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Table of contents
  1. 1. INSTRUCTIONS: 

 

I have already submitted an IRB proposal about this project to UC Davis, which was approved in Spring 2013.  This proposal received exempt status. Below the UC Davis protocol is the protocol for my home institution, UCSF. 

UC Davis Protocol: 

INSTRUCTIONS: 

·      Use “TEMPLATE PROTOCOL – No Instructions "to prepare a document with the information from following sections. You may use a different format, order, outline or template provided the necessary information is included. 

·      Depending on the nature of what you are doing, some sections may not be applicable to your research. If so mark as “NA” or delete. For simple research, such as a retrospective chart review, less than a page may be necessary to address the relevant sections. 

·      For any items described in the sponsor’s protocol, grant, contract, or other documents submitted with the application, you may reference the title and page numbers of these documents. If you reference page numbers, attach the documents referenced. 

·      When you write a protocol, keep an electronic copy. You will need to modify this copy when making changes. 

·      Omit starred (*) items if this is the activation of a protocol at a new site or sites that will be overseen by a principal investigator who will take separate and full responsibility for that site or those sites. Complete by describing information specific to the site(s). Do not repeat information in the approved protocol that applies to all site(s). 

1)        Protocol Title 

Include the full protocol title as listed on the application form. 

2)        Author of Protocol 

 

pUC Davis Researcher 

pResearcher from other institution 

pPrivate Sponsor 

pCooperative Group 

pOther: _________________ 

 

3)        IRB Review History* 

If you have submitted this protocol for review by an external IRB, provide the previous study identification number and provide details of the review including the IRB name, date of review, and IRB contact information. 

4)        Objectives* 

Describe the purpose, specific aims, or objectives. 

State the hypotheses to be tested. 

5)        Background* 

Describe the relevant prior experience and gaps in current knowledge. 

Describe any relevant preliminary data. 

Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. 

6)        Inclusion and Exclusion Criteria* 

Describe how you individuals will be screened for eligibility. 

Describe the criteria that define who will be included or excluded in your final study sample. 

Indicate specifically whether you will include or exclude each of the following special populations: (You may not include members of the above populations as subjects in your research unless you indicate this in your inclusion criteria.) 

·      Adults unable to consent 

·      Individuals who are not yet adults (infants, children, teenagers) 

·      Pregnant women 

·      Prisoners 

7)        Study-Wide Number of Subjects* 

If this is a multicenter study, indicate the total number of subjects to be accrued across all sites. 

8)        Study-Wide Recruitment Methods* 

If this is a multicenter study and subjects will be recruited by methods not under the control of the local site (e.g., call centers, national advertisements) describe those methods. 

Describe when, where, and how potential subjects will be recruited. 

Describe the methods that will be used to identify potential subjects. 

Describe materials that will be used to recruit subjects. (Attach copies of these documents with the application. For advertisements, attach the final copy of printed advertisements. When advertisements are taped for broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape.) 

9)        Study Timelines* 

Describe: 

·      The duration of an individual subject’s participation in the study. 

·      The duration anticipated to enroll all study subjects. 

·      The estimated date for the investigators to complete this study (complete primary analyses) 

10)    Study Endpoints* 

Describe the primary and secondary study endpoints. 

Describe any primary or secondary safety endpoints. 

11)    Procedures Involved* 

Describe and explain the study design. 

Provide a description of all research procedures being performed and when they are performed, including procedures being performed to monitor subjects for safety or minimize risks. 

Describe: 

·      Procedures performed to lessen the probability or magnitude of risks. 

·      All drugs and devices used in the research and the purpose of their use, and their regulatory approval status. 

·      The source records that will be used to collect data about subjects. (Attach all surveys, scripts, and data collection forms.) 

·      What data will be collected including long-term follow-up. 

·      Describe how much blood is being drawn and how often 

For HUD uses provide a description of the device, a summary of how you propose to use the device, including a description of any screening procedures, the HUD procedure, and any patient follow-up visits, tests or procedures. 

