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6 IRBNet: 1 of 1 01/10/ :17 AM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] 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. What would you like to do? Create a new wizard from scratch. Clone one of my existing wizards. Continue Cancel Copyright Research Dataware. All Rights Reserved.

7 IRBNet: 1 of 1 01/10/ :31 AM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] Smart Form Screen Shots General Instructions Jump To: Jump Please download and use the "IRBNet User Manual" in the Library to complete this application All research personnel must complete required training. Please answer all questions. You can save your work, so you do not need to complete the submission in one sitting. When you complete the form, a checklist will appear to assist with compiling required documents. Please update this form as changes are made to this project Save and Exit Preview Next Copyright Research Dataware. All Rights Reserved.

8 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Track Training (26) Library Manager Principal Investigator Information Please enter the following information for the PI, Cindy Gates. PI Title * PI Degrees * PI Department * Jump To: Principal Investigator Information Jump PI Department Other If you selected "Other," please specify the PI's department. PI Phone * PI * Consent * Will the Principal Investigator be involved in the consent process? Copyright Research Dataware. All Rights Reserved. 1/1

9 IRBNet: 1 of 1 01/10/ :36 AM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] Smart Form Screen Shots Jump To: Co-Principal Investigator(s) * Is there a Co-Principal Investigators? A co-pi is required for all clinical trials. Jump Copyright Research Dataware. All Rights Reserved.

10 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Track Training (26) Library Manager Jump To: Co Principal Investigator Information Jump Co Principal Investigator Information Co PI First Name * Co PI Last Name * Co PI Degrees * Co PI Title * Co PI Department * Co PI Department Other If you selected "Other," please specify the Co PI's department. Co PI Phone * Co PI * Co PI Obtain Consent * Will the co Principal Investigator be involved in the consent process? Copyright Research Dataware. All Rights Reserved. 1/1

11 IRBNet: 1 of 1 01/10/ :43 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] Smart Form Screen Shots Jump To: Primary Contact * Is the Principal Investigator the primary contact for this study? Jump Copyright Research Dataware. All Rights Reserved.

12 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Track Training (26) Library Manager Primary Contact Information Please enter provide the following information for the primary contact. Primary Contact First Name * Primary Contact Last Name * Primary Contact Phone * Primary Contact * Jump To: Primary Contact Information Jump Primary Contact Obtain Consent * Will the primary contact be involved in the consent process? Copyright Research Dataware. All Rights Reserved. 1/1

13 2/10/2015 IRBNet: IRBNet ID: UC Davis Initial Review Application [ ] screen shots My Reminders (29) Review Information Jump To: Review Information Jump Reviewing IRB * Are you relying on an IRB other than the UC Davis IRB? External Sites Relying on UC Davis IRB * Are any external sites relying on the UC Davis IRB? UC Reliance * Is this review part of the UC Reliance? UC Reliance Number If yes, please provide the Reliance Number Copyright Research Dataware. All Rights Reserved. 1/1

14 2/10/2015 IRBNet: IRBNet ID: UC Davis Initial Review Application [ ] screen shots My Reminders (29) Other IRB Project Information Author of Protocol * Research Supported by CTSC? * Is this research supported by CTSC? Jump To: Other IRB Project Information Jump Epic EMR * Does your study bill visits or procedures using Epic EMR? 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? * IND Number If you have an IND, what is the IND Number? Holder of IND If you have an IND, who is the IND Holder? Do you have an IDE/HDE? * IDE Number If you have an IDE, what is the IDE Number? Holder of IDE 1/2

16 IRBNet: 1 of 1 01/10/2014 1:04 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] Smart Form Screen Shots Additional Personnel * Are there additional personnel for this study? Jump To: Jump Copyright Research Dataware. All Rights Reserved.

17 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Track Training (26) Library Manager Additional Personnel Information Please provide the following for each additional personnel for this study. Person 1 First Name * Last Name * Degrees * Title * Jump To: Additional Personnel Information Jump Consent * Will this person participate in the consent process? Sub Investigator * Is this individual a sub investigator? Add Another Person Copyright Research Dataware. All Rights Reserved. 1/1

18 IRBNet: 1 of 1 01/10/2014 1:17 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] Smart Form Screen Shots Jump To: Related Financial Interest * Do any personnel involved in the design, conduct or reporting of the protocol have a Related Financial Interest? Jump Copyright Research Dataware. All Rights Reserved.

