INVESTIGATOR'S STATEMENT OF ASSURANCE

The attached investigation involves the use of human subjects. I understand the University policy concerning the use of human subjects and I agree:

1. To obtain informed consent of subjects who are to participate in this project;
2. To report to the Human Subjects in Research Committee any unanticipated effects on subjects which become apparent during the course, or as a result, of experimentation and the actions taken as the result;
3. To cooperate with members of a committee charged with the continuing review of the project;
4. To obtain prior approval from the Committee before altering or amending the scope of the project or implementing changes in the approved consent form; and
5. To maintain documentation of consent forms and progress reports as required by institutional policy.

____________________________________________________________

PRINICIPAL INVESTIGATOR’S SIGNATURE (CLS)

     _____________________________________________________________

PRINICIPAL INVESTIGATOR’S SIGNATURE (Dental Hygiene)

Does the subject group include healthy volunteers? _X_yes ___no

Does the subject group include ill persons? ___yes _X_no

Are subject groups excluded for medical reasons? _X_yes ___no

Are there vulnerable subject groups? ___yes _X_no

If yes, is the exclusion criteria for the study specified? ___yes ___no

Are any subjects under the age of 18? ___yes _X_no

Are any subjects under the age of 12? ___yes _X_no

Are any subjects over the age of 70? ___yes _X_no

Scott Wright                                            Clincal Laboratory Sciences

PRINCIPAL INVESTIGATOR'S NAME (faculty)      DEPARTMENT

Susan L. Dougherty                                                          Dental Hygiene_      

PRINICIPAL INVESTIGATOR’S NAME (faculty)        DEPARTMENT

Judy Ball and Leesa Gabrielsen_______          Clinical Laboratory Sciences

STUDENT RESEARCHER'S NAME                         DEPARTMENT

Rachelle Roe and Kelsie Garrett                           __         Dental Hygiene____

STUDENT RESEARCHER’S NAME                         DEPARTMENT 

 MC3905 (CLS)  3920 (Dental Hygiene) ________              _Ogden. Utah 84404__

MAILING ADDRESS/MAIL CODE                                 CITY, STATE, ZIP

 ___________________________________________ _                       626-6716____

PRINCIPAL INVESTIGATOR'S SIGNATURE (CLS)                TELEPHONE

 ________________________________________________________626-7199____

PRINICIPLE INVESTIGATOR’S SIGNATURE (Dental Hygiene)          TELEPHONE

 ______________________________________________________  626-7079______

DEPARTMENT CHAIR'S SIGNATURE (CLS)                                    TELEPHONE

 _________________________________________________________626-6451    ___

DEPARTMENT CHAIR’S SIGNATURE (Dental Hygiene)                 TELEPHONE

_________________________________

DATE

A. APPLICATION FORM

1. TITLE

Two Methods of Detection for Streptococcus mutans

2. DESCRIPTION OF THE STUDY

Streptococcus mutans is a Gram positive organism that is a member of the Streptococcus viridans group.  This bacterium is a predominant organism of oral flora in most individuals.  Because of its ability to convert sugars and carbohydrates into lactic acid, it is a major cause of tooth decay and dental caries.  The presence, or even absence, can be a strong predictor of high or low susceptibility to dental caries (Orion).

The dental hygiene students, Rachelle and Kelsie, will be collecting samples from 50 people between the ages of 19-25 years.  Participants will be asked to chew paraffin for one minute, which will stimulate the secretion of saliva and transfer S. mutans from tooth surfaces into the saliva (Orion).  They will then be asked to spit at least one milliliter of saliva into a 12 x 75 mm test tube.  Another saliva sample will be collected by placing the rough surface of the Dentocult SM Strip on the tongue.  4-5 teeth will be scraped with a tooth pick two separate times, to collect plaque samples.  One plaque sample will go into the tubes with saliva for the PCR procedure, and the other plaque sample will be added to the rough side of the Dentocult SM Strip.

3. DURATION OF THE STUDY

This project will be completed in March 2005.

4. MULTICENTER STUDY

This is not a multicenter study.

5. NUMBER OF SUBJECTS

Fifty

6. HEALTH STATUS OF THE SUBJECTS

Healthy subjects will be tested.

7. SUBJECT GROUPS EXCLUDED

Any subject that has taken an antibiotic within the last two months will be excluded due to its affect on the bacterium.

8. AGES OF SUBJECTS

19-25 years

9. DESIGN OF THE STUDY

Two rapid methods of detection have been developed to identify S. mutans: one involving polymerase chain reaction (PCR) and another using Dentocult SM Strips.  The first phase of the project will be to optimize and validate the PCR procedure to work in the Clinical Laboratory Science microbiology laboratory.  For the PCR procedure, four primers specific to S. mutans will be used to identify the presence of the bacterium.  The second phase will be to validate the Dentocult SM Strips.  This requires a 48 hour incubation in a selective broth for detection of S. mutans.   Phase three will be to compare the two methods by calculating the specificity and sensitivity.

