<html> <head> <title>Rule 20:06:39:0B Notice of Research Exception.</title> <META NAME="Keywords" Content="Administrative Rules 20:06:39:0B"> <META NAME="Description" Content="Administrative Rules 20:06:39:0B Notice of Research Exception."> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Generator content="Microsoft Word 14 (filtered)"> <style> <!-- /* Font Definitions */ @font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {margin-top:0in; margin-right:0in; margin-bottom:0in; margin-left:-.7pt; margin-bottom:.0001pt; text-align:justify; font-size:12.0pt; font-family:"Times New Roman","serif";} @page WordSection1 {size:8.5in 11.0in; margin:49.7pt 1.0in 49.7pt 63.35pt;} div.WordSection1 {page:WordSection1;} --> </style> </head> <body lang=EN-US> <div class=WordSection1> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>DEPARTMENT OF LABOR AND REGULATION</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>DIVISION OF INSURANCE</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>NOTICE OF RESEARCH EXCEPTION</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>Chapter 20:06:39</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>APPENDIX B</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>SEE: &#167;&nbsp;20:06:39:47</span></font></p> <p class=MsoNormal align=center style='text-align:center'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b><span style='font-weight:bold'>Source:</span></b> 37 SDR 47, effective September 20, 2010.</span></font></p> <font size=3 face="Times New Roman"><span style='font-size:12.0pt;font-family: "Times New Roman","serif"'><br clear=all style='page-break-before:always'> </span></font> <p class=MsoNormal align=center style='text-align:center'><b><i><font size=3 face="Times New Roman"><span style='font-size:12.0pt;font-weight:bold; font-style:italic'>Notice of Research Exception</span></font></i></b></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><b><font size=3 face="Times New Roman"><span style='font-size:12.0pt;font-weight:bold'>PART I: Entity Classification and Identification</span></font></b></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>1.&nbsp;&nbsp;Date of submission: ________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>2.&nbsp;&nbsp;Specify whether the entity claiming the research exception is:</span></font></p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <i><span style='font-style:italic'>(A)</span></i>&nbsp;&nbsp;</span></font><font size=5><span style='font-size:20.0pt'>&#9633;</span></font>&nbsp; A group health plan (plan); or</p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <i><span style='font-style:italic'>(B)</span></i>&nbsp;&nbsp;</span></font><font size=5><span style='font-size:18.0pt'>&#9633;</span></font>&nbsp; A health insurance issuer (issuer).</p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>3.&nbsp;&nbsp;If the entity is a plan (as designated in Box 2A), is the plan:</span></font></p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <i><span style='font-style:italic'>(A)</span></i>&nbsp;&nbsp;</span></font><font size=5><span style='font-size:18.0pt'>&#9633;</span></font>&nbsp; A plan subject to Part 7 of Title I of ERISA;</p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <i><span style='font-style:italic'>(B)</span></i>&nbsp;&nbsp;</span></font><font size=5><span style='font-size:18.0pt'>&#9633;</span></font>&nbsp; A church plan; or</p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <i><span style='font-style:italic'>(C)</span></i>&nbsp;&nbsp;</span></font><font size=5><span style='font-size:18.0pt'>&#9633;</span></font>&nbsp; A nonfederal governmental plan.</p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>4.&nbsp;&nbsp;If the entity is an issuer (as designated in Box 2B), is the issuer claiming the exception in connection with the provision of:</span></font></p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <i><span style='font-style:italic'>(A)</span></i>&nbsp;&nbsp;</span></font><font size=5><span style='font-size:18.0pt'>&#9633;</span></font>&nbsp; Group health insurance coverage only;</p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <i><span style='font-style:italic'>(B)</span></i>&nbsp;&nbsp;</span></font><font size=5><span style='font-size:18.0pt'>&#9633;</span></font>&nbsp; Individual health insurance coverage only; or</p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <i><span style='font-style:italic'>(C)</span></i>&nbsp;&nbsp;</span></font><font size=5><span style='font-size:18.0pt'>&#9633;</span></font>&nbsp; Both group and individual health insurance coverage.</p> <p class=MsoNormal style='margin-left:0in'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>5a.&nbsp;&nbsp;Name and address of the entity claiming the exception:</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;__________________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;__________________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;__________________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>5b.&nbsp;&nbsp;Telephone number of entity claiming the exception:</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;__________________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>5c.&nbsp;&nbsp;Employer Identification Number (EIN) of the entity claiming the exception:</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;__________________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>5d.&nbsp;&nbsp;If the entity is a plan (as designated in Box 2A), specify plan number:</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;______________________________________________________</span></font></p> <font size=3 face="Times New Roman"><span style='font-size:12.0pt;font-family: "Times New Roman","serif"'><br clear=all style='page-break-before:always'> </span></font> <p class=MsoNormal><b><font size=3 face="Times New Roman"><span style='font-size:12.0pt;font-weight:bold'>PART II: Research Project Information</span></font></b></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>6.&nbsp;&nbsp;Title of the research project:</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;______________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>7.&nbsp;&nbsp;Name of the principal investigator:</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;______________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>8.&nbsp;&nbsp;Research project number ( if available):</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;______________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><b><font size=3 face="Times New Roman"><span style='font-size:12.0pt;font-weight:bold'>PART III: Attestation of Compliance with the Requirements of the Research Exception</span></font></b></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>With respect to the research project described in Part II, I attest that the following is true:</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>(i)&nbsp;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)&nbsp;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.</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>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.</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>Signature:&nbsp;_______________________________________&nbsp;&nbsp;Date:&nbsp;________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>Type or print name, address, and telephone number:</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________</span></font></p> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> <font size=3 face="Times New Roman"><span style='font-size:12.0pt;font-family: "Times New Roman","serif"'><br clear=all style='page-break-before:always'> </span></font> <p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size: 12.0pt'>&nbsp;</span></font></p> </div> </body> </html>