Passive consent for clinical research in the age of HIPAA.

Journal of General Internal Medicine
Benjamin Littenberg, Charles D Maclean

Abstract

Federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) of 1996, intended primarily to protect individuals, have been described as significant barriers to the use of clinical registries and other population-based tools for health care research. Although these regulations allow for the waiver or alteration of usual consent procedures when the research meets certain specific criteria, waivers and alterations are rarely used in health care research. The Vermont Diabetes Information System is a multistate randomized trial of a quality improvement intervention that uses a novel alteration of informed consent to help ensure that the study sample is representative of the target population. Patients are notified by mail that they are eligible for the study and that they may opt out of the study, if they desire, by calling a toll-free number. Seven thousand five hundred and fifty-eight patients were invited to participate. Two hundred and ten (2.8%) opted out. Three patients (0.04%) filed complaints, all of which were addressed satisfactorily. Health Insurance Portability and Accountability Act and other federal regulations raise challenges to the use of clinical registries in research, bu...Continue Reading

References

May 25, 2002·The New England Journal of Medicine·Lawrence KwanLee Levitt
Oct 9, 2002·JAMA : the Journal of the American Medical Association·Thomas BodenheimerKevin Grumbach
Oct 11, 2002·The New England Journal of Medicine·Jennifer Kulynych, David Korn
Oct 17, 2002·JAMA : the Journal of the American Medical Association·Thomas BodenheimerKevin Grumbach
Apr 11, 2003·The New England Journal of Medicine·George J Annas
Jul 17, 2003·JAMA : the Journal of the American Medical Association·Rita McWilliamsGarry Cutting
Apr 9, 2004·The New England Journal of Medicine·Jack V TuUNKNOWN Investigators in the Registry of the Canadian Stroke Network
May 29, 2004·Annals of Surgery·Jacquelyn K O'HerrinKenneth A Kudsk
Aug 6, 2004·The New England Journal of Medicine·Alexander M ClarkIain N Findlay
Jan 25, 2005·Health Services Research·Kathleen DziakSarah Hudson Scholle
Jul 16, 2005·BMJ : British Medical Journal·Araceli BusbyDavid Stone

❮ Previous
Next ❯

Citations

Apr 15, 2009·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·David R Nerenz
Oct 29, 2009·Journal of General Internal Medicine·Charles D MacleanBenjamin Littenberg
Jan 18, 2013·Journal of Empirical Research on Human Research Ethics : JERHRE·Susan MazanecMary Step
Sep 28, 2010·The Orthopedic Clinics of North America·Eve Blair
Oct 27, 2010·Health Outcomes Research in Medicine·Shamima KhanBenjamin Littenberg
Feb 29, 2008·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·Alice M Mitchell, Jeffrey A Kline
Sep 10, 2015·Internal Medicine Journal·S WilkinsS M Evans
Aug 28, 2016·Pediatric Clinics of North America·Timothy Ryan Smith
Mar 4, 2015·Clinical Trials : Journal of the Society for Clinical Trials·Monique L AndersonUNKNOWN participants in the NIH Health Care Systems Research Collaboratory Cluster Randomized Trial Workshop
Mar 6, 2010·The Medical Journal of Australia·John J McNeilPeter A Cameron
Jul 9, 2014·Pediatrics·Renee A HiggersonUNKNOWN PALISI PICFlu Study Investigators

❮ 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

American Journal of Preventive Medicine
Michael G GoldsteinPlanning Committee of the Addressing Multiple Behavioral Risk Factors in Primary Care Project
The New England Journal of Medicine
Fernando AlthabeGuidelines Trial Group
© 2022 Meta ULC. All rights reserved