"Report of the Committee constituted to evolve Guidelines for "
Report of the Committee constituted to evolve Guidelines for Accreditation of Health Research Organizations 1. The Secretary, DHR, constituted a Committee under the chairmanship of Prof. Rajinder Kumar, Retired Professor of Indian Institute of Science, Bangalore to evolve guidelines for accreditation of health research organizations in the country. The composition of the Committee is at Annexure I. The Committee met on 26th October 2010, 29th November, 2010, 3rd January, 2011 and 17th February, 2011 and deliberated the issue in depth. 2. The committee was informed that one of the mandates of the DHR is to accord accreditation to health research organizations in the country for improved research governance for which guidelines were required. The committee noted that at present, a number of agencies like NABL, Quality Council of India (QCI) , NABH etc. are accrediting the institutions/centers/ laboratories related to health sector. In addition the Govt. has also introduced “Clinical Establishment Bill” to regulate various organizations providing health care facilities. In the long run, it will be necessary to rationalize all the existing national and international standards and procedures being followed for according accreditation. The DHR will initiate necessary action in that direction at an appropriate time. In the meantime the committee decided to develop guidelines for recognizing health research institutes/ centers with a view to promote health research governance structure as a number of funding agencies including ICMR at present insist on the recognition of the institute/ centers etc, by DSIR for supporting research proposals from these institutes. Further, at present DHR/ICMR do not have the data of various organizations involved in health research in its entirety though some data related to premier institutions and other organizations which are seeking financial support for research from ICMR or from international agencies are available. The DHR is keen to collate such data, so necessary for effective health research governance. 3. The Committee observed that the Department of Scientific Industrial Research (DSIR) grants recognition to various R&D organizations/ centers/ laboratories & assists them in promoting research. Several public & private Organizations pursuing health research are also given recognition by the DSIR under the scheme. The Committee noted that Health research has some special features like translation, adaptation, diffusion, public health, innovative health management & health system research, and social & behavioural research beneficial to the Community etc which may not result in publications and patents but are extremely important to provide inclusive healthcare to the country which would also include rural and semi-urban areas. Such research and development contributions need to be taken into account while according recognition to health research Organizations. The Committee also noted that as per the mandate of DHR it has to accelerate development of products/ translational technology etc., for application especially in rural and semi-urban areas. The committee went through the procedures followed by DSIR and proforma used by it and was impressed by them. At one stage it considered the possibility of having a few more medical experts identified by DHR as additional members in the existing DSIR Committee to decide on the recognition to be accorded to Health Research Institutes. However, considering the very special features of Health research and the fast evolving needs for the future, the DHR decided to have an independent arrangement for handling the recognition of health research organizations. 4. The DHR decided to develop its own guidelines for recognition of Organizations of Health Research for the following important reasons: (i) The DHR has a special mandate to recognize and accord accreditation to health research organizations. Recognition is the first step towards accreditation. This area is so vast and so special that a separate set- up for the purpose is required. (ii) The whole advisory and decision making mechanism must involve primarily those who belong to the health sector who can understand and appreciate the special nuances of the sector. This is best achieved when it is managed by the Department of Health Research which will be involved in all facets of health sector. (iii) A significant percentage of India’s population depends on the Traditional Systems of Medicine for health-care. There is need to recognize research in these systems in terms of efficacy validation, standardization, development of cleaner and safer preparations and incorporating modern drug