UIC IRB Humanitarian Use Device Version 2.1

UIC IRB Humanitarian Use Device version 2.1

To Be Completed By the Investigator / For OPRS Use Only
Date Application Completed: / UIC Protocol #:
Application Document Version #: / Assigned IRB:

I. Title:

II. Personnel

A. PRIMARY HEALTH CARE PRACTITIONER (PRINCIPAL INVESTIGATOR)

Name (Last, First) / Degree(s) / University Status/Title
Department / College
Mailing Address / M/C
Phone Number / Fax Number / E-mail Address

B. LIST ALL ADDITIONAL KEY PERSONNEL (i.e those involved with use of device or obtaining consent) ON APPENDIX P and SUBMIT WITH THIS APPLICATION PACKET.

III. Humanitarian Use Device

NAME OF HUMANITARIAN USE DEVICE

HDE NUMBER

/

HDE HOLDER

A. Will application of the humanitarian use device (HUD) be limited to the indication(s) approved by the FDA in the HDE?

Yes. Continue to question B.

No. STOP, this is not the correct form for you to complete. You are required to submit the Initial Review Application: Health and Biological Sciences.

B. Will safety and efficacy data, excluding FDA-mandated Adverse Device Event reporting, be collected?

Yes. This activity qualifies as research. All sections of the HUD application must be completed and a protocol submitted.

No. You do not need to complete section VIII, IX and XI of the HUD application.

C. Are any research related procedures or other testing planned?

Yes. Describe.

No.

IV. Background

A. Provide a description of the device:

B. What disease(s) or condition(s) will the device be used to treat or diagnose at UIC or JBVAMC?

C. What alternatives are available to treat or diagnose the disease(s) or condition(s) described above?

D. Describe the patient population who will receive the device at UIC or JBVAMC, including criteria for determining patient eligibility.

V. SUBJECT POPULATION

A. Requested number of patients: UIC: JBVAMC:

Note: The number stated here will be the total number of approved patients and will appear in the approval letter. This is a specific number and you must not exceed this number. To increase the number of approved patients, an amendment must be submitted and IRB-approved prior to using the HUD in additional patients.

B. Age Range (check all that apply):

Newborn to 17 years of age*

18 - 64 Years

65+ Years

*Submit Parental Permission Document, Assent Document, and, if collection of safety and efficacy data or other research is being conducted, submit Appendix B

C. Indicate which populations below may receive the HUD at UIC or JBVAMC.

Check all that apply

Adults

Pregnant Women: submit Appendix U if collection of safety and efficacy data or other research is being conducted*

Prisoners (NOTE: Prisoners may receive the HUD for the FDA-approved indication(s) as part of clinical care, but may not participate in research, i.e., collection of safety and efficacy data or other research)

Decisionally Impaired: submit Appendix V if collection of safety and efficacy data or other research is being conducted*

Economically and/or Educationally Disadvantaged

Vulnerable to Coercion or Undue Influence

JBVAMC

VI. PROCEDURES

A. Summarize the procedures for use of the device, including any ancillary procedures associated with use of the HUD such placement or implantation and any screening procedures.

B. Is any training required from the HDE holder (sponsor) prior to the health care practioner using the device?

No

Yes. If yes, indicate when the training will occur and which UIC personnel will receive training.

C. List the locations and health care personnel who will use the device at UIC or JBVAMC.

D. Describe how the HUD will be controlled , including the storage location, the procedures for storage, dispensing, and limiting access to the individuals listed as personnel on this application to prevent the inappropriate use of the device or the use by non-approved health care practitioners.

E. Outline the schedule for monitoring the clinical use and safety of the HUD, including follow-up patient visits, tests, or procedures.

F. What financial obligations will the patient incur as a result of receiving this device?

G. If research with the HUD is occurring; indicate any research-related cost for which the patient will be responsible (exclude cost of HUD).

VII. Risks and Benefits

A. List the possible risks and/or adverse events associated with: 1. the clinical use of the HUD (include risks associated with ancillary procedures required for use of the HUD, such as placement or implantation); 2. the research use of the HUD (if safety and efficacy data will be collected, include loss of privacy and confidentiality as risk).

