PI ______
INSTITUTIONAL REVIEW BOARD
APPLICATION FOR APPROVAL TO USE HUMAN SUBJECTS IN RESEARCH
EXEMPT PROJECT
1. Project Title: ______
______
2. Principal Investigator (Must be a faculty/ staff member at UNH; if thesis project- faculty advisor is PI and student is co-PI):
______
Degree (PhD, MA, MFA, etc…): ______
Administrative Unit/Department: ______
Phone (UNH Extension): ______
E-mail: ______
Status (Mark one):
______UNH Faculty
______UNH Staff
______UNH Administration
3. Co-PI : ______
Affiliation (if non-UNH) ______
Affiliation Address (if non-UNH) ______
______
Degree (PhD, MA, MFA, etc…): ______
Administrative Unit/Department: ______
Phone (UNH Extension): ______
E-mail: ______
Status (Mark one):
______UNH Faculty
______UNH Staff
______UNH Administration
______Graduate Student (must have a UNH faculty research advisor)
Undergraduate Student (must have a UNH faculty research advisor)
_ Other (please explain) ______
(Non-UNH PI’s must have UNH faculty/staff/administration primary PI)
4. Project Status (Mark one): Faculty Scholarship Graduate Research
Undergraduate Faculty-Mentored Research ______
Master’s Thesis ______Dissertation Research ______
Honor’s Thesis ______Senior Project ______
SURF Project ______Other (please explain) ______
5. For student researchers only, who is/are your UNH affiliated faculty advisor(s)
Faculty Advisor(s): ______
Degree (PhD, MA, MFA, etc…): ______
If different from PI above please provide the following information:
Administrative Unit/Department: ______
Phone (UNH Extension): ______
E-mail: ______
Status (Mark one): Faculty______Staff______Other _____
NOTE: The IRB will not review protocols submitted by students without the signature of a faculty advisor on the signature page.
6. Does your study involve the collection of data from a vulnerable population?
yes no ______
If yes, please specify: ______
7. Does this study involve deception (research in which the subject is purposely lead to have false beliefs or assumptions)? yes no ______
8. If the study involves risk to subjects, is the risk greater than that incurred in ordinary life or tasks?
yes no ______
9. Has this study ever been previously approved by the UNH Human Subjects IRB? yes no ______
10. Has this study ever been previously approved by a non-UNH Human Subjects IRB?
yes no ______
If yes, please specify what IRB: ______
If yes, please append the decision of the other IRB to this application
11. Check if this proposal is new or revised in response to previous IRB review.
12. Is funding being sought for this study? If yes, through what sponsoring agency?
______
______
EXEMPT REVIEW
A. Research that meets all the requirements of the following categories may receive Exempt status.
1. Research that involves the study of normal educational practices in commonly accepted educational settings.
2. Research that involves the use of educational tests, surveys, or interviews where identifiers are not recorded by the observer or where there is neither a risk of harm to subjects nor information sought concerning sensitive aspects of the subjects’ own behavior. Research involves observation of public behavior where identifiers are not recorded by the observer or there is neither a risk of harm to subjects nor observation of sensitive aspects of the subjects’ own behavior. This exemption does not apply to research with children when the investigator(s) participate in the activities being observed; for example, in classroom situations where the researcher is taking part in the classroom activities being studied or surveys and interviews with children.
3. Research that involves the use of educational tests, surveys, interviews, or observation of public behavior that is not exempt under the above category if: (a) subjects are elected or appointed public officials or candidates for public office or (b) federal statute(s) require(s), without exception, that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research that involves merely the collection or study of existing data, documents, records, pathological or diagnostic specimens, where publicly available or where the information is private but identifiers are not recorded by the researcher.
5. Research that examines current public benefit or service programs, or alternatives to existing programs.
6. Taste and food quality evaluation and consumer acceptance studies, if food or additives consumed meet FDA safety standards.
B Only the IRB may grant Exempt status to projects. Therefore all research projects using human subjects must be submitted for IRB review BEFORE data collection commences. The IRB CANNOT approve projects retroactively.
C. If exempt status is granted, the study will no longer be under the jurisdiction of the IRB. However, if procedures are revised which deviate from those originally reviewed by the IRB the project must be resubmitted to the IRB BEFORE data collection commences. The IRB CANNOT approve projects retroactively.
D. Research involving protected populations, e.g., children, prisoners, pregnant women or fetuses, is NOT eligible for exempt status.
E. I believe my research can be classified as exempt under category number(s) ______above.
F. Please append to this document a description of your research sufficiently detailed (1 to 2 paragraphs) to justify exemption the categories chosen. This description should include information detailing how you will ensure that all participants are over 18 (note that, under most circumstances, studies with persons under 18 cannot be exempted)
G. Please append to this document any surveys, interview questions or tests you plan to use in your project. While, the IRB understands that interviews are often fluid and questions may deviate from those submitted, a list of sample questions and areas of inquiry are essential so that the IRB may properly evaluate your application.
H. I certify that all of the information and materials provided in and in support of this application are to the best of my knowledge and belief true, correct and complete.
I agree to use procedures with respect to safeguarding human subjects in this activity that conform to University policy. If significant changes in investigative procedure involving human subjects is called for during the activity covered by this application, I shall seek prior approval for such changes from the IRB and agree to follow the advice of the IRB.
The faculty sponsor's signature indicates that he/she has reviewed this application and accepts the responsibility of insuring that the procedures approved by the IRB are followed.
PI Signature Date ______
Co-PI Signature Date ______
Faculty Advisor’s Signature ______Date ______
(Required for student research)
Add more signature lines, if needed
Please email all applications and supporting documents to:
Dr. Alexandria E. Guzmán, IRB Chair at
******************************************************************************
For IRB use:
Date Received:
Protocol # ______
Date Revision Requested ______
Comments
Nature of Revision:
Date Completed: ______
Decision:
Documentation OK? ______
***********************************************************************
XXX