Human Subject Research Office

University of Miami

Non Human SubjectResearch Determination Application

INSTRUCTIONS: Please type directly on this form. You can expand the document if you need more space. If your research involves a survey or questionnaire, please attach it to this completed form.

Completed forms (with all required signatures) may be sent to the HSRO by FAX (305-243-3328) or by email to an IRB Regulatory Analyst. If you have any questions, call the HSRO at (305) 243-3195

To: HUMAN SUBJECTS RESEARCH OFFICE, JMT-East, Suite 1002

Principal Investigator: Telephone Number:
University Title: Department:
Email Address:Campus:
Mailing Address: Locator Code:

Title:

The Principal investigator is an employee of: UM JHS

If neither, please explain:

If applicable, list your non-UM/JHS Collaborating Investigator(s). NA

Name Institution Address Tel. # FAX #

Proposed start date of your activity Proposed completion date

Provide a lay summary of the purpose of the study.

Describe all study procedures you intend to perform.(please use lay terms):

A. Quality Improvement activities

Yes No Is the activity to assess or improve a process, program, or system OR to improve

performance as judged by established/ accepted standards.

Describe what is being assessed :

If “yes” Describe how the knowledge sought will benefit the process/program/system.

B. DHHS Determination of “Research”

1. Yes NoIs the activity an investigation? (Investigation: A searching inquiry for facts: detailed or careful

examination )

2. Yes NoIs the investigation systematic? (Systematic: Having or involving a system, method, or plan.)

3. Yes NoIs the investigation designed to develop or contribute to generalizable knowledge?(Designed: observable behaviors used to develop or contribute to knowledge. Develop: to form the basis for a future contribution. Contribute: to result in. Knowledge: truths, facts, information.Generalizable: Universally or widely applicable.)

C. DHHS Determination of “Human Subjects”

1. Yes NoIs the data/sample you are planning to obtain about living individuals?

What kind of human samples (e.g., tissue, blood) or data (e.g., private information,

responses to questionnaires) will be involved in your research?

a) Indicate the number of participants data/samples you are planning to include:

b)Yes NoIs this a case report?

c)Yes NoIf this is a case report, the patients are those treated by the clinician preparing

the report

2.Where are the subjects of this research activity located?

3. Yes No If human subjects are located elsewhere (not at UM/JHS), will you have direct

contact or intervention with them? (Examples: as subject's physician; in obtaining

samples directly from the subject; by interviewing the subject?)

4. Samples or Data Handling. (check appropriate item(s))

Yes No Will be collecting samples or Data?

Yes NoWill be receiving samples or Data?

Yes NoWill be sending samples or Data?

5. Do the samples or data:

(a) Yes NoAlready exist? Or

(b) Yes NoAre they being collected for the express purpose of this study?

If “yes,” please describe:

Please describe:

6. If the samples, data, do not come from an IRB approved protocol, do they come

from:

(a) Yes NoRepository

(b) Yes No Pathological waste

(d) Yes No Publicly available source

(e) Other

7. Please check the box(es) that apply(ies) to the samples/data that you will receive.

(a) Samples and/or data will be anonymized/unlinked. (The samples/data cannot

be linked to individual subjects by you or your collaborators at other sites.)

(b) Samples and/or data will be coded, however that code cannot be used by

either the sender or the receiver to identify specific individuals.

them to specific individuals but the receiver will not be able to do so.

8. What role will you have in this research project? (Check all that apply)

Analyze samples/data only.

Consultant/advisor to collaborator(s) listed above.

Author of the protocolthat is being implemented by your collaborating

investigator (identified in question #2).

Co-authorship on publication(s)/ manuscript(s) pertaining to this research.

You or collaborator holds an IND for this research.

Decisional authority over the design or implementation of the research at the IRB

approved site? If so, please explain.

If other (describe your role in this research).

9. Has the research activity that you are proposing in this form been approved by

an Institutional Review Board (IRB) elsewhere?

No IRB review of the research activity described in question #1 above has

taken place.

Yes, the research activity has been reviewed by the following IRB (s) (Please

provide the following information for each IRB):

Name of institution that provided the review

Address of reviewing institution

Name of PI for the IRB approved protocol

Title of IRB approved protocol and protocol #

Federal Wide Assurance (FWA) number**

(**An FWA is a contract between the U.S. Department of Health and Human Services (DHHS) and an entity receiving DHHS funds to conduct clinical research that the latter will follow ethical guidelines and federal regulations for the protection of human subjects.

10. Will you send results back to the provider(s))?

(a)No, I will not send results back to the provider(s).

(b)Yes, I will send aggregate results to the provider(s).

Yes No If yes, does the provider intend to link your data to identifiable individuals?

D. FDA Determination of Human Subject Research

1. Yes NoIs the activity an experiment to evaluate the safety or effectiveness of a drug or

device?

2. Yes NoDoes the activity involve one or more of the following test articles?

* Foods or dietary supplements that include a nutrient content claim or a health claim

* Infant formulas

* Food and color additives

* Drugs for human use

* Medical devices for human use

* Biological products for human use

* Electronic products

Yes NoWill the study involve using test articles with one or more human participants?

Yes NoIs the study being done as part of an IND or IDE submission?

Yes NoCould the data be submitted to the FDA or held for inspection by the FDA?

CONFLICT OF INTEREST

1. Yes No NAHave conflicts of interest by the research personnel, if any, been resolved?

______

Signature of Principal InvestigatorDate

I hereby confirm that I have read this application and my signature denotes departmental/unit approval of this project. To the best of my knowledge, the information in the application relating to members of my department is correct.

______

Print Name of Department Head

______

SIGNATURE of Department HeadDate

Non-Human / Non-Research Determination Application

Version 050912