r...uc davis initial review application [534301] screen shots jump to: other irb project information...

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DIRECTIONS Use your username and password to log into IRBNet

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DIRECTIONS Select "Create New Project" to create a new study in IRBNet

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DIRECTIONS Provide the requested information and select "Continue"

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DIRECTIONS Select "Add New Document".

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DIRECTIONS Use the dropdown list in the On-Line Document section to select "UC Davis Initial Review Application. Click "Add"

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IRBNet Document WizardUC Davis - Project Information Worksheet - [52832-1] Smart Form Screen Shots

To get started you can either create a new wizard from scratch or you can clone one of your existing wizards.

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Copyright © 2002-2014 Research Dataware. All Rights Reserved.

Welcome to IRBNetDavis Researcher

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Create a new wizard from scratch.

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IRBNet ID: 52832-1

IRBNet: IRBNet Document Wizard https://training.irbnet.org/training/study/wizard.do

1 of 1 01/10/2014 11:17 AM

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DIRECTIONS The “Wizard” is the tool that creates your application. You can choose to use an existing application or start a new application from scratch. Using an existing application may save time but may result in error if you do not make all of the changes you need to make. If you choose this option, carefully review the questions to ensure they are completed correctly. If you choose “Clone one of my exiting wizards,” a list of previously completed forms will appear. Choose the previously completed application that best matches your current submission. If you choose “Create a new wizard from scratch, IRBNet will present a new application for you to complete.

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General Instructions

Please download and use the "IRBNet User Manual" in the Forms and Templates Library tocomplete this application

All research personnel must complete required training. Please answer all questions. You can save yourwork, so you do not need to complete the submission in one sitting. When you complete the form, achecklist will appear to assist with compiling required documents. Please update this form as changesare made to this project

Save and Exit Preview Next



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IRBNet ID: 52832-1

IRBNet: IRBNet Document Wizard https://training.irbnet.org/training/study/wizardsvc.do?action=create&ctx...

1 of 1 01/10/2014 11:31 AM

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DIRECTIONS If you are returning to this form from a previous session, you can use the "Jump" button to access pages you have already completed. If you are just beginning this submission select "Next" to begin the Initial Application form.

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IRBNet Document WizardUC Davis Initial Review Application [7919881] Smart Form Screen Shots

Jump To: Principal Investigator Information Jump

Principal Investigator InformationPlease enter the following information for the PI, Cindy Gates.

PI Title *

PI Degrees *

PI Department *

PI Department OtherIf you selected "Other," please specify the PI's department.

PI Phone *

PI Email *

Consent *Will the Principal Investigator be involved in the consent process?

Yes

No

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Copyright © 20022015 Research Dataware. All Rights Reserved.

Welcome to IRBNetNicole Walters

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IRBNet ID: 7919881

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DIRECTIONS Please enter the principal investigator’s name, title, department, phone number and email.

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Co-Principal Investigator(s) *Is there a Co-Principal Investigators? A co-PI is required for all clinical trials.

Yes

No




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IRBNet ID: 52832-1


1 of 1 01/10/2014 11:36 AM

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DIRECTIONS Clinical trials must have an assigned co-Principal Investigator. If this study is a clinical trial or if it is not a clinical trial but there is a co-clinical investigator, please mark “yes.” If this study is not a clinical trial and does not have a co-clinical investigator, please mark “no.”




Jump To: CoPrincipal Investigator Information Jump

CoPrincipal Investigator Information

CoPI First Name *

CoPI Last Name *

CoPI Degrees *

CoPI Title *

CoPI Department *

CoPI Department OtherIf you selected "Other," please specify the CoPI's department.

CoPI Phone *

CoPI Email *

CoPI Obtain Consent *Will the coPrincipal Investigator be involved in the consent process?

Yes

No







IRBNet ID: 7919881

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DIRECTIONS Please enter the co-principal investigator’s title, department, phone number and email.

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Primary Contact *Is the Principal Investigator the primary contact for this study?

Yes

No




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IRBNet ID: 52832-1


1 of 1 01/10/2014 12:43 PM

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DIRECTIONS Please indicate whether the Principal Investigator is the contact for the study or if another individual, such as the study coordinator, will be the primary contact. The primary contact person is the individual the IRB will contact to obtain administrative information about the study.




Jump To: Primary Contact Information Jump

Primary Contact InformationPlease enter provide the following information for the primary contact.

Primary Contact First Name *

Primary Contact Last Name *

Primary Contact Phone *

Primary Contact Email *

Primary Contact Obtain Consent *Will the primary contact be involved in the consent process?

Yes

No







IRBNet ID: 7919881

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DIRECTIONS Please enter the primary contact person’s name, phone number and email.

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https://training.irbnet.org/training/study/wizard.do 1/1

IRBNet Document WizardUC Davis Initial Review Application [534301] screen shots

Jump To: Review Information Jump

Review Information

Reviewing IRB *Are you relying on an IRB other than the UC Davis IRB?

Yes

No

External Sites Relying on UC Davis IRB *Are any external sites relying on the UC Davis IRB?

Yes

No

UC Reliance *Is this review part of the UC Reliance?

Yes

No

UC Reliance NumberIf yes, please provide the Reliance Number




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IRBNet ID: 534301

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IRBNet Document WizardUC Davis Initial Review Application [534301] screen shots

Jump To: Other IRB Project Information Jump

Other IRB Project Information

Author of Protocol *

Research Supported by CTSC? *Is this research supported by CTSC?

Yes

No

Epic EMR *Does your study bill visits or procedures using Epic EMR?

Yes

No

Anticipated Number of Participants *What is the anticipated number of participants to be enrolled in this study?

Anticipated Number of Local Participants *What is the anticipated number of local participants?

Clinical Trial Phase *Phase I

Phase I/II

Phase II

Phase II/III

Phase III

Phase IV

This is not a clinical trial

Do you have an IND? *Yes

No

IND NumberIf you have an IND, what is the IND Number?

Holder of INDIf you have an IND, who is the IND Holder?

Do you have an IDE/HDE? *Yes

No

IDE NumberIf you have an IDE, what is the IDE Number?

Holder of IDE





IRBNet ID: 534301

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If you have an IDE, who is the IDE Holder?



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DIRECTIONS Please provide the information requested. If you are relying on an IRB other than UC Davis your Initial Review Application is complete. If this project is part of the UC Reliance please complete the Reliance Registry at https://irbreliance.ucop.edu/


Jump To: Jump

Additional Personnel *Are there additional personnel for this study?

Yes

No




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IRBNet ID: 52832-1


1 of 1 01/10/2014 1:04 PM

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DIRECTIONS This section will capture the information that is included on a Research Personnel List. If there are study personnel in addition to the PI and CoPI, please mark "yes". If there are no additional research personnel, please mark “no.”

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Jump To: Additional Personnel Information Jump

Additional Personnel InformationPlease provide the following for each additional personnel for this study.

Person 1First Name *

Last Name *

Degrees *

Title *

Consent *Will this person participate in the consent process?

Yes

No

SubInvestigator *Is this individual a subinvestigator?