19 IRBNet: 1 of 1 03/10/ :33 PM IRBNet ID: My Reminders (26) Reviews UC Davis - Project Information Worksheet - [ ] How to manage your anger Related Financial Interest Information Jump To: Jump Financial Interest Disclosure Forms * Have you submitted the appropriate financial interest disclosure forms? (e.g. 700-U, Form 800 and Supplemental form) which can be found online at the Office of Research Webpage? Conflict of Interest * Does your study have any actual or perceived conflict of interest as defined by institutional policies, PPM or PPM , which can be found at the Office of Research webpage? Copyright Research Dataware. All Rights Reserved.

20 IRBNet: 1 of 1 03/10/2014 2:29 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Protocol Information Protocol Title * Jump To: Author * Who authored (wrote) the protocol? Previous IRB Review * Has this study previously been reviewed by an IRB? Previous Reviews If yes, please explain. Jump Copyright Research Dataware. All Rights Reserved.

21 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Funding Information * How is this study funded or supported? Jump To: Funding Information Jump Industry Sponsored Federal Grant Other Grant Department Funded Other Track Training (26) Library Manager Copyright Research Dataware. All Rights Reserved. 1/1

22 IRBNet: 1 of 1 03/10/2014 2:46 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Industry Sponsor(s) Information Jump To: Jump Industry Sponsor Name * 1. Add Another Sponsor Copyright Research Dataware. All Rights Reserved.

24 IRBNet: 1 of 1 03/10/2014 3:09 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Other Funding * As you selected "Other" as a funding source, please specify. Jump Copyright Research Dataware. All Rights Reserved.

25 IRBNet: 1 of 1 03/10/2014 3:10 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Clinical Trial Billing Information * Does your study bill visits or procedures as required by the protocol to either insurance, patient or study using Epic EMR? Jump Copyright Research Dataware. All Rights Reserved.

26 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Research Location Information Research Setting * Jump To: Research Location Information Jump Format Font family Font size Track Training (26) Library Manager Resources Available * Format Font family Font size Copyright Research Dataware. All Rights Reserved. 1/1

28 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) External Sites * Will you conduct or oversee research at one or more external sites? Jump To: External Sites Jump Track Training (26) Library Manager Copyright Research Dataware. All Rights Reserved. 1/1

29 2/12/2015 IRBNet: IRBNet ID: UC Davis Initial Review Application [ ] Here we go again My Reminders (29) External Site(s) Information Jump To: External Site(s) Information Jump List each external research site at which the PI will conduct or oversee the protocol: Site 1 Site Name * Contact Name * Contact * Add Another Site Copyright Research Dataware. All Rights Reserved. 1/1

30 IRBNet: 1 of 1 03/10/2014 3:46 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Multi-Site * Is this research part of a collaborative, multi-site project? Jump Copyright Research Dataware. All Rights Reserved.

31 IRBNet: 1 of 1 03/10/2014 3:49 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Coordinating Study * Is UC Davis the Coordinating Center for this study? Jump To: Jump Copyright Research Dataware. All Rights Reserved.

32 IRBNet: 1 of 1 03/10/2014 3:51 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) IRB of Record * Is UC Davis the IRB of record for this study? Jump To: Jump Copyright Research Dataware. All Rights Reserved.

33 IRBNet: of /10/2014 1:12 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Investigator Initiated * Is this research investigator-initiated? Jump To: Jump Copyright Research Dataware. All Rights Reserved.

34 IRBNet: 1 of 1 07/10/2014 1:13 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: UC Davis Clinical and Translational Science Center * Is this research supported by the UC Davis Clinical and Translational Science Center (CTSC)? Jump Copyright Research Dataware. All Rights Reserved.

35 IRBNet: 1 of 1 07/10/2014 1:14 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Study Information Jump To: Cancer Patients * Does your study involve cancer patients or their data? Radiation * Does your study involve radiation? Stem Cells * Does your study involve stem cells? Hazardous Material * Does your study involve Recombinant DNA Molecules, Human Gene Transfer, infectious agents, or biohazardous material? Patient Care Services * Does your study include patient care services billed in the UC Davis Health System? Coded/Linked Biological Samples * Does your study include the analysis of coded and linked biological samples? Anonymous Biological Samples * Does your study include the analysis of completely anonymous biological samples? Identifiable Health Information * Does your study include access, collection, or use of identifiable health information? Jump Copyright Research Dataware. All Rights Reserved.

36 IRBNet: 1 of 1 07/10/2014 1:15 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Recruitment Information Jump To: Recruitment Methods * Please check any of the following methods that will be used to identify and recruit participants for this study: Advertising Medical record review From a database of participants who have given prior permission to be contacted for research studies From personal contact (i.e. patients, former research participants, friends, etc.) Referrals Clinical Trials Websites Internet Jump Social Media Other Recruitment Methods - Other If you selected "Other", please specify. Copyright Research Dataware. All Rights Reserved.

