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									             Standard Operating Procedure (SOP)
Institutional Animal Ethics Committee for Experimentations
                        on Animals




   Sanjay Gandhi Postgraduate Institute of Medical
                 Sciences, Lucknow
                       2009
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   Sanjay Gandhi Postgraduate Institute of Medical Sciences
                               Raebareli Road, Lucknow-226 014 ( U. P.)
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Prof. A K Mahapatra                                                      Extn : 2001(O), 2002 (R)
MS,MCh,DNB,FNASc                                                         QSDl/Fax : 91-0522-2668129, 2668017 & 2668078
DIRECTOR                                                                 Ã&essy/E-mail : director@sgpgi.ac.in


                                                   Foreword
   Animal experiments are found in the writings of the Greeks in the second and fourth centuries BCE. Aristotle
and Erasistratus were among the first to perform experiments on living animals. Galen, a physician in second-
century Rome, dissected pigs and goats, and is known as the “father of vivisection.

    Animals have been used throughout the history of scientific research. In the 1880s, Louis Pasteur convincingly
demonstrated the germ theory of medicine by inducing anthrax in sheep. In the 1890s, Ivan Pavlov famously used
dogs to describe classical conditioning. Insulin was first isolated from dogs in 1922, and revolutionized the
treatment of diabetes. In the 1970s, antibiotic treatments and vaccines for leprosy were developed using armadillos,
then given to humans.

   It has been estimated that approximately 20 million animals are being used for testing and are killed annually;
about 15 million of them are used to test for medication and five million for products.

   The animal testing base their argument on the grounds of morality, the necessity or the validity of this procedure,
with authority to perform such tests is granted, whether such tests are actually needed and whether such tests
practically provide useful information in scientific research.

   The Committee for Purpose of Control and Supervision of Experiments on Animals (CPCSEA) has been
constituted under the provisions of the Prevention of Cruelty to Animals Act, 1960 and the rules made there
under. Thus the CPCSEA has been in existence for the past 40 years.

    The role of the CPCSEA is not to cause any hindrance to scientific research involving experiments on animals
but to ensure that:

     i) Animals are not subjected to unnecessary pain or suffering before during and after performance of
          experiments on them and they are maintained in a proper manner.
     ii) There is no unnecessary sacrifice of animals for the sake of science. There should be no duplication of
          research.
     iii) Animals are kept pathogen free to ensure proper data collection
     iv) Animals are procured from registered breeders
     v) Experiments on large animals are avoided when it is possible to achieve the same results by experiments
          on small laboratory animals etc.
For effective implementation of these rules and guidelines, the Institutional Animals Ethics
Committees (IAEC) has been constituted in institutions conducting experiments on animals. This is a
scientific body nominated by the Head of the Institution with only one nominee of the CPCSEA. The
IAEC is required to examine proposals for conducting experiments on small animals, which would
basically examine the necessity of performing of the experiment, and ensure that experiments are not
performed only in a routine manner. The nominee of the CPCSEA to the IAEC also examines if the
animals are being properly looked after both before and after the experiment. The proposals for
experiments on larger animals are referred to the sub committee of the CPCSEA which is chaired by a
senior scientist. The CPCSEA is represented by all sections of the scientific community. All decisions
are taken with the approval of the Committee.

    The animal ethics committee of the Institute has been functioning from the year 1999 and so far
addressed various issues on ethical aspects of animal experimentations submitted as projects, thesis
and collaborative studies etc. A need has been felt from years to have a compact guideline including
various formats, review, procedures and submission of proposals etc.

   I would like to thank to the Chairman, Animal Ethics Committee, Member Secretary, Animal
Ethics Committee of this Institute and CPCSEA nominee, who has taken a sincere and dedicated effort
and guided for making of this Standard Operating Procedures for Institutional Animal Ethics
Committee for Experimentation on Animals at Sanjay Gandhi Postgraduate Institute of Medical
Sciences, Lucknow. I hope that the Standard Operating Procedures for Institutional Animal Ethics
Committee for Experimentations on Animals, definitely help the Principal Investigators, Animal
Ethics Committee members and scientific researchers, for better understanding the ethical procedures
involved in animal experimentations.




