Case Study, Clinical Trials, Crisis Management, Guidelines & Regulations, Informed Consent, Research Participants

A Tribute to Ellen Roche

In recognition of World Asthma Day, we wish to underline the importance of pursuing clinical research in order to improve the quality of life for the 300 million people affected by this disease. It is also important to remember those, like Ellen Roche, who participated in such clinical research. Ellen Roche was an employee at […]

Clinical Trials, Guidelines & Regulations, Informed Consent

The Revised Common Rule:
Trans-border Research and Henrietta Lacks

It is refreshing to see policy changes influenced by the evolution of science as opposed to crisis. The increased engagement of research participants in research coupled with increasing complexities in the research landscape have catalyzed revisions to the Common Rule. Inspired by the Belmont Report, the Common Rule was developed to ensure that research involving […]

Veritas IRB
AER15, Data Collection, en, Informed Consent

What Am I Consenting To? Research Privacy and Data Collection in a World of Applications and Technology

November has no doubt been a month of interesting discussions and debates surrounding research and bioethics, as showcased recently at the 2015 PRIM&R Conference in Boston. (Editor’s note: for an in-depth look at our coverage from PRIM&R 2015, we welcome you to view our blog posts on PRIM&R Pre-Conference Highlights: From IRB 101 to Biobanking, […]

en, Informed Consent

How to write a confidentiality clause in a research consent form?

We all know how challenging drafting an effective informed consent form for research can be. As a researcher, you have the dual duty to disclose all the information considered to be legally and ethically necessary to make an informed decision in a manner that will be understandable to the prospective research participant. Many efforts have […]

en, Informed Consent

When does the informed consent process begin?

When do you think this process begins? Take a moment to think about it before reading on… Does the informed consent process begin with the informed consent discussion? It may surprise you, but the “FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection process”. This means […]

en, Informed Consent

Is research without consent legally or ethically possible?

Comments on articles recently published in NEJM In a recent edition of the New England Journal of Medicine, prominent bioethicists argued that “some studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all”. The authors also propose to streamline the oversight of some studies that fall “below […]