Research Ethics Review Committee
WHO ERC
20, AVENUE APPIA – CH-1211 GENEVA 27 – SWITZERLAND – HTTP://INTRANET.WHO.INT/HOMES/RPC/ERC – HTTP://WWW.WHO.INT/RPC/RESEARCH_ETHICS
The Process of Obtaining Informed Consent
1. Obtaining genuine informed consent from research participants is best thought of as
a process of sharing information and addressing questions and concerns, rather than
simply obtaining a signature on a prescribed form.
2. It starts with the researcher developing an awareness of national or regional
guidelines, and may involve discussions with, and the involvement of, the community
and/or discussions with the family members of potential participants. Participants
must then give their individual consent to participate on an informed consent form
(ICF) developed specifically for the research project.
3. There are very few research situations which do not require the participant's
signature on an informed consent form. Permission from an ethics review committee
is always necessary for waiving off this requirement.
4. Researchers should follow an appropriate and culturally-sensitive process of
information sharing leading up to, and including, obtaining the participant's signature
on the informed consent form.
5. This process may continue even after the signature is obtained as it is often
appropriate for researchers to check back with participants throughout the research
to ensure continued consent or because a new consent is required for an additional
or changed intervention.
6. This document provides information which may be helpful to researchers as they
consider the informed consent process for their research.
I. Awareness of, and consultation with, national and/or regional health research
bodies
• Be aware of existing national and/or regional health research guidelines which may
set out specific expectations to protect the interests and well-being of participants,
their communities and the national health research system
• Consult national and/or regional research institutions on any proposed human
subject research which will take place within their boundaries
• Where appropriate, consult with the local leadership or, when the research involves
vulnerable populations, with the organizations representing or working in the
interests of potential participants.
• At all stages of the informed consent process, be prepared to discuss the capacity-
building potential of the research and the benefits for the
community/country/region, as well as any benefits for individual participants.
Researchers should note that prior to submitting proposals to the ERC for review, the
research proposal must have been submitted for review by a national/local IRB.