KPNCInstitutional Review Board
Research Application
If this project is for … / Then…Internal quality assessment / improvement only / PLEASE STOPand contact the IRB.
Phone: 8/428-4588 or (510) 625-4588
Human subject research that might be exempt from IRB review
All links are accessible through the KP Intranet only and cannot be accessed externally.
Research Support
This research application is periodically updated. Please confirm that youare using
the current IRBapplication posted on the KPNC Research Support website. [ ] Yes [ ] No
The KPNC Principal Investigator (PI) is responsible forunderstanding the information contained in Guidance for Researchers. If you have questions, please contact the IRB.
For definitions of terminology used in this application, refer to the HRPPP Glossary.
Submission Deadline
The research application submission deadline date is 5:00 PM on the 20th of the month.
If the 20th falls on a weekend or holiday, the deadline is 5:00 PM on the preceding Friday. Complete research applications received by the deadline will be reviewed for placement on the following month’s IRB agenda.
What is a Complete Research Application?
If project funding is contingent upon IRB approval, the “core research application components“identified in the Section A checklist are sufficient to constitute a complete research application. If funding has been secured or a clinical trial budget is being negotiated by KFRI, the core applicationcomponents combined with any applicable supplemental documents collectively constitute a complete research application.
All required approvals and files must be attached with your research application when you submit it to the IRB. Incomplete submissionsmaycause your application to be held for a later month’s IRB review cycle.
Preparing Your Research Application Submission
The KPNC IRB must receive only electronic documents for entry in our system (iRIS).
File Type / Required File FormatKPNC Research Application / Word 2003 (.doc)
Study Documents (ex: protocols, recruitment materials, surveys, phone scripts, investigator brochures, and so on) / Word 2003 (.doc) or Adobe Acrobat PDF
Consent Forms / Word 2003 (.doc)
Approval emails exported from Lotus Notes / .RTF, .doc, or Adobe Acrobat PDF
File Naming Recommendations
Naming your files clearly and consistently according to a standard convention will help facilitate timely and accurate entry of your study into iRIS.
Convention / File Name ExamplesNew Research Application / Kpnc applic and [PI first initial and last name] / kpnc applic cschaefer.doc
Facility approval emails saved as separate files
LRC (Local Research Chair)
PIC (Physician in Chief)
COS (Chief of Service)
AM (Area Manager) / LRC approval [area/region and last name]
PIC approval [area/region and last name]
COS approval [area/region and last name]
AM approval [area/region and last name] / LRC approval FRE Offerman.
PIC approval SAC Isaacs
COS approval SFOMasters
AM approval SAC Hogerty
Other approval emails saved as separate files / Approval and [approver name or role] / approval Michael Silverberg
approval Phil Madvig
approval academic advisor
CV / Biosketch / CV and name / CV John Smith.doc
Study documents / Document type and description / Recruitment email to providers.doc
Diagnosis specific patient letter.doc
Please submit the research application and all supporting documents byEmailto.
After Your Protocol Has Been Approved by the KPNC IRB
Changes to any part of your study must be approved by the KPNC IRB prior to implementation. To request approval for proposed modifications, submit a modificationrequest form to the KPNC IRB.
Section A: ChecklistCheck the Y or N/A column to indicate whether the item is included.
CheckY N/A / CORE RESEARCH APPLICATION COMPONENTS
Unless otherwise noted, the following core application components are required.
[ ] / Section A:Checklist
[ ] / Section B:Coversheet
[] / Section C:Study Abstract
[ ] / Section D:Study Overview
[ ] / Section E:ProtocolSummary
[ ] / Section F:Data Privacy and SecurityForm
[ ] / [ ] / Section G:RAMP Form If determined in section F as not required, check N/A.
[ ] / Section H:Investigator Biographical Sketch(es)
[ ] / Section I:Approvals
[ ] / Training attestations for all KPNC workforce members (employees and physicians) listed on the coversheet (section B).If unsure, contact training coordinator Deborah L. Williams at 8/428-3239.
[ ] / [ ] / Proposed KPNC consent form(s) and privacy authorization form(s). Required unless a waiver is requested. If a waiver is requested, check N/A.
