Bioequivalence and Bioavailability Forum • reg IRB (India)

reg IRB (India) [Regulatives / Guidelines]

posted by Sasi – 2008-11-21 08:54 (6431 d 08:28 ago) – Posting: # 2759
Views: 10,118

❝ As per the ICH guidelines, the IEC/IRB should composed of the following

❝

❝ a. At least five members.

❝ b. At least one member whose primary area of interest is in a nonscientific area.

❝ c. At least one member who is independent of the institution/trial site

But as per the Schedule Y of India specifies :

The number of persons in an Ethcis Committee should have at least seven members. Ethics Committee should appoint, from among its members, a Chairperson (who is from outside the institution) and a Member Secretary. Other members should be a mix of medical/non-medical, scientific and non-scientific persons, including lay public, to reflect the different viewpoints.

For review of each protocol the quorum of Ethics Committee should be at least 5 members with the following representations:

basic medical scientists (preferably one pharmacologist).
clinicians
legal expert
social scientist / representative of non-governmental voluntary agency / philosopher / ethicist / theologian or a similar person
lay person from the community.

Regards
Sasi

Complete thread:

reg IRB drshayana 2007-03-08 10:31
- reg IRB Dr.Tarak Parikh 2007-04-05 08:40
  - reg IRB drshiv 2007-04-07 19:02
    - reg IRB hitesh shah 2007-04-09 09:40
      - reg IRB Dr.Tarak Parikh 2007-04-09 13:19
        
        reg IRB Ohlbe 2007-04-09 23:54
        
        reg IRB Ohlbe 2007-04-10 10:26
        reg IRB hitesh shah 2007-04-11 06:48
        
        reg IRB Ohlbe 2007-04-11 11:02
        
        reg IRB hitesh shah 2007-04-12 08:43
        
        reg IRB sureshcology 2008-10-28 06:15
        
        Control of IRB/IECs Ohlbe 2008-10-28 16:42
        
        Control of IRB/IECs sureshcology 2008-10-29 04:12
        
        IECs in France Ohlbe 2008-10-29 22:42
        Germany H_Rotter 2008-10-29 23:09
        
        Germany sureshcology 2008-10-30 04:35
        
        reg IRB (India)Sasi 2008-11-21 07:54
        
        reg IRB (Canada) M.Vasu 2007-05-04 15:51
        
        reg IRB (Canada) Dr.Tarak Parikh 2007-05-15 09:40