Obstetrics and Periodontal Therapy (opt) Study Manual of Operations Version 1 March 3, 2003 Brief Table of Contents



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Compensation:

You will not be paid for participating in this study. After you are enrolled in the study, you will receive a $20.00 gift certificate from Target Stores for each visit you complete. Every effort will be made to schedule your dental exam appointment on the same day as your prenatal visit so you will not have the expense of extra trips to the clinic.


Potential Risks:
Pregnant women can receive routine dental care without harm to themselves or their baby. However, routine dental exams and treatment can cause bacteremia which means germs that are normally in your mouth get into your bloodstream, something which happens whenever you routinely brush your teeth, too. There is no information to say that this will cause harm to your baby or you. In order to reduce the risks of preterm delivery, maternal infection, premature rupture of membranes, spontaneous abortion or other unknown adverse events, all gum treatment and dental care for this study will be done after the first trimester when the formation of your baby is complete and after the time when most spontaneous miscarriages occur.
Some studies have shown that treating certain vaginal infections with antibiotics during pregnancy can lead to premature birth. No antibiotics will be used in this study. No studies have ever shown that treating periodontal disease leads to premature birth.
Pregnancy may cause your gums to become swollen and sore but the bone that holds your teeth in is generally not harmed by pregnancy. Gum disease progresses very slowly over many years in most people who do not have other health problems. If a person has gum disease, it generally does not get worse over a nine-month period to the point where teeth are lost. If your monthly examination confirms that your gum disease is getting worse, you will be withdrawn from the study and you will be treated.
Some people find having their gums and teeth examined and cleaned is uncomfortable. A small amount of local anesthesia is safe during pregnancy and may be helpful to make you more comfortable. If the soreness bothers you so that you cannot eat, you can call the Principal Investigator, Dr. William Buchanan, at the UMC School of Dentistry (601) 984-6118. After hours, Dr. Buchanan may be called at 601 594-6551.

During the third trimester, reclining in a dental chair may be uncomfortable. Every effort will be made to assure your comfort. The dental chair can be adjusted.


Participating in this study may involve risks to you and your baby which are currently unforeseeable.
Alternatives:
You may choose to not participate in the study.


Potential Benefits:
You may receive no direct benefit from participating in this study. According to the National Institutes of Health and the Surgeon General's Report on Oral Health, over 90% of Americans have gum disease. By participating in this study, you will

learn if you have gum disease. One half of the women in the study will have their disease treated before the baby is born and the other half will have it treated after the baby is born. Finding and treating gum disease at an early age helps prevent tooth loss as you get older. It is possible that treatment of your gum disease will reduce your chances of having a premature baby or other adverse event. We hope to learn information that may help others in the future.


Everyone who has cavities will have them treated. If a tooth needs to be extracted or needs a root canal to save it, that will also be done. If you lose a tooth during the study that causes space in the front of your mouth or changes your bite so you cannot chew, a temporary partial denture will be made for you. No permanent bridgework or caps will be done. No cosmetic dentistry will be done.
Confidentiality:
The study doctors and study staff will have access to your records, and the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), the University of Mississippi’s Medical Center’s Institutional Review Board (IRB) and Office of Compliance may review the study records. You will not be personally identified in any published reports of this study.
Other Dental Visits During the Study:
If you choose to see your own dentist for dental work during the course of the study, you may do so. However, you will not be reimbursed for those visits and you will have to pay for them yourself. As a condition of staying in the
study, you will be asked not a have your teeth cleaned or to have any periodontal treatment other than what is being done for you in the study by the study doctors and dental hygienists. If you have cleanings or periodontal treatment outside the research clinic, you will be asked to leave the study and no further treatment will be provided or paid for by the study. If you have any questions or concerns about the care you receive, an outside independent dentist is available for consultation.
I have carefully reviewed the contents of this form. I have had the opportunity to ask my doctor questions about this study and my participation in it. Before giving my consent by signing this form, I have been sufficiently informed of the reason, means and duration of this study; and the reasonably foreseeable inconveniences, hazards or adverse effects that may result from my participation. By signing this form, I have not waived any of the legal rights that I would otherwise have.
I understand there are risks, both known and unknown. The known risks have been explained to me. I understand there are unforeseeable risks to my baby and myself. I accept these risks and desire to participate.
I understand I am participating of my own free will and that I may discontinue whenever I choose. I understand that if I have any questions regarding this study or this form, they will be answered so that I satisfactorily and completely understand.
I acknowledge my responsibility to keep my appointments with my doctors and to report to them immediately any changes in my health or the earliest suggestion of something wrong. I understand I will be dropped from the study if I fail to keep my appointments.
I understand I may see my dentist for care during the study only after discussing it with the research doctors. I will be responsible for the cost of these visits. This dental care cannot include any periodontal treatment until after the baby is born. I understand I will be dropped from the study if I receive any cleanings or periodontal treatment from any one other than the research staff. I understand that if I withdraw from the study or if I am removed from the study by the investigators, the study will not provide or pay for any needed dental or periodontal care.
I understand that the dental treatment I receive is for improvement of my oral health. No cosmetic dental work will be provided.
I understand the study doctor will inform me if my periodontal disease begins to progress rapidly and that, if it does, I will receive the appropriate therapy or be referred to another doctor for treatment.
I, ________________________________ have read and do understand all the preceding information describing this study, and all my questions have been answered to my satisfaction. I voluntarily consent to participate in this study.
I understand that by signing this form I am not waiving any legal rights I may have.
________________________________ _________________________

