r...UC Davis Initial Review Application [534301] screen shots Jump To: Other IRB Project Information...
Transcript of r...UC Davis Initial Review Application [534301] screen shots Jump To: Other IRB Project Information...
IRBNet Document WizardUC Davis - Project Information Worksheet - [52832-1] Smart Form Screen Shots
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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
IRBNet Document WizardUC Davis - Project Information Worksheet - [52832-1] Smart Form Screen Shots
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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
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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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IRBNet ID: 7919881
IRBNet Document WizardUC Davis - Project Information Worksheet - [52832-1] Smart Form Screen Shots
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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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1 of 1 01/10/2014 11:36 AM
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IRBNet Document WizardUC Davis Initial Review Application [7919881] Smart Form Screen Shots
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
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IRBNet ID: 7919881
IRBNet Document WizardUC Davis - Project Information Worksheet - [52832-1] Smart Form Screen Shots
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Primary Contact *Is the Principal Investigator the primary contact for this study?
Yes
No
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IRBNet Document WizardUC Davis Initial Review Application [7919881] Smart Form Screen Shots
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
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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
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If you have an IDE, who is the IDE Holder?
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IRBNet Document WizardUC Davis - Project Information Worksheet - [52832-1] Smart Form Screen Shots
Jump To: Jump
Additional Personnel *Are there additional personnel for this study?
Yes
No
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IRBNet Document WizardUC Davis Initial Review Application [7919881] Smart Form Screen Shots
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
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IRBNet ID: 7919881
IRBNet Document WizardUC Davis - Project Information Worksheet - [52832-1] Smart Form Screen Shots
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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 Document WizardUC Davis - Project Information Worksheet - [52855-2] How to manage your anger
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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
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1 of 1 03/10/2014 12:33 PM
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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1 of 1 03/10/2014 2:29 PM
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IRBNet Document WizardUC Davis Initial Review Application [7919881] Smart Form Screen Shots
Jump To: Funding Information Jump
Funding Information *How is this study funded or supported?
Industry Sponsored
Federal Grant
Other Grant
Department Funded
Other
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IRBNet ID: 7919881
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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Industry Sponsor(s) Information
Industry Sponsor Name *1.
Add Another Sponsor
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1 of 1 03/10/2014 2:46 PM
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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Other Funding *As you selected "Other" as a funding source, please specify.
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1 of 1 03/10/2014 3:09 PM
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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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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1 of 1 03/10/2014 3:10 PM
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IRBNet Document WizardUC Davis Initial Review Application [7919881] Smart Form Screen Shots
Jump To: Research Location Information Jump
Research Location Information
Research Setting *Format Font family Font size
Resources Available *Format Font family Font size
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IRBNet Document WizardUC Davis Initial Review Application [7919881] Smart Form Screen Shots
Jump To: External Sites Jump
External Sites *Will you conduct or oversee research at one or more external sites?
Yes
No
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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
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IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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Multi-Site *Is this research part of a collaborative, multi-site project?
Yes
No
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1 of 1 03/10/2014 3:46 PM
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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Coordinating Study *Is UC Davis the Coordinating Center for this study?
Yes
No
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1 of 1 03/10/2014 3:49 PM
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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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
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1 of 1 03/10/2014 3:51 PM
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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Investigator Initiated *Is this research investigator-initiated?
Yes
No
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1 of 1 07/10/2014 1:12 PM
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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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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1 of 1 07/10/2014 1:13 PM
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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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
Save and Exit Preview ( * required ) Previous Next
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IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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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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1 of 1 07/10/2014 1:15 PM
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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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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1 of 1 07/10/2014 1:16 PM
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.
IRBNet Document WizardUC Davis - Project Information Worksheet - [52862-1] xx
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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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Explain Consent Process *Please describe the consent process.
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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.
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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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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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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.
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Participants' Rights *Please explain how waiving consent does not adversely affect the participants' rights.
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Reasoning for Waiver *Please explain why this research cannot be conducted without this waiver.
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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?
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Proration of CompensationHow will this compensation be prorated? (e.g. XX per visit)
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Form of PaymentWhen and how (form of payment) will participants be compensated?
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Drugs and Biologics *Are drugs, biologics or dietary supplements used for research purposes in this study?
Yes
No
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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.
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IND *
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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.
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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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Medical Device(s) *Are medical devices to be used for research purposes in this study?
Yes
No
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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.
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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"
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International Study *Will you conduct or oversee research outside of the US?
Yes
No
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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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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.
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Monitoring of Compliance *Will this study be monitored for compliance? Please confirm.
Yes
No
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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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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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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.
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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;
(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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Greater Than Minimal Risk Rationale *Please explain how this research involves greater then minimal risk.
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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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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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No Prospect of Direct Benefit Rationale *Please explain how this research involves 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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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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Cognitively Impaired Adults
Determining Capacity for Consent *Describe your process for determining whether an adult has capacity to consent.
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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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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.
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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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Tissue Banking *Will human tissue be banked for future use?
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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?
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Coded and Linked Specimens *Will the specimens be coded and linked to the individual?
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Identifiable Data *Will any identifiable data be stored with the specimens?
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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.
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IRBNet Document WizardUC Davis Initial Review Application [7919881] Smart Form Screen Shots
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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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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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