UNIVERSITY OF MINNESOTA



IRB New Submission Application

INSTRUCTIONAL MEMO

Dear Investigator:

This New Submissions Application is the next step in compiling your submission packet for IRB consideration and review. It is absolutely essential that you follow all requirements. Incomplete submissions can cause delays and affect submission deadlines.

You will notice a list of required documents in the “Requirements” section of this application. The Primary Investigator (PI) is require to sign each document and encouraged to fill out all forms. Please submit one paper copy and an electronic copy of all materials.

• Remember to check EACH box in the “Requirements” section.

• DO NOT include this instructional page in your submission packet

• Submit 1 COMPLETE paper packet and 1 electronic packet

• Use the order outlined in the “Requirements” sections as your guide when assembling your packets.

Regards

IRB Office

(253) 403.3877 ▪ P.O. Box 5299 ▪ MS: 315-C3-QM ▪ Tacoma, WA 98415

IRB New Submission Application

|Submit To: | |Date: |

|MultiCare Health System |The MultiCare Health System (MHS) Institutional Review Board (IRB) convenes the | |

|IRB Office |first Monday of most months. |      |

|P.O. Box 5299, MS: 315-C3-QM |For submission deadlines and questions please contact the | |

|Tacoma, WA 98415 |IRB Coordinator at 253-403-3877 or see our Submission Deadline Calendar posted on| |

|Email: |the website. | |

|irb@ | | |

|!! REQUIREMENTS – |

|Have you contacted the MHS Research and Innovation Office? The Research department must be made aware of all research conducted at MHS, you may contact them at |

|Research@ or 253-403-7249. |

|This application is for all non-device submissions. For investigational devices, obtain and submit the MHS IRB HDE Application. |

|Ensure that all documents have been completed and signed. We require you submit 1 paper copy and 1 electronic copy of each of the following (each packet MUST BE in|

|order as outlined below): |

|IRB New Submissions Application - The IRB Application must include sufficient detail to facilitate IRB review. |

|IRB Internal Review Memo |

|Primary Investigator (PI) Application |

|The PI must also include (if not already on file): |

|Curriculum Vitae (CV) |

|Professional License - if applicable |

|Proof of Human Subjects Training |

|Co-Investigator Application(s) and all supporting documentation (if applicable) |

|IRB Handbook – Confirmation and Assurance form |

|IRB Consent Form Checklist (if applicable) |

|Consent/Assent Form(s) - Adult, proxy, and parental consent, and youth and child assent forms per the subject population. All consent and assent forms must comply|

|with MHS IRB requirements (refer to template). Particular attention should be given to the format, use of simplistic language and include required HIPAA |

|statements. |

|Protocol (must be a separate, stand-alone document) |

|Copy of grant from study sponsor |

|All related study material including but not limited to: recruitment material (advertisements, web postings), surveys, assessment tools, etc. |

|Investigator’s Brochure (IB) – only 1 paper copy and 1 electronic copy (can be emailed or saved to a cd/disk) |

|Fee of $1500.00 must accompany this submission for review consideration (if applicable) |

| A. STUDY INFORMATION |

|Study Title: |      |

|Sponsor Protocol Number: |      |

|(if applicable) | |

|B. PRIMARY INVESTIGATOR INFORMATION |

|Full Name, Degree, Title:       |Phone Number:       |

|Mailing Address / MHS Mail Stop: |Email:       |

|      | |

| |Other:       |

| |PI Specialty(ies):       |

|C. STUDY TEAM – List ALL immediate personnel who will have direct contact with subjects |

|Full Name: |Contact Information: |Role: Co-Investigator, Study |*Training |Should this contact |

| |Phone Number | E-mail |Coordinator, etc... | |receive regulatory |

| | | | |documents? |

|      |      |       |      |      |Yes No |

|      |      |       |      |      |Yes No |

|      |      |       |      |      |Yes No |

|*Indicate what type of Human Subject Protection training each study member has completed (i.e. CITI, NIH, OHRP) and provide documentation of completion. |

|D. CONTINUING REVIEW CONTACT |

|Please indicate which contact will be responsible for providing Annual Review submissions.       |

|E. RESEARCH SITE(S) – Indicate ALL sites in which study conduct will occur (please use separate page if necessary) |

|List hospital research sites |Describe specific location/area. |List any clinic research sites |Describe specific location/area. |

|Allenmore Hospital |      |Tacoma General Hospital |      |

|Auburn Medical Center |      |Urgent Care Clinic: |      |

|Covington Medical Center |      |Primary Care Facility: |      |

|Gig Harbor Medical Center |      |Specialty Clinic: |      |

|Good Samaritan Hospital |      |*Other: |      |

|Mary Bridge Children’s Hospital |      |*Other: |      |

|*If Other – Does the site have an obligation to use another IRB? Yes No |

|F. LEVEL OF RISK |

|Indicate the level of risk: |

| |

|Minimal Risk* Greater than Minimal Risk |

| |

|* Minimal Risk: the probability and magnitude of harm or discomfort anticipated 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 [45 CFR 46.102(i)] |

|G. STUDY MODE |

|Indicate the type of research this will be: |

|Clinical Research Involving an Investigational Drug Prospective Research |

|Masters Thesis / Doctoral Dissertation Quality Assurance / Quality Improvement Activities |

|Retrospective (data collection) Research Behavioral and Social Science Research |

|Post-Marketing Device Study (Approved by FDA-include approval letter) Tissue or Blood Repository |