12)    Data and Specimen Banking* 

If data or specimens will be banked for future use, describe where the specimens will be stored, how long they will be stored, how the specimens will be accessed, and who will have access to the specimens. 

List the data to be stored or associated with each specimen. 

Describe the procedures to release data or specimens, including: the process to request a release, approvals required for release, who can obtain data or specimens, and the data to be provided with specimens. 

13)    Data Management* 

Describe the data analysis plan, including any statistical procedures. 

Provide a power analysis. 

Describe the steps that will be taken secure the data (e.g., training, authorization of access, password protection, encryption, physical controls, certificates of confidentiality, and separation of identifiers and data) during storage, use, and transmission. 

Describe any procedures that will be used for quality control of collected data. 

Describe how data and specimens will be handled study-wide: 

·      What information will be included in that data or associated with the specimens? 

·      Where and how data or specimens will be stored? 

·      How long the data or specimens will be stored? 

·      Who will have access to the data or specimens? 

·      Who is responsible for receipt or transmission of the data or specimens? 

·      How data and specimens will be transported? 

14)    Provisions to Monitor the Data to Ensure the Safety of Subjects* 

This is required when research involves more than Minimal Risk to subjects. 

The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor. 

Describe: 

·      The plan to periodically evaluate the data collected regarding both harms and benefits to determine whether subjects remain safe. 

·      What data are reviewed, including safety data, untoward events, and efficacy data. 

·      How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants). 

·      The frequency of data collection, including when safety data collection starts. 

·      Who will review the data. 

·      The frequency or periodicity of review of cumulative data. 

·      The statistical tests for analyzing the safety data to determine whether harm is occurring. 

·      Any conditions that trigger an immediate suspension of the research. 

15)    Withdrawal of Subjects* 

Describe anticipated circumstances under which subjects will be withdrawn from the research without their consent. 

Describe any procedures for orderly termination. 

Describe procedures that will be followed when subjects withdraw from the research, including partial withdrawal from procedures with continued data collection. 

16)    Risks to Subjects* 

List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the subjects’ participation in the research. Include as may be useful for the IRB’s consideration, describe the probability, magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, legal, and economic risks. 

If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable. 

If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or become pregnant. 

If applicable, describe risks to others who are not subjects. 

17)    Potential Benefits to Subjects* 

Describe the potential benefits that individual subjects may experience from taking part in the research. Include as may be useful for the IRB’s consideration, the probability, magnitude, and duration of the potential benefits. 

Indicate if there is no direct benefit. Do not include benefits to society or others. 

18)    Vulnerable Populations* 

If the research involves individuals who are vulnerable to coercion or undue influence, describe additional safeguards included to protect their rights and welfare. 

·      If the research involves pregnant women, review “CHECKLIST: Pregnant Women (HRP-412)” to ensure that you have provided sufficient information. 

·      If the research involves neonates of uncertain viability or non-viable neonates, review “CHECKLIST: Neonates (HRP-413)” or “HRP-414 – CHECKLIST: Neonates of Uncertain Viability (HRP-414)” to ensure that you have provided sufficient information. 

·      If the research involves prisoners, review “CHECKLIST: Prisoners (HRP-415)” to ensure that you have provided sufficient information. 

·      If the research involves persons who have not attained the legal age for consent to treatments or procedures involved in the research (“children”), review the “CHECKLIST: Children (HRP-416)” to ensure that you have provided sufficient information. 

·      If the research involves cognitively impaired adults, review “CHECKLIST: Cognitively Impaired Adults (HRP-417)” to ensure that you have provided sufficient information. 

19)    Multi-Site Research* 

If this is a multi-site study where you are the lead investigator, describe the processes to ensure communication among sites, such as: 

·      All sites have the most current version of the protocol, consent document, and HIPAA authorization. 

·      All required approvals have been obtained at each site (including approval by the site’s IRB of record). 

·      All modifications have been communicated to sites, and approved (including approval by the site’s IRB of record) before the modification is implemented. 

