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SURAKSHA INDEPENDENT ETHICS COMMITTEE NARSAPUR MEDAK, AP INDIA

2012
Office for Human Research Protections (OHRP)

Reg No: IORG0007193

Committee for Scientific Review & Evaluation of Biomedical Research

(Undertaken by ClinFOX International)
VISHNU INSTITUTE OF PHARMACEUTICAL EDUCATION & RESEARCH Vishnupur, Narsapur, Medak District 502313 Andhra Pradesh (India)

e-Mail: surakshaiec@gmail.com

URL: www.surakshaiec.webs.com

Suraksha Independent Ethics Committee (SIEC) is a group that has been constituted to provide ethical advice to physicians and others engaged in biomedical research in order to assist in protecting potential and actual human participants in research projects Our objective is to protect and safe guard the dignity, rights, safety and wellbeing of all potential participants undertaking Clinical Trials there by promoting highest ethical standards. SIEC group constituted of medical / scientific professionals and non-medical / non-scientific members operates in compliance with guidelines for research on human subjects set by ICH Guidelines for Good Clinical Practice, Schedule Y, current Good Clinical Practice guidelines issued by the Central Drug Standards Control Organization (CDSCO) and Ethical guidelines for Biomedical Research on Human subjects issued by the Indian Council of Medical Research (ICMR).

SIEC MISSION: Our Mission is to accelerate research there by helping to bring novel drugs to the society by reviewing and timely approving the clinical studies prior to their initiation on human subjects that are scientific, ethical & regulatory SIEC RESPONSIBILITY & AUTHORITY:

All human subjects research carried out at SIEC must be reviewed and approved or determined exempt by the SIEC prior to the involvement of human subjects in research. Accordingly, the SIEC has the following responsibilities and authority:

To ensure a competent review of all ethical aspects of the project proposals received involving human subjects prior to the initiation of research and execute the same free from any bias and influence that could affect their objectivity.

To provide advice to the researchers on all aspects of welfare and safety of the research participants after ensuring the scientific soundness of the proposed research

To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs

Shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the SIECs requirements or that has been associated with unexpected serious harm to the subjects.

To assist in the development and the education of a research community responsive to local health care requirements.

PRINCIPLES OF SIEC:

Independence

Competence

Pluralism

Transparency
COMPOSITION OF SIEC: The SIEC is constituted to ensure

Competent review of the ethical aspects of the research Independence from influence that could affect the performance of unbiased review Following are the members comprising Suraksha Independent Ethics Committee (SIEC)

S. No 1

Name of the EC Member Dr. Kama Raju Chitarpu

Designation Chairman & Legal Expert

Qualification PhD- IPR

Current Affiliation Senior Researcher-IPR at ISBWadwani Centre for Entrepreneurship Development Principal at Vishnu Institute of Pharmaceutical Education & Research (VIPER) Professor & H.O.D of Pharmacology Retired CGHS Civil Surgeon CEO & Director- Cito Healthcare (P) Ltd Freelance Healthcare Professional Treasurer- MVS Welfare Society Coordinator

Dr. Ramesh Alluri

Vice-Chairman/Scientist

PhD- Pharmacology

3 5 6 7 8 9

Dr. K. Narahari Rao Dr. Ashalatha Mr. S.V.Krishna Prasad Mr. Singamala Sreedhar Mr. M.V.Sainath Reddy Ms. Mynam Archana

Clinician/Pharmacologist Clinician Non-Medical Scientist Member Secretary Social Activist Member/Layman

MD-Pharmacology M.B.B.S., D.G.O MBA MS-Clinical Research MBA Intermediate

Brief Profiles of Suraksha Independent Ethics Committee Members Dr. Kama Raju Chitrapu (Chairman-SIEC) is a Fellow from National Academy of Legal Studies and Research (NALSAR) University of Law, Hyderabad with a Masters of Law and Ph.D., in International Intellectual Property Law Enforcement and Compliance. Currently associated with Wadhwani Centre for Entrepreneurship Development as a Senior Researcher-IPR. He has over twelve years of Cross functional in-house experience in handling and leading Intellectual Property Capacity Building Initiatives, Public Private Partnerships in Technology Management, Technology Transfer for public and private sectors along with various clients from fortune five hundred companies. Prior to joining WCED, he worked as a Head & IP Attorney of Confederation of Indian Industry (CII) Karnataka MSME-IPR Dr. Ramesh Alluri (Vice-Chairman & Biomedical Scientist -SIEC) is a highly seasoned and illustrious researchers of International repute holds a PhD in Pharmacology from JNTU, Hyd specialized in preclinical studies along with emphasis on Diabetes and its complications,

