﻿0.002	19091	(too few spaces)
0.003	15360	(too few spaces)
0.003	976	(too few spaces)
0.003	1423	(too few spaces)
0.004		(too few spaces)
0.004	Source:	(too few spaces)
0.004	https://www.who.int/ethics/review-committee/informed_consent/en/	(too few spaces)
0.005	==	(too few spaces)
0.005	{!{!{!{ \ethics-ICFparentalConsent-qualitative.doc.sdlxliff }!}!}!}	(too few spaces)
0.006	Page	(too few spaces)
0.006	Research Ethics Review Committee	(too few spaces)
0.007	(WHO ERC)	(too few spaces)
0.039	[x]20, avenue Appia – CH-1211 Geneva 27 – Switzerland – [x]http://www.who.int/ethics/review-committee	(no match)
1	{{[x]20, avenue Appia – CH-1211 Geneva 27 – Switzerland –  [x]http://www.who.int/ethics/review-committee}}	99
2.067	http://www.who.int/rpc/research_ethics	(too few spaces)
2.068	Informed Parental Consent Template for	(too few spaces)
2.068	Research Involving Children (Qualitative Studies)	(too few spaces)
2.068	l C	(too few spaces)
2.073	(For use with Participant Observation, Focus Group Discussions, Interviews, and Surveys)	(no match)
3.83	(language used throughout form should be at the level of a local student of class 6[x]th/8[x]th)	(no match)
5.628	Notes to Researchers:	(too few spaces)
5.628	1.	(too few spaces)
5.633	Please note that this is a template developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF).	(no match)
7.739	It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study.	(no match)
9.94	The logo of the Institution must be used on the ICF and not the WHO logo.	(no match)
11.234	2.	(too few spaces)
11.239	The informed consent form consists of two parts: the information sheet and the consent certificate.	(no match)
11	{{The informed assent form consists of two parts: the information sheet and the consent certificate.}}	96
13.391	3.	(too few spaces)
13.397	Do not be concerned by the length of this template.	(no match)
14.025	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.	(no match)
14	{{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.}}	98
14	{{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
15.354	4.	(too few spaces)
15.359	This template includes examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex.	(no match)
16.585	These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.	(no match)
19.069	5.	(too few spaces)
19.069	In this template:	(too few spaces)
19.073	square brackets indicate where specific information is to be inserted	(no match)
20.268	bold lettering indicates sections or wording which should be included	(no match)
21.462	standard lettering is used for explanations to researchers only and must not be included in your consent forms.	(no match)
21	{{standard lettering is used for explanations to researchers only and must not be included in your assent forms.}}	97
23.59	The explanation is provided in black, and examples are provided in red in italics.	(no match)
25.131	Suggested questions to elucidate understanding are given in black in italics.	(no match)
26.47	TEMPLATE ON FOLLOWING PAGE	(too few spaces)
26.47	[YOUR INSTITUTIONAL LETTER HEAD]	(too few spaces)
26.475	Please do not submit consent forms on the WHO letter head	(no match)
26	{{Please do not submit assent forms on the WHO letter head}}	94
27.266	[Informed Consent Form for _____________________]	(too few spaces)
27.271	Name the group of individuals for whom this consent is written.	(no match)
27	{{Name the group of individuals for whom this assent is written.}}	95
28.354	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.	(no match)
28	{{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.}}	79
28	{{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.}}	84
29.007	[x](e.g. This informed consent form is for parents of adolescent girls and boys participating in the research [x]titled.	(no match)
31.221	"What do we want:	(too few spaces)
31.222	Adolescents and health systems ")	(too few spaces)
31.222	[Name of Principle Investigator]	(too few spaces)
31.222	[Name of Organization]	(too few spaces)
31.222	[Name of Sponsor]	(too few spaces)
31.222	[Name of Project and Version]	(too few spaces)
31.228	This Informed Consent Form has two parts:	(no match)
31	{{This Informed Assent Form has two parts:}}	92
31.577	Information Sheet (to share information about the study with you)	(no match)
31	{{Information Sheet (gives you information about the study)}}	76
32	{{Information Sheet (to share information about the research with you)}}	91
32.585	Certificate of Consent (for signatures if you agree that your child may participate)	(no match)
34.267	You will be given a copy of the full Informed Consent Form	(no match)
34	{{You will be given a copy of the full Informed Assent Form}}	94
34	{{You will be given a copy of the full Statement of Consent}}	81
35.161	Part I:	(too few spaces)
35.161	Information Sheet	(too few spaces)
35.161	Introduction	(too few spaces)
35.167	Briefly state who you are and explain that you are inviting them to have their child participate in research which you are doing.	(no match)
37.22	Inform them that may talk to anyone they feel comfortable talking with about the research and that they can take time to reflect on whether they want their child to participate or not.	(no match)
38.736	Assure the parent 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 may ask questions now or later.	(no match)
40.19	(Example:	(too few spaces)
40.195	I am X, and I work at Y organization in _____.	(no match)
40.663	I am doing some research which might help your clinic/hospital  do more to help teenagers become and stay healthier.	(no match)
42.854	In our research we will talk to many teenagers, both girls and boys, and ask them a number of  questions.	(no match)
44.886	Whenever researchers study children, we talk to the parents and ask them for their permission.	(no match)
46.656	After you have heard more about the study, and if you agree, then the next thing I will do is ask your daughter/son for their agreement as well.	(no match)
48.629	Both of you have to agree independently before I can begin.	(no match)
49.465	You do not have to decide today whether or not you agree to have your child participate in this research.	(no match)
51.464	Before you decide, you can talk to anyone you feel comfortable with.	(no match)
52	{{Before you decide, you can talk to anyone you feel comfortable with about the research.}}	87