Signature of the Participant Date


_________________________________ __________________________

Signature of Witness to the Signature Date


I have explained to the volunteer the purpose of participation in this study, and have answered the volunteer's questions. To the best of my knowledge, she understands the purpose, procedures, risks and benefits of this study.
Person obtaining informed consent: ___________________________________
Signature of person obtaining informed consent: ________________________ Date_________________
Signature of Investigator:__________________________ Date_______________
Principal Investigator: William Buchanan, DDS

University of Mississippi

School of Dentistry

Department of Periodontics

2500 North State Street

Jackson, Mississippi 39216-4505

(601) 984-6118
Chairman of the Institutional Review Board: Stanley Chapman, MD

Department of Medicine

Division of Infectious Diseases

2500 North State Street

Jackson, Mississippi 39216-4505

(601) 984-2815

LBW 2002patient informed consentIRB 1115 02.doc

III.7. Maintaining Confidentiality
A violation of patient confidentiality will be regarded as a serious protocol violation. Ultimately, each Enrollment Site's Obstetric and Periodontal Investigators are jointly responsible for confidentiality of study documents. In day-to-day practice, that responsibility is delegated to the Site's Study Coordinator.
All study documents should be treated as confidential, but some are more sensitive than others. In particular, any document that would permit a Patient Identification (PID) number to be associated with a subject's name and clinical data is especially sensitive. Such documents should never be transmitted to the Data Coordinating Center (DCC) or to any other site. A subject's name, even her first name, should never be written on any form that may be sent to the DCC or seen by DCC staff.
A second class of sensitive documents includes any document that identifies a subject's randomized treatment assignment or that would permit an informed reader to infer a subject's randomized treatment assignment.
Any document in either of these classes must at all times either be in a locked cabinet maintained for this purpose by the Study Coordinator, or be in the custody of a clinic employee designated by the Study Coordinator and appropriately trained. In particular, such documents must never be left unattended outside of the designated locked cabinet.
Sensitive documents that must not be transmitted to the DCC or elsewhere include: Form 02 (Patient Locator Information), Form 03 (Patient Log), Form 06 (Patient Tracking Information) and any document containing subjects' Patient ID (PID) numbers along with their names.
Documents identifying the subject's randomized treatment include: Form 04 (Randomization), Form 05 (Event Checklist), Form 21 (Confirmation of Study Periodontal Treatment), and Form 22 (Confirmation of Deferred Periodontal Treatment).
If in doubt, the Study Coordinator should presume a document is sensitive until this can be checked with the Statistical Study Manager at the Data Coordinating Center.

III.7.1 HIPAA Requirements
The Health Insurance Portability and Accountability Act (HIPAA) requires that all research collecting identifiable health information on an individual person be in compliance with HIPAA standards and regulations. HIPAA regulations specifically apply to research studies collecting Protected Health Information (PHI).
PHI is defined by HIPAA as health information transmitted or maintained in any form or medium that:

1. identifies or could be used to identify an individual; and

2. is created or received by a healthcare provider, health plan or employer; and

3. relates to past, present or future physical or mental health or condition of an



individual.
Given that the OPT study will obtain subjects’ PHI, all sites must comply with the HIPAA regulations as they relate to research.
Compliance for each site will require that each subject read and sign the form, “HIPAA Authorization To Use And Disclose Individual Health Information For Research Purposes.” A template of this form is found on the next page. Each Study Coordinator will complete the form specific to their site. This completed document must be submitted to each site’s IRB for the purposes of fulfilling HIPAA regulations.
Following the informed consent process, each subject must read and sign the site specific HIPAA Authorization. Subject’s must be given a copy of the signed authorization.
It is of importance to note that a, “Certificate of Confidentiality” issued to a specific site for the purposes of the OPT study, will override the HIPAA authorization.

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