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We have received a research study protocol of student thesis. The objective is to conduct study the effect of type 2 diabetes mellitus on bone density. For this the patients will undergo DXA scan. The student has requested approval of research as observational study. Should the ethics committee approve this as an observational study?
Dr Nitin Baghel
This study is based on a diagnostic intervention. So, this study will not be considered non-interventional observational study.
As per European Commission Article 2(c) of 2001/20/EC, in a non-interventional observational study, no additional diagnostic or monitoring procedures are applied to the patients, and epidemiological methods are used for the analysis of collected data.
ICMR 2017 guidance considers diagnostic agents and devices as interventions.
7.0 A clinical trial is any research/study that prospectively assigns human participants or groups of humans to one or more health-related intervention(s) to evaluate the effects on health outcomes. The intervention could be drugs, vaccines, biosimilars, biologics, phytopharmaceuticals, radiopharmaceuticals, diagnostic agents, public health interventions, socio-behavioural interventions, technologies, devices, surgical techniques or interventions involving traditional systems of medicine, etc.
ICMR 2017 definition of medical device includes instruments for detection or diagnosis.
7.7.1 A defined as a medical tool which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means but which may be assisted in its intended function by such means. It may be an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes of:
(i) detection, diagnosis, prevention, monitoring;
(ii) treatment or alleviation of any physiological condition or state of health, or illness;
(iii) replacement or modification or support of the anatomy or congenital deformity;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; or
(vi) control of conception.
DXA scan uses low-dose X-ray to diagnose osteoporosis. Although the amount of radiation used in DEXA scans is very low and like the amount of radiation used in X-rays, added radiation exposures can slightly increase the risk of developing cancer later in life (US Centers for Disease Control and Prevention). Hence, Ethics Committee should thoroughly review risk benefit of this interventional study before giving approval.
If the Principal Investigator/sponsor of a clinical trial is not happy with the decision of the Ethics Committee, can they complain against the EC decision with CDSCO/DCGI?
Dr Sreevatsa
As per NDCTR 19, In case an Ethics Committee of a trial site rejects the approval of the protocol, the details of the same should be submitted to the CDSCO/DCGI prior to seeking approval of another Ethics Committee for conduct of the trial at the same site. So, the ethics committee should inform the CDSCO/DCGI about the rejection of the approval of the protocol with the justification.
NDCTR 19 on page 156 in Clinical Trial Section describes the appeal process by an applicant:
An applicant who is aggrieved by the decision of the Central Licencing Authority under sub-rule (1) or sub-rule (3), may file an appeal before the Central Government in the Ministry of Health and Family Welfare within forty-five days from the date of receipt of such decision and the that Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty working days.
The applicant means sponsor.
In NDCTR 19 there is no appeal process for an investigator/ sponsor to complain against the EC decision.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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