 Lucknow                                                                        (A. K. Mahapatra)
 Dated:10.08.09                                                                          Director
                                  TABLE OF CONTENTS

1.   Standard Operating Procedure                                            1-7

2.   Institutional Animal Ethics Committee Format                            8-11

3.   Investigator’s Declaration                                              12

4.   Certificate                                                             13

5.   Check List                                                              14

6.   Record of Animals Acquired (Form D)                                     15

7.   Undertaking by the Principal Investigator                               16

8.   One Page CV of Non-SGPGI Investigators                                  17

9.   One Page CV of Institutional Animal Ethics Committee Members            18

10. Secrecy Undertaking by Member of Institutional Animal Ethics Committee   19

11. Format for Progress Report (Six Monthly/Final)                           20

12. List of Members of Institutional Animal Ethics Committee                 21

13. List of Members of Biosafety Committee                                   22
        Standard Operating Procedure (SOP) for Institutional
    Animal Ethics Committee for Experimentations on Animals at
  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
1. Objective

  The objective of Standard Operating Procedure (SOP) is to ensure quality and consistency in
  review of research proposals and to prevent infliction of unnecessary pain & sufferings before,
  during and after experiments on animals, to follow the CPCSEA guidelines under the provision of
  Section 15 of PCA Act 1960 (Ministry of Environment and Forests, Government of India-2008)
  and the Gazette of India 1998 for experiments on Animals.

  In terms of Rule (2) e of Breeding and Experiments on Animals (Control and Supervision) Rule
  1998 as amended “Experiment” means any programme or project involving use of animal (s) for
  the acquisition of knowledge of a Biological, Physiological, ethological, Physical or chemical
  nature, and includes the use of animal(s) in the production of reagents and products such as antigen
  and antilbodies, routine diagnostics, testing activity and establishment of transgenic stocks, for the
  purpose of saving or prolonging life or alleviating suffering or significant gains in the well being
  for people of the country or for combating any disease, whether on human beings, animals or
  plants.

2. Functions of Institutional Animal Ethics Committee (IAEC)

  IAEC should provide independent, competent and timely review of the ethics of proposed studies
  before the commencement of a study and regularly monitor the ongoing studies.

  IAEC will review and approve all research proposals involving animal experiments up to
  physiological level only with a view to assure quality maintenance and welfare of animals used in
  laboratory studies while conducting biomedical and behavioral research and testing of products.

  For experiments on higher animals, the IAEC will forward its recommendation to the CPCSEA,
  New Delhi, for its approval.

  IAEC will review the proposals before start of the study as well as monitor the research throughout
  the study and after completion of the study through six monthly reports, final report and visit of the
  laboratory in the animal house where the experiments are conducted. The committee will also
  ensure compliance with all regulatory requirements, applicable guidelines and laws.

  IAEC will also:

  •   Monitor and inspect the housing of animals of breeders/establishments and ensure that it is as
      per specified standards.
  •   Grant permission to SGPGI for conducting experiments on animals. Regulate experiments on
      animals as per stipulated conditions and standards.
  •   Ensure that animals which in course of the experiments are so injured that their recovery would
      involve serious sufferings are euthanized as per specified norms.



                                                  1
  •   Ensure that experiments on animals are avoided whenever it is possible to do so and propagate
      the principles of 3Rs (Reduce, Refine & Replace the use of animals in experiments).
  •   Ensure that experiments on larger animals are avoided when it is possible to achieve the same
      results by experiments upon small laboratory animals like guinea-pigs, rabbits, frogs, rats, mice
      and pottery.
  •   Ensure that required records are maintained with respect to experiments performed on animals.
  •   Ensure that as far as possible experiments are not performed merely for the purpose of
      acquiring manual skill.
  •   Ensure that animals intended for the performance of experiments are properly looked after both
      before and after experiments.

3. Composition of IAEC

  IAECs shall be multidisciplinary and multisectorial in composition.

  The committee will be nominated by the Dean & will be approved by Academic Board. The
  composition of the committee will be as follows, and will fulfill the CPCSEA norms vide gazette
  Rule 13 of Breeding of and Experiments on Animals (Control and Supervision) Rules 1998.

  The composition may be as follows:

      1. Chairperson
      2. Dean
      3. Two faculty members of the institute, preferably involved in animal experiments, out of
          two one from the non-clinical discipline
      4. One veterinarian involved in the care of animals
      5. Incharge Animal House
      6. A scientist from outside the institute
      7. One non-scientific socially aware person
      8. One representative or nominee of CPCSEA
      9. One specialist may be co-opted while reviewing special projects using hazardous agents
          such as radio-active substance and deadly micro organisms
      10. Member-Secretary

  The Chairperson of the committee shall be from outside the Institution and not Head/former Head
  of SGPGI. The Member Secretary, drawn from SGPGI itself, shall conduct the business of the
  Committee. Other members will be a mix of medical and non-medical, scientific and non-scientific
  persons including one CPCSEA nominee, to reflect differed viewpoints.