·      All engaged participating sites will safeguard data as required by local information security policies. 

·      All local site investigators conduct the study appropriately. 

·      All non-compliance with the study protocol or applicable requirements will reported in accordance with local policy. 

Describe the method for communicating to engaged participating sites: 

·      Problems. 

·      Interim results. 

·      The closure of a study 

20)    Community-Based Participatory Research* 

Describe involvement of the community in the design and conduct of the research. 

Note: “Community-based Participatory Research” is a collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. Community-based Participatory Research begins with a research topic of importance to the community, has the aim of combining knowledge with action and achieving social change to improve health outcomes and eliminate health disparities. 

21)    Sharing of Results with Subjects* 

Describe whether results (study results or individual subject results, such as results of investigational diagnostic tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care physicians) and if so, describe how it will be shared. 

22)    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: 

o   Site-specific regulations or customs affecting the research for research outside the organization. 

o   Local scientific and ethical review structure outside the organization. 

23)    Resources Available 

Describe your staff and their roles. 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. 

If you specify a person by name, a change to that person will require prior approval by the IRB. If you specify people by role (e.g., coordinator, research assistant, co-investigator, or pharmacist), 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. 

24)    Prior Approvals 

Describe any approvals that will be obtained prior to commencing the research. (E.g., school, external site. funding agency, laboratory, radiation safety, or biosafety approval.) 

25)    Recruitment Methods 

If a multicenter study, please describe the recruitment methods by UC Davis investigators. 

Describe when, where, and how potential subjects will be recruited. 

Describe the source of subjects. 

Describe the methods that will be used to identify potential subjects. 

Describe materials that will be used to recruit subjects. (Attach copies of these documents with the application. For advertisements, attach the final copy of printed advertisements. When advertisements are taped for broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape.) 

Describe the amount and timing of any payments to subjects. 

If the research procedures include accessing personal health information (PHI) to identify prospective subjects without HIPAA Authorization please describe:  

·      Why getting HIPAA Authorization is not practicable.  

·      Why the research can’t be conducted without access to this PHI.  

·      Your plan to protect the PHI from improper use and disclosure, including the plan to destroy the PHI at the earliest opportunity.  

·      Assurance that the protected health information will not be inappropriately reused or disclosed to any other person or entity. 

·      Description of the protected health information which will be accessed 

26)    Local Number of Subjects 

Indicate the total number of subjects to be accrued locally. 

If applicable, distinguish between the number of subjects who are expected to be enrolled and screened, and the number of subjects needed to complete the research procedures (i.e., numbers of subjects excluding screen failures.) 

27)    Confidentiality 

If this is a multicenter study, describe the local procedures for maintenance of confidentiality. 

·      Where and how data or specimens will be stored locally? 

·      How long the data or specimens will be stored locally? 

·      Who will have access to the data or specimens locally? 

·      Who is responsible for receipt or transmission of the data or specimens locally? 

·      How data and specimens will be transported locally? 

28)    Provisions to Protect the Privacy Interests of Subjects 

Describe the steps that will be taken to protect subjects’ privacy interests. “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal information. 

Describe what steps you will take to make the subjects feel at ease with the research situation in terms of the questions being asked and the procedures being performed. “At ease” does not refer to physical discomfort, but the sense of intrusiveness a subject might experience in response to questions, examinations, and procedures. 

Indicate how the research team is permitted to access any sources of information about the subjects. 

29)    Compensation for Research-Related Injury 

If the research involves more than Minimal Risk to subjects, describe the available compensation in the event of research related injury. 

Provide a copy of contract language, if any, relevant to compensation for research-related injury. 

30)    Economic Burden to Subjects 

Describe any costs that subjects may be responsible for because of participation in the research. 

31)    Consent Process 

Indicate whether you will you be obtaining consent, and if so describe: 

·      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. 

·      Whether you will be following “SOP: Informed Consent Process for Research (HRP-090).” If not, describe: 

o   The role of the individuals listed in the application as being involved in the consent process. 

o   The time that will be devoted to the consent discussion. 

o   Steps that will be taken to minimize the possibility of coercion or undue influence. 

o   Steps that will be taken to ensure the subjects’ understanding. 