53.835	There may be some words that you do not understand.	(no match)
54	{{There  may be some words that you do not understand.}}	98
54.766	Please ask me to stop as we go through the information and I will take time to explain.	(no match)
56.456	If you have questions later, you can ask them of me or of another researcher.)	(no match)
57.813	Purpose	(too few spaces)
57.818	Explain[x] in lay terms why the research is being done and what is expected from the results.	(no match)
59.547	Explain why you need to conduct the research with children.	(no match)
60.397	It is possible that the clinics and the hospital in this region are not providing some of the services that are important for teenagers.	(no match)
62.622	In this study we will talk to teenage girls and boys about what they know about caring for their bodies in a healthy way including sexual and reproductive health.	(no match)
64.334	We will invite them to share their knowledge and understanding with us so that we can find ways of meeting their needs at the local clinics and hospital.)	(no match)
66.275	Type of Research Intervention	(too few spaces)
66.275	Briefly state the intervention.	(too few spaces)
66.282	This will be expanded upon in the procedures section.	(no match)
67.042	A questionnaire OR a focus group OR an interview)	(no match)
67.547	Selection of Participants	(too few spaces)
67.554	State clearl[x]y why you have chosen their child to participate in this study.	(no match)
68.962	Parents may wonder why their children have been chosen for a study and may be fearful, confused or concerned.	(no match)
70.849	We want to talk to many teenagers about their health and what information or services they want for themselves.	(no match)
73.196	One part of health that we want to talk to them about is sexuality.	(no match)
74.327	We would like to ask your daughter/son to participate because she/he is a teenager and lives in this region.)	(no match)
76.476	Example of question to elucidate understanding:	(no match)
76	{{Examples of question to elucidate understanding:}}	97
76.918	Do you know why we are asking your child  to take part in this study?	(no match)
78.016	Do you know what the study is about?	(no match)
78.279	Voluntary Participation	(too few spaces)
78.285	Indicate clearly that they can choose for their child to participate or not and reassure they will still receive all the services they usually do if they choose not to participate.	(no match)
79.966	Also inform them that their child will also have input into the decision.	(no match)
81.348	This can be repeated and expanded upon later in the form as well.	(no match)
82.285	It is important to state clearly at the beginning of the form that participation is voluntary so that the other information can be heard in this context.	(no match)
84.094	Participants may also be more alert at the beginning.	(no match)
84.767	You do not have to agree that your daughter/son can talk to us.	(no match)
85.745	You can choose to say no and any services that you and your family receive at this centre will not change.	(no match)
87.627	We know that the decision can be difficult when it involves your children.	(no match)
88.897	And it can be especially hard when the research includes sensitive topics like sexuality.	(no match)
90.581	You can ask as many questions as you like and we take the time to answer them.	(no match)
91.961	You don't have to decide today.	(no match)
92.131	You can think about it and tell me what you decide later.)	(no match)
92.946	If you decide not to allow your child to take part in this research study, do you know what the optionsfor him are?	(no match)
94.901	Do you know that your child does  not have to take part in this research study, if you do not wish so?	(no match)
96.733	Do you have any questions?	(too few spaces)
96.734	Procedure	(too few spaces)
96.738	Explain what each of the steps or procedures involve.	(no match)
97.352	Indicate when the research will take place and where.	(no match)
97.933	If there are surveys, indicate where and how the surveys will be collected and distributed.	(no match)
99.792	(Examples:	(too few spaces)
99.797	[x]1) the following applies only to focus group discussions[x]:	(no match)
99	{{1) The following applies only to focus group discussions:}}	92
100.753	[x]Your daughter/son will  [x]take part in a discussion with 7-8 other teenagers , or a mix of teenagers  and social service workers from the community.	(no match)
102.89	The girls and boys will be in separate groups.	(no match)
103.368	This discussion will be guided by[ give name of moderator] or me.	(no match)
104.437	[x]2) the following applies only to  interviews[x]:	(no match)
104	{{[x]2) The following applies only to interviews:}}	96
105	Your daughter/son will participate in an interview with [name of interviewer] or myself.	(no match)
106.571	[x]3) the following applies only to questionnaire surveys[x]:	(no match)
106	{{3) The following applies only to questionnaires and surveys:}}	86
107.477	Your daughter/son will fill out a questionnaire which will be provided by [name of distributor of blank questionnaires] and collected by [name of collector of completed questionnaires].[x]OR The questionnaire can be read aloud and she/he can give me the answer which she/he wants me to write.)	(no match)
107.98	Explain the type of questions that the participants are likely to be asked in the focus group discussion, interview or in the questionnaire.	(no match)
109	{{B. Explain the type of questions that the participants are likely to be asked in the focus group, the interviews, or the survey.}}	77
110.159	If the questions are sensitive, acknowledge this, try to anticipate parents' concerns and protective responses, and address these.	(no match)
112.383	Parents may be concerned that if researchers talk to their children about sexuality it  may encourage them to explore sexual activities with their peers.	(no match)
114.409	Other concerns may include disbelief that their child is ready to talk about sexuality, or parents may be personally embarrassed.	(no match)
116.492	The group discussion will start with me, or the focus group guide  (use the local word for group discussion leader), making sure that the participants are comfortable.	(no match)
118.133	We will also answer questions about the research that they might have.	(no match)
