UNDERSTANDING THE CONCEPTS OF IRB / IEC IN CLINICAL TRIAL. WHY ETHICS COMMITTEE IS CRUCIAL FOR CLINICAL RESEARCH ?

                                       

While conducting clinical trial, the safety of the human subjects comes first. The main two safeguard for human subjects are

• institutional review board (IRB)
• informed consent form

by regulatory definition, IRB is," any board, committee or group formally designated by an institution to review, approve and initiation of and to conduct periodic review of  biomedical research involving human subjects. the primary purpose of  such review is to assure the protection of the rights and welfare of human subjects. " 

International council of harmonization (ICH) defines IRB as, "an independent body constituted of medical, scientific, nonscientific members, whose responsibility is to ensure the protection of the fights , safety and well-being of  human subjects involved in a trial by, among other things, reviewing , approving and providing continual review of trial protocol, and amendments and of the methods and materials to be used in obtaining and documenting informed consents of the trial subjects."

independent ethics committee (IEC) is the body analogue to IRB outside the united state. the former one provides favorable opinions where later gives actual approval of study. 

         Fundamental purpose of establishment of IRB/IEC

• To protect the right, safety and well being of  human subjects participating in research.
• To provide approval of conduct of trial and give favorable opinion.

         Responsibilities of institutional review board (IRB)

1. IRB members must have assurance that the study is scientifically valid, i.e. there should be a properly designed protocol. however, it is not the responsibility of them to judge scientific merit/ worth of trial.
2. IRB should always look for sound research design. only properly designed program helps to minimize risks to human subject. 
3. IRB must compare anticipated benefits in terms of treatment and knowledge gained by research with possible risk might subject have to face. 
4. Should go through selection process of subjects and advertisement plan for study. this review insures that selection is equitable and that no group are excluded / included based on non- study related characteristics. 
5. Informed consent form should be reviewed properly. this should provide basic information related to trial and should state participation is voluntary and not influenced by any claim, greed or threat.
6. special care should be provided to vulnerable subjects. these subjects are those whose voluntariness can be influenced by other non study related factors. these group of specially has diminished autonomy. eg: children, pregnant women, old age patient, hospital staff, military force etc. 
7. consideration of state and local regulations. these are particular to population where study is being conducted and can influence recruitment and retention of  subjects throughout the study.