10. RISKS TO SUBJECTS

There will be no risks to the subject.

ANY MODERATE OR HIGH RISK STUDY MUST GO THROUGH A SEPARATE REVIEW PROCEDURE WHICH INCLUDES THE APPROPRIATE ADMINISTRATIVE OFFICER AND THE UNIVERSITY ATTORNEY.

11. BENEFITS TO SUBJECTS AND OTHERS

No benefits will be given to the subjects that participate.  With this study we are hoping

to determine which method is more specific and sensitive for the detection of S. mutans.

12. COSTS TO BE BORNE BY SUBJECTS

The participant is not financially responsible for any part of the study.

13. IS CONFIDENTIALITY ASSURED

Rachelle and Kelsie will make a short announcement at the beginning of class in the

Clinical Laboratory Sciences program and Dental Hygiene program asking for

volunteers.  The informed consent proposal will be handed to each volunteer to

thoroughly read and decide if they would like to participate.  Upon collection, the sample

will be assigned a sequential number within the study, and the name will not be

associated with the sample number.

14. CONTRACT OR GRANT NUMBER

This project has received funding through the WSU Undergraduate Research Office

15. NAME OF PRINCIPAL INVESTIGATOR AND DEPARTMENT

Investigators:  Judy Ball and Leesa Gabrielsen (CLS), Rachelle Roe and Kelsie Garrett (Dental Hygiene)

________________________________________________________________________

Principle Investigators Signatures                                                   

Weber State University Clinical Laboratory Sciences and Dental Hygiene

DEPARTMENTS

Wright 626-6716, Dougherty 626-7199___

PHONE NUMBERS

 ________________________________________________________________________

DEPARTMENT CHAIR – CLS

_______________________________________________________________________

DEPARTMENT CHAIR – Dental Hygiene

B. DESCRIPTION OF THE STUDY

Streptococcus mutans is a Gram positive organism that is a member of the Streptococcus viridans group.  This bacterium is a predominant organism of oral flora in most individuals.  Because of its ability to convert sugars and carbohydrates into lactic acid, it is a major cause of tooth decay and dental caries.  The presence, or even absence, can be a strong predictor of high or low susceptibility to dental caries (Orion).   Since the human mouth contains a large variety of oral flora, standard nutrient cultures tend to be very time consuming and non-specific for the detection of S. mutans.  Two other tests have recently been developed for rapid and specific identification of the bacterium, polymerase chain reaction (commonly known as DNA fingerprinting) and Dentocult SM Strips.  The objective of this project is to compare the two techniques.

Polymerase chain reaction (PCR) has greatly expanded the abilities of molecular biology by providing a quick, easy, and specific method for generating copies of any fragment of DNA.  It involves a repeating three-step process using primers to amplify a specific DNA sequence (Mahon 199).  The presence of S. mutans in saliva and plaque samples can be detected with PCR using two sets of primers specific for the organism (Oho 259).

The Dentocult SM Strips have been designed so that the dentist can perform the sample collection in the dental office.  Both saliva and plaque samples are inoculated onto two plastic strips that are treated to simulate a tooth surface.  The strips are then incubated for 48 hours and examined for S. mutans (Orion).

The first phase of the project will be to validate the PCR procedure for S. mutans.  Using a published procedure, the sample collection, DNA extraction, and PCR conditions will be optimized for validation (Oho 259).  The second phase of the project will be to validate the Dentocult SM Strips using the package insert (Orion).  In both method validations, we will be using a control strain of S. mutans.  Phase three will be to collect saliva and plaque from 50 participants and perform both the PCR and Dentocult detection methods on each sample.  The two methods will be compared statistically by calculating the specificity and sensitivity using the Predictive Value Theory.

Rachelle and Kelsie will make a short announcement at the beginning of class in the Clinical Laboratory Sciences program and Dental Hygiene program asking for volunteers.  The informed consent proposal will be handed to each volunteer to thoroughly read and decide if they would like to participate.  Upon collection, the sample will be assigned a sequential number within the study, and the name will not be associated with the sample number.

