4.2.6.2). Most people understand what inhibitor Dasatinib conflict of interest means, but would find it difficult to decide the level at which the conflict interferes with a fair decision. There are two main areas of uncertainty relation and financial investment. Relation There is clearly a conflict of interest when a member’s near relative (spouse) is the partner/shareholder in the sponsor’s business. Yet if the spouse were to be an employee at a lower cadre in the sponsor’s business, would that be a conflict of interest? Alternately if a more distant relative of the member is a partner/shareholder in the sponsor’s business, would the member be considered to have a conflict of interest? Investment There is a clear conflict of interest when an IRB member holds significant stock in the sponsor’s company.

Today a large number of people invest in mutual funds, who invest the money in shares. Few people would be aware as to how much of their money is invested in which company at any given time. The CDSCO’s GCP does not define a conflict of interest, in hard terms and it is difficult for a member to know whether there exists a conflict or not. Compensation Medical or surgical management of injuries during clinical research and compensation to subjects are vexing issues before IRBs. Any discussion on the challenges facing the IRBs will be incomplete if the recent compensation rules were not to be discussed. However, a lot has already been said about these rules.[18,19,20] Further discussion on this is deferred since the Drug Technical Advisory Board has already considered issues raised by the industry and others, and have made recommendations to the government to revisit the compensation rules.

[21] Whether the rules of compensation are fair or not is to be discussed at a different level. When an IRB meeting is in progress, the role of the members is to calculate and recommend compensation, without going into the merits or demerits of the rules. The government has provided a formula of calculating compensation and that needs to be followed. The formula is quite simple and its use does not really constitute a hurdle in the IRBs activity. However, a large number of situations have cropped up in the last 6 months, where IRB members are in a real confusion as to whether medical management or compensation needs to be granted or not.

Cilengitide There is no mechanism by which an IRB member or the entire http://www.selleckchem.com/products/Paclitaxel(Taxol).html IRB could approach an expert body to ask for advice. Approaching the regulator does not help, since in our experience, the regulators rarely reply a question and in time. Continuing review Continuing review is an IRB’s most basic but neglected activity.[22] This activity should take up the maximum amount of an IRB’s meeting time, and in the era of multicentric trials, this does not increase subject safety.