118	{{We can also answer questions about the research that you might have.}}	88
119.131	Then we will ask questions about the health system in this community.	(no match)
120.144	We will talk about where they go for information about health, and whether they get the information and services they need and want.	(no match)
122.203	We will encourage them to talk about sexual and reproductive health as well as other important health topics such as food and nutrition.	(no match)
124.465	These are the types of questions we will ask.	(no match)
124	{{These are the types of questions we will ask…...}}	95
124.821	We will not ask them to share personal stories or anything that they are not comfortable sharing.	(no match)
126.427	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.	(no match)
127	{{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.}}	94
127.995	The entire discussion will be tape-recorded, but no-one will be identified by name on the tape.	(no match)
129	{{The entire interview will be tape-recorded, but no-one will be identified by name on the tape.}}	89
129.686	The tape will be kept [explain how the tape will be stored].	(no match)
130.513	The information recorded is confidential, and no one else except [name of person(s) with access to the tapes] will be allowed to listen to the tapes.	(no match)
132.407	[The tapes will be destroyed after ____period of time.]	(no match)
132	{{[The tapes will be destroyed after ________period of time.]}}	98
133.085	If your daughter  does not wish to answer any of the questions during the interview, she may say so and the interviewer will move on to the next question.	(no match)
134.918	The interview will take place in [location of the interview], and no one else but the interviewer will be present unless your child asks for someone else to be there.	(no match)
136.536	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.)	(no match)
136	{{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.}}	84
137.869	If your daughter/son does not wish to answer some of the questions included in the questionnaire, she/he may skip them and move on to the next question.	(no match)
139.572	[The questionnaires will be destroyed after _____period of time.])	(no match)
140.537	Duration	(too few spaces)
140.542	Include a statement about the time commitments of the study for the child and any time commitments on the part of the parent(s).	(no match)
142.693	Include both the duration of the study and follow-up, if relevant.	(no match)
143.782	We are asking your child to participate in an interview which will take about 1 hour of her/his  time.	(no match)
145.623	We can do this outside of school/work hours.	(no match)
146.025	There is also a questionnaire that we will either provide to your child or which we will do together with her/him.	(no match)
148.005	This also takes about an hour.	(no match)
148.174	[x]Altogether, we are asking for about 2 hours of your child's  time.[x])	(no match)
149.322	If you decide that your child can  take part in the study, do you know how much time will the interview take?	(no match)
151.051	Where will it take place?	(too few spaces)
151.057	Do you know that we will be sending a  transport to pick  up your child from your home?	(no match)
152.569	Do you know how much time will the discussion with other people take?	(no match)
153.755	If you agree that your child can  take part, do you know if he/she can stop participating?	(no match)
155.296	Do you know that your child  may not respond to the questions that he/she  deso not wish to respond to?	(no match)
156.998	Etc. Do you have any more questions?	(no match)
157	{{Etc. Do you have any other questions?}}	89
157.219	Risks and Discomforts	(too few spaces)
157.226	Explain any risks or discomforts including any limits to confidentiality.	(no match)
158.461	(If the discussion is on sensitive and personal issues e.g. reproductive and sexual health, personal habits etc. then an example of text could be something like "We are asking your son/daughter  to share with us some very personal and confidential information, and he/she may feel uncomfortable talking about some of the topics.	(no match)
158.749	You must know that he/she does not have to answer any question or take part in the discussion/interview/survey if he/she  doesn't wish to do so, and that is also fine.	(no match)
160.377	He/she does not have to give us any reason for not responding to any question, or for refusing to take part in the interview"	(no match)
162.343	OR If for example, the discussion is on opinions on government policies and community beliefs, and in general no personal information is sought, then the text under risks could read something like "There is a risk that your son/daughter may share some personal or confidential information by chance, or that he/she  may feel uncomfortable talking about some of the topics.	(no match)
162.5	However, we do not wish for this to happen.	(no match)
162.862	You must know that he/she does not have to answer any question or take part in the discussion/interview/survey if he/she feels the question(s) are too personal or if talking about them makes him/her uncomfortable.)	(no match)
163.839	Your daughter/son may choose to tell you about the interview and the questionnaire but she/he does not have to do this.	(no match)
165.893	We will not be sharing with you either the questions we ask nor the responses given to us by your child.)	(no match)
167.806	Benefits	(too few spaces)
167.811	Describe any benefits to their child, to the community, or any benefits which are expected in the future as a result of the research.	(no match)
169.717	There will be no immediate and direct benefit to your child or to you, but your child's participation is likely to help us find out more about the health needs of teenage girls and boys and we hope that these will help the local clinics and hospitals to meet those needs better in the future.)	(no match)
170.106	Reimbursements	(too few spaces)
170.113	State clearly what you will provide the participants with as a result of their participation.	(no match)
171.641	WHO does not encourage incentives beyond reimbursements for expenses incurred as a result of participation in research.	(no match)
172	{{WHO does not encourage incentives beyond reimbursements for expenses incurred  as a result of participation in the research.}}	91