SUPPLEMENTAL DOCUMENTS (as applicable)
[ ] / [ ] / Sponsor’s or Investigator’s protocol
[ ] / [ ] / Recruitment materials
[ ] Participant contact letter [ ] Telephone script [ ] Advertisement
[ ] Provider contact letter[ ] Envelope/postcard[ ] Flyer
[ ] Other:
[ ] / [ ] / Study tools
[ ] Focus group script [ ] Diary[ ] Data collection worksheet
[ ] Questionnaire[ ] Survey[ ] Wallet card
[ ] Newsletter[ ] Other:
[ ] / [ ] / Student Researcher: letters from faculty advisor and DOR Scientific Review Committee
[ ] / [ ] / If accessing substance-use records, attestation from the Chief of Clinical Dependency Services stating that your research complies with 42 CFR 2.52
[ ] / [ ] / Sponsor’s consent form template
[ ] / [ ] / Investigator’s brochure (required for all investigational drugs and biologics)
[ ] / [ ] / Federal grant or subcontract
Investigator Eligibility Advisory
This research application is updated periodically to comply with new KPNC policies regarding personnel eligibility to be principal and sub-investigators on research studies.
Principal Investigator Eligible / Sub-InvestigatorEligible
Medical students and residents / / Applications to conduct research must list a qualified KP physician or employee as principal investigator.
Pharmacy students and residents /
Fellows / / Applications to conduct research must list a qualified KP physician or employee as principal investigator.
A cover letter from the qualified KP physician or employee must be attached to the application stating their agreement to serve as principal investigator and/or faculty mentor to the fellow.
TPMG Retired Physicians / To ensure compliance with IRS regulations, TPMG policy prohibits a retired TPMG physician from returning to work or providing volunteer services to TPMG, MAPMG or KFH/P after retirement. Accordingly, a retired TPMG physician may not work or volunteer on a KPNC research project.
Financial Conflicts of Interest Declaration Form
A new Financial Conflicts of Interest (FCOI) in Research policy in Northern California became effective on August 24, 2012.
All investigators must complete Financial Conflict-of-Interest Disclosure forms and submit them to KPNC Regional Compliance. The forms, along with the directions for submitting the forms directly to Compliance, can be found at the website locations listed below.
If you have questions / Contact the KPNC Regional Compliance Conflict of Interest Officer at 510-625-2400KPNC Investigator Conflict of Interest Disclosure Form & the PI certification form. /
E-fax forms to 510-336-4101
Introduction to the new FCOI regulations, a link to the policy, and more information. /
Your research application cannot go forward until you meet
the Compliance requirement.
Section B: Coversheet
Study Investigators and Contact Information
Complete/Formal Study Title (and sponsor protocol number, if applicable)
Abbreviated study title or protocol number / Use key words to quickly identify this study and distinguish it from others:
KPNCPI
Name and degree(s) / Facility / DeptPhone where the IRB Tie line
canreach you directly
8/ / Fax / Email(KP Lotus Notes email only)
Your signature below verifies that you accept responsibility for this application and the accuracy of all information in it. A completed application form emailed directly from the KPNC PI’s Lotus Notes address will be accepted in lieu of a signature.
PI Signature / Date
Project Manager or Research Coordinator (N/A if none)
Name Tie line8/ / Phone / Fax
Facility / Dept / Email(KP Lotus Notes email only)
Regulatory Specialist (N/A if none)
Name / Phone / FaxFacility / Dept / Email(KP Lotus Notes email only)
KPNC Subinvestigators (attach a biosketch for each and add additional rows if needed)
Name / Facility / Phone / Email (KP Lotus Notes email only)1.
2.
3.
4.
5.
6.
Non-KPNC Principal Investigator (N/A if none)Attach a biosketch
Name / Phone / FaxInstitution Federalwide Assurance # / Dept / Email
Non-KPNC Subinvestigators (attach a biosketch for each and add additional rows if needed)
Name / Institution / Phone / Email / Federalwide Assurance #1.
2.
3.
4.
5.
6.
Project Information
[ ] Check here if requesting Community Benefit Research Grant funds. If checked, provide a copy of this applicationto the Division of Research before it is submitted to the IRB. For information and deadlines,
emailDOR
Sponsor (N/A if none) (If NIH, specify Institute) / Funding source, if different from sponsor
IRB Communication
Indicate who should receive official IRB communications such as letters and notifications about the study.
Name / Email (KP Lotus Notes email only)
1.
2.
3.
4.
Page 1 of 242/03/2014
Section C: Study AbstractThis abstract will be used to inform researchers and organizational leaders about research activities. The format restrictions noted below are designed to accommodate IRB processing requirements.
