U.S. Federal Regulations for emergency research: a practical guide and commentary

Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine
Andrew McRae, Charles Weijer

Abstract

Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enroll subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the element...Continue Reading

References

Jul 16, 1987·The New England Journal of Medicine·B Freedman
Apr 30, 1998·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·M H BirosC Doherty
Sep 16, 1999·The New England Journal of Medicine·P J KudenchukT Walsh
Dec 28, 1999·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·E P SloanJ Barrett
May 15, 2002·Critical Care Medicine·Andrew D McRae, Charles Weijer
Apr 4, 2003·The New England Journal of Medicine·Jason H T Karlawish
Oct 2, 2003·Annals of Emergency Medicine·Michelle H Biros
Nov 5, 2003·Pediatrics·Jan Ellen Berger, UNKNOWN American Academy of Pediatrics Committee on Medical Liability
Dec 26, 2003·American Journal of Respiratory and Critical Care Medicine·Henry J SilvermanJack Schwartz
Jun 1, 2004·Nature Medicine·Charles Weijer, Paul B Miller
Aug 31, 2004·Annals of Emergency Medicine·Andrew D McRae, Charles Weijer
Jan 7, 2005·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·David McD TaylorPeter A Cameron
Apr 5, 2005·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Catherine A MarcoAlisa Roberts
Apr 9, 2005·Critical Care Medicine·Charles Weijer
Jul 1, 2005·Annals of Emergency Medicine·Faiqa QureshiBonnie L Burke
Sep 17, 2005·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Andrew D McRaeCharles Weijer
Nov 3, 2005·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Vincent N Mosesso, David C Cone
Nov 3, 2005·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Drew WattersRobert Silbergleit
Nov 3, 2005·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Amy A Ernst, Susan Fish
Nov 12, 2005·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Marc MartelMichelle Biros
Aug 1, 2006·Emergency Medicine Clinics of North America·Judy B Shahan, Gabor D Kelen
Aug 12, 2006·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Christine M StorkLawrence H Brown
Apr 3, 2007·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Michelle Biros
Apr 3, 2007·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Jill M Baren, Michelle H Biros

❮ Previous
Next ❯

Citations

Jul 28, 2011·Neurocritical Care·C E HallUNKNOWN First Neurocritical Care Research Conference Investigators
Sep 24, 2013·The Journal of Emergency Medicine·Joseph D IsaacsZoltan Szomor
Mar 31, 2012·Burns : Journal of the International Society for Burn Injuries·Martha G BlackfordMichael D Reed
Jun 3, 2009·Surgery·Peter K MooreFrederick A Moore
Mar 21, 2009·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Angela Del GiudiceJill M Baren
Apr 19, 2012·ANZ Journal of Surgery·Ben HickeyAndrew Logan
Oct 30, 2013·The Journal of Animal Ecology·Katherine A HarrissonPaul Sunnucks
Jul 22, 2014·Emergency Medicine Australasia : EMA·Erin MillsEd Oakley
Nov 28, 2017·Accountability in Research·Linus Broström, Mats Johansson
Dec 5, 2008·AAOHN Journal : Official Journal of the American Association of Occupational Health Nurses·Randal BeatonPatricia Butterfield
May 25, 2010·Journal of Food Science·Caitlin E LaClair, Mark R Etzel
Nov 6, 2009·The American Journal of Clinical Nutrition·Susan B RacetteRichard E Ostlund
Feb 26, 2019·Journal of Genetic Counseling·Mike Darren SuguitanKrista Redlinger-Grosse
Dec 18, 2018·Teaching and Learning in Medicine·Maria C CusimanoCheryl Cline
May 10, 2011·Journal of Cancer Education : the Official Journal of the American Association for Cancer Education·Jamie S OstroffErica I Lubetkin
Apr 24, 2012·The American Journal of Hospice & Palliative Care·Lisa C Lindley
May 5, 2012·Occupational Therapy International·Gunilla M LiedbergCarol S Burckhardt
Oct 30, 2012·Journal of Psychosocial Oncology·Julianne S OktayKathleen C Kern
May 4, 2018·Journal of Aging and Physical Activity·Jen D WongToni Liechty
Aug 6, 2019·Traffic Injury Prevention·Narayan YoganandanFrank A Pintar
Jan 22, 2014·Risk Analysis : an Official Publication of the Society for Risk Analysis·Dirk ScheerGaby-Fleur Böl
Oct 4, 2014·Journal of Continuing Education in Nursing·Brenda L MaddoxLatricia D Weed
Feb 11, 2016·Journal of Racial and Ethnic Health Disparities·Judith L SingletonDeepa Rao
Aug 3, 2017·BMJ Open·Mira S StaphorstSuzanne van de Vathorst

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine
Jill M Baren, Susan Fish
Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine
N Clay MannLynne D Richardson
© 2021 Meta ULC. All rights reserved