INSTITUTIONAL REVIEW BOARD
INITIAL PROTOCOL SUBMISSION OF RESEARCH STUDY
Return This Form and Attachments to:
Office of Research Integrity
1055 N. Curtis Rd.
Boise, ID 83706
(208)367-8897
(208)367-6821 (fax)
Date of application: _______________
Type of Request:
Full Board Review
Date Received by Research Integrity (for office use only):
Expedited Review: Submit the Expedited Review application also
Please note: Applications must be typed. Incomplete or inaccurately completed applications will NOT receive IRB
review. For any questions/answers that are 'non-applicable', indicate with 'N/A'.
Study Title: _____________________________________________________________________________________
A. Investigator/Study Team Information
1. PRINCIPAL INVESTIGATOR (PI) INFORMATION: Please provide information about the person legally responsible for
the conduct of the research. The Institutional Review Board and hospital must be assured that the investigator can personally
oversee the conduct of the research and the protection of human research participants [21 CFR 56.102(h)]. The Principle
Investigator has the following status (complete 1.a. and 1.b. or 1.c. as appropriate):
1.a. If member of Medical Staff:
Active Staff
Courtesy Staff
Affiliate Staff
Medical Associate Staff
Honorary Staff
1.b. The Medical Staff member has received a recommendation for a reappointment period of less than two years.
Yes. Explanation attached.
No
1.c. If not a member of Medical Staff:
Hospital Employee
Contracted Hospital Employee
Not Affiliated with Hospital (please describe relationship with hospital and name/telephone number of any hospital employee
affiliated with this research study)________________________________________________________
Confidential pursuant to Idaho Code
IRB Frm
Revised 03/18/13
Page 1 of7
Investigator’s Last Name: _________________________
Study Title
1.d. Principal Investigator:
Name:
Company Name:
Mailing Address:
Telephone:
Fax number:
e-mail address:
Medical license, Degree(s) AND Specialties/Resume/Curriculum Vitae attached or on file with SARMC IRB.
Human Ethics training attached or on file with the SARMC's IRB (required).
2. Additional Study Team Information (please provide the required information for all study team members):
2a. Name:
Role:
Co-Principal Investigator
Co-I investigator
Study Coordinator
Data Manager
Other (specify)
Company Name:
Mailing Address:
Telephone:
Fax number:
e-mail address:
Medical license, Degree(s) AND Specialties/Resume/Curriculum Vitae attached or on file with SARMC IRB.
Human Ethics training attached or on file with the SARMC's IRB (required).
Please include this person in all official study related communications from the IRB/Office of Research Integrity
2b. Name:
Role:
Co-Principal Investigator
Co-I investigator
Study Coordinator
Data Manager
Other (specify)
Company Name:
Mailing Address:
Telephone:
Fax number:
e-mail address:
Medical license, Degree(s) AND Specialties/Resume/Curriculum Vitae attached or on file with SARMC IRB.
Human Ethics training attached or on file with the SARMC's IRB (required).
Please include this person in all official study related communications from the IRB/Office of Research Integrity
2c. Name:
Role:
Co-Principal Investigator
Co-I investigator
Study Coordinator
Data Manager
Other (specify)
Company Name:
Mailing Address:
Telephone:
Fax number:
e-mail address:
Medical license, Degree(s) AND Specialties/Resume/Curriculum Vitae attached or on file with SARMC IRB.
Human Ethics training attached or on file with the SARMC's IRB (required).
Please include this person in all official study related communications from the IRB/Office of Research Integrity
2d. Name:
Role:
Co-Principal Investigator
Company Name:
Co-I investigator
Study Coordinator
Confidential pursuant to Idaho Code
IRB Frm
Revised 03/18/13
Page 2 of 7
Data Manager
Other (specify)
Study Title
Investigator’s Last Name: _________________________
Mailing Address:
Telephone:
Fax number:
e-mail address:
Medical license, Degree(s) AND Specialties/Resume/Curriculum Vitae attached or on file with SARMC IRB.
Human Ethics training attached or on file with the SARMC's IRB (required).
Please include this person in all official study related communications from the IRB/Office of Research Integrity
B. Study Information
1. In non-technical language, please briefly summarize the following. (This section is required. Please limit your summary to
this page only. 'See protocol' will not be accepted. A copy of the full protocol is to be sent with this application.)
 The objective of the study
 Brief description of the desired protocol study outcome
 Study design and all procedures
 Potential risks
 Measures to minimize these risks
 Potential benefits to the patient and/or the community
 Alternative treatments available
 Subject inclusion/exclusion criteria
2. Does this research involve (mark all that apply):
Biologic Device
Device name____________________________________________
Product labeling and/or bio-safety recommendations are attached.