Study Abstract:Answer the following questions concerning your proposed study.Do not repeat these questionsin the abstract.
- What is the research question?
- What study methods will you use? Identify investigational agents, experimental procedures or interventions.
- How will you select your study population?
- What knowledge do you expect to gain?
Format for abstract:
- Format as one paragraphconsisting of not more than 300 words.
- Address each question with only one or two succinct sentences.
- Do not use bulleted or numbered lists orparentheses.
- Do not use symbols (>, ≥, <, ≤, =, ~, %, etc.).
Page 1 of 242/03/2014
Section D: Study OverviewHave youbeen a Principal Investigator on a research project within[ ] Yes [ ] No
KPNC prior to this submission?
If no, you may be requested to present your study to the IRB in person.
Is this a data-only study (no research participant contact by mail, phone,[ ] Yes [ ] No
or in person)?
How many participants will be enrolled in this study, or how many electronic records or medical records will be used? Provide your best estimate if you are not sure.
Numberof KPNC participants or records:
(KPNC participants includes KPNC members/patients, KPNC employees,
and TPMG physicians):
Number of non-KPNC participants or records:
Total number of participants or records:
Is there intent to publish or otherwise disseminate findings from this study [ ] Yes [ ] No outside of KP?
Will the results of this study contribute to generalizable knowledge?[ ] Yes [ ] No
Who developed the protocol/study plan?
[ ] KPNC PI[ ] Sponsor [ ] Outside PI [ ] Other:
What is the funding status of this study?
[ ] Funded [ ] Pending[ ] None anticipated[ ] Conditional on IRB approval
Does this study use federal grant funding?[ ] Yes [ ] No
If No, skip to question 9.
If Yes, is KP the primary awardee of a federal grant for this study? [ ] Yes [ ] No
If Yes,are you the lead investigator on this grant? [ ] Yes [ ] No
If Yes, include a copy of the grant application with this submission to the IRB and forward a copy of the grant application to Division of Research.
How will participants be identified for purposes of inclusion or recruitment into this study?
[ ] KP electronic databases (e.g., OSCR, PIMS) - List:
[ ] KP disease registries - List:
[ ] KP medical records/KP HealthConnect
[ ] Investigators’ own patient panels
[ ] Through TPMG physicians or KP providers or employees – submit associated script or letter if applicable
[ ] Other:
Will the HIV status of participants be identified and validated for this study? (e.g., inclusion or exclusion) [ ] Yes [ ] No
If Yes, the study must be approved by the HIV Steering Committee.
ContactMichael J. Silverberg PhD, MPHat [510-891-3801] for additional information.
Attach the approval with this application.
Is access to databases or medical records required for this study[ ] Yes [ ] No
other than for identification of study subjects or recruitment?
If No, skip to question 12.
If Yes, complete A – C.
- From which sources will data or records be extracted?
[ ] KP disease registries. List:
[ ] KP patient charts (medical records/KP HealthConnect)
[ ] Data from other KP studies (contact the IRB for study IDs [“short titles”] as needed).
. List:
[ ] Other:
- Can the existing source data be linked directly or indirectly to an [ ] Yes [ ] No
- Will data be sent outside KPNC?[ ] Yes [ ] No
(i.e., information stripped of all identifiers that could be used to link
an individual to data)?
Is this study a clinical trial?[ ] Yes [ ] No
A clinical trial is a prospective biomedical or behavioral research study of human participants involving a licensed or investigational drug, device, biologic, or behavioral intervention and is designed to answer specific questions about biomedical or behavioral interventions (e.g., treatments, devices, drugs, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe and effective.
If No, skip to question 15.
If Yes, check the appropriate status of your study:
[ ] it has been registered at
[ ]it has not yet been registered at but will be
[ ] itis not and will not be registeredat Describe why not:
If this study is a clinical trial, what is the intervention being studied? Choose all that apply.
[ ] Behavioral
[ ] Biohazardous Agents
[ ] Device: Significant Risk
[ ] Device: Non-Significant Risk (NSR)
[ ] Diagnostics
[ ] Drug: Investigational
[ ] Drug: FDA-Approved / [ ] Drug: Over the Counter
[ ] Radiation: External Delivery
[ ] Radiation: Internal Delivery
[ ] Recombinant DNA/Gene Therapy [ ] Surgical Procedure
[ ] Vaccine/Biologic
[ ] Other. Specify:
Will participants be required to waive their right to access their study records containing PHI collected during their participation in the clinical trial? Note: In California, participants in HIV/AIDS clinical trials cannot be asked to waive their right to access their study records.
