id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2018-N-2727-0075,FDA,FDA-2018-N-2727,Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,Notice,Announcement,2024-01-18T05:00:00Z,2024,1,2024-01-18T05:00:00Z,,2024-01-18T13:44:49Z,2024-00886,0,0,09000064863a76e8
FDA-2018-N-2727-0066,FDA,FDA-2018-N-2727,15 SACHRP (2017) Recommendations on the Expedited Review List,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:54:47Z,,0,0,090000648634e019
FDA-2018-N-2727-0065,FDA,FDA-2018-N-2727,14 FDA (1998) Protection of Human Subjects Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:54:32Z,,0,0,090000648634e018
FDA-2018-N-2727-0067,FDA,FDA-2018-N-2727,16 OHRP (2021) Revised Common Rule Q&As,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:54:52Z,,0,0,090000648634e639
FDA-2018-N-2727-0062,FDA,FDA-2018-N-2727,11WMA (2022) Declaration of Helsinki--Ethical Principles for Medical Research Involving Human Subjects,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:54:05Z,,0,0,090000648634e015
FDA-2018-N-2727-0064,FDA,FDA-2018-N-2727,13 FDA (2010) Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:54:24Z,,0,0,090000648634e017
FDA-2018-N-2727-0070,FDA,FDA-2018-N-2727,TAB A - IRB Waiver RIA as Submitted to OMB,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:56:09Z,,0,0,090000648638fd1f
FDA-2018-N-2727-0069,FDA,FDA-2018-N-2727,TAB A - IRB Waiver Final Rule as Submitted to OMB,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:55:56Z,,0,0,090000648638f8a8
FDA-2018-N-2727-0071,FDA,FDA-2018-N-2727,TAB B - IRB Waiver Final Rule Track Changes,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:56:32Z,,0,0,090000648638fd20
FDA-2018-N-2727-0068,FDA,FDA-2018-N-2727,Memorandum to FDA DMS on IRB Waiver FR (FDA-2018-N-2727),Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:55:33Z,,0,0,090000648638f8a5
FDA-2018-N-2727-0059,FDA,FDA-2018-N-2727,8 FDA and OHRP (2018) Institutional Review Board (IRB) Written Procedures Guidance for Institutions and IRBs,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:53:47Z,,0,0,090000648634e012
FDA-2018-N-2727-0063,FDA,FDA-2018-N-2727,12 FDA (2006) Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:54:17Z,,0,0,090000648634e016
FDA-2018-N-2727-0060,FDA,FDA-2018-N-2727,9 FDA (2006) Information Sheet Guidance for IRBs Clinical Investigators and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:53:54Z,,0,0,090000648634e013
FDA-2018-N-2727-0052,FDA,FDA-2018-N-2727,1 US Dept of State (2011) Fourth Periodic Report of the United States of America to the United Nations Committee on Human Rights Concerning the ICCPR,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:52:48Z,,0,0,090000648634e5ef
FDA-2018-N-2727-0058,FDA,FDA-2018-N-2727,7 Kraft et al. (2017)Research on Medical Practices Why Patients Consider Participating and the Investigational Misconception,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:53:34Z,,0,0,090000648634e011
FDA-2018-N-2727-0073,FDA,FDA-2018-N-2727,TAB C - IRB Waiver Final Rule as Cleared by OMB,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:57:08Z,,0,0,090000648638fd24
FDA-2018-N-2727-0053,FDA,FDA-2018-N-2727,2 SACHRP (2008) Recommendations Related to Waiver of Informed Consent and Interpretation of Minimal Risk,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:52:56Z,,0,0,090000648634e5f0
FDA-2018-N-2727-0055,FDA,FDA-2018-N-2727,4 Baker and Merz (2018) What Gives Them the Right Legal Privilege and Waivers of Consent for Research,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:53:05Z,,0,0,090000648634e5f2
FDA-2018-N-2727-0061,FDA,FDA-2018-N-2727,10 CIOMS (2016) International Ethical Guidelines for Health-related Research Involving Humans,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:53:58Z,,0,0,090000648634e014
FDA-2018-N-2727-0057,FDA,FDA-2018-N-2727,6 Kripalani et al. (2021) Disparities in Research Participation by Level of Health Literacy,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:53:25Z,,0,0,090000648634e010
FDA-2018-N-2727-0056,FDA,FDA-2018-N-2727,5 van Zon et al. (2016) Active Recruitment and Limited Participant-load Related to High Participation in Large Population-based Biobank Studies,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:53:13Z,,0,0,090000648634e5f3
FDA-2018-N-2727-0072,FDA,FDA-2018-N-2727,TAB B - IRB Waiver RIA Track Changes,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:56:50Z,,0,0,090000648638fd21
FDA-2018-N-2727-0074,FDA,FDA-2018-N-2727,TAB C - IRB Waiver RIA as Cleared by OMB,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:57:31Z,,0,0,090000648638fd25
FDA-2018-N-2727-0054,FDA,FDA-2018-N-2727,3 EoP (1997) Strengthened Protections for Human Subject of Classified Research,Supporting & Related Material,Background Material,2024-01-10T05:00:00Z,2024,1,,,2024-01-10T16:53:01Z,,0,0,090000648634e5f1
FDA-2018-N-2727-0051,FDA,FDA-2018-N-2727,"Institutional Review Board Waiver or Alteration of Informed Consent for
Minimal Risk Clinical Investigations",Rule,Direct Final Rule,2023-12-21T05:00:00Z,2023,12,2023-12-21T05:00:00Z,,2023-12-21T15:50:35Z,2023-27935,0,0,090000648634dce5
FDA-2018-N-2727-0042,FDA,FDA-2018-N-2727,Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Reopening of Comment Period,Proposed Rule,Extension of Comment Period,2019-02-25T05:00:00Z,2019,2,2019-02-25T05:00:00Z,2019-03-08T04:59:59Z,2019-03-09T02:02:09Z,2019-03195,0,0,0900006483aa313c
FDA-2018-N-2727-0011,FDA,FDA-2018-N-2727,"Institutional Review Board Waiver or Alteration of Informed Consent for
Minimal Risk Clinical Investigations; Extension of Comment Period",Proposed Rule,Extension of Comment Period,2018-12-20T05:00:00Z,2018,12,2018-12-20T05:00:00Z,2019-02-14T04:59:59Z,2019-02-15T02:02:47Z,2018-27519,0,0,09000064839b9103
FDA-2018-N-2727-0006,FDA,FDA-2018-N-2727,Request for Extension from Advanced Medical Technology Association (AdvaMed),Other,Request for Extension,2018-11-28T05:00:00Z,2018,11,2018-11-28T05:00:00Z,,2018-11-28T21:09:16Z,,0,0,09000064838e21ce
FDA-2018-N-2727-0001,FDA,FDA-2018-N-2727,Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2018-11-15T05:00:00Z,2018,11,2018-11-15T05:00:00Z,2019-01-15T04:59:59Z,2019-01-15T02:01:45Z,2018-24822,0,0,09000064838d9668
FDA-2018-N-2727-0002,FDA,FDA-2018-N-2727,Reference - 2 - 2017-9-20 Memo to file.FDA data analysis re: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,Supporting & Related Material,Background Material,2018-11-15T05:00:00Z,2018,11,,,2018-11-15T21:03:12Z,,0,0,09000064838db0ae
FDA-2018-N-2727-0003,FDA,FDA-2018-N-2727,Reference 3- 2018-8-20 Memo re: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,Supporting & Related Material,Background Material,2018-11-15T05:00:00Z,2018,11,,,2018-11-15T21:00:17Z,,0,0,09000064838db657