Internal Review Boards
RSSArticles
-
Counterpoint: Transplant Recipients of Research Organs Entitled to Informed Consent
Interventional research to preserve the viability of donor organs means the transplant recipient is a research subject entitled to give informed consent — period, experts say.
-
Sample of Two-page Informed Consent Document
The University of Cincinnati developed a two-page informed consent form that could be used in an emergency research study, involving the administration of pain medication to people who were in acute traumatic pain.
-
Study Looks at Use of Emergency Research Informed Consent
Emergency research is essential to improving healthcare, but following regulatory human research protection rules can be challenging — particularly with informed consent.
-
How to Ensure Exempt Studies Maintain Data Confidentiality
Whether the Common Rule changes requirements for handling exempt studies, IRBs might choose to stay involved in these decisions. How they accomplish that depends on the IRB’s policies, procedures, and goals, but one important focus should be on data confidentiality.
-
Clinical Trials Often Exclude Women, Even When There Could Be Compelling Benefit
Clinical trials often exclude pregnant women, citing additional risks. However, women almost never are asked what they think about participating in those studies and the risks. This is an issue some researchers are working to correct.
-
Revisiting the ‘Unfortunate Experiment’ in New Zealand
It’s astonishing in retrospect that women in New Zealand diagnosed with an increasingly clear precursor to cervical cancer were left untreated and uninformed in an unethical study that continued for two decades.
-
Are Organ Transplant Recipients in a Trial Protocol Considered Research Subjects?
Research protocols to extend the viability period of transplant organs are of great interest, but does that mean organ recipients must give informed consent as research subjects? Here we enter an ethical impasse, that if adequately resolved could increase the supply of organs for transplant.
-
PRIM&R Finds Itself Caught in State Travel Ban Controversy
The 2017 PRIM&R conference was scheduled for November in San Antonio, TX. All was well until the Texas legislature passed legislation in May 2017 that allows adoption providers to turn away potential parents, including lesbian, gay, bisexual, and transgender families and others, based on the adoption providers’ religious beliefs.
-
Informed Consent Conundrum: Making the Complex Concise
New language regarding informed consent in the revised Common Rule seems benign enough at first reading, but actually accomplishing the directives in a scientifically valid manner is a formidable undertaking.
-
Finding a Path to Informed Consent for the Addicted
As an opioid epidemic ravages the country, a cutting-edge question on the frontier of neuroscience is: Can addiction be blocked in the brain? Even if it could, the question for IRBs will immediately be: Can an addict give informed consent?