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1 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | HIPAAForm.docx | Wed May 2 23:26:00 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | HIPAAForm.docx | Tue Jul 17 21:40:06 2018 UTC |
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1 | Authorizat ion for Us e & Releas e of Indiv idually Id entifiable Health In formation for Vetera ns Health Administra tion (VHA) Research | |
2 | Subject Na me (Last, First, Mid dle Initia l): | |
3 | ||
4 | Subject SS N (last 4 only): | |
5 | ||
6 | Date of Bi rth: | |
7 | ||
8 | VA Facilit y (Name an d Address) : | |
9 | ||
10 | VA Princip al Investi gator (PI) : | |
11 | ||
12 | PI Contact Informati on: | |
13 | ||
14 | Study Titl e: | |
15 | ||
16 | Purpose of Study: | |
17 | ||
18 | ||
19 | USE OF YOU R INDIVIDU ALLY IDENT IFIABLE HE ALTH INFOR MATION (II HI): | |
20 | ||
21 | Your indiv idually id entifiable health in formation is informa tion about you that contains y our health informati on and inf ormation t hat would identify y ou such as your name , date of birth, or other indi vidual ide ntifiers. VHA is ask ing you to allow the VA Princi pal Invest igator (PI ) and /or the VA res earch team members t o access a nd use you r past or present he alth infor mation in addition t o new heal th informa tion they may collec t for the study name d above. T he investi gators of this study are commi tted to pr otecting y our privac y and the confidenti ality of i nformation related t o your hea lth care. | |
22 | Signing th is authori zation is completely voluntary . However, your auth orization (permissio n) is nece ssary to p articipate in this s tudy. Your treatment , payment, enrollmen t, or elig ibility fo r VA benef its will n ot be affe cted, whet her or not you sign this autho rization. | |
23 | ||
24 | Your indiv idually id entifiable health in formation used for t his VA stu dy include s the info rmation ma rked below : | |
25 | ||
26 | Informati on from yo ur VA Heal th Records such as d iagnoses, progress n otes, medi cations, l ab or radi ology find ings, etc. | |
27 | ||
28 | Specific informatio n concerni ng: | |
29 | ||
30 | alcohol a buse drug abuse si ckle cell anemia HI V | |
31 | ||
32 | Demograph ic Informa tion such as name, a ge, race, etc. | |
33 | ||
34 | Billing o r Financia l Records | |
35 | ||
36 | Photograp hs, Videot apes, and/ or Audiota pes of you | |
37 | ||
38 | Questionn aire, Surv ey, and/or Subject D iary | |
39 | ||
40 | Other, as immediate ly describ ed below: | |
41 | ||
42 | ||
43 | ||
44 | ||
45 | Authorizat ion for Us e & Releas e of Indiv idually Id entifiable Health In formation for Vetera ns Health Administra tion (VHA) Research | |
46 | Subject Na me (Last, First, Mid dle Initia l): | |
47 | ||
48 | Subject SS N (last 4 only): | |
49 | ||
50 | Date of Bi rth: | |
51 | ||
52 | USE OF YOU R DATA OR SPECIMENS FOR OTHER RESEARCH: (This sect ion must o nly be com pleted whe n banking is a requi red compon ent of thi s study. W hen bankin g is an op tional com ponent of this study complete page 5 of this form in lieu of this sect ion.) | |
53 | ||
54 | Not Appli cable - No Data or S pecimen Ba nking for Other Rese arch | |
55 | ||
56 | An importa nt part of this rese arch is to save your | |
57 | ||
58 | Data | |
59 | ||
60 | Specimen | |
61 | ||
62 | in a secur e reposito ry/bank fo r other re search stu dies in th e future. If you do not agree to allow t his use of your data and/or sp ecimen for future st udies appr oved by th e required committee s, such as the Insti tutional R eview Boar d, you wil l not be a ble to par ticipate i n this stu dy. | |
