Notification of Emergency Use of a Test Article

Notification of Emergency Use of a Test Article ► HANDWRITTEN FORMS WILL NOT BE ACCEPTED ◄ Please answer each question completely. For those questions requiring additional explanation, please attach materials and return with this form. Any question left blank or incomplete will delay your review. This study cannot be reviewed by the IRB until this form and all supporting documentation are received.

SECTION 1: GENERAL STUDY INFORMATION

Sponsor of Test Article:

SECTION 2: PRINCIPAL INVESTIGATOR CONTACT INFORMATION

Principal Investigator (PI) Name: Site Name: Address:

City: State: Zip Code: Mailing Address: Same as above

Address:

City: State: Zip Code: PI Phone Number: PI Email: @ Please attach a list of names and addresses of all locations where the emergency use was conducted.

SECTION 3: TEST ARTICLE INFORMATION

Test Article Name:

Test Article Type: Drug Biologic Device Diagnostic IND or IDE #: Does this study involve a radioactive drug? No Yes – please provide a copy of the Radioactive Drug Research Committee approval

Please support your IND# or IDE# by submitting one of the following: (1) the Sponsor protocol with the IND# cited; (2) a letter from the Sponsor; or (3) a letter from the FDA. If you have not obtained an IND# or IDE#, please submit an explanation as to why not.

Has the Sponsor agreed to the use of this drug or biologic for this subject? Yes No Has the FDA given permission for this use with this subject? Yes No Will the test article be provided at cost or free of charge?

Aspire IRB, LLC 11491 Woodside Avenue Santee, CA 92071 619.469.0108 (phone) Version Date: October 1, 2014 619.469.4108 (fax) Page 1 of 6 Notification of Emergency Use of a Test Article

SECTION 4: SPONSOR / MANUFACTURER INFORMATION

Contact Person: Company: Address:

City: State: Zip Code: Phone: FAX: Email: @

SECTION 5: IRB REVIEW INFORMATION

Has this protocol ever been submitted to another IRB for review? No Yes – list name of the IRB(s) and the outcome of the review(s) on a separate page.

SECTION 6: DETAILS OF EMERGENCY USE

The participant was confronted by a life-threatening or severely debilitating situation necessitating the use of a test article. True False No alternative method of approved or generally recognized therapy was available that provides and equal or greater likelihood of saving the participant’s life. True False There was not sufficient time to obtain IRB approval in advance of the use of the test article True False Do you intend to use this test article in the future? No Yes – Any subsequent use of the test article is subject to full and prospective IRB review. If you intend to use the test article in the future, you must submit an Initial Study Application to the IRB. Please contact us at 619-469-0108 to discuss.

Was Informed consent obtained from the participant or the participant’s LAR? Yes - Date Informed Consent was obtained: ; please attach documentation of the informed consent No - If informed consent was NOT obtained from the participant or the participant’s legally authorized representative, you MUST arrange for an independent physician to complete Section 7 below and answer the following questions

Informed consent could not be obtained from the participant because of an inability to communicate with, or Yes* No obtain legally effective consent from, the participant N/A * If Yes, explain why the participant was unable to provide informed consent:

Time was not sufficient to obtain informed consent from the participant’s legal representative. Yes* No * If Yes, explain why there was insufficient time, and describe efforts made (if any) to contact the participant’s N/A legally authorized representative and obtain informed consent:

Aspire IRB, LLC 11491 Woodside Avenue Santee, CA 92071 619.469.0108 (phone) Version Date: 10/1/2014 619.469.4108 (fax) Page 2 of 6 Notification of Emergency Use of a Test Article

SECTION 7: INDEPENDENT PHYSICIAN CERTIFICATION: EMERGENCY USE WITHOUT INFORMED CONSENT Certification of Independent Physician Who is Not Otherwise Participating in the Clinical Investigation of the Test Article: The participant was confronted by a life-threatening or severely debilitating situation necessitating the use of a True False test article. Informed consent could not be obtained from the participant because of an inability to communicate with, or True False obtain legally effective consent from, the participant Time was not sufficient to obtain consent from the participant’s legal representative. True False No alternative method of approved or generally recognized therapy was available that provided an equal or True False greater likelihood of saving the life of the participant.

