University of North Dakota Human Subjects Review Form
IRB Application for Research Protocols
Please provide the information requested below:
PRINCIPAL INVESTIGATOR / (WMU School of Medicine Medical Students or Residents must be Sub-Investigator(s), with Faculty as Principal Investigator)Name:
Job Title:
Telephone: / E-mail Address:
Complete Mailing Address:
Company/Organization: / Department:
Have you ever been part of a FDA (site or study) inspection? NO YES (if yes, attach FDA Form 483 or inspectional
observations)
PRIMARY CONTACT PERSON (If not PI)
Name: / Study Role:
Telephone: / E-mail:
Address:
Preferred Contact Method: Phone E-mail / Comments:
RESEARCH PROTOCOL DETAILS
Title:
Proposed Project Beginning Date:
Proposed Project Completion Date (including data analysis):
If dissertation or thesis, list advisor:
FUNDING
Is this research sponsored? YES or NO If yes, list sponsor(s):
Has this research been submitted for funding? YES or NO
List funding agencies supporting this research:
Type of agency: Commercial/Industry Federal University Other
If Other, please define:
PARTICIPATION OF ORGANIZATIONAL PARTNERS
Will another organization (ex., hospitals, schools) help in the recruitment of research subjects? YES or NO
If yes, list all institutions:
Will assistance with the data collection be obtained from another organization? YES or NO
If yes, list all institutions:
BUDGET
Include the total budget as well as a breakdown including physician or department incentives per patient, reimbursement or incentives to patient, and the basis of the payment(s).
Investigator:
Study Personnel:
Research Supplies & Equipment:
Tests/Procedures:
Travel:
Subject Payments:
Other:
Subtotal Costs/Year:
Total for Entire Proposed Period of Support:
OTHER REVIEWS (Intention to submit to additional IRBs and the status of each submission)
Other IRB:
STATUS: Plan to Submit Pending ApprovedDate Submitted:
Other IRB:
STATUS: Plan to Submit Pending ApprovedDate Submitted:
Other IRB:
STATUS: Plan to Submit Pending ApprovedDate Submitted:
Has this protocol been suspended or closed by another IRB? YES or NO
If yes, explain:
PROTOCOL CLASSIFICATIONS
Subject Classification: Check all that apply.
Adults (>18 years) / Persons permanently or temporarily unable to consent
Children (<18 years) / Cognitively impaired persons
Pregnant Women/Fetuses / Adults with diminished decision-making capacity
Non-English Speaking / Prisoners
Employees / Other institutionalized individuals
Students / Other
Please explain the rationale for the involvement of the above special classes of subjects:
This study will involve: Check all that apply.
Use of protected health information (PHI) without consent (Attach Request for Waiver) / Stem Cells
Radiation / Discarded Tissue
New Drugs (IND) IND # Attach Approval / Fetal Tissue
Non-approved Use of Drug(s) / Human Blood or Fluids
Investigational Device Exemption (IDE) # Attach Approval / Genetic Research
Non-approved Device(s) / Other :
Humanitarian Use Device (HUD) # Attach Approval / None of the above will be involved
SUMMARY OF THE PROTOCOL
Include a brief statement for each of the following:
1. Purpose of study:2. Study Design:
3. Summary of Methods:
4. Planned Statistical Analysis:
5. List Subject Inclusion and Exclusion Data:
6. Method of selection and recruitment:
7: Number of subjects to be enrolled in the study:
8. Potential risks (including confidentiality risks) and benefits to the subject:
9. Scientific benefits:
10. Is there intent to present or publish research outside of the institution? Yes No
Please specify:
Borgess IRB approved for use: V5 8/2014
Bronson IRB Reviewed & Approved: V5 8/2014
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IRB # ______
Research Team Members
A research team member is anyone who interacts with subjects, research data, or PHI related to the study.
(Copy this page if additional space is needed.)
Name and Address
Include department name and mail code number.*Please notify and provide IRB with any change or address or affiliation /
Degree
/Contact Information
/Role on Project (PI, SubPI, research team member, coordinator, volunteer, etc.)
/Company/ Institution
/If this person will be working at a hospital facility, list Department & Manager name
/If research will be conducted on site at a hospital or affiliated entity, please check the following that apply:
/Protection of Human Subjects in Research Education Completion Date*
In office area
/Out-patient
/In patient
Wk Phone Number:
Cell/Pager Number:Fax Number:
Email:
If Resident, list graduation date:
Wk Phone Number:
Cell/Pager Number:Fax Number:
Email:
If Resident, list graduation date:
Wk Phone Number:
Cell/Pager Number:Fax Number:
Email:
If Resident, list graduation date:
Wk Phone Number:
Cell/Pager Number:Fax Number:
Email:
If Resident, list graduation date:
Wk Phone Number:
Cell/Pager Number:Fax Number:
Email:
If Resident, list graduation date:
Wk Phone Number:
Cell/Pager Number:Fax Number:
Email:
If Resident, list graduation date:
Wk Phone Number:
Cell/Pager Number:Fax Number:
Email:
If Resident, list graduation date:
*Provide evidence that all individuals on the research team have participated in education regarding the protection of human subjects. Human Participant Protections Education is required every three years. (Therefore, keep your original completion certificate in the event you submit another protocol.)
Borgess IRB approved for use: V5 8/2014
Bronson IRB Reviewed & Approved: V5 8/2014
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NECESSARY ATTACHMENTSFull protocol/study (include version date and pagination)
Consent form, or Waiver or Alteration of Informed Consent Requirements (8th grade reading level)
Surveys, interview questions, etc. (if applicable)
Data collection forms
Assent
Advertisements
Signed & dated curriculum vitae (for each PI & co-PI)
Certificate of completion for CITI training (required for each member). CITI can be found at
Documentation of support/acceptance from department manager/director where the research study will be conducted. Management approval of a protocol is required before a research study may be conducted.
ORGANIZATION/IRB SPECIFIC FORMS
IRB applications must be submitted to each respective hospital when research will be conducted at both facilities; approval from one IRB does not constitute approval from the other IRB.
Borgess IRB
Forms can be accessed at:
Borgess Conflict of Interest Form for each member listed on the research team
Borgess Investigator Agreement
If applicable, HIPAA Researcher Application for Waiver
Bronson IRB
Forms can be accessed at:
Bronson Conflict of Interest form (for each PI & co-PI)
Bronson Investigator agreement form (for each PI & co-PI)
If applicable, Request for Waiver of Informed Consent and Waiver of HIPAA Authorization
I certify that the statements herein are true, complete, and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports.
Printed Name of Principal Investigator:
Signature of Principal Investigator:
Date:Printed Name of Resident/Medical Student Investigator:
Signature of Resident/Medical Student Investigator:
Date:Borgess IRB approved for use: V5 8/2014
Bronson IRB Reviewed & Approved: V5 8/2014
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