Hence, at IRB meetings the members need to review the patient recruitment status and little more. This activity should be led by an SOP, which enough would standardize the attention paid to every trial in progress. Documentation and archiving With increasing space crunch in cities, archiving is bound to take a hit. Electronic formats are being used at all stages of clinical trial activities and are controlled by 21 Code of Federal Regulation part 11 (21CFR11). There is need for national guidelines on electronic archiving, since sooner or later this is going to be the norm. Additional issues In the list of IRBs registered by the CDSCO, one finds mostly IRBs. IECs have been registered only for reviewing bioavailablity/bioequivalance (BA/BE) studies.
Does this mean that IECs will no longer be allowed to review clinical research projects? Does it also mean that IEC which are not institutional will no longer have a role? Additionally, a number of medical schools and hospitals are conducting nontherapeutic research. In this type of research, there is no sponsor behind the study. In such studies compensation is going to be a problematic issue and a decision needs to be taken about these studies. Whether they review clinical trials or research projects done as a part fulfillment of Doctor of Medicine (MD) or Diplomate in National Board (DNB) studies, IRBs must function on similar lines. CONCLUSIONS While hanging up her boots, the Secretary Department of Health and Human Services (DHHS) wrote that she was worried about the fairness with which research was reviewed in the US.
She announced that the NIH and FDA would take up the responsibility of training investigators, IRB members, and IRB staff in bioethics. Similar initiatives were taken in Germany by private hospital based groups and they have been responsible for setting up Carfilzomib IECs throughout the country. It would lighten the burden on our regulators if we could take this responsibility ourselves and not cast it on them. The Indian Society of Clinical Research (ISCR) represents organizations and people who have the largest stake in clinical research in India. It would therefore be appropriate if ISCR takes the lead in setting up a Forum of ECs to undertake this activity. This forum could be formed by getting as many Indian IRBs as inhibitor Pfizer possible of ECs together, working in a democratic fashion. The Forum should lay down the requirements for training of IRB members; and also create a core team of trainers to actually deliver the training modules.