37 IRBNet: 1 of 1 07/10/2014 1:16 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: HIPAA * You are using identifiable health information for this study. How will you comply with the HIPAA requirements? (Check all that apply) Signed HIPAA Research Authorization from the participant or the participant's legally authorized representative HIPAA Waiver of Authorization for participant identification and recruitment HIPAA Waiver of Authorization for the study t applicable, I am not using identifiable health information for my study Jump Copyright Research Dataware. All Rights Reserved.

39 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 (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.

41 IRBNet: 1 of 1 07/10/2014 1:23 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Consent * Which of the following are involved? (Check all that apply) Jump To: A written consent form signed by study participants IRB waiver of the requirements for a signed consent form. IRB approved waiver of consent Jump Copyright Research Dataware. All Rights Reserved.

42 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Explain Consent Process * Please describe the consent process. Jump To: Explain Consent Process Jump Paragraph Font family Font size Track Training (26) Library Manager Copyright Research Dataware. All Rights Reserved. 1/1

45 IRBNet: 1 of 1 07/10/2014 1:24 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Request for Waiver of Signed Consent Jump To: You indicated that you want the IRB to waive the requirement for a signed consent form. To help the IRB determine whether the signature can be waived, please answer the following: Minimal Risk Rationale * Please explain how this research involves only minimal risk. Paragraph Font family Font size Jump Written Consent * Does this research involve any procedures for which written consent is usually required? Confidentiality * Is the only risk involved with this research to the participant's confidentiality? Consent Document * Is the consent document the only document linking the participant to the research? Copyright Research Dataware. All Rights Reserved.

46 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.

47 IRBNet: 1 of 2 07/10/2014 1:25 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Request for Waiver of Consent Jump To: You indicated that you want the IRB to waive the requirement for consent. To help the IRB determine whether consent can be waived, please answer the following: FDA Regulation * Is this research regulated by the FDA? (If yes, consent cannot be waived.) Minimal Risk Rationale * Please explain how this research involves only minimal risk. Paragraph Font family Font size Jump Participants' Rights * Please explain how waiving consent does not adversely affect the participants' rights. Paragraph Font family Font size Reasoning for Waiver * Please explain why this research cannot be conducted without this waiver. Paragraph Font family Font size

52 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Compensation for Participation Compensation * Will the participants receive payment for participation in this research? Jump To: Compensation for Participation Jump Participants will be compensated for their time. Total Compensation What is the total compensation participants may receive? Participants will be reimbursed for their expenses. Participants will not be compensated or reimbursed. Format Font family Font size Track Training (26) Library Manager Pro ration of Compensation How will this compensation be pro rated? (e.g. XX per visit) Format Font family Font size Form of Payment When and how (form of payment) will participants be compensated? Format Font family Font size 1/2

54 IRBNet: 1 of 1 07/10/2014 1:27 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Drugs and Biologics * Are drugs, biologics or dietary supplements used for research purposes in this study? Jump Copyright Research Dataware. All Rights Reserved.

55 2/12/2015 IRBNet: IRBNet ID: UC Davis Initial Review Application [ ] Here we go again My Reminders (29) Drugs and Biologics Information Drug/Biologic 1 Drug, Biologic, or Dietary Supplement Name * Generic Name FDA Approval * Is this drug, biologic or dietary supplement approved by the FDA? Jump To: Drugs and Biologics Information Jump 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 labeling change? Change in Advertising * If approved by the FDA, will the results of this study be used to support a significant change in advertising? 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 or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the drug? Explanation If no, please explain below. N/A N/A Format Font family Font size IND * 1/2

56 2/12/2015 IRBNet: Do you have an IND number? IND Number If yes, please provide the IND number. Holder of IND * Who holds the IND? Holder of IND Other If you selected "Other", please specify. Sponsor Investigator Other N/A Add Another Drug/Biologic Copyright Research Dataware. All Rights Reserved. 2/2

57 IRBNet: 1 of 1 01/12/2014 9:55 AM IRBNet ID: UC Davis - Initial Review Application - [ ] Test prog flow, paper (pdf) organization & output My Reminders (26) Jump To: 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 Jump Copyright Research Dataware. All Rights Reserved.

58 IRBNet: 1 of 1 07/10/2014 1:30 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Medical Device(s) * Are medical devices to be used for research purposes in this study? Jump Copyright Research Dataware. All Rights Reserved.

