Ethics Committee

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The Independent Ethics Committee (TIEC) at Fortis Escorts Heart Institute promotes the highest ethical standards in achieving our institutional and research goals:

• Respect
• Innovation
• Collaboration
• Integrity
• Accountability
• Excellence

Research integrity rests on institute culture and the judgment and conscience of the research community member. Our service orientation emphasizes education of the research community and focuses on problem solving maintaining highest integrity of scientific research. With our focus on education we actively:

• Train research personnel to comply with local & international laws, regulations and institutional policies
• Monitor advancement through our evaluation quality improvement program, Train members by external experts and other initiatives to assess adherence, compliance and progress.

We seek to strengthen public trust of our patient communities and foster commitment to conducting research in accord with the fundamental principles of respect for persons, beneficence and justice.

The Independent Ethics Committee

The purpose of the TIEC is to evaluate and recommend fairness of research. The Committee reviews and make unbiased recommendations on all types of research proposals with a view to safeguard the dignity, rights, safety and well being of all actual and potential research participants.

The goals of research, however important, should not be permitted to override the health and well being of the research subjects. The Committee will take care that all the cardinal principles of research ethics viz. Autonomy, Beneficence, Non-maleficence, Proportionality and Justice are adequately taken care of in planning, conduct and reporting of the proposed research as envisioned in the ICMR and WHO guidelines. For this purpose, it will look into the informed consent process, risk benefit ratio, distribution of burden and benefit and provisions for appropriate compensation process wherever required.

It reviews all the submitted research proposals before start of the study and monitor the research throughout the study until and after completion of the study through appropriate well documented procedures for example annual reports, final reports and site visits etc. The committee will also examine compliance with all regulatory requirements, applicable guidelines and laws.

Fortis Escorts Heart Institute -TIEC has filed an assurance called FWA with the OHRP in the Department of Health and Human Services (DHHS). An FWA is an agreement between IEC and DHHS which states that Fortis Escorts Heart Institute - TIEC is guided by the ethical principles and will comply with federal regulations for all research involving human subjects.

• The registration is listed on the website at http://ohrp.cit.nih.gov/search
• Registration number is IRB00000533, parent organization no is IORG0000432 valid till 16 Sept 2012

Meeting Schedule

List of Meetings held in year 2009

Calendar Schedule of meeting: 2010

EC meeting timelines:

• Submission- 2 weeks before meeting date
• Written decision- 2 weeks after meeting date
• Verbal decision- within 3 days of meeting date
• EC review fees- before meeting date (* exemptions)
  Note: TIEC accept parallel regulatory submission for review of study proposal- on submission of acknowledgement letter from the applicable regulatory agency(es)-however gives favorable decision/approval only subject to regulatory agency approvals.

Fees structures: Refer to TIEC SOP 3.2.1

Initial Review fee: The EC at Escorts shall charge a non-refundable, Initial Review fee of Rs 50,000 for any new application that will be valid for one year from the date of the project approval. The initial review fee funds the costs of the initial research review, as well as the costs of the ongoing review of adverse events, protocol variances and site visits.

Study Renewal fee: The EC at Escorts shall charge a yearly Rs 20,000 for review of all ongoing projects annually. The study renewal review fee funds the costs of the Committee renewal review of the ongoing review of adverse events, protocol variances and site visits. The committee examines each investigator’s progress reports and activities for the previous year. * The fee does not apply to federally funded research, investigator initiated research or research supported by grants from non-profit foundations or organizations. The fee shall be paid by cheque drawn in favour of “Fortis Escorts Heart Institute”.

The Independent Ethics Committee encourages the Research Community to

• Act Responsibly –patient safety first
• Comply with rules, regulations, laws and institutional policies
• Educate and train research staff, colleagues & other support team in responsible conduct of research to ensure public trust
• Honor and adhere to professional codes of ethics & Medical Practice
• Identify and evaluate areas for improving research practices
• Value the contributions of human subjects for voluntary participation
• Evaluate, manage and eliminate potential conflicts of interest at all time

Address and Contact Details

The Independent Ethics Committee (TIEC)

Fortis Escorts Heart Institute
Ethics Committee coordination office
RC- room no 22A, Residential Tower
Phone: +91-11-47135138
Fax:

Ethics Coordinator: Ms. Priyadarshini Arambam

Administrator: Dr Vibhu Ranjan Gupta (Member Secretary- TIEC)

Table of Organization: The Independent Ethics Committee

Independent Ethics Committee -  Members Committee
Member Name	Highest Degree Earned	Primary Scientific or Nonscientific Specialty	Designation	Affiliation with Institution
Prof. Hari Gautam (Chairman)	M.S.	Medical Scientist	Chancellor, KIIT University, Bhubaneswar, Ex. Vice Chancellor (KGMU, Lucknow & BHU /Chairmen UGC /Dean or Principal Various Institutes	No
Ms. Vidya Ben Shah- Member	M.A.	Non Scientist Social Worker	Leading Social Activists-especially health & education of Women & Child; Former Chairperson-Central Social Welfare Board/ Recipient of 14 Awards including Padma Shri-1992	No
Dr. T.S. Kler -Member	D.M.	Medical Scientist	Executive Director (Cardiac Sciences) Escorts Heart Institute & Research Centre, ND-25	Yes
Dr. C.L. Kaul- Member	Ph.D.	Basic Medical Scientist-Pharmacologist	Former Director-NIPER; Director The Boots Pharma, Director- Modi Apollo Intl. Institute; Research Scientist CIBA	No
Dr. Sanjiv Malik- Member	M.D.	Medical Scientist Clinician from different institute	President-SAARC Medical Associations; Director- Mediworld Clinical Research Operations; Former President IMA-HQ	No
Justice J.K. Mehra- Member	L.L.B.	Non Scientist Legal Expert	Senior Advocate; Former Judge, Delhi High Court; Former Member National Consumer Dispute Redressal Commission	No
Dr. R.N.K. Bamezai- Member	D.Phil.	Non-Medical Scientist –Human Genetics Professor & Head School of Life Science, JNU	Prof & Head School of life Sciences JNU, New Delhi-67	No
Ms. Vidya Parthasarathi - Member	M.A.& Post Graduate Degree	Non Scientist Educationist	Ex. Principal; Sarder Vidyalaya School; New Delhi	No
Dr. Rakesh Yadav - Member	Ph.D.	Medical Scientist	Associate Professor of Cardiology, All India Institute of Medical Sciences, New Delhi	No
Dr. Raajiv Singhal - Member	M.S (Gen Surgery)	Medical Scientist Director Facility	Director Facility- Escorts Heart institute & Research Centre; Dean & Medical Director , Members of FERCAP; Surgical consultant –Indian Army,	Yes
Dr. Vibhu Ranjan Gupta – Member Secretary	M.Phil	Medical Scientist Medical Superintendent	Medical Superintendent Administrator , NABH Assesor	Yes

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