Yes

No

Add Another Person







IRBNet ID: 7919881

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DIRECTIONS Please add the name and title of each individual on your research team and also indicate whether the member will obtain informed consent from participants. Also indicate if this person is considered a sub-investigator. A sub-investigator is person who performs critical trial-related procedures and/or makes important trial-related decisions. If there is more than one individual to be added, please click “Add Another Person” and repeat this process. Remember, the principal investigator is responsible for the conduct of the study, including training and supervision of the all members of the research team. The principal investigator can delegate the tasks associated with this responsibility but he or she cannot delegate the responsibility itself. Before listing an individual on this application, the PI must ascertain that each individual has the appropriate credentials, has been trained for each delegated protocol task that he or she will conduct, and has also received required human research subject protection training.


Jump To: Jump

Related Financial Interest *Do any personnel involved in the design, conduct or reporting of the protocol have a Related FinancialInterest?

Yes

No




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IRBNet ID: 52832-1


1 of 1 01/10/2014 1:17 PM

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DIRECTIONS Please ask each member of the research staff whether or not they have a related conflict of interest that meets the description below. If yes, please check the box yes and submit the appropriate reports to the Conflict of Interest committee. Information about these forms is available on the next page. You will not be able to start the research until the conflicts are reviewed by the Conflict of Interest Committee and a conflict management plan is implemented. •“Related Financial Interest” means any of the following interests in the sponsor, product(s) or service(s) being tested, or competitor of the sponsor held by the individual or the individual’s immediate family that was received within the last 12 months or that you expect to receive in the next 12 months: o Ownership interest of any value including, but not limited to stocks and options, exclusive of interests in publicly-traded, diversified mutual funds. o Compensation of any amount including, but not limited to honoraria, consultant fees, royalties, or other income. o Proprietary interest of any value including, but not limited to patents, trademarks, copyrights, and licensing agreements. o Board or executive relationship, regardless of compensation. o Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated research institute, academic teaching hospital, or medical center. “Immediate Family” means spouse, domestic partner, children, and dependents.

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IRBNet Document WizardUC Davis - Project Information Worksheet - [52855-2] How to manage your anger

Jump To: Jump

Related Financial Interest Information

Financial Interest Disclosure Forms *Have you submitted the appropriate financial interest disclosure forms? (e.g. 700-U, Form 800 andSupplemental form) which can be found online at the Office of Research Webpage?

Yes

No

Conflict of Interest *Does your study have any actual or perceived conflict of interest as defined by institutional policies, PPM230-05 or PPM 230-07, which can be found at the Office of Research webpage?

Yes

No




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IRBNet ID: 52855-2


1 of 1 03/10/2014 12:33 PM

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DIRECTIONS If you reported a financial conflict of interest please answer the questions. Links are provided to the required forms. If you haven’t already, you need to submit the forms to the Conflict of Interest Committee. You can continue with this submission, but you will not be able to start you research until the Committee has received and reviewed the required forms.

IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx

Jump To: Jump

Protocol Information

Protocol Title *

Author *Who authored (wrote) the protocol?

Previous IRB Review *Has this study previously been reviewed by an IRB?

Yes

No

Previous Reviews

If yes, please explain.




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IRBNet ID: 52862-1


1 of 1 03/10/2014 2:29 PM

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DIRECTIONS Please enter the protocol title and use the drop-down box to select the appropriate information about the protocol author. If the study was previously reviewed by UC Davis, please let us know so we can access the previous documents on file. If you know the previous IRB number, it would be helpful if you provide it. If you are transferring review of your protocol to the UC Davis IRB, please indicate that your study has previously been reviewed by an IRB and provide the name of the IRB, the IRB determination (approved/deferred) and your reason for transferring the study to the UC Davis IRB.




Jump To: Funding Information Jump

Funding Information *How is this study funded or supported?

Industry Sponsored

Federal Grant

Other Grant

Department Funded

Other







IRBNet ID: 7919881

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DIRECTIOSN: Select the type of funding supporting this research. Multiple types may be selected.

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Industry Sponsor(s) Information

Industry Sponsor Name *1.

Add Another Sponsor




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IRBNet ID: 52862-1


1 of 1 03/10/2014 2:46 PM

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DIRECTIONS You indicated that your project is industry sponsored. Please provide the sponsor’s name. If there is more than one sponsor, please select “Add Another Sponsor” and enter any additional sponsors' names.

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DIRECTIONS You have indicated that your study is funded by a grant. Please provide the information requested. If there is more than one grant, please select “Add Another Grant” and provide the information requested.

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Other Funding *As you selected "Other" as a funding source, please specify.




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IRBNet ID: 52862-1


1 of 1 03/10/2014 3:09 PM

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DIRECTIONS You selected “Other” as a funding source. We need to know about the financial support for this research. Please provide information such as the funder's name and the type of funding (e.g. foundation.)

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Clinical Trial Billing Information *Does your study bill visits or procedures as required by the protocol to either insurance, patient or studyusing Epic EMR?

Yes

No




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IRBNet ID: 52862-1


1 of 1 03/10/2014 3:10 PM

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DIRECTIONS Please indicate whether your study will bill visits or procedures required by the protocol to insurance, patient or study using Epic EMR. Visits and/or procedures includes both research related procedures and standard care procedures.




Jump To: Research Location Information Jump

Research Location Information

Research Setting *Format Font family Font size

Resources Available *Format Font family Font size







IRBNet ID: 7919881

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DIRECTIONS Research Setting: Describe the sites or locations where your research team will conduct the research. •Identify where your research team will identify and recruit potential subjects. •Identify where research procedures will be performed. •Describe the composition and involvement of any community advisory board. •For research conducted outside of the organization and its affiliates describe: oSite-specific regulations or customs affecting the research for research outside the organization; and oLocal scientific and ethical review structure outside the organization.

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Resources Available: Describe your staff by roles (e.g. coordinator, research assistant, co-investigator, or pharmacist). Describe the qualifications (e.g., training, experience, oversight) required to perform each role. When applicable describe their knowledge of the local study sites, culture, and society. Provide enough information to convince the IRB that you have qualified staff for the proposed research. When specifying people by role, a change to that person will not require prior approval by the IRB, provided that person meets the qualifications described above to fulfill their roles. Describe other resources available to conduct the research: For example, as appropriate: •Justify the feasibility of recruiting the required number of suitable subjects within the agreed recruitment period. For example, how many potential subjects do you have access to? What percentage of those potential subjects do you need to recruit? •Describe the time that you will devote to conducting and completing the research. •Describe your facilities. •Describe the availability of medical or psychological resources that subjects might need as a result of an anticipated consequences of the human research. •Describe your process to ensure that all persons assisting with the research are adequately informed about the protocol, the research procedures, and their duties and functions.

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Jump To: External Sites Jump

External Sites *Will you conduct or oversee research at one or more external sites?

Yes

No







IRBNet ID: 7919881

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DIRECTIONS If your research involves collaboration with other sites and/or personnel outside UC Davis and a UC Davis researcher has oversight of the research activities taking place off site, please answer "yes". If your research involves collaboration with other sites, and there is a non-UC Davis principal investigator overseeing the research at the other sites, or if no external sites will be part of this research, please answer "no". This information is needed so we can evaluate whether we need a written IRB agreement as required by UC Davis policy and federal regulations.

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IRBNet Document WizardUC Davis Initial Review Application [534401] Here we go again

Jump To: External Site(s) Information Jump

External Site(s) InformationList each external research site at which the PI will conduct or oversee the protocol:

Site 1Site Name *

Contact Name *

Contact Email *

Add Another Site







IRBNet ID: 534401

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DIRECTIONS Please provide the information listed above for each external site. If more than one external site exists, select "Add Another Site" and complete the necessary information.

