Indiana University Health Bloomington Institutional Review Board (IRB)
SINGLE USE IND or COMPASSIONATE USE (IDE)
Submission Form
A Single Use (Compassionate Use) protocol generally refers to the use of an investigational drug, device or biological product, in the treatment of an individual patient that is not part of the overarching research protocol. The physician must request an IND or IDE for compassionate use of a single patient from the FDA. For more information please refer to http://www.fda.gov/oc/ohrt/irbs/drugsbiologics.html#treatment
Because the IU Health Bloomington IRB must conduct an initial review and continuing reviews of single use treatment submissions, the investigator will need to complete and submit this form before initiating treatment.
Investigator:
Address:
E-mail: Phone:
Test Article To Be Used:
IND/IDE Number:
Projected Date of Treatment:
PROJECT INFORMATION (Check all that apply):
Investigator initiated Industry sponsored
INDEMNIFICATION (Indicate the source responsible for liability coverage):
Investigator Industry Sponsor
If Industry Sponsor is not providing indemnification, please attach explanation to this submission.
Other:
ASSURANCES:
Your signature below indicates that you accept responsibility and will follow the ethical guidelines set forth by the Belmont Report, Declaration of Helsinki, the Nuremberg Code, or the Ethical Principles of the American Psychological Association for the research described.
The signature of the Principal Investigator indicates that he/she has the requisite funding, credentials, training and any necessary hospital privileges, if needed, to carry out all procedures and treatments involved in the protocol. The signatures also affirm that the activities involving patients will not begin without prior review and approval by the
Institutional Review Board, and that all activities will be performed in accordance with state and federal regulations and IU Health Bloomington Hospital’s Assurance with the
Department of Health and Human Services. The undersigned assures that if the investigator or his/her research team access protected health information from a IU
Health Bloomington Hospital covered entity in order to seek consent/authorization for
06/24/2014
SC 501-A
1

treatment, such access is necessary for the treatment, is solely for that purpose, and the information will not be removed from the covered entity without IRB authorization or approved waiver.
Treating Physician:
Signature:
1.
Summary and Justification for the Single Use Treatment:
2.
Single Use Enclosures: check all that apply.
*Note: these documents are required for review
Sponsor’s Protocol or Protocol Prepared by a Physician*
FDA Notification and Information*
Patient Information Booklet – from the sponsor, if available
Clinical Consent Form, if applicable
Date:
Package Insert, if available
Summary of Safety Information and Probably Benefit Brochure,
if available
Supporting Literature
Other:
A.
TEAM
List names of all members of the clinical team along with their degrees, title, affiliation with IU Health Bloomington Hospital, experience and assigned study duties. In the third column, provide sufficient detail regarding an investigator’s experience to reflect his/her ability to capably perform the duties listed in protocol.
The clinical team includes all individuals who have contact or interactions with patients or with patient’s private identifiable information or individuals who are specifically designated to perform an integral component of treatment. By submitting the protocol, the principal investigator affirms that each individual named has reviewed the protocol and has consented to his or her inclusion. If the treatment involves an investigator from outside our jurisdiction, it is the responsibility of the Principal Investigator (PI) to ensure they have obtained IRB approval from his/her institution (if applicable). A copy of the approval letter from the cooperating institution’s IRB must be attached to your submission.
The principal investigator (PI), sub-investigators, and research team must have completed human subjects and conflict of interest education. Investigators from other institutions with an IRB may provide their institution’s human subjects certification to meet IU Health
Bloomington IRB education requirements. This IRB submission will not be reviewed if any
06/24/2014
SC 501-A
2

of the members of the clinical team have not completed an acceptable form of human subjects’ education.
Name(s), Degree, Title
1. Y
N
Experience
(Specify experience which reflects the ability to capably perform study related duties
– such as other trials conducted, related courses completed, etc.)
Study Duties
2.
3.
Y
N
Y
N
4. Y
N
5.
6.
Y
N
Y
N
You may add members to the table above by expanding as needed (place cursor in the last box of the table, right side, and hit the ‘tab’ key).
06/24/2014
SC 501-A
3

B.
SITE(S)
1.
Indicate where the study will be conducted (name of site, address and contact information):
1.
2.
3.
2.
Will any portion of the study be conducted at IU Health Bloomington Hospital?
No Yes N/A
3.
Will data or specimens (blood/tissue) be sent outside of IU Health Bloomington
Hospital?
No Yes
If yes, indicate where or to whom they will be sent and whether data or specimens will be sent. Examples include: external collaborators listed above, a study sponsor, outside labs.
In the third column, indicate whether data will be sent with identifiers or with codes.
Name
1.)
Address Data or
Specimen?
Sent
Coded?
(Yes/No)
2.)
06/24/2014
SC 501-A
4

