RESEARCH SUBJECT INFORMATION AND Consent FORM

RESEARCH SUBJECT INFORMATION AND Consent FORM

 

TITLE:                                                Development of a Correlated Genetic and Genealogical Database

 

PROTOCOL NO.:                            SMGF-2003-1

                                                               WIRB® Protocol #20031734

 

SPONSOR:                                         Sorenson Molecular Genealogy Foundation

                                                               Salt Lake City, Utah

                                                               United States

 

INVESTIGATOR:                            Scott R. Woodward, Ph.D.

                                                               Sorenson Molecular Genealogy Foundation

                                                               2511 South West Temple

                                                               Salt Lake City, Utah 84115

                                                               United States

                                                                801-461-9700

                                                               801-244-2542 (24 hours)

                                                              

SITE(S):                                              Sorenson Molecular Genealogy Foundation

                                                               2511 South West Temple

                                                               Salt Lake City, Utah 84115

                                                               United States

STUDY

COORDINATOR:                              Ugo Perego

                                                                801-461-9775

 

This consent form may contain words that you do not understand.  Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand.  You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.

 

In this consent form, “you” always refers to the subject.  If you are a legally authorized representative, please remember that “you” refers to the study subject.

 

Description of the Study

You are invited to participate in a research study designed to create a large database of combined genetic and genealogical information.  The primary purpose of the database will be to link molecular genetic information to written pedigrees.  The research study is being conducted by The Sorenson Molecular Genealogy Foundation, a not-for-profit organization.  This study will use molecular testing methods to determine how individuals and populations are genetically related.  Additionally, written genealogical pedigrees will be verified.  From this information, a database will be created that will correlate genetic markers with family pedigrees.  Once finished, the database can be a tool to help others in their search for genealogical information prior to 1900.  The unique identification of the individual subject in the study will not be directly associated with the information in the later public release of the database. 

 

If you decide to participate, you will be required to supply the following:  (1) a record of your known genealogy, including at least four generations of names, dates and places of births, and (2) a biological sample of your cells. 

 

DNA will be taken from your cells and a genetic profile created.  The genetic profile derived from your DNA together with your genealogical pedigree will be placed into the database.  All information and samples will be encoded in such a way as to remove your personal identification, however, a link will remain available to the researchers.  The information from this study will be used for genealogical services and determination of family migration patterns and geographic origins.

 

Procedures Include the Following

1)    Submission of a record of your own genealogy containing at least 4 generations in the form of a pedigree chart or an information disk containing that information in a GEDCOM file; and

2)    Providing a biological sample such as skin cells from your mouth.  You will do this by swishing mouthwash and spitting it into a collection cup.  You will be given specific directions by study staff.

 

Risks, Inconvenience, and Discomfort

It is possible that the confidentiality of your records could be compromised. 

 

There are risks associated with a loss of confidentiality of your health information and genetic testing results.  Information about genetic test results may affect your employment, insurance, or family relationships.  The sponsor cannot be certain that your genetic test results could never be linked to you.

There is no significant physical risk to your health for participating in this study.  Generating the genealogical information and providing a biological sample may be an inconvenience to you.  Travel may be required to submit the genealogical and genetic information.  You may have a tingling feeling in the mouth from the mouthwash rinse. 

 

Additional risks.  There may be additional risks that we cannot predict at this time.  If in the future, substantial risks associated with your participation are identified, you will be contacted.

 

New Findings

You will be told about any new information that might change your decision to be in this study.

 

Benefits

There is no immediate benefit to you for participating in this study.  We will not be providing genetic information back to you.

 

Future benefits.  The results of this study may benefit people in the future who use it to further their ancestral research. 

 

Payment for Participation

There will be no payment for your participation.

 

Alternatives

This is not a treatment study.  Your alternative is not to participate in this study.

 

Voluntary Participation/Withdrawal

Participation in this study is voluntary.  You may choose not to participate.  You have the right to end your participation at any time, and to decide whether your biological sample, genetic information, or genealogy already collected can remain part of the study or must be destroyed.

Your participation in this study may be stopped at any time by the study doctor or the sponsor without your consent.

 

Research Subject’s Rights

You may ask questions at any time during your participation.