4. Membership duration and responsibilities

  1. The duration of membership will be 3 years
  2. There will be no bar on the members serving for more than one term but it is desirable to have
     around one third fresh members.
  3. A member can be replaced in the event of long-term non-availability (three consecutive
     meetings). Authority to replace the member shall be with the Director.
  4. Members should maintain confidentiality of all discussions during the meeting and sign a
     confidentiality form at the start of their term. Each member of the committee will submit a
     declaration to maintain the confidentiality of the documents submitted to them during their
     membership period.
                                                  2
  5. No Institutional Animal Ethics Committee meeting can be held in the absence of the nominee
     of CPCSEA. No decision pertaining to animal allotment and projects on the approval of
     projects can take place in the absence of the nominee.

5. Quorum requirements

  A minimum of 5 members, including at least two outside members, is required for quorum. The
  presence of CPCSEA member or nominee is mandatory for every meeting. The proposals of
  emergent need may be considered through circulation which will be decided by the Dean.

6. Offices/conduct of the meeting

  The Chairperson will conduct all meetings of the IAEC. If, for reasons beyond control, the
  Chairperson is not available, an alternate Chairperson will be elected by the members present from
  among themselves. The Member Secretary will be responsible for organizing the meetings,
  maintaining the records and communicating with all concerned. He/she will prepare the minutes of
  the meetings and get them approved by the Chairperson & nominee of CPCSEA before
  communicating to the PI. In any case the meeting should not be held without the presence of
  CPCSEA member or nominee.

  Before finalizing a project, the IAEC Chairperson should call for a preliminary meeting with the
  project leaders or guides and request them to detail the projects. After finalizing the project
  proposal, the IAEC protocols dealing with small animals should be posted to the nominee one
  month prior to the IAEC meeting while 16 copies with check list of each protocol dealing with
  large animals must be sent to CPCSEA, New Delhi Office, for scrutiny by the Sub-committee
  members. Clearance of large animal project will be subject to the approval received from the Sub-
  Committee for Large Animal Projects.

  The CPCSEA may authorize an additional representative to attend the IAEC meeting. Such
  authorized personnel should be permitted to attend the meeting and take part in the proceedings.

7. Independent consultants

  IAEC may call upon subject experts as consultants for review of selected research protocols. These
  experts may be specialists in ethical or legal aspects, specific subjects or methodologies, or
  representative of CPCSEA. They will not take part in the decision making process.

8. Application procedure

  1. All proposals should be submitted in the prescribed application form, copies of which will be
     available with the Member Secretary.
  2. All relevant documents should be enclosed with application.
  3. The required number of copies of the proposal along with the application and documents in
     prescribed format duly signed by the PI and Co-investigators/Collaborators should be
     forwarded by the Head of the Department.
  4. The Member Secretary will acknowledge the receipt and indicate any lacunae. Missing
     information should be supplied within two weeks.
  5. The date of meeting will be intimated to the PI who should be available to offer clarifications if
     necessary.
                                                 3
  6. The decision of IAEC will be communicated in writing. If revision is to be made, the revised
     document in required number of copies should be submitted within a stipulated period of time
     as specified in the communication.

9. Documentation

  All research proposals should be submitted with the following documents:

  1.  Title of the project
  2.  Names of the PI and Co-investigators with designation.
  3.  Name of any other Institute/Hospital/Field area where research will be conducted.
  4.  Endorsement of the Head of the Department.
  5.  Protocol of the proposed research.
  6.  Ethical issues in the study and plans to address these issues.
  7.  Proposal should be submitted with all relevant annexures like proforma, CV of outside
      members, undertaking etc. to be used in the study.
  8. Any other information relevant to the study.
  9. Agreement to submit six monthly progress report and final report at the end of study.
  10. The PI should provide the details of other ongoing research projects related to the Animal
      studies (Title of the project, Date of starting and duration, source and amount of funding).