Stress & toxicity. More than 20 plus national & international publications describes the contribution and his thirst towards the research arena. Dr. Ramesh is currently heading Vishnu Institute of Pharmaceutical Education & Research (VIPER) as Principal carries over 14 plus years of expertise in both academics and research. Dr. K. Narahari Rao (Pharmacologist/Clinician) with over 30+ years of experience specializing in Pharmacology from Osmania University in 1976 with an additional Dip. in Anesthesia. His key skills include Pharmacology, Clinical Trials & Research, teaching , Research & Practice is currently heading as Professor & H.O.D. of Pharmacology in various medical colleges of the government and private, in India by delivering theory lectures, supervised practical classes, guiding research and seminars for masters, graduate & diploma students of M.B;B.S., M.D., Ph.D., B.Pharma., B.Sc.(Nursing), Dental Surgery, Diploma in laboratory technology and other paramedical courses. Dr. Rao is also expertise in various techniques & methods in clinical & invitro research contributing the best of his expertise and experience to medicine

Dr. Asha Latha (Clinician) has recently retired as CSS Civil Surgeon specializing in Obstetrics and Gynecology. Dr. Lata holds a MBBS and DGO degree from Osmania University worked in ESI Dispensary & ESI Hospital Sanath nagar for 20 years and being awarded with Gold Medal in Family Planning. Dr. Latha actively associated with various reputed hospitals and Clinical Research for the past many years.

Mr.Krishna Prasad (Non Medical Scientist), CEO Director, Cito Healthcare P Ltd has been associated in various positions with SOL Pharmaceuticals Ltd, Nicholas Piramal India Ltd (Now Piramal Healthcare), Aurobindo Pharma Ltd, QPS Bioserve India Pvt Ltd, RAChem Pharma Ltd (CRBio), ClinSync Clinical Research P Ltd, Development & Advisory Board member, Larasan Pharmaceutical Corporation, Florida, Orem Access Bio for medical/diagnostic kits in the fields of Commercial Management, Materials Management, Project Management, Human Resources, Administration, Business Development & Marketing, invited speaker at APITCO, SIPS, VIPER, Chitkara University, Member-Ex-SOL, Usha Alumni, ALCAA

Mr. Sreedhar S (Member Secretary) is a first generation entrepreneur in the segment of Clinical Research Industry carries over 7+ years of experience in Pharma-BiotechClinical Research currently a freelance healthcare professional was earlier headed as Director Business Development at ClinFOX International. Mr. Sreedhar is one of the few Business Development/operations Professionals in India who worked in all the verticals and horizontals of Drug Discovery and Development industries. After pursuing his Bachelors in Technology specializing in Biotechnology and PG in Clinical Research associated with organizations like Auroprobe Laboratories, New Delhi, Nexus Clinical Research Pvt. Ltd, Mumbai, Nexus Clinical Research Institute, Mumbai and Mart Laboratory Pvt. Ltd in the various entry and middle level management positions..

M.V. Sainath Reddy (Social Activist-SIEC) is treasurer of Merupati Veera Reddy Shanakaramma Welfare Society contributing the best of their resources for the children education , Old Age Homes and Rural Health Programs. Mr. Sainath holds a MBA in Human Resources & Marketing.

GUIDELINES FOR SUBMITTING APPLICATIONS TO SURAKSHA INDEPENDENT ETHICS COMMITTEE:

The monthly meeting of Suraksha Independent Ethics Committee will be on 2 nd and 4th Saturday of every month. However, additional meeting may be called if required from the investigators/sponsors

All applications sent to Suraksha Independent Ethics Committee should be submitted 07 days prior to scheduled date of meeting.