59 2/12/2015 IRBNet: IRBNet ID: UC Davis Initial Review Application [ ] Here we go again My Reminders (29) Medical Device(s) Information Medical Device 1 Device Name * IDE/HDE * Do you have an IDE/HDE for use of this device in this study? IDE/HDE Number If yes, what is the IDE/HDE Number? Jump To: Medical Device(s) Information Jump N/A Exemption from IDE Requirement * Do you believe this device is exempt from the requirement for an IDE? FDA Approval * Is this device approved by the FDA? Humanitarian Use Device (HUD) * Is this device a Humanitarian Use Device (HUD)? Use of FDA Approved Device * If this device is approved (including HUD), is it being used according to its approved label? Use of n Exempt 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 approved but is not being used according to its approved label) and you do not have an IDE number please select one of the following: N/A N/A 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 non significant risk device (NSR) N/A Justification for NSR Determination Please provide justification for the NSR determination. Format Font family Font size 1/2

60 2/12/2015 IRBNet: Holder of IDE * Who holds the IDE? Holder of IDE Other If you selected "Other," please specify. Sponsor Investigator Other N/A Additional Information For information: "Significant Risk and n significant Risk Medical Device Studies" Add Another Medical Device Copyright Research Dataware. All Rights Reserved. 2/2

61 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (277) International Study * Will you conduct or oversee research outside of the US? Jump To: International Study Jump Track Training (26) Library Manager Copyright Research Dataware. All Rights Reserved. 1/1

62 IRBNet: 1 of 1 07/10/2014 1:31 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: 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 Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

63 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Monitoring for Safety and Compliance Jump To: Monitoring for Safety and Compliance Jump Research 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? Review of Data Please describe your monitoring plan. Medical Monitor Data Safety Monitoring Committee t Applicable/Minimal Risk Format Font family Font size Track Training (26) Library Manager Monitoring of Compliance * Will this study be monitored for compliance? Please confirm. Copyright Research Dataware. All Rights Reserved. 1/1

65 IRBNet: 1 of 1 07/10/2014 1:33 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Number of Participants Jump To: Jump *Enrolled means: Consented, meets inclusion and exclusion criteria, and are scheduled to participate/are participating/or have participated in the research in accordance with protocol. For charts/records that will be reviewed and specimens to be collected/obtained, please provide the total number that will be reviewed. Study-Wide * Number of anticipated participants enrolled* study-wide. Locally * Number of anticipated participants enrolled* locally (under UC Davis PI Oversight). Copyright Research Dataware. All Rights Reserved.

66 IRBNet: 1 of 1 30/10/2014 8:30 AM IRBNet ID: UC Davis - Initial Review Application - [ ] PDF Test My Reminders (26) Jump To: Vulnerable Participants * Which of the following categories of vulnerable participants will be recruited/enrolled into your study? Jump 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 ne of the above Copyright Research Dataware. All Rights Reserved.

67 2/12/2015 IRBNet: IRBNet ID: UC Davis Initial Review Application [ ] Here we go again My Reminders (29) Children Participant Information Jump To: Children Participant Information Jump Category Research for Children * Regulations require that research fall under an approval category before children can be included. Please select the 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 te If 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 one parent has legal responsibility for the care and custody of the child. (If the research involves greater than minimal 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 not routinely 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 of consent 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 t Obtaining Assent If assent will not be obtained from some or all of the children and the reasons are not described above, describe the children from whom assent will not be obtained and provide justification why assent will not be obtained. Format Font family Font size 1/2

68 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 (i); and 21 CFR (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;

69 (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.

70 IRBNet: 1 of 1 07/10/2014 1:36 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] xx Jump To: Minimal Risk to Children * Please explain how this research presents no more than minimal risk to the children. Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

71 IRBNet: 1 of 1 07/10/2014 1:37 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] xx Jump To: Greater Than Minimal Risk Rationale * Please explain how this research involves greater then minimal risk. Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

72 IRBNet: 1 of 1 07/10/2014 1:38 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] xx Jump To: Prospect of Direct Benefit Rationale * Please explain how the research presents the prospect of direct benefit to the children. Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

74 IRBNet: 1 of 1 07/10/2014 1:40 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: 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 by alternative approaches. Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

75 IRBNet: 1 of 1 07/10/2014 1:41 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] xx Jump To: Prospect of Direct Benefit Rationale * Please explain how this research involves a minor increase over minimal risk. Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

76 IRBNet: 1 of 1 07/10/2014 1:42 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Experiences Presented by Intervention * Please explain how the intervention presents experiences to the children that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations. Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