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Multi-Site *Is this research part of a collaborative, multi-site project?

Yes

No




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IRBNet ID: 52862-1


1 of 1 03/10/2014 3:46 PM

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DIRECTIONS Please indicate whether this is a multi-site project. A multi-site project is a project that is being conducted at one or more sites other than the site at UC Davis with a principal investigator (PI) who is not the same as the PI at UC Davis." If you mark “Yes,” you will be asked for additional information. If it is a multi-site, industry sponsored study please mark “No,” because we do not need additional information.

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Coordinating Study *Is UC Davis the Coordinating Center for this study?

Yes

No




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IRBNet ID: 52862-1


1 of 1 03/10/2014 3:49 PM

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DIRECTIONS A Data Coordinating Center is the site that that supports the trial by receiving and managing data from other sites. If UC Davis is the Coordinating Center for this study, please mark “Yes.” If UC Davis is not the Coordinating Center, please mark “No.”


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IRB of Record *Is UC Davis the IRB of record for this study?

Yes

No




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IRBNet ID: 52862-1


1 of 1 03/10/2014 3:51 PM

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DIRECTIONS If the UC Davis IRB will approve this study for only UC Davis, mark “No.” If the UC Davis IRB is expected to oversee one or more external sites, please mark “Yes,” but read the information below. In general, UC Davis will consider serving as the IRB for external sites in the following situations: (1) The role of the external site or personnel is limited to activities such as data analysis, consultation, or other administrative roles; or (2) The study is minimal risk and the role of the external site or personnel is either limited or very straightforward (e.g., administration of a single survey, assisting with recruitment of subjects). (3) UC Davis has an existing agreement to review studies on behalf of the other institution. The UC Davis will usually not consider serving as the IRB for external sites when: (1) When UC Davis faculty, staff, or students are not involved in the research; (2) The external site is an enrolling site or coordinating center for a clinical trial (regardless of phase); (3) The study is more than minimal risk and the role of the external site or personnel is substantial (e.g., interaction with subjects, conduct of study procedures); (4) The UC Davis IRB does not have sufficient knowledge of the local context (as required by federal guidelines) to assume IRB oversight for sites or personnel that are requesting UC Davis to serve as IRB of record; (5) The study likely qualifies for exemption; (6) The UC Davis IRB feels it cannot adequately oversee the external site or personnel in manner that will ensure the protection of human subjects. If you have questions, please contact IRB Administration.

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Investigator Initiated *Is this research investigator-initiated?

Yes

No




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IRBNet ID: 52862-1

IRBNet: IRBNet Document Wizard https://training.irbnet.org/training/study/wizard.do?action=edit&ctx_id...

1 of 1 07/10/2014 1:12 PM

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DIRECTIONS If this study is not sponsored by another entity and you are initiating this study as sponsor-investigator, please indicate “Yes.” Otherwise, indicate "No."

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UC Davis Clinical and Translational Science Center *Is this research supported by the UC Davis Clinical and Translational Science Center (CTSC)?

Yes

No




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:13 PM

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DIRECTIONS If this study is being supported by the UC Davis Clinical and Translational Science Center (CTSC), please indicate “Yes.” A study is "supported" by the CTSC whenever the CTSC provides any services to support the research. Such services could include but are not limited to assistance with regulatory documentation, protocol drafting and study monitoring and/or coordinating.

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Study Information

Cancer Patients *Does your study involve cancer patients or their data?

Yes

No

Radiation *Does your study involve radiation?

Yes

No

Stem Cells *Does your study involve stem cells?

Yes

No

Hazardous Material *Does your study involve Recombinant DNA Molecules, Human Gene Transfer, infectious agents, orbiohazardous material?

Yes

No

Patient Care Services *Does your study include patient care services billed in the UC Davis Health System?

Yes

No

Coded/Linked Biological Samples *Does your study include the analysis of coded and linked biological samples?

Yes

No

Anonymous Biological Samples *Does your study include the analysis of completely anonymous biological samples?

Yes

No

Identifiable Health Information *Does your study include access, collection, or use of identifiable health information?

Yes

No




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:14 PM

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DIRECTIONS Please answer each of the questions. We will use the information to determine whether we need additional approvals and/or additional information about your research.


Jump To: Jump

Recruitment Information

Recruitment Methods *Please check any of the following methods that will be used to identify and recruit participants for thisstudy:

Advertising

Medical record review

From a database of participants who have given prior permission to be contacted for researchstudies

From personal contact (i.e. patients, former research participants, friends, etc.)

Referrals

Clinical Trials Websites

Internet

Social Media

Other

Recruitment Methods - Other

If you selected "Other", please specify.




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:15 PM

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DIRECTIONS The IRB must approve the methods you will use to recruit participants into your study. Please mark the box beside each method you plan to use. If you later decide to use a method that you previously did not select, you will need to submit a modification to the research to describe the additional recruitment method by updating this form. If you will use any written material for recruitment such as advertisements or flyers, you will need to upload copies of these materials when you complete this form.


Jump To: Jump

HIPAA *You are using identifiable health information for this study. How will you comply with the HIPAArequirements?(Check all that apply)

Signed HIPAA Research Authorization from the participant or the participant's legally authorizedrepresentative

HIPAA Waiver of Authorization for participant identification and recruitment

HIPAA Waiver of Authorization for the study

Not applicable, I am not using identifiable health information for my study




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:16 PM

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If the research requires access to identifiable health information (PHI) held by UC Davis Medical Center, you must comply with the Federal Privacy Rule (HIPAA) requirements by obtaining a signed HIPAA Research Authorization or a HIPAA Waiver of Authorization from the IRB. If you plan to obtain a signed authorization, check the box, "Signed HIPAA Research Authorization from the participant or the participant's legally authorized representative." If you plan to access PHI at UC Davis to identify and/or recruit research participants without a signed authorization, check the box, "HIPAA Waiver of Authorization for participant identification and recruitment." If you plan to access PHI at UC Davis for research purposes, and you will not be obtaining a signed authorization check the box, "HIPAA Waiver of Authorization for the study." An example of this would be a medical chart review. If you are not accessing any identifiable health information for your research, check the box, "Not applicable, I am not using identifiable health information for my study."

Directions

The HIPAA Privacy Rule applies to research involving identifiable health information obtained, accessed or used at the UC Davis Medical Center campus and research sites associated with the medical center. The Rule does not apply to research activities conducted at the UC Davis campus.

If your research site is associated with UCDMC, you will need either an authorization from the individual (or his or her legal representative) or a waiver of authorization from an IRB to obtain, access, use or share identifiable health information (PHI).

This page should be used to request a waiver of authorization if you plan to access PHI for recruitment or obtain, access, use, or share PHI for the research itself.

To approve the waiver, the IRB must make specific determinations.

(1) The IRB must determine that the research activities covered by the waiver involve no more than minimal risk to the privacy of the individual. The regulation provides requirements that must be met to satisfy this criterion, and those requirements are in the list. Each box in the list must be checked to obtain the waiver, and you must have procedures in place to ensure that the requirement is met. The last checkbox pertains to the regulatory requirement for UCDMC to account for every use or disclosure of PHI, and this requirement is explained in P&P 2446.

