Patients' written consent is mandatory to publish their personal data

For obtaining the data from patients and publishing the same in a literature or a booklet, can we take telephonic consent from patient? Is written consent mandatory in India?

It is advisable to take written consent from patients for any publication of their personal data.

ICMR 2006 guidance recommends a clear consent (excerpt below). This would imply a well documented consent in writing.

It is recommended that a clear consent for publication be obtained besides the consent for participation in research or treatment and such consent should preferably be obtained on two different occasions and not as a blanket one at the commencement of the study.

Maintenance of confidentiality while publishing data should be taken care of. In case there is need for publication/presentation of photographs/slides/videos of participant (s), prior consent to do so should be obtained. Identification features should be appropriately camouflaged. The same safeguard should be observed for video coverage.

Do we require approval if there is any change in the principal investigator at the site?
Change of principal investigator is a major amendment, which always required approval of CDSCO. The current checklist is for submission for approval of different categories of applications. In CDSCO meetings, the officials have clarified that protocol amendments need approval of CDSCO.

The same checklist covers BE studies. Hence, the same criteria will be applicable in case of protocol amendment / change of investigator.

I am keen to import live embryonic stem cell extracts from Switzerland. What are the guidelines for import of stem cells?
ICMR-DBT guidelines on stem cell research cover the procedures for import of stem cells. An excerpt is given below:

All established human stem cell lines from any source, imported or created in India, should be registered with Institutional Committee for Stem Cell Research (IC-SCR) and National Apex Committee for Stem Cell Research (NAC-SCR). Import shall also follow import/export policy of the GOI for biological materials. Permission for import or procurement from other Indian laboratories shall be obtained from IC-SCR. The investigator shall ensure that imported cell line has been established in accordance with the ethical guidelines of the country of origin which are comparable to those of our country. An appropriate MTA shall be adopted for the purpose. Clinical trials using cells after major manipulation or those sponsored by multinationals involving stem cell products imported from abroad shall require prior approval of the NAC-SCR through IC-SCR, IEC, DCGI and respective funding agency as per its procedure/Health Ministry’s Screening Committee (HMSC). The import of biological materials for research and development is regulated by GOI (F. No. L./950/53/97-H1(Pt.) dated 19th  Nov 1997). Import of approved and marketed ‘drugs’ (therapeutic products) from abroad requires license from the DCGI as per its Act and Rules.

What is the regulatory guideline regarding the location of ethics committee?
The following statement is in the document checklist for applications for grant of approval of various categories of New Drug, Global Clinical trial and Bioequivalence study for export purpose.

Ethics Committee Approval: Ethical approval should be obtained from Ethics Committee located in the same area where the clinical trial site is located.

During the study, if there is an amendment in ICF (due to additional adverse events not related to drug), is it fine if subjects are informed about this new information verbally and documented in source notes and upon receipt of EC approval, a written ICF is obtained from these subjects?
Yes See ICH guidance below.
ICH 4.8.2     The written informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that may be relevant to the subject’s consent. Any revised written informed consent form, and written information should receive the IRB/IEC's approval/favourable opinion in advance of use. The subject or the subject’s legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject’s willingness to continue participation in the trial. The communication of this information should be documented

As such information would be vital for the subject safety, waiting for written approval from EC will delay the ethical need to inform the subject in timely manner. Hence, a verbal information to subject given in a timely manner and documenting the same in source notes is the right approach.