Suraksha Independent Ethics Committee is committed towards its environment policy of saving paper hence we request you to kindly send one set of complete proforma documents in soft copy to surakshaiec@gmail.com and 2 sets of hard copies of complete proforma documents and consent forms + DD/ Cheque of prescribed ethics review fee (in favor of ClinFOX International Payable at Hyderabad) to the Vice Chairman on the below mentioned address (one copy will be sent back for your office records) Suraksha Independent Ethics Committee (Administrative Office)

C/O Dr. A. Ramesh (Principal) Vishnu Institute of Pharmaceutical Education & Research (VIPER) Vishnupur, Narsapur Medak District- 502313 Andhra Pradesh (India) If you are interested to submit your documents by hand you can visit our local contact office located at: Off. No: 14 & 15, 1st Floor, Soni Business Complex Prashanthi Nagar, Kukatpally Hyderabad-500 072 (India) from Monday to Saturday from10:00 Am to 05:00 Pm

However if sending 12 copies is part of your SOP then send 2 sets of hard copies of complete proforma documents and consent forms + DD/ Cheque of ethics review fee, one soft copy of complete set of documents to surakshaiec@gmail.com and10 hard copies of only protocol and consent forms to the Vice Chairman on the above mentioned address.

The date of meeting will be intimated to the Principal Investigator (PI), to be present, if necessary to offer clarifications.

The decision 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 or before the next meeting.

For a thorough and complete review, all research proposals should be submitted in the prescribed application form with the following documents :

1. Name of the applicant/Investigator with affiliation 2. Name of the Institute/ Hospital / Field area where research will be conducted. 3. Protocol of the proposed research (for scientific rationale) / Amendments to the Protocol Ethical issues in the study and plans to address these issues. 4. Proposal should be submitted with all relevant enclosures like protocol, CVs of all Investigators, Investigator undertaking, Informed Consent Form along with back translations, Case Report Forms and Investigator brochure etc 5. DCGI approval letter where applicable 6. Insurance certificate and policy 7. CTRI registration number status 8. Informed Consent Document along with back translations, and patient information sheet 9. For any drug / device trial, all relevant pre-clinical animal data and clinical trial data from other centers within the country / countries, if available. 10. Any regulatory clearances required. 11. Source of funding and financial requirements for the project 12. Other financial issues including those related to insurance 13. An agreement to report only Serious Adverse Events (SAE) to SIEC. 14. Statement of conflicts of interest, if any. 15. A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants; a description of the arrangements for indemnity, if applicable (in study-related injuries); a description of the arrangements for insurance coverage for research participants, if applicable; all significant previous decisions (e.g., those leading to a negative decision or modified protocol) by other IECs or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of the modification (s) to the protocol made on that account. The reasons for negative decisions should be provided. 16. Plans for publication of results positive or negative- while maintaining the privacy and confidentiality of the study participants. 17. Any other information relevant to the study

FOLLOW-UP SIEC has established a monitoring procedure to monitor the progress of all studies for which a approval accorded, from the time the decision was taken until the termination of the research. The ongoing lines of communication between the SIEC and the applicant should be clearly specified. SIEC REVIEW FEE STRUCTURE: The IEC fees applicable with every application is as follows: S. No 1 2 3 3 4 5 6 7 8 Description BA/BE/PK studies on the drugs already approved in India BA/BE/PK studies on the drugs not approved in India but approved in an ICH region country Medical Device Clinical Trials Phase I/ First in man studies Clinical Developmental studies including Phase II/IV Investigator Initiated Clinical Trials (not for commercial use) Academic Researchers/ Students research projects Approval for multiple sites (Per site) Protocol Amendments/ Serious Adverse Events reports Amount in INR 15000 20000 25000 30000 25000 15000 7500 3000 3000

If you are interested in submitting your research proposals

Please correspond with: Suraksha Independent Ethics Committee (SIEC)
Sreedhar S (Member Secretary-SIEC) Vishnu Institute of Pharmaceutical Education & Research Vishnupur, Narsapur Medak District 502313 Andhra Pradesh (India) Phone: +91-9700456708/ +91 9052108526 e-mail: surakshaiec@gmail.com URL: www.surakshaiec.webs.com