(2) The IRB must determine that the wavier will not adversely affect the privacy rights of the individual. The waiver of authorization complies with the federal Privacy Rule and California State Law. If other laws or regulations provide a privacy right to the individual in addition to the HIPAA Privacy Rule, then you need to explain how you will comply with that law. Unless the research is being conducted outside of California, the answer to this question would usually be that you are unaware of any other privacy rights of the individuals in your research.

(3) The IRB must determine that you would be unable to conduct the research unless the IRB granted the waiver. The waiver must also cover only the minimum necessary PHI needed to conduct the research. Please tell us the specific PHI you need and why you cannot conduct the research unless the IRB approves the wavier.

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DIRECTIONS If you plan to communicate information about this research by telephone, please indicate "Yes." If you will communicate information about the study by telephone, the IRB will need to review a written script of the information you will provide and the questions you will ask of potential participants. Likewise, if you will use a web page, email or other means to provide information and ask questions of potential participants for recruitment purposes, the IRB will need to see copies of these documents.


Jump To: Jump

Consent *Which of the following are involved?(Check all that apply)

A written consent form signed by study participants

IRB waiver of the requirements for a signed consent form.

IRB approved waiver of consent




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:23 PM

cmgates

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DIRECTIONS The IRB must approve the process you plan to use if you obtain consent. If you plan to conduct the research with a consent process but without having the participants sign the a consent document, please check the box for "IRB waiver of the requirement for a signed consent form." The IRB can waive the requirement for a signed consent form only if the requirements for this waiver are satisfied. You will be asked to provide additional information to help the IRB determine if the requirements are met. If you plan to conduct the research without obtaining consent from participants, please check the box, "IRB approved waiver of consent." The IRB can waive the requirement for consent only if the requirements for this waiver are satisfied. You will be asked to provide additional information to help the IRB determine if the requirements are met.




Jump To: Explain Consent Process Jump

Explain Consent Process *Please describe the consent process.

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IRBNet ID: 7919881

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DIRECTIONS: You have indicated that you will not follow HRP 90 and 91 for your consent process. Please describe your consent process. •Where will the consent process take place •Any waiting period available between informing the prospective subject and obtaining the consent. •Any process to ensure ongoing consent. oThe time that will be devoted to the consent discussion. oSteps that will be taken to minimize the possibility of coercion or undue influence. oSteps that will be taken to ensure the subjects’ understanding.

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Waiver or Alteration of the Consent Process (consent will not be obtained, required information will not be disclosed, or the research involves deception) •Review the “CHECKLIST: Waiver or Alteration of the Consent Process (HRP-410)” to ensure you have provided sufficient information for the IRB to make these determinations. •If the research involves a waiver the consent process for planned emergency research, please review the “CHECKLIST: Waiver of Consent for Emergency Research (HRP-419)” to ensure you have provided sufficient information for the IRB to make these determinations. Subjects who are not yet adults (infants, children, teenagers) •Describe the criteria that will be used to determine whether a prospective subject has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. (E.g., individuals under the age of 18 years.) oFor research conducted in the state, review “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013)” to be aware of which individuals in the state meet the definition of “children.” oFor research conducted outside of the state, provide information that describes which persons have not attained the legal age for consent to treatments or procedures involved the research, under the applicable law of the jurisdiction in which research will be conducted. One method of obtaining this information is to have a legal counsel or authority review your protocol along the definition of “children” in “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013).” •Describe whether parental permission will be obtained from: oBoth parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. oOne parent even if the other parent is alive, known, competent, reasonably available, and shares legal responsibility for the care and custody of the child. •Describe whether permission will be obtained from individuals other than parents, and if so, who will be allowed to provide permission. Describe the process used to determine these individuals’ authority to consent to each child’s general medical care. •Indicate whether assent will be obtained from all, some, or none of the children. If assent will be obtained from some children, indicate which children will be required to assent. •When assent of children is obtained describe whether and how it will be documented. Cognitively Impaired Adults •Describe the process to determine whether an individual is capable of consent. The IRB allows the person obtaining assent to document assent on the consent document and does not routinely require assent documents and does not routinely require children to sign assent documents. Adults Unable to Consent •List the individuals from whom permission will be obtained in order of priority. (E.g., durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.) oFor research conducted in the state, review “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013)” to be aware of which individuals in the state meet the definition of “legally authorized representative.” oFor research conducted outside of the state, provide information that describes which individuals are authorized under applicable law to consent on behalf of a prospective subject to their participation in the procedure(s) involved in this research. One method of obtaining this information is to have a legal counsel or authority review your protocol along the definition of “legally authorized representative” in “SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013).”

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•Describe the process for assent of the subjects. Indicate whether: oAssent will be required of all, some, or none of the subjects. If some, indicated, which subjects will be required to assent and which will not. If assent will not be obtained from some or all subjects, an explanation of why not. oDescribe whether assent of the subjects will be documented and the process to document assent. The IRB allows the person obtaining assent to document assent on the consent document and does not routinely require assent documents and does not routinely require subjects to sign assent documents. Adults Unable to Consent For HUD uses provide a description of how the patient will be informed of the potential risks and benefits of the HUD and any procedures associated with its use. 30)Process to Document Consent in Writing If not following HRP 90 describe whether and how consent of the subject will be documented in writing. If your research presents no more than minimal risk of harm to subjects and involves no procedures for which written documentation of consent is normally required outside of the research context, the IRB will generally waive the requirement to obtain written documentation of consent. (If you will document consent in writing, attach a consent document. If you will obtain consent, but not document consent in writing, attach a consent script. Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” to ensure that you have provided sufficient information. You may use “TEMPLATE CONSENT DOCUMENT (HRP-502)”to create the consent document or script.)

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Jump To: Jump

Request for Waiver of Signed Consent

You indicated that you want the IRB to waive the requirement for a signed consent form. To help the IRB determine whether thesignature can be waived, please answer the following:

Minimal Risk Rationale *Please explain how this research involves only minimal risk.


Written Consent *Does this research involve any procedures for which written consent is usually required?

Yes

No

Confidentiality *Is the only risk involved with this research to the participant's confidentiality?

Yes

No

Consent Document *Is the consent document the only document linking the participant to the research?

Yes

No




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:24 PM

Cindy

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DIRECTIONS A “waiver of documentation of consent” is a waiver of the requirement for a signature on the consent form. Even though the requirement for a signature is waived, investigators must obtain informed consent. “Informed consent” includes providing potential participants with all of the information required by UC Davis policy and federal regulation, so you must have a plan to provide this information to participants either verbally or through a written information sheet. (cont.)

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The IRB can waive the requirement for a signature on a consent form under two sets of circumstances: (1) The research involves only minimal risk to participants; and (2) There are no procedures for which consent is usually required. OR (1) The only document linked to the subject’s identity is the consent document; and (2) The main risk of the research is the consent document. Only the first circumstance above applies to clinical trials under FDA jurisdiction. Please provide information to support each required determination. To determine whether your project involves only minimal risk, consider all of the risks and discomforts participants will face, including physical, psychological, financial, reputational, and employment risks. Then explain how these risks are similar to the risks faced by participants in their normal everyday life.

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Jump To: Jump

Request for Waiver of Consent

You indicated that you want the IRB to waive the requirement for consent. To help the IRB determine whether consent can bewaived, please answer the following:

FDA Regulation *Is this research regulated by the FDA? (If yes, consent cannot be waived.)

Yes

No

Minimal Risk Rationale *Please explain how this research involves only minimal risk.


Participants' Rights *Please explain how waiving consent does not adversely affect the participants' rights.


