APPLICATION FOR IRB REVIEW

OF

NEW RESEARCH PROJECT

ALL FORMS MUST BE TYPEWRITTEN AND FULLY COMPLETED!

Submit the required number of copies of this form, the consent form, and the complete protocol for distribution to the IRB no fewer than three weeks prior to the IRB meeting. Materials received fewer than three weeks prior to the meeting will not be reviewed until the next IRB meeting. Incomplete forms will be returned.

PROJECT NUMBER:
PROJECT TITLE:
INVESTIGATOR(S):
PROJECT COORDINATOR:
MAILING ADDRESS:
E-MAIL ADDRESS:
PHONE NUMBER:
FUNDING SOURCE:

I understand that if this project is approved by the Institutional Review Board, I will be required to submit periodic reports.

Principal Investigator:______

Signature Date

Printed Name of Principal Investigator :

Dean of College:______

Signature Date

Printed Name of Principal Investigator :

External Agency Supervisor/Director (if appropriate): ______

SignatureDate

Printed Name of External Agency Supervisor/Director:
  1. PROJECT DESCRIPTION:
  1.  NEW PROJECT

 NEW PROJECT qualifying for EXPEDITED REVIEW

(Complete the Expedited Review Form and this application)

 NEW PROJECT qualifying for EXEMPTION FROM REVIEW

(Complete the Claim of Exemption from Review Form and this application)

  1. Project will be conducted at the following site(s):
  1. This project involves the use of an INVESTIGATIONAL NEW DRUG (IND) or an APPROVED DRUG FOR AN UNAPPROVED USE. YES NO
  1. This project involves the use of an INVESTIGATIONAL MEDICAL DEVICE or an APPROVED MEDICAL DEVICE FOR AN UNAPPROVED USE. YES NO
  1. This project involves the use or RADIATION or RADIOISOTOPES.

 YES  NO

  1. HUMAN SUBJECTS from the following population(s) would be involved in this project

 MINORS  PRISONERS COGNITIVELY IMPAIRED

 FETUSES PREGNANT WOMEN NONE OF THE ABOVE

  1. HUMAN SUBJECTS with whom the researcher has another relationship would be involved in this project

 STUDENT PSYCHOTHERAPIST/CLIENT

 PATIENT  PROFESSIONAL/CLIENT

 EMPLOYEE NONE OF THE ABOVE

  1. BIOLOGICAL SAMPLES:
  2. Is a biopsy involved?YES  NO
  3. Is a blood sample involved?YES  NO
  4. If yes, how much? How often?
  5. For what purpose is the above procedure being done?
    DIAGNOSTIC THERAPEUTIC RESEARCH
  6. Are other body fluids or tissues involved?YES  NO
  7. For what purpose is the above procedure being done?

DIAGNOSTIC THERAPEUTIC RESEARCH

PROJECT TITLE:
  1. TOTAL NUMBER OF SUBJECTS TO BE STUDIED:
  1. PROJECT TIMELINE:

Start Date:
(Note: Study may not begin prior to receiving IRB approval)
Anticipated duration of project:
Duration of participant involvement:
Completion of data collection:
  1. PROJECT ABSTRACT: (Briefly describe (200 words or less) the scientific or investigational focus of the Project)
  1. RISKS: (Describe the risks to subjects and the precautions that will be taken to minimize them. The concept of risk goes beyond physical risk and includes psychological and social risks)
  1. BENEFITS: (Describe the benefits to the subjects or to mankind in general that make the risks acceptable)
  1. ALTERNATE PROCEDURES: (Describe any alternate procedures available to the subject)
  1. FINANCIAL REMUNERATION TO SUBJECTS:
  1. PROTOCOL – Attach the complete proposal and methodology.
  1. CONSENT – Attach one copy of the CONSENT FORM(S) to be signed by the subject, any STATEMENT(S) to be read to the subject, and any INFORMATIONAL LETTER(S) to be directed to the subject.

ATTACHMENTS

  1. Data collection tools and permission to use them (as appropriate)
  2. Principal Investigator and Co-Investigator(s) Certificates of Completion of Computer Based Training offered by the Office of Human Studies Research, NIH.
  3. Principal Investigator and Co-Investigator(s) Conflict of Interest Forms.
  4. Proposal
  5. Consent forms

Revision Date: 5/17/2012New Project Application

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