77 IRBNet: 1 of 1 07/10/2014 1:42 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Generalizable Knowledge * Please explain how the intervention or procedure is likely to yield generalizable knowledge about the child's disorder or condition which is of vital importance for understanding or amelioration of the child's disorder for condition. Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

78 IRBNet: 1 of 1 07/10/2014 1:43 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] xx Cognitively Impaired Adults Jump To: Determining Capacity for Consent * Describe your process for determining whether an adult has capacity to consent. Paragraph Font family Font size Jump California Requirements for Surrogate Consent * Will you follow California requirements for surrogate consent? Assent from Cognitively Impaired Adults * Will assent be obtained from all adults who lack capacity to consent and are capable of assenting? Obtaining Consent When and If She/He Regains Capacity * Will you obtain consent from the participant when s/he regains capacity? Copyright Research Dataware. All Rights Reserved.

79 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.

80 IRBNet: 1 of 1 29/10/ :54 AM IRBNet ID: UC Davis - Initial Review Application - [ ] PDF Test My Reminders (26) Jump To: 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 these are not your students, please mark N/A in the textbox below. Paragraph Font family Font size Jump Copyright Research Dataware. All Rights Reserved.

81 IRBNet: 1 of 1 07/10/2014 1:45 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Tissue Banking * Will human tissue be banked for future use? Jump Copyright Research Dataware. All Rights Reserved.

82 IRBNet: 1 of 1 07/10/2014 1:45 PM IRBNet ID: My Reminders (26) UC Davis - Project Information Worksheet - [ ] xx Tissue Banking Information Jump To: 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? Jump Identifiers Stored With Specimens * Will any identifiers be stored with the specimens? Coded and Linked Specimens * Will the specimens be coded and linked to the individual? Identifiable Data * Will any identifiable data be stored with the specimens? Copyright Research Dataware. All Rights Reserved.

83 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 obtain 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.

84 IRBNet: 1 of 1 07/10/2014 1:46 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Jump To: Jump Data Confidentiality * I confirm that only authorized persons will be granted access to the identifiers; identifiers stored on computers, electronic notebooks, mobile devices, and/or data-storage devices will be encrypted and password protected; identifiers maintained in paper format will be kept in a locked area with access limited only to research staff who require access to conduct the study. Copyright Research Dataware. All Rights Reserved.

85 8/7/2015 IRBNet: IRBNet ID: Nicole Walters UC Davis Initial Review Application [ ] Smart Form Screen Shots Submission Manager Agendas and Minutes My Reminders (276) Jump To: PI Assurance Jump PI Assurance * I attest, as the PI, that all personnel assigned to this study are qualified to perform the protocol procedures assigned to them, have completed required CITI/NIH training, have reported any and all conflicts of interest to the UC Davis Conflict of Interest Committee, and will receive appropriate training on the protocol prior to engaging in research activities. Track Training (26) Library Manager Copyright Research Dataware. All Rights Reserved. 1/1

86 IRBNet: 1 of 1 07/10/2014 1:47 PM IRBNet ID: UC Davis - Project Information Worksheet - [ ] xx My Reminders (26) Form Complete Jump To: Jump Thank you for completing this application form. Please review it for accuracy and obtain the signatures on HRP-226. By submitting this application, the PI agrees to comply with all IRB and protocol requirements listed in HRP-103. Please upload the following additional documentation in the IRBNet : Conflict of Interest Committee (COIC) Letter (If not yet recieved, submit when available) HRP-226 Administrative Approval HRP-503 Protocol Questionnaires/Surveys/Interview Questions (if applicable) Form 1571 and Product Labeling Cancer Center Scientific Review Committee (CCSRC) Approval Radiation Use Committee (RUC) Approval Institutional Biosafety Committee Approval for Stem Cell research SCRO submission Institutional Biosafety Committee Approval for research involving Recombinant DNA Molecules, Human Gene Transfer, infectious agents, or biohazardous material Recombinant DNA Advisory Committee (RAC) Approval QCT Form Recruitment Material Screening Script Consent Document Consent Script or Information Sheet Include IB or Package Insert Evidence 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 Save and Exit Preview Previous Copyright Research Dataware. All Rights Reserved.

4.1. Accurate: The information is a true reflection of the original observation.

4.1. Accurate: The information is a true reflection of the original observation. SOP #: DOC-101 Page: 1 of 7 Effective Date: 1. POLICY STATEMENT: The Principal Investigator and research team members are required to prepare and maintain adequate and accurate case histories designed