Reasoning for Waiver *Please explain why this research cannot be conducted without this waiver.



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IRBNet ID: 52862-1


1 of 2 07/10/2014 1:25 PM




2 of 2 07/10/2014 1:25 PM

Cindy

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DIRECTIONS The IRB can approve a waiver of consent only if the following requirements are met: (1)The study is not subject to FDA jurisdiction; (2)The study involves only minimal risk; (3)Waiving consent will not adversely affect the participants’ rights. (4)The research cannot practicably be done without the waiver. Please provide information to support each required determination. To determine whether your project involves only minimal risk, consider all of the risks and discomforts participants will face, including physical, psychological, financial, reputational, and employment risks. Then explain how these risks are similar to the risks faced by participants in their normal everyday life. To determine whether waiving consent will adversely affect a participants’ rights, consider the rights the participants have and provide your opinion as to whether these rights will be adversely affected. To meet the final requirement please consider what would happen to your research if informed consent were required. How would the requirement for consent affect your ability to conduct the research, keeping in mind that the IRB must determine that you will not be able to practicably conduct the research if consent is required.

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DIRECTIONS The IRB provides standard operating procedures for the informed consent process and written documentation of informed consent. If you will be following these standard operating procedures indicate so here.

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Jump To: Compensation for Participation Jump

Compensation for Participation

Compensation *Will the participants receive payment for participation in this research?

Participants will be compensated for their time.

Participants will be reimbursed for their expenses.

Participants will not be compensated or reimbursed.

Total CompensationWhat is the total compensation participants may receive?

Format Font family Font size

Proration of CompensationHow will this compensation be prorated? (e.g. XX per visit)


Form of PaymentWhen and how (form of payment) will participants be compensated?






IRBNet ID: 7919881

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DIRECTIONS The IRB must review the amount and timing of compensation to ensure that undue influence is minimized. If participants will be compensated, describe the total amount of compensation, the timing of payments and the form of payment (check, gift card, etc). If your study includes more than one or two visits, participants must be compensated as the study progresses to avoid undue influence to complete the study.


Jump To: Jump

Drugs and Biologics *Are drugs, biologics or dietary supplements used for research purposes in this study?

Yes

No




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:27 PM

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Jump To: Drugs and Biologics Information Jump

Drugs and Biologics Information

Drug/Biologic 1Drug, Biologic, or Dietary Supplement Name *

Generic Name

FDA Approval *Is this drug, biologic or dietary supplement approved by the FDA?

Yes

No

Potential New Indication or Labeling Change *If approved by the FDA, will the results of this study be reported to the FDA to support a new indication or labelingchange?

Yes

No

N/A

Change in Advertising *If approved by the FDA, will the results of this study be used to support a significant change in advertising?

Yes

No

N/A

Increased Risks Associated with the Drug or Biologic *If approved by the FDA, does this study involve a route of administration, dosage level, or use in a population orother factor that significantly increases the risks (or decreases the acceptability of the risks) associated with thedrug?

Yes

No

N/A

ExplanationIf no, please explain below.


IND *





IRBNet ID: 534401

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Do you have an IND number?Yes

No

IND NumberIf yes, please provide the IND number.

Holder of IND *Who holds the IND?

Sponsor

Investigator

Other

N/A

Holder of IND OtherIf you selected "Other", please specify.

Add Another Drug/Biologic



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General Information The FDA requires an Investigational New Drug Exemption (IND) before an investigational drug or biologic can be investigated in clinical research. In some instances the FDA also requires an IND before a marketed drug or a dietary supplement can be used in clinical research. The FDA does not require an IND for a clinical study of a marketed drug if all of the following are met: (1) The drug product is lawfully marketed in the United States. (2) The study is not intended to be reported to FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling of the drug. (3) The study is not intended to support a significant change in the advertising for the drug. (4) The study does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product. More information on IND requirements can be found on the FDA's website. Directions 1. Enter the trade name of the drug/biologic/dietary supplement in the first text box. If you do not know the trade name, enter N/A. 2. Enter the generic name or the current name used by the sponsor in the second box. 3. Indicate if the FDA has approved (cleared for marketing) the product. If the product is approved, please answer the next question. If the product is not approved, skip to the questions relating to the IND (see #4 below). If the product is approved, answer the next three questions and provide an explanation in the text box, if applicable. 4. Indicate whether there is an IND Number. If there is a number, document the number on this application and indicate who holds the IND. You will also need to submit a document that includes the number such as correspondence from the sponsor or FDA. In some instances the number is included on the protocol. If more than one drug/biologic/dietary supplement is being studies, click “Add Another Drug/Biologic.”

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IRBNet Document WizardUC Davis - Initial Review Application - [52968-1] Test prog flow, paper (pdf) organization & output

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Clinical Trial Phase *Please indicate the phase of this clinical trial:

Phase I

Phase I/II

Phase II

Phase II/III

Phase III

Phase IV

This is not a clinical trial




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1 of 1 01/12/2014 9:55 AM

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Medical Device(s) *Are medical devices to be used for research purposes in this study?

Yes

No




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Jump To: Medical Device(s) Information Jump

Medical Device(s) Information

Medical Device 1Device Name *

IDE/HDE *Do you have an IDE/HDE for use of this device in this study?

Yes

No

N/A

IDE/HDE NumberIf yes, what is the IDE/HDE Number?

Exemption from IDE Requirement *Do you believe this device is exempt from the requirement for an IDE?

Yes

No

N/A

FDA Approval *Is this device approved by the FDA?

Yes

No

Humanitarian Use Device (HUD) *Is this device a Humanitarian Use Device (HUD)?

Yes

No

Use of FDA Approved Device *If this device is approved (including HUD), is it being used according to its approved label?

Yes

No

N/A

Use of NonExempt Device without an IDE *If this device is not exempt from the requirement for an IDE and is not approved by the FDA (or if it is approvedbut is not being used according to its approved label) and you do not have an IDE number please select one of thefollowing:

This device is a significant risk device (SR) (If you choose SR, you will need an IDE to conduct this study)

This device is a nonsignificant risk device (NSR)

N/A

Justification for NSR DeterminationPlease provide justification for the NSR determination.






IRBNet ID: 534401

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Holder of IDE *Who holds the IDE?

Sponsor

Investigator

Other

N/A

Holder of IDE OtherIf you selected "Other," please specify.

Additional InformationFor information: "Significant Risk and Nonsignificant Risk Medical Device Studies"

Add Another Medical Device



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General Information The questions on this page are designed to help the IRB determine whether an IDE is required or to capture information the IRB must obtain about the IDE. The FDA requires an Investigational Device Exemption before a device can be investigated in a clinical trial unless: (1) The device is cleared for marketing and is being used according to its label. (2) The device is a diagnostic devices and the testing is noninvasive; does not require a sampling procedure that presents significant risk, does not introduce energy into the subject; and is not used as a diagnostic procedure without confirmation by another, medical established diagnostic product or procedure. (3) The IRB determines the device is a non-significant risk device. A Humanitarian Device Exemption (HDE) is an exemption for a Humanitarian Use Device (HUD). Please see the FDA Website for more information on HUDs. Directions 1. If you have an IDE/HDE for this study, indicate yes and provide the IDE/HDE number, then answer the four questions. 2. If you believe the device is a non-significant risk device, you must provide justification. You will need to show that the device, as used in your study, does not present a potential for serious risk to the health safety or welfare of the subject. If the device is an implant or if it is used in supporting or maintaining life, or in diagnosing, curing, mitigating or treating disease or impairment of health, the IRB will likely determine that the device is a significant risk device. For additional information, use the link to FDA guidance on “Significant Risk and Non-Significant Risk Device Studies” that is provided on the application. 3. If there is an IDE, indicate who holds the IDE. 4. If additional devices are being studied, click “Add Another Medical Device.”

