编辑给的意见信如下:Dear Dr. Yin, We've checked your submis...

Created on: November 12, 2025

Answered using GPT-5 Thinking by Chat01

Question

PLOS_Human_Participants_Research_Checklist_2025.pdf
citiCompletionCertificate_13968729_66757149.pdf
citiCompletionCertificate_13968729_66757150.pdf
citiCompletionReport_13968729_66757149.pdf
citiCompletionReport_13968729_66757150.pdf

编辑给的意见信如下:Dear Dr. Yin,

We've checked your submission and before we can proceed, we need you to address the following issues:

  1. Please remove your figures from within your manuscript file, leaving only the individual TIFF/EPS image files. These will be automatically included in the reviewer’s PDF.

  2. Please complete all items on the Human Participants Research Checklist that are relevant for your submission, by following this link: https://journals.plos.org/plosone/s/file?id=d3c7/PLOS_Human_Participants_Research_Checklist_2025.pdf (Contact us at [email protected] if you cannot access the document.) There may be overlap between the checklist items and other queries listed below; please address any duplicated queries both in your response email and on the checklist itself. Upload the completed Human Participants Research Checklist as file type “Other” when you re-submit your manuscript. This document is for internal journal use only and will not be published if your article is accepted. The requested information will help us to assess whether your submission complies with PLOS ONE’s policies and adheres to applicable reporting standards. Note that your manuscript may be rejected if you provide incomplete or inadequate responses to the checklist questions and that changing the ‘Section/Category’ of your article does not affect this requirement.

We've returned your manuscript to your account. Please resolve these issues and resubmit your manuscript within 21 days. If you need more time, please email the journal office at [email protected]. We are happy to grant extensions of up to one month past this due date. If we do not hear from you within 21 days, we will withdraw your manuscript.

Please log on to PLOS Editorial Manager at https://www.editorialmanager.com/pone/ to access your manuscript. You will find your manuscript in the 'Submissions Sent Back to Author' link under the New Submissions menu. Be sure to remove your previous manuscript file if you are uploading a new file in response to these requests. After you've made the changes requested above, please be sure to view and approve the revised PDF after rebuilding the PDF to complete the resubmission process.

We are requesting these changes to comply with the PLOS ONE submission guidelines (https://journals.plos.org/plosone/s/submission-guidelines). Please note that we won't send your manuscript for review until you have resolved the above requests.
附件为我通过链接下载的,以及我猜测可以用做证明的文件,请帮我梳理一下我根据信中内容应该做什么?是否需要额外的回复信和声明?这几个文件可以上传吗?编辑给我的pdf如何填写?填写后如何提交?
我写了一段类似于声明的文字信息可供参考Author Yue Yu completed the National institutes of Health's online training course titled “Protecting Human Research Participants” (Record ID: 13968729) and was granted authorized access to the MlMlC-lV database for data extraction. Due to the retrospective nature and de-identified status of the data, the requirement for informed consentwas waived by the Ethics Committee at Beth lsrael Deaconess Medical Center.

Thought

Providing submission instructions

The user asked how to fill out and submit their PDF. I'll suggest a simple solution: they can use PLOS Editorial Manager to upload files. Step 2 will guide them through attaching files, selecting the right file types, and adding necessary alt text. I'll also offer a revised English version of their declaration for clarity.

Providing additional instructions

PLOS requires 300 dpi for figures, and while we shouldn’t quote specific numbers, the submission guidelines will clarify that. I’ll also explain how to fill out the human subjects research checklist based on their scenario and offer sample text in English for the Methods section. Finally, I’ll suggest recording line numbers after typesetting.

Providing resubmission instructions

I'll guide the user on how to resubmit their manuscript. The steps include logging into EM, selecting "Revise Submission," uploading the new documents, and updating file types. Also, I'll explain how to fill the PDF by providing examples for specific questions and asking for date details without directly prompting for an answer.

Clarifying steps and details

It's advisable to include a Response to Editor but it's not strictly required.

