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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 | Form_10-0398_RPSS_59.docx | Wed May 2 23:25:58 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 | Form_10-0398_RPSS_59.docx | Tue Jul 17 21:37:34 2018 UTC |
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1 | RESEARCH P ROTOCOL SA FETY SURVE Y | |
2 | ||
3 | ||
4 | PRINCIPAL INVESTIGAT OR (PI): ______ __________ __________ __________ _ | |
5 | ||
6 | PROJECT TI TLE: __________ __________ __________ __________ __________ __ | |
7 | ||
8 | DATE OF SU BMISSION: _____ __________ __________ __________ __________ _ | |
9 | ||
10 | LIST VA AN D NON-VA L OCATIONS I N WHICH PI CONDUCTS RESEARCH: | |
11 | ||
12 | ||
13 | ||
14 | ||
15 | ||
16 | DOES THE R ESEARCH IN VOLVE THE USE OF ANY OF THE FO LLOWING? | |
17 | ||
18 | a. Biologi cal Hazard s (Microbi ological o r viral ag ents, path ogens, tox ins, selec t agents a s defined in Title 4 2 Code of Federal Re gulations (CFR) 72.6 , or anima ls) | |
19 | ||
20 | YES ( )NO ( ) | |
21 | ||
22 | b. Human o r non-huma n cell or tissue sam ples (incl uding cult ures, tiss ues, blood , other | |
23 | ||
24 | bodily flu ids or cel l lines) YES( ) NO ( ) | |
25 | ||
26 | c. Recombi nant deoxy ribonuclei c acid (DN A) YES ( ) NO ( ) | |
27 | d. Chemica ls: | |
28 | (1)Toxic c hemicals ( including heavy meta ls) YES( ) NO ( ) | |
29 | (2)Flammab le, explos ive, or co rrosive ch emicals Y ES( ) NO ( ) | |
30 | (3)Carcino genic, mut agenic, or teratogen ic chemica ls YES( ) NO ( ) | |
31 | (4)Toxic c ompressed gases YES ( ) NO ( ) | |
32 | (5)Acetylc holinester ase inhibi tors or ne urotoxins YES( ) NO ( ) | |
33 | e. Control led Substa nces YES( ) NO ( ) | |
34 | f. Ionizin g Radiatio n: | |
35 | (1)Radioac tive mater ials YES( ) N O( ) | |
36 | (2)Radiati on generat ing equipm ent YES() NO( ) | |
37 | g. Nonioni zing Radia tion: | |
38 | (1)Ultravi olet Light YES( ) NO( ) | |
39 | (2)Lasers (class 3b or class 4 ) YES( ) NO( ) | |
40 | (3)Radiofr equency or microwave sources YES ( ) NO ( ) | |
41 | ||
42 | ||
43 | If the ans wer to any of these questions is YES, co mplete all sections of this su rvey that apply. | |
44 | ||
45 | ||
46 | If all ans wers are N O, a docum ented revi ew by the local Subc ommittee o n Research Safety is still req uired prio r to submi ssion. If the resear ch involve s the use of human s ubjects or human tis sues, Inst itutional Review Boa rd (IRB) r eview is r equired. N OTE: Use o f animals also requi res submis sion of an Instituti onal Anima l Care and Use Commi ttee (IACU C)-approve d Animal C omponent. | |
47 | ||
48 | VA FORM | |
49 | 10-0398 | |
50 | ||
51 | MAY 2002 | |
52 | ||
53 | ||
54 | ||
55 | ||
56 | ||
57 | ||
58 | ||
59 | ||
60 | 1 | |
61 | ||
62 | 2. BIOLOGI CAL HAZARD S | |
63 | ||
64 | a. Does yo ur researc h involve the use of microbiol ogical or viral agen ts, pathog ens, toxin s, | |
65 | ||
66 | poisons or venom? YE S ( ) NO ( ) If N O, skip to the secti on on Cell s and Tiss ue Samples . | |
67 | ||
68 | ||
69 | If YES, li st all Bio safety Lev el 2 and 3 agents or toxins us ed in your laborator y. It is t he respons ibility of each PI t o: | |
70 | ||
71 | Consult ei ther: | |
72 | ||
73 | The Nation al Institu tes of Hea lth (NIH)- Center for Disease C ontrol and Preventio n (CDC) pu blication entitled B iosafety i n Microbio logical an d Biomedic al Laborat ories or | |
74 | The CDC on line refer ence (http ://www.cdc .gov) | |
75 | Identify t he Biosafe ty Level ( also calle d Risk Gro up) for ea ch organis m, agent, or toxin. Enter it i nto the fo llowing ta ble. | |
