Some sponsors, to safeguard themselves, make it mandatory for the participant to sign each page of the ICF, which means that the participant has to sign around 20-25 times to indicate that he/she agrees to be a part of clinical trial. If AV recording is used, the number of signatures per first ICF could reduce dramatically. This will help the patient a lot because signing a single ICF multiple times is a cumbersome process for patients suffering from major illnesses. Reliability As per good clinical practice, the participant should be given the signed and dated copy of the informed consent document. One of the reasons is that this document helps the participants to refer to the details of the trial anytime. However, trial participants may not recollect all the answers provided by the physician to their doubts.
If a copy of the informed consent AV recording is given to the participants, they can access the discussion with the investigator anytime, provided they have access to the required technology to be able to view this recording. This can be of special importance in case of illiterate participants or those who have a limited understanding of medical terminologies. Transparency Lack of transparency is a reason for the public to be suspicious of industry’s intentions. The AV recording of the informed consent will increase the transparency of the informed consent process in clinical trials, this will in-turn increase the confidence of the society in the ethical conduct of clinical research in India, which is currently a pressing concern.
As per amendments to Indian Evidence Act, 1872 (1 of 1872) the definition of ??evidence?? has been changed to include electronic records (Section 3(a) of the Evidence Act) produced for the inspection Cilengitide of the court. Also the definition of ??Admission?? has been amended to include statement in electronic form in addition to oral or documentary form. As per the Information Technology (IT) Act, 2000 ??electronic records?? means data, record or data generated, image or sound stored, received or sent in an electronic form or microfilm or computer-generated microfiche. Hence in case of any allegation by the subject, AV recording could be used as evidence in the court of law provided prescribed process is followed for recording and maintaining the records.
Also name of the nominees and the income status can be confirmed with the recordings, which may help reduce likelihood of misinterpretation (example false claims) in the compensation process. Improvement in conduct of informed consent process Introduction selleck chemicals llc of the AV recording could take the informed consent process to higher standards than those followed today. Since the process will be recorded, the investigator will have greater accountability to ensure that the participants truly understand the clinical trial before enrollment.