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 NARSAPUR MEDAK, AP

INDIA

2012 Office for Human Research Protections (OHRP)

Reg No: IORG0007193

+91 9700456708

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 hu-

man 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 Clini-

cal Practice guidelines issued by the Central Drug Standards Control Organization (CDSCO) and Ethical guide-

lines 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 ac-

cordance with the SIEC’s 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:

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)

Independence

Competence

Pluralism

Transparency

S. No Name of the EC Mem-ber

Designation Qualification Current Affiliation

1 Dr. Kama Raju

Chitarpu

Chairman & Legal Expert PhD- IPR Senior Researcher-IPR at ISB- Wadwani Centre for Entrepreneur-ship Development

2 Dr. Ramesh Alluri Vice-Chairman/Scientist PhD- Pharmacology Principal at Vishnu Institute of Pharmaceutical Education & Research (VIPER)

3 Dr. K. Narahari Rao Clinician/Pharmacologist MD-Pharmacology Professor & H.O.D of Pharmacology

5 Dr. Ashalatha Clinician M.B.B.S., D.G.O Retired CGHS Civil Surgeon

6 Mr. S.V.Krishna Prasad Non-Medical Scientist MBA CEO & Director- Cito Healthcare (P) Ltd

7 Mr. Singamala Sreedhar Member Secretary MS-Clinical Research Freelance Healthcare Professional

8 Mr. M.V.Sainath Reddy Social Activist MBA Treasurer- MVS Welfare Society

9 Ms. Mynam Archana Member/Layman Intermediate Coordinator

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 Re-

searcher-IPR. He has over twelve years of Cross functional in-house ex-

perience in handling and leading Intellectual Property Capacity Building

Initiatives, Public Private Partnerships in Technology Management, Technology Transfer for pub-

lic 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 publica-

tions 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 aca-

demics 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 tech-

nology 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 spe-

cializing in Obstetrics and Gynecology. Dr. Lata holds a MBBS and DGO de-

gree from Osmania University worked in ESI Dispensary & ESI Hospital

Sanath nagar for 20 years and being awarded with Gold Medal in Family Plan-

ning. 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 Re-

search 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, Administra-

tion, Business Development & Marketing, invited speaker at APITCO, SIPS, VIPER, Chitkara Univer-

sity, 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-Biotech-

Clinical Research currently a freelance healthcare professional was earlier headed as Di-

rector 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 or-

ganizations 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 chil-

dren 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 2nd 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 docu-

ments 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 of-

fer 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 communica-

tion 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, Investi-

gator undertaking, Informed Consent Form along with back translations, Case Report Forms and Investi-

gator 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 medi-

cal care) to be given to research participants; a description of the arrangements for indemnity, if applica-

ble (in study-related injuries); a description of the arrangements for insurance coverage for research par-

ticipants, 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 ac-

corded, 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:

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

S. No Description Amount in INR

1 BA/BE/PK studies on the drugs already approved in India 15000

2 BA/BE/PK studies on the drugs not approved in India but approved in an ICH region country

20000

3 Medical Device Clinical Trials 25000

3 Phase I/ First in man studies 30000

4 Clinical Developmental studies including Phase II/IV 25000

5 Investigator Initiated Clinical Trials (not for commercial use) 15000

6 Academic Researchers/ Students research projects 7500

7 Approval for multiple sites (Per site) 3000

8 Protocol Amendments/ Serious Adverse Events reports 3000