76 | ||
77 | Organism, Agent, or ToxinBiosa fety Level ** | |
78 | ||
79 | _____ __________ __________ __________ __________ __________ _____ | |
80 | ||
81 | _____ __________ __________ __________ __________ __________ _____ | |
82 | ||
83 | _____ __________ __________ __________ __________ __________ _____ | |
84 | ||
85 | _____ __________ __________ __________ __________ __________ _____ | |
86 | ||
87 | For each B iosafety L evel 2 or 3 agent or toxin lis ted, provi de the inf ormation r equested o n the foll owing page (s). (Desc ription of Biosafety Levels 2 and 3 can be found i n Appendix A.) | |
88 | ||
89 | Are any of the bioha zardous ag ents liste d above cl assified a s a “Selec t Agent” b y the | |
90 | ||
91 | Centers fo r Disease Control?YE S ( )NO ( ) | |
92 | ||
93 | BIOLOGICAL HAZARDS – Descripti on of Use NOTE: Phot ocopy this page, as necessary. | |
94 | ||
95 | Identify t he microbi ological a gent or to xin (name, strain, e tc.): | |
96 | ||
97 | _____ __________ __________ __________ __________ __________ __________ ____ | |
98 | ||
99 | If this is a Select Agent (42 CFR 72.6), provide t he CDC Lab oratory Re gistration # and the date of t he CDC ins pection: | |
100 | ||
101 | _____ __________ _____ __________ | |
102 | ||
103 | Indicate t he largest volume an d/or conce ntration t o be used: | |
104 | ||
105 | _ __________ __________ __________ __________ __________ __________ ______ | |
106 | ||
107 | Indicate w hether ant ibiotic re sistance w ill be exp ressed, an d the natu re of this antibioti c resistan ce: | |
108 | ||
109 | _____ __________ __________ __________ __________ __________ __________ __ | |
110 | ||
111 | ||
112 | ||
113 | ||
114 | 2 | |
115 | ||
116 | Describe t he contain ment equip ment (prot ective clo thing or e quipment, biological safety ca binets, fu me hoods, containmen t centrifu ges, etc.) to be use d in this research: | |
117 | ||
118 | _____ __________ __________ __________ __________ __________ _________ | |
119 | ||
120 | __________ __________ __________ __________ __________ __________ _________ | |
121 | ||
122 | __________ __________ __________ __________ __________ __________ _________ | |
123 | ||
124 | Describe t he propose d methods to be empl oyed in mo nitoring t he health and safety of person nel involv ed in this research: | |
125 | ||
126 | _____ __________ __________ __________ __________ __________ _________ | |
127 | ||
128 | __________ __________ __________ __________ __________ __________ _________ | |
129 | ||
130 | __________ __________ __________ __________ __________ __________ _________ | |
131 | ||
132 | __________ __________ __________ __________ __________ __________ _________ | |
133 | ||
134 | ||
135 | 4. CELLS a nd TISSUE SAMPLES | |
136 | ||
137 | a. Will pe rsonnel wo rk with an imal blood , human or non-human primate b lood, body fluids, | |
138 | organs, ti ssues, cel l lines or cell clon es?YES ( )NO ( ) | |
139 | ||
140 | If yes, sp ecify: | |
141 | ||
142 | ||
143 | ||
144 | ||
145 | ||
146 | ||
147 | b. Will re search stu dies repre sent a pot ential bio hazard for lab perso nnel? | |
148 | NA ( ) Y ES ( )NO ( ) | |
149 | ||
150 | If yes, sp ecify the potential hazard and precautio ns employe d to prote ct personn el in the laboratory : | |
151 | ||
152 | ||
153 | ||
154 | ||
155 | ||
156 | ||
157 | NOTE: If t hese studi es involve animals, the Animal Component of Resear ch Protoco l (ACORP) must be co mpleted. | |
158 | ||
159 | c.Specify precaution s employed to protec t personne l working in the lab oratory: | |
160 | ||
161 | ||
162 | ||
