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About single-patient expanded access:  
On June 2, 2016, FDA released three documents regarding expanded access - a guidance document titled "Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers," a guidance document titled "Charging for Investigational Drugs Under an IND — Questions and Answers," and a final version of the FDA form 3926 Individual Patient Expanded Access Investigational New Drug Application (IND).  

For more information on expanded access go to:
http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

Submission requirements:  
In order to request review for a single-patient expanded access, provide the following information:
•	This form with all questions answered
•	Completed FDA form 3926 Individual Patient Expanded Access Investigational New Drug Application (IND)
•	Consent Form, if available. For your convenience, a single patient consent form template is available from WIRB. Use it to write your own and submit to WIRB for review. 
•	Documentation of FDA IND Number, if available 
•	IB (or reference to existing information) or supporting literature 
•	CV for the treating physician (if a current one is not already on file with WIRB)
•	Medical License for the treating physician (showing the expiration date) (if a current one is not already on file with WIRB).

You will not be billed for this review.

If you have any questions, or if we can be of further assistance, please contact us.  If, after submitting the requested information, the patient’s condition changes such that he/she no longer needs approval of the single patient expanded access request, please notify us at your earliest opportunity.

Instructions for completing this form: 
 
•	WIRB does not accept handwritten versions of this form.  You must submit a typed version to prevent errors and delays due to legibility problems. 
•	All questions must be answered.  “N/A” is only an option where indicated. 
•	If the contact information provided in this form changes, please provide the updated information to us. 
•	The information provided in this submission form (addresses, phone numbers, contact names, , etc.) will be used to produce your final regulatory documents and consent forms.  Please note that your review may be delayed if we need to obtain clarification from you because information listed below differs from the information listed in the additional submitted documents.  
•	Please check the WIRB web site to ensure you are completing the most current version of this form – form may be updated at any time. 

1.		Patient’s Initials: 	
	
2.		Name of the entity that will supply the drug (generally the manufacturer):  	
	
3.		Is the patient scheduled to receive the investigational drug? 
 Yes       No

If yes, provide a date:      

Note: WIRB cannot provide a review sooner than 3 business days from receipt of a completed request for review. If the patient needs treatment in the next four business days, please consider the applicability of emergency use to your situation. Please see the separate form (www.wirb.com/Documents/Emergency Use Post Report Form) for reporting Emergency Use submissions within five days of the use. 
	
4.		Has another IRB reviewed this treatment at this site and decided to table, defer, disapprove, suspend, terminate, or decline to approve it?
 Yes       No     If yes, attach a detailed explanation of the previous review(s) by other IRB(s)

Is IRB oversight being transferred to this IRB from another IRB?
 Yes       No     If yes, attach a completed "IRB Transfer" form available on the IRB Web Site along with copies of consent forms approved by the previous IRB
	
5.		Name and mailing address of treating physician:

Prefix 	
First	
Middle	
Last	
Suffix	

     	
     	
     	
     	
     	

Phone	
Degrees	
Email	

     	
     	
     	

Company	

     	

Address Line 1	

     	

Address Line 2	

     	

City	
State	
Postal Code	

     	
     	
     	

	

6.		Name and mailing address of entity supplying the drug:

Prefix 	
First	
Middle	
Last	
Suffix	

     	
     	
     	
     	
     	

Phone	
Degrees	
Email	

     	
     	
     	

Company	

     	

Address Line 1	

     	

Address Line 2	

     	

City	
State	
Postal Code	

     	
     	
     	

	
7.		Is there a coordinator or other designated contact other than the treating physician? 
 Yes       No

If yes, name and mailing address of coordinator or other designated contact:

Prefix 	
First	
Middle	
Last	
Suffix	

     	
     	
     	
     	
     	

Phone	
Degrees	
Email	

     	
     	
     	

Company	

     	

Address Line 1	

     	

Address Line 2	

     	

City	
State	
Postal Code	

     	
     	
     	

 Copy this person on all correspondence
 Send continuing review progress report forms to this person
	
8.		Licensing Information:  Please fill in the information requested below and attach legible copies of all pertinent current licenses and registrations (if not on file at WIRB).  If necessary, please enlarge the copy of the license for legibility.

