IRB-HSR Neuronext Protocol Information Form

IRB-HSR NeuroNEXT Protocol Information Form

IRB-HSR #

Protocol Title:

Sponsor Protocol #: (If applicable)

GENERAL INFORMATION
Yes No / Do you/will you have a contract with an outside sponsor for this protocol?
If yes- name of group you will have contract with:
Yes No / Is this protocol funded by a Grant?
If Yes- GHIC# for Approved Grant
Yes No / Does this study involve the use of recombinant DNA, biological vectors or infectious agents?
If Yes, IBC approval required. IBC#
Yes No / To avoid any conflict of interest are any IRB-HSR members/alternates listed on the protocol or 1572 form?
If Yes, please list names:
Yes No / Will you be using any human specimens in this protocol?
If yes, will all collection (i.e. blood drawing) and processing (i.e. anything that involves the specimen container to be opened) occur in a UVA clinic/hospital or clinical lab? If No- attach approval from the Institutional Biosafety Board IBC#: If you need to register with the IBC go to
Yes No
Yes No / Will this study involve the use of radiation for research purposes?
If yes, attach approval from the UVa Radiation safety/ HIRE/ RDRC Committee as applicable.
Yes No / Does this study involve a medical device that will be used at the UVa Health System that is not currently used at the UVa Health System?
If yes, attach New Medical Device Application Form you submitted to UVa Clinical Engineering.
If there are questions on how to complete the form contact Clinical Engineering at 982-3857
Yes No / Does this study require review of the UVA Cancer Center Protocol and Review Committee (PRC)?
Answer YES, if you answer YES to 2 or more of the following questions and you have NOT received a waiver from the PRC. Contact the PRC at if you have questions.
In this protocol are subjects with a cancer diagnosis eligible to enroll?
Does the study's focus address therapy, management or understanding of cancer or its sequelae (recurrence, pain management, alopecia, nausea, fatigue, quality of life, end of life issues, etc.)?
Does this protocol involve the testing of a new device or improvement of a method of detection or diagnosis for cancer?
Will this study involve the prospective use or banking of tissue or blood samples from patients with cancer or retrospective use of tissue or blood samples from patients with cancer?

Submission Documents

The following documents are included with this submission (please check all that apply):

One copy of this form (NeuroNEXT Protocol Information Form)

One Sponsor’s Protocol and one of each Consent Form

One original signed IRB-HSR/NeuroNEXT Investigator’s Agreement

One copy of the Investigator’s Brochure, if applicable

Any additional information such as questionnaires /surveys

UVA Radiation Safety /HIRE/RCRC Committee Approval

New Medical Device Application

PRC Approval

Conflict of Interest Information

Is there a conflict of interest in this project? Yes No

Examples

Investigator, investigator's spouse or anyone else in their immediate family together owns more than 3% share of stock in the sponsoring company or receives more than $10,000 a year in income from the sponsor of the study
Investigator holds or has applied for patent on investigational drug, device or intellectual property. The IRB strongly recommends that a protocol NOT be submitted to the IRB until the patent application has been submitted.
Investigator invented the device
Investigator serves on an advisory board or gives lectures for the company sponsoring this protocol
A complex relationship with the sponsor, which may give the appearance of a conflict to someone outside the project
If any of the previous examples might be true for relationships with a competing companies or drug or device manufacturers.

If YES, explain the potential conflict.

2. Does anyone listed as personnel on this protocol, their spouse or any members of their immediate family serve as a director, officer, or member of an advisory board with the sponsoring company? Yes No

3. Does anyone listed as personnel on this protocol , their spouse or any members of their immediate family together receive direct or indirect income from cash payment, stock, stock options, own >3% equity in the sponsoring company, or have a consulting agreement etc. totaling greater than $10,000 in personal income/year (excluding salary support from study budget) from the sponsor? Yes No

For more information see the UVa Conflicts of Interest Policy and FAQ at

IF YES, submit a copy of the Conflict of Interest Committee Management Plan with this protocol to the IRB.

IF YES, has this conflict been reported? Yes No

IF YES, indicate where you reported the conflict:

Grants and Contracts/OSP Office

Annual Reporting on Conflicts of Interest to the School of Medicine

Development (for donated products to be used in research)

IF NO, STOP and complete an Exemption Request for Conflict of Interest Form which can be found at

Before submitting your disclosure form it is recommended you contact one of the persons below to discuss this financial interest:

School of Medicine / Steve Wasserman / 243-7088
School- Other / Dave Hudson / 243-0900

If you have not previously disclosed this financial interest, additional time may be required for the Conflicts of Interest Committee and the IRB to consider your financial disclosure and protocol respectively. Consideration of significant financial interests related to research is one of the factors the IRB takes into consideration in reviewing protocol safety.

STUDY PERSONNEL

PLEASE NOTE THAT ALL PERSONNEL LISTED BELOW MUST HAVE COMPLETED IRB-HSR ONLINE TRAINING IN HUMAN SUBJECT RESEARCH PROTECTION BEFORE PROTOCOL WILL BE REVIEWED BY IRB-HSR.

If an individual is a UVA employee, please list his/her official UVA registered e-mail address. Do not list an alias e-mail address on IRB-HSR forms. Ex: use , not
ALL individuals having contact with subjects or their identifiable information for this protocol must be listed below.
All e-mails from the IRB-HSR regarding a protocol will be sent to the PI, Study Coordinator(s) , Department Contact and IRB Departmental Coordinator (if applicable)

Principal Investigator:First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address

School: Department:: ______Division:

Note: only 1 person may be listed as the PI by the IRB-HSR- please list others as sub-investigators. If the PI is NOT a faculty member, a faculty member must be listed as a sub-investigator. Students are not allowed to be the Principal Investigator.

Study Coordinator I:
First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address:

School: Department:: ______Division:

Study Coordinator II:First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address:

School: Department:: ______Division:

Department Contact:First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address:

School: Department:: ______Division:

Note: This is usually a person who knows how to get in touch with the PI or Study Coordinator if they’re unavailable (i.e. PI secretary/department manager). The Department Chair should not be listed as the Department Contact.

Departmental IRB Coordinator: First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address:

School: Department:: ______Division:

Sponsor/Granting Agency:

Name:

Address:

Phone: Fax:

Sub-investigators:

List ALL individuals who will have contact with subjects or will have access to research data that has identifying information (e.g.-subject name or medical record number)

First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address:

School: Department:: ______Division:

First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address:

School: Department:: Division:

First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address:

School: Department:: Division:

First name: Last name: Degree:

Phone: E-mail: Messenger Mail Address:

School: Department:: Division:

Yes No Are there additional sub-investigators? If Yes, attach additional pages.

Version Date: 06/28/12