What are the guidelines for adverse event following immunization (AEFI)?

The Ministry of Health and Family Welfare released operational guidelines on Surveillance and Response to AEFI in 2010. These guidelines are meant for field workers to detect, report and monitor AEFI in the National Immunization Programme.

For new vaccines, the safety issues are under CDSCO, to whom the vaccine manufacturer should report serious adverse events and submit periodic safety update reports (PSUR).

Is it necessary to obtain approval from EC and consent in epidemiological studies?


ICMR 2006 Ethical Guidelines for Biomedical Research on Human Participants covers these issues. It describes the challenges/guidance as follows:

Ethics in epidemiological studies is multidimensional covering clinical medicine, public health and the social milieu. General ethical principles of respect for persons, duty to maximize possible benefits and minimize possible harm are important considerations. Some of the crucial issues are consent are:

• Consent of the individual and community

• Influence of community / societal pressure for participation

• Inducements for participation

• Risks involved including the risk of loss of privacy

• Maintaining confidentiality

• Minimization of harm

The approval of EC is essential. EC should have at least one or two individuals with an understanding of the principles of epidemiological ethics. The EC should be independent and comprise of epidemiologists, clinicians, statisticians, social scientists, philosophers, legal experts and representatives from community / voluntary groups who should be aware of local, social and cultural norms, as this is the most important social control mechanism.

Are there any guidelines for clinical trials in alternative systems of medicine?


Department of Ayush notified guidelines for clinical trials in 2008. The guidelines categorize the medicines in different categories:

I  Ayurveda, Siddha and Unani drugs

II  Patent and proprietary

III  Indian Ethno-medicines

IV  Medicines based on extracts of medicinal plants


The guidelines describe requirements for animal studies - pharmacology, toxicity - and clinical trials and published evidence. The guidelines recommend that the applicant should provide following documents before conducting clinical trials:

Introduction

• Information on formulation – composition, method of manufacture, standardization parameters

• Experimental pharmacology

• Safety data

• Investigator brochure

• Protocol

• Patient information sheet

• Informed consent form English + local language

In 2010, Dept of Ayush also issued GCP guidance, which is developed along the Indian GCP guidance released by CDSCO.

Do we need to have a witness to sign the ICF when the subject is adult and can read, write and subject himself/herself is signing the ICF?

If the subject is adult, and can read and write, witness is not required.
If the subject cannot read and write, an impartial witness is required.
If the subject is incapable of giving consent e.g. mental retardation, unconsciousness, and the legal representative cannot read and write, an impartial witness is required.