Medical or Professional License #:      

State/province:      
	
9.		Has the physician or any other personnel who will be involved in this treatment ever been issued any
of the following:
•	At any time in the past:
o	Conviction of a crime
o	FDA Warning Letter
o	NIDPOE (Noticed of Initiation of Disqualification Proceedings and Opportunity to Explain)
o	Suspension or termination by an IRB
o	Suspension by a federal or governmental agency (such as FDA, HHS, or Health Canada)
o	OHRP Determination Letter, Health Canada Inspection Letter or similar
•	Within the past five years:
o	Form FDA 483

 Yes       No

If yes, attach details about the specific issue, the approximate start date of the occurrence,  the individual involved and the role of this individual in the treatment, unless already on file with WIRB.
	
10.		Has the physician or any other personnel who will be involved in this treatment ever had any of the
following denied, revoked, suspended, reduced, limited, placed on probation, not renewed, relinquished,
sanctioned, fined, or subject to disciplinary action?
•	Clinical privileges at any site
•	DEA licensure
•	Fellowship/board certification
•	Medical licensure in any state, nation, or province
•	Membership on any hospital staff
•	Prescribing privileges
•	Professional sanctions including fines and public reprimands
•	Professional society membership
•	Research privileges at any site

 Yes       No

If yes, attach details about the specific issue, the approximate start date of the occurrence,  the individual involved and the role of this individual in the treatment, unless already on file with WIRB.
	
11.		Is there any action or investigation currently pending before any court of law, federal agency, or state licensing board concerning the professional conduct of the physician, or any other personnel who will be involved in this treatment in that individual's capacity as a research investigator or as a clinician?

 Yes       No

If yes, attach details about the specific issue, the approximate start date of the occurrence the individual involved and the role of this individual in the treatment, unless already on file with WIRB.
	
12.		Does the treating physician, the treating physician’s immediate family, or any other personnel involved in this treatment or their immediate families, have any of the following financial interests in an entity that is providing the drug?
•	Any remuneration from the entity in the previous twelve months that exceeds $5,000, when aggregated for the individual and their immediate family. (Remuneration includes salary and any payment for services not otherwise identified as salary, such as consulting fees, honoraria, or paid authorship)
•	Any equity interest in the entity. (Equity interest includes any stock, stock option, or other ownership interest)
•	Any intellectual property rights and interests (e.g., patents, copyrights)
•	Any governance or executive relationship with the entity (e.g., board of director, CEO)

 Yes       No

If yes, attach details about the specific interest, the amount of the interest, the name of the individual, and the role of this individual in the treatment, unless already on file with WIRB.
	
13.		Is the patient: (Select all that apply)

 An adult unable to consent (complete question 14 below)
 A child
 Pregnant
 A prisoner
 None of the above
	
14.		How will the staff verify who constitutes a legally authorized representative (LAR) in the state in which the procedures are conducted? (Select all that apply)

 Legal counsel  
 State law reference material
 State law codes and statutes 
 Other, describe: 	

Describe how the capacity of a cognitively impaired patient will be determined.

15.		Will translated documents be used? (Consent documents must be translated into a language understandable by
the person providing consent and translated documents must be IRB approved before use)

 Yes       No

If yes, Submit a completed "Translation Request" form available on the IRB Web Site.
	
16.		Will the treatment team do all of the following?
•	Give the person providing informed consent as much time as they need to make a decision.
•	If the person providing informed consent needs more time than is allowed by the treatment design, not enroll the prospective patient.
•	Evaluate whether the person providing informed consent is experiencing time pressure to make a decision, and if so, do not enroll the prospective patient, even if the person providing informed consent agrees to be in the treatment.
•	Ensure there is no threat of harm or adverse consequences to the prospective patient for a decision to not take part in the treatment.
•	Stop the informed consent process once the person providing consent indicates that he or she does not want to take part in the treatment.
•	Evaluate whether the person providing informed consent is being coerced or unduly influenced by others to take part in the treatment, and if so, not enroll the prospective patient, even if the person providing informed consent agrees to be in the treatment.
•	Communicate in the preferred language of the person providing informed consent.
•	Adapt the presentation of the information to the patient’s capacities in terms of intelligence, rationality, maturity and language.
•	Invite and answer questions from the person providing informed consent.
•	Evaluate whether the person providing informed consent understands the information provided, and not enroll a prospective patient who does not understand, even if that person providing informed consent agrees to be in the treatment.
•	Ensure that no information is provided to the prospective patient or the person providing informed consent that is made to waive or appear to waive any of the prospective patient’s legal rights, or releases or appears to release the treating physician, the sponsor, the institution or its agents from liability for negligence.
•	Communicate to the person providing informed consent all the information in the consent document or script approved by the IRB.
•	Not enroll a prospective patient when the person obtaining informed consent is unwilling to listen to or consider the information, even if the person providing informed consent agrees to be in the treatment.