163 | ||
164 | ||
165 | ||
166 | ||
167 | ||
168 | ||
169 | ||
170 | ||
171 | ||
172 | ||
173 | ||
174 | ||
175 | 3 | |
176 | ||
177 | RECOMBINAN T DNA | |
178 | ||
179 | a. Are pro cedures in volving re combinant DNA used i n your lab oratory? | |
180 | ||
181 | YES ( )NO ( ) | |
182 | ||
183 | b. Are rec ombinant D NA procedu res used i n your lab oratory li mited to P CR amplifi cation of | |
184 | ||
185 | DNA segmen ts (i.e., no subsequ ent clonin g of ampli fied DNA)? YES ( )NO ( ) | |
186 | ||
187 | If YES, yo ur recombi nant DNA s tudies are exempt fr om restric tions desc ribed in t he NIH Gui delines fo r Research Involving Recombina nt DNA Mol ecules. | |
188 | ||
189 | If NO, it is the res ponsibilit y of each PI to: | |
190 | ||
191 | Consult th e current NIH Guidel ines for R esearch In volving Re combinant DNA Molecu les which can be fou nd at the Internet s ite http:/ /www4.od.n ih.gov/oba /rac/guide lines/guid elines.htm . | |
192 | ||
193 | Identify t he experim ental cate gory of th eir recomb inant DNA research. | |
194 | ||
195 | Descriptio n of Recom binant DNA Procedure s: | |
196 | ||
197 | Identify t he NIH cla ssificatio n (and bri ef descrip tion) for these reco mbinant DN A studies: | |
198 | ||
199 | _____ __________ __________ __________ __________ __________ ________ | |
200 | ||
201 | Biological source of DNA inser t or gene: | |
202 | ||
203 | _____ __________ __________ __________ __________ __________ ________ | |
204 | ||
205 | Function o f the inse rt or gene : | |
206 | ||
207 | _____ __________ __________ __________ __________ __________ ________ | |
208 | ||
209 | Vector(s) used or to be used f or cloning (e.g., pU C18, pCR3. 1): | |
210 | ||
211 | _____ __________ __________ __________ __________ __________ ________ | |
212 | Host cells and/or vi rus used o r to be us ed for clo ning (e.g. , bacteria l, yeast o r viral st rain, cell line): _______ __________ __________ __________ __________ __________ ______ | |
213 | ||
214 | USE OF CHE MICALS | |
215 | ||
216 | a. Has the use of ch emicals in your labo ratory bee n reviewed by an app ropriate c ommittee o r | |
217 | ||
218 | subcommitt ee in the past 12 mo nths?YES ( )NO ( ) | |
219 | ||
220 | b. Are per sonnel kno wledgeable about the special h azards pos ed by: | |
221 | ||
222 | (1)Carcino gens?NA () YES ()NO ( ) | |
223 | (2)Teratog ens and Mu tagens?NA ()YES ()NO () | |
224 | (3)Toxic g ases?NA () YES ()NO ( ) | |
225 | (4)Neuroto xins?NA () YES ()NO ( ) | |
226 | (5)Reactiv e and pote ntially ex plosive co mpounds?NA ()YES ()N O () | |
227 | ||
228 | NOTE: Subm ission of the labora tory chemi cal invent ory is req uired for local revi ew. | |
229 | ||
230 | ||
231 | ||
232 | 4 | |
233 | ||
234 | 7. CONTROL LED SUBSTA NCES | |
235 | ||
236 | a. Does yo ur researc h involve the use of any subst ance regul ated by th e Drug Enf orcement | |
237 | ||
238 | Agency?YES ()NO ( ) | |
239 | ||
240 | If yes, li st control led substa nces to be used: | |
241 | ||
242 | _____ __________ __________ __________ ________ | |
243 | ||
244 | _____ __________ __________ __________ ________ | |
245 | ||
246 | _____ __________ __________ __________ ________ | |
247 | ||
248 | _____ __________ __________ __________ ________ | |
249 | ||
250 | _____ __________ __________ __________ ________ | |
251 | ||
252 | _____ __________ __________ __________ ________ | |
253 | ||
254 | b. Are all Schedule II and III drugs sto red in a d ouble-lock ed vault | |
255 | ||
256 | NA ( ) YES ( ) NO ( ) | |
257 | ||
258 | NOTE: The schedule o f controll ed substan ces can be found at the Intern et site ht tp://www.u sdoj.gov/d ea/pubs/sc hedule.pdf | |
