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SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION & RESEARCH

(Deemed to university-Declared under Section 3 of UGC Act, 1956)

CONSULTANCY POLICY AND RULES”

1.0. DEFINITION:

  • 1.1. Consultancy includes all advisory, technical and R&D project implementation activities undertaken by Faculty members and Researchers for clients from Government/Non-Government agencies, industries, Start-ups/Incubatees and needy individuals which are meant to mobilize extra-mural resources to the Deemed University with an in-built revenue sharing formula between the Consultants and the University.

    1.2. Consultants are the Faculty members and Researchers of all the constituent Faculties of the Deemed-to be University who possess proven track record of Consultancy potentials

    1.3. Consultancy policy is the set of norms stipulated by Sri Ramachandra Institute of Higher education and Research(SRIHER) as approved by its Board of Management (BOM)

    1.4. Consultancy Rules are the guiding principles governing the implementation of the Consultancy activities/programmes at Sri Ramachandra Institute of Higher Education and Research as approved by its Board of Management(BOM)

2.0. Governance: The Consultancy Programmes of SRIHER shall be operated through the Central Research Facility of SRIHER.

  • 2.1 The Consultancy programmes is to be administratively coordinated by the Dean (Research), who is the authorized signatory of SRIHER for approvals, monitoring and financial management of the Consultancy programmes/activities of SRIHER.

    2.2 The Consultancy programmes shall be guided by the Research Advisory Board of SRIHER and the annual performance report need to be presented before the Research Advisory Board and the BOM.

3.0 Consultancy activities and programmes of SRIHER:

  • To create data bases on the consultancy potentials of the Faculty and Research staff of SRIHER with details of facilities available in SRIHER and to disseminate the data through various modes including printing of a directory on Consultancy potentials of SRIHER.
  • To bring out brochures, fliers and e-newsletters regarding the ongoing Consultancy activities, including the training programmes and discoveries made by the Departments/Researchers of SRIHER so as to keep the interacting industries/community informed of the developments and also to maintain good networking and liaison with them.
  • To co-ordinate R & D projects between University Departments and Industries in the areas of Product/process development and technology transfer.
  • To assist in (a) bringing about and registration of inter-institutional alliances/ Research collaborations in the form of MOUs/ Agreements (b) in development of IPR/ Patenties by the Faculty/ researchers of SRIHER based on the products and processes invented by them.
  • To provide consultancy services of variable nature as outlined in the consultancy rules.
  • To provide sophisticated medical laboratory diagnostic and reporting facilities to potential clients.
  • To facilitate the faculty to undertake studies relating to translational R&D projects including preclinical toxicology, drug development and evaluation, standardization of drug candidates, development of diagnostic kits and clinical trials as per the Regulatory requirements.
  • To link up experts of the industries in the academic and R&D programmes of the SRIHER Departments like (a) teaching programmes (b) curriculum development (c) Ph.D. programmes and (d) research projects
  • To conduct periodic dissemination programmes on the Consultancy potentials of SRIHER by way of Seminars, Workshops, Open Houses and Exhibitions
  • Any other function assigned by the Vice Chancellor, Research Advisory Board of SRIHER from time to time.

4.0.CONSULTANCY RULES

  • 4.1 The faculty members and Researchers of SRIHER may, with prior intimation to the Dean (Research)/ appropriate authorities, undertake consultancy or provide technical services to the industry and other organizations using, if necessary, the facilities of the University.

    4.2 The services/consultancy provided maybe of the following types:

    1. Institutional Consultancy,
    2. Individual Consultancy,

    III. Technical/Testing and Diagnostic services.

    1. Clinical Research/Clinical trials

      4.2.1 Institutional consultancy relates to project-based expert advice/expert-report rendered to an Industry/organization (Government/Non-Government), or work done for them by a Department/Group/Individual on behalf of SRIHER. The requests of such consultancy will be identified/approved by the Vice-Chancellor, on the recommendations of the proposal by the Dean (Research)

      4.2.2. Individual consultancy relates to such R & D project work undertaken by the academic staff member of the University based on his/ her own expertise.

      4.2.3Technical, testing and diagnostic services relate to providing advice on development of gadgets/equipments etc., for use in patient services; conduct of sophisticated investigations, experiments of research value, evaluation of diagnostic kits/reagents and standardization of candidate drugs and certification of commercial drugs for clients as per the Regulatory requirements.