Thought for 1m 28s

Answer

没问题,我来把编辑信要求逐条拆解,并给你现成可用的文字与操作步骤(含如何填 PDF、是否需要额外回复、这些附件能否上传)。

你需要做什么(逐条对应编辑信)

  1. 从主稿件中移除所有插图
  • 在稿件 Word/LaTeX 文件内删除所有图片,仅保留“图题/图注(Figure captions)”一节。
  • 把每个图像单独作为 TIFF 或 EPS 文件上传;不要把图片再嵌进主稿件。
  • 重新构建(Build)并预览 PDF,确认审稿版会自动把这些图像合并进去(这是 PLOS 的流程)。
  1. 完成人体受试者研究核对表(Human Participants Research Checklist)并上传
  • 你已下载了最新版 PDF(文件名:PLOS_Human_Participants_Research_Checklist_2025.pdf)。该表用于前瞻性与回顾性研究;其中第 1 题问伦理审批(ethics approval),第 2 题用于前瞻性招募情况,第 3 题用于回顾性数据研究细节,并要求在方法学中给出对应行号(line numbers)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • 该表说明“如未获得伦理审批或为国际多中心但未覆盖所有国家审批,需要在表中解释原因”,并把完成的核对表作为“Other”类型文件上传。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  1. 在稿件的方法学中补充与核对表一致的信息,并记录行号
  • 表的第 2/3 题都要求你在方法学写明相应信息,并在表中填入行号(例如“Methods,第 142–151 行”)。提交前先更新文稿,再回到表里填写行号。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  1. 在 Editorial Manager 中重新提交
  • 登录:https://www.editorialmanager.com/pone/
  • 进入 New Submissions → Submissions Sent Back to Author,点 Revise Submission
  • Attach Files 步骤:
    • 删除旧版主稿件(若你要上传新文件)。
    • 上传新主稿件(无嵌入图片)。
    • 上传各个图像(文件类型选 Figure,格式 TIFF/EPS)。
    • 上传已填写完成的核对表(文件类型选 Other)。
    • 如需,可把培训证明等支持性材料也选 Other 上传(见下文)。
  • Rebuild PDF → View/Approve,最后 Submit

这几个附件能否上传?

  • Human Participants Research Checklist 2025:** 必须**上传,文件类型选 Other。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • CITI 课程完成证书/成绩单:可作为支持性材料上传(Other),证明你接受了人类研究与利益冲突相关培训;但它们不能替代伦理审批或豁免函
    • Human Research(Data or Specimens Only Research,Stage 2 Refresher),完成日期 2024-12-06,记录号 66757149。(citiCompletionCertificate_13968729_66757149.pdf) (citiCompletionReport_13968729_66757149.pdf)
    • Conflicts of Interest(Basic Course),完成日期 2024-12-06,记录号 66757150。(citiCompletionCertificate_13968729_66757150.pdf) (citiCompletionReport_13968729_66757150.pdf)

重要提示:如果你手头有你所在机构的 IRB 审批/豁免/不需审查的认定函,请一并上传(文件类型 Other)。若没有,也可在核对表第 1 题按“未获得伦理审批”的路径充分解释原因(见下文“如何填表”)。核对表文本明确要求遇到此情形需在表中说明。(PLOS_Human_Participants_Research_Checklist_2025.pdf)


核对表 PDF 如何填写(结合你这篇:回顾性、去标识、MIMIC-IV 数据

按表中的三道题逐项作答(表见你上传的 PDF,最后修改时间 2025 年 9 月)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)

第 1 题:是否获得伦理审批?

  • 若你本机构 IRB 的批件/豁免/不需审查函:
    • 选择 Uploaded,并把批件(及任何延期/补充批件、必要时的英文译件)作为 Other 上传。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • 若你没有本机构 IRB 文件(常见于仅用公开、去标识数据库的二次研究):
    • 在表格的空白说明处写明:使用的是事先去标识的公开数据库(MIMIC-IV),你方未接触任何可识别信息,且未直接招募受试者;数据平台/数据拥有方在原始采集阶段已完成伦理审批并对公众数据提供访问治理;你已完成规定培训并获准访问数据。
    • 同时在方法学中加入相应说明,并在表内解释未获得审批的原因(这是表格的明确要求)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)

第 2 题:前瞻性招募

  • 你的研究为回顾性二次分析,此题选择 N/A。表中该题仅适用于“临床试验/问卷/为本研究而收集的样本/数据”等前瞻性招募。(PLOS_Human_Participants_Research_Checklist_2025.pdf)

第 3 题:回顾性研究需在方法中报告(并在表上填行号)包括:

  • 为研究目的访问数据的日期(日/月/年)”;
  • 作者在数据收集期间或之后是否能接触到可识别信息”。
    请把这两点写进方法学并在表中填写其准确行号(例如“Methods,第 150–156 行”)。这是表格对回顾性研究的明确要求。(PLOS_Human_Participants_Research_Checklist_2025.pdf)

建议加入到方法学中的英文声明(可直接粘贴后按实际调整)

This study is a retrospective analysis of the de-identified MIMIC-IV database. The author (Yue Yu) completed the required human-subjects training (“Protecting Human Research Participants”/CITI Program) and was granted authorized access to the MIMIC-IV database for data extraction. Because the dataset is fully de-identified and no direct participant contact occurred, informed consent was waived by the relevant ethics committee overseeing the original data collection. The authors did not have access to any direct identifiers during or after data access. Data for the present analysis were accessed on [DD-Mon-YYYY].