173	{{WHO does not encourage incentives beyond reimbursements for expenses incurred as a result of participation in the research.}}	99
173.565	The expenses may include, for example, travel expenses and reimbursement for time lost.	(no match)
174	{{These expenses may include, for example, travel expenses and reimbursement for time lost.}}	98
175.129	The amount should be determined within the host country context.	(no match)
176.085	Your daughter/son will not be provided with any payment to take part in the research.	(no match)
177.472	However, she/he will be given with [provide a figure, if money is involved] for her/his  time, and travel expense (if applicable).)	(no match)
179.358	Can you tell me if you have understood correctly the benefits that your child  will have if you allow him/her to take part in the study?	(no match)
181.356	Do you know if the study will pay for your travel costs and time lost, and do you know how much you will be re-imbursed?	(no match)
183.164	Do you have any other questions?	(no match)
183.327	Confidentiality:	(too few spaces)
183.333	Explain how the research team will maintain the confidentiality of data, especially with respect to the information about the participant.	(no match)
185.134	Outline any limits there are to confidentiality.	(no match)
185.536	Note that with focus groups confidentiality cannot be guaranteed because what is said within the group becomes common knowledge.	(no match)
187.468	Participants can be asked not to share outside of the group but this does not guarantee confidentiality.	(no match)
189.149	Because something out of the ordinary is being done through research in your community, it  will draw attention.	(no match)
190.887	If your daughter/son participates, she and you may be asked questions by other people in the community.	(no match)
192.543	We will not be sharing  information about your son or daughter outside of the research team.	(no match)
194.006	The  information that we collect from this research project will be kept confidential.	(no match)
195	{{The information that we collect from this research project will be kept confidential.}}	98
195	{{The information that we collect from this research project will be kept private.}}	86
195.464	Information about your child that will be collected from the research will be put away and no-one but the researchers will be able to see it.	(no match)
197.3	Any information about your child will have a number on it instead of his/her name.	(no match)
198.686	Only the researchers will know what his/her number is and we will lock that information up with a lock and key.	(no match)
199	{{Only the researchers will know what your number is and we will lock that information up with a lock and key.}}	96
200.361	[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].	(no match)
200	{{[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
201.944	[x]The following applies to focus groups[x]:	(no match)
202	{{The following applies to focus groups:}}	88
203.179	We will ask your child and others in the group not to talk to people outside the group about what was said in the group.	(no match)
205.421	We will, in other words, ask each participant to keep what was said in the group confidential.	(no match)
206.938	You should know, however, that we cannot stop or prevent participants who were in the group from sharing things that should be confidential.)	(no match)
208.761	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?	(no match)
209	{{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?}}	82
210.246	Do you understand that the we cannot guarantee complete confidentiality of information that your child  shares with us in a group discussion Do you have any more questions?	(no match)
211.616	Sharing of Research Findings	(too few spaces)
211.621	Include a statement indicating that the research findings will be shared in a timely fashion but that confidential information will remain confidential.	(no match)
213.125	If you have a plan and timeline for the sharing of information, include the details.	(no match)
213	{{If you have a plan and a timeline for the sharing of information, include the details.}}	98
214	{{If  you have a plan and a timeline for the sharing of information, include the details.}}	97
214.533	Also inform the parent that the research findings will be shared more broadly, for examples, through publications and conferences.	(no match)
216.244	At the end of the study, we will be sharing what we have learnt with the participants and with the community.	(no match)
217.787	We will do this by meeting first with the participants and then with the larger community.	(no match)
219.22	Nothing that your child will tell us today will be shared with anybody outside the research team, and nothing will be attributed to him/her by name.	(no match)
220.844	A written report will also be given to the participants which they can share with their families.	(no match)
222.631	[x][x]We will also publish the results in order that other interested people may learn from our research[x].)	(no match)
224.618	Right to refuse or withdraw	(too few spaces)
224.624	Explain again the voluntary nature of consent.	(no match)
225.135	Also explain that their child will be asked to agree - or assent - and that the child's concerns and wishes will be taken very seriously.	(no match)
226.831	You may choose not to have your child participate in this study and your child does not have to take part in this research if she/he does not wish to do so.	(no match)
228.472	Choosing to participate or not will not affect either your own or your child's future treatment at the Centre here in any way.	(no match)
230.277	You and your child will still have all the benefits that would otherwise be available at this Centre.	(no match)
231.788	Your child may stop participating in the discussion/interview at any time that you or she/he wish without either of you losing any of your rights here.)	(no match)
233.434	Who to Contact	(too few spaces)
233.44	Provide the name and contact information of someone who is involved, informed and accessible (a local person who can actually be contacted.	(no match)
235.111	State also that the proposal has been approved and how.	(no match)
235.797	If you have any questions you may ask them now or later, even after the study has started.	(no match)
