    •  An alternative method of approved or generally recognized therapy that provides equal or greater likelihood of treating the patient is unavailable.
    • Either:
      • In advance of the treatment, have a physician who is NOT otherwise participating in the treatment certify in writing that findings justifying an exception to informed consent are met.
      • After the treatment, certify that immediate use of the drug or biologic was required to preserve the life of the patient such that there was insufficient time to obtain a determination from an independent physician in advance of using the drug or biologic, and within 5 working days after the treatment, have an independent physician who is NOT otherwise participating in the treatment evaluate the treating physician's determinations justifying NOT obtaining informed consent
You must provide the IRB with a report of the conditions constituting the emergency and documentation of the above findings within 5 working days after the use.
Use “FORM: Emergency Use of a Drug or Biologic (HRP-280)” to submit a report. This form is on the IRB Web Site. Submit your completed report via e-mail (clientservices@wirb.com) or via Connexus®. The “Required Materials” section of this form lists the documents you must submit with your report.
 
 
Emergency use of devices

You may use an unapproved device without prior FDA authorization or IRB Chair concurrence if:

  • The patient has a life-threatening or serious disease or condition that needs immediate treatment, diagnosis, or monitoring.

Life-threatening disease or condition means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life- threatening or to immediately result in death. Rather, the patients must be in a life-threatening situation requiring intervention before obtaining FDA approval.

Serious disease or condition means a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. Serious disease or condition includes sight-threatening and limb-threatening conditions as well as other situations involving risk of irreversible morbidity.

  • NO generally acceptable alternative exists.
  • Because of the immediate need to use the device, there is NO time to use existing procedures to obtain FDA approval for the use.
  • The treating physician has assessed the potential for benefit from the use of the unapproved device, and have substantial reason to believe that benefits will exist.
  • The treating physician will follow as many of the following patient protection procedures as possible:
    • Informed consent from the patient or a legal representative

See the IRB’s Web Site for the Template for Informed consent for Emergency and Compassionate Use - for emergency use of a device, change all references from "drug" to "device".

    • Clearance from the institution as specified by their policies
    • Concurrence of an IRB chair
    • An independent assessment from an uninvolved physician
    • Authorization from the device manufacturer

You must provide the IRB with a report of the conditions constituting the emergency, documentation of the above findings, and the patient protection measures that you followed within 5 working days after the use


Use “FORM: Emergency Use of a Device (HRP-281)” to submit a report. This form is on the IRB Web Site. Submit your completed report via e-mail (clientservices@wirb.com) or via Connexus®. The “Required Materials” section of this form lists the documents you must submit with your report.


If no IDE exists, you must submit a follow-up report on the use of the device (description of device used, details of the case, and the patient protection measures that you followed) to:


Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Ave
Document Control Center
WO66 Rm G-609
Silver Spring, MD 20993

 
Compassionate use of drugs and biologics
 
You may use an unapproved drug or biologic without prior FDA authorization if:
  • The patient has a life-threatening or severely debilitating illness.
Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do NOT require the condition to be immediately life-threatening or to immediately result in death. Rather, the patients must be in a life-threatening situation requiring intervention before a chair can concur with the use.
 
Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
  • NO generally acceptable alternative for the condition exists.
  • The patient cannot obtain the drug under another IND or protocol.
  • The probable risk to the patient from the drug is NOT greater than the probable risk from the disease.
  • FDA has issued an Individual Patient Expanded Access IND authorizing the treating physician to treat this patient.

For questions about and requests for emergency use and expanded access for drugs, biologics, devices or to get an emergency IND or IDE, contact FDA at:

  • During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays):
    • Drugs: 301-796-3400 [CDER's Division of Drug Information]
    • Biologics: 800-835-4709 [CBER's Office of Communication, Outreach and Development]
    • Devices: 301-796-7100 [CDRH's Division of Industry and Consumer Education]
  • Nights/Weekends: (866) 300-4374 [Office of Crisis Management & Emergency Operations Center] 
  • An IRB Chair concurs with the use before the treatment begins. (See below for how to submit a request for IRB Chair concurrence.)
  • The treating physician will obtain informed consent from the patient or legal representative.
 
To request IRB Chair concurrence for compassionate use of a drug or biologic, Completed “FORM: Compassionate Use of a Drug or Biologic (HRP-282)” and submit that form with all required attachments listed in the form to the IRB via e-mail (clientservices@wirb.com) or via Connexus®. The “Required Materials” section of this form lists the documents you must submit with your request.
 
 
Compassionate use of devices
 
You may use an unapproved device without prior FDA authorization if: 
  • The patient has a life threatening or serious disease or condition. 
Life-threatening disease or condition means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the patients must be in a life-threatening situation requiring intervention before obtaining FDA approval.
 
Serious disease or condition means a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. Serious disease or condition includes sight-threatening and limb-threatening conditions as well as other situations involving risk of irreversible morbidity. 
  • NO generally acceptable alternative treatment, diagnostic, or monitoring for the condition exists.
  • The probable risk to the patient from the device is NOT greater than the probable risk from the disease.
  • The treating physician has devised an appropriate schedule for monitoring the patient to detect any possible problems arising from the use of the device, taking into consideration the investigational nature of the device and the specific needs of the patient.
  • If any problems occur as a result of device use, these will be reported to the IRB as soon as possible.
  • The treating physician will obtain informed consent from the patient or legal representative.

If you do not have consent form, see the IRB’s Web Site for the Template for Informed consent for Emergency and Compassionate Use - for compassionate use of a device, change all references from "drug" to "device".

  • The treating physician has obtained clearance from the institution, if any, as required by their policies.
  • FDA has issued an IDE and will approve or has approved the use.

For questions about and requests for emergency use and expanded access for drugs, biologics, devices or to get an emergency IND or IDE, contact FDA at:

  • During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays):
    • Drugs: 301-796-3400 [CDER's Division of Drug Information]
    • Biologics: 800-835-4709 [CBER's Office of Communication, Outreach and Development]
    • Devices: 301-796-7100 [CDRH's Division of Industry and Consumer Education]
  • Nights/Weekends: (866) 300-4374 [Office of Crisis Management & Emergency Operations Center
 
To request IRB Chair concurrence for compassionate use of a device, Completed “FORM: Compassionate Use of a Device (HRP-283)” and submit that form with all required attachments listed in the form to the IRB via e-mail (clientservices@wirb.com) or via Connexus®. The “Required Materials” section of this form lists the documents you must submit with your request.
 
  
 
Additional References