?? This committee later christened as the Institutional Review Board (IRB) Seliciclib or Ethics Committees (ECs) was recommended by the Food and Drug Administration in the US, since 1971. Approval by an IRB was essential for studies if institutionalized subjects were used for research or the institution had an IRB. After the expose of the Tuskegee Syphilis Study the National Research Act was signed in 1974, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) was created. The mandate of the Commission was to make recommendations for the protection of vulnerable population. The Commission’s report (Belmont Report) was published in 1979 and it reaffirmed the need for IRBs.
Around the same time the World Medical Association amended its Declaration of Helsinki (DOH) at Tokyo in 1975 enlarging the declaration to almost double the original size and incorporating review by an IRB before a study could proceed In India the Indian Council of Medical Research (ICMR) issued the guidelines for the formation and working of ECs. Today, there are a large number of ECs operating in India, as of 16th August 2013, 565 IRBs have been registered. The three amendments (GSR 53 (E) of 30.01.2013, GSR 63 (E) of 01.02.2013 and GSR 72 (E) of 08.02.2013) have detailed rules for compensation of injuries, IRB review and IRB registration, respectively. It is too early to see an effect of these regulations, yet the number of trials being done in the country has dropped in the last 2 years and a number of studies have been withdrawn from the country.
IRBs are bodies with high power and responsibility. They stand as a bridge between the researcher and the ethical guidelines of the country. However, a lot of questions are being asked about the competence of IRBs in India. These questions center on the composition of the IRBs, the competence and training of their members, their independence, and their overall approach towards protection of human subjects. A number of studies have doubted the competence of IRB and a full session was devoted to this problem at a recent conference in Gurgaon. As stated, Cilengitide the Central Drug Standards and Control Organization (CDSCO) has granted registration to 565 IRBs in the country, this means that at least on paper these IRBs are compliant to the norms. Beyond that, not much can be said www.selleckchem.com/products/VX-770.html in the absence of detailed studies on the IRB functioning. There is no doubt that there are IRBs that are very competent, but there are many which are not.