FDA letter granting an Investigational Device Exemption for the proposed use is attached, or
Letter from sponsor stating that this is a non-significant risk device is attached, or
Letter explaining why the investigation is exempt from the IDE requirements under 21 CFR 812.2© is attached.
Investigational New Drug
Investigational New Drug (IND) number assigned by the FDA_______________
Submit US FDA Form 1572
If an IND number is not available, please attach an explanation why an IND was not obtained
A copy of the Investigator’s Drug Brochure, applicable package inserts, or the background information for food
supplements is attached.
2a. Data Safety Monitor (required only for Biologic Devices or Investigational New Drugs):
Name:
Address:
Telephone number:
Fax:
e-mail address:
Approved and Marketed Drug or Biologic
A copy of the Investigator’s Drug Brochure, applicable package inserts and product labeling, or the background
information for food supplements, is attached.
Behavioral research
Confidential pursuant to Idaho Code
IRB Frm
Revised 03/18/13
Page 3 of 7
Investigator’s Last Name: _________________________
Study Title
Study Information (cont'd)
Survey research
Retrospective Medical Record Audit research
Other (please describe)
3. There have been recent events in our community (deaths or serious injuries) related to this research or device.
No
Yes, a written statement describing the events is attached.
4. The Principal Investigator has an obligation to use another Institutional Review Board for any site in this study.
No
Yes, a written statement from the other Institutional Review Board acknowledging its review
decision is attached.
5. This research study has been disapproved or terminated by another Institutional Review Board prior to submission to Saint
Alphonsus Institutional Review Board.
No
Yes, a written statement from the other Institutional Review Board acknowledging its review
decision is attached.
6. Equipment is available at this research location to treat life-threatening adverse reactions:
No
Yes
Not Applicable
7. Explain how the confidentiality of any direct or indirect patient identifiers will be maintained:
8. Describe how the study team will notify the hospital (including registration and/or billing) of patients entering studies and
how these participants will be identified:
9. Please list clinical areas within the hospital where the patient may receive study-related care:
C. Study Financial Information
1. Sources of funding for any aspect of the study:
Federal Sponsor
Copy of the federal contract attached
Copy of the investigator-sponsor agreement attached
Commercial/For-profit Sponsor
Copy of the complete grant or award attached
Copy of the investigator-sponsor agreement attached
Private/Foundation Sponsor
Copy of the complete grant or award attached
Copy of the investigator-sponsor agreement attached
No financial support
Confidential pursuant to Idaho Code
IRB Frm
Revised 03/18/13
Page 4 of 7
Investigator’s Last Name: _________________________
Study Title
Study Financial Information (cont'd)
2. Sponsor Contact
Name:
Address:
Telephone number:
Fax:
e-mail address:
3. This study has been certified as a Medicare-qualifying clinical trial.
Yes
No
4. This study involves procedures, equipment, drugs or other items that will be paid for by the study sponsor.
Yes; attach list of items, frequency of use/occurrence and how hospital will bill study sponsor
No
D. Recruitment, Consent & Participant Information
1. Check which of the following recruitment materials will be used. Attach a copy of each to application.
Brochure(s)
Public Service Announcement (script; tape)
Newspaper
Radio (script; tape)
Letter /Memo
Posting
Television (script; tape)
Web Site(s) (include a hard copy of the recruitment section):
Other (please specify)
2. Will participants receive payment for being in this study?
Yes, Research participant(s) will be paid according to attached Payment Schedule or as stated in the submitted
Consent Form, or reimbursement(s) for travel, parking or similar expenses as follows:
No, Research participant(s) will not be paid.
3. Please identify approximate dates and numbers for the following (indicate 'N/A' if not applicable) :
Anticipated national enrollment start date: ________ Anticipated national enrollment completion date: _________
Anticipated local enrollment start date: ________ Anticipated local enrollment completion date: _________
Local enrollment target number: _________ National enrollment target number: ________
Length of time (approximate) participants will be in follow-up: ___________
4. Check which of the following vulnerable participant groups this research may enroll, even those clearly identified in the
protocol inclusion criteria (check all that apply):
Chronic Condition
Pregnant Women
Terminally Ill
Hospitalized
Limited or Non-Readers
Non-English Speaking
Poor/Uninsured
Students of Principal Investigator or Study Staff
Decisionally Impaired (brain injury, mental disability or illness, psychological/psychiatric condition, etc)
Employees of SARMC
Employees of Research Site (non-SARMC), Principal Investigator, or Sponsor
Prisoners (please contact Research Integrity for prisoner enrollment information)
Fetuses
Military Personnel
Children (informed assent form and/or parental consent form required – contact Research Integrity)
Others Vulnerable to Coercion (Specify): __________________________________________
Confidential pursuant to Idaho Code
IRB Frm
Revised 03/18/13
Page 5 of 7
Investigator’s Last Name: _________________________
Study Title
Study Information (Cont’d)
5. Will informed consent be required?
Yes - Attach a copy of the informed consent in SARMC format.
