Not Human Subjects Research Protocol

INSTRUCTIONS:

Depending on the nature of your study, some sections may not be applicable to your research. If so mark as “NA”.

As you are writing the protocol, remove all instructions in italics so that they are not contained in the final version of your site supplement.

PROTOCOL TITLE:
Include the Full Protocol Title

PRINCIPAL INVESTIGATOR
Name
Department
Enter the PI’s Contact Number
Enter the PI’s Email Address

Table of Contents

1.0	No Human Subjects Research Determinations	2

2.0	Objective/Purpose	3

3.0	Source Information	3

4.0	Recruitment of Participants	3

5.0	Data Collection and Usage	3

6.0	Study Duration	3

7.0	Retrospective Research	3

8.0	Risk Level	3

9.0	Intent of Project	4

10.0	Identifiable Information	4

11.0	Protection of Data	4

12.0	Research Locations	4-5

Not Human Subjects Research Determination

Department of Health and Human Services (DHHS) Human Subjects Research

Does the research involve Human Subjects? Is the study considered research? Select applicable:

☐	Human subject	A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction, or identifiable private information.
☐	Research	A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

If both of these boxes are checked, STOP and choose a different template since your study does not meet the criteria for a Not Human Subjects Research Determination under DHHS Regulations.

Food and Drug Administration (FDA) Human Subjects Research

Does the research involve any of the following? Select Applicable:

☐	Drugs or Biologics	The proposed research involves the administration of an article (e.g. drug, biologic, herbal preparation, dietary supplement, etc.) to a human where the article is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or is intended to affect the structure or any function of the body. For both FDA and non-FDA approved article.
☐	Devices	Any research that involves the use of a device (medical or other devices, approved or investigational) to test the safety or effectiveness of the device or the device is the focus of the research. Note: This includes research that will use human samples to test the safety or effectiveness of a device.
☐	Data Collection	Any research that involves the collection of data or other results from individuals that will be submitted to, OR held for inspection by, the FDA. In general, this would include research that involves any data that will be provided (in any form) to a pharmaceutical, medical device or biotech company.
☐	Specimens	Any research activity where specimens (of any type) from individuals, regardless of whether the specimens are identifiable, are used to test the safety or effectiveness of any device (medical or other devices, approved or investigational) and the information will be submitted to, or held for inspection by, the FDA.
☐	None of the Above	None of the above describes my research.

If any of the boxes except “None of the Above” are checked, STOP and choose a different template since your study does not meet the criteria for a Not Human Subjects Research Determination under FDA regulations.

Objective/Purpose

Please state the objective/purpose of the research:
Please state the objective/purpose of the research

Source of Information

How, and/or from where, do you plan to gather the information?
Describe where you are getting the data/information that you are collecting

Recruitment of Participants

How will the participants be recruited?
If people are participating, how will you recruit them?

Data Collection and Usage

What data will be collected and how will it be used/analyzed?
Please state how the date will be collected, used, and analyzed

Study Duration

State the anticipated beginning and end dates of the research (or approximated length of data gathering activities:
State the anticipated beginning and end dates of the research (or approximated length of data for gathering activities

Retrospective Research

Select if applicable:

☐	This study is for retrospective research review.

Risk Level

Is the risk to the individuals whose information you are using…? Select and fill if applicable:

☐	Minimal risk	More than minimal risk explanation:
☐	More than minimal risk	If you selected more than minimal risk, please describe what the risk is.

Intent of project

Is the primary intent of this project to benefit/improve the care of patients or a process or program at this institution? If not, please explain the intention.
Please state primary intent of the project to benefit/improve the care of patients or a process or program at this institution

Identifiable Information

As a part of this project, will you be receiving, collecting, or assessing data that can be linked to identifiers of human subjects?
Will any of the data or information be identifiable or possibly be linked to identifying information?

Protection of Data

11.1 What security measures will you take to protect information from improper use, disclosure, or reuse?
Please describe how the data will be handled and stored to protect the information collected.
11.2 When and how do you plan to destroy the data? If you do not plan to destroy the data, please give rationale.
Describe your plan to destroy data/information collected or explain why if you will not destroy the data.
11.3 What identifiers will be collected?
Will any of the data or information be identifiable or possibly be linked to identifying information?

Research Locations

Where will the activities take place? Select all applicable The Christ Hospital Health Network research sites: *Note- Add location in boxes for asterisked sites.

☐ The Christ Hospital- Mt. Auburn	☐ Outpatient Center*-	☐Surgery Center*-
☐ The Christ Hospital Medical Center- Liberty Township	☐ Outpatient Clinic*-	☐Testing Center*-
☐ Imaging Center*-	☐ Physical & Occupational Therapy*-	☐Urgent Center*-
☐ Lindner Research Center	☐Sleep Center*-	☐ Wound & Ostomy Care*-