Informed Consent in Clinical Trials (CT) What is Informed Consent Process? In clinical research(CR) trial Informed Consent Process is a series of conversions between the clinical trial participants and principle investigators. It is very essential before enrolling a participant and ongoing process. As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find. If the participant wants to get involved in the clinical research trial, he or she gives voluntary consent by sighining and dating the written informed consent document of which he or she also receives a copy. The potential participant has right to back out from consent at any time without penalty, reverberation or reason. Why Is Informed Consent so Important? Informed consent is a very important part of enrolling in a CT because it yields the potential patient all the information that they require to understand what they are volunteered for. It is very essential for people thinking about participating in a CR trial to accept their role in study. These studies are expected to test the assurance and efficacy of new treatments and therapies on people. Due to this, participants must be aware that they are acting as subjects in clinical research study and not as patients. Even supposing participants may receive personal treatment and care from physicians or doctors over the course of trial, they must also informed that
There are hazards involved in CT participation Research team doesn’t guarantee about the benefits Investigators have right to exit the CT Sometimes the study may not follow standard medical procedures
This information provided through the informed consent process allows you to know what you are signing up for.
Participants of Informed Consent process The informed consent process in clinical research trials consists of a document and a series of conversation between the trial participant (Potential Participant) and the principal investigator (PI). The main participants of informed consent process are potential patient and principle investigator whereas this activity requires doctors, researchers and investigators. Role of Principle Investigator in Informed Consent Process  Principle Investigator discusses the risks, benefits and other aspects of clinical trial with potential participant and, if required the participants legal representative before the trial begin. Informed consent is an open ended process that consists of document and a  The Principle Investigator provides enough time to the potential participant and convenience to ask questions about the clinical trial and discuss them with his relatives and family members. Guidelines of Informed Consent Process The principle Investigator must follow the International Council on Harmonization (ICH) good clinical practice (GCP) guidelines. Investigators should obey to national and local regulatory requirements, sponsor requirements and personal d data security regulations applicable in the country in which the study is being conducted, in addition to following ICH guidelines. The informed consent document must have to fully approve by an institutional review board i.e. IRB or an independent ethics committee- ICE prior to its use with trial participants. Elements Included in Informed Consent document An appropriate informed consent document should include the following elements
Unexpected risks in the trial for example unborn baby, if the subject is or may become pregnant. Hence the document should include a statement about research treatment. Reasons when the clinical trial investigator ends research subject participation. e.g. failing to follow the requirements of the trial Consequences of leaving a trial before it is completed Number of subjects that will be enrolled in the study.
Language used in Informed Consent process The language used for documentation should be simple and easy to understand to the potential patients and investigators. Generally many clinical research trials insist to use the universal language or the language of that particular country for documentation.