(把方括号内的访问日期替换为你真实的访问日期;加入文稿后,回到核对表第 3 题填写其行号。)

你给我的草稿我已润色并更正拼写(“MlMlC-lV”→“MIMIC-IV”),保持了核心含义。


是否需要额外的“回复信/声明”?

强烈建议写一封简短的 Response to Editor/Staff(放在 Editorial Manager 的“Response to Editor”文本框里,或作为 Cover letter 上传),把你做了哪些修改说清楚。示例英文模板:

Dear Editorial Office,
We have addressed the requested items as follows:

  1. Removed all figures from the main manuscript and uploaded each figure as an individual TIFF/EPS file.
  2. Completed and uploaded the “Human Participants Research Checklist” (file type “Other”).
  3. Revised the Methods section to report the ethics and data-access details required for retrospective human-data studies, including the date of data access and a statement that no identifiable information was available to the authors (see Methods, lines [XXX–YYY]).
    Additionally, we uploaded the author’s CITI training certificates as supporting documentation.
    Please let us know if anything further is needed.

表格填好后如何提交?

  1. 在本地把核对表 PDF 填好并保存(若表单不可直接填写,可用“填写与签名/注释”功能输入文字,或打印成 PDF 再上传)。
  2. 在 Editorial Manager 的 Attach Files 步骤,把该 PDF 作为 Other 类型上传(文件名可包含“Human Participants Research Checklist”方便识别)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  3. 重建并预览审稿 PDF(Build PDF → View/Approve),确认主稿件无嵌图、图像已自动拼入审稿版、方法学段落与核对表一致;然后 Approve Submission 并提交。

小结与你当前附件的用途

  • Checklist:必传(Other)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • CITI 结业证书与成绩单:可作为支持性材料(Other),证明培训合规;不等同于 IRB 批件。(citiCompletionCertificate_13968729_66757149.pdf) (citiCompletionReport_13968729_66757149.pdf) (citiCompletionCertificate_13968729_66757150.pdf) (citiCompletionReport_13968729_66757150.pdf)
  • 若有 IRB 批件/豁免函:一并上传(Other)。若无,则在核对表第 1 题充分解释原因并在方法学中写明。(PLOS_Human_Participants_Research_Checklist_2025.pdf)

如果你愿意,我也可以把上面的英文声明改成最终可直接贴进你文稿“Methods”的版本(按你提供的真实数据访问日期与文稿行号补齐即可)。

Question

我方法学中的原文如下:We conducted a retrospective cohort study using MIMIC‑IV v3.1, a publicly available ICU database from Beth Israel Deaconess Medical Center (2008–2019). The database contains de‑identified data and is approved by the BIDMC IRB with a waiver of informed consent. The current analysis was conducted under certification number 13968729 and follows STROBE guidelines.13,数据获取时间为2024-12-06,1.重新编辑method部分关于mimic数据库及伦理的解释;2.编辑关于核对表问题一:没有本机构 IRB 文件的解释;3.核对表问题三需要加在method部分的内容不要忘记加上;4.回复信请正式书写,编辑署名为:Jonafer Estoque Miranda,PLOS ONE;4.检查编辑信件中提到需要重复提交的内容都要在各部分写上

Thought

Crafting documents

I’m working through rewriting the Methods section, explaining ethics and MIMIC database usage, and addressing checklist questions. Also drafting a response letter to the editor.

Refining protocols

I’m updating the Methods section to include precise details about MIMIC-IV data and STROBE compliance, ensuring no direct identifiers were accessible, and addressing checklist questions effectively.

Finalizing details

I’m drafting the response letter to Editor Jonafer Estoque Miranda, ensuring clarity on changes made, addressing all checklist questions, and confirming adherence to PLOS guidelines.

Completing the checklist

I’m ensuring each checklist question is addressed, including ethical approval reasons, and incorporating accurate citations for clarity. This involves filling out forms and detailing the necessary actions.

Clarifying ethical approval

I’m gathering details on ethical approval for the de-identified MIMIC-IV database, including local IRB requirements and the necessary training and access for researchers.

