Request for Exemption

Instructions

Certain categories of research are exempt from Federal regulations requiring IRB review.

Only the IRB can determine if a protocol is exempt. To request an exemption, complete the Request for Exemption form and submit it to the IRB office shown below. Requests for exemption are reviewed on a rolling basis and can be submitted at any time.

If the IRB determines that the proposed project qualifies for exemption, you will receive a letter to this effect. No further action will be required.

Please read these instructions carefully. The most common reason for delay in review of protocols is that the IRB does not have enough information about the project.

Submitting your protocol for review
What to submit:

Submit the original plus two (2) copies of:

The signed Request for Exemption form

Protocol description

Copies of surveys, interview questions, tests or other instruments

Certificate of completion of the training program

Letters of permission from study sites

Protocols WILL NOT be reviewed without:

· Phone and email address for the Principal Investigator (PI) or Instructor

· Phone and email address for the Student Investigator

· Signatures of the PI/Instructor (Instructor should sign as both PI and Instructor)

· Signature of Student Investigator

Where:

Requests for Exemption should be submitted to Office of Sponsored Programs and Research, North House, Second Floor.

When:

Requests for exemption can be submitted at any time. There are no deadlines. Please allow a minimum of 2 weeks for review.

Request for Exemption

Complete and sign this page and respond to the attached questions on a separate sheet.

Principal Investigator (PI)/Instructor Name:

Phone Number:

Email Address:

Address (to which correspondence should be sent):

Student Investigator Name:

Student Email Address;

Student Phone Number:

NYIT ID Number:

Course Number:

Project Title:

Study Location⁽¹⁾ :

Start Date:

/ /

End Date:

/ /

Exemption Category: Review the categories for exemption carefully. If your protocol does not fit precisely into one or more of these categories, it cannot be considered for exemption. If your protocol does not fit the exemption categories, refer to the guidelines for expedited or full review.

Category 1 2 3 4 5 6

Human Protections training completed?⁽²⁾ Yes Completion Date:

/ /

Principal Investigators:

I certify that to the best of my understanding I am in compliance with the policies of NYIT regarding human protections and will perform my research consistent with the description above. I have completed the required training in human participants research and a copy is on file with OSPAR or I have attached a copy of the certificate of completion.

PI Signature:

Date:

/ /

Instructors:

I certify that I have instructed this student in research techniques, have reviewed his/her complete research proposal and have found it to be consistent with the attached description and in compliance with NYIT Human Protections Policies.

Instructor Signature:

Date:

/ /

Students:

I certify that to the best of my understanding I am in compliance with the policies of NYIT regarding human protections and will perform my research consistent with the description above. I have completed the required training in human participants research and a copy is on file or I have attached a copy of the certificate of completion.

Student signature:

Date:

/ /

Please respond to the questions on the following page on separate sheet of paper.

(1) Letter(s) of permission from the study site(s) must be attached.

(2) Protocols will not be reviewed without the certificate of completion of the required training program.

Project Description:

Please respond to the following questions one by one on a separate page. Refer to Describing your research to the IRB for additional guidance.

1. What is the purpose of the proposed study? Describe the purpose of the study and your hypothesis. State the type of research design.

2. How will subjects be recruited and selected? Describe how you will advertise the study, compensation or incentives you will give to participants, inclusion and exclusion criteria, and the number of participants you hope to recruit.

3. Describe the study procedures (what the participants will be asked to do). You should attach copies of the surveys, interview questions, or other instruments that you plan to use. You may want to include a timeline or diagram to show how the participants will be involved.

4. Discuss the potential harms and benefits to the participants.

5. Describe how you plan to preserve the participants’ anonymity or protect their confidentiality. Where will the data be stored? Who will have access to it? What will happen to it after the study is completed?

6. Provide a consent and/or assent form if needed. If the study qualifies for exemption, it will generally be exempt from the requirement for a consent form.

Exempt Categories

(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as

i. research on regular and special education instructional strategies, or

ii. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Research with participants under 18 years of age may be included in this category.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

i. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

ii. 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.

Research with participants under 18 years of age may NOT be included in this category UNLESS it involves the observations of public behavior where the researcher does not participate in the behaviors being observed.

(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 (b)(2) of this section, if:

i. the human subjects are elected or appointed public officials or candidates for public office; or

ii. 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 which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:

i. public benefit or service programs;

ii. procedures for obtaining benefits or services under those programs;

iii. possible changes in or alternatives to those programs or procedures; or

iv. 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,

i. if wholesome foods without additives are consumed or

ii. 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

This information was taken fromNYIT website, however similar information may be found at almost all university sites.