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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 | ConsentForm.docx | Sun Aug 26 17:51:28 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 | ConsentForm.docx | Thu Nov 8 23:51:26 2018 UTC |
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1 | Informed C onsent For m | |
2 | ||
3 | Informed C onsent For m | |
4 | ||
5 | INTRODUCTI ON | |
6 | ||
7 | You are be ing invite d to take part in a research s tudy. Befo re you dec ide to tak e part, it is import ant for yo u to know why the re search is being done and what it will in volve. Th is include s any pote ntial risk s to you, as well as any poten tial benef its you mi ght receiv e | |
8 | ||
9 | Read the i nformation below clo sely, and discuss it with fami ly and fri ends if yo u wish. A sk one of the study staff if t here is an ything tha t is not c lear or if you would like more details. Take your time to d ecide. If you do de cide to ta ke part in this stud y, your si gnature on this cons ent form w ill show t hat you re ceived all of the in formation below, and that you were able to discuss any quest ions and c oncerns yo u had with a member of the stu dy team. | |
10 | BACKGROUND AND PURPO SE | |
11 | ||
12 | ||
13 | This rese arch study is sponso red by | |
14 | This rese arch study is funded by | |
15 | The Princi pal Invest igator __ __________ for this study: | |
16 | receives financial support fo r the cond uct of the research project fr om: | |
17 | Specify: | |
18 | receives personal i ncome for( such as ot her work s uch as pay ments for lectures o r for cons ultations) : | |
19 | Specify: | |
20 | has a fin ancial int erest in ( for exampl e stocks): | |
21 | Specify: | |
22 | may recei ve royalti es or mone y form pat ents relat ed to the subject of the resea rch | |
23 | Specify: | |
24 | A total of sub jects at insti tutions wi ll be aske d to parti cipate in this study . You will be one of approxima tely subjects to be aske d to parti cipate at this locat ion. | |
25 | ||
26 | STUDY PROC EDURES | |
27 | If you dec ide to tak e part in this study this is w hat will h appen: | |
28 | ||
29 | ||
30 | DURATION O F THE RESE ARCH | |
31 | This resea rch study is expecte d to take approximat ely . Your in dividual p articipati on in the project wi ll take . | |
32 | POSSIBLE R ISKS OR DI SCOMFORTS | |
33 | Any proced ure has po ssible ris ks and dis comforts. The proce dures in t his study may cause all, some, or none o f the risk s or side effects li sted. Rar e, unknown , or unexp ected risk s also may occur. Risks of t he usual c are you re ceive are not risks of the res earch. Th ose risks are not in cluded in this conse nt form. You should talk with your heal th care pr oviders if you have any questi ons about the risks of usual c are. | |
34 | ||
35 | There may be unknow n risks or discomfor ts involve d. Study s taff will update you in a time ly way on any new in formation that may a ffect your decision to stay in the study . | |
36 | Sometimes during the course of a researc h study, n ew informa tion becom es availab le about t hat might change a p erson’s de cision to stay in th e study. If this ha ppens, you r research doctor wi ll tell yo u about it and discu ss with yo u whether you want t o continue in the st udy. If y ou decide to withdra w from the study, yo ur researc h doctor w ill arrang es for you r medical care to co ntinue. I f you deci de to cont inue in th e study, y ou might b e asked to sign an u pdated inf ormed cons ent form. Your rese arch docto r could al so decide it to be i n your bes t interest s to withd raw you fr om the stu dy. If so , he or sh e will exp lain the r easons and arrange f or your us ual medica l care to continue. Potential benefits: | |
37 | POTENTIAL BENEFITS | |
38 | The benef its of par ticipating in this s tudy may b e: | |
39 | ||
40 | You may re ceive no b enefit fro m particip ating, how ever, your participa tion may h elp the in vestigator s better u nderstand . | |
41 | ALTERNATIV ES TO PART ICIPATING IN THIS RE SEARCH | |
42 | The follo wing alter native pro cedures or treatment s are avai lable if y ou choose not to par ticipate i n this stu dy : | |
43 | ||
44 | ||
45 | ||
46 | RIGHT OF I NVESTIGATO R TO TERMI NATE PARTI CIPATION | |
47 | ||
48 | CONFIDENTI ALITY | |
49 | ||
50 | Informatio n about yo u will be combined w ith inform ation from other peo ple taking part in t he study. We will w rite about the combi ned data w e have gat hered. An y talks or papers ab out this s tudy will not identi fy you. | |
51 | We will i nclude inf ormation a bout your study part icipation in your me dical reco rd. | |
52 | If the st udy involv es a produ ct regulat ed by the FDA, there are times when we m ight have to show yo ur records to other people. Fo r example, someone f rom the Of fice of Hu man Resear ch Protect ions, the Government Accountab ility Offi ce, the Of fice of th e Inspecto r General, the VA Of fice of Re search Ove rsight, th e VA Centr al IRB, ou r local Re search and Developme nt Committ ee, [FDA, is checked above] an d other st udy monito rs may loo k at or co py portion s of recor ds that id entify you . | |
