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:
- To obtain informed consent of subjects who are to participate in this project;
- 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;
- To cooperate with members of a committee charged with the continuing review of the project;
- 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
- 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 (
MAILING ADDRESS/MAIL CODE CITY, STATE, ZIP
___________________________________________ _ 626-6716____
PRINCIPAL INVESTIGATOR'S SIGNATURE (CLS) TELEPHONE
________________________________________________________626-7199____
PRINICIPLE INVESTIGATOR’S SIGNATURE (Dental Hygiene) TELEPHONE
______________________________________________________
DEPARTMENT CHAIR'S SIGNATURE (CLS) TELEPHONE
_________________________________________________________626-6451 ___
DEPARTMENT CHAIR’S SIGNATURE (Dental Hygiene) TELEPHONE
_________________________________
DATE
A. APPLICATION
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
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
Polymerase chain reaction (
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
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
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: ________
- Are presently healthy? __ Yes __ No
- Have you taken any antibiotics within the last two months? __Yes __ No
- Have you eaten anything within the last 1-2 hours? __ Yes __ No
- Have you smoked within the last 1-2 hours? __ Yes __ No
- Have you brushed your teeth within the last 1-2 hours? __ Yes __ No
- Have you used mouth wash within the last 1-2 hours? __ Yes __ No
- 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: _________________