Doing clinical research has its own gratifications. However, as investigators, one should be aware of the ethical considerations involved in research, so that the confidentiality and dignity of participants is maintained. The rapid proliferation of clinical research globally has prompted governments to bring in regulations to ensure that investigators follow norms in sync with international standards. Informed consent is perhaps, the most important aspect of this entire exercise. Today, I see many physicians participating in multicentric clinical trials or providing patient data to sponsors, without being aware of the nuances of the consent process.
In this blog, I have highlighted the essentials of informed consent mandated by the ICMR and the DCGI, Govt. of India.
The “Schedule Y (Appendix V)” is the most important document that highlights different aspects of the informed consent process. The Essential elements are as follows:
Statement that the study involves research and explanation of the purpose of the research.
Expected duration of the Subject’s participation.
Description of the procedures to be followed, including all invasive procedures.
Description of any reasonably foreseeable risks or discomforts to the Subject.
Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected Subject should be made aware of this.
Disclosure of specific appropriate alternative procedures or therapies available to the Subject.
Statement describing the extent to which confidentiality of records identifying the Subject will be maintained and who will have access to Subject’s medical records.
Trial treatment schedule(s) and the probability for random assignment to each treatment (for randomized trials).
Compensation and/or treatment(s) available to the Subject in the event of a trial-related injury.
An explanation about whom to contact for trial related queries, rights of Subjects and in the event of any injury.
The anticipated prorated payment, if any, to the Subject for participating in the trial.
Subject’s responsibilities on participation in the trial.
Statement that participation is voluntary, that the subject can withdraw from the study at any time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise entitled.
Additional costs to the Subject that may result from participation in the study.
Approximate number of Subjects enrolled in the study.
Any other pertinent information.
As clinicians, we may find it very exciting be associate ourselves with multicentric trials, and believe me, the opportunities are coming in large numbers. For e.g., the LUMINOUS trial – A global phase 4 study to analyze real world outcomes of Ranibizumab for AMD/Vascular pathologies has enrolled centers from 42 countries, out of which only 14 countries contributed >100 patients, India being one of them. To participate in these studies, you must familiarize yourself with the informed consent process, because, remember, the final responsibility for the patient related data is yours.
Sengupta’s Research Academy is in the process of creating a series of online lectures to explain the nitty-gritties of the consent process, ethics committee creation and its operations, differentiation between sponsored vs. investigator initiated studies, compensations involved with clinical trials, good clinical practice guidelines and other Ethical aspects of research soon. Till then, you can enjoy online lectures on other aspects of clinical research available at the Academy’s website.
A Model Informed Consent form and Model patient information sheet can be accessed here.
** Disclaimer: The Essential aspects of the informed consent process and the informed consent form have been reproduced from the Schedule Y document, as an educative initiative, in public interest. Sengupta’s research Academy does not claim this to be their original material and does not hold the copyright for these contents; nor are they infringing on the copyrights held by the DCGI.
By – Dr Sabyasachi Sengupta.