?? A consent document is not a consent process nor can it substitute for the required interaction between the investigator and Gemcitabine synthesis the prospective participant where the investigator describes the trial, including, but not limited to, its purpose, risks, potential benefits, procedures, alternatives to enrolling in the trial, provisions to protect privacy and maintain confidentiality of data in which the prospective participant would be identifiable, the right to decide whether to participate and the right to withdraw at any time from the trial, and the availability of compensation should the participate suffer an injury related to the trial. Even for the most sophisticated person, absorbing and understanding the purpose and methods of a trial let alone the implications and consequences of participating in a trial can be daunting.
Asking questions, discussing the trials, and having time to consider whether to participate are paramount to a good consent process. In countries, such as India, where there are many different languages spoken and understood and large numbers of individuals who are illiterate, obtaining voluntary informed consent poses many hurdles. This is evident in the current debates about clinical trials in India. The consequences of failing to obtain consent or not fully informing prospective participants can be dire, leading not only to allegations of unethical research, allegations of research misconduct, but also to harm of participants and widespread mistrust by the public.
Witness the current environment in India today where a few highly visible cases of failure to obtain consent have negative colored the way all clinical trials and pharmaceutical sponsors are viewed. Role of EC The independent EC has the primary responsibility of ensuring that proposed research is ethically justifiable. Other partners or players share responsibility for protecting human research participants but only the EC is charged solely with this responsibility. Many documents in the form of laws, regulations, guidelines, and principles exist to regulate and guide EC in their review of proposed research. At a minimum, by Indian law and guidance, ECs must determine that risk of harms are minimized by using the sound research design, risks are reasonable in relation to potential benefits, selection of participants is equitable, voluntary consent is obtained and documented, and privacy interests of participants are protected and confidentiality of identifiable data are maintained.
ECs have other responsibilities Drug_discovery such as ensuring compensation for research-related injury is available and in India, determining the amount of compensation. ECs pay special attention to vulnerability of prospective participants and ensure provisions exactly are made in the research to reduce any coercion or undue influence on vulnerable participants.