Instructions on Consent and Assent

Instructions for submitting information sheets, consent forms and assent forms
Please refer http://www.who.int/rpc/research_ethics/informed_consent/en/ for detailed instructions.

Please note that these are templates developed by the WHO, ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study.You can download templates for the following


• Informed Consent for Clinical Studies.
• Consent for Storage and Future Use of Unused Samples.
• Informed Consent for Qualitative Studies.
• Informed Assent for Children/Minors.
• Informed Parental Consent for Research Involving Children (qualitative).
• Informed Parental Consent for Research Involving Children (clinical).


All studies involving human participants (both verbal and written consent) must have
Form A

Informed consent form in two parts

Part I -

  1. Information sheet/s (for verbal and written consent) addressing each category of participant.
  2. The information here is written by the researcher addressing the participant .

Part II -

  1. consent form is a declaration by the participant.

Parts I and II must be on separate sheets of paper

Important: All information sheets should carry the following statement in the relevant language:

This study has been approved by the Ethics Review Committee of the Faculty of Medicine, University of Ruhuna. If you have any complaints/concerns regarding this study you may contact the following: 091-2234801/803 Ext : 161

Form B An assent form: for studies involving children aged 12 years - 18 years, child’s assent must be obtained in addition to the parent’s consent.
All documents submitted must carry the date and version

Workshop on ‘SOP training and reviewing a proposal in view of granting Ethical approval’ for ERC members

Date: 13 August 2020

Venue: Conference Hall, Department of Community Medicine, Faculty of Medicine, UOR, Galle More