PharmD Info

A forum for Indian Pharmacy Professionals

Clinical Research Courses, Clinical Research Types, Indian Clinical Research Organizations, Pharmcovigilance Studies, Pharmacy Journals and Publications, Clinical Research Ethics, Clinical Research Jobs in India, Clinical Research Associate Roles
Forum rules: Dear User, Kindly read our forum rules before you proceed with our PharmD Info, Your first 5 posts/topics requires moderator approval and this website is purely meant for educational and knowledge sharing purpose only so you should not make any topics/replies/messages which criticize, threaten or abuse any member, pharmacy governing bodies and organizations. Your post will be deleted automatically by our BB Pruning System if your topic is not viewed by members for more than 5 days. So, make sure that your topics and its related contents are unique and valuable. We expect you to be an active member of our forum to continue with your free membership.Kindly note that if a member received more than five warnings from moderator/members they will be blocked automatically by our Bulletin Board system.
  • User avatar
#3055
Indian Council of Medical Research’s (ICMR) National Ethical Guidelines for Biomedical Research has become mandatory and needs to be adhered to for all biomedical research in the country as per the New Drugs and Clinical Trials Rules 2019 released recently by Ministry of Health and Family Welfare, Government of India.

This will be effective after 180 days from the date of publication of Gazette. These details are included under clauses 15, 16, 17, 18 under Chapter IV of the New Drugs & Clinical Trial Rules.

This is for the first time that biomedical and health research is going to be regulated through the ethics committees and the system is being set up by Ministry of Health and Family Welfare which has designated Department of Health Research, as the authority for registration of ethics committee that review such research and thereby help in safeguarding the safety, rights, welfare of research participants. The salient
requirements are:

1. Any institution or organization which intends to conduct biomedical and health research shall be required to have an Ethics Committee (EC) which has been constituted, functions and maintains records in accordance to ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017. ECs shall review the research before initiation and oversee throughout the duration of the research.

2. The EC shall be required to register with the Authority and the registration would remain valid for a period of five years from the date of its issue, unless suspended or cancelled by the authority. The ICMR National Ethical Guidelines will guide the ethical requirements for all institution that are engaged in such research whether it is medical colleges, research institutions, universities, public or private funded institutions, non-governmental organisation or others.

Dr. Balram Bhargava, Secretary, Department of Health


View the guidelines here:

https://www.icmr.nic.in/sites/default/f ... elines_201
7.pdf

View the handbook on guidelines here:

http://ethics.ncdirindia.org//asset/pdf ... elines.pdf

Reference:
Last bumped by Admin on 01 May 2019, 15:06.
Similar Topics
Topics Statistics Last post
0 Replies 
1566 Views
by Admin
29 Sep 2017, 08:09
0 Replies 
2004 Views
by Admin
05 Oct 2017, 07:18
0 Replies 
1868 Views
by Admin
01 May 2019, 15:06
0 Replies 
925 Views
by Admin
28 Jun 2019, 16:45
0 Replies 
843 Views
by unbreakable
08 Sep 2018, 10:24

Tags

In order to acquire certification from the Foreign[…]

Is pharm d graduates are also eligible for this? ?

NAPRA created the Gateway for Pharmacists Canada t[…]

Herewith i enclose the chapterwise Questions of CL[…]

WELCOME TO OUR E-LEARN COURSE WORK MODULES