GINA Exception Notice

Notice of Research Exception
Under
The Genetic Information Nondiscrimination Act

PART I: Entity Classification and Identification
1. Date of submission: __________________________
2. Specify whether the entity claiming the research exception is:
(A)  A group health plan (plan); or
(B)  A health insurance issuer (issuer).
3. If the entity is a plan (as designated in Box 2A), is the plan:
(A)  A plan subject to Part 7 of Title I of ERISA;
(B)  A church plan; or
(C)  A nonfederal governmental plan.
4. If the entity is an issuer (as designated in Box 2B), is the issuer claiming the exception in
connection with the provision of:
(A)  Group health insurance coverage only;
(B)  Individual health insurance coverage only; or
(C)  Both group and individual health insurance coverage.

5a. Name and address of the entity claiming the exception:
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
5b. Telephone number of the entity claiming the exception:
________________________________________________________

5c. Employer Identification Number (EIN) of the entity claiming the exception:
________________________________________________________
5d. If the entity is a plan (as designated in Box 2A), specify plan number:
________________________________________________________
PART II: Research Project Information
6. Title of the research project:
________________________________________________________
7. Name of the principal investigator:
________________________________________________________
8. Research project number (if available):
________________________________________________________
Part III: Attestation of Compliance with the Requirements of the Research Exception
With respect to the research project described in Part II, I attest that the following is true:
(i) The research complies with 45 CFR part 46 or equivalent federal regulations and
applicable State or local law or regulations for the protection of human subjects in research;
(ii) each request of a participant or beneficiary (or in the case of a minor child, the legal
guardian of such beneficiary) to undergo genetic testing as part of the research will be made
in writing and clearly indicate that compliance with the request is voluntary and that noncompliance will have no effect on eligibility for benefits or premium or contribution
amounts; and (iii) no genetic information collected or acquired through this research will be
used for underwriting purposes.
Under penalty of perjury, I declare that I have examined this notice, including any
accompanying attachments, and to the best of my knowledge and belief, it is true and
correct. Under penalty of perjury, I also declare that this notice is complete.
Signature: _______________________________

Date:_________________

Type or print name, address, and telephone number:
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________

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Paperwork Reduction Act Statement
According to the Paperwork Reduction Act of 1995 (Pub. L. 104-13) (PRA), no persons are
required to respond to a collection of information unless such collection displays a valid Office
of Management and Budget (OMB) control number. The Department notes that a Federal
agency cannot conduct or sponsor a collection of information unless it is approved by OMB
under the PRA, and displays a currently valid OMB control number, and the public is not
required to respond to a collection of information unless it displays a currently valid OMB
control number. See 44 U.S.C. 3507. Also, notwithstanding any other provisions of law, no
person shall be subject to penalty for failing to comply with a collection of information if the
collection of information does not display a currently valid OMB control number. See 44 U.S.C.
3512.
The public reporting burden for this collection of information is estimated to average
approximately 15 minutes per respondent. Interested parties are encouraged to send comments
regarding the burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden, to the U.S. Department of Labor, Office of the Chief
Information Officer, Attention: Departmental Clearance Officer, 200 Constitution Avenue,
N.W., Room N-1301, Washington, DC 20210 or email [email protected] and
reference the OMB Control Number 1210-0136.

OMB Control Number 1210-0136 (expires 11/30/2015)

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