 

Confidentiality

Your unique personal identity is considered strictly confidential and private.  Your unique personal identity will not be disclosed in any general or scientific publication of the data.  Samples and files containing this information will be stored in a secure facility.  The individuals who will have access to the codes and genealogy information will be the principal investigator and the research staff.

 

Who else might get this information?

Your information may be given to the sponsor of this research.  “Sponsor” includes any persons or companies that are working for or with the sponsor, or are owned by the sponsor.

Information about you may be given to The Western Institutional Review Board® (WIRB®).  WIRB is a group of people who perform independent review of research as required by regulations.

 

Family relationships.  In the course of this study, it is possible that we may learn information about relationships within your family, such as adoption or paternity.  We will not provide such information to you or any member of your family.

 

Collection of, Research on, and Storage of Biological Sample.  Your biological sample is intended to be used for research and development of a correlated genetic and genealogical database.  At our sole discretion we may have your DNA analyzed by an outside lab (with samples identified by encoded labels).  Stored biological samples will be labeled and stored by identifiers defined by us, and not identified by your name. 

 

Questions

If you have questions regarding the research your rights as a research subject, or if at any time you feel you have experienced a research-related injury, contact:

Scott R. Woodward, Ph.D. or Ugo Perego of The Sorenson Molecular Genealogy Foundation, a non-profit corporation, at 801-461-9700, 801-461-9775 or 801-244-2542 (24 hours).

                            

 

 

 

 

If you have questions about your rights as a research subject, you may contact:

 

Western Institutional Review Board® (WIRB®)

3535 Seventh Avenue, SW

Olympia, Washington  98502

Telephone:  1-800-562-4789.

 

WIRB is a group of people who perform independent review of research.

 

Do not sign this consent form unless you have had a chance to ask questions and have received satisfactory answers to all of your questions.

If you agree to participate in this study, you will receive a signed and dated copy of this consent form for your records.

 

Source of Funding

Funding for this research study will be provided by, the Sorenson Molecular Genealogy Foundation.

 

Consent

I have read the information in this consent form (or it has been read to me).  All my questions about the study and my participation in it have been answered.  I freely consent to participate in this research study.

By signing this consent form, I have not waived any of the legal rights, which I otherwise would have as a subject in a research study.

 

Consent and Assent Instructions:

Consent:        Subjects 18 years and older must sign on the subject line below

                        For subjects under 18, consent is provided by the Legally Authorized Representative

Assent:           Is not required for subjects 6 years and younger

                        Is required for subjects ages 7 through 12 years using the separate Assent Form

                        Is required for subjects ages 13 through 17 years using the Assent Section below

 

 

                                                                                                                                                                        Gender:          M   F

Subject Name (Print)                                                                  Today’s Date

 

 

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               

Permanent Mailing Address (Street, City, State, Zip Code)

 

 

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               

Phone                                                                                                                     Email Address

 

CONSENT SIGNATURE:

 

 

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               

Subject Signature (18 years and older)                                                                                           Date

 

 

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               

Signature of Legally Authorized Representative (when applicable)                                          Date

 

 

______________________________________________________________________________

Authority of Subject’s Legally Authorized Representative or Relationship to Subject

 

 

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               

Person Conducting Informed Consent Discussion Signature                                                      Date

 

 

                                                                                                                                                                                                                                                                                                                                                                                                                                               

Witness Signature

 

 

ASSENT SIGNATURES, For Subjects Ages 13 through 17 years:

 

Assent:

This research study has been explained to me and I agree to be in this study.

 

 

________________________________________                   _____________                  __________

Subject’s Signature for Assent                                                          Date                                       Age (years)

 

I confirm that I have explained the study to the extent compatible with the subject’s understanding, and that the subject has agreed to be in the study.

 

 

__________________________________________________                           __________________

Signature of Person Conducting Assent Discussion                                                      Date

 

 

-----------------------------------Use the following only if applicable-----------------------------------

 

If this consent form is read to the subject because the subject (or legally authorized representative) is unable to read the form, an impartial witness not affiliated with the research or investigator must be present for the consent and sign the following statement:

 

I confirm that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject (or the subject’s legally authorized representative).  The subject (or the subject’s legally authorized representative) freely consented to participate in the research study.

 

 

                                                                                                                                                                ________________

Impartial Witness Signature                                                                                                              Date

 

Note:  This signature block cannot be used for translations into another language.  A translated consent form is necessary for enrolling subjects who do not speak English.

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