Non-English Speaking Subjects 

·      Indicate what language(s) other than English are understood by prospective subjects or representatives. 

·      If subjects who do not speak English will be enrolled, describe the process to ensure that the oral and written information provided to those subjects will be in that language. Indicate the language that will be used by those obtaining consent. 

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.) 

o   For 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.” 

o   For 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: 

o   Both 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. 

o   One 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.) 

o   For 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.” 

o   For 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).” 

·      Describe the process for assent of the subjects. Indicate whether: 

o   Assent 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. 

o   If assent will not be obtained from some or all subjects, an explanation of why not. 

o   Describe 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. 

32)    Process to Document Consent in Writing 

Describe whether you will be following “SOP: Written Documentation of Consent (HRP-091).” If not, 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.) 

33)    Drugs or Devices 

If the research involves drugs or device, describe your plans to store, handle, and administer those drugs or devices so that they will be used only on subjects and be used only by authorized investigators. 

If the drug is investigational (has an IND) or the device has an IDE or a claim of abbreviated IDE (non-significant risk device), include the following information: 

·      Identify the holder of the IND/IDE/Abbreviated IDE. 

·      Explain and/or provide reference material for procedures that will follow and comply with FDA sponsor requirements for the following: 

 

Applicable to: 

FDA Regulation 

IND studies 

IDE studies 

Abbreviated IDE studies 

21 CFR 11 

·      Electronic Records and Signatures 

X 

X 

 

21 CFR 54 

·      Financial Disclosure by Clinical Investigators 

X 

X 

 

21 CFR 210 

·      Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs 

X 

 

 

21 CFR 211 

·      Current Good Manufacturing Practice for Finished Pharmaceuticals 

X 

 

 

21 CFR 312 

·      Investigational New Drug Application 

X 

 

 

21 CFR 812 

·      Investigational Device Exemptions 

 

X 

X 

21 CFR 820 

·      Quality System Regulation 

 

X 

 

 

 

UCSF Protocol (exempt status):

Exempt Application Sections (Updated 11/4/10) 

This is a copy of the online application. Only the sections that may be required for exempt projects are included. Use this application as a guide when preparing to submit an exempt application. As noted, some of the sections of the application are only required if your research has certain characteristics. A Microsoft Word version of this document is located here.  

General Information  

 

*Enter the full title of your study: 

 
 
 

*Enter the study number or study alias 

  

 
 

Add Department(s)  

 

List of Departments associated with this study: 

 
 
 
   

Assign key study personnel(KSP) access to the study   

 

*Please add a Principal Investigator for the study: 

 

If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below. 

 
 
 

If applicable, please select the Protocol Staff personnel: 

A)   Additional Investigators 

B)   Research Support Staff 

 
 

* Please add a Study Contact: 

 

The Study Contact(s) will receive all important system notifications along with the Principal Investigator. (e.g. The study contact(s) are typically either the Study Coordinator or the Principal Investigator themselves). 

 
 
 

If applicable, please add a Faculty Advisor: 

  

 
 

If applicable, please select the Designated Department Approval(s): 

 

Add the name of the individual authorized to approve and sign off on this protocol from your Department (e.g. the Department Chair or Dean). 

 

 

 

 
 

Qualifications of Key Study Personnel  

 

List the study responsibilities and qualifications of any individuals who qualify as Key Study Personnel (KSP) at UCSF and affiliated sites ONLY by clicking the "Add a new row" button:  

NOTE: This information is required and your application will be considered incomplete without it. 

