Page 3 - Standard Operating Procedures (SOPs)

Exemption from Peer Review

Research proposal from under graduate students of any University / Medical
College / Institution and submitted through proper channel (recommendation
from Head of institution / Department / Supervisor or approval from local
IRB) may be given exemption from the peer review with a condition that
there is no intervention, risk of distress or injury, physical or psychological to
the subjects. Chairman of NREC can give an ethical approval of this proposal
in condition that the proposal must submit in the next NREC meeting.

Terms and conditions for Post approval completion of research:

• Reports should be submitted at intervals prescribe by NREC for
review.

• Report should be submitted periodically & at the end of the study.
• In Clinical Trial, formation of Data Safety and Monitoring Board

(DSMB) is mandatory.
• At least 2 (two) members shall be included from NREC during

formation of DSMB.
• All Serious Adverse Events (SAEs) and Adverse Events (AEs)

should be addressed with proper medical care.
• Protocol deviation, if any, should be informed with adequate

justifications.
• Any amendment to the protocol should be resubmitted for renewed

approval.
• Any new information related to the study should be communicated

to NREC.
• Change of investigators / place of study need to be approved by

NREC.
• Safety and confidentiality of participant shall be maintain.

SOP OF BMRC ETHICAL GUIDELINE Page 2