      4.2.4. Clinical research/ Clinical trials constitute the contract R&D projects/ animal-

      based preclinical toxicology studies/ human clinical trials sponsored by Contract

      Research Organisations/Pharmaceutical Industries/Biotech Industries etc., to be

      carried out by a team of clinical and laboratory investigators/Faculty members co-

      ordinate by the Clinical Research division of the Central Research Facility,SRIHER.

    4.3.The charges payable to SRIHER for the above Four types of Consultancy activities including sophisticated Investigations, testing and certification and use of equipment facilities would be approved by Dean (Research) as per the recurring expenses involved on yearly basis and defined project budgets to be worked out inconsultation with the respective Consultant(s) as per the norms under Rule 4.8. Yearly guidelines would be circulated to all departments/Units of SRIHER by Dean (Research)

    4.4.The Consultancy services may be categorized into three classes

    • 4.4.1 Advisory Consultancy in which SRIHE facilities are not used and include retainer consultancies by the Consultants of SRIHER

      4.4.2. Service Consultancy-Category I- in which SRIHER equipments and infrastructure only are used, but either consumables, other materials or patients are not required.

      4.4.3. Service Consultancy-Category II- in which University equipments are used and material including patients and consumables are provided by the Consultant/Institution.

      4.4.4. Service Consultancy-Category III-in which Clinical Research/Clinical trials are conducted utilizing all the facilities , infrastructure, consumables and patient study subjects are utilized.

    4.5 All requests for Consultancy services will be referred to Dean (Research) SRIHER. If received directly by a faculty member it will be forwarded to Dean (Research) for processing and facilitation.

    4.6. Approval of the consultancy proposal will be governed by the procedure specified below.

    • 4.6.1 All consultancy projects obtained through Head of the Department/college concerned or directly from client organizations can be approved by Dean (Research) with due consultation with Director (Finance & Accounts). All Consultancy works/Projects will be accounted and audited as per the norms governing the financial administration of the Central Research Facility through the Finance &Accounts office of the Central Research Facility functioning under the supervision of Director (Finance & Accounts).

      4.6.2. MoUs with Industries, governmental and non-governmental agencies for conducting such consultancies on a continuing basis can be established by the consultants/faculty members upon prior approval by the Vice-Chancellor, based on the recommendations of the Dean (Research).

    4.7. While approving a consultancy proposal, the following aspects will be taken into consideration.

    • 4.7.1 An individual teacher does not allot more than one third of his/her time to consultancy, the other two thirds of time being spent in teaching and research in approximately equal proportion without being detrimental to the allotted teaching & academic research responsibilities.

    • 4.8. While working out the estimate of consultancy project, the following aspects will be taken into consideration:-

      • 4.8.1 Cost of man-days of the teacher and staff taking part in the project;

        4.8.2 Cost of inputs relating to chemicals, reagents/kits experimental animals patients and other types of consumables;

        4.8.3 Usage of equipments;

        4.8.4 Payments to outside consultants;

        4.8.5. Payments to Research Staff/field workers

        4.8.6. Cost of undertaking field work including field station expenditure/survey charges;

        4.8.7. Cost of stationery;

        4.8.8. Computer, internet charges;

        4.8.9. Equipment/Product cost if to be purchased exclusively for the work

        4.8.10. Miscellaneous charges;

        4.8.11. Consultancy charges including SRIHER administrative charges (a Minimum of 20% of the total budget); and

        4.8.12. Intellectual fee in cases where development of concept or analysis and IPR protection is required (whenever applicable);

        4.8.13. The consultancy project budget shall ordinarily exclude TA/DA as an arrangement between the consultant and the client unless the client prefers it as a part of the project budget. In such instances of inclusion in the budget, SRIHER shall provide TA/DA guidelines for consultancy projects on yearly basis.

        4.8.14. The cost of equipment where it exceeds Rs.50,000 will not be taken into consideration for calculating the consultancy charges. Such equipment(s)/Product(s) on completion of the consultancy project shall be retained as the property of the concerned department.

      4.9. The Client shall be required to pay an advance of 50% of the total project cost, or the cost of materials whichever is higher. All payments shall be made by D.D.drawn infavour of “Sri Ramachandra Institute of Higher Education & Research – CRF a/c” or by RTGS Bank transfer on to the specified SRIHER-Bank A/C payable at Chennai.

      4.10. Once the terms of consultancy are approved and contract signed and advance payment is received, it becomes the duty of the Project Investigator in-charge of the consultancy to ensure satisfactory progress and time bound completion of the project. For this purpose, he may make temporary appointments of staff, draw advances and expenditure in accordance with the rules prescribed from time to time.

