Institutional Review Board (IRB) Approval Form

This form is to be used for requesting review and approval of a new project before it is initiated. Full details must be given and all necessary documentation submitted. Please read this cover page carefully and fill it out thoroughly before proceeding with the rest of this form. Each researcher must provide verification of completing the "Protecting Research Participants training at the following website: http://phrp.nihtraining.com/users/login.php

* = Required information

 



Section 1: Personnel Information

Full name of principal investigator:
First Name:
Last Name


Mailing address of principal investigator:
Street Address:
City
State
Zip Code


Additional Contact Information:
Phone Number
*Elms Email


Please Choose One of the following:
Faculty Member
Student
Staff
Other
If Faculty, Department/School:
If student, Candidate for degree of:
If staff, Position:
If other, Specify:


**For students and their adivisors. Each student research proposal must be read and endorsed by the student's advisor.

Advisor: By submitting this form to the IRB, I attest to having read it and endorsed it.
Date:
Advisor's Name:


Section 2: Project Information
Short title of the project (use no more than ten words):
Names of co-investigators (if any):
If approved by the committee, project will start on:
If research proceeds as planned, project will end on:

I certify that the statements made in this request are accurate and complete, and if I receive IRB approval for this project, I agree to inform the committee in writing of any emergent problems or proposed procedural changes. I further agree not to proceed in the research until the problems have been resolved or the IRB has reviewed and approved of the changes.

*Date:
*Name of Investigator


Section 3: Project Information (part 2)

I. In lay language, state concisely the hypothesis/research question, purpose, and/or objectives of the proposed research (a few sentences only):


II. The Human Subjects involved in this research:
1. Who are the subjects? How many will be involved in the project?
2. How will you recruit or select the subjects, or how will you gain access to them?  Be specific here and indicate whether the subjects will be recruited from your place of employment and, if so, how this research relates to your job role; and any other information pertinent to your relationship with the subjects (e.g., how will you ensure against the possibility of coercion?).

3. Are you advertising/posting notice for subjects/volunteers?
If yes, submit a copy of the advertisement or notice.
Yes
No

4. For how long a time will each subject be involved in the project? If you are using your subjects on more than one occasion, indicate the number of such occasions and their duration.

5. Are you paying your subjects?
Yes
No

If yes, indicate how much and describe how you will pro-rate the payments to subjects who withdraw before the project ends.

6. Are your subjects students?
Yes
No

If yes, name the institution in which they are enrolled.

7. Identify possible risks to the participant as a result of the research.  Consider possible psychological harm, loss of confidentiality, financial, social, or legal damages as well as physical risks.  What is the seriousness of the risks and what is the likelihood that they may occur?

8. Describe in detail the safeguards that will be implemented to minimize risks.  What follow-up procedures are in place if harm occurs?

III. Confidentiality

1. Describe in detail the procedures that will be used to maintain anonymity or confidentiality during collection and entry of data.
a. Who will have access to data?
b. How will the data be used, now and in the future?
2. How and where will data be stored?
a. When will data, including audiotapes and videotapes, be destoyed?  If data is to be retained, explain why.
b. Will identifiers or links to identification be destroyed? When?
c. Signed consent documents must be retained for 3 years follwing the end of the study.  Where and how will they be maintained?


Section 4: IRB Decision

(To be filled out be the IRB Committee)

Only commence data collection when the IRB accepts and authorizes your request for review and approval of new research and a study number is assigned to your study.
Accepted
Denied
Resubmit after recommendations applied
Other action required:
Authorized Signature:
Date:
Study Number: