Informed consent is an approval given by the patients for the concerned health care professionals before they start any clinical trials. The Case Report File (CRF) will be used significantly in the clinical trial research which collects the data from each participating site. Likewise, ICF (Informed Consent Form) should be written, signed and dated while submitting for approval.
Important aspects of IC
The document that contains the complete information about the body of an investigative product is known as the Investigational brochure. The investigational product would be either IP or study drug obtained during a drug trial. For the purpose of monitoring, designation to approval and to review biomedical and behavioral research involving humans, a special committee called Independent ethics committee has been formed. It is also known as institutional review board (IRB), ethical review board (ERB) or research ethics board (ERB).
Acquiring written Informed consent doesn’t simply confine to just a signature on a form from a potential subject. In fact, the consent document serves as an important material to build a bridge providing a meaningful mode of exchange between the investigator and the subject. One should understand the primary importance of Informed consent rather than assume it as just about signing a form. IC is entirely dependent on the people’s understanding of the potential risks and benefits of their involvement, purpose, and procedures and their alternatives to participation. Indeed, they should be willing to participate in a study.
Patient’s consent is a part of Informed consent that establishes a process of communication between patient and the physician. Patient consent gives the authorization or agreement to undergo a specific medical intervention.
Detailed summary of process in IC
Informed consent deals with providing a potential participant with necessary data containing the approval of an informed consent regarding the participants involved in the clinical investigation, framing agreement that has voluntary wish of the potential participants, ensuring the understanding (about nature of IC) of the potential participant, analysis of research protocol in an appropriate given time that allows a participant to discuss with his or her family and friends regarding their participation and an assurance to continue to provide information whenever the subject or situation or the clinical investigation progresses require.
Further, the potential research subject that is about to enroll in a clinical trial should be briefed with the certain explanations of the processes. Some of them are explaining about the statement and purposes involved in the research, expected length of time, description of all the procedures, predictable risks, vulnerable factors such as frequency of blood tests and injections, expected benefits and alternative procedures or treatment. A detailed statement with the confidential information of the data collected during the clinical research, records gathered to fetch out the subject and the scope of FDA that may inspect the records should be manifested.
Feasibility of access for a potential research subject
A potential research subject involved in an informed consent can avail a lot of opportunities such as reading the consent document, taking the consent document to their home in order to discuss with their family, friends, and advocate. But, it is allowed only on the criteria that they have considered participating in a clinical trial. The participant can ask questions about anything that is very complex or hard for them to understand. On the other hand, an investigator can be able to acquire consent from a potential subject only if the potential research subject had been given with ample amount of time to make their consideration besides remaining genuine by not trying to persuade or influence the potential research subject. It has to be noted that the information provided to a potential research subject should be in the language that they understand.