      4.11 The fee received towards consultancy by the Investigator/Consultant shall be distributed as under:

      • 4.11.1 The fee realized from consultancies will be classified in relation to:

        Group(a) Consultancy/developmental fee on R&D projects and in Advisory consultancy and service consultancy (category I & II of rule 4.4.1 &4.4.2);

        Group (b) Sophisticated investigation, use of facilities, testing and certification charges; and (category III of rule 4.4.3 &4.4.4.

        Group (c) Licensing fee of Intellectual property/patents and royalty payments on commercialization of products/processes.(category III of rule 4.4.3 & 4.4.4)

      4.12. For Group (a) & (b) Consultancy:

      • 40% of the 20% consultancy charges included in the budget of group (a) and group (b) consultancies shall be distributed amongst the staff involved in the consultancy as per the formula in (ii) below. 10% would be made available to the department by CRF and 50% shall accrue with CRF a/c. The 10% share of the department could be utilized for
      • Hospitality for Scientists/ Professors visiting the department
      • Attending Seminars, Conferences, etc.,
      • Publication charges for the research papers/ articles
      • Minor infrastructure strengthening requirements of the department.
      • The distribution formula of the consultant’s share of 40% shall be as follows depending upon their inclusion in the proposal prior to the approval.
      • Consultant/ Principal Investigator: 20%
      • Co-investigator(s): 10%
      • Technicians/ Project fellows etc.,: 7%

      (iv)Administrative staff: 3%

      • For Group (c) Consultancy: (i) 50%of the monies received by the University through licensing fee of the intellectual property/patents and periodic royalty payments received on commercialized products out of the patents shall be distributed as 30% to the inventor/inventors as mentioned in IPR/Patents; 15% to strengthen the departmental infrastructure in which such discoveries were made and 5% for the administrative staff of the concerned department and CRF. (ii) The remaining 50% shall accrue with CRF/SRIHER.
      • The consultant/Principal investigator and other supportive staff members who are involved at the time of successful Group (c) consultancy are entitled to receive his / her share of monies even in the event of his / her transfer / retirement / resignation from the University. In the event of death of the staff, monies from the Royalties as per norms will go into SRIHER for Research promotion activities of the Faculty members/researchers
      • On completion of the consultancy project, a copy of the report shall be submitted to the CRF along with the statement of accounts/bills/vouchers for verification/ record and issue of utilization certificate(s).
      • The Consultant/ faculty member and CRF shall be jointly responsible for submitting utilization certificates periodically during the course of the project and final audited statements of accounts on completion of the said consultancy project, certified either by a Chartered Accountant or by the University auditors, as provided in the project to the sponsor/funding agency.
      • The details of consultancy amount drawn by each individual faculty shall be submitted by the faculty concerned to the Accounts section of CRF/SRIHER for Income Tax calculation purpose by the end of January of each financial year.

    5.0.Guidelines for the conduct of Clinical trials by approved Consultants/Faculty members of the Constituent Colleges of SRIIHER:

    • 5.1. All Out Patient-based clinical Trials are to be conducted at Sri Ramachandra Hospital & In Patient-based Clinical Trials to be conducted at Sri Ramachandra Medical Centre. Both shall be co-ordinated both administratively and financially by the Clinical Research Division(CRD) / CRF of SRIHER

      5.2. All the Clinical Trial Documents should be submitted by the PI/Clinical Research Division to Institutional Ethics Committee (IEC) for approval before the start of any clinical trial.

      5.3. The Objective of Clinical Research Division of CRF is to create a professionally managed and long term revenue model for SRIHER and Principal Investigators by creating and utilizing institutional competencies for clinical trials/clinical research.

      5.4. Clinical Trials may get sanctioned either by established Principal Investigators or through the marketing efforts of Clinical Research Division of CRF.

      5.5. Clinical Trials are envisaged to be conducted in true partnership with the Principal Investigators and the Institution as per the approved ethical standards laid down by the Regulatory bodies (DCGI/ICMR/CDSCO etc.,) through the IEC and CRD

      5.6.Clinical Research Division (CRD) will take the legal, administrative, financial, accounting, personnel, documentation, internal reporting and archiving responsibilities of the conduct of Clinical trials/Clinical research consultancy projects.

      5.7. The PI will be responsible for feasibility assessment, planning the study, recruitment of patients, conduct of the study, presentation before the Institutional Ethics Committee for its approval and other statutory bodies, as and when required, besides participation in and leading the meetings with the Sponsors or the CRO's.

