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Compliance In Focus
Posted by Stephani Hulec on Mon, Nov 4, 2013

What We Do To Protect Human Subjects

Clinical research trials have a multitude of stakeholders.  For the monitor, though, our first andWhat We Do To Protect Human Subjects most important priority is the human research subjects who have altruistically volunteered to participate in these trials.  Our goal is to ensure that the rights, safety, and well-being of clinical trial subjects are being maintained.  We remember the ethical principles as outlined in the Belmont Report- respect for persons; beneficence, and justice- as we travel all around the world to investigative sites conducting clinical research trials to ensure that they are being conducted appropriately.

IMARC monitors ensure human subject protection by knowing the regulations governing clinical trials, as well as having a thorough understanding of the requirements of the protocol, particularly enrollment eligibility criteria.  We review the investigative site’s regulatory files to confirm that the site has obtained permission from their IRB or Ethics Committee to conduct the study and enroll subjects.  We also verify that everyone working at that investigative site is qualified and trained to conduct the research trial that the subject will be participating in.

We perform a thorough review of each informed consent form that every subject signs, as well as any other documentation about the informed consent process; we do this to ensure that the consent was obtained properly, according to all applicable Federal Regulations, GCP guidelines, and IRB/EC requirements, and prior to conducting any study procedures.  We review subjects’ medical histories to ensure the subjects met all eligibility criteria set forth in the clinical investigational plan, and that the investigative site accurately records the data for each subject during the course of his/her clinical trial participation.  This includes making sure that adverse events are captured and reported as required to the study sponsor and/or regulatory committee.  For this to occur, IMARC monitors take it upon ourselves to obtain and understand the requirements of study approval of the IRB/ethics committee for each study site.  We partner with the site’s study staff to ensure that they are also aware of the governing federal regulations and of their own IRB/ethics committee SOPs.

We review each human subject’s research records to make sure the site is following the investigational  plan by completing all of the necessary screening evaluations, study procedures, follow-up visits, etc. required in the protocol.  We do this with the idea in mind that every research procedure the IRB approved was included in the protocol for a reason, and a missed study procedure could potentially be a safety risk for the patient.

IMARC monitors complete training in the therapeutic disease areas of the clinical studies that they monitor.  Additionally, IMARC monitors are keenly aware of Good Clinical Practices (GCP) and how this process should be documented by the sites who should also understand GCP.  Although our first priority is to those who are directly participating in the clinical research study, we are also cognizant that good clean data through source data verification (using ALCOA as a guide) ensures an appropriate approval of the investigational product and subsequently, the safety of potentially millions of humans who will utilize the product post-market.  To effectively monitor with the mindset of protecting human subjects, we learn the federal regulations, review the sponsor’s agreement, understand the investigational plan, and comprehend each site’s IRB/EC requirements so we can speak up on the behalf of the human subject that volunteered for the trial, if any one of these requirements are not being met.

In summary, we put human subjects first, always!  Share you thoughts on the importance of human subject protection below.

Photo Credit:Lighttruth

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Topics: Federal Regulations, Human Subjects Protection, IMARC Monitors

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