237.235	If you wish to ask questions later, you may contact any of the following:	(no match)
238.249	[name, address/telephone number/e-mail]	(too few spaces)
238.254	This proposal has been reviewed and approved by [name of the IRB], which is a committee whose task it is to make sure that research participants are protected from harm.	(no match)
239.599	If you wish to find about more about the IRB, contact [name, address, telephone number.])	(no match)
240	{{If you wish to find about more about the IRB, contact [name, address, telephone number.]).}}	99
240.956	Do you know that you do not have to allow your child take part in this study if you do not wish to?	(no match)
242.441	You can say No if you wish to?	(no match)
242.586	Do you know that you can ask me questions later, if you wish to?	(no match)
243.461	Do you know that I have given the contact details of the person who can give you more information about the study?	(no match)
245.108	Etc.	(too few spaces)
245.108	PART II:	(too few spaces)
245.108	Certificate of Consent	(too few spaces)
245.114	This section can be written in the first person.	(no match)
245	{{This section must be written in the first person.}}	91
245.528	It should include a few brief statements about the research and be followed by a statement similar to the one in bold below.	(no match)
246	{{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.}}	83
246	{{It should include a few brief statements about the research and be followed by a statement similar the one in bold below.}}	99
247.234	If the participant is illiterate but gives oral consent a witness must sign.	(no match)
247	{{If the participant is illiterate but gives oral consent, a witness must sign.}}	98
248.341	A researcher or the person going over the informed consent must sign each consent.	(no match)
249.523	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.	(no match)
250	{{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.}}	94
251.075	[x]I have been asked to give consent for my daughter/son to participate in this research study which will involve her completing one interview and one questionnaire [x]I have read the foregoing information, or it has been read to me.	(no match)
251.795	I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction.	(no match)
253	{{I have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction.}}	92
253.651	I consent voluntarily for my child to participate as a participant in this study.	(no match)
254.925	Print Name of Parent or Guardian __________________	(no match)
254	{{Signature of Parent of Guardian___________________}}	77
255.445	Signature of Parent of Guardian___________________::!!!::	(too few spaces)
255.445	Date ___________________________	(too few spaces)
255.446	Day/month/year	(too few spaces)
255.446	If illiterate	(too few spaces)
255.451	A  literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team).	(no match)
256	{{[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).}}	99
257.16	Participants who are illiterate should include their thumb print as well.	(no match)
257	{{Participants who are illiterate should include their thumb-print as well.}}	98
258.199	I have witnessed the accurate reading of the consent form to the parent of the potential participant, and the individual has had the opportunity to ask questions.	(no match)
259.617	I confirm that the individual has given consent freely.	(no match)
259	{{I confirm that the individual has given assent  freely.}}	94
260.237	Print name of witness_____________________             AND         Thumb print of participant	(no match)
261.799	[x]Signature of witness ______________________	(too few spaces)
261.8	Date ________________________	(too few spaces)
261.805	Statement by the researcher/person taking consent	(no match)
262.207	I  have accurately read out the information sheet to the parent of the potential participant, and to the best of my ability made sure that the person understands that the following will be done:	(no match)
263.228	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.	(no match)
263	{{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.}}	96
264.395	I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.	(no match)
266.175	A copy of this Informed Consent Form has been provided to the parent or guardian of the participant  ____	(no match)
267.836	[x]Print Name of Researcher[x][x]/person taking the consent_[x]_______________________	(no match)
268	{{[x]Print Name of Researcher[x][x]/person taking the assent_[x]_______________________}}	96
269.319	An Informed Assent Form will ____ OR will not ____ be completed.	(no match)
270.137	{!{!{!{ \ethics-InformedAssent.doc.sdlxliff }!}!}!}	(too few spaces)
270.138	[x]Page [x] of	(too few spaces)
270.138	http://www.who.int/ethics/review-committee_	(too few spaces)
270.143	Informed Assent Form Template for Children/Minors	(no match)
270.57	(language should be at a level appropriate to the child's age and development)	(no match)
271.704	This template is written for a pre-adolescent or young adolescent.	(no match)
272.552	An Informed Assent Form does[x] [x]not replace a consent form signed by parents or guardians.	(no match)
274.018	The assent is in addition to the consent and signals the child's willing cooperation in the study.	(no match)
275.387	[Informed Assent Form for _____________________]	(too few spaces)
275.401	( This informed assent form is for children between the ages of 12 - 16 who attend clinic X and who we are inviting to participate in research Y.)	(no match)
277.004	Certificate of Assent (this is where you sign if you agree to participate)	(no match)
277.97	This is a brief introduction to ensure the child knows who you are and that this is a research study.	(no match)
279.352	Give your name, say what you do[x] and clearly state that you are doing research.	(no match)
280.48	Inform the child that you have spoken to their parents and that parental consent is also necessary.	(no match)
281.865	Let them know that they can speak to anyone they choose about the research before they make up their mind.	(no match)
283.321	My name is ____and my job is to research and test vaccines to see which work best to stop malaria before it makes someone sick .We want to know if this new vaccine will stop children from getting sick and we think this research could help tell us that.	(no match)