B. What are the potential benefits to the patient associated with: 1. the clinical use of the HUD; 2. the research use of the HUD?

C. Is there a data and safety monitoring plan? No Yes

1. If YES, please describe the data safety monitoring plan in detail here:

If NO, please describe the methods to be used in this study to monitor the ongoing safety of the subjects (for example: sponsor medical monitor, AE reporting, protocol specific safety features like stopping rules, etc.).

VIII. Maintenance of Confidentiality when Safety and Effectiveness Data is Collected

(This section must be completed if you answered “yes” to questions III. B. or III.C.)

A. Indicate the identifiable elements that will be collected and/or included in the research records for the study.

Check all that apply.

Names Social Security Numbers* Device identifiers/Serial numbers

Phone numbers Medical record numbers Web URLs

Street address Health plan numbers IP address numbers

City or state Account numbers Biometric identifiers[1]

Zip Code Fax numbers Vehicle ID numbers

E-mail address License/Certificate numbers Facial Photos/Images

Financial account information (including student ID)

All elements of dates (except year) for dates directly related to an individual; and all ages over 89 and all elements of dates (including year) indicative of such age

Any other unique identifier - Specify:

None of the identifiers listed above

Biometric Identifiers are observable biological characteristics which could be used to identify an individual, e.g., fingerprints, iris/retina patterns, and facial patterns.

*NOTE: If social security numbers will be collected, explain below why they are necessary and how they will be used:

B. Is the provision of safety and effectiveness data (i.e., participation in the research) by the patient optional or required for treatment or diagnosis with the HUD? (Please note that if participation in the research is required to receive the HUD, the IRB will require consultation with the sponsor and FDA.)

C. Data Security Plan. This section asks you to describe provisions you will make to maintain the confidentiality of the research data.

1. Indicate how subject identifiers will be linked to the research data.

Indirectly with a code linked to the identity of the subject.*

Describe the coding method and specify who will have access to the code/master key and how it will be protected against unauthorized access. Key should be stored separate from study data:

Directly, personal or private identifiers (identifiable elements) are maintained with the data.*

Justify the inclusion of direct subject identifiers:

*NOTE: Requires Consent and, if health information, Authorization from the subject.

2. Electronic Data Collection: (This refers to the collection process through mechanisms such as a survey or testing program)

a.  In which of the following ways will you be conducting electronic data collection: via the internet and/or some other electronic means of data capture.

Not Applicable – the study will not involve electronic data collection (Skip to question 3 - Storage and Security Measures for Research Data)

Internet-based application/package

Non-internet based application (i.e. directly on a desktop/laptop).

b.  Describe the mechanism by which the data will be collected:

REDCap (define host CCTS/IHRP Other (define): )

Qualtrics

Other - A thorough description of the characteristics of the application/tool must be provided. This description should address the following elements if applicable: product/tool name, host, security measures, encryption mechanism, and how collected data is maintained and stored by the application/tool.

*NOTE: Any investigator who uses external survey software must provide evidence of a business associate agreement between the University and the external survey software provider. For more information, refer to the POLICY: Research Data Security (http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/policies/0927.pdf).

c.  Verify that the data collection application/tool(s) identified above will be configured so that it will not collect or track IP addresses of the respondents. . If you are tracking or collecting IP addresses, please provide a detailed justification below.

IP addresses will not be collected or tracked

IP address will be collected tracked – If IP addresses will be collected or tracked provide justification:

d.  Describe how collected data will be transmitted/transferred from the electronic data collection tool to a local computer or file server or other electronic storage medium.

Type of identifiers:

Not Applicable – the data will not be transferred from the application noted above

As a De-identified dataset

As a Limited dataset with DOB ZIP code

With direct identifiers

Format:

As an Encrypted File (define method):

Other (describe the means- i.e. coded data set w/o direct identifiers and key stored separately and re-identified only when in use):

3. Storage and Security Measures for Research Data

a. In what format/media will research data be maintained (Please mark all that apply)?

Paper Electronic stored specimens recording media

b. Electronic data. Please mark all that apply.

