﻿Suggested questions to elucidate understanding are given in black in italics.	64	Example of question to elucidate understanding:
Suggested questions to elucidate understanding are given in black in italics.	64	Examples of question to elucidate understanding:
Please do not submit consent forms on the WHO letter head	94	Please do not submit assent forms on the WHO letter head
Name the group of individuals for whom this consent is written.	95	Name the group of individuals for whom this assent is written.
This Informed Consent Form has two parts:	92	This Informed Assent Form has two parts:
This Informed Consent Form has two parts:	52	[Informed Consent form for  ______________ _______]
This Informed Consent Form has two parts:	52	[Informed Consent Form for _________________________________]
Information Sheet (to share information about the study with you)	76	Information Sheet (gives you information about the study)
Information Sheet (to share information about the study with you)	70	Information Sheet (to share information about unused samples with you)
Information Sheet (to share information about the study with you)	91	Information Sheet (to share information about the research with you)
Certificate of Consent (for signatures if you agree that your child may participate)	52	Certificate of Consent (to record your agreement)
Certificate of Consent (for signatures if you agree that your child may participate)	75	Certificate of Consent (for signatures if you agree to take part)
I am X, and I work at Y organization in _____.	61	I am X, working for the Y organization.
There may be some words that you do not understand.	98	There  may be some words that you do not understand.
Explain[x] in lay terms why the research is being done and what is expected from the results.	51	Explain [x]in lay terms why  you are doing the research.
You do not have to agree that your daughter/son can talk to us.	51	You do not have to decide immediately.
You don't have to decide today.	55	You don't have to wait for a scheduled visit.)
[x]1) the following applies only to focus group discussions[x]:	65	[x]2) the following applies only to  interviews[x]:
[x]1) the following applies only to focus group discussions[x]:	66	[x]3) the following applies only to questionnaire surveys[x]:
[x]1) the following applies only to focus group discussions[x]:	92	1) The following applies only to focus group discussions:
[x]1) the following applies only to focus group discussions[x]:	68	[x]2) The following applies only to interviews:
[x]1) the following applies only to focus group discussions[x]:	57	3) The following applies only to questionnaires and surveys:
[x]1) the following applies only to focus group discussions[x]:	54	[x]The following applies to focus groups[x]:
This discussion will be guided by[ give name of moderator] or me.	61	This discussion will be guided by [name of moderator/guider] or myself.
We will also answer questions about the research that they might have.	56	Do you have any questions about them?
These are the types of questions we will ask.	95	These are the types of questions we will ask…...
[The tapes will be destroyed after ____period of time.]	98	[The tapes will be destroyed after ________period of time.]
[The tapes will be destroyed after ____period of time.]	73	The tapes will be destroyed after ______number of days/weeks.
Etc. Do you have any more questions?	89	Etc. Do you have any other questions?
Outline any limits there are to confidentiality.	52	Outline any limits to confidentiality.
The  information that we collect from this research project will be kept confidential.	51	We are inviting you to take part in this research project.
This section can be written in the first person.	91	This section must be written in the first person.
This section can be written in the first person.	51	(This section is mandatory)
Print Name of Parent or Guardian __________________	77	Signature of Parent of Guardian___________________
Print Name of Parent or Guardian __________________	53	[x]Signature of witness ______________________
Print Name of Parent or Guardian __________________	51	[Informed Assent Form for _____________________]
Print Name of Parent or Guardian __________________	60	Print name of child ___________________
Print Name of Parent or Guardian __________________	66	Print name of researcher_________________
Print Name of Parent or Guardian __________________	51	Signature of researcher___________________
Print Name of Parent or Guardian __________________	52	[give name of current research]
Print Name of Parent or Guardian __________________	70	Print Name of Participant__________________
Print Name of Parent or Guardian __________________	57	Signature of Participant ___________________
Participants who are illiterate should include their thumb print as well.	98	Participants who are illiterate should include their thumb-print as well.
I confirm that the individual has given consent freely.	94	I confirm that the individual has given assent  freely.
Statement by the researcher/person taking consent	58	Signature of Researcher /person taking the assent __________________________
Statement by the researcher/person taking consent	63	Signature of Researcher /person taking the consent__________________________
[x]Print Name of Researcher[x][x]/person taking the consent_[x]_______________________	96	[x]Print Name of Researcher[x][x]/person taking the assent_[x]_______________________
An Informed Assent Form will ____ OR will not ____ be completed.	53	Informed Consent Form Template for
You can decide whether to participate or not after you have talked it over.	58	It is your choice whether to participate or not.
Why are you doing this research?	62	Why are you asking me?
(Example:You don't have to be in this research if you don't want to be.	76	(Example:You do not have to be in this research.
If you decide not to be in the research, its okay and nothing changes.	59	Can I choose not to be in the research?
If you decide not to take part in this research study, do you know what your options are?	59	You are being asked to take part in a research study.
If you decide not to take part in this research study, do you know what your options are?	52	I voluntarily agree to take part in this study.
Information on the Trial Drug [Name of Drug]:	98	Information on the Trial Drug [Name of Drug]
(Example:The vaccine we are testing in this research is called ABX.	52	(Example:The vaccine is considered safe.
We know of no greater risk or other side effects.	51	We know of no other problem or risks.
At the end of seven months, the research will be finished.	93	At the end of six months, the research will be finished.)
(This template is for either clinical trials or clinical research)	55	[x]If the protocol is for a clinical trial:
Your participation in this research is entirely voluntary.	67	Your participation in this study is voluntary.
Confidential information will not be shared.	60	[x]CONTACT INFORMATION 
The example used here is for a patient at a clinic.	65	The example used here is for a community social worker.
I have read the foregoing information, or it has been read to me.	59	Please read the following information carefully.
Print name of witness____________[x]    	61	Signature of witness    _____________
Participant's signature ______________________________ Date __________ 	86	Investigator's signature _____________________________ Date __________
