Exempt Determination Request Form

EXEMPT DETERMINATION REQUEST FORM

Please submit this form to obtain a written determination that a proposed research project is exempt from IRB review. Please submit the following with your request:  A copy of the protocol or a detailed description of the research (required)  Copies of all data capture forms include case report forms and surveys (required)  Copies of any interview or focus group questions that will be used (if applicable)  All requests for exempt determination for research being conducted at a Providence Health Care ministry or by a Providence Health Care/Providence Medical Group investigator must be accompanied by a signed “Facility Approval Form” located on our website (if applicable)  If this research includes the collection of PHI, a waiver of HIPAA Authorization may be required. Please complete the “Application for IRB Waiver or Alteration of Patient Authorization For Use of Protected Health Information (PHI) in Research” located on our website (required)

Investigator Information

PI Name:

PI Address:

PI Phone Number:

PI E-mail:

Title of Research Project:

If this form is being completed by designated research personnel other than the PI, please complete the following: Name of Person completing form/supplying information:

Role in research project (i.e. undergraduate student, graduate student, coordinator etc):

Phone Number:

E-mail:

Where will research be performed?

Location Address Research to be performed A. B. C.

Mailing Address: 104 W. Fifth Ave., Suite 340W, Spokane, WA 99204 Electronic Submission: [email protected] Version 11-15 Website: http://irbspokane.phc.org Page 1 of 5 List names of principal investigator, sub-investigators, coordinators and other key personnel involved in this research.

Name Role in research Privileges granted CITI Training by institution? Certificate** (Yes/No/NA) Completed? (Yes/No) 1. Y N NA Y N 2. Y N NA Y N 3. Y N NA Y N 4. Y N NA Y N 5. Y N NA Y N 6. Y N NA Y N **See IRB website for information about required CITI training certification (located under Human Subject Training).

1. Does this research involve an FDA regulated product such as drug or device? Exemption cannot be granted for research involving products regulated by the FDA except for taste and food quality evaluations and/or consumer acceptance studies (category 6 below). Yes, this research involves research on an FDA regulated product. **If yes, no not submit this form - you must complete and submit an IRB application for full board review. No, this research does not involve research on an FDA regulated product

2. Do you intend to include prisoners in this research? Yes, this research includes prisoners. **If yes do not submit this form - contact the IRB for further discussion. No, this research does not involve prisoners.

Categories of Exemption under 45 CFR 46.101(b) (If checking “NO” on any of the categories below, do not complete questions under that category heading)

Category 1 – 45 CFR 46.101(b)(1) YES No

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 the comparison among instructional techniques, curricula, or class room management methods.  Please explain why you believe this research involves an established or commonly accepted education practice(s):  Please explain why you believe this research will be conducted in an established or commonly accepted educational setting:

Mailing Address: 104 W. Fifth Ave., Suite 340W, Spokane, WA 99204 Electronic Submission: [email protected] Version 11-15 Website: http://irbspokane.phc.org Page 2 of 5 Category 2 – 45 CFR 46.101(b)(2) Yes No

1. 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.

2. Will this research include children as research subjects? Yes* No *If research involves children, the exemption for this category is limited to educational tests and observation of public behavior where the investigator(s) will NOT participate in the activities being observed. You must complete and submit an IRB application.

Category 3 – 45 CFR 46.101(b)(3) Yes No

1. Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2 above, 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.

1. Research involving the collection of study or 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. *Existing means data, documents, records, pathological specimens or diagnostic specimens that are already existing “on the shelf” at the time of exempt determination request. This exemption may not be applied to activities involving prospective collection of such materials. You must complete and submit an IRB application.

1. 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: (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.

Mailing Address: 104 W. Fifth Ave., Suite 340W, Spokane, WA 99204 Electronic Submission: [email protected] Version 11-15 Website: http://irbspokane.phc.org Page 3 of 5 2. Check all that apply: Yes No The program under study delivers a public benefit or service Yes No The research or demonstration project is conducted pursuant to specific federal statutory authority. Yes No There is no statutory requirement that the project be reviewed by an IRB Yes No The project does not involve significant physical invasions or intrusions upon the privacy of the subjects. Yes No The funding agency concurs with the exemption (provide written documentation).

Category 6 – 45 CFR 46.101 (b)(6) Yes No

1. Taste and food quality evaluation or consumer acceptance studies, (i) only wholesome foods without additives will be 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 and Safety and Inspection Service of the U.S. Department of Agriculture.

Additional Information:

Yes No Is the research a systematic investigation designed to develop or contribute to generalizable knowledge? Yes No Does this research involve any intervention or interaction with a living individual? Yes No Does the research involve obtaining information about living individuals? Yes No Does the project involve biological samples from living individuals? Yes No Was the information or were the samples collected specifically for this study? Yes No Was the information or were the samples collected for another purpose? Please describe: Yes No Will the investigator be able to discover the identity of the individual? Yes* No Will the information or samples include any codes which links to the identity of the individual? *If yes, check the following statements that are true (at least one must be selected): There is an agreement between the investigator and the holder of the key that prohibits the release of the key to the investigators under any circumstances. There are IRB approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances. There are other legal requirements prohibiting the release of the key to the investigators. Other (specify):

Mailing Address: 104 W. Fifth Ave., Suite 340W, Spokane, WA 99204 Electronic Submission: [email protected] Version 11-15 Website: http://irbspokane.phc.org Page 4 of 5 SIGNATURES

Principal Investigator – I certify that the information provided above is correct and that, to the best of my ability to judge, this research qualifies for exemption and will be conducted in accordance with Federal and State regulations and laws as well as any additional IRB requirements.

Signature of PI: ______Date: ______

IRB Reviewer -

Recommendation:

Exempt Defer for Expedited Review Defer for Full Board Review Not Research with Human Subjects or personally identifiable private information

Print Name: ______

Signature: ______Date:______

Mailing Address: 104 W. Fifth Ave., Suite 340W, Spokane, WA 99204 Electronic Submission: [email protected] Version 11-15 Website: http://irbspokane.phc.org Page 5 of 5