ࡱ> 352 bjbj .$xx  /GGG[[[8[.,......Yz.G.GGC@GG,,H[pY0drG... : Office of Legal Affairs Last Revised 06/06/12 RESEARCHER QUESTIONNAIRE TO DETERMINE IF A HIPAA AUTHORIZATION IS REQUIRED If a researcher wishes to use Protected Health Information or PHI (as defined in the HIPAA Privacy Rule) for research purposes, the researcher must obtain either (i) a signed Authorization Form from each participant that complies with the Privacy Rule, or (ii) a Waiver of Authorization approved by the Internal Review Board or IRB. The purpose of this questionnaire is to help researchers determine if they are in fact using PHI in their study and must therefore obtain certain authorizations from their participants before using this information, or obtain an IRB waiver. Do you wish to access a participants health information from a covered entity (i.e. medical records)? The key question a researcher must ask is whether the information he/she wishes to access was created or maintained by a covered entity. Most hospitals, clinics, and other health care agencies are covered entities under HIPAA. In addition, certain 51 Covered Departments are covered under HIPAA. If the researcher is accessing a patients medical records from any covered entity, those records are protected by HIPAA and, as such, that the required HIPAA authorizations must be obtained from the research participants to use this information. Are you conducting research in connection or collaboration with an entity covered by HIPAA? If you are conducting research in connection or collaboration with a covered entity, and in doing so you will use or generate individual health information (including information relating to any past, present, or future physical or mental health of an individual, provision of healthcare to the individual or the payment for healthcare), you must obtain the required HIPAA authorizations. Again, most hospitals, clinics and other health care agencies are covered by HIPAA, as are certain 51 Covered Department. Are you using information from a database that was created using health care information obtained by a covered entity? If you use information obtained from a database that was created using health care information from a covered entity, it is likely that you will need to obtain the required HIPAA authorizations from participants. Covered entities and researchers may seek authorization from participants to place their protected health information in a database. However, if the database is kept by a HIPAA covered entity, the HIPAA rules still apply. As a result, in order to use the information in the database, subsequent researchers would need to obtain the required HIPAA authorizations. As a practical matter, if you want to use information in a database, it may be easier to try to obtain a limited data set, or a waiver from the IRB. Are you asking a participant to self-report his medical history? If you do not wish to see a participants medical record, but rather are asking him/her questions, outside of a clinical or hospital setting, about his/her past medical history, you do not need to obtain the required HIPAA authorizations from your participants unless you meet one of the other criteria discussed in this questionnaire.  For more information on how HIPAA affects researchers, consult 51s HIPAA Overview for Researchers which can be found online at: https://www4.uwm.edu/legal/hipaa/overviews/researchers/index.cfm. The Informed Consent required by the IRB may be combined with the Authorization Form required by HIPAA. However, 51s IRB prefers that researchers obtain a separate Authorization Form and Informed Consent from participants. See the sample Authorization Form for Researchers at  HYPERLINK "https://www4.uwm.edu/legal/hipaa/other_resources/index.cfm" https://www4.uwm.edu/legal/hipaa/other_resources/index.cfm. If you are using PHI and wish to include the required HIPAA authorizations in your informed consent you must seek permission from 51s IRB to do so. See HIPAA Requirements for Combined Informed Consent Documents which can be found at https://www4.uwm.edu/legal/hipaa/other_resources/index.cfmfor more information.  