Independent Physician Name: Date:

Signature of Independent Physician:

SECTION 8: PRINCIPAL INVESTIGATOR

If supporting documentation has been previously submitted to Aspire IRB, there is no need to re-submit. Simply check “On File”. However, changes or new information must be submitted to Aspire IRB in a timely manner. a. Please provide a copy of the PI’s signed and dated CV (current within 2 years) On File b. PI Specialty(ies):

Board Certified? Yes – please describe No c. Medical License (attach copy) Expiration Date: On File N/A d. Has the PI’s medical license ever been suspended, revoked, placed on probation or restricted? No Yes – provide explanation On File e. Have the PI’s hospital privileges ever been suspended, revoked, placed on probation or restricted at any facility? No Yes – provide explanation On File f. Has the PI ever been charged with a misdemeanor or felony that relates to the practice of medicine? No Yes – provide explanation On File g. Has the PI ever had an IRB impose any sanctions or restriction on him/her? No Yes – provide explanation On File h. Has the PI ever had an IRB terminate or suspend its approval of a study for any reason? No Yes – provide explanation On File i. Has the PI ever undergone a FDA/OHRP inspection, or received an FDA 483 (within the past 5 years), Warning Letter or NIDPOE (Notice of Intention of Disqualification Proceedings and Opportunity to Explain)? No Yes – provide copies of letters and correspondence On File j. Principal Investigators are required to complete human research-related training and/or education in the area of Good Clinical and protection of human subjects. Has the PI met this requirement in the past two years? Yes No

SECTION 9: SUBJECT POPULATION a. Please check all groups that apply: Children / minors Employees of the PI/site and/or their immediate family (NOTE: Age of majority in Alabama and Nebraska - 19; Puerto Rico - 21) members Pregnant women / fetuses Students of the PI/site Economically and/or educationally disadvantaged Decisionally impaired individuals individuals Nursing home residents / institutionalized individuals Limited or non-readers / illiterate individuals Comatose individuals / traumatized individuals Hearing / visually impaired individuals Terminally ill individuals / individuals with life-threatening conditions Other (specify): Non-English speaking individuals – complete questions 1 & 2 below 1. Do you require a translated consent form? Yes – contact Aspire IRB upon receipt of your initial approval documents to request specified language. No 2. Is there be someone available onsite to communicate with subjects in their primary language? Yes No – explain how you plan to communicate with the subject during the consent process and subsequent study visits.

In the event that a subject from a vulnerable population presents him/herself as a potential study subject, Aspire IRB must be notified and provided with a description of the specific measures that will be used to safeguard the vulnerable subject during the consenting and enrollment processes

SECTION 10: MAIL DELIVERY INFORMATION

Note: All documents will be delivered via First Class US Mail unless otherwise instructed. a. Would you prefer overnight courier delivery of approval documents?

No –proceed to next section Yes – complete remainder of this section b. Service Provider: FedEx DHL UPS Other: c. Account Number: Reference Number:

SECTION 11: BILLING INFORMATION

Contact Person: Company: Address:

City: State: Zip Code: Phone: FAX: Email: @

Payments should be sent with a copy of the invoice(s) to: Aspire IRB, 11491 Woodside Avenue, Santee, CA 92071 ► NOTE: Any changes to billing information must be sent to Aspire IRB at [email protected] ◄

INVESTIGATOR AGREEMENT WITH ASPIRE IRB

As the Principal Investigator, I agree to uphold ethical standards and practices in research and conduct this research in accordance with applicable federal regulations, state and local laws, and requirements of Aspire IRB as follows:  Conduct this study according to the approved protocol and in accordance with ICH Guidelines for Good Clinical Practices, 21 CFR 50, 56, 312, and 812, and any conditions imposed by Aspire IRB.  Agree to protect the rights, safety and welfare of subjects to the best of my ability in accordance with the three ethical principles set forth in the Belmont Report: respect for persons, beneficence, and justice.  Report the following occurrences within 5 calendar days from the date of discovery: unanticipated problems and unanticipated adverse device effects.  Respond to all requests from Aspire IRB in a timely fashion.

I certify that the information provided in this application is true and correct. As Principal Investigator, I am requesting that Aspire IRB review the information submitted.

I understand that Aspire IRB accepts responsibility for providing IRB oversight of this emergency use. This emergency use of the test article was not a systematic investigation designed to develop or contribute to generalizable knowledge. However, I certify that I have agreements in place with the manufacturer of the test article, that obligate the manufacturer to promptly report to me any findings or results that could directly affect the safety or medical care of the patient receiving the emergency use test article.

I understand that Aspire IRB has the right to conduct a site visit at any time with proper notification.

My signature below indicates that I will comply with my responsibilities as Principal Investigator, as outlined.

Principal Investigator’s Date Name: :

Signature of Principal Investigator:

SUBMISSION CHECKLIST

The following information must be included with your completed. Do not forget to include this page with your application.

Support for IND or IDE # Signed Consent Form with HIPAA Authorization (if applicable) N/A Principal Investigator signed and dated CV (within 2 years) On File Principal Investigator current license On File Audit information for Principal Investigator or any Sub-investigators (if applicable) On File Copy of Massachusetts Research Registration (if applicable) N/A Site Information Form(s) (a separate form is required for each facility utilized in this emergency use)

Form Completed by:

Name (Printed) Date

@ Telephone Number E-mail

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