KSP Name  

Description of Study Responsibilities  

Qualifications  

 

 

Initial Screening Questions   

 

* This study involves human stem cells (including iPS cells and adult stem cells), gametes or embryos:  

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No   

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Yes, and requires CHR and GESCR review   

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Yes, and requires GESCR review, but NOT CHR review   

 

* This application involves a Humanitarian Use Device:  

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No   

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Yes, and it includes a research component   

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Yes, and it involves clinical care ONLY   

 

* This is a CIRB study (e.g. the NCI CIRB will be the IRB of record):  

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* This application includes a request to rely on another IRB (other than NCI CIRB):  

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Note: If this request is approved, the CHR will NOT review and approve this study. Another institution will be the IRB of record.  

 
 

 

Application Type   

 

* This research involves:  

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Minimal risk   

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Greater than minimal risk   

 

* This application is:  

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Full Committee   

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Expedited   

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Exempt   

 

If you think this study qualifies for expedited review, select the regulatory category(ies) that the research falls under:  

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Category 1: A very limited number of studies of approved drugs and devices  

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Category 2: Blood sampling  

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Category 3: Noninvasive specimen collection (e.g. buccal swabs, urine, hair and nail clippings, etc.) 

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Category 4: Noninvasive clinical procedures (e.g. physical sensors such as pulse oximeters, MRI, EKG, EEG, ultrasound, moderate exercise testing, etc.) 

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Category 5: Research involving materials (data, documents, records, or specimens) that were previously collected for either nonresearch or research purposes  

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Category 6: Use of recordings (voice, video, digital or image) 

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Category 7: Low risk behavioral research or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies 

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Category 8: Continuing review of previously approved full committee research that is essentially complete 

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Category 9: Continuing review of research NOT involving an IND or IDE where the IRB has determined that the research poses no greater than minimal risk 

 

* This study involves:  

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Subject contact (including phone, email or web contact)   

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No subject contact (limited to medical records review, biological specimen analysis, and/or data analysis)   

 

 

Funding  

 

Identify all sponsors and provide the funding details: 

 

External Sponsor:  

[Click on the green bar to add a study sponsor and provide the information below for each sponsor.*]   

 

Gift, Program, or Internal Funding (check all that apply): 

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Funded by gift (specify source below)  

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Funded by UCSF or UC-wide program (specify source below)  

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Specific departmental funding (specify source below, if applicable)  

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Unfunded (miscellaneous departmental funding)  

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Unfunded student project  

List the gift, program, or departmental funding source: 

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* For each external funding source, provide the following information:  

Sponsor Name:  

 

Sponsor Type: [Automatically selected based on the sponsor name you select] 

 

Sponsor Role: (Check all that apply) 

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Funding 

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Protocol Control 

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Data Coordination 

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Monitoring 

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Auditing 

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Passthrough 

 

*Awardee Institution: (e.g. are funds coming through UCSF or an affiliate institution, such as Gladstone or NCIRE?) Select one:  

·      UCSF 

·      Blood Centers of the Pacific 

·      Blood Systems Research Institute 

·      CHORI 

·      CPMC 

·      Gallo 

·      Gladstone 

·      Institute on Aging 

·      Jewish Home 

·      Kaiser 

·      NCIRE 

·      SF Dept of Public Health 

·      SF VAMC Research Office 

·      UC Santa Cruz 

·      Other (No funding comes through UCSF C&G Unit) 

 

Is Institution the Prime Grant Holder: File:localhost/Users/Goodwin/Library/Caches/TemporaryItems/msoclip/0/clip_image078.gifYes File:localhost/Users/Goodwin/Library/Caches/TemporaryItems/msoclip/0/clip_image080.gifNo 

 

Contract Type: (choose one)  

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Cooperative Agreement 

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Contract 

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Drug/Device Donation 

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Fellowship 

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Gift 

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Grant 

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Subcontract 

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Unfunded Research Collaboration 

 

UCSF RAS System Proposal Number ("P" + 7 digits): 

 

UCSF RAS System Award Number ("A" + 6 digits): 

 

Grant Title:
(If different from CHR application title) 

 

PI Name:
(If PI is not the same as identified on the study.) 