      5.8. Once a clinical trial inquiry is received by the Clinical trial division and/or Central Research Facility, the following process will be initiated:

      • Designated personnel from Clinical Research Division will interface with the PI and assist in developing the feasibility.
      • The Protocols will be evaluated for inclusion/exclusion criteria, informed consent formats and a set of benchmarks that are to be created as per the Standard Operating Procedures(SOPs) to facilitate approvals, monitoring and management of the study.
      • The PI may have to sign Confidential disclosure agreement (CDA) with the Sponsor/CRO in the process of protocol development and feasibility assessment.
      • The draft Clinical Trial Agreement (CTA) will be evaluated by the CRF legal expert and requisite modifications, if necessary, will be recommended to either the sponsor or the CRO. All the CTAs will have the mandatory clauses of Indemnity. Insurance and Compensation as per the Regulatory requirements. The CTA will have the study budget with complete list of budget heads and there will be a 25% Institutional Overhead Charges added on the overall budget worked out.
      • All CTAs will be signed by the Dean (Research) on behalf of CRF as the approved signatory of SRIHER along with the PI and Sponsor in a three-party CTA. In a four-party agreement, the CRO also would be a signatory.

    6.0 Requisite personnel will be planned for assignment to the study & charged as per the study budget.

    7.0 Should there be a limitation in recruitment of patients within Sri Ramachandra Hospital/Sri Ramachandra Medical Centre, the Clinical Research Division of CRF will make arrangements for induction of external co-investigators who can recruit additional patients and support the Principal Investigator, costs if any will be booked into the account of the P.I

    8.0 Clinical Research Division will, in collaboration with the PIs, create and maintain databases of patients and potential recruits for various areas.

    9.0 Should there be a paucity of Principal Investigators within SRIHER , then Clinical Research Division may work with external investigators to conduct the study successfully.

    10.0 Once the CTA is signed, Clinical Research Division will facilitate the management and administrative matters of the study including coordination, documentation, accounting, finance and archival, while the PI will look after the technical aspects of the study.

    11.0 Clinical Research Division will circulate periodic progress and accounting updates to the PI and the CRF/SRIHER administration. Clinical Research Division will also facilitate internal review meetings at regular intervals.

    12.0 Once the study is completed, closed and all financial parameters met, then a post study costing will be conducted to enable clear understanding of surpluses/deficits, if any.

    13.0 Clinical Research Division will continue to interact with the Sponsor/ CRO for any post study dissonance.

    14.0 Principal Investigator/ Co-Investigators are directly responsible for all the study related documentation. They also have to ensure all the Adverse Events(AE)/Serious Adverse Events (SAE) reporting to be done as per SOP - CT012 to the Institutional Ethics Committee as well as the Sponsor/CRO.

    15.0 In cases of any adverse events requiring financial support/compensation, Clinical Research Division & P.I will interface with the sponsor / CRO and arrange for support/compensation to the affected study-subject / their families. (refer Compensation in the case of injury or death during clinical trial as per Rule 122 - DAB )

    16.0 All pre and post study legal issues will be managed by Clinical Research Division and PI.

    17.0.The financial methodology to be followed in the Clinical Research Division -PI Partnership is the following:

    • 17.1.Once the CTA is signed and Clinical Trial feasibility is established, sponsors will be requested to pay a minimum of 25% advance to meet initial expenses.

      17.2 It is envisaged that the Clinical trial expenditures will be met as per the head of the budget allocation agreed upon in the CTA.

      17.3 The balance revenues will be shared between the PI and the team (100%) after deducting all the expenses of the clinical trial including the institutional overheads of 25% on the entire clinical trial budget and any admissible Income-Tax.

      17.4 The investigators’ payment will be shared in the formula of Principal Investigator – 50%, Co-Investigator – 30% and Sub-Investigator – 20%. The Study Coordinator / Nurse / Technician / Social Worker payment will be disbursed to the individual as per the allocations provided in the clinical trial budget.

    18.0.Once the trial is completed and the accounts are finalized and audited internally, final payments will be made to P.I. Subject to the prerequisite of the applicable I.T rules.

    19.0.Clinical Research Facility will maintain absolute transparency in the accounting of each project and share this data with the PI on a regular basis.

    20.0.The left over amount, if any, in the clinical trial after close out will be transferred to the hospital/SRIHER account.

    21.0. All clinical trial accounts will be audited and Utilisation Certificate/Statement of Accounts shall be issued by CRF based on the details provided by Clinical Research Division

    22.0 Notwithstanding the above consultancy norms, if any dispute arises between the faculty consultant and the consultancy organization it will be resolved by Dean (Research).The Vice-Chancellor of SRIHER will be appellant and his/her decision shall be final and binding on all concerned.