Finalizing elements

I'm wrapping up the editorial response, ensuring clarity on ethical approval, addressing checklist questions, and maintaining a consistent style throughout the manuscript and supporting documents.

Crafting the final response

I’m focusing on integrating citations effectively, detailing PDF completion instructions, and maintaining clarity and brevity throughout the manuscript and accompanying documents.

Reasoned for 14m 45s

Answer

太好了,有了你提供的原始 Methods 句子和日期(数据访问:2024‑12‑06),我把你需要的四件事全部一次性准备好:
(1) Methods 可直接替换的英文段落;(2) 核对表第 1 题的英文解释;(3) 确保满足第 3 题所需、已写入 Methods 的两点;(4) 发给编辑的正式回复信(署名:Jonafer Estoque Miranda,PLOS ONE)。
最后还附上核对表 PDF 的逐项填写与重新提交步骤清单,把编辑信里要求的重复事项全部覆盖。


1) Methods(关于 MIMIC 与伦理)——可直接替换粘贴

Data source and ethics
We conducted a retrospective cohort study using the Medical Information Mart for Intensive Care IV (MIMIC‑IV), version 3.1, a publicly available database of de‑identified ICU records from Beth Israel Deaconess Medical Center covering 2008–2019. The creation and open release of MIMIC‑IV were approved by the BIDMC Institutional Review Board with a waiver of informed consent. For the present analysis, the author (Yue Yu) completed the required human‑subjects training (CITI Program; learner ID 13968729; Human Research—Data or Specimens Only Research, Record ID 66757149, completion 06‑Dec‑2024) and obtained certified access to the MIMIC‑IV database. Data for this study were accessed on 06‑Dec‑2024. Only de‑identified data were used; the authors had no access to direct identifiers at any time. This study followed the STROBE reporting guideline.

  • 上面两句加粗部分正是核对表第 3 题要求的方法学信息(“访问日期”“是否接触可识别信息”),已嵌入 Methods。核对表指引明确要求回顾性研究在方法学中写出这两点并在表上填行号。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • 你提供的 CITI 课程信息(Record ID 66757149;完成日期 2024‑12‑06;Learner ID 13968729)来自你上传的证书/成绩单,可作为支持材料一并上传(“Other”文件类型)。
  • 你也可以把 COI 的培训证书作为补充材料上传(非必需)。

2) 人体受试者研究核对表(Question 1)——“未获得本机构 IRB 审批”的解释文本

Q1 (Ethics approval) — Explanation
Local IRB review was not sought for this analysis because the study uses de‑identified, publicly available data from MIMIC‑IV v3.1 and involves no interaction or intervention with human participants. The custodians of MIMIC‑IV (Beth Israel Deaconess Medical Center) obtained IRB approval with a waiver of informed consent for the creation and public release of the dataset. Per the MIMIC data‑use requirements, the author completed human‑subjects training (CITI Program; learner ID 13968729; Record ID 66757149; completion 06‑Dec‑2024) and obtained certified access. The authors did not access identifiable private information at any time during or after data access.
(Supporting documents: CITI training certificate/report uploaded under file type “Other”.)

  • 该题在 2025 版核对表的说明是:若未取得伦理审批,需要在表内解释原因;若取得审批则上传批件(文件类型“Other”)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • 实操:不要勾选 “Uploaded”;勾选 “N/A” 并在空白框贴上面解释即可;同时把 CITI 证明作为 Other 上传(这不是 IRB 批件,但可佐证培训与合规访问)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)

3) 核对表第 3 题需要在 Methods 的内容(你已包含,但这里再次列明)

核对表第 3 题要求回顾性研究在方法学中报告:

  • i. 数据被用于研究目的的访问日期(日/月/年)
  • ii. 作者在数据收集期间或之后是否可接触到可识别信息;并在表上填写这些内容在 Methods 中的行号。(PLOS_Human_Participants_Research_Checklist_2025.pdf)

你在上面的 Methods 段落里已经写入:

  • Data for this study were accessed on 06‑Dec‑2024.” —— 对应 i
  • Only de‑identified data were used; the authors had no access to direct identifiers at any time.” —— 对应 ii

接下来要做的唯一动作:在最终生成的稿件 PDF 上数出该段落的行号,把它填进核对表第 3 题的 “Please state the line number(s)…”。(例如:Methods, lines 148–157


4) 发给编辑的正式回复信(Response to Staff)

收件人:Jonafer Estoque Miranda, PLOS ONE

Subject: Resubmission in Response to Pre‑Review Checks (Manuscript ID: [填 ID])

