If you have run a clinical trial, you are most likely familiar with the Western Institutional Review Board, more commonly referred to as WIRB. They are the largest central IRB in the world, servicing pharmaceutical, device, and biologics trials across the globe. One of their most useful resources for clinical professionals is “A Guide for Researchers”, which outlines their current policies. These policies are based on an integrated regulatory framework, consisting of the Food and Drug Administration (FDA) regulations (namely 21 CFR 50 & 56), the Department of Health and Human Services (HHS) (45 CFR 46 Parts A-D), and the International Conference of Harmonization (ICH) Guidance for Industry (E6- Good Clinical Practice). As the clinical research landscape continues to evolve, the WIRB policies are adjusted to match that climate. This is evident in the four revisions/updates to “A Guide for Researchers”, updated August 17, 2017. These updates are described below.
ConsentNow™ e-Consent technology
The FDA has issued guidance on the “Use of Electronic Informed Consent” which describes components within electronic informed consents, like electronic media, graphics, interactive Web sites, etc. The issuance of this guidance has prompted WIRB to create a best practice guide surrounding electronic informed consent (eIC) that includes information regarding submission timing, content, and approval. WIRB has also specified their preferred vendor for eIC as Patient Genesis, using their ConsentNow™ eConsent technology. With this software, clinicians can utilize custom video animations, language translation, patient retention assessments, real-time analytics, e-signatures with audit trails, and other features to improve the eIC process. The latest version of study protocols are also loaded in ConsentNow™ providing an extra level of regulatory compliance by not allowing the consent process to continue until all required protocol signatures are in place. With an improved process, the eIC will yield patients with a deeper level of clinical trial education and a true understanding of the potential benefits and risks associated with their study participation, thus increasing overall patient retention rates in clinical trials.
Required Documentation for Canadian Research Review
There are a number of required elements that must be submitted to WIRB prior to any research review. Among them include items such as the Investigator’s Brochure, an FDA approved IND or IDE, and the CV/Medical license for the Principal Investigator of the trial. For protocols being run in the U.S. and Canada or if the research was pre-reviewed by a U.S. panel, a U.S. WIRB Panel and a Canadian WIRB Panel will both be utilized to review the trial and there may be additional elements required with the submissions. The WIRB updates cite two such items: the Health Canada No Objection Letter (NOL) (if available) and a per capita based, preferably itemized, budget plan (TCPS 2 Article 11.11). These additional elements are used to identify and manage any potential conflict of interest. Additionally, Canadian research sites must adhere to both the U.S. regulations, as well as Health Canada regulations, the Tri-Council Policy Statement(TCPS, 2014), Canadian privacy legislation, and any other applicable regulations when the research is also performed in the U.S. Overlapping research requirements and regulations may be challenging to comply with, but further clarification may be provided by using the FAIR Shake™ model.
Institutional Biosafety Committee
Depending on the type of funding source, Institutional Biosafety Committees (IBCs) may be required entities when a trial involves any type of Human Gene Transfer (HGT). The National Institute of Health (NIH) has provided the “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules” to help navigate some of the processes and regulations regarding these types of trials and are applicable to all NIH funded studies and preclinical and nonclinical research associated with NIH funding. These guidelines were updated in 2016 to add the requirement of oversight by an IBC and IRB for HGT protocol registration with the NIH Office of Science Policy.
FAQ - Pennsylvania Supreme Court Ruling on Pennsylvania Statutes Title 40
The Pennsylvania Supreme Court cited malpractice by a physician who delegated the informed consent process to a subordinate, according to local regulations. The court interpreted the regulations as designating the responsibility to the acting physician conducting the surgery or treatment only, and that the informed consent process was not a delegable task, except in emergencies. This decision sets a new standard for conducting informed consents in the state of Pennsylvania, and demonstrates the importance of adhering to the most stringent set of applicable regulations, whether state, federal, or otherwise specified. WIRB acknowledges this ruling and the expectation is that informed consent is obtained by a study-trained investigator for sites in Pennsylvania.
With the constantly shifting landscape of clinical research, it can seem like an unequal playing field. Staying current on regulations, IRB protocols and processes, and other relevant materials will increase the likelihood of clinical trial success and more importantly, ensure patient safety.Roll up, Roll up! via photopin (license)