For a list of 51s Covered Departments click here: https://www4.uwm.edu/legal/hipaa/policies/index.cfm#sectionB  See 51s Policies and Procedures on the Protection of Patient Health Information: https://www4.uwm.edu/legal/hipaa/policies/index.cfm  See HIPAA Overview for Researchers: https://www4.uwm.edu/legal/hipaa/overviews/researchers/index.cfm..     $%'(*+-/9C|   - / 0 w Z [ ] B F S T U V ؿЩЩГГГЭ hF#hF#hGhwNjhwN0JUh)#h6hF# h656 hM^56 hF#56jh0JUhhMh h5 hM5 h<2I5 hj25 hwN5 hk5 h55./[{| / 0 U V +,$a$gdS8$a$gdM$a$gd $`a$gd$a$gdb $a$gd$a$gd)*+,s~pJ!azŽŹŵű𵹵| h7h7hFAvjhFAv0JU hfh)# h)#56jhwN0JUhLhS8hMh.hZLh6hx Ghfhl( h56 h656 hM56 hf56 h756hwNh)#h 4h/IJBAgd<2I$a$gdS8$a$gd)#z{*BCvx   @ABfgi߿߸ߴ hfh)#jhkqUhkq h7hV hVhVhVh7jhFAv0JU h7h7hFAvh?h<2I0J h7h<2Ih<2Ijh<2IU',1h/ =!"#$% ^ 666666666vvvvvvvvv666666>6666666666666666666666666666666666666666666666666hH6666666666666666666666666666666666666666666666666666666666666666662 0@P`p2( 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p 0@P`p8XV~_HmH nH sH tH @`@ NormalCJ_HaJmH sH tH DA`D Default Paragraph FontRiR  Table Normal4 l4a (k (No List 6U@6  Hyperlink >*B*ph>@>  Footnote TextCJaJ@&@@ Footnote ReferenceH*H"H <2I0 Balloon TextCJOJQJ^JaJN/1N <2I0Balloon Text CharCJOJQJ^JaJPK![Content_Types].xmlj0Eжr(΢Iw},-j4 wP-t#bΙ{UTU^hd}㨫)*1P' ^W0)T9<l#$yi};~@(Hu* Dנz/0ǰ $ X3aZ,D0j~3߶b~i>3\`?/[G\!-Rk.sԻ..a濭?PK!֧6 _rels/.relsj0 }Q%v/C/}(h"O = C?hv=Ʌ%[xp{۵_Pѣ<1H0ORBdJE4b$q_6LR7`0̞O,En7Lib/SeеPK!kytheme/theme/themeManager.xml M @}w7c(EbˮCAǠҟ7՛K Y, e.|,H,lxɴIsQ}#Ր ֵ+!,^$j=GW)E+& 8PK!Ptheme/theme/theme1.xmlYOo6w toc'vuر-MniP@I}úama[إ4:lЯGRX^6؊>$ !)O^rC$y@/yH*񄴽)޵߻UDb`}"qۋJחX^)I`nEp)liV[]1M<OP6r=zgbIguSebORD۫qu gZo~ٺlAplxpT0+[}`jzAV2Fi@qv֬5\|ʜ̭NleXdsjcs7f W+Ն7`g ȘJj|h(KD- dXiJ؇(x$( :;˹! I_TS 1?E??ZBΪmU/?~xY'y5g&΋/ɋ>GMGeD3Vq%'#q$8K)fw9:ĵ x}rxwr:\TZaG*y8IjbRc|XŻǿI u3KGnD1NIBs RuK>V.EL+M2#'fi ~V vl{u8zH *:(W☕ ~JTe\O*tHGHY}KNP*ݾ˦TѼ9/#A7qZ$*c?qUnwN%Oi4 =3ڗP 1Pm \\9Mؓ2aD];Yt\[x]}Wr|]g- eW )6-rCSj id DЇAΜIqbJ#x꺃 6k#ASh&ʌt(Q%p%m&]caSl=X\P1Mh9MVdDAaVB[݈fJíP|8 քAV^f Hn- "d>znNJ ة>b&2vKyϼD:,AGm\nziÙ.uχYC6OMf3or$5NHT[XF64T,ќM0E)`#5XY`פ;%1U٥m;R>QD DcpU'&LE/pm%]8firS4d 7y\`JnίI R3U~7+׸#m qBiDi*L69mY&iHE=(K&N!V.KeLDĕ{D vEꦚdeNƟe(MN9ߜR6&3(a/DUz<{ˊYȳV)9Z[4^n5!J?Q3eBoCM m<.vpIYfZY_p[=al-Y}Nc͙ŋ4vfavl'SA8|*u{-ߟ0%M07%<ҍPK! ѐ'theme/theme/_rels/themeManager.xml.relsM 0wooӺ&݈Э5 6?$Q ,.aic21h:qm@RN;d`o7gK(M&$R(.1r'JЊT8V"AȻHu}|$b{P8g/]QAsم(#L[PK-![Content_Types].xmlPK-!֧6 +_rels/.relsPK-!kytheme/theme/themeManager.xmlPK-!Ptheme/theme/theme1.xmlPK-! ѐ' theme/theme/_rels/themeManager.xml.relsPK] Z  $ z 'bX8@0(  B S  ? ~ en3333$%'(*+-99-./]U)s~? K L p    AB%*+-?>S8 kL+Uj2d!)#F#1%x?).0i327x G<2I[ LwN_]/-]M^7^ikqFAvfV zaG?~fF*R('6 M @yyBAiZLSJ 4rC 8Hf!b l(X r @X@UnknownG*Ax Times New Roman5Symbol3. *Cx Arial5. .[`)TahomaA BCambria Math"hbGbGbG  !24d 3QHP ?SJ2!xxOffice of Legal Affairsmcgeed Donna McGeeOh+'0\    $ 0<DLTOffice of Legal Affairsmcgeed Normal.dotm Donna McGee3Microsoft Office Word@_@)H@ߘH@H ՜.+,D՜.+,P  hp  UW-Milwaukee  Office of Legal Affairs Title 8@ _PID_HLINKSAO.;https://www4.uwm.edu/legal/hipaa/other_resources/index.cfm*  !#$%&'()+,-./014Root Entry FVH61TableWordDocument.$SummaryInformation("DocumentSummaryInformation8*CompObjy  F'Microsoft Office Word 97-2003 Document MSWordDocWord.Document.89q