10. Review procedure

  1. Meetings of IAEC shall be held on scheduled intervals as prescribed (every 6 months, for
     which the month will be decided at the end of previous meeting). Additional meetings will be
     held as and when necessary.
  2. Even if there are no projects, it is mandatory to call for an IAEC meeting at least once in 6
     months to discuss matters related with maintenance of the animals in the animal houses. The
     animal house in-charge must be present with all available records at every IAEC meeting.
  3. The proposals will be sent to members at least 2 weeks in advance.
  4. PI/Co-investigator should be available during the meeting and may be invited to offer
     clarifications.
  5. Independent consultants/Experts may be invited to offer their opinion on specific research
     proposals.
  6. The decisions of the meeting shall be recorded in the minutes book and shall be confirmed
     during the next meeting with signature of Chairperson at each page.
  7. The minutes of each meeting will be signed by Chairperson, Member Secretary, within 15 days
     of the meeting.

11. Element of review

  1.   Scientific design and conduct of the study.
  2.   Approval of scientific review committee and regulatory agencies.
  3.   Assessment of predictable risks/harms to the animals.
  4.   Protocol and proforma of the study.
  5.   Plans for data analysis and reporting.
  6.   Adherence to all regulatory requirements and applicable guidelines.
  7.   Competence of investigators, research and supporting staff.
  8.   Facilities and infrastructure in the animal house.

                                                 4
12. Decisions making

  1. Decision of IAEC would normally be taken by consensus. If divergent views are expressed by
     the members, these may be recorded in the minutes and a broad consensus be recorded as per
     understanding of the Chair.
  2. A member shall withdraw from the meeting during the decision procedure concerning an
     application where a conflict of interest arises. This shall be indicated to the chairperson prior to
     the review of the application and recorded in the minutes.
  3. Only members will make the decision. The decisions shall be taken in the absence of
     investigators & consultants.
  4. Decision may be to approve, reject or revise the proposals. Specific suggestions for
     modifications and reasons for rejection should be given.

13. Communicating the decision

  1. Decision will be communicated to PI by the Member Secretary in writing.
  2. Suggestions for modifications and reasons for rejection shall be communicated to the PI.

14. Follow up procedures

  1. Deviations from the project is not allowed, without the permission from IAEC.
  2. Any new information related to the study should be communicated to IAEC.
  3. Premature termination of study should be notified with reasons along with summary of the data
     obtained so far. The un-used animals may be surrendered to Animal House.
  4. Change of investigators should be done with the approval of IAEC.

15. Record keeping and archiving

  All following documents must be stored for a period of five years.

  1. Curriculum Vitae (CV) of all members of IAEC.
  2. Minutes of all meetings duly signed by the Chairperson & CPCSEA nominee. Copy of all
     correspondence with members, researchers and other regulatory bodies.
  3. Copy of existing relevant national and international guidelines on research ethics and laws
     along with amendments.
  4. All study related documents (study projects with enclosed documents) should be archived for
     minimum of five years after the completion of study. A copy of filled proforma related to the
     projects shall remain with the PI for minimum of five years.

16. Updating IAEC members

  1. All relevant information on Animal ethics will be brought to the attention of the members of
     IAEC by the Member Secretary.
  2. Institute Members will be encouraged to attend national and international training
     programs/conferences/seminars in the field of research related to the animal ethics to help in
     improving the quality of research projects/animal ethics committee submissions and review.



                                                  5
17. Performance of experiments

  1. Experiments shall be performed under supervision of a qualified person (Veterinary/
     Medicine/Post graduate above in life sciences/Pharmaceutical sciences/Lab animal science)
     and under the responsibility of the person performing the experiment.
  2. Experiment shall be performed with due care and humanity.
  3. Animals intended for the performance of experiments shall be properly looked after both
     before and after experiments.
  4. Personnel using experimental animal(s) shall be responsible for the welfare of animal(s) during
     their use in experiments.
  5. Investigators shall be responsible for the aftercare and rehabilitation of animal(s) after
     experimentation, and shall not euthanise animal(s) except in situations as defined.
  6. The following parameters shall be adopted for application of euthanasia. Namely;
     (a) When the animal is paralyzed and is not able to perform its natural functions or it becomes
         incapable of independent locomotion or it can no longer perceive the environment in an
         intelligible manner.
     (b) If during the course of experimental procedure the animal has been left with a recurring
         pain wherein the animal exhibits obvious signs of pain and suffering.
     (c) Where the non-termination of the life of the experimental animal will be life threatening to
         human beings or other animals.
  7. Rehabilitation treatment of an animal after experimentation shall extend till the point the
      animal is able to resume a normal existence and will involve providing a lump-sum amount as
      costs for rehabilitation and care of such animal to cover its entire statistical expected life span.
      It is mandatory that the cost of after care and rehabilitation should be met from the contingency
      of the project.
  8. Experiments involving operative procedures shall be performed under anesthesia to be
      administered by a veterinary surgeon/scientist/technician so trained for the purpose.
  9. Animals which in course of experiments under the influence of anesthesia are so injured that
      their recovery would involve pain or suffering shall be destroyed humanely.
  10. Experiments shall not be performed by way of an illustration.
  11. Experiments shall not be performed as a public demonstration.
  12. No experiment the result of which is already conclusively known shall be repeated without
      justification.

