Form G-1295 DNA Collection Consent Form (Rapid Test)

DNA Collection Consent Form
(Rapid Test)

USCIS
Form G-1295

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)

Middle Name

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2.

Case Number

4.

Are you the applicant or the parent of the applicant?

3.

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.
The purpose of this research study is to evaluate the accuracy of an investigational electronic process used to test DNA
(Deoxyribonucleic acid), which 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 samples will be collected and analyzed with an on-site Rapid DNA analysis system for research purposes. You understand
that this test will not be used by U.S. Citizenship and Immigration Services (USCIS) to determine whether you are biologically related
to a parent or child in your case or related cases.
The RAPID DNA results may be compared to results produced by separate samples sent to an American Association of Blood Banks
(AABB) accredited laboratory in the United States. Only the results of the AABB accredited laboratory DNA test may be used when
considering your refugee application. A staff member will swab the inside of your cheek with five different cotton swabs so that five
samples of your DNA are collected. This will take about five to ten minutes to complete. Study staff members will dispose of all
cheek swab samples after testing is complete. There is no physical discomfort from saliva collection. We do not anticipate any risks
from analysis of your samples and 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. Your alternative is to not participate. 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 such immigration benefits. USCIS will make the decision on your refugee application based on all
relevant evidence that you submit, including whether that evidence demonstrates the claimed biological parent/child relationship.
You may ask the representative present at the time of testing about any questions, concerns or complaints about this study or a problem
due to the research, and you may email [email protected] about your rights as a research participant, questions, concerns or complaints.

Form G-1295 08/21/2015

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

Date of Signature (mm/dd/yyyy)

DRAFT
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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 samples collected for the Rapid DNA pilot will only be used to evaluate the effectiveness of the Rapid DNA
prototype equipment. Separate samples will be collected and sent to an American Association of Blood Banks (AABB) accredited
laboratory.
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-1295 08/21/2015

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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
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-1295 to this address.

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Form G-1295 08/21/2015

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