Naturopaths International
3011 N. West ST
Flagstaff, AZ 86004
Naturopaths International Protocol for Research
Institutional Review Board
Human Subjects Review Committee Application
This form is to be submitted to the Naturopaths International (NI) Institutional Review Board (IRB) for consideration of clinical trials on human subjects. The form must be typed, not hand-written, completed in full, and submitted electronically to the IRB Chair, . The Chairperson will alert you to receipt of your application. After submission, the IRB Chair will respond within two-three weeks of your proposed research with comments and/or approval of your study. You must also include in your application your source for funding.
IRB Applications may be submitted at any day during the month; please allow two-three weeks for processing and comment. If you do not receive a response from the Chair within two weeks, please contact the NI Headquarters at 928-214-8793.
If you have any problems completing the form, please contact the IRB Chair via email, or phone the NI headquarter office.
The principal physician and all physicians within the study must have current FDA form 1572, Supplemental Investigator Data Form (SIDF), and CV on file with the IRB Chair. CV may be submitted at the time of application submission.
PLEASE NOTE: AFTER YOUR STUDY IS ACCEPTED, YOU WILL BE REQUIRED TO COMPILE A STUDY DOCUMENT THAT IS HANDED TO YOUR PATIENTS OUTLINING YOUR STUDY, WITH YOUR LETTERHEAD. YOU MAY LIST US ON YOUR DOCUMENT AS OVERSEEING YOUR STUDY. THIS PAPERWORK MUST BE SUBMITTED TO OUR IRB FOR APPROVAL AND/OR COMMENT AND/OR EDITS PRIOR TO THE START OF YOUR STUDY.
Type of Application:
New
Revised. Date first submitted:
Purpose of Study (briefly summarize):
Title:
Who is performing this study?
Please list sites(s) of study (i.e. your clinic) and primary contact:
Please list your malpractice carrier, and provide a copy of your insurance at the time of submission of this proposal. If the insurance is pending approval of this study, please specify this information.
Principal Investigator (may list only one):
Address:
Telephone:
Fax:
Email:
Credentials (attach CV):
Co-Investigator (may list up to two):
Name of Co-investigator:
Address:
Telephone:
Fax:
Email:
Credentials (attach CV):
Name of Co Investigator #2:
Address:
Telephone:
Fax:
Email:
Credentials (attach CV):
Statistician (if applicable):
Address:
Telephone:
Fax:
Email:
Credentials (attach CV):
Study Coordinator/Marketer (if applicable):
Address:
Telephone:
Fax:
Email:
Credentials (attach CV):
Nurse (if applicable):
Address:
Telephone:
Fax:
Email:
Credentials (attach CV):
Other staff: please list the names, address, phone no, fax, email and credentials of additional staff who will be assisting in your study. Be sure to also submit each of their CV’s. (create space here as needed)
Date you would like to begin study:
Background information on proposed study. Provide a short summary here (up to 100 words), with citations to references (if applicable).
What is the rationale for conducing your study (in 100 words or less)?
What is your working hypothesis (in 50 words or less)?
Who is eligible for your study?
Please describe all parameters used to screen eligible patients for your study (i.e. labs, blood work, clinical presentation?).
Please list all exclusion criteria (i.e. patients you are excluding from your study).
How will you recruit patients?
What is your source of patients?
How will patients register for your study?
What is your sample size.
Please submit a copy of your HIPPA authorization form to the IRB Chair, as well as any additional forms you will require patients complete either prior to, during, or after the research study.
Provide a complete, succinct description of your research study including all methods, measure of outcomes, testing, questionnaires and patient information. Limit your description to 500 words. You may bullet information in outline form if you prefer.
Duration of treatment:
Duration of follow-up:
Criteria for Removal from study:
Please summarize the dosing with the timeline of any medications or herbs administered:
Adverse events must be reported and documented immediately to the NI IRB. You must report immediately any event that led to a hospitalization or paramedic/EMT response. For non-emergent adverse events, use the following grading in your protocol:
Grade one: no risk to patient health; no risk of death
Grade two: slight risk to patient health, patient being monitored by PI
Grade three: patient sent to hospital/received emergency care
And use the following adverse events reporting:
Definite: the event is clearly related to the study treatment
Probable: the event may be related to study treatment
Unlikely: the event is most likely not related to study treatment
Unrelated: the event is NOT related to study treatment
ADVERSE EVENTS MUST BE REPORTED WITHIN THE ROUTINE STUDY SUBMISSIONS TO NI. You must submit the MedWatch Form FDA 3500 to the IRB Chair within 24 hours of adverse event. No exceptions. Sumbit Adverse Events to
What study results will you submit to NI IRB during the course of study treatment?
If you are using a supplement or herb for treatment, please list all possible adverse events, potential risks to the patients, as well as proposed mechanism of action of your treatment (100 words or less, you may bullet information).
Will study participants be paid for their time?
Is a third party funding your study?
If yes, please list contact information for the funder.
Address:
Telephone:
Fax:
Email:
How will you maintain patient confidentiality?
We request you use a coding system to track patients, as opposed to using names. What will be your coding system?
Will you be using audiovisual or any recordings of patient consults/results? Explain.
Attach your written consent form, which MUST include (you must use the NI Informed Consent Template Form):
- Naturopaths International Research Division or with mailing address and contact information.
- Name and contact of all investigators.
- Signature for subject or parent/guardian as well as researcher.
- Purpose of study.
- Benefits of study.
- Description of treatment, procedure and time frame of study.
- Any costs to patient.
- Voluntary nature of participation and freedom to withdraw at any time without penalty.
- Assurance of confidentiality.
- Listing of who will have access to data from the study.
As the principal investigator, I acknowledge I am responsible for reporting adverse events within 24 hours to the Naturopaths International IRB Chair. I agree to begin the clinical trail only after approval of the NI IRB Board, and that no changes to the study will be put into effect without IRB consent. I have provided all information necessary for conduction of a clinical trial to the NI IRB, and will provide additional information if requested.
Signature of PIdate
Printed name