﻿[x]20, avenue Appia – CH-1211 Geneva 27 – Switzerland – [x]http://www.who.int/ethics/review-committee	99	[x]20, avenue Appia – CH-1211 Geneva 27 – Switzerland –  [x]http://www.who.int/ethics/review-committee
The informed consent form consists of two parts: the information sheet and the consent certificate.	96	The informed assent form consists of two parts: the information sheet and the consent certificate.
It is long only because it contains guidance and explanations which are for you and which you will not include in the informed consent  forms that you develop and provide to participants in your research.	98	It is long only because it contains guidance and explanations which are for you and which you will not include in the informed assent forms that you develop and provide to participants in your research.
It is long only because it contains guidance and explanations which are for you and which you will not include in the informed consent  forms that you develop and provide to participants in your research.	99	It is long only because it contains guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.
standard lettering is used for explanations to researchers only and must not be included in your consent forms.	97	standard lettering is used for explanations to researchers only and must not be included in your assent forms.
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.
Because research for a single project is often carried out with a number of different groups of individuals - for example healthcare workers, patients, and parents of patients - it is important that you identify which group this particular consent is for.	79	Because research for a single project is often carried out on a number of different groups of individuals - for example children with malaria, children without malaria, students - it is important that you identify which group particular assent is for.
Because research for a single project is often carried out with a number of different groups of individuals - for example healthcare workers, patients, and parents of patients - it is important that you identify which group this particular consent is for.	84	Because research for a single project is often carried out with a number of different groups of individuals - for example counselors, community members, clients of services - it is important that you identify which group this particular consent is for.
This Informed Consent Form has two parts:	92	This Informed Assent Form has two parts:
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)	91	Information Sheet (to share information about the research with you)
You will be given a copy of the full Informed Consent Form	94	You will be given a copy of the full Informed Assent Form
You will be given a copy of the full Informed Consent Form	81	You will be given a copy of the full Statement of Consent
Before you decide, you can talk to anyone you feel comfortable with.	87	Before you decide, you can talk to anyone you feel comfortable with about the research.
There may be some words that you do not understand.	98	There  may be some words that you do not understand.
Example of question to elucidate understanding:	97	Examples of question to elucidate understanding:
[x]1) the following applies only to focus group discussions[x]:	92	1) The following applies only to focus group discussions:
[x]2) the following applies only to  interviews[x]:	96	[x]2) The following applies only to interviews:
[x]3) the following applies only to questionnaire surveys[x]:	86	3) The following applies only to questionnaires and surveys:
Explain the type of questions that the participants are likely to be asked in the focus group discussion, interview or in the questionnaire.	77	B. Explain the type of questions that the participants are likely to be asked in the focus group, the interviews, or the survey.
We will also answer questions about the research that they might have.	88	We can also answer questions about the research that you might have.
These are the types of questions we will ask.	95	These are the types of questions we will ask…...
The discussion will take place in [location of the FGD], and no one else but the people who take part in the discussion and the guide  or I will be present during this discussion.	94	The discussion will take place in [location of the FGD], and no one else but the people who take part in the discussion and guide or myself will be present during this discussion.
The entire discussion will be tape-recorded, but no-one will be identified by name on the tape.	89	The entire interview will be tape-recorded, but no-one will be identified by name on the tape.
[The tapes will be destroyed after ____period of time.]	98	[The tapes will be destroyed after ________period of time.]
The information recorded is confidential, and no one else except [name of person(s) with access to the information] will have access to the information documented during your interview.)	84	The information recorded is confidential, and no one else except [name of person(s) with access to the information] will have access to her questionnaire.
Etc. Do you have any more questions?	89	Etc. Do you have any other questions?
WHO does not encourage incentives beyond reimbursements for expenses incurred as a result of participation in research.	91	WHO does not encourage incentives beyond reimbursements for expenses incurred  as a result of participation in the research.
WHO does not encourage incentives beyond reimbursements for expenses incurred as a result of participation in research.	99	WHO does not encourage incentives beyond reimbursements for expenses incurred as a result of participation in the research.
The expenses may include, for example, travel expenses and reimbursement for time lost.	98	These expenses may include, for example, travel expenses and reimbursement for time lost.
The  information that we collect from this research project will be kept confidential.	98	The information that we collect from this research project will be kept confidential.
The  information that we collect from this research project will be kept confidential.	86	The information that we collect from this research project will be kept private.
Only the researchers will know what his/her number is and we will lock that information up with a lock and key.	96	Only the researchers will know what your number is and we will lock that information up with a lock and key.