C. INFORMED CONSENT

TITLE:  Two Methods of Detection for Streptococcus mutans

INVESTIGATORS:  Professor Scott Wright (801-626-671), Judy Ball, and Leesa Gabrielsen, Professor Sue Dougherty (801-626-7199), Rachelle Roe, and Kelsie Garrett

IRB Chair:  Dr. Marjukka Ollilainen 801-626-6238

PURPOSE OF STUDY:  You are being asked to voluntarily participate in a research study designed to compare two methods of detection for Streptococcus mutans.  S. mutans is a Gram positive organism that is a member of the Streptococcus viridans group.  This bacterium is a predominant organism of oral flora in most individuals.  Because of its ability to convert sugars and carbohydrates into lactic acid, it is a major cause of tooth decay and dental caries.  The presence, or even absence, can be a strong predictor of high or low susceptibility to dental caries. 

This study will be conducted at Weber State University, and will include fifty Clinical Laboratory Science and Dental Hygiene students.  Samples will be tested in the CLS microbiology laboratory.

STUDY PROCEDURE:  You will be considered if you are between the ages of 19-25 years old, and have no significant medical problems, and have not been taking an antibiotic for at least two months.  This will be determined with a questionnaire that each participant is required to fill out. 

Given that you are qualified for the study, you will be required to do the following:

1.         For the study it is critical that the following things be avoided 1-2 hours prior to sample collection:         Eating                                                   Smoking

                        Brushing teeth                                       Mouth wash

                        Fluoride varnish treatment (varnish avoided within last 2 weeks)

            This may affect the presence of S. mutans in the mouth   

2.         Chew paraffin for one minute to build up saliva,

3.         Spit at least one milliliter of saliva into a 12 x 75 glass test tube,

4.         Place rough end of plastic Dentocult SM Strip onto your tongue to expose strip to saliva,

 5.         Scrape 4-5 teeth two separate times using a toothpick to obtain a plaque sample, one sample will go into the test tube with saliva, and the other sample will go onto the Dentocult SM Strip.

RISKS:  There are no serious risks in participating in this research study.

BENEFITS:  With this study we are hoping to determine which method is more specific

and sensitive for the detection of S. mutans.

CONFIDENTIALITY:  You have a right to privacy.  All information that is obtained in

connection with this study that can be identified to you will remain confidential. Upon

collection, your sample will be assigned a sequential number within the study, and your

name will not be associated with the sample number.  The results of this study will be

used in presentations and may be used in a paper to be published in a scientific journal,

but no individual participant will be identified by name.

VOLUNTARY PARTICIPATION:  Your decision to participate in this study is

completely voluntary and you are free to refuse at any time.

COST TO SUBJECTS:  There will be no cost to participate in this study.

CONSENT:  In signing this consent, I have given permission for the investigators to use

any results obtained during the test process with the understanding that all efforts will be

made to keep my identity confidential.

My signature indicates that I have read the above information and I have had a chance to

ask questions to help me understand what my participation will involve.  I agree to

participate in this study.  I also acknowledge having received a copy of this agreement.  I

understand that by signing this form, I have not waived any of the legal rights to which I

otherwise would have as a participant in a research study.

_______________________________________________________________________

Name of Participant (Print)

________________________________________________________________________

Participant’s Signature:                                                                          Date

D. EXPERIMENTAL SUBJECT'S BILL OF RIGHTS

The rights below are the rights of every person who is asked to be in a research study.

As an experimental subject, I have the following rights:

1.      To be told what the study is trying to find out.

2.      To be told what will happen to me and whether any of the procedures, drugs, or devices are different from what would be used in standard practice.

3.      To be told about the frequent and / or important risks, side effects or discomforts of the things that will happen to me for research purposes.

4.      To be told if I can expect any benefit from participating and, if so, what that benefit might be.

5.      To be told what other choices I might have and how they may be better or worse than being in the study.

6.      To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study.

7.      To be told what sort of medical treatment is available if any complications arise.

8.      To refuse to participate at all or to change my mind about participating after the study is started.

9.      To receive a copy of the signed and dated consent form.

10.  To be free of any pressure when considering whether I wish to agree to be in the study.

QUESTIONAIRE FOR PARICIPATION IN

STREPTOCOCCUS MUTANS STUDY

NAME: __________________________________________           AGE: _________

SAMPLE NUMBER: ________                     

1. Are presently healthy?  __ Yes __ No 
2. Have you taken any antibiotics within the last two months?  __Yes __ No
3. Have you eaten anything within the last 1-2 hours?  __ Yes __ No
4. Have you smoked within the last 1-2 hours?  __ Yes  __ No
5. Have you brushed your teeth within the last 1-2 hours?  __ Yes __ No
6. Have you used mouth wash within the last 1-2 hours?  __ Yes __ No
7. Have you had a fluoride varnish treatment within the last 2 weeks? __ Yes  __ No

I have completed this questionnaire to the best of my knowledge.  I understand that I may not be eligible to participate in the study by the answers I have given.  I also understand that by completing this questionnaire I am not obligated to participate in this study.   

PARTICPANT’S SIGNATURE:_____________________________________________

DATE: _________________