Last fall, the FDA kept us busy by soliciting comments on a sweeping proposal to revise the Common Rule. This spring, the FDA again is keeping us busy – this time by asking for input on “Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice.” The agency has asked how to: Modernize [...]

In February 2012, the FDA issued a final guidance regarding IRB Continuing Review after Clinical Investigation Approval[1], which supersedes the Information Sheet Continuing Review After Study Approval.[2]  The guidance describes the Agency’s current thinking on continuing review and provides recommendations about criteria, process, and frequency of continuing review. The guidance covers four areas the FDA [...]

Under the federal regulations, an IRB must make additional considerations for research involving minors (children as defined by the local law where the research is taking place) because they are considered a vulnerable population.[1] In most cases, the researcher must obtain permission from the child’s parent or guardian and assent (a child’s affirmative agreement to [...]

Healthy Recipe of the Month Baked Meatballs These are so quick and easy because you cook them in the oven.  Make this large amount and freeze for later use.  This recipe also works well in diabetic menus. 1 cup oatmeal or oat bran 1 cup fat-free milk 1/2 cup egg substitute (=2 eggs) 1 tablespoon [...]

UPDATED 04/12/12:  Linda Coleman, JD, CHC, CHRC, Director of Regulatory Affairs and General Counsel for Quorum Review IRB, received top honors on Thursday night in Seattle, WA, winning the Puget Sound Business Journal’s Award for 2012 Outstanding Corporate Counsel at a Small Company (<1000 employees). Ms. Coleman joined Quorum Review in 2007 as the Director [...]

The standard for IRB review of website content is virtually the same as print or media advertising. FDA expects IRBs to review the advertising to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol. This is especially critical when [...]

In research, informed consent is based on the principle that persons should be allowed to make their own decisions.  The first principle of the Belmont Report, is respect for persons, which is explained as follows: “first,…individuals should be treated as autonomous agents, and second, …persons with diminished autonomy are entitled to protection.” It is generally [...]

Quorum Review was honored to receive an Eagle Award as “The Best IRB to Work With” during the 2011 Site Solutions Summit conference in Florida. Four hundred site personnel and other attendees were asked to vote for the best IRB, CRO and sponsor to work with on the grounds of professionalism, support and integrity – [...]

Quorum Review IRB has introduced a new ethics board located in Cambridge, Massachusetts. This unique panel includes members from academia with significant expertise in oncology research. The Cambridge Board began reviewing studies on October 4, 2011. Quorum will continue to hold 8 board meetings each week. Oncology is a complex, fast-moving and innovative area of [...]