Protection of research participants

All investigators should ensure that the planning conduct and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013.All authors should seek approval to conduct research from an independent local,regional or national review body （e.g.,ethics committee,institutional review board）.If doubt exists whether the research was conducted in accordance with the Helsinki Declaration,the authors must explain the rationale for their approach and demonstrate that the local,regional or national review body explicitly approved the doubtful aspects of the study.Approval by a responsible review body does not preclude editors from forming their own judgment whether the conduct of the research was appropriate.

Patients have a right to privacy that should not be violated without informed consent.Identifying information,including names,initials,or hospital numbers,should not be published in written descriptions,photographs,or pedigrees unless the information is essential for scientific purposes and the patient（or parent or guardian） gives written informed consent for publication.Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published.Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication.Patient consent should be written and archived with the journal,the authors,or both,as dictated by local regulations or laws.Applicable laws vary from locale to locale,and journals should establish their own policies with legal guidance.Since a journal that archives the consent will be aware of patient identity,some journals may decide that patient confidentiality is better guarded by having the author archive the consent and instead providing the journal with a written statement that attests that they have received and archived written patient consent.

Nonessential identifying details should be omitted.Informed consent should be obtained if there is any doubt that anonymity can be maintained.For example,masking the eye region in photographs of patients is inadequate protection of anonymity.If identifying characteristics are de-identified,authors should provide assurance,and editors should so note,that such changes do not distort scientific meaning.

The requirement for informed consent should be included in the journal’s instructions for authors.When informed consent has been obtained,it should be indicated in the published article.

所有研究人員應當確保人體研究的實施計劃和報告符合2013 年修訂的《赫爾辛基宣言》（www.wma.net/policies-post/wma-declaration-of-helsinkiethical-principles-for-medical-researchinvolving-human-subjects/）的要求。所有作者都應當從獨立的地方、區域或國家審查機構（例如，倫理委員會、機構審查委員會）尋求批準。如果研究的實施是否符合《赫爾辛基宣言》的要求受到質疑，則作者必須解釋采用其研究方法的理由，并證明地方、區域或國家審查機構已明確批準了受到質疑的那部分研究。審查機構的批準并不排除編輯對研究的實施是否恰當作出他們自己的判斷。

患者有隱私權，不應在沒有獲得知情同意的情況下受到侵犯。可辨認身份的信息，包括姓名和其首字母縮寫，或住院號，都不應在書面描述、照片或遺傳譜系中公開，除非出于科學的目的該信息必不可少，并且患者（或其父母或監護人）簽有知情同意書，同意發表。出于此目的簽署知情同意書時，要求將準備發表的稿件讓可能被識別出來的患者過目。作者應該向這些患者公開，論文發表后是否還有其他可能使患者被認出來的材料會出現在互聯網上或印刷品中。患者的同意必須是書面的，并要依照當地的法律或規定，或由期刊存檔，或由作者存檔，或雙方都存檔。適用的法律各地不同，期刊應依法制定自己的規定。由于存檔知情同意書的期刊將會知曉患者的身份，有些期刊認為知情同意書由作者存檔會使患者的隱私得到更好的保護，作者只需向期刊提供一份書面聲明，證實他們收到并存檔了患者的書面知情同意。

應省略非必要的能識別患者身份的細節。只要有任何疑問不能做到匿名，就應該獲得知情同意。例如，遮蔽患者照片中的眼區是不足以保護患者不被認出的。如果對身份識別特征作了“去識別”處理，則作者應該作出保證且編輯也應注明，這種更改不會歪曲科學意義。

期刊的作者須知中應該包括對知情同意的要求。如果已取得知情同意，在發表的論文中應有說明。