Genesis and Development of CITI-INDIA and designation of Sri Ramachandra Institute of Higher Education and Research (SRIHER) as CITI-INDIA CENTRE OF EXCELLENCE IN RESEARCH ETHICS EDUCATION

The Collaborative Institutional Training Initiative (CITI) was launched in March 2000 as collaboration between the University of Miami and the Fred Hutchinson cancer Research centre to develop a web based training program in human research subject protection. In response to the June 2000 education policy announcement, the collaboration was expanded to include content experts from 10 institutions who provided the content for the first 12 biomedical modules. In addition to the "Basic" content, the CITI module provides the opportunity for institutions to post additional institutional materials specific to their institutions. The first version of the CITI course in the protection of Human Research Subjects, hosted at the University of Miami, was rolled out to participants on September 3, 2000. In December 2000, the CITI course site was made available to institutions by subscription.

Dr. Paul Braunschweiger and Dr. Sergio Litweka from Miller School of Medicine at University of Miami championed the launch of CITI program on Research Ethics Education.

In spring 2004, the CITI program was migrated to a new software platform to broaden its scope and to expand the courses offered to offer to our participating institutions and organizations around the world.

The CITI Program, co-founded by Karen Hansen and Paul Braunschweiger Ph.D, is now on its 10 ^th iteration and includes:

• Basic courses in the Protection of Human Research Subjects.
  • Biomedical Focus
  • Social and Behavioral Focus
  • Refresher Courses

• Good Clinical Practice Courses
  • Good Clinical Practice Courses
  • Good Clinical Practice Course for Clinical Trials Involving drugs (ICH-Focused)
  • Good Clinical Practice Course for Clinical Trials Involving Devices

• Health Information Privacy and Security Course (HIPS) including HITECH

• Laboratory animal Research Courses for Investigators and IACUC Members
  • Animal Model Specific Courses

• Responsible Conduct of Research (RCR) Courses
  • Biomedical Research Focus
  • Social, Education, Behavioural Research Focus
  • Physical Sciences Research Focus
  • Scholarly activities in The Humanities Focus
  • RCR for Engineers
  • RCR for science Administrators

• Bio-safety and Bio-Security

A multi language course site, with materials in Spanish, Portuguese, French, Chinese, Thai, Japanese and Russian languages is now available for our international participants. Additional Non-English content is being abed every year.

A of May 2010, the CITI program is used by over 1130 participating institutions and facilities from around the world. Over 1,300,000 people have registered and completed a CITI course since September 2000 and now more than 35000 new learners complete a CITI program course every month. The CIT program could not remain dynamic and responsive to the needs of our participants without the unselfish efforts of the CITI developers group. The Group meets semi annually to review the courses, make editorial changes and to develop new initiatives for the CITI program.

Collaborative Institutional Training Initiative (CITI) - INDIA

On 24^th November 2009 an MOU was sighed between CITI of University of Miami, USA and Sri Ramachandra Institute of Higher Education and Research, Chennai, India to further develop the program and make it available for researchers in India as CITI-India program.

The program was officially launched on 20^th September 2010 by the Honorable Minister of Shipping, Shri. G.K. Vasan during the Silver jubilee celebrations of Sri Ramachandra Institute of Higher Education and Research. The Program is now available for individuals in a nominal registration Fee.

The program comprises of different modular courses and will be useful to anyone interested in doing research related to human subjects (Clinical, Social and Behavioral) and research using laboratory animals. The modules have been developed by experts in the field of ethics and content is updated periodically. The modules have been developed in simple language and are easy to understand. As the course in online the user has the flexibility to do the course at any convenient time.

The CITI-India provides 25 different modular courses in the protection of Human research Subjects and in the welfare of laboratory animals. Each course comprises of several modules. At the end of each module, the researcher has to get a minimum score. A certificate would be automatically generated online after completion of each course, which can be printed by the user for his/her record.

The courses which are currently made available are based on the modules developed by the CITI program, USA, which are to a great extend applicable to India and research done using human beings as study subjects and in research done using laboratory animals.

Salient achievements of CITI-INDIA at SRIHER:

1. Significance awareness created across the country through Seminars and Group discussions of research ethics education for clinical researchers, University academic faculty and PhD Scholars


2. Introduced 'Research Ethics Education' as one of the Course work for all PhD candidates/ PG researchers in SRIHER


3. Recently the curriculum development committee of CITI-INDIA incorporated India specific content in the CITI Good Clinical Practice modules, mainly from ICMR Ethical guidelines for Biomedical Research on human participants 2006 and from Good Clinical Practices for Clinical research in India mainly to benefit researchers working in India and also researchers working in other countries


4. CITI-INDIA in collaboration with the central Institute of Classical Tamil, Chennai have developed the Tamil translation of the CITI course on "Social and Behavioral research"


5. In March 2014, CITI Program has elevated the CITI-India centre at SRIHER as "CITI centre of Excellence in Research Ethics Education"


6. In October, 2015, Sri Ramachandra University organized the SRU, CITI-USA, AIIMS – NEW DELHI & IPC – International Workshop on "Pharmacovigilance" with participation of experts from USA and India


7. In October, 2018, Dr. Sergio Litweka participated in the INDO-US – Seminar on "Research Integrity & Responsible conduct of Research" and planned for the development of a NIH collaborative proposal on "Research Ethics Education"

The training program through not-for-profit would be chargeable to individuals at a nominal cost towards logistic of offering the CITI-India program. This will be valid for one year.

A certificate would be automatically generated online after completion of each course, which can be printed by the user for record. Hard copy certificates are also provided by Central Research Facility.