delivery systems to provide better value to the users of these systems. As these systems are based on different principles than allopathic system, there is need to have special procedures to recognize organizations engaged in research in these systems. There is also a great need to build bridges among various systems of medicine prevalent today so that community can benefit from the optimum integration of these systems. This must be done through the use of concepts of contemporary science. This can be best achieved by DHR where expertise in all disciplines will together be available. (iv) The recognition system evolved should appreciate and provide for those features of health research and development which may not result in patents and publications but are extremely important in successful diffusion of techniques, products and technologies to rural and semi-urban areas. Some of the areas requiring special attention are translational research, child nutrition research and development, social and behavioural research beneficial to the community , health management research, health systems research, innovative community communication for health benefit, health information technologies, public health engineering etc.. Many other areas can be added. The health care scenario is evolving so fast that new areas and considerations about community health may have to be added all the time. This is best achieved when the management and control of recognition process is with the Department of Health research. (v) Further, one of the mandates of the DHR is to facilitate and accelerate the development of products/techniques/vaccines and technologies etc. for application, especially in rural and semi-urban areas and States where health delivery system and research and development are inadequate. This can be achieved with greater efficiency if DHR manages the process on its own as it will then be able to bring about necessary interventions based on the analysis of existing information. It can also undertake collection of additional information required for effective analysis if necessary. (vi) Accreditation is an international activity. With time, it will be necessary to interact with other countries and share our procedures with them to possibly develop common formats. Such interactions would result in mutual benefits and improved international credibility of the procedures followed by our Country. As DHR will have to take a lead in such interactions, it is necessary for it to manage the whole process on its own. 5. The Committee, after deliberating on the proforma used by DSIR and vastly benefiting from it has devised a comprehensive proforma for obtaining details from various organizations in the country which are involved in health research and may include institutions imparting education in all recognized systems of medicines, public health & allied fields like public health engineering, health information system, health system management etc. A copy of the proforma is enclosed as Annexure II. These organizations will be assessed by a technical team as well as by a Central Committee set up by the DHR for grant of recognition by DHR. Such recognition will be for a period of not more than 3 years & will be renewed after due review. The criteria to be used for according recognition may be devised by the Committee of experts to be formed by the DHR. While according recognition, these criteria need to be followed in a transparent fashion. One expert on management research may be taken as a Member, as some of the research areas have interface with management. The committee also noted that DHR/ ICMR are already mapping health research organizations in the country. The committee feels that the proforma devised by it may also be useful for collecting this information for institutional mapping. Collection of such information and assessment of these inputs will enable DHR to prioritize organizations/areas for strengthening/improving the health research by way of funding to promote health research in the country. Annexure-I Composition of the Committee 1. Dr. V.M. Katoch, Secretary (DHR) & DG, ICMR 2. Dr. Rajinder Kumar, Emeritus Prof., Deptt. Of Chemical Engg., IIS, Bangalore 3. Dr. Girish Sahni, Director, Instt. Of Microbial Technology (CSIR), Chandigarh – 160 036 4. Dr. I.D. Gaba, Consultant, ICMR, New Delhi 5. Mrs. Bhawani Thayagarajan, Consultant, ICMR, New Delhi 6. Dr. R.R. Abhyankar, Scientist ‘G’ & Head, Tech. Devp. & Transfer, Min. of Science & Technology, New Delhi 7. Dr. O.P. Agarwal, Emeritus Scientist, CSIR, New Delhi 8. Ms. Shalini Prasad, Joint Secretary, Deptt. of Health Research, MOHFW, New Delhi 9. Dr. Sarman Singh, Prof. & Head of Clinical Microbiology, Dept. of Lab. Medicine, AIIMS, New