IRB Advisor – January 1, 2018
January 1, 2018
View Issues
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
OHRP and FDA Issue Guidance on IRB Meeting Minutes
The Office for Human Research Protections and the FDA prepared guidance to inform IRBs about how best to prepare and maintain IRB meeting minutes under both agencies’ regulatory requirements.
-
Purdue IRB Shuts Down Youth Study
An IRB at Purdue University in West Lafayette, IN, has terminated a study of young people with high blood pressure after a youth camp last summer was plagued by multiple incidents of violence and sexual harassment.