IRB

APPLICATION FOR DETERMINATION OF EXEMPT STATUS

Note: This form cannot be used if vulnerable subjects are included in the study population, translation of materials is required, or if the project is funded by an external funding agency.

Principal Investigator:

Phone: Fax: Email:

Department, Building and Room No:

Project Title:

Student Investigator(s):

Designated Contact:

Education Training Certification:

CITI, date completed:

NIH, date completed:

Other, explain:

Exempt Category Claimed (check all that apply):
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: the human subjects are elected or appointed public officials, or candidates for public office; or 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 involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5. Research and demonstration projects conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Please check one and provide the information as requested.

For Research Involving the Use of Existing Specimens, Data or Documents*:

*For this exemption to apply, all specimens, documents, or data must be in existence at the time that the research is reviewed by the IRB. Provide an abstract including the research objectives; description of the existing specimens, data, or documents; the origin of the data, the name of the institution, protocol number, and approval date under which the original data was collected; the current location of the data; who has the authority to release the specimens, data, or documents; and identifiers you will keep for your research. Include your methods section here in the second field.

Methods:

For all Other Research

Summarize or provide an abstract of the proposed research using language understandable to committee members whose primary concerns are nonscientific. Include a brief description of the subject population and plans for recruitment, describe what kind of permission or consent you will seek from human subjects to participate in the research, and describe steps taken to protect the privacy and/or confidentiality of subjects. Attach copies of any questionnaires, surveys, or other intervention tools to be used.

Methods:

PRINCIPAL INVESTIGATOR ASSURANCE AND SIGNATURE PAGE

I understand that as the PI, I have ultimate responsibility for the protection of the rights and welfare of human subjects and the ethical conduct of this research protocol. I agree to comply with all IRB and UML policies and procedures, as well as with all applicable federal, state, and local laws regarding the protection of human subjects in research, including, but not limited to, the following:

• The project will be performed by qualified personnel according to the research protocol,
• Maintaining a copy of all questionnaires, survey instruments, interview questions, data collection instruments, and information sheets for human subjects for three years following termination of the project,
• Necessary review by the IRB will be sought if any changes are made in the research protocol since a change may result in the research no longer meeting the criteria for exemption.

I have received and reviewed the UML IRB policies and procedures.

I have completed the required human subject research training.

I certify that the information provided in this claim of exemption is complete and correct.

PI Signature:	Date:
Printed Name of PI:
Co-PI Signature:	Date:
Printed Name of Co-PI:
Student Investigator(s):

For IRB Use Only:

Exempt per 45 CFR 46.101 (b)

Signature of Authorized IRB member Date: