University of Pittsburgh
Institutional Review Board
3500 Fifth Avenue
Ground Level
Pittsburgh, PA 15213
(412) 383-1480
(412) 383-1508 (fax) MEMORANDUM
TO: Alexandre R. Vieira, DDS FROM: Christopher Ryan, PhD, Vice Chair
DATE: June 15, 2007 SUBJECT: IRB #0606091: Dental Registry and DNA Repository, School of Dental Medicine University of Pittsburgh

Your renewal with modifications of the above-referenced proposal has received expedited review and approval by the Institutional Review Board under 45 CFR 46.110 (5).
Please note that the modified advertisement that was submitted for review has been approved as written.
Please include the following information in the upper right-hand corner of all pages of the consent form(s).
Approval Date: June 14, 2007 Renewal Date: June 13, 2008 University of Pittsburgh Institutional Review Board IRB #0606091
Please note that it is the investigators responsibility to report to the IRB any unanticipated problems involving risks to subjects or others [see 45 CFR 46.103(b)(5) and 21 CFR 56.108(b)]. The IRB Reference Manual (Chapter 3, Section 3.3) describes the reporting requirements for unanticipated problems which include, but are not limited to, adverse events. If you have any questions about this process, please contact the Adverse Event Coordinator at 412-383-1504.
The protocol and consent forms, along with a brief progress report must be resubmitted at
least one month prior to the renewal date noted above as required by FWA00006790 (University of Pittsburgh), FWA00006735 (University of Pittsburgh Medical Center),
FWA00000600 (Childrens Hospital of Pittsburgh), FWA00003567 (Magee-Womens Health Corporation), FWA00003338 (University of Pittsburgh Medical Center Cancer Institute).
Please be advised that your research study may be audited periodically by the University of Pittsburgh Research Conduct and Compliance Office.
CR:dj Page 1 of 15
Dental Registry and DNA Repository School of Dental Medicine, University of
Pittsburgh

Abstract
The NIH/NIDCR has recently established new scientific priorities and research initiatives
evoking multi and interdisciplinary research to solve the puzzle of complex diseases
and conditions. There is an overwhelming need to better understand the genes, behavior,
diet/nutrition, infectious agents, environment, and society of complex diseases, not to
mention the need to find the best way to conduct research opportunities during these
challenging budget times. With all of this in mind, we have established a plan which has
created a Clinical Registry and DNA Repository at the School of Dental Medicine in
order to obtain clinical information and a biological sample from individuals seeking
treatment at the University of Pittsburgh School of Dental Medicine. Preliminary research
initiatives will involve studies of genetic contributions to caries, periodontal diseases,
malocclusion, dental abnormalities, temporomandibular joint dysfunction, and bone
density. To our knowledge, the SDM Clinical Registry and DNA Repository will be the
only project in the world to keep a comprehensive set of dental phenotypes linked to
DNA samples.

1. OBJECTIVE AND SPECIFIC AIMS
The overall aim of the Dental Registry and DNA Repository, School of Dental Medicine, University of Pittsburgh, is to serve as a one-source provider of clinical data
linked to DNA samples for educational and research purposes. Collecting clinical
information and DNA samples from patients with a variety of diseases will accomplish
this. The research material resulting from the collection of the clinical information and biological specimens is intended to provide research resources for investigators. This will
allow the researchers to pursue individual research initiatives. The Dental Registry and
DNA Repository is meant primarily for investigators inside the School of Dental
Medicine. However, collaborative relationships are permissible as long as (1) appropriate
institutional approval, (2) standard material transfer agreements and, (3) sponsored
research agreements (where applicable) are in place.
In the first research initiatives, we will investigate genotypic features associated with several complex dental traits in individuals residing in the Pittsburgh area. The overall goal is to map genetic loci involved in a number of complex dental traits. We will test the hypothesis that genetic factors modulate disease processes: (a) by comparing individuals with the phenotype of interest and
individuals not affected by the phenotype of interest, or; (b) by comparing individuals with extremely distinct presentations of the
same phenotype (e.g. very mild disease versus very severe disease) A description of these phenotypes can be found in the appendix.

Page 2 of 15
2. SIGNIFICANCE AND BACKGROUND

2.1 Significance
A careful clinical description and the application of sophisticated human genetics tools are a promising combination to shed light into the etiology of complex dental traits.
If we unravel a predisposing (or protective) genetic factor, we can propose a new line of
studies to prevent and treat the conditions described in the appendix. A more immediate
resource would be to provide the clinician a genetic tool to access risk, which can allow
personalized management of patients. On a longer term basis, gene therapy could be
proposed. Any positive finding coming out of this project would be the first step to
develop a new tool to better prevent and treat complex dental conditions.

2.2 Background Although current technologies are allowing for more rapid characterization of genetic variation, the success rate of finding genetic causes for complex traits is very low. Part of
the reason for this is because individual genes contribute only modestly to specific
phenotypes; therefore, large samples are needed. Another reason the success rate of
finding genetic causes for complex traits is very low is that clinical information is usually
not very sophisticated, and phenotypes are described in a simplified way, which increases
genetic heterogeneity. The use of human clinical information tied with biological samples is an essential requirement for many experimental and research protocols to help develop a better
understanding of disease. This is imperative to improve our current diagnostic and
therapeutic modalities. The Dental Registry and DNA Repository serves to provide a broad-based supply of clinical information tied with DNA samples for research purposes. The Dental Registry
encourages the rapid dissemination of research and results, provides a higher visibility for
the institution and seeks to find much needed answers in the various fields of dental
research. 3. RESEARCH DESIGN AND METHODS
Proposed Workflow for the Dental Registry and DNA Repository School of Dental
Medicine, University of Pittsburgh

Introductory Remarks The Federal Policy defines human subject research as a process where an investigator conducting research obtains (1) data through intervention or interaction with
the individual; or (2) identifiable private information. As per the new guidance from
the OHRP (August 10, 2004), research activity involving de-identified specimens and
data would not be considered as research involving human subjects and would not need
specific IRB approval. We have based the functioning of the Dental Registry and DNA Repository on this revised definition of human subject research. The Dental Registry and DNA Repository
has put into place the appropriate infrastructure, software tools and IRB approvals to Page 3 of 15 handle the collection of clinical data and biological samples as well as their de-identified
disbursement. This honest broker entity essentially covers all aspects of biological specimen and data needs for researchers. The combined capabilities of the Dental Registry and DNA
Repository with this honest broker status will address all needs of researchers in a manner
compliant with current legal and ethical considerations, which is consistent with current
OHRP recommendations.

Banking Methods The research material (clinical information and DNA samples) always comes from consented patients. These patients are approached for a saliva sample donation for
research purposes in their doctors offices. The consent form used to consent patients is
non-specific regarding the nature of the future research to be done since the exact nature
of such projects may not be fully known at this time. Participants will be asked to provide their written informed consent to allow their past, current and future identifiable medical record information related to their dental
disease to be placed in this research registry. The clinical information to be stored will consist of all information currently present in the dental charts: identification information,
medical history information, current health information, and complete oral and dental
examination information. Medical charts will be reviewed and all the information from
the patients existing medical record will be recorded. The saliva specimens from these patients are stored using a linkage code that allows subsequent clinical data aggregation. We will utilize a bar code system, which further
addresses issues pertaining to patient confidentiality and identification of specimens. There might be instances when a patient decides not to participate in the registry. We will have a field in the patient chart alerting the doctors to not invite this patient again.
This field consists of a mandatory data field regarding consenting to participate in the
Dental Registry and DNA Repository. In the near future (summer of 2008), the School of Dental Medicine will be changing to a system where all dental records will become electronic. Therefore, clinical data will
be extracted from this new database on an as-needed basis. This system has the advantage
of keeping up to date information at all times. In the electronic version of the dental
records, a mandatory field Dental Registry will be created. A consented individual will
have a yes recorded under this field. Data extraction from the Dental Registry will
always be done after a query to the Dental Registry field and data will be extracted
only from the individuals with a yes recorded. In addition, this new electronic system
easily accommodates the cases where the individuals decided not to participate in the
Dental Registry since the Dental Registry field will be recorded with a no. The
Dental Registry field will also be used to generate the total numbers of individuals
enrolled in the Dental Registry and the total number of individuals invited to the Dental
Registry for the IRBs annual reports.

Disbursement of Clinical Data with or without DNA Samples for Research All clinical information and DNA samples are disbursed in a de-identified fashion. The honest broker functionality of the Dental Registry and DNA Repository will be
utilized to provide investigators with needed clinical data and DNA samples in a Page 4 of 15 completely de-identified fashion. The Dental Registry and DNA Repository uses linkage
codes and stores the key to these codes on password protected computers within the
secure protective firewall of the University of Pittsburgh. No DNA samples and clinical
information are ever provided with identifiers.

Administrative infrastructure and oversight As part of institutional infrastructure, the Dental Registry and DNA Repository will utilize the Dental Medicine Research Office and its Scientific Review Committee to
approve requests for research materials from the Dental Registry and DNA Repository.
We propose the following workflow: (1) Researchers should submit their clinical data and DNA samples requirements
directly to the Dental Registry and DNA Repository. (2) The Dental Registry and DNA Repository would direct the application to the
Dental Medicine Research Office. (3) If approved, the Dental Registry and DNA Repository would provide
appropriate clinical information and DNA samples in a de-identified manner
to the investigators. (4) The investigators will need to enter into an agreement by which they guarantee
that no additional data mining will be attempted without additional approval.
This means that if the investigators would like to request additional
information on the provided data set (i.e. outcome of specific treatment that
was performed after a certain period of time), they will need additional
approval, and steps (1), (2), and (3) will have to be repeated. In addition, the
researchers cannot share these materials with other investigators, or with
outside institutions without additional approval. This agreement is attached
with this IRB submission. (5) The Dental Registry and DNA Repository will keep track of all these requests.
The Dental Registry and DNA Repository will also provide a report to the IRB
of clinical information and DNA sample utilization on a yearly basis. This
report will consist of a summary document as well as a copy of every request
processed by the Dental Registry and DNA Repository in the preceding year
period.
Investigators cannot sell the DNA samples. Sharing the DNA samples with other
investigators can be done only after formal approval from the Dental Registry and DNA
Repository.

Use of Clinical Data and DNA Samples for Research Studies The Dental Registry and DNA Repository will provide clinical data and DNA samples for research purposes to researchers for different research protocols. The
materials provided for these research protocols would be procured and stored in the
Dental Registry and DNA Repository using the methodologies discussed above. The
methodologies of providing materials to the researchers are as follows: 1. Anonymized provision of Clinical Data. Clinical data will be provided to
researchers without any subject identifiers or linkage codes. The data
provided would thus be completely anonymized. Page 5 of 15 2. Honest broker provision of clinical data. Clinical data are completely
anonymized, and assigned a unique code number by the Dental Registry
and DNA Repository, prior to providing the information to researchers.
This unique code number will permit the researchers to obtain additional
information about the sample; however the Dental Registry and DNA
Repository (i.e. the Honest Broker) will retain information linking the
unique code number with the subjects identity. 3. Honest broker provision of clinical data tied with DNA samples. Clinical
data and corresponding DNA samples are completely anonymized, and
assigned a unique code number by the Dental Registry and DNA
Repository, prior to providing the information and samples to researchers.
This unique code number will permit the researchers to obtain additional
information about the sample or additional DNA of the sample; however
the Dental Registry and DNA Repository (i.e. the Honest Broker) will
retain information linking the unique code number with the subjects
identity. At the end of the project, researches are obligated to return DNA
samples to the Dental Registry and DNA Repository. There is a small
chance that DNA samples can be contaminated by another DNA sample.
Because of that, returned aliquots of DNA samples will be stored in
separate stock tubes. The bank will request the investigators a report on
quality control of their experiments (Hardy-Weinberg equilibrium
calculations and allele gain/loss profiles as a way to assure there in no
obvious contamination of individual samples). The appropriate follow-up
experiments (typing XY markers and a set of highly polymorphic markers)
will be done to elucidate if a contamination is really likely. With any of the above methodologies, the samples will be provided to the researchers in such a manner whereby the subjects cannot be identified (by the
researchers) directly or indirectly through identifiers linked to the subjects. Hence the
researchers would not be required to re-obtain informed consents from the patients whose
clinical information and biological materials have been banked for research (Sec 45 CFR
46.101 (b) (4).
The honest broker role will be performed by a Research Specialist, who will be also responsible for assisting the principal investigator in the day-by-day management of
the Dental Registry and DNA Repository, including processing the saliva samples into
DNA. In the near future, UPMC will have a system in place that links all clinical registries in the university. Although no one is 100% sure, we anticipate that many of the
patients treated at the School of Dental Medicine are also seen in the UPMC health
system. When this resource is available, additional data from individuals that consented
to be part of DRDR can be obtained from their medical charts in the eventuality that a
research project requires additional medical information. We anticipate that, on occasion, an investigator may want to collect additional information not currently available in the dental records, or additional biological samples
from subjects participating in the registry. After obtaining appropriate IRB approval, the
investigator could request that the principal investigator (Dr. Vieira) send a letter inviting Page 6 of 15 the research subject to participate in this new study and contact directly the investigator.
The registry will not provide addresses or contact telephone numbers to the investigator.

SUBJECT RECRUITMENT AND INCLUSION/EXCLUSION CRITERIA

Subject Recruitment All individuals responsible for subject recruitment will ensure that subjects understand the consent completely and give informed consent prior to performing any of
the research procedures. Individuals will be recruited in any of the clinical settings of the School of Dental Medicine. All School of Dental Medicine faculty can potentially recruit subjects for the
Dental Registry and DNA Repository. Also, a number of staff personnel will be involved
in recruiting subjects (or assisting faculty in the recruitment) depending on the specific
clinical setting within the school. Subjects can be recruited at any of the following clinics: Diagnostic Sciences, Oral and Maxillofacial Surgery, Orthodontics and Dentofacial Orthopedics, Pediatric
Dentistry, Periodontics/Preventive Dentistry, Prosthodontics, and Restorative
Dentistry/Comprehensive Care, Oral Hygiene, the Implant Center and the Emergency
Care Clinic. Besides faculty, additional personnel can also be involved in the recruitment process, such as dental residents and dental hygienists. The principal investigator will ensure that
faculty as well as all other key personnel involved in the recruitment process is well
aware of the Dental Registry and DNA Repository purposes and the ethical procedures
involved in research investigations. All clinical parameters described in this proposal will be collected from all individuals. The racial, gender and ethnic characteristics of the proposed population
reflects the demographics of Pittsburgh and the surrounding area. We shall attempt to
recruit subjects in respective proportion to these demographics. No exclusion criteria
shall be based on race, ethnicity, gender, age, or HIV status.

Recruitment Procedures Individuals visiting the School of Dental Medicine will be invited to the study. When individuals receive the paperwork related to their clinical appointment, a brochure
introducing the study and the consent forms will be given to the potential study
participants (please see appendix) for their appreciation while they wait for their
appointments. In addition, a recruitment flier explaining details of the study will be hung
throughout the School of Dental Medicine in order to increase awareness about the study.
Individuals will be asked if they want to join the study by one of the subject recruiters
(faculty or supporting staff) who will go over the consenting form with them in the
privacy of their clinical examination room. The physician will make a note in the cover of
the chart indicating whether the subject is a study participant or not. When the electronic charting system is in place, the consent forms and recruitment materials (brochure and flier) will be in the system, and will be provided to the potential
participants in the same way during check-in procedures. A mandatory field Dental
Registry will be introduced to the electronic chart and the physician has to indicate if the
subject is a study participant or not. Page 7 of 15 It is also very important to understand the reasons why individuals withdraw from research studies, and, in addition, why individuals choose not to participate in research
studies at all. Individuals opting not to participate or choosing to withdraw from the study
will be asked if they would mind answering a few quick questions about their decision.
If the individual agrees, all answers will be recorded in a brief, one page survey without
identifiers. In the case where an individual declines to participate in the study, the form will be presented to this individual at that exact moment in which he/she has declined to
participate. In the case where an individual decides to withdraw from the study, a copy
of the survey will be mailed to the individual along with a cover letter stating that his/her
request to withdraw has been received, that the DNA sample has been destroyed and that
clinical chart information will no longer be utilized in future research initiatives. We will
also include a self-addressed, stamped envelope to facilitate the return of the survey, and
we will emphasize that its completion is optional, and that the individual should not
include any identifiers such as names or return addresses.
Rationale for inclusion of children This study will look for genetic factors that contribute to risks for many dental complex traits. Children of all ages can participate in aspects of the study that relate to
conditions that can only be found in them, or are more prevalent during childhood.
Obtaining samples from children will increase the power of the study, since children will
represent the majority of cases for some of the phenotypes listed in this protocol. Children are typically seen in the Orthodontics and Dentofacial Orthopedics and Pediatric Dentistry clinics. However, in some instances, children can be treated in other
clinics for specific procedures (i.e. endodontics, oral surgery). Dr. Vieira is a pediatric
dentist, and in addition, the faculty at the Orthodontics and Dentofacial Orthopedics and
Pediatric Dentistry clinics has great experience treating children of all ages. The
Orthodontics and Dentofacial Orthopedics and Pediatric Dentistry clinics are designed
specifically to assist children, and the majority of pediatric patients that are cared for by
the School of Dental Medicine are assisted in these facilities. Although this research project involves a procedure that does not hold out the potential for direct individual benefit, the risk of exposing confidential information has
been minimized, and the Dental Registry and DNA Repository is considered minimal
risk. The study procedures present experiences to the potentially involved children that
are reasonably commensurate with those inherent in their actual or expected dental care,
and the procedure is likely to contribute to increased generalizable knowledge about
many dental conditions, which can revolutionize the understanding and amelioration of
them.
Consent for Continuing Participation
Because the samples will be collected during the time when the child is a minor, such recruited individuals will need to be re-contacted when they reach the age of 18. At this
point, they will be asked for permission for continued storage and use of their samples.
The DRDR will maintain a schedule for re-contacting these individuals when they turn
18 years old. This schedule will be kept in a computer file, and the information on the Page 8 of 15 research participants will be added to this database under the appropriate month and year
the subjects need to be re-contacted for continuing participation. At this time, the child
that just turned 18 years old will be presented with a consent form which he/she will sign
in order to appropriately document continued participation. Potential risks include the inappropriate release of confidential information. There will be no direct benefit to the study subjects. However, the potential benefits that might
arise from the investigations we will perform are many and far-reaching. Dr. Vieira, the Principal Investigator, will be responsible for all the stored data and samples. Subject identifiable information will be kept in the Dental Registry and DNA
Repository office in a locked cabinet, which is not accessed by any other person. Samples
are de-identified and kept in freezers only accessible to the Dental Registry personnel. At
any time, subjects can request that their data and/or their samples be withdrawn from the
study. When the subjects turn 18, the Research Specialist will attempt to re-contact these individuals in order to ask permission to keep storing and using their data and DNA
samples. If, after three tries, it is not possible re-contact the subject for any reason (such
as change of address, telephone number etc.), then the subject will be considered lost to
follow-up. Subjects that cannot be re-contacted will have their data and sample
completely anonymized by the Research Specialist so that this sample can continue to be
part of the Dental Registry and DNA Repository. A database of the anonymized
information will be created and stored in a secure file. This database will contain all of
the information present in the dental records up to the moment that the data is
anonymized, and before the expiration of the parents consent for disclosure and use of
the sample and medical information. The DNA sample will be relabeled with the new
anonymized code. No identifiable information (i.e. name, address, telephone number,
social security number) will be stored by the honest broker or by Dr. Vieira.

