Phase IV study of device is required DCGI, EC approvals

We are planning to conduct one PMS study (device study) in a private hospital. Hospital doesn’t have its own Ethics Committee (EC), in such case to whom do we contact for approval? Is it necessary to take EC approval for phase IV study also, or notification to DCGI is sufficient?

For phase IV study of device, you will require DCGI and EC approval.

If a hospital does not have EC, you can obtain approval from an independent EC registered with CDSCO. See excerpt from Schedule Y below

Schedule Y 2.  Clinical Trial (1)  Approval for clinical trial

The trial site(s) may accept the approval granted to the protocol by the ethics committee of another trial site or the approval granted by an independent ethics committee (constituted as per Appendix VIII), provided that the approving ethics committee(s) is/are willing to accept their responsibilities for the study at such trial site(s) and the trial site(s) is/are willing to accept such an arrangement and that the protocol version is same at all trial sites.

The DCGI guidelines state that local ethics committee should be used for protocol review, but for a phase 4 protocol which does not require DCGI approval, can an ethics committee take up the review of the protocol with multiple centres or should the committee take only local centers?
It would critical to review what the design of phase IV trials is. If the phase IV is post-marketing surveillance, required by regulatory authorities, the protocol requires approval from DCGI office. If the phase IV trial is for a new unapproved indication, approval from DCGI office is required. In The Draft Guidance on Approval of Clinical Trials & New Drugs Draft Guidance (July 2011) has a section guidelines on data required to be submitted for approval of clinical trials (phase-I/II/III/IV).

The condition “EC should be local" means that the EC should only approve local centers, which they can monitor from the angle of protection of rights, safety and well being of subjects. Also, unless an EC has received registration, it cannot approve any protocols.

An investigator is planning a study with a lab, the purpose of which is commercialization of research outcome. What are the ethical issues?
Commercial use of patient samples requires a thorough review of the project/consent and also protection of patient's rights over his/her tissues/samples. ICMR 2006 guideline has discussed this situation under general ethical issues.

Some relevant items in consent are:  

• Benefit sharing in the event of commercialization
• Right to prevent use of her/ his biological sample (DNA, cell-line, etc.) at any time during the conduct of the research;
• Foreseeable extent of information on possible current and future uses of the biological material and of the data to be generated from the research and if the material is likely to be used for secondary purposes or would be shared with others, clear mention of the same;
• Risk of discovery of biologically sensitive information and provision to safeguard confidentiality;

The section on conflict of interest specifically describes investigator's financial interest in research and his/her and EC's obligation.

In a clinical trial curriculum vitae of the PI, Co-PI and Sub Investigators is required to document qualification and eligibility to conduct trial. What about laboratory investigators? Is it not required to document lab investigators qualification and eligibility to carry out the lab test in support of clinical trial?
GCP guidelines, under essential documents, require accreditation/certification of laboratory. During accreditation/certification process, the CVs of lab personnel are reviewed. However, there is no separate requirement in GCP for CV of lab personnel.

ICMR has issued guidelines for good clinical lab practice, for labs participating in clinical research and or medical care of patients. This guideline requires the lab to keep a personnel file which would include CV and training records of all lab personnel.

For safety and efficacy of FDC, Is clinical trial mandatory? Or can we justify safety and efficacy of FDC by literature review?
There are 2 guidelines for FDCs 1) Guidance for FDC Apr 2010 and 2) Approval of clinical trials and new drugs July 2011. The need for clinical trials would depend on the type of FDC, therapeutic rationale and available literature supporting the FDC.