|01||Ramaiah Medical College and Hospitals (RMCH)
is acknowledged as one of the most premiere
institutes in the country. Over the years, the
institute’s emphasis on scientific rigor and a
robust research culture has led to a significant
increase in the number of clinical trials being
conducted. This, in turn, has given rise to the
need for an efficient and consistent ethical
review mechanism for health and biomedical
research that works to ensure the protection of
human rights as mandated by Indian law.
|05||The Ethical Review Board was registered with the
Drug Controller General, India (DCGI). Since the
DCGI registration letter dated 20th April, 2013 is
in the name of the ‘Ethics Committee (EC), M S
Ramaiah Medical College and Hospitals,’ the
Ethical Review Board was renamed the ‘Ethics Committees, M S Ramaiah Medical College and
Hospitals. The Registration No.
ECR/215/Inst/Ker/2013 is issued to the EC under
Rule 122DD of the Drugs & Cosmetic Rules 1945.
The registration was renewed in 2016 with Re-Registration No. ECR/215/Inst/KA/2013/RR-16.
|02||In lieu of the above, the Ethics Review Board
(ERB) of RMCH was established by the Chief
Executive, Gokula Education Foundation
(Medical) [CE, GEF (M)], in the year 2000. The ERB
reviews both, scientific and ethical aspects of
studies. Timely review and the safeguarding of
high ethical standards form the basis of the ERB
|06||The EC is also registered with the Office for
Human Research Protections (OHRP) with the
Institutional Review Board (IRB) Organization
registration no of IORG0006935.
|03||The Committee is constituted and
administratively governed by the Chief Executive,
Gokula Education Foundation (Medical).
|07||All the registrations are periodically renewed, as
and when required.
|04||The Board will independently examine,
scrutinize, review and oversee all the Clinical
Trials/Studies involving pharmaceutical drugs,
devices, herbal or Ayurvedic products, BA/BE
studies, epidemiological studies, registry, and
observational and retrospective studies in
addition to the academic studies of students and
faculty involving patients/human participants
proposed to be carried out in Ramaiah Medical
College and Hospitals (which includes both, the
Ramaiah Teaching Hospital and the Ramaiah
Memorial Hospital) and any other outside
hospital or institution.
|08||A list of the members of the Ethics Committee
can be found here.