18. Laboratory animal ethics

  All scientists working with laboratory animals must have a deep ethical consideration for the
  animals they are dealing with. From the ethical point of view it is important that such
  considerations are taken care at the individual level, at institutional level and finally at the national
  level.

19. Institutional Bio-Safety Committee (SBSC)

  Institutional Biosafety Committee (IBSC) is to be constituted in all centers engaged in genetic
  engineering research & production activities. The committee will constitute the following.

  (i) Head of Institution/his nominee


                                                   6
   (ii) 3 or more scientists engaged in DNA work/molecular biology with an external expert in the
        relevant discipline
   (iii)A member with Medical Qualification (Bio-safety Officer) in case of work with pathogenic
        agent
   (iv) One member nominee by DBT

   The Institutional Biosafety Committee shall be the point for interaction within institution for
   implementation of the guidelines. Any research project which is likely to have biohazard potential
   (as envisaged by the guidelines) during the execution stage or which involve the production of
   either micro-organisms or biologically active molecules that might cause biohazard should be
   notified to ISBC. ISBC will allow genetic engineering activity on classified organisms only at
   places where such work should be performed as per guidelines. Provision of suitable safe storage
   facility of donor, vectors, recipients and other materials involved in experimental work should be
   made and may be subjected to inspection on accountability.

   The biosafety functions and activity include the following:

   (i) Registration of Biosafety Committee membership composition with RCGM and submission of
        report.
   (ii) ISBC will provide half yearly reports on the ongoing projects to RCGM regarding the
        observance of the safety guidelines on accidents, risks and on deviations if any. A
        computerized Central Registry for collation of periodic reports on approved projects will be
        setup with RCGM to monitor compliance on safeguards as stipulated in the guidelines.
   (iii)Review and clearance of project proposals failing under restricted category that meets the
        requirements under the guidelines.

      IBSC would make efforts to issue clearance certificate quickly on receiving the research
      proposals from investigators.

   (iv) Tailoring biosafety program to the level of risk assessment
   (v) Training of personnel on bio safety

20. Penalties

   If any person/institution contravenes any order made by CPCSEA/commits a breach any
   conditions imposed by committee punishable accordingly:

   1. He/She may be punishable with fine which may extended to Rs. 3,000/- and when the
      contravention or breach of conditions has taken place in any institutions, the person, Incharge
      of institution shall be deemed to be guilty of the offence and shall be punishable accordingly.

21. Contract animal experiments

   Amendment of Rule-12, in the breeding and experiments on animal Rule 1998, this rule has been
   amended to allow to establishment to undertake contract research as per provision of PCA-Act
   1980, and the rules made their under.




                                                   7
  SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL
                 SCIENCES, LUCKNOW
APPLICATION FOR PERMISSION FOR ANIMAL EXPERIMENTS

Application to be submitted to the CPCSEA, New Delhi after approval of Institutional Animal Ethics
Committee (IAEC)

Part A

1. Name and address of establishment

2. Registration number and date of registration.

3. Name, address and registration number of breeder from which animals acquired (or to be acquired)
   for experiments mentioned in parts B & C

4. Place where the animals are presently kept (or proposed to be kept).

5. Place where the experiment is to be performed (Please provide CPCSEA Reg. Number)

6. Date on which the experiment is to commence and duration of experiment.

7. Type of research involved (Basic Research / Educational/ Regulatory/ Contract Research )


                                                                                          Signature

                                                                          Name and Designation of
                                                                                     Investigator

Date:

Place:

*The filled in Form B having above information / details / supporting documents (1 original + 14
copies and 1 soft copy in CD) should be sent to:-

The Member Secretary,
CPCSEA, Ministry of Environment & Forests,
8th floor, Jeevan Prakash Building,
25, Kasturba Gandhi Marg,
New Delhi-110 001




                                                   8
Part B

Protocol from for research proposals to be submitted to the committee / Institutional Animal
Ethics Committee, for new experiments or extensions of ongoing experiments using animals
other than non-human primates.