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International Study *Will you conduct or oversee research outside of the US?

Yes

No







IRBNet ID: 7919881

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DIRECTIONS If any study procedures will be conducted outside of the United States, please mark the “Yes” box. If it is an industry sponsored study please mark “No,” because we do not need additional information.

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International Study Information *How will you comply with the requirements for the conduct of research in locations outside of the US?For information: International Studies





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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:31 PM

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DIRECTIONS If you are conducting research outside of the United States, you must comply with UC Davis policies, applicable US federal regulations, and applicable law in the jurisdiction where the research will be conducted. Whenever possible, you must obtain review of your research by a local ethical review committee or authority. Please describe your plan to comply with these requirements.

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Monitoring for Safety and ComplianceResearch that is greater than minimal risk must be monitored for safety and compliance.

Method for Monitoring Safety *How will this research be monitored for safety?

Medical Monitor

Data Safety Monitoring Committee

Not Applicable/Minimal Risk

Review of DataPlease describe your monitoring plan.


Monitoring of Compliance *Will this study be monitored for compliance? Please confirm.

Yes

No







IRBNet ID: 7919881

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DIRECTIONS Monitoring for Safety If this study is a clinical trial that involves more than minimal risk, please indicate how you plan to monitor this research for safety. The protocol should describe the monitoring plan and address each of the items listed below. If this information is present in the protocol, please state the page/section where it can be found in the space labelled "Review of Data". If this information is not in the protocol, please describe it in the space labelled "Review of Data". • The plan to periodically evaluate the data collected to identify risk issues. • The frequency of data collection, including when safety data collection starts. • Who will review the safety data. • The frequency of review • Any conditions that trigger an immediate suspension of the research. If this research is not a clinical trial, but includes procedures that are greater than minimal risk, you should consider the need to monitor the research data to look for signals that the research involves more risk than was anticipated. Please note that investigator initiated clinical trials must be monitored for both safety and compliance. If you are both the sponsor and the investigator, your protocol must include your plan to comply with this requirement.

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Monitoring for Compliance Please indicate if there is a plan to monitor this research for compliance. Clinical trials must be monitored for compliance with the protocol, UC Davis Policies, applicable regulations and IRB requirements. If this research is sponsored by an entity outside of UC Davis, that entity will be required to monitor the study for compliance. If the research is investigator initiated, the investigator must have a plan to monitor the research for compliance. If this research is not a clinical trial, the requirement for monitoring should be based on the complexity of the research, the number of participants expected to enroll and the experience of the investigator and research staff.

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Number of Participants

*Enrolled means: Consented, meets inclusion and exclusion criteria, and are scheduled to participate/areparticipating/or have participated in the research in accordance with protocol. For charts/records that willbe reviewed and specimens to be collected/obtained, please provide the total number that will bereviewed.

Study-Wide *Number of anticipated participants enrolled* study-wide.

Locally *Number of anticipated participants enrolled* locally (under UC Davis PI Oversight).




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:33 PM

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DIRECTIONS Please indicate the number of participants you plan to enroll. If this study will be conducted at additional sites, please also indicate the total number of participants to be enrolled study-wide. If this study will only be conducted at UC Davis, the number of participants study-wide and locally are the same. An “enrolled” participants is considered to have: (1)Given consent; (2)Met formal inclusion and exclusion criteria; and (3)Will participate in the research If this study involves only record review or examination of bio-specimen samples and a waiver of informed consent is being requested, please give an approximate number of records that will be reviewed or specimens that will be analyzed. Please consider this number carefully and take steps to avoid over-enrollment. For example, if your study involves no more than minimal risk, provide the uppermost number of participants you could reasonably enroll. Providing the uppermost number will prevent you from having to submit a modification to increase enrollment and will also help to prevent a finding of non-compliance for over-enrollment.

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IRBNet Document WizardUC Davis - Initial Review Application - [52973-1] PDF Test

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Vulnerable Participants *Which of the following categories of vulnerable participants will be recruited/enrolled into your study?

Children

Pregnant Women/Fetuses

Neonates

Prisoners (prisoners in California may not be included in clinical trials or other biomedical studies)

Cognitively Impaired Adults

Students

Employees of UC Davis

None of the above




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IRBNet ID: 52973-1


1 of 1 30/10/2014 8:30 AM

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DIRECTIONS UC Davis policy and federal regulations identify several categories of participants considered vulnerable to coercion and undue influence. The IRB must make specific determinations that could affect whether participants from one or more of the listed categories can enroll in the study. If you plan to enroll any participants from any of the listed categories, please check the box beside the applicable category(ies). If, during the course of the research, you find that you want to enroll participants form one or more categories and you did not indicate this intention in your initial submission form, you must submit a modification to the IRB requesting approval of the enrollment of the vulnerable participants.

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Children Participant Information

Category Research for Children *Regulations require that research fall under an approval category before children can be included. Please selectthe applicable category for your research and provide protocol specific justification for inclusion.

Minimal Risk Research

Greater than Minimal Risk Research with prospect of direct benefit

Greater than Minimal Risk with no prospect of direct benefit

NoteIf the research does not fit within a category above, please call the IRB for additional information. Parental Permission *Permission for the childs participation will be obtained from:

Both parents, unless one parent is deceased, unknown, incompetent, or not available, or when only oneparent has legal responsibility for the care and custody of the child. (If the research involves greater thanminimal risk with no direct benefit)

One parent (or legal guardian)

Neither parent (nor guardian) as this research meets the requirements for a waiver of consent

Obtaining Assent from Children *The IRB allows the person obtaining assent to document the assent on the consent form. Children are notroutinely required to sign an assent document.(Check all that apply)

Assent will be obtained from all children capable of assenting

Assent will not be obtained from children who are too young to understand the research

Assent will not be obtained from children because this research meets the requirements for a waiver ofconsent

Assent will be documented by the person obtaining assent on the consent document

Children who can read will be given an Information Sheet about the study

Justification For Not Obtaining AssentIf assent will not be obtained from some or all of the children and the reasons are not described above, describethe children from whom assent will not be obtained and provide justification why assent will not be obtained.







IRBNet ID: 534401

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DIRECTIONS

UC Davis policy and federal regulations require the IRB to make specific determinations before the IRB can approve the enrollment of children into a research study. The information you provide in this section will help us make the required determinations. Category Research for Children An IRB can approve the inclusion of children in a research study only if the research falls under one of the following three categories.

1. Minimal Risk, which means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. [see federal regulation 45 CFR 46.102(i); and 21 CFR 56.102(i)]

2. Greater than minimal risk but a prospect of direct benefit - The IRB can only approve enrollment of children in this category if: (1) the risk is justified by the potential of direct benefit to the subject; and (2) the relation to the anticipated benefit to the risk is at least as favorable as that presented by available alternatives.

