<P> The International Conference on Harmonisation sets out guidelines for registration of pharmaceuticals in multiple countries . It defines Good Clinical Practice (GCP), which is an agreed quality standard that governments can transpose into regulations for clinical trials involving human subjects . </P> <P> Here is a summary of several key regulatory guidelines for oversight of clinical trials: </P> <Ul> <Li> Safeguard the rights, safety, and well - being of all trial subjects . Special attention should be paid to trials that may include vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension . </Li> <Li> Obtain trial protocol (s) / amendment (s), written Informed Consent Form (s) (ICFs) and consent form updates the investigator proposes for use in the trial, subject recruitment procedures (e.g., advertisements), written information to be provided to subjects, investigator's brochure, available safety information, information about payments and compensation available to subjects, the investigator's current curriculum vitae and / or other documentation evidencing qualifications, and any other documents the IRB may need to fulfill its responsibilities . </Li> <Li> Review both the amount and method of payment to subjects to assure neither presents problems of coercion or undue influence on the trial subjects . Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject . Information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, should be set forth in the written informed consent form and any other written information to be provided to subjects . The way payment will be prorated should be specified . </Li> <Li> Ensure that the proposed trial is reviewed within a reasonable time and document opinions and decisions in writing, clearly identifying the trial, the documents reviewed and recorded dates for approvals, required modifications prior to approval, disapproval of a proposed trial, or termination / suspension of any prior approval . Continuing review of ongoing trials is required at intervals appropriate to the degree of risk to human subjects, but at least once per year . </Li> </Ul> <Li> Safeguard the rights, safety, and well - being of all trial subjects . Special attention should be paid to trials that may include vulnerable subjects, such as pregnant women, children, prisoners, the elderly, or persons with diminished comprehension . </Li>

Which of the following is a goal of an irb