[x]It will not be shared with or given to [x]anyone except [name who will have access to the information, such as research sponsors, DSMB board, your clinician, etc].	99	[x]It will not be shared with or given to [x]anyone except [name who will have access to the information, such as research sponsors, DSMB board, your clinician, etc].)
[x]The following applies to focus groups[x]:	88	The following applies to focus groups:
Did you understand the procedures that we will be using to make sure that any information that we as researchers collect about your child  will remain confidential?	82	Did you understand the procedures that we will be using to make sure that any information that we as researchers collect about you will remain confidential?
If you have a plan and timeline for the sharing of information, include the details.	98	If you have a plan and a timeline for the sharing of information, include the details.
If you have a plan and timeline for the sharing of information, include the details.	97	If  you have a plan and a timeline for the sharing of information, include the details.
If you wish to find about more about the IRB, contact [name, address, telephone number.])	99	If you wish to find about more about the IRB, contact [name, address, telephone number.]).
This section can be written in the first person.	91	This section must be written in the first person.
It should include a few brief statements about the research and be followed by a statement similar to the one in bold below.	83	It should include a few brief statements about the research and be followed by a statement similar to the one identified as 'suggested wording' below.
It should include a few brief statements about the research and be followed by a statement similar to the one in bold below.	99	It should include a few brief statements about the research and be followed by a statement similar the one in bold below.
If the participant is illiterate but gives oral consent a witness must sign.	98	If the participant is illiterate but gives oral consent, a witness must sign.
Because the certificate is an integral part of the information sheet and not a stand-alone document, the layout or design of the form should reflect this.	94	Because the certificate is an integral part of the informed consent and not a stand-alone document, the layout or design of the form should reflect this.
I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction.	92	I have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction.
Print Name of Parent or Guardian __________________	77	Signature of Parent of Guardian___________________
A  literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team).	99	[x] A  literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team).
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.
I confirm that the parent was given an opportunity to ask questions about the study, and all the questions asked by him/her have been answered correctly and to the best of my ability.	96	I confirm that the child was given an opportunity to ask questions about the study, and all the questions asked by him/her have been answered correctly and to the best of my ability.
[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]_______________________
I am going to give you information and invite you to be part of a research study.	90	I am going to give you information and invite you to be part of this  research.
I am going to give you information and invite you to be part of a research study.	92	I am going to give you information and invite you to be part of this research.
Information on the Trial Drug [Name of Drug]:	98	Information on the Trial Drug [Name of Drug]
There is no risk associated with that drug and no known side effects.)	89	There is no risk associated with that drug and no known problems.
At the end of seven months, the research will be finished.	93	At the end of six months, the research will be finished.)
Information about you that will be collected from the research will be put away and no-one but the researchers will be able to see it.	96	Information about you that will be collected during the research will be put away and no-one but the researchers will be able to see it.
Any information about you will have a number on it instead of your name.	98	Any information about you will have a number on it instead of your  name.
Signature of Researcher /person taking the assent __________________________	94	Signature of Researcher /person taking the consent__________________________
I want my identity to be removed from my (TYPE OF SAMPLE) sample.	86	I want my identity to be kept with my (TYPE OF SAMPLE) sample.
[Informed Consent form for  ______________ _______]	86	[Informed Consent Form for _________________________________]
Inform them that they may talk to anyone they feel comfortable talking with about the research  and that they can take time to reflect on whether they want to participate or not.	99	Inform them that they may talk to anyone they feel comfortable talking with about the research and that they can take time to reflect on whether they want to participate or not.
Assure the participant that if they do not understand some of the words or concepts, that you will take time to explain them as you go along and that they can ask questions now or later.	94	Assure the participant that if they do not understand some of the words or concepts, that you will take time to explain them as you go along and that they can ask questions at anytime.
This will be expanded upon in the procedures section but it may be helpful and less confusing to the participant if  they know from the very beginning whether, for example,  the research involves a vaccine, an interview, a biopsy or a series of finger pricks.	86	This will be expanded upon in the procedures section but it may be helpful and less confusing to the participant if  they know from the very beginning whether, for example,  the research involves a vaccine, an interview, a questionnaire, or a series of finger pricks.
State, [x]only if it is applicable, that they will still receive all the services they usually do whether they choose to participate or not.	87	State, [x]only if it is applicable, that they will still receive all the services they usually do if they choose not to participate.
You should also inform the participant that the research findings will be shared more broadly, for example, through publications and conferences.	97	You may also inform the participant that the research findings will be shared more broadly, for example, through publications and conferences.
After these meetings, we will publish the results in order that other interested people may learn from our research.)	85	Following the meetings, we will publish the results so that other interested people may learn from the research.)
Participant's signature ______________________________ Date __________ 	86	Investigator's signature _____________________________ Date __________
