NHRC guidelines on clinical drug trials<br>

The National Human Rights Commission has come out with some guidelines on clinical drug trials as suggested by its Expert Group. These have been sent to the Union Health Ministry for its comments. [Deliberation upon them in the meeting of the State government representatives.] The Commission has also decided to intervene in the matter before the Supreme Court.
The Members of the NHRC's Expert Committee were:-
(i) Dr D.C. Doval, Director Research & Director, Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi,
(ii) Prof. Vivekanand Jha, Department of Nephrology, PGIMER, Chandigarh,
(iii) Prof. B.N. Dhawan, former Director, Central Drug Research Institute, Lucknow and Chairman, Institutional Ethics Committee of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow,
(iv) Dr. Subhash Yadav, Addl. Professor, Department of Endocrinology & Member Secretary, IEC, SGPGI, Lucknow,
(v) Dr. Nilima Kshirsagar, National Chair in Clinical Pharmacology, Indian Council of Medical Research, and Dean, ESI-PGIMER, MGM Hospital, Mumbai.
Highlights of the guidelines are as follows:-
1. There should be a uniform definition of clinical trial to distinguish it from clinical studies as it varies in different Rules, Schedules and Appendices of the Drug and Cosmetics Act and Rules.
2. Ethics Committees should be set up and registered as per the Drugs and Cosmetics Act in all institutions, which undertake studies on human subjects.
3. All Ethics Committee Members should familiarize themselves with various aspects of Ethics Guidelines and Provisions of Act, Rules, etc. for clinical trials.
4. A Standard Operating Procedure (SOP) should be laid down and followed in all clinical trials/ clinical studies, based on prevailing Good Clinical Practices (GCP) and Guidelines issued by CDSCO, ICMR, as per the provisions of the Act.
5. Procedure for recruitment of participants/volunteers for a trial should be documented in the SOP.
6. There should be an effective mechanism for monitoring the implementation of the SOPs.
7. It is necessary to set up Regional/State Training Centres which should be attached with Ethics Committees of their region/state and develop a common minimum syllabus for the training course. Attendance in the programme could be made compulsory for persons eligible to be elected members of Institutional Ethics Committees (IEC).
8. Informed consent procedure should be standardized and simplified. Information given to the patient should be latest and include details of risks involved. In case of injury or death during study, information about participant's right for compensation should be given as per the prevailing provisions of Drugs and Cosmetics Act and Rules, Regulations.
9. Participants of the clinical trial should be provided medical care from the time of enrolment in the study, for the duration of study and for the period of follow up as specified in the protocol. The details regarding the distance and location of availability of medical care from the residence of the participants should be specified in the patient information sheet.
10. In addition to providing patient information sheet in writing, an informative, audio video CD by the investigator may be prepared, shown and given to participants, under receipt that they had seen it, especially if a study was being done on illiterate subjects.
11. An investigator should ensure adherence to the Medical Council of India's Code of Ethics, especially for research, as stated in Chapter 7, and for human rights, as stated in Chapter 6.