283.899	I am going to give you information and invite you to be part of a research study.	(no match)
284	{{I am going to give you information and invite you to be part of this  research.}}	90
284	{{I am going to give you information and invite you to be part of this research.}}	92
285.037	You can choose whether or not you want to participate.	(no match)
285.533	We have discussed this research with your parent(s)/guardian and they know that we are also asking you for your agreement.	(no match)
287.131	If you are going to participate in the research, your parent(s)/guardian also have to agree.	(no match)
288.4	But if you do not wish to take part in the research, you do not have to, even if your parents have agreed.	(no match)
289.721	You may discuss anything in this form with your parents or friends or anyone else you feel comfortable talking to.	(no match)
291.154	You can decide whether to participate or not after you have talked it over.	(no match)
292.106	You do not have to decide immediately.	(no match)
292.331	There may be some words you don't understand or things that you want me to explain more about because you are interested or concerned.	(no match)
293.878	Please ask me to stop at anytime and I will take time to explain).	(no match)
294.693	Purpose:	(too few spaces)
294.699	Why are you doing this research?	(no match)
294.843	Explain the purpose of the research in clear simple terms.	(no match)
295.438	(Example:We want to find better ways to prevent malaria before it makes children sick.	(no match)
296.644	We have a new vaccine to prevent malaria which we are hoping might be better than the one that is currently being used.	(no match)
298.194	In order to find out if it is better we have to test it.)	(no match)
298.909	Choice of participants:	(too few spaces)
298.91	Why are you asking me?	(too few spaces)
298.915	Children, like adults, like to know why they are being invited to be in the research.	(no match)
300.296	It is important to address any fears they may have about why they were chosen.	(no match)
301.322	(Example:We are testing  this vaccine on children who are  your age - between 12 and 16 years old - who live in a place where there is malaria .	(no match)
302.953	We are only  testing the vaccine on children who do not have malaria.)	(no match)
303.869	Participation is voluntary:	(too few spaces)
303.874	Do I have to do this?	(no match)
303.937	State clearly and in child-friendly language that the choice to participate is theirs.	(no match)
305.346	If there is a possibility that their decision not to participate might be over-ridden by parental consent, this should be stated clearly and simply.	(no match)
307.563	(Example:You don't have to be in this research if you don't want to be.	(no match)
308.449	Its up to you.	(too few spaces)
308.454	If you decide not to be in the research, its okay and nothing changes.	(no match)
309.51	This is still your clinic, everything stays the same as before.	(no match)
310.619	Even if you say "yes" now, you can change your mind later and its still okay.	(no match)
312.01	If applicable:	(too few spaces)
312.016	If anything changes and we want you to stay in the research study even if you want to stop, we will talk to you first .)	(no match)
313.948	If you decide not to take part in this research study, do you know what your options are?	(no match)
315.806	Do you know that you do not have to take part in this research study, if you do not wish to?	(no match)
317.426	I have checked with the child and they understand that participation is voluntary __(initial)	(no match)
318.866	Information on the Trial Drug [Name of Drug]:	(no match)
319	{{Information on the Trial Drug [Name of Drug]}}	98
319.279	What is this drug and what do you know about it?	(no match)
319.684	Include the following section only if the protocol is for a clinical trial:	(no match)
320.772	1) give the phase of the trial and explain what that means.	(no match)
321.425	Explain to the participant why you are comparing or testing the drugs.	(no match)
322.237	2) provide as much information as is appropriate and understandable about the drug such as its manufacturer or location of manufacture and the reason for its development.	(no match)
323.56	3) explain the known experience with this drug	(no match)
323.889	4) explain comprehensively all the known side-effects/toxicity of this drug, as well as the adverse effects of all the other  medicines that are being used in the trial	(no match)
325.132	(Example:The vaccine we are testing in this research is called ABX.	(no match)
325.854	It has been tested twice before with adults who do not have malaria but who live in areas where malaria is common.	(no match)
327.368	We now want to test the vaccine  on teenagers who do not have malaria.	(no match)
328.192	This second research is called a "phase 2" trial.	(no match)
328.611	The vaccine ABX is made by Company C.  It has very few side effects.	(no match)
329.61	It can make you feel tired for the first 24 hours after being given the drug.	(no match)
330.543	Also, 20% of the people who tried the drug in previous research experienced temporary swelling where the injection entered the skin.	(no match)
332.341	We know of no greater risk or other side effects.	(no match)
332.742	Some participants in the research will not be given the drug which we are testing.	(no match)
334.048	Instead, they will be given the drug XYZ, the drug which is most commonly used in this region to treat malaria.	(no match)
335.582	There is no risk associated with that drug and no known side effects.)	(no match)
335	{{There is no risk associated with that drug and no known problems.}}	89
336.427	Procedures:	(too few spaces)
336.433	What is going to happen to me?	(no match)
336.562	Explain the procedures and any medical terminology in simple language.	(no match)
337.571	Focus on what is expected of  the child.	(no match)
337.811	Describe which part of the research is experimental.	(no match)
338.265	(Example:We are going to test the vaccine by giving some of  the  children in the research study the new vaccine and the others are going to get the vaccine that is already being used to prevent malaria.	(no match)
339.21	Neither you nor the researchers will know which vaccine you were given until after the study is over.	(no match)