 Yes       No

If no, describe the consent process:

17.		Provide contact names and numbers as they are to appear in the submitted consent form

Contact to be included in the consent form or script for questions about the treatment:

Name	
Phone Number	
Office Hours	
24 hours	

		

Contact to be included in the consent form for whom to contact about treatment-related injury:

Name	
Phone Number	
Office Hours	
24 hours	

		

	
18.		Confidentiality precautions: Confidentiality refers to the agreements regarding how data will be managed and used.

Do you comply with HIPAA?
 Yes       No

If no, describe what procedures will be followed to protect the  confidentiality of data collected about the patient: 					
	
19.		Privacy Protections:  Privacy refers to persons’ interest in controlling the access of others to themselves, such as the ability to control who sees them, hears them, touches them, and has access to their private information. Additional privacy interests include the time and place where individuals provide information, the nature of the information provided
by the individuals, the nature of the individual’s experiences during the trial, and who receives and can use the information.

Will procedures be performed in a private location?
 Yes       No

If no, describe what procedures will be followed to protect the privacy of the patient: 					
	
20.		Mailing address of the site where treatment will take place:

Company	

     	

Address Line 1	

     	

Address Line 2	

     	

City	
State	
Postal Code	

     	
     	
     	

	
21.		Which of the following best describes this site's function? (Select one)

 College/University 
 Dialysis Center 
 Hospital 
 Medical Office
 Nursing Home 
 Psychiatric Institution 
 Research Clinic 
 Other, describe: 	
	
22.		Does a local IRB have jurisdiction over this site for research studies? (If this site is covered by a Master Services Agreement
(MSA) or is a member of our Global Research Network (GRN), you may check "No")
 Yes       No

If yes, submit a "Reliance Agreement" available on the IRB Web Site
	
23.		Does this site have all emergency equipment, personnel, and procedures required by the product information?
 Yes       No

If no, explain: 	
	
24.		Indicate any additional resources. (Select all that apply.)

 Interpreters
 Bilingual staff members
 Counseling services
 Other, describe: 	
	
25.		Person completing this form:

Prefix 	
First	
Middle	
Last	
Suffix	

     	
     	
     	
     	
     	

Phone	
Degrees	
Email	

     	
     	
     	

Company	

     	

Address Line 1	

     	

Address Line 2	

     	

City	
State	
Postal Code	

     	
     	
     	

26.		Required attachments:

•	This form with all questions answered
•	Completed FDA form 3926 Individual Patient Expanded Access Investigational New Drug Application (IND)
•	Consent Form
•	Documentation of FDA IND Number, if available 
•	IB (or reference to existing information) or supporting literature 
•	CV for the treating physician (if a current one is not already on file with WIRB)
•	Medical License for the treating physician (showing the expiration date) (if a current one is not already on file with WIRB).
	
27.		Provide any special instructions or additional relevant information for this submission:
		
28.		Acknowledgement

By submitting this form, I confirm that:

I am the treating physician or the treating physician’s designee authorized to submit on behalf of the treating physician.

The treating physician has full awareness of the information within this form.

The information within this form is accurate and complete.

As a requirement of IRB approval, the physician treating this patient will:

•	Not commence treatment until receipt of the IRB approval letter.
•	Comply with all requirements and determinations of the IRB.
•	Protect the rights, safety, and welfare of the patient involved in the treatment.
•	Personally provide the treatment.
•	Submit proposed modifications to the IRB prior to their implementation.
o	Not make modifications to the treatment without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to the patient.
•	Submit continuing review reports when requested by the IRB. (If the treatment continues longer than one year, a continuing review report will be requested.)
•	Submit a closure form when the treatment is completed or ends.
•	If approval expires, immediately contact the IRB.
•	Promptly report to the IRB the information items listed in the IRB's "Prompt Reporting Requirements” available on the IRB's Web site.
•	When required by the IRB ensure that consent, permission, and assent are obtained and documented in accordance with the relevant current protocol as approved by the IRB.
•	Promptly notify the IRB of any change to information provided on this form.

 I confirm