4.8.10 Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of the following:
知情同意讨论和提供给受试对象的书面的知情同意书以及其他文字资料应当包括以下问题的解释：
k) The anticipated prorated payment, if any, to the subject for participating
in the trial.
给参加试验受试对象的预期按比例分配的报酬(如果有)
l) The anticipated expenses, if any, to the subject for participating in the
trial.
受试对象因参加试验的预期花费(如果有)
m) That the subject's participation in the trial is voluntary and that the
subject may refuse to participate or withdraw from the trial, at any time,
without penalty or loss of benefits to which the subject is otherwise
entitled.
受试对象参加试验是自愿的，受试对象可以拒绝参加试验，或在任何时候退出试验而不会收到损失或损失本来受试对象有权利得到的利益。
n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory
authority(ies) will be granted direct access to the subject's original medical
records for verification of clinical trial procedures and/or data, without
violating the confidentiality of the subject, to the extent permitted by the
applicable laws and regulations and that, by signing a written informed consent
form, the subject or the subject's legally acceptable representative is
authorizing such access.
监查员、稽查员、IRB/IEC和管理当局将被准予在不违反受试对象的保密性、在适用法律与规定准许的程度直接访问受试对象的原始医学记录以查证临床试验程序和/或数据，受试对象或受试对象的合法可接受的代表通过签署书面的知情同意书授权这种访问。
o) That records identifying the subject will be kept confidential and, to the
extent permitted by the applicable laws and/or regulations, will not be made
publicly available. If the results of the trial are published, the subject’s
identity will remain confidential.
在适用法律和/或规定允许的范围，能鉴别受试对象的记录应保密，不得公开这些记录。如果试验结果发表，受试对象鉴别仍然是保密的。
p) That the subject or the subject's legally acceptable representative will
be informed in a timely manner if information becomes available that may be
relevant to the subject's willingness to continue participation in the
trial.
如果得到与受试对象继续参加试验的愿望可能相关的资料，受试对象或受试对象的合法可接受代表将得到及时通报。
q) The person(s) to contact for further information regarding the trial and
the rights of trial subjects, and whom to contact in the event of trial-related
injury.
需要进一步了解有关试验资料和试验受试对象的权利时的联系人，以及在发生与试验有关的伤害时的联系人。
r) The foreseeable circumstances and/or reasons under which the subject's
participation in the trial may be terminated.
受试对象参加试验可能被终止的可预见情况和/或理由
s) The expected duration of the subject's participation in the trial.
受试对象参加试验的预期持续时间
t) The approximate number of subjects involved in the trial.
参加试验受试对象的大约人数