340.949	By doing the research like this, we can compare which of the vaccines is better without being influenced by what we think or hope the research will show.	(no match)
342.766	If you decide that you want to do this, there will be three  things that happen.	(no match)
343.937	In about ten days, you will come to the clinic with your parents and you will get an injection/shot in your arm.	(no match)
345.615	This is either the vaccine that we are testing or the vaccine that is usually used to prevent malaria.	(no match)
347.055	2..	(too few spaces)
347.062	At the clinic we will also give you a mosquito net to take home and sleep under.	(no match)
348.141	Maybe you have seen these before.	(no match)
348.309	They stop mosquitoes from biting you during the night when you sleep.	(no match)
349.16	Once a month for six months after that, you will come to the clinic and the nurse will take your temperature.	(no match)
350.695	She will also take a little bit of your blood, about three or four drops, from your finger with a finger prick.	(no match)
352.207	This might hurt a little but the hurt will go away before very long.	(no match)
353.077	Altogether you will come to the clinic 7  times over 7 months.	(no match)
353.833	At the end of seven months, the research will be finished.	(no match)
354	{{At the end of six months, the research will be finished.)}}	93
354.475	I have a picture here to show you what will happen.	(no match)
354.902	You can ask me to stop and explain again at any time and I will explain more about the process).	(no match)
356.207	Can you tell me if you remember the number of times that we are asking you  to come to the hospital to complete the treatment?	(no match)
357.812	How many times extra will you have to come if you decide to take part in the research study?	(no match)
359.194	How many injections will you be given?	(no match)
359.42	How many tablets?	(too few spaces)
359.427	How much blood will be taken from your veins, using a syringe and needle?	(no match)
360.31	Over how many weeks?	(too few spaces)
360.318	Do you want me to go through the procedures again?	(no match)
360.706	I have checked with the child and they understand the procedures ________(initial))	(no match)
361.824	Risks:	(too few spaces)
361.83	Is this bad or dangerous for me?	(no match)
361.961	Explain any risks using simple, clear language.	(no match)
362.304	(Example:The vaccine is considered safe.	(too few spaces)
362.31	It has already been tested on adults and on other children.	(no match)
362.859	There has been nothing that has worried us at all.	(no match)
363.24	If anything unusual happens to you, however, we need to know and you should feel free you to call us anytime with your concerns or questions.	(no match)
364.897	Another way of us knowing how you are is by having you come to the clinic every month for a check-up.	(no match)
366.26	If you get sick or have concerns or questions in-between the scheduled visits to clinic, you should let me or the staff nurse know.	(no match)
367.891	You don't have to wait for a scheduled visit.)	(no match)
368.199	Discomforts:	(too few spaces)
368.2	Will it hurt?	(too few spaces)
368.204	If there will be any discomforts state these clearly and simply.	(no match)
368.887	State that they should tell you and/or their parents if they are sick, experience discomfort or pain.	(no match)
370.27	Address what may be some of the child's worries, for example,  missing school or extra expense to parents.	(no match)
371.814	(Example:There are a few  other things that I want you to know.	(no match)
372.558	The injection might hurt for just a second when it goes into your arm.	(no match)
373.426	It might get a little bit red and hard around the place where the injection/needle goes in. That should go away in a day.	(no match)
375.13	If it hurts longer than that, or if it stays hard for longer or swells up, tell your parents or me.	(no match)
376.423	If you feel bad or strange, tell us.	(no match)
376.597	Sleeping under a mosquito net can be uncomfortable because it can be hot and stuffy.	(no match)
377.715	Sometimes you may not want to come to the clinic to get your blood checked or have your temperature taken.	(no match)
379.141	Its important that you try to come.	(no match)
379.29	It won't take very long.	(too few spaces)
379.296	You will miss a little bit of school - about an hour every month - and we will tell your teacher about that so that she knows its okay.)	(no match)
381.004	Do you understand that, while the research study is on-going, no-one may know which medicine you re receiving?	(no match)
382.485	Do you know that the medicine that we are testing  is a new medicine, and we do not know everything about it?	(no match)
383.916	Do you understand that you may have some unwanted side-effects from the medicines?	(no match)
384.955	Do you understand that these side-effects can happen whether or not you are in the research study?	(no match)
386.201	I have checked with the child and they understand the risks and discomforts ____(initial)	(no match)
387.427	Benefits:	(too few spaces)
387.433	Is there anything good that happens to me?	(no match)
387.672	Describe any benefits to the child.	(no match)
387.828	(Example:Nothing really good might happen to you.	(no match)
388.262	The vaccine may not stop you from getting malaria.	(no match)
388.618	But this research might help us to find a vaccine now or later that could help other children.	(no match)
389.825	There are a couple of good things if you do decide that you want to do this.	(no match)
390.663	You do get regular check-ups with the nurse so that if you are sick, we will know very soon and this can be important.	(no match)
392.189	And you will keep the mosquito net which will help keep mosquitoes away from you.	(no match)
393.291	Because mosquitoes cause malaria, this is important.)	(no match)
393.76	I have checked with the child and they understand the benefits_____ (initial)	(no match)
394.582	Reimbursements:	(too few spaces)
394.588	Do  I get anything for being in the research?	(no match)
394.898	Mention any reimbursements or forms of appreciation that will be provided.	(no match)
395.752	Any gifts given to children should be small enough to not be an inducement or reason for participating.	(no match)