C.
SPECIAL POPULATIONS
Treatments involving pregnant women, human fetuses, neonates of uncertain viability, nonviable neonates, prisoners, or children as subjects requires additional protections set forth by the Department of Health and Human Services (DHHS). Please see the Code of
Federal Regulations (45 CFR part 46) for specific regulations:
 Additional Protections for Pregnant Women, Human Fetuses and Neonates: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb
 Additional DHHS Protections Pertaining to Biomedical and Behavioral treatments
Involving Prisoners as patients: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc
 Additional DHHS Protections for Children Involved as patients for treatments: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd
For this treatment protocol, please check all that apply:
Pregnant subjects or fetuses
Neonates
Prisoners, parolees, incarcerated subjects
Subjects less than 18 years old
D.
THE PROCEDURE WILL INVOLVE
Types of subjects
Subjects whose major language is not
English
Employees specifically targeted as subjects
Students specifically targeted as subjects
Mentally incompetent subjects
Administration of drug
Questionnaires and/or tests
(psychological, behavior, etc.)
Interviews and/or focus groups
Study involves deception
Procedures
Use of medical device
Registries
Data collection via e-mail or the Internet
Filming, video or voice-recording subjects
Terminally ill subjects
Subjects requiring hospitalization
None of these groups
Other:
Collection or storage of specimens
HIV testing
Genetic testing
Fetal tissue
Data banks, archives, medical records
Stem cell transplantation
Ionizing radiation
Recombinant DNA/Gene transfer therapy
06/24/2014
SC 501-A
5

Venipuncture/blood drawing Other:
E.
STUDY DESIGN
DURATION
Expected total duration of each subject’s participation (treatment and follow-up):
RELATED STUDIES
If this study is related to another IUBH IRB protocol (e.g., sub-study, extension), please indicate the IRB number and explain how it is related:
F.
FINANCIAL COMPONENTS
COSTS
Who will cover the study-related costs?
Please clarify who covers the costs of the treatment:
(Please check all applicable statements.)
All procedures and/or medications will be provided at no charge to the subject and will be billed to or covered by .
 Have appropriate arrangements been made with the hospital to bill the procedures to the Investigator or Sponsor? Not Applicable Yes No – If no, explain:
The insurance provider will be billed for procedures that are considered standard
of good clinical care. NOTE: Subjects will be responsible for standard-of-care charges that are not covered by their insurance provider.
Financial counseling is available to subjects to discuss possible costs resulting from participation in this treatment.
Other
G.
CONFLICT OF INTEREST
Complete and attach a Financial Conflict of Interest form for the PI and each member of the study team.
06/24/2014
SC 501-A
6

H.
OTHER LEVELS OF REVIEW
IU Health Bloomington Hospital Radiation Safety
Treatments involving non-standard of care ionizing radiation must be reviewed by the IU Health
Bloomington Hospital Radiation Safety Officer (RSO). Examples of such procedures include: use of xrays, including fluoroscopy, CT, and use of radioactive materials. Please contact the IRB Office for more information.
Not Applicable
Request is Pending
Review Completed/Approval
Institutional Biosafety
Treatments involving administration of recombinant DNA (e.g. gene therapy) and/or infectious agents
(including select agents and toxins as defined by CDC) must be reviewed by the IU Health Bloomington
Hospital Biological Safety Officer. Please contact the IRB Office for more information.
Not Applicable
Request is Pending
Review Completed/Approval
Pharmacy, Therapeutics, Nutrition, and Transfusion
IU Health Bloomington Hospital requires that all research involving the administration of medications within the hospital (including outpatient areas) be reviewed and all doses are coordinated, controlled, and dispensed by the hospital's pharmacy department. Please contact the IRB Office for more information.
Not Applicable
Request is Pending
Review Completed/Approval
06/24/2014
SC 501-A
7

I.
DRUGS, BIOLOGICS, DEVICES
1.
List the names of all drugs or devices under consideration:
2.
Check and/or complete the following information (repeat for each drug/device as needed):
Investigational New Drug or Biologic Product
Name:
IND Number:
Name of sponsor (individual or industry sponsor) who holds the IND:
Investigational Device
Name:
IDE Number (or indicate “exempt” from IDE requirements):
Name of sponsor (individual or industry sponsor) who holds the IDE:
Indicate level of risk per FDA regulations: Significant risk
Non-significant risk
See level of risk per FDA regulations and guidance and attach supporting documentation (device information or documentation from FDA indicating it is exempt from IDE requirements). The risk determination should be based on the proposed use of a device in an investigation and not on the device alone.
For IU Health Bloomington IRB Office Use Only.
Recorded in the Minutes of:
This form must be electronically signed by the Principal Investigator or designee. The electronic signature certifies that the information provided above is accurate, current and complete.
06/24/2014
SC 501-A
8