53 | A descrip tion of th is clinica l trial wi ll be avai lable on h ttp://www. ClinicalTr ials.gov a s required by U.S. L aw. This website wi ll not inc lude infor mation tha t can iden tify you. At most, the websit e will inc lude a sum mary of th e results. You can search thi s website at any tim e. | |
54 | ||
55 | COSTS TO P ARTICIPANT S AND PAYM ENT | |
56 | You will n ot be char ged for an y treatmen ts or proc edures tha t are part of this s tudy. If you usuall y pay co-p ayments fo r VA care and medica tions, you will stil l pay thes e co-payme nts for VA care and medication s that are not part of this st udy. | |
57 | ||
58 | ||
59 | This inst itution do es not pla n to pay r oyalties t o you if a commercia l product is develop ed from bl ood or tis sue obtain ed from yo u during t his study. | |
60 | There is the possib ility that cell line s will be developed with this sample. | |
61 | MEDICAL TR EATMENT AN D COMPENSA TION FOR I NJURY | |
62 | Every reas onable saf ety measur e will be used to pr otect your well-bein g. If you are injur ed as a re sult of ta king part in this st udy, the V A will pro vide neces sary medic al treatme nt at no c ost to you unless th e injury w as due to your not f ollowing t he study p rocedures. You do n ot give up any of yo ur legal r ights and you do not release t he VA from any liabi lity by si gning this form. | |
63 | The VA ma y not prov ide necess ary medica l care for treatment for injur ies in res earch cond ucted for VA under c ontract wi th an indi vidual or non-VA org anization. | |
64 | ||
65 | Insert nam es and con tact telep hone of su bject(s) i f the subj ect has a medical co ncern or g ets hurt o r sick as a result o f taking p art of thi s study: | |
66 | DURING THE DAY: ____ __________ at ______ _____. | |
67 | AFTER HOUR S: ______ _________ at ______ ______. | |
68 | PARTICIPAT ION IS VOL UNTARY | |
69 | It is up t o you to d ecide whet her or not to take p art in thi s study. I f you deci de to take part you may still withdraw a t any time . If you do not wis h to be in this stud y or leave the study early, yo u will not lose any benefits t o which yo u are enti tled. If you don’t take part, you can s till recei ve all usu al care th at is avai lable to y ou. | |
70 | If you ar e a VA emp loyee, Ref usal to ta ke part in the study will in n o way infl uence your employmen t, ratings , or subse quent reco mmendation s, | |
71 | If you ar e a studen t learner, or traine e, refusal to take p art in the study wil l in no wa y influenc e your rat ings, subs equent rec ommendatio ns, or aca demic prog ress | |
72 | Your signa ture on th is consent form mean s that you have rece ived the i nformation about thi s study an d that you agree to volunteer for this r esearch st udy. | |
73 | You will b e given a copy of th is signed form to ke ep. You ar e not givi ng up any of your ri ghts by si gning this form. Eve n after yo u have sig ned this f orm, you m ay change your mind at any tim e. Please contact th e study st aff if you decide to stop taki ng part in this stud y. | |
74 | If you cho ose not to take part in the re search or if you dec ide to sto p taking p art later, your bene fits and s ervices wi ll stay th e same as before thi s study wa s discusse d with you . You will not lose these bene fits, serv ices, or r ights. | |
75 | PERSONS TO CONTACT A BOUT THIS STUDY | |
76 | The invest igator and /or someon e he/she a ppoints in his/her p lace will try to ans wer all of your ques tions. If you have q uestions o r concerns at any ti me, you ma y speak wi th a membe r of the s tudy staff : | |
77 | Research S taff Membe r Name: | |
78 | Research S taff Membe r Phone Nu mber: | |
79 | Members of the Insti tutional R eview Boar d c an also an swer your questions and concer ns about y our rights as a rese arch subje ct. The IR B office n umber is . Cal l the IRB office if you would like to sp eak to a p erson inde pendent of the inves tigator an d research staff for complaint s about th e research , if you c annot reac h the rese arch staff , or if yo u wish to talk to so meone othe r than the research staff. | |
80 | GENETIC RE SEARCH | |
81 | ||
82 | ||
83 | ||
84 | Federal la ws and pol icies prov ide you wi th protect ion from d iscriminat ion by hea lth insura nce compan ies, group health pl ans, and m ost employ ers based on your ge netic info rmation. A new fede ral law, t he Genetic Informati on Nondisc rimination Act (GINA ) generall y will pro tect you i n the foll owing ways : | |
85 | Health ins urance com panies and group hea lth plans may not re quest your genetic i nformation obtained from this research. | |
86 | Health ins urance com panies and group hea lth plans may not us e your gen etic infor mation obt ained from this rese arch when making dec isions reg arding you r eligibil ity or pre miums. | |
87 | Employers with 15 or more empl oyees may not use yo ur genetic informati on obtaine d from thi s research when maki ng a decis ion to hir e, promote , or fire you or whe n setting the terms of your em ployment. Be aware t hat this n ew Federal law does not protec t you agai nst geneti c discrimi nation by companies that sell life insur ance, disa bility ins urance, or long-term care insu rance. | |
88 | ||
89 | FUTURE USE OF DATA A ND RE-CONT ACT | |
90 | ||
91 | ||
92 | ||
93 |
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