259 | ||
260 | ||
261 | 8. RADIOAC TIVE MATER IALS | |
262 | ||
263 | Does your research i nvolve the use of ra dioactive materials? YES ( )NO ( ) | |
264 | ||
265 | If YES, pr ovide the following: | |
266 | ||
267 | Identity o f radioact ive source (s): _________ __________ __________ ________ | |
268 | ||
269 | Radiation Safety Com mittee App roval (dat e): _ __________ __________ ______ | |
270 | ||
271 | ||
272 | PHYSICAL H AZARDS | |
273 | ||
274 | Are physic al hazards addressed in the fa cility Occ upational Safety and Health Pl an? | |
275 | ||
276 | YES ()NO ( ) | |
277 | ||
278 | b. Do empl oyees rece ive annual training addressing physical hazards? | |
279 | ||
280 | YES ()NO ( ) | |
281 | ||
282 | ||
283 | ||
284 | ||
285 | ||
286 | ||
287 | ||
288 | ||
289 | 5 | |
290 | ||
291 | Acknowledg ement of R esponsibil ity and Kn owledge | |
292 | ||
293 | I certify that my re search stu dies will be conduct ed in comp liance wit h and full knowledge of Federa l, State, and local policies, regulation s, and CDC -NIH Guide lines gove rning the use of, bi ohazardous materials , chemical s, radiois otopes, an d physical hazards. I further certify th at all tec hnical and incidenta l workers involved w ith my res earch stud ies will b e aware of potential hazards, the degree of person al risk (i f any), an d will rec eive instr uctions an d training on the pr oper handl ing and us e of bioha zardous ma terials, c hemicals, radioisoto pes, and p hysical ha zards. A c hemical in ventory of all Occup ational Sa fety and H ealth Admi nistration (OSHA) an d Environm ental Prot ection Age ncy (EPA)- regulated hazardous chemicals is attache d to this survey. | |
294 | ||
295 | _____ __________ __________ __________ __________ __________ ___ __ _ | |
296 | ||
297 | Principal Investigat or’s Signa tureDate | |
298 | ||
299 | ||
300 | ||
301 | Certificat ion of Saf ety Office r’s Approv al | |
302 | ||
303 | A complete list of c hemicals t o be used in the pro posal has been revie wed. Appro priate occ upational safety and health, e nvironment al, and em ergency re sponse pro grams will be implem ented on t he basis o f the list provided. | |
304 | _____ __________ __________ __________ __________ _______ _______ | |
305 | ||
306 | Safety Off icer’s Sig natureDate | |
307 | ||
308 | ||
309 | ||
310 | Certificat ion of Res earch Appr oval | |
311 | ||
312 | The safety informati on for thi s applicat ion has be en reviewe d and is i n complian ce with Fe deral, Sta te, and lo cal polici es, regula tions, and CDC-NIH G uidelines governing the use of biohazard ous materi als, chemi cals, radi oisotopes, and physi cal hazard s. Copies of any add itional su rveys used locally a re availab le from th e Research and Devel opment (R& D) Office. | |
313 | ||
314 | ||
315 | _____ __________ __________ __________ __________ __________ ____ | |
316 | ||
317 | Chair, Sub committee on Researc h SafetyDa te | |
318 | ||
319 | _____ __________ __________ __________ __________ __________ ____ | |
320 | ||
321 | Chair, Res earch & De velopment CommitteeD ate | |
322 | ||
323 | _____ __________ __________ __________ __________ _________ ____ | |
324 | ||
325 | Radiation Safety Off icer (if a pplicable) Date | |
326 | ||
327 | _____ __________ __________ __________ __________ __________ ____ | |
328 | ||
329 | Facility S afety Offi cerDate | |
330 | ||
331 | ||
332 | ||
333 | ||
334 | ||
335 | ||
336 | ||
337 | ||
338 | ||
339 | ||
340 | ||
341 | ||
342 | ||
343 | ||
344 | 6 |
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