Not applicable

De-identified data only (i.e., no personal identifiers, including 18 HIPAA identifiers, are included with or linked to the data)

Password access

Coded, with a master list secured and kept separately

Encryption software will be used. Specify encryption software:

Secure network server will be used to store data. Specify secure server:

Stand alone desktop/laptop computer will be used to store data

Not connected to server/internet

An organization outside of the UIC covered entity will store the code key. The organization will have a business associate agreement with UIC (attach documentation).

Other (specify):

c. Hardcopy data, recordings and specimens. Please mark all that apply.

Not applicable

De-identified data only (i.e., no personal identifiers, including 18 HIPAA identifiers, are included with or linked to the data)

Coded, a master list secured and kept separately.

Locked file cabinet

Locked office/lab

Locked suite

Locked refrigerator/freezer

Specimens coded with a master list secured and kept separately

Other (specify):

d. Indicate below whether data will be hosted at any time, even temporarily, on electronic portable devices (e.g., laptops, PDAs, smart phones, mp3 players, external hard drives). Note: only the “minimum data necessary” should be stored on portable devices.

Personal or private identifiable data WILL NOT be stored on portable devices.

Personal or private identifiable data WILL be stored on portable devices. Note: PHI stored in this manner must be encrypted.

Rationale for keeping personal or private identifiable data on electronic portable devices:

e. Indicate the physical location for data (all formats/media) storage (specify):

D. Other than UIC clinical or research personnel, please indicate below any individuals (for example: collaborators), organizations, or groups (e.g., IDE holder, sponsor or CRO), including state and federal auditors, who may have access to identifiable information (consent documents, financial records, case report forms, etc.), including any raw* research data.

*Raw data is the research data in its original form, before any manipulation or “cleaning,” and in its original format (e.g. source documents, surveys, data print-outs). Generally the data may be identifiable at this stage.

Specify any state or federal agencies you know will have specific rights to access this information (for example: FDA, if the activity qualifies as research) and include this information here and in the consent document. If you are aware of no additional groups having rights to access this information, please indicate so in the space above.

Please note: The UIC OPRS/IRB and Auditors from UIC or the State of Illinois always have the right to inspect research records for research conducted at UIC. Although that is understood and it is not necessary to list them here it is necessary to list these entities in the consent document (HIPAA authorization document, if applicable).

E. Indicate why the individuals, organizations, or groups identified in D above will be provided access to the research data and indicate how they will be given access.

F. Describe any procedures for sharing research data.

G. Will the research data be coded to protect the identity of the subject when shared?

H. Will the data be de-identified or destroyed? Yes No

If yes, explain how and when this will occur:

Note: FDA Regulations limit the charge to patients for the device to cost of research, development, fabrication, and distribution.

IX. Recruitment of Subjects

(This section must be completed if you answered “yes” to questions III.B. or III.C.)

A. How will potential subjects be initially identified for this research study?

Own Clinical Practice (face to face)

Registry or bank

Records (e.g.: medical, employment, school)

Subject responding to flyer or other advertisement

Other: specify

B. Initial Contact

Indicate who will make the initial contact with the potential subjects for the purpose of recruiting them for the research.

Principal Investigator

Co-Investigator

Research Coordinator

Other Key Research Personnel – specify:

C. Describe how, where, and when subjects will be recruited for the research:

Please note that recruitment of subjects at JBVAMC must not occur until approved by the JBVAMC R&D Committee.

D. Recruitment Materials

Check all materials that will be used for recruitment. See the UIC requirements for recruitment materials available on the OPRS web site: (http://www.research.uic.edu/protocolreview/irb/policies/0233.pdf).

No recruitment materials will be used / Mass Mailing
Ad (print) / Physician letter
Ad (radio-provide script, then tape) / Patient letter
Ad (TV- provide script, then video) / Physician referral
Internet – UIC / Telephone script (for response to ad)
Internet - Other / Recruitment script (to aid in consent process)
Information sheets (before study) / Brochure
Information sheets (during study) / Flyer
E-mail notice / Other: specify

X. INFORMED CONSENT

A. Please indicate whether the primary health care provider (Principal Investigator) will personally perform the consent process, including the documentation of informed consent, parental permission, and/or assent, or whether the PI will retain responsibility for overseeing this process but delegate the authority to perform these duties to others: