Information for Researchers | Human Subject Research Office | University of Miami

The eProst System (IRB8) is now an archived read-only site.

The new IRB10 System is now part of the IBISResearch suite, click here to login: https://ibis-research.miami.edu/IRB

For more information on the new system, including FAQs, please visit the IRB10 Project webpage

Before opening a submission, be sure that the correct Forms & Templates are used.  Answer the questions and click Continue to save your information.  When you reach the end, click the Finish button. 

Revising Research Documents

• Save the last changes of the revised documents before you add any new changes. This allows only new changes appear as “tracked.”
  
  
• It is unnecessary to provide a clean version of the revised documents AND a word track changes version.
  
  
• For pdf protocols, please save the clean final version under the Protocol section using the update button to replace the old version and add a tracked changes version to the Other attachments section.
  
  
• For updated Drug/Device documents, please upload the clean final version to the Drug/Device section and add a tracked changes version and summary of changes document to the Other attachments section.

• Your study may require specilized review by an Ancillary Committee which is conducted in parallel with the IRB review. You will need to contact the committee assigned to your study and submit the research to that Committee according to the Committee’s requirements.
  
  
• If your study is cancer related, please submit all study related materials to the PRMC via the PRMC Electronic Submission (PES) Form at PES https://bbcapps.ad.med.miami.edu:8443/PES/login.htm
  
  
• Principal Investigators are required ensure that all study team members hold current CITI certification
  
  
• All team members must complete the Disclosure process

1. Log in to IBISResearch
   
2. Navigate to an approved submission (see Follow-On Submissions tab on the protocol landing page).
   
3. Click the Follow-on Submissions tab and click the “Correspondence Letter” link to see any/all Modification or Continuing Review letters.  To view a letter, click on any Correspondence link and to save a letter, right-click and select ‘Save Link As.’
   
   

1. Log in to IBISResearch
   
2. Navigate to an approved study
   
3. Click the Documents tab on the main study workspace.
   
4. Click on the appropriate document link to view the version you’re looking for. To save a document, right-click and select ‘Save Link As.’

The regulations allow clinicians to use an unapproved drug, biologic or device without prior IRB approval in limited circumstances; however, the clinician must comply with FDA requirements in these situations. 

When seeking to use an unapproved product, it is critical that the patient and his/her licensed physician consider all possible risks because the FDA has not determined whether the products are safe. Such products may, or may not, be effective in the treatment of the condition.

“Emergency Use” is a provision of the FDA regulations that allows a physician to use an investigational product in a life-threatening emergency when there isn’t sufficient time to obtain IRB review and approval. 

When seeking to use an unapproved product, it is critical that the patient and his/her licensed physician consider all possible risks because the FDA has not determined whether the products are safe. Such products may, or may not, be effective in the treatment of the condition. See more details at: https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians

Check to see if the regulatory criteria for use of the investigational product without IRB approval are met by reviewing  Worksheet Emergency Use (HRP-322).

When its decided that the investigational product is the best option for the patient in an emergency, physicians must complete the following steps.

• Contact the sponsor and obtain authorization 
  
• Contact the FDA to obtain approval. 
  • For an investigational drug or biologic call (888) 463-6332 or email druginfor@fda.hhs.gov
  • For an investigational device call (301) 796-7100 or email dice@fda.hhs.gov.
    
    

• When time permits, submit the following to IRB via email to an HSRO analyst or directly to an IRB chair to discuss the use.
  • Patient’s current disease or condition - including the justification of the use
  • Treatment plan/protocol
  • Sponsor’s authorization
  • Consent template (HRP-502) -hrp-502h---template-consent-document--expanded_access.docx
  • eIND (if the use involves investigational drug)- FDA email approval
  • IB or device manual/information   
    

• If the patient is not able to provide informed consent due to incapacity and there is insufficient time to obtain consent from a legally authorized representative, see the "Exception from the Requirement for Informed Consent for Emergency Use" in the next tab.   
  
  
• You must submit the completed Emergency Use Report Form (post-use) within 5 days using the electronic Report of New Information Smart Form (RNI)*. Details can be found in chapter 11.1 in the Investigator Manual.
  
