Meeting Unique Requirements: Community Consultation and Public Disclosure for Research in Emergency Setting Using Exception from Informed Consent

2021 ◽  
Author(s):  
Neal W. Dickert ◽  
Kathleen Metz ◽  
Michael D. Fetters ◽  
Adrianne N. Haggins ◽  
Deneil K. Harney ◽  
...  
Keyword(s):  
Informed Consent ◽  
Emergency Setting ◽  
Public Disclosure ◽  
Community Consultation

Ethics Committee Experience with Emergency Exception from Informed Consent Protocols

2007 ◽  
Vol 2 (3) ◽  
pp. 23-30 ◽  
Author(s):  
Nicole M. DeIorio ◽  
Katie B. McClure ◽  
Maria Nelson ◽  
K. John McConnell ◽  
Terri A. Schmidt
Keyword(s):  
United States ◽  
Public Opinion ◽  
Informed Consent ◽  
Community Involvement ◽  
Human Subjects ◽  
Ethics Committee ◽  
Public Disclosure ◽  
Federal Regulations ◽  
Community Consultation ◽  
Consultation Process

Since 1996, U.S. federal regulations allow research without informed consent to study emergency conditions, if there is currently no satisfactory treatment for the condition, no time to obtain advance consent from the patient or representative, and if there is community involvement through a public disclosure and community consultation process. REB experiences since then are unknown. We surveyed REB chairpersons at the 126 United States medical schools to quantify reviewed protocols and identify attitudes about the rule, to better understand the rule's impact on REBs. Sixty-nine surveys were returned (55%). Fifty-two respondents reviewing human research had heard of the Rule. Forty-eight percent (25/52) had reviewed such a study; 40% of those had rejected at least one. Seventy-eight percent believe the rule protects human subjects, and 88% feel prepared to implement them. REB views differed from public opinion on how best to enact notification and consultation.

scholarly journals Preliminary Experience With Social Media for Community Consultation and Public Disclosure in Exception From Informed Consent Trials

Circulation ◽  
2013 ◽  
Vol 128 (3) ◽  
pp. 267-270 ◽  
Author(s):  
Shannon W. Stephens ◽  
Carolyn Williams ◽  
Randal Gray ◽  
Jeffrey D. Kerby ◽  
Henry E. Wang
Keyword(s):  
Social Media ◽  
Informed Consent ◽  
Public Disclosure ◽  
Community Consultation

Implementing Emergency Research Requiring Exception From Informed Consent, Community Consultation, and Public Disclosure

2007 ◽  
Vol 50 (4) ◽  
pp. 448-455.e4 ◽  
Author(s):  
Joshua G. Salzman ◽  
Ralph J. Frascone ◽  
Bobette K. Godding ◽  
Terry A. Provo ◽  
Elie Gertner
Keyword(s):  
Informed Consent ◽  
Public Disclosure ◽  
Community Consultation ◽  
Emergency Research

scholarly journals Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial

2014 ◽  
Vol 12 (1) ◽  
pp. 67-76 ◽  
Author(s):  
Maija Holsti ◽  
Roger Zemek ◽  
Jill Baren ◽  
Rachel M Stanley ◽  
Prashant Mahajan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Public Disclosure ◽  
Community Consultation

scholarly journals Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure

2020 ◽  
Vol 12 (1) ◽  
pp. 24-32
Author(s):  
Makini Chisolm-Straker ◽  
Denise Nassisi ◽  
Mohamud R. Daya ◽  
Jennifer N.B. Cook ◽  
Ilene F. Wilets ◽  
...  
Keyword(s):  
Informed Consent ◽  
Public Disclosure ◽  
Community Consultation

scholarly journals Using social media for community consultation and public disclosure in exception from informed consent trials

2016 ◽  
Vol 80 (6) ◽  
pp. 1005-1009 ◽  
Author(s):  
Shannon W. Stephens ◽  
Carolyn Williams ◽  
Randal Gray ◽  
Jeffrey D. Kerby ◽  
Henry E. Wang ◽  
...  
Keyword(s):  
Social Media ◽  
Informed Consent ◽  
Public Disclosure ◽  
Community Consultation

Implementation of Community Consultation for Waiver of Informed Consent in Emergency Research: One Institutional Review Board's Experience

2004 ◽  
Vol 52 (2) ◽  
pp. 113-116 ◽  
Author(s):  
Emily S. Dix ◽  
Domenic Esposito ◽  
Frances Spinosa ◽  
Nancy Olson ◽  
Stanley Chapman
Keyword(s):  
Informed Consent ◽  
Community Consultation ◽  
Emergency Research ◽  
Institutional Review
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