[ ] No, participants will not be required to waive their right to access their study records during the clinical trial.
[ ] Yes, participants will be required to waive their right to access their study records during the clinical trial.
Is this study FDA-regulated?[ ] Yes [ ] No
Will an investigational drug(s) or biologic(s) be used in this study?[ ] Yes [ ] No
If Yes, list the investigational agent(s):
IND number:
Will an approved drug(s) be used in this study for a[ ] Yes [ ] No – skip to question 18
non-approved purpose, delivery, or dosage?
If Yes, is an IND required?[ ] Yes – skip to question 18 [ ] No
If No, did the FDA provide you with a notification that[ ] Yes [ ] No
an IND is not required?
If No, justify why an IND is not required.
Will an investigational device(s) be used in this study? [ ] Yes [ ] No – skip to next question
If Yes, identify device name and IDE number:
Indicatethe device risk:[ ] Significant risk device [ ] Non-significant risk device
Will study participants be included or depicted in any of the following? [ ] Yes [ ] No
If Yes, check all that apply:
[ ] Videotapes [ ] Audiotapes[ ]Photographs [ ] Other, list:
Check all of the following that will be used to communicate with participants, if applicable:
[ ] Internet/email[ ] CD/DVD [ ] Letters/other mailed communications
[ ]Telephone [ ] Other, list:
a. Will you use datawithin KPNC? [ ] Yes [ ] No
b. Will you release dataoutside of KPNC? [ ] Yes [ ] No
If Yes, check all that apply:
[ ] Electronic transmission (Internet/email) [ ] CD/DVD
[ ] Courier[ ] FedEx/UPS[ ] USPS[ ] Other:
c. Will you store data electronically within KPNC? [ ] Yes [ ] No
If Yes, where will the data be stored?check all that apply:
[ ]Server[ ]endpoint computing device (e.g., workstation, laptop, PDA)
[ ]removable media (e.g., flashdrive, CD/DVD)[ ] Other:
Are any of the following listed as principal investigator or subinvestigators? [ ] Yes [ ] No
[ ] KP resident physician [ ] Pharmacy Resident/Student
[ ] Fellow [ ] TPMG Retired Physician
See Investigator Eligibility Advisory on page 4.
If Yes, indicate name(s):
Is this study being used to satisfy an academic degree requirement by the PI?[ ] Yes [ ] No
If Yes, note that you must first submit the completed application to the KPNC Division of Research (DOR) Scientific Review Committee for approval. For assistance, contact DOR at (510) 891-3529.
After obtaining DOR approval, attach the following when submitting this application to the IRB:
- Approval from the academic advisor stating that the study will be used to fulfill the degreerequirements
- Verification from KPNC Division of Research that the study has received a scientific review
Is this study being used to satisfy an academic degree requirement by a subinvestigator? (This does not include KP Medical and Pharmacy residents.) [ ] Yes [ ] No
If Yes, indicate the name of the subinvestigator.
- Attach approval from the academic advisor stating that the study will be used to fulfill the degree requirements.
- If Yes, the completed application must be submitted to the KPNC Division of Research (DOR) Scientific Review Committee for approval. For assistance, contact DOR at (510) 891-3529. After obtaining DOR approval, attach Verification from KPNC Division of Research that the study has received a scientific review when submitting this application to the IRB.
Have you completed the Compliance requirement to submit all [ ] Yes [ ] No
Financial Conflict-of-Interest forms to KPNC Regional Compliance as
referenced on page 3 of this application? If No, this application cannot go
forward for IRB review.
Section E: Protocol Summary
- 1.
Objectives:List your measurable study objectives.
Significance
A. Summarize the background of and rationale for the proposed study; include existing relevant knowledge discussed in the literature.
B. Why is this study important to Kaiser Permanente and/or the community?
Methods
A. Describe the study design, the protocols to be followed, and the methods to be used to accomplish the objectives listed in #2 above.
B. Identify and explain any experimental procedures, investigational and non-formulary medications or devices, and clearly distinguish how these differ from KPNC routine care. If the study involves an investigational drug, device, or biologic, state who will administer or dispense the drug, device, or biologic to the participant.
C. What is the rationale for the number of participants selected for the study, including sample size/power calculations, and the statistical method(s) by which the data will be analyzed?
D.Describe the sequence of the components of the study, including the expected duration of each component and timeline for the study