1. Project / Dissertation / Thesis Title:

2. Principal Investigator / Research Scholar / Research Guide / Advisor:

   a.    Name
   b.    Designation
   c.    Dept / Div/ Lab
   d.    Telephone No.
   e.    Experience

3. List of names of all individuals authorized to conduct procedures under this proposal.

   Co-guides
   a. Name
   b. Address
   c. Experience

4. Funding source with complete address (Please attach the proof)

5. Duration of the project

   a. Number of months
   b. Date of initiation (Proposed)
   c. Date of completion (Proposed)

6. Detailed study plan may be given (Not more than one page)

7. Animals required

   a.    Species / Common name
   b.    Age/ weight/ size
   c.    Gender
   d.    Number to be used (Year-wise breakups and total figures needed to be given)
   e.    Number of days each animal will be housed.
   f.    Proposed source of animals.

8. Rationale for animal usage

   a. Why is animals usage necessary for these studies?
   b. Why are the particular species selected required?
   c. Why is the estimated number of animals essential?
   d. Are similar experiments conducted in the past? If so, the number of animals used and results
      obtained in brief.
   e. If yes, why new experiment is required?
   f. Have similar experiments been made by any other organization agency? If so, their results in
      your knowledge.
                                                   9
9. Description the procedures to be used.

   List and describe all invasive and potentially stress full non-invasive procedures that animals will
   be subjected to in the course of the experiments.

   Furnish details of injections schedule

   Substances                         :
   Doses                              :
   Sites                              :
   Volumes                            :

   Blood withdrawal

   Volumes                        :
   Sites                          :
   Radiation (dosage and schedules):

10. Please provide brief descriptions of similar studies from invitro / invivo (from other animal
    models) on same / similar test component or line of research. If, enough information is available,
    justify the proposed reasons.

11. Does the protocol prohibit use of anesthetic or analgesic for the conduct of painful procedures (any
    which cause more pain than that associated with routine injection or blood withdrawal)? If Yes,
    explanation and justification.

12. Will survival surgery be done?

   If Yes, the following to be described.

   a.   List and description of all such surgical procedures (including methods of asepsis)
   b.   Names, qualifications and experience levels of operators
   c.   Description of post-operative care
   d.   Justification in major survival surgery is to be performed more than once on a single individual
        animals.

13. Methods of disposal post-experimentation

   a. Euthanasia (Specific method) :
   b. Method of carcass disposal :
   c. Rehabilitation               :

14. Animal transportation methods if extra-institutional transport is envisaged.




                                                   10
15. Use of hazardous agents (use of recombinant DNA-based agents or potential human pathogens
    requires documented approval of the Institutional Biosafety Committee (IBC). For each category,
    the agents and the biosafety level required, appropriate therapeutic measures and the mode of
    disposal of contaminated food, animal wastes and carcasses must be identified)

   a.   Radionuclides
   b.   Microorganisms / Biological infectious Agents
   c.   Hazardous chemicals or drugs
   d.   Recombinant DNA
   e.   Any other (give name)

   If, your project involved use of any of the above, attach copy of the minutes of IBC granting
   approval.




                                                 11
                                       Investigator’s Declaration

1. I certify that I have determined that the research proposal herein is not unnecessarily duplicative of
   previously reported research.

2. I certify that, I am qualified and have experience in the experimentation on animals.

3. For procedures listed under item 11, I certify that I have reviewed the pertinent scientific literature
   and have found no valid alternative to any procedure described herein which may cause less pain
   or distress.

4. I will obtain approval from the IAEC/ CPCSEA before initiating any significant changes in this
   study.

5. Certified that performance of experiment will be initiated only upon review and approval of
   scientific intent by appropriate expert body (Institutional Scientific Advisory Committee / funding
   agency / other body (to be named).

6. Institutional Biosafety Committee’s (IBC) certification of review and concurrence will be taken
   (Required for studies utilizing DNA agents of human pathogens).

7. I shall maintain all the records as per format (Form D)

8. I certify that, I will not initiate the study unless approval from CPCSEA received in wiring.
   Further, I certify that I will follow the recommendations of CPCSEA.

