作者是他研究的对象。他耗尽了自己的一个重要的营养素，直到他有明显的临床和生化迹象的不足。他监测各种生化参数，因为他变得越来越缺乏，并提交了两份手稿提出了他的结果：一个详细的生化变化和一个详细的结果差异，从不同的商业上可用的分析营养。
第一份手稿的审稿人对所使用的实验模型提出了一些担忧，也对研究的伦理道德提出了担忧，特别是缺乏机构研究委员会的任何监督。第二份手稿没有被审查，两份手稿都被拒绝，理由是审查者提出了伦理问题，并担心从一个人那里获得的结果的科学有效性。
The author feels very strongly that his experiment was not unethical and argues for the autonomy of researchers. He provided the following arguments for his study:
-作者既是实验者又是单一受试者，因此不适用知情同意的要求。
— There is no institutional involvement, so there is no possibility of coercion.
-受试者由精神病医生进行评估，发现有能力评估风险和益处，并对实验的进行承担全部责任。
-赫尔辛基宣言没有评论自我实验；它关注的是对病人和健康志愿者的研究。因此，道德批准的要求不适用。《赫尔辛基宣言》不能作为拒绝独立自我实验报告的理由。该宣言并不是为了阻止自主独立的人类进行和报告自我实验
-受试者由一名合格的精神科医生进行监测，他不断地评估受试者的状况。双方事先同意，如果（但仅当）出现立即危及生命的情况，精神科医生将进行干预。
-进行这项实验的动机是合乎道德的，因为受试者想调查他在早期实验中发现的免疫测定之间的显著差异，因为他意识到这种错误在测量这种营养素时可能产生的严重后果。没有利益冲突。
-需要IRB或伦理委员会的批准将完全排除在由独立研究人员进行的任何自我实验研究的出版之外，因为他们将无法访问任何伦理委员会或机构审查委员会。这将阻止发表非常有用的报告(http://careers.bmj.com/careers/advice/view-article.html?id=20002566andhttp://www.bmj.com/content/341/bmj.c7103.long)
The author appealed the decision to reject his manuscripts. Although the appeal was not upheld, we agreed to bring the author's arguments for self-experimentation to the COPE Forum for wider discussion. It is worth noting that the author’s two papers were eventually published in another peer reviewed journal without any negative response over the ethical issues.
COPE论坛的问题
•COPE论坛上的其他编辑是否在未经IRB正式批准的情况下考虑自我实验的手稿？
•编辑使用什么标准来确定这些研究是否可以接受？
论坛建议这里有两个问题：自我实验的伦理问题，以及研究是否需要以n=1发表。
The Forum agreed that the author has the right to perform the experiments on himself, but he does not the right to have his findings published. There have been some highly publicised cases of self-experimentation, which in one case led to a Nobel prize for Barry Marshall after he infected himself with Helicobacter pylori (the causative organism of peptic ulcers). There was also the case of Spurlock’s documentary, Super Size Me, a social experiment in fast food gastronomy.
Regarding the second issue, the Forum agreed that this has to be a judgement call for any editor. Does the study warrant scientific publication? The author has the option of blogging about his experiments if he wants to disseminate his results.
The editor told the Forum that they were interested in learning if any journals had a specific policy on this issue, but among the Forum audience, no journal had such a policy. The discussion ended in agreement that this is a topic that needs further debate.
Comments
For me, publishing a scientific paper based on the results obtained from a single individual should have the same consideration as a Case report and be treated as such.
I believe that a scientist should be able to experiment on him/herself, assuming that he/she does not have a psychiatric problem and that the results of these experiments should be publishable. This is a long tradition in medicine and science (eg Walter Reed, Victor Herbert, etc). This belief comes from a conviction that the individual, not the government, is responsible for a person's rights and liberties.
Availability of ethics committees or institutional review boards can vary per country/depends on national regulations. Certain countries (eg. the Netherlands) do provide the possibility to submit a research proposal to an ethics committee. And also, there are examples of n=1 studies that have received EC approval in accordance with national regulations of the country concerned.
所以，声明说“。。。。他们将无法访问任何道德委员会或机构审查委员会。”这并不完全正确。
沃纳·弗罗斯曼的案子注意。他的在他身上做实验完全是因为社区的不信任。1929年，他对自己进行了革命性的心导管插入术，开始了一项新的专业，并获得了诺贝尔奖。道德问题并不重要那么。不过在本案中还出现了另一个人权问题。一个人有权进行危及自己生命的实验吗？
我个人认为，这是不能鼓励的，因为它可能导致更严重的个人实验单例报告。此外，如果此人是在一个学术机构，他应该得到IRB的许可。