Guidelines and Handbook for IBSCs - Department of Biotechnology

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CHECK LIST FOR IBSCSGuidelines and Handbook for Institutional Biosafety Committees (IBSCs) 21
IICheck List for IBSCsAs indicated in the above mentioned guidelines, IBSC is responsible forevaluating activities involving the use of GMOs/LMOs and rDNA material inan organisation.The aspects to be reviewed by IBSC broadly include scientific considerationsand availability of appropriate facilities. In addition, DBT nominee is also expectedto review the organisational set up, facilities, and status of other approvalsrequired/obtained etc. of rDNA research projects on a case-to-case basis.A checklist is presented here to assist IBSC members in reviewing the researchproposals from investigators. It may be noted that this list is indicative. Specificadditions/deletions or modifications would need to be made to suit therequirements of each project on a case-to-case basis.1. Scientific ConsiderationsSafety assessment is a scientific process that makes use of the best up-to-datescientific knowledge and experience. Although details of safety assessment mayvary from case-to-case, there are some logical steps that need to be followed.Information requirements for review of project proposal by an IBSC are givenin Table-1 and elaborated in the context of safety assessment in the text below.It may be noted that information requirements and analysis shall depend onthe stage and application area of a proposal.Guidelines and Handbook for Institutional Biosafety Committees (IBSCs) 23
Page 3 and 4: Guidelines and Handbookfor Institut
Page 5 and 6: 8. Role of IBSC in approval .......
Page 7 and 8: 3.3 Source of funding .............
Page 12 and 13: IntroductionIntroductionIn India, G
Page 14 and 15: Introductionand responsibilities of
Page 16 and 17: GUIDELINES FOR IBSCS
Page 18 and 19: Guidelines for IBSCs3. Terminology
Page 20 and 21: Guidelines for IBSCs6. Composition6
Page 22 and 23: Guidelines for IBSCsrenewal of IBSC
Page 24 and 25: Guidelines for IBSCs• In case of
Page 26 and 27: Guidelines for IBSCs• Ensure that
Page 28 and 29: Guidelines for IBSCs• Inspection
Page 30 and 31: Guidelines for IBSCs13. Reporting r
Page 32 and 33: Guidelines for IBSCsiv. Application
Page 34 and 35: Guidelines for IBSCsand guidance fr
Page 38 and 39: Check List for IBSCsParticularsTabl
Page 40 and 41: Check List for IBSCs1.1 Molecular b
Page 42 and 43: Check List for IBSCsantigen, part o
Page 44 and 45: Check List for IBSCsv. Characterist
Page 46 and 47: Check List for IBSCsi. Toxicity stu
Page 48 and 49: Check List for IBSCs2. Containment
Page 50 and 51: Check List for IBSCsantivirus scree
Page 52 and 53: Check List for IBSCs3.2 Organisatio
Page 54 and 55: SUBMISSION OFAPPLICATIONS TO REVIEW
Page 56 and 57: Submission of Applications to RCGMb
Page 58 and 59: Submission of Applications to RCGMC
Page 60 and 61: FORM A1APPLICATION FOR REGISTRATION
Page 62 and 63: FORM A2APPLICATION FOR FOR RENEWAL
Page 64 and 65: 12. Suggestion for three suitable e
Page 66 and 67: 7. Examination & Clearance of the p
Page 68 and 69: FORM A4MEDICAL SURVEILLANCE REPORT1
Page 70 and 71: CONFIDENTIALITY AGREEMENT WITHIBSC
Page 72 and 73: FORM B1APPLICATION TO RCGM FOR IMPO
Page 74 and 75: 9. Source and transport details:9.1
Page 76 and 77: FORM B2PERMIT LETTER FOR AUTHORIZAT
Page 78 and 79: Kindly acknowledge the receipt of t
Page 80 and 81: (c) Vector(s) (Please enclose the m
Page 82 and 83: FORM B4PERMIT LETTER FOR AUTHORIZAT
Page 84 and 85: FORM B5APPLICATION TO RCGM FOR RECE
Page 86 and 87:
9. Source & transport details9.1 So
Page 88 and 89:
FORM B6PERMIT LETTER FOR AUTHORIZAT
Page 90 and 91:
9. Handling and packing instruction
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(b) Nucleic acid sequence (Please e
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Note:1. Please submit 23 copies of
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Name: _____________________________
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FORM C1INFORMATION TO RCGM TO CARRY
Page 100 and 101:
10. Risk management (Emergency plan
Page 102 and 103:
FORM C3APPLICATION TO RCGM TO CONDU
Page 104 and 105:
8.5 Overall recovery of the product
Page 106 and 107:
19. Declaration :I declare that the
Page 108 and 109:
) The route of administration of th
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FORM C5FORMAT FOR SUBMISSION OF PRE
Page 112 and 113:
Note:1. Please submit 23 copies of
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D. ACTIVITIES INVOLVINGRESEARCH AND
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5.3 Description of the target gene
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FORM D2INFORMATION ON RECORD TAKEN
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5.5 Copy number of gene(s):5.6 Nucl
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FORM D4PERMIT FOR CONDUCT OF SAFETY
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FORM D5FORMAT FOR SUBMISSION OF SAF
Page 126:
120NOTES
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