  Regulations require that you submit this report even when you discussed the use of the investigational product with the sponsor and IRB Chair. If you fail to submit the report within five days, you will be restricted from submitting new Human Research until the IRB receives this report and your action plan to ensure you submit timely emergency use reports in the future.
  
  For Jackson Health System: In addition to the above information, JHS needs the below which can be sent to JHS-CTO-Submissions@jhsmiami.org
  1. IRB Acknowledgment (if applicable)
  2. Date of administration/Location of the patient
  3. Will drug be provided free to the patient and JHS?
  4. Are any deliverables being requested from the manufacturer?
  5. If there is a need for a JHS HIPAA authorization contact JHS-CTO-Submissions@jhsmiami.org
  6. Once patient has consented send the Consent to ClinicalTrialsOffice@jhsmiami.org

  Note, once JHS ORA receives information, the case will be escalated to the CMO and CFO of the facility where the patient will be treated.

  
  
• Finally, according to the FDA, the emergency use provision can be used only once.  If there is any possibility that you will need to use the same investigational product with the same patient or with a different patient, you must submit a protocol to the IRB and obtain an IND or IDE from the FDA.  The FDA regulations have provisions for expanded access use through a treatment protocol.  See FDA Guidance on Expanded Access for additional information. 

The FDA regulations allow the use of an investigational product without informed consent when the investigator and a physician who is not involved in the study, both certify the following in writing: 

1. The human subject is confronted by a life-threatening situation necessitating the use of the test article;
2. Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from the subject;
3. Time is not sufficient to obtain consent from the subject's legal representative; and
4. There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

If the investigator is not able to obtain the second opinion due to time constraints and the above requirements are met, the investigator must:

1. Make and document the required determinations above;
2. Have a physician who is not part of the research review and evaluate the documentation;
3. Have the physician sign the document indicating his/her concurrence;
4. Submit the document to the IRB by completing an electronic Report of New Information SmartForm through IBIS within five business days.
5. If the Investigational product is a device, the investigator must submit a report of the use of the product without informed consent to the sponsor within five business days.

Under FDA regulations (21 CFR § 312.300), expanded access (often referred to as “treatment use” or “compassionate use”) is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device). This access is for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy options are available. Even though expanded access is not a clinical investigation, FDA submission and IRB review are required.

The IRB will require an eProst submission for initial review. This submission must include at least:

• Protocol
• If the investigational product will be used in only one patient, the IRB will need redacted information demonstrating the patient’s need for the product.
• TEMPLATE CONSENT DOCUMENT – Expanded Access (HRP 502h) revised to indicate the use is for non-emergency treatment use
• Information about the investigational product such as an investigator brochure

If the need for the investigational product is urgent, the IRB will forego the requirement for a formal protocol but will require sufficient information to make the determinations required under 21 CFR § 56.111. In these instances, the IRB will require:

• Information about the efficacy and risks of the investigational product
• Information about the patient’s condition supporting a finding that the patient has a condition for which no other comparable treatment or therapy is available
• FDA approval of use of the investigational product for that patient (IND or IDE)
• The procedures the physician will follow when using the investigational product, including the procedures to monitor patient safety during and after use of the investigational product.

The “Right to Try Act” (H.R.878 - Right to Try Act of 2017) allows investigational drugs, biological products or devices without FDA approval under the following conditions:

• To be eligible for “Right to Try,” the patient must:
  • Be diagnosed with a life-threatening disease or condition;
  • Have exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying);
  • The subject or their LAR must provide written informed consent for use of the investigational drug;
• The investigational drug or biologic must meet the following criteria:
  • A Phase 1 clinical trial must have been completed;
  • The drug/biologic/device must not have been approved FDA approved for any use;
  • One of the following must be met:
    • An application has been filed with the FDA;
    • The drug/biologic is undergoing a clinical trial subject to an IND that is intended to provide data to support FDA;
  • Clinical trials are ongoing and have not been discontinued or placed on hold by the FDA. 

UM strongly encourages the use of the expanded use pathway initiated by the FDA (described above) instead of Right to Try. Therefore, physicians should gently inform patients who invoke the Right to Try Act of the following:

• The Act does not require institutions to accede to requests for unapproved drugs
• UM follows Federal research regulations, and
• Efforts to obtain unapproved drugs should be made to the FDA under its emergency use expanded access program.