 

Explain Any Significant Discrepancies From the CHR Application (grant only): 

 
 

If you tried to add the sponsor in the question above and it was not in the list, follow these steps: 

  • If funding has already been awarded or the contract is being processed by the Contracts and Grants or Industry Contracts unit, your sponsor is already in the system and the project has a UCSF RAS System Proposal or Award number. Check with your department's Research Services Analyst (RSA) to ask how the sponsor is listed in the UC sponsor list and what the Proposal or Award number is. 
  • If you need additional assistance, contact the Contracts and Grants Award Team at CGAwardTeam@ucsf.edu and list the sponsor in the box below.  

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Sponsor not in list   

  

Only if your sponsor is not yet in the list, type the sponsor's name:  

 

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If the funding is administered by the UCSF Office of Sponsored Research, your study will not receive CHR approval until the sponsor and funding details have been added to your application.  

 
 

This study is supported in whole or in part by Federal funding: 

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If yes, indicate which portion of your grant you will be attaching: 

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The Research Plan, including the Human Subjects Section of your NIH grant or subcontract  

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For other federal proposals (contracts or grants), the section of the proposal describing human subjects work  

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The section of your progress report if it provides the most current information about your human subjects work  

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The grant is not attached. The study is funded by an award that does not describe specific plans for human subjects, such as career development awards (K awards), cooperative agreements, program projects, and training grants (T32 awards)  

 

 

Statement of Financial Interest  

 

* The Principal Investigator and/or one or more of the key personnel has financial interests related to this study: 

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If Yes, attach the Disclosure of Investigators' Financial Interests Supplement to this application.  

 

 

Sites  

 

Institutions (check all that apply): 

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UCSF  

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China Basin  

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Helen Diller Family Comprehensive Cancer Center  

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Mission Bay  

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Mount Zion  

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San Francisco General Hospital (SFGH)  

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SF VA Medical Center (SF VAMC)  

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Blood Centers of the Pacific (BCP)  

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Blood Systems Research Institute (BSRI)  

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Fresno (Community Medical Center)  

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Gallo  

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Gladstone  

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Institute on Aging (IOA)  

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Jewish Home  

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SF Dept of Public Health (DPH)  

 

Check all the other types of sites not affiliated with UCSF with which you are cooperating or collaborating on this project:  

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Other UC Campus  

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Other institution  

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Other community-based site  

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Foreign Country  

List the foreign country/ies: 

 
 
 

* This is a multicenter study:  

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Check any research programs this study is associated with:  

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Cancer Center  

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Center for AIDS Prevention Sciences (CAPS)  

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Global Health Sciences  

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Immune Tolerance Network (ITN)  

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Neurosciences Clinical Research Unit (NCRU)  

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Osher Center  

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Positive Health Program  

 

 

 

 

 

Relying on Another IRB – Only required if you are relying on another IRB (as indicated in the Initial Screening Questions section) 

 

* Which IRB will provide review: 

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UC Berkeley   

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UC Davis   

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UC Irvine   

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UC Lawrence Berkeley National Lab   

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UC Los Angeles   

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UC Merced   

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UC Riverside   

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UC San Diego   

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UC Santa Barbara   

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UC Santa Cruz   

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Children's Hospital Oakland Research Institute (CHORI)   

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Community Medical Center (Fresno)   

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Fred Hutchinson Cancer Research Center   

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Kaiser   

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Western IRB (WIRB)   

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Other (specify below)   

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Level of review by the other IRB: 

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Exempt   

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Expedited    

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Full Committee   

 

 

Studies Involving Other Sites  – Only required if this is a multicenter study 

 

UCSF is the coordinating center: 

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If Yes, describe the plan for communicating safety updates, interim results, and other information that may impact risks to the subject or others among sites:  

 
 

If Yes, describe the plan for sharing modification(s) to the protocol or consent document(s) among sites:  

 
 
 

Check any other UC campuses where this study is being carried out:  

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UC Berkeley  

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UC Davis  

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Lawrence Berkeley National Laboratory (LBNL)  

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UC Irvine  

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UC Los Angeles  

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UC Merced  

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UC Riverside  

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UC San Diego  

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UC Santa Barbara  

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UC Santa Cruz  

 

Are the above UC campuses requesting to rely on UCSF's IRB (check all that apply)?  

