Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Informed consent: protection or obstacle? Some emerging issues

S S Ellenberg1

  • 1Division of Biostatistics and Epidemiology, Food and Drug Administration, Rockville, Maryland, USA.

Controlled Clinical Trials
|December 31, 1997
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Effect of testosterone treatment on the trabecular bone score in older men with low serum testosterone.

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·2021
Same author

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges.

Journal of veterinary internal medicine·2017
Same author

Surrogate endpoints: the debate goes on.

Pharmacoepidemiology and drug safety·2002
Same author

Safety considerations for new vaccine development.

Pharmacoepidemiology and drug safety·2002
Same author

The epidemiology of fatalities reported to the vaccine adverse event reporting system 1990-1997.

Pharmacoepidemiology and drug safety·2002
Same author

Evaluating the safety of combination vaccines.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2001
Same journal

On the generation and ownership of alpha in medical studies.

Controlled clinical trials·2004
Same journal

An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia.

Controlled clinical trials·2004
Same journal

Symptom recording in a randomised clinical trial: paper diaries vs. electronic or telephone data capture.

Controlled clinical trials·2004
Same journal

Statistical comparison of random allocation methods in cancer clinical trials.

Controlled clinical trials·2004
Same journal

Analyzing bronchodilation with emphasis on disease type, age and sex.

Controlled clinical trials·2004
Same journal

Geographic variability in patient characteristics, treatment and outcome in an International Trial of Magnesium in acute myocardial infarction.

Controlled clinical trials·2004
See all related articles

Informed consent in medical research is debated. Innovative approaches like randomized consent and waiving consent in emergencies present ethical challenges, with varied responses from the medical community and regulators.

Area of Science:

  • Medical Ethics
  • Clinical Research Methodology

Background:

  • Informed consent is a cornerstone of medical research ethics.
  • Controversies exist regarding specific informed consent procedures.
  • Innovative research designs introduce novel ethical considerations.

Purpose of the Study:

  • To examine controversial aspects of informed consent in medical research.
  • To discuss innovative approaches to informed consent, including randomized consent and waiver of consent in emergencies.

Main Methods:

  • Review of established ethical principles for informed consent.
  • Analysis of proposed modifications to informed consent procedures, such as Zelen's randomized consent design.
  • Examination of proposals for waiving informed consent in emergency research.

Related Experiment Videos

Main Results:

  • Zelen's randomized consent design allows randomization before consent for the experimental arm.
  • Waiver of informed consent is proposed for emergency research when patients are incapacitated and proxy consent is unavailable.
  • The medical community and regulatory bodies have shown divergent responses to these proposals.

Conclusions:

  • Ethical debates continue regarding the balance between research advancement and patient autonomy.
  • Innovative consent models require careful ethical scrutiny and regulatory consideration.
  • Divergent responses highlight the complexity of adapting informed consent to evolving research practices.