S.D. Admin. R. 20:06:40 app B

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Current through Register Vol. 50, page 159, June 17, 2024

Appendix B - Notice of Research Exception

Notice of Research Exception

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 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:

_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

S.D. Admin. R. 20:06:40 app B

37 SDR 47, effective 9/20/2010.