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Yes (Submit a reliance request through the UC IRB Reliance Registry) 

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No (Complete Outside Site Information section)  

 

 

 

 

       

 

Outside Site Information Sub-Form– Only required if you are collaborating with outside site(s) 

 
 

Click "Add a new row" to enter information for a site. Click it again to add a second site and again and again for a third, a fourth, etc. 

Non-UCSF affiliated site information:   

Site name:  

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Contact name: 

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Email: 

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Phone:  

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For Federally-funded studies only, corresponding FWA#:  

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* The research at this site will be reviewed by:  

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Non-affiliated site's IRB or private IRB   

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Neither: the site is requesting UCSF to be the IRB of record for this study   

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Neither: the site is not engaged in the human subjects research and has provided a letter of support   

If the other site's IRB approval letter is available now, attach it to the application.  If the IRB approval letter is not yet available, submit it once you receive it. 

Or, if the other site is not engaged in human subjects research, attach the letter of support to your application.  

 
 

 

Request for UCSF to Serve As the IRB of Record  

 

The non-affiliated site has reviewed UCSF's Guidance "When the CHR Can Serve as the IRB of Record and When It Cannot" and made an initial determination that UCSF's IRB can serve as the IRB of record:  

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If not, do NOT submit your application until after the other site has completed this step.  

 
 

List the collaborators and describe the scope of work that will be carried out at the non-affiliated site:  

 
 
 

A letter from the non-affiliated site deferring IRB approval to the UCSF IRB is attached:  

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Note: your application cannot be processed without this letter.  

 
 

Collaborators' training certificates for a Human Subjects Training Course are attached:  

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Note: your application cannot be processed without the training certificates.  

 
 
 

 

Exempt Research Type  

 

* Does this research involve access to Protected Health Information (i.e. medical or other health records)? 

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If Yes, are you recording any identifiers in the research records at ANY point in time? 

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No   

Clear  

If Yes, this research is NOT Exempt. Return to the Application Type section and select "Expedited" or "Full Committee." 

 
 

* This study involves: 

  • Inpatients at UCSF or affiliated institutions  
  • Prisoners (other than incidental inclusion, e.g. in chart review studies)  

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No   

If Yes, this research is NOT Exempt. Go back and select "Expedited" or "Full Committee" in the Application Type section. 

 
 

* This study involves:  

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Category 1: Normal educational practices that are conducted in commonly accepted educational settings  

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Category 2: Use of educational tests, surveys, interviews, or observations of public behavior  

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Category 3: Use of educational tests, surveys, interviews, or observations of public behavior when the subjects are elected or appointed officials or candidates for public office, or if federal statute(s) require without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter  

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Category 4: Records review and/or data analysis (the study of already existing data, documents or records)  

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Category 4: Biological specimen analysis (the study of already existing human biological specimens)  

 

 

Exempt Screening (Category 2 Research) – only required for this exempt category 

 

Information obtained will be recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects 

AND

Any disclosure of this information outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability or reputation:  

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No   

 

If Yes, this research is NOT Exempt. Go back and select "Expedited" or "Full Committee" in the Application Type section. 

 
 

This study deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol

AND

The research will not be conducted in an anonymous fashion:  

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No   

 

If yes, this research is NOT Exempt. Go back and select "Expedited" or "Full Committee" in the Application Type section. 

 
 

This study involves children (people under 18 years of age who do not have the legal right to consent for themselves): 

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No   

 

If Yes, this research is NOT Exempt. Go back and select "Expedited" or "Full Committee" in the Application Type section. 

 

 

Exempt Categories 1, 2 and 3 – only required for these exempt categories 

 

Describe the study purpose and activities: 

 
 
 

Describe the population that will be evaluated:  

 
 
 

Subjects will be contacted for the study:  

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If yes, describe how:  

 
 
 

* Explain how subjects will be told about the experimental nature of the study and whether people will have an opportunity to opt out: 

 
 

Submit any documents that will be used for this purpose with the application.  