63 | DISCLOSURE : The VA r esearch te am may nee d to discl ose the in formation listed abo ve to othe r people o r institut ions that are not pa rt of VA. VA/VHA com plies with the requi rements of the Healt h Insuranc e Portabil ity and Ac countabili ty Act of 1996 (HIPA A), Privac y Act of 1 974 and al l other ap plicable f ederal law s and regu lations th at protect your priv acy. The V HA Notice of Privacy Practices (a separa te documen t) provide s more inf ormation o n how we p rotect you r informat ion. If yo u do not h ave a copy of the No tice, the research t eam will p rovide one to you. G iving your permissio n by signi ng this au thorizatio n allows u s to discl ose your i nformation to other institutio ns or pers ons outsid e the VA/V HA as note d below. O nce your i nformation has been disclosed outside VA /VHA, it m ay no long er be prot ected by f ederal law s and regu lations an d might be re-disclo sed by the persons o r institut ions recei ving the i nformation . These no n-VA/VHA i nstitution s or perso ns include the entit ies marked below: | |
64 | ||
65 | Non-VA In stitutiona l Review B oard (IRB) at who wi ll monitor the study | |
66 | ||
67 | Study Spo nsor (name ): | |
68 | Perso n or entit y who take s responsi bility for and initi ates a cli nical inve stigation | |
69 | ||
70 | Academic Affiliate (instituti on/name/em ployee/dep artment): | |
71 | A rel ationship with VA in the perfo rmance of this study | |
72 | ||
73 | Complianc e and Safe ty Monitor s: | |
74 | Advis es the Spo nsor or PI regarding the conti nuing safe ty of this study | |
75 | ||
76 | Other Fed eral agenc ies requir ed to moni tor or ove rsee resea rch (such as FDA, OH RP, GAO): | |
77 | ||
78 | A Non-Pro fit Corpor ation (nam e and spec ific purpo se): | |
79 | ||
80 | Other (e. g. name of contracto r and spec ific purpo se): | |
81 | ||
82 | ||
83 | ||
84 | Authorizat ion for Us e & Releas e of Indiv idually Id entifiable Health In formation for Vetera ns Health Administra tion (VHA) Research | |
85 | Subject Na me (Last, First, Mid dle Initia l): | |
86 | ||
87 | Subject SS N (last 4 only): | |
88 | ||
89 | Date of Bi rth: | |
90 | ||
91 | Note: Offi ces within VA/VHA th at are res ponsible f or oversig ht of VA r esearch su ch as the Office of Research O versight ( ORO), the Office of Research a nd Develop ment (ORD) , the VA O ffice of I nspector G eneral, th e VA Offic e of Gener al Counsel , the VA I RB and Res earch and Developmen t Committe e may also have acce ss to your informati on in the performanc e of their VA/VHA jo b duties. | |
92 | Access to your Indiv idually Id entifiable Health In formation created or obtained in the cou rse of thi s research : While th is study i s being co nducted, y ou | |
93 | ||
94 | Yes, the subject wi ll have ac cess to th eir resear ch related health re cords | |
95 | ||
96 | This will not affect your VA h ealthcare including your docto r's abilit y to see y our record s as part of your no rmal care and will n ot affect your right to have a ccess to t he researc h records after the study is c ompleted. | |
97 | REVOCATION : If you s ign this a uthorizati on you may change yo ur mind an d revoke o r take bac k your per mission at any time. You must do this in writing a nd must se nd your wr itten requ est to the Principal Investiga tor for th is study a t the foll owing addr ess: | |
98 | ||
99 | ||
100 | ||
101 | ||
102 | ||
103 | If you rev oke (take back) your permissio n, you wil l no longe r be able to partici pate in th is study b ut the ben efits to w hich you a re entitle d will NOT be affect ed. If you revoke (t ake back) your permi ssion, the research team may c ontinue to use or di sclose the informati on that it has alrea dy collect ed before you revoke d (took ba ck) your p ermission which the research t eam has re lied upon for the re search. Yo ur written revocatio n is effec tive as so on as it i s received by the st udy's Prin cipal Inve stigator. | |
104 | EXPIRATION : Unless y ou revoke (take back ) your per mission, y our author ization to allow us to use and /or disclo se your in formation will: | |
105 | ||
106 | Not expir e | |
107 | ||
108 | Expire at the end o f this res earch stud y | |
109 | ||
110 | Expires a t the end of this re search stu dy unless you have: (1) provid ed additio nal permis sion to st ore your d ata and/or biologica l specimen s in a res earch data repositor y or (2)wh en further optional analysis o f your spe cimens has been comp leted | |
