IMARC Research, a contract research organization (CRO) recently published a list of the “Top Five FDA Warning Letter Findings for Clinical Investigators.” Warning letters are issued when FDA finds objectionable conditions upon inspection. IMARC’s top 5 noted...
Two articles in the Hastings Center Report, entitled “Ethical Oversight of Learning Health Care Systems” challenge the current ethical practices for protecting human volunteers in medical studies, according to a recent article on medicalnewstoday.com. The Hastings...
In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the...
Our Board will still meet the holiday week of 4th of July. Please submit all documents and forms by end of day July 3rd for review in the July 12, 2012 regularly scheduled meeting. To discuss your upcoming study review needs, contact us at 317.899.9341 or email...
All of us in research are aware of the challenges with length and understandability of informed consent documents. In a new article found in the December issue of Anesthesiology News entitled “Uninformed Consent: Average Study Participant Likely Unaware of...
Today, we announced some very exciting news. Pearl IRB has grown. To meet the needs of our clients, we have expanded our service offerings. Pearl Pathways, the new parent company, will be organized into three distinct and efficient business units. Pearl IRB remains...