Delhi 10. Dr. Jitendra N. Verma, Life Care Innovations Pvt. Ltd., Gurgaon 11. Dr. B. Sesikaran, Director, National Institute of Nutrition, Hyderabad 12. Dr. Queen B. Saxena, New Delhi 13. Dr. G.J. Samathanam, Sc. ‘G’ & Head, Tech. Devp. & Transfer, MST, New Delhi 14. Dr. Uday Donde, Director, UXL Advisor, Mumbai 15. Dr. AV Chainulu, Scientist ‘E’, DSIR, New Delhi 16. Dr. Javed Agrewala, Instt. Of Microbial Tech. (CSIR), Chandigarh – representing Dr. Girish Sahni ICMR Secretariat Dr. Dipali Mukherjee Dr. Prashant Mathur Dr. Ashoo Grover Annexure-II DEPARTMENT OF HEALTH RESEARCH APPLICATION FOR RECOGNITION AS HEALTH RESEARCH ORGANIZATION ------------------------------------------------------------- File No. Date of receipt in DHR (For office use only) --------------------------------------------------------------- 1. Name and address of the organization: 1.1 Name of the organization: 1.2. Name & Designation of the Head: 1.2.1 Mobile No. 1.3. Registered Office: 1.3.1 Telephone No. : 1.3.2 Fax No. : 1.3.3 E-mail address 1.4. Address for correspondence: 1.4.1 Telephone No. : 1.4.2 Fax No. : 1.4.3 E-mail address 2. Legal status of the organization: 2.1. Central/State Govt. 2.2. Registered Society 2.3. Registered Trust/NGO 2.4. University / College 2.5. Company incorporated u/s 25 of Companies Act, 1956 2.6. Any other category [ Please specify ]. (a. State the source of recognition,-central/state/any other, b. recognition no., c. attach copy of letter of recognition and other supportive documents including MOA/MOU etc.) 3. Evolution and current management structure of the organization: 3.1. Organogram (may be provided in the form of a flow chart) 3.2. Milestones of growth of the organization from the beginning. 4. System of healthcare to which the organization belongs: 4.1. Allopathic 4.2. Ayurveda 4.3. Siddha 4.4. Unani 4.5. Homeopathy 4.6. Yoga and Naturopathy 4.7. Public health and allied fields 4.8. Any other [ Please specify ] 5. Nature of activities of the organization 5.1. Teaching and training 5.2 Health Care Services (basic, speciality, superspeciality) 5.3 Research (basic, clinical, epidemiological, applied, translational) 5.4 Product development like Discovery and manufacture of drugs, formulations, reagents, devices etc. 6. Financial Status 6.1 Profit and loss statement of the organization ( the balance sheet and audited statement of accounts for the past three years a. if the investment made in accordance with prov. Of IT act, b. Enclose audit statement of accounts) 6.2 Funds/Donations from foreign and local sources for the past three years: [Detailed information supported by requisite permissions required for funds received from foreign sources other than UN agencies] Local Donations above Rs 5000/- may also be indicated. 6.3 A statement on R&D expenditure incurred by the organization for the preceding three years. Expenditure: SNo Items 1st 2ndyear 3rdyear Total year 1. Capital R&D Non R&D 2. Revenue R&D expenditure other than Non salaries R&D 3. Salaries R&D Non R&D 4. others R&D Non R&D Total Total Income 6.4 Kindly give for the last three years the sources of funds in the following categories for R&D work: A] Contribution from your own organization B] Grant in aid projects from various sources C] Donations from Indian and foreign sources D] Funds received from Industry for conducting its out-sourced work and E] Any other sources not mentioned above. Income: SNo Items 1st 2ndyear 3rdyear Total year 1. Budget grant R&D Non R&D 2. Grants R&D Non R&D 3. Donations R&D Non R&D 4. Projects R&D related Non R&D 5. Foreign R&D contributions Non R&D 6. Testing/ R&D training Non R&D 7. Other R&D (corpus/ Non Interest) R&D 8. Sale of technology/IPR 6.5. Funds generated by sale of technology/knowhow/patents etc , if any, for the preceding five years (please provide this information in tabulator form) 6.6 Are you notified by the CBDT ? 6.7 Is the organization compliant with all the requirements of IT act? 7. Management structure of R&D Set-up: 7.1. In case R&D set-up has an independent identity: 7.1.1. Please provide an organizational chart for it. 7.1.2. Name of the head of the R&D set-up 7.1.3. Address, phone numbers, e-mail etc. for communication with R&D group 7.2. In case R&D set-up does not have an independent existence: 7.2.1. Indicate how R&D is managed in the organization 7.2.2 Is there any advisory board for research? If so, is it local, national or international ? 7.3. Special policies promoting R&D , if any (kindly mention briefly ) 8. Infrastructure for R&D : 8.1. Provide a list of not more than fifteen equipment and special facilities like animal house and indicate for each the year of acquisition and whether used exclusively or partially for research 8.2. Indicate the national and international accreditations like NABL , JCI, NABH,GLP etc received. 