Q. We have planned for a clinical study on diabetic patients using our non-invasive medical device along with a treatment which involves approved marketed drug. As the device is non-invasive medical device and treatment involves approved marketed drug, the dilemma is whether an ethics committee approval is required for the study?
● S. Gurunath
TAll the relevant research guidelines recommend as follows:
ICMR: All the research involving human subjects should be conducted in accordance with the four basic ethical principles, namely Autonomy or respect for person/subject, Beneficence, Non-maleficence and Justice.
ICH-GCP: The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.
Indian GCP: They should be followed for carrying out all biomedical research in India at all stages of drug development, whether prior or subsequent to product registration in India
Besides, Indian GCP recommends that the procedure for clinical trials of devices is similar to drugs.
7.3 Clinical trials with surgical procedures/ medical devices
All the general principles of clinical trials described for clinical trials should also be considered for trials of medical devices. Informed consent procedures should be followed as in drug trials. The patient information sheet should contain information on following procedures to be adopted if the patient decides to withdraw from the trial.
Besides, you need to consider whether concomitant use of a device and a drug is well established or is likely to be considered a new therapy. In addition, all reputed journals demand that EC as a pre-requisite for publication. In view of all these considerations, I feel that EC approval is necessary for your study.
Q. Do we have to follow all the regulations (Schedule Y) and all the GCP guidelines (ICH and Indian) for clinical trials?
● Manoj Sharma
AIndian GCP recommends that the researcher has to follow the regulations which provide greater protection to subjects. The relevant excerpt is:
2.4.1. Ethical Principles
All research involving human subjects should be conducted in accordance with the ethical principles contained in the current revision of Declaration of Helsinki and should respect three basic principles, namely justice, respect for persons, beneficence (to maximize benefits and to minimize harms and wrongs) and non-malaficence (to do no harm) as defined by "Ethical Guidelines for Biomedical Research on Human Subjects" issued by the Indian Council of Medical Research and any other laws and regulations of the country, which ensure a greater protection for subjects.
Q. Which of the following is the most appropriate way of guarding a subject's confidentiality?
a) Putting a subject identi-fier code on the Case Report Form
b) Telling the subject that every reasonable effort would be made to protect his/her confidentiality
c) Reporting the data in the aggregate
● Manoj Sharma
The most appropriate way of guarding a subject's confidentiality Option a; Indian GCP recommends;
3.3.8 Progress Reports
All reportings made by the investigator should identify the subjects by unique code numbers assigned to the study subjects rather than by the subjects' name(s), personal identification number(s) and/or addresses. Option b is just an assurance.
Option c aggregate trial report also requires indivi-dual subject's data to be listed by using a unique patient identifier.