Page 8 - Standard Operating Procedures (SOPs)
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ANNEXURE - B
PREPARATION OF AN ABSTRACT
FOR
NATIONAL RESEARCH ETHICS COMMITTEE (NREC)
The Ethical Review Committee will not consider any application which does not
include a specific abstract/summary for the committee. The abstract should
summarize the purpose of the study, the methods and procedures to be used, by
addressing each of the following items. If an item is not applicable, please note
accordingly:
1. Describe the requirements in respect of the population and explain the
rationale for using population of special groups such as children, Incompetent person
or groups whose ability to give voluntary informed consent is questionable.
2. Describe and assess any potential risks - physical, psychological, social, legal
or other and assess the likelihood and seriousness of such risks. If methods of research
create potential risks, describe other methods, if any, that were considered and why
they cannot be used.
3. Describe procedures for protecting against or minimizing potential risks and
assessment of their likely effectiveness.
4. Include a description of the methods for safeguarding confidentiality or
protecting anonymity.
5. When there are potential risks to the subject, or the privacy of the individual
may be involved, the investigator is required to obtain a signed informed consent from
the participant. For minors, informed consent must be obtained from the authorized
legal guardian or parent of the subject. Describe consent procedures to be followed
including how and where informed consent will be obtained.
(a) If signed consent will not be obtained, explain why this requirement should be
waived and provide an alternative procedure such as a verbal consent.
(b) If information is to be withheld from a subject, justify this course of action.
(c) If there is a potential risk to the subject or privacy of the individual or loss of
work time is involved in any particular procedure, include a statement in the consent
form stating whether any compensation will be available.
SOP OF BMRC ETHICAL GUIDELINE Page 7