8.3. If the Library facilities exist, please give the number of books, the number of journals ,the back volumes available along with the library budget. 9. Ethics in R&D: 9.1. Indicate whether Institutional Ethics Committee/ Institutional review Board for Human Studies exist. If yes, kindly give the necessary compositional details. 9.2. Mention any other Institutional Committees relevant to R&D work functioning in your organization. 9.3. If you are engaged in R&D on translation and other unconventional areas like social and behavioural research relevant to the health of the community etc, please enumerate the special facilities and set-ups available at your place for that work. 9.4. If your research areas include health based communication, health management and health system research, diffusion and translational research, adaptation and validation research , please enumerate the special infrastructure and facilities available with you for the research work. 9.5. If any of your research areas fall outside the ones mentioned in the proforma please mention them under this section and mention the infrastructural facilities available with your organization for conducting R&D in that area. 9.6. Please indicate the compliance with any statutory and regulatory bodies which exist in the country (a list may be provided) 10. Manpower engaged in R&D Activities: 10.1. Mention the number of Ph.D. / M.D. or equivalent degree holders engaged fully or partially in R&D. 10.2. If applicable, please provide for the last three years research scholars registered from your organization for various degrees and the numbers currently on roll for each of the research degrees. 10.3. For all the areas mentioned under 9.3 to 9.5 above , please provide a list of active research workers with their qualifications in the respective areas. 11. Areas of R&D interest and the outputs in them: 11.1. Indicate the areas of research being pursued from the list given below: Epidemiology of communicable and non-communicable diseases, Maternal and/or child health and nutrition ; Basic research with defined translational aspects; New technologies for improving health status of the community e.g. vaccines, diagnostics, new processes and procedures etc. ; Clinical research other than required for regulatory purposes ; Social and behavioural research beneficial to the community; Public health Engineering; Information/ digital technology/communication for the benefit of health and well being of the community; Health management and health systems research; Any other areas meeting the goals of improving the health of the community [please specify]. 11.2. Kindly give the titles of the following: A] Three major R&D projects being handled at your organization not involving collaboration, B] Major collaborative projects involving national organizations, C] Major international collaborative projects. 11.3. Provide a list of refereed publications of your R&D workers for the last three years arranged in the following manner: A] International Journals B] National Journals C] Conference Proceedings D] Technical reports 11.4. Kindly list the international / national conferences , symposia etc arranged by your organization during the last three years. 11.5. Kindly give the titles of all the patents granted as well as filed during the past five years, arranged in the following manner: A] Granted [ provide international and national separately] B] Filed [ provide national, PCT and international separately] 11.6. Transfer of knowhow, sale of IPR, commercialization of IPR during the past five years; Kindly provide a short write up of all the R&D based developments which have been either commercialized or handed over to Industry for possible commercialization. Also mention the terms [ including financial] of transfer of technology, knowhow, and knowledge. 11.7. Technologies developed but not yet commercialized: Kindly mention the technologies which have been developed but not patented or commercialized. 11.8. Kindly indicate where the research on translation, social and behavioural science and all the topics mentioned from 9.3 to 9,5 above have reached the stage of application and the implication of such applications. 11.9. Awards, recognitions etc: Please give a list of Awards, recognitions etc received by your organization or your research workers based on the R&D outputs during the past five years. 12. Plans for the Future: 12.1. Kindly give areas of R&D which you plan to pursue during the coming five years. Mention two or three specific projects which you would like to specially concentrate on. Duly signed and stamped by Head of Organization