Hello all,
In my last post I paused at the two pillars of ethics i. e. " IEC"
and 'protocol'

Ethics comittee can be institutional or extra-institutional. Both
Shedule Y and ICMR provide guidelines for smooth functioning of IEC.
In general the composition is
1] One chairperson- He should be from out of institute.
2] 1-2 medical scientists
3] 1-2 senior clinicians
4] One legal expert- Commonly he is a retired Judge
5] one social scientist ( a nonmedical scientist)
6] One philosopher
7] one lay person
8] one secretory- commonly a person from Pharmacology department,who
co-ordinates with other people.
thus maximum 15 members are allowed.

Protocol should have following in general....
1] Aims and objectives
2] Inclusion and exclusion criteria
3] Study design.
4] Curriculum vitae of all investigators
5] Indicators of stopping a trial.
6] Statistical analysis method.
7] Procedure for consent
8] Safety data of Proposed intervention.
9] Proposed compensation/reimbursment.
10] Data processing methods.
11] Plans on publishing results.
12] Aggrement to comply with GCP rules.
13] Details of funding agency & conflict of interest.
14] Written informed consent form proforma.( The most Important)

i think this much of basic is suffucient to start this discussion.
I am open for corrections.

Regards
Dr. Narendra
GMC, Nagpur