|Gene Transfer* (i.e., experiments involving the deliberate transfer of recombinant DNA, or DAN or RNA derived from recombinant DNA into human research |

|participants) |

| |

|Identify the following (if applicable): |

|Investigational Drug:       |

|( IND Number:       |

|(attached documentation from the sponsor or FDA) |

|Retrospective research sites:       |

|Will this study involve a Waiver of Consent? Yes No |

|Federal Wide Assurance number            |

|Do you have an Individual Investigator Agreement with MultiCare Health System? Yes No |

|You will need an FWA to conduct federally funded research in your office or clinic. Please call the IRB office at 253-403-3877 for addition information. |

|Has any other IRB declined to review, tabled, deferred, disapproved, or terminated this study? Yes No |

|If yes, please provide the IRB Correspondence. |

|H. DATA SAFETY MONITORING |

|Is there a safety monitoring committee (i.e., DSMB, DMC) overseeing this research? Yes No |

|Is there an Institutional Biosafety Committee (IBC) overseeing this research? Yes No |

|I. SUBJECT POPULATION ▪ RECRUITMENT |

|Yes No |1. Does subject population include equitable gender and minority representation? |

| |( If no, explain: |

| |      |

|1A. How will you provide access for non-English speakers (please see the MHS policy on non-English Speakers on our website )?       |

|Yes No |2. Do you plan to recruit patients/subjects from vulnerable populations including but not limited to patients with cognitive impairment |

| |(psychiatric disorders, organic impairment such as dementia, developmental disorders, physical disorders, and/or disabilities)? |

| | |

| |( If Yes, Indicate measures which will be taken to protect these patients and the methods that will be used |

| |to determine their ability to understand the Consent Form and its process. |

| |      |

|Yes No | 2A. Does the Protocol allow for an adult proxy or Legally Authorized Representative (LAR) to provide consent for adults who do not have |

| |the legal capacity to consent? |

|Yes No | 2B. Will you enroll adult subject who require a proxy or LAR to consent? |

|2C. Describe how you will determine which individuals meet the criteria for being a proxy/LAR.       |

|2D. Describe how you will verify that a given individual is qualified to serve as an LAR.       |

|Yes* No | 3. Do you plan on enrolling and/or recruiting children? |

| |( Age Range:       |

|Yes No | 4. Do you plan on enrolling and/or recruiting prisoners? |

|Yes No |5. Do you plan on enrolling pregnant women? |

|6. Who will perform the screening examination of the patients to determine if they are eligible for the research?? |

|      |

|7. Explain the methods that will be taken to avoid coercion during the recruitment process: |

|      |

|8. Explain what methods that will be taken to protect patient privacy, and Patient Health Information (PHI): |

|      |

|9. Describe the circumstances and location of the consent process.       |

|Yes No |10. Will subjects receive compensation for participating in this study? |

| |( If yes, explain. Include amount(s) and reason: |

| |      |

|J. Contact Information to be listed in Consent Form: |

|Name and number of the contact for questions about the study: |

|      |

| |

|Name and number of the contact in the event of a research related injury: |

|      |

|K. FUNDING |

|1. Indicate the funding source: | Other:       |

|Federal Grants | |

|Sponsor Name:       |Research not funded / No support |

|Awardee Institution:       | |

|Grant Number:       |2. Does the Primary Investigator, Co-Investigators, and/or research |

|Grant Title:       |assistants/coordinators have any financial interest in this company (including |

|Commercial / Industry Grants |but not limited to stocks, bonds, or direct financial support)? |

|Manufacturers Name:       |Yes No |

|Foundation | |

|Sponsor Name:       | |

|L. ASSURANCE ▪ AUTHENTICATION |

| |

|I assure that the information provided in this “IRB New Submission Application” form is complete and accurate, and that it is consistent with that of |

|MultiCare Health System Institutional Review Board policies and the Office for Human Research Protections (OHRP). Additionally, I assure that any |

|modifications to this protocol will not take place without prior review and approval by the MHS IRB, and that all activities will be preformed in accordance |

|with state and federal regulations and those of the MHS IRB. |

| |      |

|Signature of Primary Investigator (PI) |Date |

|M. Billing Contact |

| |

|If the primary investigator is NOT a MultiCare physician, or if this study has an external funding source, please provide the name and contact information of |

|the individual who will be responsible for the billing of this review. |

|      |

NOTES -

* Study Mode

1. Masters Thesis / Doctoral Dissertation: Graduate work, which involves research on human subjects or a clinical investigation and results in a thesis or dissertation.

2. Clinical Research: A clinical trial is a planned experiment or research study designed to answer a specific question regarding a medical intervention. For example, the efficacy of one drug compared to another or the effectiveness of a procedure in the treatment of a specific disease.

3. Behavioral and Social Sciences Research: Focuses on individual and group behavior, mental processes, or social constructs and usually generates data by means of surveys, interviews, observations, studies of existing records, and experimental designs involving exposure to some type of stimulus or environmental intervention.

4. Quality Assurance / Quality Improvement Activities: Activities that attempt to measure the effectiveness of programs or services. An example: Using customer service response cards in Tacoma General Hospital to gauge the level of service provided.

5. Prospective Study: A research study that follows over time groups of individuals who are alike in many ways but differ by a certain characteristic.

6. Retrospective Study: A research study in which the medical records of groups of individuals who are alike in many ways but differ by a certain characteristic (records review).

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