SOPs lead to consistency of processes, and if followed assiduously, they ensure that deviation from norms will be minimal. nearly The Indian regulator could issue a guidance document on each of these issues, which reflects the thinking of the current regulators. This guidance may change at times; it is not a ??gospel truth?? that is immutable. Guidance documents do not require parliamentary clearance as do amendments and will help IRBs keep in sync with the current thinking of the regulators. Completeness of its ethical review process (including challenges related to conduct of meeting) It is the responsibility of the Chairman to ensure that the IRB focuses on relevant issues and the ethical review is complete. In the absence of adequate training the members tend to deviate from the norms neglecting some very important issues.

In addition to the mandated issues, those that must be reviewed include the following: Inclusion/exclusion criteria Use of placebo Post trial access to investigational product (IP) Use of legally authorized representative (LAR)/witness Compensation in case of injury Continuing review Documentation and archiving. Inclusion/exclusion criteria This section of the protocol decides the type of subjects that will be recruited for the study. Whether the study includes vulnerable subjects or not becomes clear from these criteria. Guidelines describe different classes of vulnerable subjects; however the personal judgment of the investigator to use about every subject’s vulnerability is the key to ethical research.

In cases where the investigator feels that the subject lacks the power of self-determination, such a subject may be excluded. Vulnerability of some subjects such as women is very situational and dependent on the society they live in. These factors should be considered, while recruiting the subjects. Ethical codes merely define the bar below which and IRB or investigator should operate, there is no rule preventing anyone from being more ethical than required. Use of placebo The use of placebos (and denial of treatment) is a very controversial issue. In India the DOH is the guiding principle for research (in addition to the ICMR Guidelines).[12] The DOH categorically does away with the use of the placebo except under two situations,[13] while the ICMR guidelines are Entinostat not very clear on this issue.

Many trials originating from the US (which does not follow the current version of the DOH) have a placebo arm; placebos and ethical research are not considered customer review mutually exclusive.[14] The IRB must carefully consider the implications of having a placebo in trials at an Indian site. The use of placebo could put the subject at high risk. Should one of the subjects on the placebo arm, suffer an attack, in the US 911 would be dialed and the subject would be in the hands of the doctors within the next hour, if not sooner.