No - please attach explanation of how waiver criteria are met per 45 CFR 46 116(d).
5a. The following will be conducting the consent discussion (mark all that apply):
Principal Investigator
Co-Investigator
Research Coordinator
Site staff
Waived consent
5b. An interpreter will be available for consent discussion.
Yes: provide name(s) of interpreters and/or method of interpretation.
No
E. Research Principal Investigator Statement of Integrity
By signing this form, I certify that the information provided is both complete and accurate. As the principal investigator for this
study, I understand that I have the ultimate responsibility to ensure protection of the rights and welfare of human subjects. I am
aware that it is my responsibility to be aware of the current Saint Alphonsus Health System, state and federal requirements
related to research. I agree to comply with Saint Alphonsus policy and procedure research requirements and those imposed by
the Saint Alphonsus IRB, as well as any applicable Federal, State, and local laws pertaining to human research subjects.
Printed or Typed Name of Principal Investigator and Title
_______________________________________
Printed or Typed Company Name
______________________________________________
Signature
________________________________________
Date Signed
Confidential pursuant to Idaho Code
IRB Frm
Revised 03/18/13
Page 6 of 7
Investigator’s Last Name: _________________________
Study Title
IRB Application Check List: Please review to ensure all the following documents are included in your application.
Incomplete or inaccurately completed applications will NOT receive IRB review.
To submit a research proposal to the SARMC Institutional Review Board for consideration, please provide copies of the protocol
and all supporting documentation, three hole-punched, to the Office of Research Integrity.
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
Copy of complete study or device protocol
Initial Protocol Submission Application
Application for Expedited Review (if applicable)
St. Alphonsus Regional Medical Center pre-formatted informed consent form
Participant payment schedule (if applicable)
Signed Financial Disclosure forms for all investigators and co-investigators
St. Alphonsus Institutional Review Board prior disapproval or termination letter, with explanation
Other Institutional Review Board approval or disapproval, with explanation
Documentation of any criminal or medical organization proceeding against the PRINCIPAL INVESTIGATOR
Documentation of recommendation for approval of the PRINCIPAL INVESTIGATOR for less than two years
Documentation of any recent events in our community (deaths or serious injuries) related to this research or device
Copy of medical/professional license(s) for all investigators and study team members
Curriculum vitae for all investigators and co-investigators
Documentation of human research ethics training for all investigators and study team members
Sponsor/Investigator Contract (if applicable)
Sponsor Site Agreement and/or Data Use Agreement (if applicable)
Copy of Grant (if applicable)
Copy of Federal Contract (if applicable)
Any advertisement and recruitment materials
For clinical trials - Investigational New Drug information, including:
U.S. Federal Drug Administration form 1572 (if applicable)
Investigator’s Drug Brochure, applicable package insert(s), or background information
For device trials - Investigational Device Exemption information, including:
Copy of letters and supporting documentation from the device sponsor/manufacturer's application to the FDA
for IDE status
Copy of the FDA letter(s) granting IDE use
Documentation for why the device is exempt from IDE requirements
Submission fee for sponsored studies: $2,000(Full Review), $1500 (Expedited Review), $1000 (Continuing Review),
$500 (Amendments)
Administrative start-up fees $2,000
Legal fees $2,000
The Initial Protocol Submission Application, Application for Expedited Review, SARMC pre-formatted informed consent form,
and the Conflict of Interest disclosure forms are available from the Office of Research Integrity and can be downloaded at
http://www.saintalphonsus.org/forms-and-resources
The SARMC IRB convenes on the fourth Monday of every month. Proposals for new research must be received six weeks in advance of a
given meeting for initial review and recommendations by Research Integrity prior to submission to the Board. If you have any questions
about the applications or submission requirements, please contact Research Integrity at 367-8897 or mcmurrvr@sarmc.org
Confidential pursuant to Idaho Code
IRB Frm
Revised 03/18/13
Page 7 of 7