Inclusion/Exclusion Criteria - Individuals of both sexes will be recruited. - Women of childbearing potential may be recruited. In many instances, a woman is
still not aware that she is pregnant during the first 6 weeks of pregnancy.
However, there is no risk for the future baby if the mother is submitted to a dental
examination and provides a saliva sample. Potential pregnancy is part of the
routine dental anamnesis. - Adults: There are no age restrictions for participating in this study. Children: Will
be recruited only when they reach the age of one. - The racial, gender and ethnic characteristics of the proposed subject population
reflects the demographics of Pittsburgh and the surrounding area and/or the
patient population of the University of Pittsburgh Medical Center. We shall
attempt to recruit subjects in respective proportion to these demographics. No
exclusion criteria shall be based on race, ethnicity, gender, or HIV status. - Individuals with motor disabilities and other neurological conditions usually
present poorer oral health secondary to their primary conditions and will not be
included in this study. Our specific clinical criteria for determining if the
disability severity disqualifies an individual to our study will be determining if the Page 9 of 15 individual can brush his/her teeth without help. Individuals that can not brush
their own teeth without help will be not included in the registry. STUDY RISKS Potential risks include the inappropriate release of confidential information. The potential for breach of confidentiality could impact future insurability, employability, or
reproduction plans, or have a negative impact on family relationships, and/or result in
paternity suits or stigmatization. All personnel coming into contact with participants in
this study will be health care workers. No information permitting personal identification
of family members will be made public. No clinical descriptions that might permit
personal identifications will be published, and the clinical information from all sites will
be stored in secure computer files at the University of Pittsburgh. The actual risks to patient, as well as the researchers and technical support they employ in relation to the collection of the saliva sample are negligible. Precautions in
processing the saliva are taken according to hospital, OSHA, and federal regulations, and
no additional risk is expected. STUDY BENEFITS There is no direct benefit to the study subjects. The potential benefits that might arise from mapping and characterizing loci for the phenotypes we are describing in this
protocol are many and are far-reaching. Understanding the mechanisms underlying these
conditions may eventually lead to improved methods of treatment and ultimately to their
prevention.
Identification of the genes responsible for susceptibility to the phenotypes we are describing in this protocol will eventually permit us to develop clinically available
genetic tests that could improve estimates of recurrence risks. In addition, understanding
the biological basis of these conditions may eventually lead to more effective treatment
strategies, which will benefit individuals of all ages. Data and Safety Monitoring Plans Before recruitment starts, Dr. Vieira will meet will all the faculty, residents, and other supported staff that will be involved in the recruitment. At this meeting,
information about the Dental Registry and DNA Repository will be provided, as well as
the details regarding the recruitment and consenting process. All recruiting personnel will
be required to do the IRB online training on modules 1, 2, and 6. Dr. Vieira will keep a
copy of the certificate of conclusion of the three modules in the Dental Registry and
DNA Repository office. Dr. Vieira, the Principal Investigator, will be responsible for the data and safety monitoring. Subject identifiable information will be kept in the Dental Registry and DNA
Repository office in a locked cabinet, which is not accessed by any other person. When a
subject is recruited, he/she immediately receives an ID code and no identifiable
information is used in working templates. No data is ever referred to by individual
identifiable information. Page 10 of 15 The PI will meet with the Research Specialist and other research team members once a week or as needed to discuss data quality, recruitment process and confidentiality
issues. Also, Dr. Vieira, the PI, will meet with the head of each Department Clinic once a
week in the first 3 months after the recruitment starts and once every 2 months (or as
needed) after the routine for the specific Department Clinic is established. Data safety
and monitoring reports will be submitted to the IRB at the time of annual renewal. We will comply with the IRB policy for reporting any adverse and unanticipated problems that may occur during the execution of this research project. COST AND PAYMENTS TO STUDY SUBJECTS 1) Costs There are no financial obligations to the subjects in this study.
2) Payments No payments will be made.

APPENDICES

Qualifications of Investigators

Alexandre R. Vieira, DDS, MS, PhD
Dr. Vieira is assistant professor at the Department of Oral Biology, School of Dental
Medicine. He is a pediatric dentist and has worked on molecular genetics of craniofacial
anomalies for the past 9 years. Dr. Vieira has worked in the Latin American Birth Defects
Registry ECLAMC and pioneered the collection of biological samples in that multi-
country study in 1997. He will direct the Dental Registry and DNA Repository.

Jill Schaefer, BA
Ms. Schaefer received her degree in history from the University of Pittsburgh, and
completed her minor in psychology at Duquesne University. Jill is currently working as
a Research Specialist in the School of Dental Medicines Department of Oral Biology.
She is intrigued by the history of human subject research ethics and is very
knowledgeable in the proper management of clinical studies involving human subjects.
Jill will serve as the research coordinator and honest broker for the study.

Brochure (revised)

Flier (new)

Informed Consent Documents (enclosed)

Translated Informed Consent Documents (new)

User Agreement (revised)

Saliva Collection Procedures Page 11 of 15
Supplies needed: Oragene DNA Self-Collection Kit Synthetic gloves Two data matrix barcode labels Sealable plastic bag An absorbent sheet for packing Wear gloves while handling samples. Before taking the sample, ask participants to rinse
mouth with water. Have subject wait 1 minute before taking sample. Open Oragene
collection kit and take out the small sample collection container. Have the participant
spit into the collection container until liquid saliva (foam does not count) reaches the fill
to line on the side of the container. Tighten the cap. Gently mix the saliva sample with
the pre-filled Oragene liquid in the container.

Label both the inner collection container and the outer collection kit with the subjects
barcode ID number and the date. Place each tube into a plastic bag with an absorbent
sheet for shipping, and seal tightly by peeling off the blue protective strip.

Tips: Some people may find it hard to spit so much saliva. It may help to place