9. I certify that I will ensure the rehabilitation policies are adopted.



                                                                                                Signature


                                                                                    Name of Investigator
Date:




                                                     12
                                     Certificate

This is certify that the project title ………………………………………............................
………………………………………………………………………………………………
has been approved by the IAEC.


Name of Chairman/ Member Secretary IAEC:                Name of CPCSEA Nominee:




                                Signature with Date




Chairman/ Member Secretary of IAEC:                     CPCSEA Nominee:



(Kindly make sure that minutes of the meeting duly signed by all the participants are
maintained by Office)




                                        13
CHECK-LIST

(To be submitted for consideration of CPCSEA)

 Title of the protocol
 Name and address of the Institute submitting
 proposal, with Ref No. if any
 CPCSEA Registration No. and valid upto
 Status of Institute and its accreditation, if any    DST/ICMR/DBT/CSIR/Public funded Institution/ State/ Central
                                                      University/ College/ ISO-NABL certified lab/ GLP certified lab/
                                                      others
 Type of research work                                1. Academic Research
                                                      2. In-house R&D
                                                      3. Drug Development & Research
                                                      4. Preclinical toxicity study
                                                      5. Multicenter research collaborative study
                                                      6. Education
                                                      7. Contract Research
 Name & Address of CPCSEA Nominee and Link
 Nominee and date of appointment

 [Date of change of Nominee (if any) ]
 Composition of IAEC as per approved guidelines
 and the names and addresses of the establishment /
 members to which they represent
 Whether detailed signed minutes of IAEC by
 members including nominee attached with the
 protocol.
 Recommendations of IAEC

 Recommendation of Institutional Bio Safety
 Committee (IBSC)
 Recommendations of Review Committee on
 Genetic Manipulation (RCGM)
 The date of last inspection of Animal House
 Facility and approval details conveyed by
 CPCSEA.
 Name of the PI with designation, qualification and
 work experience with animals.
 Name of the Co-PI with designation, qualification
 and work experience with Large Animals.
 Source of procurement of animals, types, number,
 age & sex.
 Information regarding import / export of animals /
 material before and after experimentation.
 A signed declaration by PI is attached with
 proposal?

                                                                     Signature of Chairman IAEC / Principal Investigator

                                                  For official use only

Date of receipt of the protocol and number of copies / CD
CPCSEA Reference number
New proposal / revised proposal

Signature of Expert Consultant, CPC

                                                            14
Form D

Record of Animals Acquired and Experiments performed: (to be maintained by the
Investigator)

Date of   No. of     Name,          Date and      Date/period   Name and      Certification of
entry     animals    address and    particulars   of            address of    the
          acquired   registration   of order of   experiment    the person    investigator
          (specify   No. of the     grant of                    authorizing   authorizing the
          species,   breeder        permission                  the           experiment
          sex and    from whom      by the                      experiment    that all
          age        acquired       committee                                 conditions
                     with                                                     specified for
                     voucher/bill                                             such an
                     no.                                                      experiment
                                                                              have been
                                                                              complied with
                                                                              (Signature)




                                            15
 SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL
                SCIENCES, LUCKNOW

        UNDERTAKING BY THE PRINCIPAL INVESTIGATOR

1. NAME AND CODE NUMBER OF THE PROJECT



2. NAME, DESIGNATION AND DEPARTMENT OF THE PRINCIPAL INVESTIGATOR



3. OTHER MEMBERS OF THE RESEARCH TEAM



4. NAME AND ADDRESS OF ANY OTHER MEDICAL COLLEGE, HOSPITAL OR
   INSTITUTION WHERE PARTS OF THE STUDY WILL BE DONE

  1. I confirm that I will initiate the study only after obtaining all regulatory clearances.
  2. I will not implement any deviation from the approved project without prior consent of the
     IAEC.
  3. I confirm that the CO PI and other members of the study team have been informed about their
     obligations and are qualified to meet them
  4. I will personally supervise the study and ensure that all the requirements related to the study is
     fulfilled and will follow the CPCSEA guidelines as well as gazette of of India time to time.
  5. I will submit the progress report/final report as when as required for the study.