111 | ||
112 | Expires on the follo wing date or event: | |
113 | ||
114 | ||
115 | ||
116 | ||
117 | ||
118 | Authorizat ion for Us e & Releas e of Indiv idually Id entifiable Health In formation for Vetera ns Health Administra tion (VHA) Research | |
119 | Subject Na me (Last, First, Mid dle Initia l): | |
120 | ||
121 | Subject SS N (last 4 only): | |
122 | ||
123 | Date of Bi rth: | |
124 | ||
125 | TO BE FILL ED OUT BY THE SUBJEC T | |
126 | Research S ubject Sig nature. Th is permiss ion (autho rization) has been e xplained t o me and I have been given the opportuni ty to ask questions. If I beli eve that m y privacy rights hav e been com promised, I may cont act the VH A facility Privacy O fficer to file a ver bal or wri tten compl aint. | |
127 | I give my authorizat ion (permi ssion) for the use a nd disclos ure of my individual ly identif iable heal th informa tion as de scribed in this form . I will b e given a signed cop y of this form for m y records. | |
128 | ||
129 | ||
130 | Signature of Researc h SubjectD ate | |
131 | ||
132 | ||
133 | Signature of Legal R epresentat iveDate | |
134 | ||
135 | To Sign fo r Research Subject ( Attach aut hority to sign: Heal th Care Po wer of Att orney, Leg al Guardia n appointm ent, or Ne xt of Kin if authori zed by Sta te Law) | |
136 | ||
137 | ||
138 | Name of Le gal Repres entative ( please pri nt)Date | |
139 | ||
140 | ||
141 | Authorizat ion for Us e & Releas e of Indiv idually Id entifiable Health In formation for Vetera ns Health Administra tion (VHA) Research | |
142 | Subject Na me (Last, First, Mid dle Initia l): | |
143 | ||
144 | Subject So cial Secur ity Number (last 4 n umbers onl y): | |
145 | ||
146 | Date of Bi rth: | |
147 | ||
148 | VA Facilit y (Name an d Address) : | |
149 | ||
150 | ||
151 | VA Princip al Investi gator (PI) : | |
152 | ||
153 | PI Contact Informati on: | |
154 | ||
155 | Study Titl e: | |
156 | ||
157 | Optional A uthorizati on Supplem ent for Pl acing My D ata or My Biological Specimens in a Repo sitory or for Conduc ting Optio nal Analys is of My S pecimens F or Future Use by Vet erans Heal th Adminis tration (V HA) Resear ch | |
158 | Purpose. T his supple ment to th e authoriz ation is f or either banking of data and/ or biologi cal specim ens (for e xample blo od, urine, tissue) c ollected d uring the study for future res earch or f or conduct ing option al analysi s for this study You are not r equired to provide t his permis sion and n ot providi ng this pe rmission w ill have n o impact o n your par ticipation in this s tudy, i.e. , granting this perm ission is not a cond ition of p articipati ng in this study. | |
159 | Research S ubject Sig nature. Th is additio nal permis sion (auth orization) has been explained to me and I have bee n given th e opportun ity to ask questions about thi s activity . By signi ng below, I am givin g my permi ssion for VHA to: | |
160 | ||
161 | Store my health inf ormation i n a resear ch data re pository, | |
162 | ||
163 | Store my biological specimens (blood, t issue, uri ne, etc.) in a resea rch data r epository, or | |
164 | ||
165 | Further o ptional an alysis of my specime ns occurri ng below: | |
166 | ||
167 | ||
168 | ||
169 | ||
170 | Future res earch of d ata mainta ined withi n a resear ch data re pository w ill only o ccur after further I nstitution al Review Board and/ or other a pplicable approvals to ensure the protec tion of yo ur individ ual privac y. | |
171 | ||
172 | ||
173 | Signature of Researc h SubjectD ate | |
174 | ||
175 | ||
176 | Signature of Legal R epresentat iveDate | |
177 | ||
178 | ||
179 | Name of Le gal Repres entative ( please pri nt)Date | |
180 | ||
181 | To Sign fo r Research Subject ( Attach aut hority to sign: Heal th Care Po wer of Att orney, Leg al Guardia n appointm ent, or Ne xt of Kin if authori zed by Sta te Law) |
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