When we talk about informed consent in clinical trials, the first reaction is to require researchers to fully explain to subjects in an independent and quiet environment, which is easier to meet for inpatients and outpatients.
However, we will also encounter the situation that the subjects cannot reach the center and need informed consent: the subjects are in the follow-up period and the version of informed consent form is upgraded, but the subjects cannot reach the center for informed consent due to the epidemic. At this time, according to the requirements of GCP, how can we complete informed consent?
Our partner operated in this way: the researcher called the subject to explain the purpose, introduced the updated part of the informed consent form to the subject in detail and answered questions. Then, the researchers signed the updated version of the informed consent form and sent it to the subjects. After receiving it, the subjects signed it and sent it back to the center. At the same time, the call and operation process in the whole process will be recorded and saved together with the express record.
Is the operation of this little partner right? Where is the legal basis?
The GCP regulations we are familiar with do not contain relevant contents. Are there any other regulations or guidelines for reference? Yes, of course.
In the 《Informed Consent Information Sheet》issuedby FDA in 2014, it was proposed that:
(Scan the QR code to read the whole article)
Back to China, the CDE issued 《The Guiding Principles for the Management of Clinical Trials of Drugs During the COVID-19 (Trial)》 on July 14, 2020, which includes the following descriptions:
In conclusion, the above operations have fully informed the subjects and truthfully recorded the process, which is in line with the general principles of GCP.
Dear teachers, do you have any opinions on offsite's informed consent? Welcome to leave messages for guidance and communication.
LINKS CRO
As a CRO company providing clinical trial services. LINKS CRO focus on innovation, high-risk implantation(intervention) medical device, with one-stop clinical trial solutions for the whole process of medical device research and development.The headquarters of LINKS is based in Shanghai, with subsidiary branches in Beijing, Shanghai, Guangzhou, and Shenzhen, in addition to ten regional offices. The current workforce comprises almost 200 employees, with technical personnel making up over 85% and dispersed across almost 30 cities nationwide.
Key Services include CRO, SMO, CER, Audit, Post-market research, core laboratory registration both domestically and overseas, innovation declaration, Expert Consultancy, and overseas enterprise agency services.
Key Indications include Cardiovascular, Neurovascular, Peripheral Vascular, Surgery Robot, Oncology, Ophthalmology, Medical Cosmetology, and other fields such as orthopedics. There are almost 300 projects consultations and services by LINKS each year.
