近几天来,大家都在疯传ICMJE的新规则:Data Sharing Statements for Clinical Trials — A Requirement of the International Committee of Medical Journal Editors。
在新规则下,医生还能不能好好发SCI论文了?
“目前国内医学SCI投稿最大的障碍与ICMJE的新规则:动物伦理、临床试验伦理及临床试验注册”。我们在规划SCI前,一定要将非学术的问题解决好!
我们主要从三个方面来讨论。最后讨论ICMJE的最新规则。
1、动物伦理和临床试验的伦理:课题设计完成,在开始实验/试验之前,一定要拿到动物伦理和临床试验的伦理。伦理问题,尤其是临床试验的伦理,是比较重要的,一定要有。当然,目前关于动物伦理,也已有SCI期刊要求提供。
请看我们投稿后,编辑部在2017年的回复邮件中提出的意见,是不是很“惊喜”:
Title: ***
Dear Professor ***,
Please provide the name of the committee from which you received ethical approval for the use of rats in your study, and provide evidence of this approval.
。。。
Yours sincerely,
***
2、临床试验注册:临床试验注册”,大家也一定要注意,没有注册,估计后续会没有机会投稿。这个问题,似乎大家重视程度不够。
大家请看我们这两年遇到的一种情况,同时也有几个朋友反映:文章投稿后就拒稿,没有任何反馈意见。经过我们分析后,估计也是因为临床试验,没有伦理或者临床试验注册。
大家先请看要求提供临床试验注册的邮件(邮件是2015年编辑部回复的):
Dear Dr. **:
Before proceeding with the review orioles can you confirm the clinical trial registry number?(编辑部要求我们提供临床试验注册的注册号). I look forward to hearing from you.
Sincerely,
Dr. **
Journal of ***
大家再来看看编辑部因为作者没有按照ICMJE规则要求来注册,没有提前注册而是后补注册的后果(这个来自2016年编辑部的邮件):
Dear Dr. **,
Many thanks for clarifying the status of your clinical trial registration. Unfortunately, I cannot consider your manuscript further. As a journal, we adhere to the ICMJE guidelines, which require prospective trial registration(ICMJE的要求,前瞻性研究的临床试验,必须在纳入第一例病人前完成临床试验注册). In spite of the present decision, we look forward to submissions from you in the future.
Thank you for submitting your manuscript to the Journal of ***.
Yours sincerely
Dr. ***
然而,到这里,大家是不是认为:在还没有开始临床试验前,仅仅注册就可以了呢?看看下面最新的要求吧,目前的要求是越来越高!
3、ICMJE的新规:临床试验注册的数据,必须全部公开!!!这是最新的要求,就在6月初公布的。大家请看:
什么?什么?要全部公开?这是怎么回事??新规则下,医生还能不能好好发SCI论文了?
首先,我们看看ICMJE的要求是哪些?下图是ICMJE要求中提供的最新内容:
Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals:
1. As of July 1, 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below.
2. Clinical trials that begin enrolling participants on or after January 1, 2019, must include a data sharing plan in the trial’s registration. The ICMJE’s policy regarding trial registration is explained at http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript and updated in the registry record.
简单翻译一下,就是:
第一,2018年7月及以后提交到ICMJE期刊的临床试验报告,必须包含数据共享声明。
第二,2019年1月1日后开始入组受试者的临床试验,必须在临床试验注册平台上提交数据共享计划。
ICMJE为何这么牛气?我们来看看ICMJE的情况,ICMJE是International Committee of Medical Journal Editors(国际医学期刊编辑委员会)的简称。
ICMJE的成员包括哪些期刊呢?医学领域的话,我们搜索了一下ICMJE的网站(http://www.icmje.org/),得到如下信息:
像什么NEJM、JAMA、Lancet、BMJ、Plos等都是ICMJE的成员。这个新的声明,估计后面会有全文的翻译版,目前在各大医学期刊上全文基本上都是免费下载的,大家可以自行前往查阅:
http://www.nejm.org/doi/full/10.1056/NEJMe1705439;
http://jamanetwork.com/journals/jama/fullarticle/2630773;
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31282-5/fulltext;
综上所述,后续大家在设计医学方面课题时,尤其是在实施前,各个规则都要考虑。不然,会给后面的发表带来不可控制的损失。新规则下,医生要想好好发SCI论文,就得遵守ICMJE的规则。
在投稿过程,编辑部返回的意见中,有的期刊在拒稿信中会写明需要遵守ICMJE和临床试验注册;而有的期刊只用一句话:不符合我们期刊刊文要求!草草打发掉,根本就不告诉我们到底是哪儿不符合,甚至发邮件咨询,编辑部还会说详情在for authors中。。。您老倒是告诉我们哪儿不行啊??
Title: ******
Corresponding Author: Prof. ***
Authors:******
Dear Prof. ***,
Thank you for your submission to ***. Unfortunately, I feel that your paper is not suitable for publication in the journal and unlikely to be favorably reviewed by the referees, or lies outside the scope of the journal.
Thank you for your interest in ***.
Sincerely,
***, M.D.
Regional Editor
点击“阅读原文” 图王争霸赛答题内容已开放!快来围观吧!