 
 

Types of activities that will be carried out (check all that apply):  

  

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Interviews  

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Educational tests  

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Questionnaires/Surveys  

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Observation  

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Other (specify below)  

Attach any non-standard survey instruments or interview guides at the end of the application. 

 
 

Identifiability of information: 

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No identifiers are associated with the information obtained   

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Names and other identifying information is obtained but is not shared with anyone except the study staff   

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Names and other identifying information is obtained and potentially used in publications (This option is only applicable to Category 3)   

 

 

Exempt Category 4: Records Review and/or Data Analysis  

 

There will be contact with the subjects:  

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No   

 

If yes, this research is NOT Exempt. Return to the Application Type section and select "Expedited" or "Full Committee."  

 
 

The data are pre-existing (collected prior to this research study):  

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Yes   

  

If no, this research is NOT Exempt. Return to the Application Type section and select "Expedited" or "Full Committee."  

 
 

Data were collected specifically for this proposed research project: 

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No   

 

If yes, this research is NOT Exempt. Return to the Application Type section and and select "Expedited" or "Full Committee."  

 
 

* Describe the study purpose and activities:  

 
 

* What types of records will be reviewed? (Check all that apply) 

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Medical or other health records (e.g. STOR, APeX, patient charts, etc)  

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Data from the Integrated Data Repository (IDR)  

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Data from SF THREDS  

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Historical data sets (specify below)  

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Publicly available records (specify below)  

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Other (specify below)  

Describe Other types of records: 

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* Access to identifiers: 

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The investigator has access to identifiers, but the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.   

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The identifiers are maintained at the source only. The investigator receives de-identified data.    

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Identifiers are included in the public records.   

Note: Under limited circumstances, research involving only de-identified or coded private information or specimens is not human subjects research and does not need CHR review. 

 
 

 

Exempt Category 4: Biological Specimen Analysis  

 

There will be contact with the subjects:  

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No   

 

If yes, this research is NOT Exempt. Return to the Application Type section and select "Expedited" or "Full Committee."  

 
 

The human biological specimens are pre-existing (collected prior to this research study):  

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Yes   

 

If no, this research is NOT Exempt. Return to the Application Type section and and select "Expedited" or "Full Committee."  

 
 

Specimens were collected specifically for this proposed research project:  

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No   

 

If yes, this research is NOT Exempt. Return to the Application Type section and and select "Expedited" or "Full Committee."  

 
 

* Describe the study purpose and activities: 

 
 
 

The types of human biological specimens that will be studied are:  

 
 
 

Source(s) of the human biological specimens:  

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Historical samples (specify below)  

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On-site or off-site repository/bank (specify below)  

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Other (specify below)  

If Other, specify:  

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Description of the source:  

 
 
 

Access to identifiers: 

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The investigator has access to identifiers, but the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.   

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The identifiers are maintained at the source only. The investigator receives de-identified specimens.   

Note: Under limited circumstances, research involving only de-identified or coded private information or specimens is not human subjects research and does not need CHR review. 

 

CTSI Screening Questions 

 

* This study will be carried out at one of the UCSF Clinical Research Services (CRS) units or will utilize CRS services: 

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This project involves community-based research: 

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This project involves practice-based research:  

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End of Study Application 

 

  

To continue working on the Study Application: Click on the section you need to edit in the left-hand menu. Remember to save through the entire Study Application after making changes. 

  

If you are done working on the Study Application: Click Save and Continue. If this is a new study, you will automatically enter the Initial Review Submission Packet form, where you can attach consent forms or other study documents. Review the Initial Review Submission Checklist for a list of required attachments. 

   

Answer all questions and attach all required documents to speed up your approval 

 

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Good to hear your IRB has been submitted. That will be really helpful to you to get started in the fall. If you learn something new at the Institute and want to change your project, you can always submit an amendment. Nice job!
Posted 13:09, 14 Jul 2013
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