Form G-1294 DNA Collection Consent Form (Laboratory Test)

DNA Collection Consent Form
(Laboratory Test)

USCIS
Form G-1294

Department of Homeland Security
U.S. Citizenship and Immigration Services
1.

OMB No. 1615-NEW
Expires xx/xx/xxxx

Applicant's Name
Family Name (Last Name)

Given Name (First Name)

2.

Case Number

3.

4.

Are you the applicant or the parent of the applicant?

Middle Name

Date Submitted (mm/dd/yyyy)
Applicant

Parent

NOTE: If you are the parent, "you" in this form is the applicant.
You have been invited to participate in a research study because you or a family member has submitted a refugee application to the
United States. Your decision to be in this study is voluntary.

DRAFT
Not for
Production
09/11/2015

The purpose of this research study is to compare two methods of testing DNA (Deoxyribonucleic acid), which may be used to help
determine whether two people are biologically related to each other. The study will evaluate the accuracy of an investigational
electronic process used to test DNA with the results of DNA testing performed by accredited laboratories in the United States. DNA
testing using this electronic process may help applicants and the U.S. Government in the future immigration and refugee application
process. If you participate in this study, you will provide a saliva sample so that we can examine parent-child relationships among
refugee applicants.
If you agree with the information presented below, please select the boxes and sign in the signature box.

If you agree to participate in this study, you are agreeing to let a representative of the U. S. Government swab the inside of your cheek
to collect your DNA. DNA contains biological information that indicates family relationships, such as a parent-child relationship.
Your DNA sample will be sent to an American Association of Blood Banks (AABB) accredited laboratory in the United States for
tests to confirm whether you are biologically related to a parent or child in your case or related cases. This laboratory-based procedure
has been used for many years by the U.S. Government for voluntary DNA testing in the immigration process. You understand that
U.S. Citizenship and Immigration Services (USCIS) may use these test results when considering your refugee application.
Research is also being conducted on Rapid DNA technology. This research is separate from the AABB accredited laboratory testing.
A staff member will swab the inside of your cheek with cotton swabs so that samples of your DNA are collected. This will take about
five to ten minutes to complete. There is no physical discomfort from saliva collection. Your DNA and your claimed relative's DNA
samples will be tested with both the Rapid DNA technology and at an AABB accredited laboratory. The DNA samples will be
analyzed to determine whether a biological parent/child relationship exists using this Rapid DNA technology and the results will be
compared against the AABB laboratory results. The AABB accredited laboratory will dispose of all cheek swab samples after testing
is complete. You will be notified of the overall results of your refugee application once the laboratory analysis is complete. You will
not receive specific information of the DNA test results.
We do not anticipate any personal risk to you or your claimed relative from the analysis of your DNA samples. Every effort will be
made to protect your and your relative's privacy and the confidentiality of the DNA and the testing results from unauthorized
disclosure.
The U.S. Government, including the Food and Drug Administration, the sponsor, and the Institutional Review Board (IRB) may
review the research study records as required by law. The IRB is a group of people who perform independent review of research as
required by regulations. Your identity will be kept confidential, including in any publications.
You are NOT required to participate in this test or sign this consent form. You are volunteering to participate, and may change your
mind any time before the test begins. Your decision will not result in any penalty or loss of benefits if you are eligible for those
benefits. USCIS will make the decision on your application for refugee status based on all relevant evidence you submit, including
whether such evidence sufficiently demonstrates your claimed biological parent/child relationship.
You may ask the representative present at the time of testing about any questions about this study or a problem due to the research,
and you may email Help@wirb.com about your rights as a research participant, questions, concerns or complaints.

Form G-1294 08/21/15

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Consent and Assent Instructions
Consent: Subjects 21 years of age and older must sign on the subject line below.
For subjects under 21 years of age, consent is provided by the parent or guardian.
Assent:

Verbal assent is required for subjects under 21 years of age.

Signature of Applicant (21 years of age or older)

Date of Signature (mm/dd/yyyy)

I have explained this research study to my child and he/she understands it to the best of his or her ability. I am volunteering my child's
participation for this test.

DRAFT
Not for
Production
09/11/2015

Signature of Parent (if Applicant is under 21 years of age)

Date of Signature (mm/dd/yyyy)

I confirm that I have explained the study to the subject to the extent compatible with the subject's understanding, and that the subject
has agreed to be in the study.
Signature of USCIS Officer Conducting Consent

Date of Signature (mm/dd/yyyy)

Signature of Interpreter (if any)

Date of Signature (mm/dd/yyyy)

Assent Section

Statement of person conducting assent discussion:
1.

I have explained all aspects of the research to the subject to the best of his or her ability to understand.

2.

I have answered all the subject's questions relating to this research.

3.

The subject agrees to be in the research.

4.

I believe the subject's decision to enroll is voluntary.

5.

The study doctor and study staff agree to respect the subject's physical or emotional dissent at any time during this research
when that dissent pertains to anything being done solely for the purpose of this research.

Signature of Person Conducting Assent Discussion

Date of Signature (mm/dd/yyyy)

USCIS Privacy Act Statement

AUTHORITIES: The information requested on this form, and the associated evidence, is collected under the Immigration and
Nationality Act (INA) section 101(42) and 8 CFR parts 204.2(D)(2)(vi) and 207.
PURPOSE: The primary purpose for providing the requested information on this form is to consent to have DNA samples collected
by USCIS and analyzed by an American Association of Blood Banks (AABB) accredited laboratory. DNA samples are being
collected to confirm claimed familial relationships.
DISCLOSURE: The information you provide is voluntary and participation in the Rapid DNA pilot is voluntary. Refusal to sign the
lab DNA consent form will have no impact on your pending refugee case.
ROUTINE USES: The Department of Homeland Security (DHS) may share the information you provide on this form with other
Federal, state, local, and foreign government agencies and authorized organizations. DHS follows approved routine uses described in
the associated published system of records notices [DHS-USCIS-001 - Alien File, Index, and National File Tracking System of
Records] which you can find at www.dhs.gov/privacy. DHS may also share the information as appropriate, for law enforcement
purposes or in the interest of national security.

Form G-1294 08/21/15

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Paperwork Reduction Act
An agency may not conduct or sponsor an information collection, and a person is not required to respond to a collection of information,
unless it displays a currently valid OMB control number. The public reporting burden for this collection of information is estimated at
6 hours and 13 minutes per response, including time for reviewing instructions, gathering the required documentation and information,
completing the form, attaching necessary documentation, and submitting the form. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden, to: U.S. Citizenship and Immigration
Services, Regulatory Coordination Division, Office of Policy and Strategy, 20 Massachusetts Ave NW, Washington, DC 20529-2140;
OMB No. 1615-NEW. Do not mail your completed Form G-1294 to this address.

DRAFT
Not for
Production
09/11/2015

Form G-1294 08/21/15

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