3. Greater than Minimal Risk with no prospect of direct benefit - The IRB can only approve enrollment of children in this category if: (1) the risk represents only a minor increase over minimal risk; (2) the procedures present experiences to participants that are reasonably equal to the experiences inherent in the child’s actual expected medical, dental, psychological, social or educational situations; (3) the research is likely to yield generalizable knowledge about the subject’s disorder or condition that is of vital importance to understanding or improvement in treating the disorder or condition.

If your research does not seem to fit under any of the above categories, please contact the IRB before submitting it.

Parental Permission The IRB must determine whether permission must be obtained from one parent or both parents. If the research fits under the first or second category above, the IRB will usually determine that permission from only one parent is sufficient. However, if your study fits under the third category, the IRB will be required to determine that permission from both parents is required, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. In very rare instances, the IRB can waive the requirement for parental permission. If your research does not involve a medical experiment and you want to conduct the research without permission from a parent, please contact the IRB for more information. Obtaining Assent from Children The IRB must determine whether assent from the child will be required. The IRB is only allowed to waive the requirement for assent if:

(1) The capability of the child is so limited that he/she cannot reasonably understand the risks/benefits;

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(2) The research holds out a prospect of direct benefit that is important to the health or well-being of the children that is only available through the research;

(3) The research involves only minimal risk, waiving assent will not adversely affect the child’s rights; and the research could not be done without waiving the requirements for assent.


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Minimal Risk to Children *Please explain how this research presents no more than minimal risk to the children.





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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:36 PM

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DIRECTIONS Please describe how the potential risks and discomforts involved in the research fall under the definition of "minimal risk", which means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. [federal regulation 45 CFR 46.102(i); and 21 CFR 56.102(i)] Please consider the risks and discomforts of each research procedure.

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Greater Than Minimal Risk Rationale *Please explain how this research involves greater then minimal risk.





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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:37 PM

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DIRECTIONS You have indicated that this study is classified as greater than minimal risk. Please explain why your research involves greater than minimal risk of harm or discomfort.

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Prospect of Direct Benefit Rationale *Please explain how the research presents the prospect of direct benefit to the children.





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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:38 PM

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DIRECTIONS You have indicated that this study is classified as greater than minimal risk. Please list the possible direct benefit(s) children may receive if they participate in this research. Please note that payment and/or gifts for participation are considered compensation, not benefits.

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DIRECTIONS You have indicated that this study is classified as greater than minimal risk. Please provide justification for the exposing children to the risks associated with participating in this study based on the anticipated direct benefits.

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Relation of Anticipated Benefit to Risk *Please explain how the relation of the anticipated benefit to the risk is at least as favorable to the children as that presented byalternative approaches.





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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:40 PM

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DIRECTIONS You have indicated that this study is classified as greater than minimal risk. Consider the potential benefits and risk of any currently available alternatives that might be available to the child, and compare those potential benefits and risks to the potential benefits and risks the child might experience from enrollment in this research. Then describe how the risk/benefit profile associated with this study is at least as favorable as the risk/benefit profile of the alternatives.

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No Prospect of Direct Benefit Rationale *Please explain how this research involves a minor increase over minimal risk.





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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:41 PM

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DIRECTIONS You have indicated that this study is greater than minimal risk with no prospect of direct benefit. UC Davis Policy and the federal regulations do not allow children to be enrolled in research that does not offer a potential for direct benefit unless the risks associated with the research are no more than a minor increase over minimal risk. Consider each protocol procedure. Determine whether the procedure involves more than minimal risk. Then determine whether the risk is only a minor increase over minimal risk. Risk that is only a minor increase over minimal risk are a little more than minimal and post no significant threat to the child’s health or well-being. For example, consider the following levels of risk associated with collecting a urine specimen: 1.Urine collection cup or bag = Minimal Risk 2.Inserting a catheter into the urethra = Minor increase over minimal because inserting the catheter involves a risk of infection. 3.Inserting a needle into the bladder (suprapubic tap) = Greater than minimal because inserting a needle involves discomfort, a risk of infection and a risk of other injury. Usually collecting a blood sample though venipuncture or fingerstick is considered a minimal risk procedure. However, the risk associated with inserting and using an indwelling catheter to obtain blood samples could range from minimal to a minor increase over minimal risk depending on several factors such as the length of time the catheter will be in place and the number of blood samples that will be collected. Please explain why your research involves only a minor increase over minimal risk.

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Experiences Presented by Intervention *Please explain how the intervention presents experiences to the children that are reasonably commensurate with those inherentin their actual or expected medical, dental, psychological, social, or educational situations.





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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:42 PM

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DIRECTIONS You have indicated that this study is greater than minimal risk with no prospect of direct benefit. Please explain how the procedures the children in this this study will experience are not substantially different from the experiences children experience in their normal life. For example: Suppose the study involves children who will receive an intravenous infusion of normal saline (placebo) followed by five blood draws through the intravenous catheter. Children must remain overnight The procedures in this study include an overnight stay at the research facility, insertion of an intravenous catheter, administration of intravenous IV fluids and removal of 30 ml of blood through the catheter. Children with diabetes are sometimes hospitalized for complications of their disease, and staying at the research facility overnight will be similar to hospitalization. Children with diabetes receive IV fluids when they experience complications. They also have blood drawn to monitor their disease. In some instances, an IV catheter may be inserted to obtain serial blood samples.

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Generalizable Knowledge *Please explain how the intervention or procedure is likely to yield generalizable knowledge about the child's disorder orcondition which is of vital importance for understanding or amelioration of the child's disorder for condition.





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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:42 PM

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DIRECTIONS Children enrolled in research that involves a minor increase over minimal risk and no prospect of benefit must have a disorder or condition, and the research procedures or interventions must have a high probability of generating important knowledge about the disorder or condition. Please describe the knowledge that is likely to be gained and also describe the importance of that knowledge. For example: The children enrolled in this study have all been diagnosed with autism. If this new device can accurately diagnose autism, children can be diagnosed at a much earlier age and treatment for their autism can also begin earlier.

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Cognitively Impaired Adults

Determining Capacity for Consent *Describe your process for determining whether an adult has capacity to consent.


California Requirements for Surrogate Consent *Will you follow California requirements for surrogate consent?

Yes

No

Assent from Cognitively Impaired Adults *Will assent be obtained from all adults who lack capacity to consent and are capable of assenting?

Yes

No

Obtaining Consent When and If She/He Regains Capacity *Will you obtain consent from the participant when s/he regains capacity?

Yes

No




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:43 PM

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DIRECTIONS

Determining Capacity for Consent UC Davis policy and federal regulations require investigators to obtain “legally effective informed consent.” One major element of legally effective information consent is ensuring that the person who consents has the authority to give consent. To ensure you obtain legally effective informed consent, you must:

(1) Obtain consent from the participant if he/she has capacity to consent. (2) Obtain consent from the individual who has authority to make decision on behalf of the

potential participant, if the participant is incapacitated. In rare instances, a participant may appear to have capacity but a Court has decided the individual is incompetent and has appointed a guardian to make decisions for the participant. In these instances, the guardian must give consent for the participant’s enrollment.

In most cases, you will need a process for determining whether a potential participant has capacity to personally consent. Please document the steps you will take to make this determination.

