Request for Exemption Determination Form

Exempt and Non-Human Subjects Research Determination Request

1.Submission information: Use this form to request a determination of exemptor non-human subjectsresearch for a specific project.
2. Submission Type: / Exemption Determination Request / Non-Human Subject Research Determination Request
3. Submission requirements:
Project protocol and/or summary andadditionalproject documents
Plans for privacy, confidentiality and dissemination of findings
Expected date of completion, as applicable
4.Submission Instructions: Submit via Secure eSubmission or email to .
SECTION 1.0: Project& Contact Information
1. Project/Grant No.:
2. Project Title:
3.Investigator Name:
First: / Middle: / Last: / Suffix: / Credentials:
4. Provide the protocol number(s) of any similar/related determinations previously submitted to Schulman:
5. Contactinformation for this submission:
Name: / Title:
Company: / Address:
City: / State: / Phone:
Postal Code: / Country: / Email:
6. Party responsible for Schulman service fees:
Name: / Title:
Company: / Address:
City: / State: / Phone:
Postal Code: / Country: / Email:
7. Send invoices via: Email Hard Copy / 8.Purchase Order Number (if applicable):
9. Provide the source of funding for the project:
Pharmaceutical or Medical Device Company
Not-for-Profit Sponsor
US Government Complete a. and b.:
Other:
a. Specify the funding agency:
b. Has an IRB reviewed the grant application for the version of the project being submitted?
Yes / NoSubmit the grant for review by Schulman IRB.
10. Has this proposal previously been submitted to another IRB?
No / Yes Provide an explanation:
SECTION 2.0: Project Classification
If your project is subject to FDA regulation, complete Section 3.0.
If your project is not subject to FDA regulation, complete Section 4.0.
If you are uncertain about whether your project is subject to FDA regulation, contact the appropriate FDA office as indicated by the FDA Basics for Industry: Navigation Guide.
SECTION 3.0: FDA Regulated Research
1.Does this project include *human subjects?
*Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. 21 CFR 50.3 (g)
Yes
No The project may not be classified as human subjects research. Stop and skip toSection5.0to submit for a determination.
2. Does this project involve a *clinical investigation of a *test article?
*Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies. 21 CFR 50.3 (c)
*Test articlemeans any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other subject to regulation under the act or under sections 351 and 354-360F of thePublic Health Service Act (42 U.S.C. 262 and 263b-263n). 21 CFR 50.3 (j)
Yes
No The project may not be classified as human subjects research. Stop and skip toSection5.0to submit for a determination.
3.Does the following category of human subjects research, exempt from IRB review under FDA regulations, best fit this project?

Category 21 CFR 56.104 (d): Taste and food quality evaluations 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 FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Yes Skip toSection 5.0to submit for a determination.
No Skip toSection 5.0to submit for a determination.
SECTION 4.0: Non-FDA Regulated Research
1.Does this project include *human subjects?
*Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. 45 CFR 46.102 (f)
Yes
No The project may not be classified as human subjects research. Stop and skip toSection 5.0to submit for a determination.
2.Does the projectinvolve *research?
*Researchmeans a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45 CFR 46.102 (d)
Yes
No The project may not be classified as human subjects research. Stop and skip toSection 5.0to submit for a determination.
3.The following categories are exempt from IRB review under HHS regulations. Select the category that describes thisproject:
Category 1 [45 CFR 46.101(b)(1)]
Research conducted in established or commonly accepted educational settings, involving normal education practices, such as:
(a) research on regular and special education instructional strategies;or
(b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 2 [45 CFR 46.101(b)(2)]
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
(b) 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 subject’s financial standing, employability, or reputation.
Note:Category 2 does not apply to research involving children that includes surveys, interviews, and observations of public behavior.
Category 3 [45 CFR 46.101(b)(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 category 2, if:
(a) the human subjects are elected or appointed public officials or candidates for public office; or
(b) federal statute(s) require(s) without exception that confidentiality of personally identifiable information will be maintained throughout the research and thereafter.
Category 4 [45 CFR 46.101(b)(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.
Note: In order to be eligible for Category 4, all of the materials have to exist at the time the research is proposed.
Category 5 [45 CFR 46.101(b)(5)]
Research and demonstration projects which are conducted by or subject to the approval of federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(a) Public benefit or service programs;
(b) Procedures for obtaining benefits or services under those programs;
(c) Possible changes in or alternatives to those programs or procedures; or
(d) Possible changes in methods or levels of payment for benefits or services under those programs.
Such projects must be conducted pursuant to specific federal statutory authority, there must be no statutory requirements for IRB review, the research must not involve significant physical invasions or instructions upon the privacy of subjects and the exemption must be invoked only with authorization or concurrence by the funding agency.
Category 6 [45 CFR 46.101(b)(6)]
Taste and food quality evaluations and consumer acceptance studies,
(a) If wholesome foods without additives are consumed; or
(b) 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 contaminate 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.
SECTION 5.0: Investigator Certification Signature
As the individual responsible for completing this form, my signature certifies that:

I am the Investigator or the Investigator's designee authorized to submit on behalf of the Investigator; and
All information provided in this form is true and accurate, has been reviewed by the Investigator and communicated to all project personnel.