INFORMED CONSENT FORM FOR MEDICAL RESEARCH

CONSENT TO PARTICIPATE IN RESEARCH

Identification and Management of Displaced Tracheotomy Tubes and Accidental

Decannulation.

You are asked to participate in a research study conducted by Shirley Jordan-Seay, MSN,

MEd., RN, CNA, BC, OCN, a PhD student from the Department of Health Sciences at

Touro University International 5665 Plaza Drive, Third Floor, Cypress, CA 90630. You

have been invited as a possible participant in this study because you are a registered nurse

with an active license in one of the 50 United States.

PURPOSE OF THE STUDY

The purpose of this research is to assess the knowledge level of registered nurses

associated with the recognition and intervention of a displaced tracheotomy tube or

accidental decannulation in patients with current or potential upper airway

obstruction.

PROCEDURES

If you volunteer to participate in this study, you will be asked to read and complete the

following:

1. Demographic Data Form

2. Knowledge Assessment Form

ESTIMATED TIME COMMITMENT

It is estimated that the time required to read the Informed Consent Form and Complete the

items in the Research Study, will require 1 hour of your time. Specifically individual

components will take the approximate time as listed below:

1. Description of the study and informed consent – 15 minutes

2. Demographic Data Form – 20 minutes

2. Knowledge Assessment Form – 25 minutes

All activities will occur sequentially, that is to say, once you have advanced beyond an

item you cannot return to that particular item. Once the Knowledge Assessment Form is

complete, you may exit the web site.

POTENTIAL RISKS AND DISCOMFORTS

It is anticipated that your participation will require about 1 hour of your time. You may

complete the entire program without taking a break, or you may take a break after the

Demographic Data Form, and resume with the Knowledge Assessment Form. After this

break, it is requested that you complete the remaining segment of this research and sign

off. There are no foreseeable physical, psychological, economic, or social risks related to

participation in this research. However, you may experience minor discomfort from

sitting in one position for a long period of time. However, we have designed the study in

such a manner that will allow for comfort. If you experience minor discomfort, please

take a short break, stretch your legs, and walk around, then return to the computer for

completion of the research form.

POTENTIAL BENEFITS TO SUBJECTS AND/OR TO SOCIETY

The benefit to you is having the opportunity to participate in an important research study.

PAYMENT FOR PARTICIPATION

There is no monetary incentive for participation. In addition, there is no cost to you for

your participation in this study.

CONFIDENTIALITY

Any information that is obtained in connection with this study will be done without the

necessity to identify you by name. Hence, confidentiality will be protected and your

privacy will be assured. The results of this study will be reported in aggregate form only.

That is, the researchers will present the outcome of this study using descriptive and

inferential statistics. We will also construct tables and graphs that will help illuminate the

study findings.

PARTICIPATION AND WITHDRAWAL

You may choose whether to be in this study or not. If you volunteer to be in this study,

you may withdraw at any time without consequences of any kind. Participation or nonparticipation

will not affect you, or interfere with any other personal consideration or right

you usually expect. You may also refuse to answer any questions you don't want to

answer and still remain in the study. Participation in this study is voluntary, moreover,

once you start your participation in this study you may decide to discontinue your

participation, as you are free to withdraw at anytime. Since this is a computer-based

study, your withdrawal is completely under your control and you can terminate from the

study at anytime.

IDENTIFICATION OF INVESTIGATORS

If you have any questions or concerns about the research, please feel free to contact

Shirley Jordan-Seay Principal Investigator (216-851-2113), or Dr. Frank Gomez, PhD.

Faculty Sponsor (714-226-9840).

RIGHTS OF RESEARCH SUBJECTS

You may withdraw your consent at any time and discontinue participation without

penalty. You are not waiving any legal claims, rights or remedies because of your

participation in this research study. If you have questions regarding your rights as a

research subject, contact the Institutional Review Board for the Protection of Human

Subjects at Touro University International, 5665 Plaza Drive, Third Floor, Cypress, CA

90630; Telephone: (714) 226-9840 or email to aafrookhteh@tourou.edu.

CONSENT OF RESEARCH SUBJECT:

I understand the procedures and conditions of my participation described above. My questions

have been answered to my satisfaction, and I agree to participate in this study. I have been given 

the opportunity to print a copy of this form. By proceeding to the survey, I voluntarily give my informed

consent to participate in this study.

IDENTIFICATION OF INVESTIGATORS

If you have any questions or concerns about the research, please feel free to contact

Shirley Jordan-Seay Principal Investigator (216-851-2113), or Dr. Frank Gomez, PhD.

Faculty Sponsor (714-226-9840).

RIGHTS OF RESEARCH SUBJECTS

You may withdraw your consent at any time and discontinue participation without

penalty. You are not waiving any legal claims, rights or remedies because of your

participation in this research study. If you have questions regarding your rights as a

research subject, contact the Institutional Review Board for the Protection of Human

Subjects at Touro University International, 5665 Plaza Drive, Third Floor, Cypress, CA

90630; Telephone: (714) 226-9840 or email to aafrookhteh@tourou.edu.

CONSENT OF RESEARCH SUBJECT:

I understand the procedures and conditions of my participation described above. My

questions have been answered to my satisfaction, and I agree to participate in this study. I

have been given the opportunity to print a copy of this form. By proceeding to the survey,

I voluntarily give my informed consent to participate in this study.

STATEMENT and SIGNATURE OF INVESTIGATOR

In my judgment the subject is voluntarily and knowingly giving informed consent and

possesses the legal capacity to give informed consent to participate in this research study.

         Shirley Jordan Seay                 10/26/2007

Signature of Investigator Date

Proceed to Study