California Requirements for Surrogate Consent If you determine the potential participant does not have capacity to consent, you will need to ensure you obtain consent from an individual who has the actual authority to consent to the participant’s enrollment. We provided a link to the California requirements for surrogate consent to help you determine whether an individual has the authority to consent on behalf of the participant. Assent from Cognitively Impaired Adults Even if the participant cannot “consent,” he or she may be able to agree or disagree to participation. This agreement is called “assent” and disagreement is called “dissent.” In most instances, individuals should not be included in research if they do not affirmatively agree to participate (assent). If a potential participant indicates that he/she does not want to enroll, you should almost always honor the individual’s decision, even if you are able to obtain consent from someone with authority. Obtaining Consent When and If She/He Regains Capacity If there is a chance that participants will not have capacity to consent when they enroll but may later gain such capacity, you must obtain consent from the individual before you have interactions or interventions with the participant and before you access private identifiable information about the individual.

IRBNet Document WizardUC Davis - Initial Review Application - [52973-1] PDF Test

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Justification for Inclusion of Students *If these are your students, please justify their inclusion and describe how you will reduce undue influence and coercion. If theseare not your students, please mark N/A in the textbox below.





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IRBNet ID: 52973-1


1 of 1 29/10/2014 10:54 AM

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DIRECTIONS You have indicated that your plan to enroll students of the principal investigator. In many instances, a student can be vulnerable to coercion or undue influence when recruited into research at the institution they attend. This is especially true if their instructor, advisor or other influential person is conducting the recruiting and consenting procedures. If you are recruiting your own students, please justify their inclusion and describe the steps you will take to reduce feelings of coercion and/or undue influence.


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Tissue Banking *Will human tissue be banked for future use?

Yes

No




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:45 PM

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DIRECTIONS Please answer “yes” if you plan to bank any human tissue such as blood, biopsies, leftover tissue from surgeries, etc.


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Tissue Banking Information

Collection *How is the tissue collected?

Storage *Where will the specimens be stored?

Duration of Storage *How long will the specimens be stored?

Access to Specimens *Who will have access to the specimens?

Identifiers Stored With Specimens *Will any identifiers be stored with the specimens?

Yes

No

Coded and Linked Specimens *Will the specimens be coded and linked to the individual?

Yes

No

Identifiable Data *Will any identifiable data be stored with the specimens?

Yes

No




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:45 PM

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See Directions below

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DIRECTIONS

To approve blood and tissue banking, the IRB must ensure that minimum requirements are met for tissue collection, tissue maintenance and tissue distribution.

Two issues are very important:

(1) Whether the blood and tissue were or are being collected solely for the research or for another purpose such as standard care or a different research study; and

(2) Whether the blood and tissue will be received by the research in a manner that is identifiable, coded or anonymous.

You should be aware that in almost all instances where the research has an interaction with the individual from whom a specimen will be obtained, informed consent will required.

In some instances IRB oversight will not be required for activities involving collection or use of tissue. The requirement for IRB oversight depends upon the reason the specimen was collected and whether the specimen includes identifying information. Often terms relating to whether tissue are identifiable are used incorrectly.

Identifiable means the specimen includes identifying information about the individual from whom the tissue was obtained. Information includes, initials, any dates relating to the individual, any medical record numbers or account numbers relating to the individual, etc.

Coded means that no identifying information about the individual from whom the tissue was obtained is included with the specimen. Instead, a code of some type accompanies the specimen and the code can be linked to the individual by someone outside of the research. There must be an agreement or protocol stating that no one in the research will be able to access the individual’s identity for as long as the individual is alive.

Anonymous means that no identifying information about the individual from whom the specimen was obtainŜŘ ŀƴŘ ƴƻ ŎƻŘŜ ƭƛƴƪƛƴƎ ǘƘŜ ǎǇŜŎƛƳŜƴ ǘƻ ǘƘŜ ƛƴŘƛǾƛŘǳŀƭ ŦǊƻƳ ǿƘƻƳ ƛǘ ǿŀǎ ƻōǘŀƛƴŜŘ ƛǎ ƛƴŎƭǳŘŜŘ ǿƛǘƘ ǘƘŜ ǎǇŜŎƛƳŜƴΦ

Use of anonymous specimens collected for a purpose other than the research is not “human subject research” (HSR) requiring IRB review. In addition, when specific requirements are met, use of coded specimen that were collected for a purpose other than the research is also not HSR.

In most other instances, the use of the specimen will be considered HSR, and the collection, maintenance and use of the specimen will require (1) an exemption determination or (2) approval through the expedited review procedure or full committee review procedure.


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Data Confidentiality *I confirm that only authorized persons will be granted access to the identifiers; identifiers stored oncomputers, electronic notebooks, mobile devices, and/or data-storage devices will be encrypted andpassword protected; identifiers maintained in paper format will be kept in a locked area with access limitedonly to research staff who require access to conduct the study.

Yes

No




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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:46 PM

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DIRECTIONS The IRB cannot approve the research unless it can determine that there are adequate provisions to protect the confidentiality of the data. Anyone submitting studies to the IRB should agree to these minimum standards for protecting the confidentiality of the data, especially if the data are sensitive, in nature. If you are unable to commit to these standards, please contact the IRB Office.

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PI Assurance *I attest, as the PI, that all personnel assigned to this study are qualified to perform the protocol proceduresassigned to them, have completed required CITI/NIH training, have reported any and all conflicts of interestto the UC Davis Conflict of Interest Committee, and will receive appropriate training on the protocol prior toengaging in research activities.

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IRBNet ID: 7919881

cmgates

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cmgates

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cmgates

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DIRECTIONS It is very important that investigators understand the obligations they are assuming when they accept the role of PI for a study. Investigators may delegate duties, but they cannot delegate responsibilities, meaning they must actively supervise the research. The first responsibility is to ensure that any individual delegated to perform research-related procedures must: (1)Be qualified to conduct each delegated procedure; (2)Complete required training on human subjects research and GCP, when required; (3)Complete training on the protocol and the protocol procedures for which the individual will be delegated; and (4)Report all conflicts of interests. If any individual performs research procedures without meeting the prerequisites above, the PI will be considered non-compliant with IRB requirements. This responsibility continues throughout the conduct of the study as additional research staff are added to the research.

nwalters

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nwalters

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Form Complete

Thank you for completing this application form. Please review it for accuracy and obtain the signatures onHRP-226. By submitting this application, the PI agrees to comply with all IRB and protocol requirementslisted in HRP-103.Please upload the following additional documentation in the IRBNet Designer:

Conflict of Interest Committee (COIC) Letter (If not yet recieved, submit when available)HRP-226 Administrative ApprovalHRP-503 ProtocolQuestionnaires/Surveys/Interview Questions (if applicable)Form 1571 and Product LabelingCancer Center Scientific Review Committee (CCSRC) ApprovalRadiation Use Committee (RUC) ApprovalInstitutional Biosafety Committee Approval for Stem Cell researchSCRO submissionInstitutional Biosafety Committee Approval for research involving Recombinant DNA Molecules,Human Gene Transfer, infectious agents, or biohazardous materialRecombinant DNA Advisory Committee (RAC) ApprovalQCT FormRecruitment MaterialScreening ScriptConsent DocumentConsent Script or Information SheetInclude IB or Package InsertEvidence of IND (FDA Letter, etc. If listed in protocol, you do not need to upload another document)Evidence of IDE (FDA Letter, etc. If listed in protocol, you do not need to upload another document)and Product Labeling

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IRBNet ID: 52862-1


1 of 1 07/10/2014 1:47 PM

nwalters

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nwalters

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r...uc davis initial review application [534301] screen shots jump to: other irb project information...

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