Signature of Principal Investigator                                                              Date




                                                 16
                                        ONE PAGE CV*



           Last Name                          First Name                             Middle Initial
Date of Birth (dd/mm/yy):                                               Sex

Study Site Affiliation (e.g. Principal Investigator, Co-Investigator, Coordinator)

Professional Mailing Address                      Study Sited Address
(Include institution name)                        (Include institution name)




Telephone (Office):                               Mobile Number:
Telephone (Residence):                            E-Mail:
Academic Qualifications (Most current qualification first)
     Degree/Certificate                        Year                            Institution, Country




Current and Previous 4 Relevant Positions Including Academic Appointments
(Most current position first)
       Month and Year                          Title               Institution/Company, Country




Brief Summary of Research Experience related to the project:




Signature:                                        Date:


(Signature Required)

                                      *For Non-SGPGI Investigator
                                                   17
     ONE PAGE CV FOR MEMBERS OF THE INSTITUTIONAL
               ANIMAL ETHICS COMMITTEE



           Last Name                         First Name                    Middle Initial
Date of Birth (mm/dd/yy):                                         Sex

Professional Mailing Address
(Include institution name)




Telephone (Office):                              Mobile Number:

Telephone (Residence):                           E-Mail:

Academic Qualifications (Most current qualification first)
     Degree/Certificate                        Year                     Institution, Country




Professional Experience

       Month and Year                           Title              Institution/Company, Country




Signature:                                       Date:



(Signature Required)
                                                  18
  SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL
                 SCIENCES, LUCKNOW

  SECRECY UNDERTAKING BY MEMBER OF INSTITUTIONAL
             ANIMAL ETHICS COMMITTEE
Name:



Designation:



Address:




    I understand that as a Member of the Institutional Animal Ethics Committee I may receive
documents containing confidential or privileged information about research activities related to the
study.

    I agree not to disclose or discuss such information or minutes of the meeting with persons not
entitled to have them. I also agree either to return all documents marked
CONFIDENTIAL/PRIVILEGED to Member Secretary or destroy them after perusal.


Date


Signature




                                                19
  SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL
                 SCIENCES, LUCKNOW

          PROGRESS REPORT SIX MONTHLY/FINAL REPORT
1. Project Code Number

2. Title of the project/study

3. Principal Investigator (Name & Department)

4. Name of Funding Agency

5. Date of sanction by IAEC

6. Date of start and Duration of previous experiments/IAEC approval

7. Animals approved

   •   Species

   •   Age/Sex

   •   Numbers

8. Number of animals already utilized (please mention the specific grounds in case of non-utilization

   of the approved number)

9. Objectives of the study

10. Progress report as per objectives (attach separate sheet)

11. Report/publications/conference presentation, if any

12. Reasons for further extension of IAEC approval

13. Details of animal species and the nos. requested



Name of Investigator
Department
Signature & Date




                                                   20
  SANJAY GANDHI POSTGRADAUTE INSTITUTE OF MEDICAL
                 SCIENCES, LUCKNOW

     LIST OF MEMBERS OF INSTITUTIONAL ANIMAL ETHICS
                  COMMITTEE (2007-2010)

1. Dr. R.C. Srimal, Former-Director, Indian Institute of Toxicology      Chairman
   Research (Formerly I.T.R.C.), Lucknow

2. Dean, SGPGI                                                           Member

3. Prof. R. K. Gupta, Dept. of Radiodiagnosis, SGPGI                     Member

4. Prof. T. N. Dhole, Dept. of Microbiology, SGPGI                       Member

5. Dr. Gaurav Agrawal, Additional Prof., Dept. of Endocrinology, SGPGI   Member

6. Shri I. B. Singh, Advocate, High Court, Lucknow                       Member

7. Dr. N. D. Sharma, Veterinary Doctor & Nominee from CPCSEA             Member

8. Veterinary Doctor, Animal House, SGPGI                                Member

9. Dr. S. Srivastava, Sr. Research Officer, SGPGI                        Member Secretary




                                                 21
  SANJAY GANDHI POSTGRADAUTE INSTITUTE OF MEDICAL
                 SCIENCES, LUCKNOW

   LIST OF MEMBERS OF BIOSAFETY COMMITTEE (2008-2011)

1. Prof. M. M. Godbole, Head, Dept. of Endocrinology, SGPGI      Chairman

2. Prof. T. N. Dhole, Head, Department of Microbiology, SGPGI    Member

3. Prof. Sanjay Gambhir, Department of Nuclear Medicine, SGPGI   Member

4. Dr. Punita Lal, Assoc. Prof. Dept. of Radiotherapy, SGPGI     Member

5. Dr. Maria Das, Asst. Prof. Dept. of Radiotherapy, SGPGI       Convener




                                               22
Notes

								
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