Dear Jonafer Estoque Miranda,

Thank you for the guidance. We have addressed all items requested prior to peer review:

  1. Figures: Removed all figures from the main manuscript and uploaded each figure as an individual TIFF/EPS file.
  2. Human Participants Research Checklist: Completed the checklist and uploaded it under file type “Other.”
  3. Methods—ethics & data access: Revised the Methods to include the required statements for retrospective human‑data studies, namely the date of data access (06‑Dec‑2024) and a statement that only de‑identified data were used and no direct identifiers were accessible to the authors (see Methods, lines **[XXX–YYY]).
  4. Supporting documentation: Uploaded the author’s CITI human‑subjects training certificate and completion report (learner ID 13968729; Record ID 66757149; completion 06‑Dec‑2024) and the COI training certificate as supporting documents under file type “Other.”
  5. Resubmission workflow: Rebuilt and approved the revised PDF in Editorial Manager after replacing the manuscript file and attaching all required items.

We hope the submission now meets PLOS ONE’s pre‑review requirements. Please let us know if any further information is needed.

Sincerely,
Yue Yu, on behalf of the authors
[Affiliation]
[Email]

把上面 [XXX–YYY] 改为你最终 PDF 中该段落的行号;把 Manuscript ID 与通讯信息补齐。


5) 核对表 PDF 如何填写 & 如何提交(逐项操作)

根据你上传的《Human Participants Research Checklist(2025 版)》:

  • Q1(Ethics approval)
    • 选择 N/A(不要勾“Uploaded”),并在“explain the reasons”处粘贴本答复第 2 节的英文解释;若你后来取得了本机构 IRB 批件/豁免函,则改为勾 Uploaded 并把批件作为 “Other” 上传。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • Q2(Prospective recruitment):你的研究为回顾性二次分析,选择 N/A。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • Q3(Retrospective studies):选择 Completed,在空格里填入 Methods 的行号,并确保 Methods 已含“访问日期 + 是否接触可识别信息”两点(见第 3 节)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)

保存与上传

  1. 在 PDF 上勾选/填写后另存为(若不能直接填写,使用“注释/填写与签名”功能输入文字后另存)。文件名建议:Human_Participants_Research_Checklist_[YYYYMMDD].pdf
  2. 登录 Editorial Manager → New Submissions → Submissions Sent Back to AuthorRevise Submission
  3. Attach Files 步骤:
    • 删除旧的主稿件(若替换)。
    • 上传新的无嵌入图片的主稿件(文件类型 Manuscript)。
    • 各图分别上传为 TIFF/EPS(文件类型 Figure)。
    • 上传核对表 PDF(文件类型 Other)。
    • (可选)上传 CITI 证书/成绩单(文件类型 Other)。证书与成绩单内容见你上传的文件:** Human Research** 课程(Record ID 66757149,完成 06‑Dec‑2024)与 COI 课程(Record ID 66757150)等。
  4. Build PDF → View/Approve 审核合成的审稿版 PDF(确认图像自动纳入、Methods 与核对表一致),然后 Submit

6) 你问到的“这几个文件可以上传吗?”

  • 必须上传:已填写的 Human Participants Research Checklist(文件类型 Other)。该表在第 1/3 题对资料与报告要求有明确说明(并需填行号)。(PLOS_Human_Participants_Research_Checklist_2025.pdf)
  • 可作为支持性材料(非 IRB 替代)上传:
    • CITI Human Research 证书与完成报告(Record ID 66757149,完成 2024‑12‑06;Learner ID 13968729)。
    • CITI Conflicts of Interest 证书与完成报告(Record ID 66757150)。

给你的一行摘要(便于自检)

  • 主稿件:移除所有嵌入图,只留图题;
  • 图像:逐张 TIFF/EPS 上传;
  • Methods:粘贴上面的“Data source and ethics”段落(含访问日期 06‑Dec‑2024 与“无可识别信息”声明);
  • Checklist:Q1 勾 N/A + 粘贴解释;Q2 N/A;Q3 Completed + 填 Methods 的行号
  • Supporting:上传 CITI 证书/成绩单为 “Other”;
  • EM:重建并批准 PDF 后提交;
  • 回复信:粘贴上面的正式信件给 Jonafer Estoque Miranda, PLOS ONE

如需,我也可以把这段 Methods 直接改成带行号的版本(你生成 PDF 后,把对应行号告诉我,我会把“[XXX–YYY]”替换好并把回复信里的行号一并改好)。

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