Priyanka Kodule

Introduction
 Informed consent is a first and foremost process by
which a person voluntarily agree to participate in a
research study after being fully informed about it.
 Voluntary consent means that the participants were
able to consent, were not being coerced to do the
study and understood the risks and benefits involved.
 The documentation of informed consent is also a vital
part of research process.
Guidelines For Informed Consent
Process
 1] The Nuremberg Code,1947
 2] The Declaration of Helsinki,1964 (2000)
 3] The Belmont Report,1979
 4] ICH-GCP,1997
 5] ICMR Guidelines,2000
 Informed Consent as a Process

 1] Patient’s information sheet.

 2] Informed consent form(ICF).
 3] Integration of ICF and sheet into one document.
 Counselling – Informed Consent is communication
process between researcher and participant.
Process Of Informed Consent
 Timing – Before screening.
 Nature of research project.
 Treatment.
 Study procedures.
 Language.
 Summary
 Consent is an ethical obligation governed by federal
regulation, which requires the use of current IRB
approved consent form.
 Consent must be informed and voluntary.
 Consent must be completed prior to any study related
activity.
 Documentation of the consent process form is
required for most studies.