397.067	(Example:Because you live quite far from the clinic, we will give your parents enough money to pay for the trip here and (whatever other expense is reasonable).	(no match)
398.443	Can you tell me if you have understood correctly the benefits that you will have if you take part in the study?	(no match)
399.85	Is everybody going to know about this?	(no match)
400.048	Explain what confidentiality means in simple terms.	(no match)
400.442	State any limits to confidentiality.	(too few spaces)
400.447	Indicate what their parents will or will not be told.	(no match)
400.807	(Example:We will not tell other people that you are in this research and we won't share  information about you to anyone who does not work in the research study.	(no match)
402.204	After the research is over, you and your parents will be told which of the two injections you received and the results.	(no match)
403.66	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.	(no match)
404	{{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.}}	96
405.207	Any information about you will have a number on it instead of your name.	(no match)
405	{{Any information about you will have a number on it instead of your  name.}}	98
406.015	Do you have any questions about them?	(no match)
406.166	Compensation:	(too few spaces)
406.172	What happens if I get hurt?	(no match)
406.272	Describe to the ability of the child to understand and explain that parents have been given more information.	(no match)
407.662	(Example:If you become sick during the research, we will  look after you.	(no match)
408.434	We have given your parents information about what to do if you are hurt or get sick during the research.)	(no match)
409.663	Sharing the Findings:	(too few spaces)
409.669	Will you tell me the results?	(no match)
409.768	Describe to the ability of the child to understand that the research findings will be shared in a timely fashion but that confidential information will remain confidential.	(no match)
411.052	Also tell the child that the research will be shared more broadly, i.e. in a book, journal, conferences, etc.	(no match)
412.488	(Example:When we are finished the research, I will sit down with you and your parent and I will tell you about what we learnt.	(no match)
413.991	I will also give you a paper with the results written down.	(no match)
414.551	Afterwards, we will be telling more people, scientists and others, about the research and what we found.	(no match)
415.856	We will do this by writing and sharing reports and by going to meetings with people who are interested in the work we do.)	(no match)
417.283	Right to Refuse or Withdraw:	(too few spaces)
417.287	Can I choose not to be in the research?	(no match)
417.447	Can I change my mind?	(too few spaces)
417.452	You may want to re-emphasize that participation is voluntary and any limits to this.	(no match)
418.358	(Example:You do not have to be in this research.	(no match)
418.641	No one will be mad or disappointed with you if you say no. Its your choice.	(no match)
419.344	You can think about it and tell us later if you want.	(no match)
419.685	You can  say "yes"  now and change your mind later and it will still be okay.)	(no match)
420.521	Who to Contact:	(too few spaces)
420.527	Who can I talk to or ask questions to?	(no match)
420.684	List and give contact information for those people who the child can contact easily (a local person who can actually be contacted).	(no match)
422.083	Tell the child that they can also talk to anyone they want to about this (their own doctor, a family friend, a teacher).	(no match)
423.5	(Example:You can ask me questions now or later.	(no match)
423.789	You can ask the nurse questions.	(no match)
423.907	I have written a number and address where you can reach us or, if you are nearby, you can come and see us.	(no match)
425.01	If you want to talk to someone else that you know like your teacher or doctor or auntie, that's okay too.)	(no match)
426.029	If you choose to be part of this research I will also give you a copy of this paper to keep for yourself.	(no match)
427.067	You can ask your parents to look after it if you want.	(no match)
427.451	Do you know that you do not have to take part in this study if you do not wish to?	(no match)
428.244	You can ask me any more questions about any part of the research study, if you wish to.	(no match)
429.106	PART 2:	(too few spaces)
429.106	Certificate of Assent	(too few spaces)
429.116	If the child is illiterate but gives oral assent, a witness must sign instead .	(no match)
429.87	A researcher or the person going over the informed assent with the child must sign all assents.	(no match)
430.789	(Example:I understand the research is about testing a new vaccine for malaria and that I might get either the new vaccine which is being tested or the vaccine which is currently being used.	(no match)
431.776	I understand that I will get an injection and that I will come for regular monthly check-ups at the clinic where I will give a blood sample with a finger prick.)	(no match)
432.923	I have read this information ( or had the information read to me)  I have had my questions answered and know that I can ask questions later if I have them.	(no match)
434.09	I agree to take part in the research.	(no match)
434.211	OR	(too few spaces)
434.217	I do not wish to take part in the research and I have [x]not signed the assent below.___________(initialled by child/minor)	(no match)
435.355	Only if child assents:	(too few spaces)
435.356	Print name of child ___________________	(too few spaces)
435.356	Signature of child:	(too few spaces)
435.356	____________________	(too few spaces)
435.356	Date:________________	(too few spaces)
435.356	If illiterate:	(too few spaces)
435.361	A  literate witness must sign (if possible, this person should be selected by the participant, not be a parent, and should have no connection to the research team).	(no match)
436.448	I have witnessed the accurate reading of the assent form to the child, and the individual has had the opportunity to ask questions.	(no match)
437.544	Print name of witness (not a parent)_________________  AND    Thumb print of participant	(no match)
438.505	I have accurately read or witnessed the accurate reading of the assent form to the potential participant, and the individual has had the opportunity to ask questions.	(no match)
439.536	Print name of researcher_________________	(too few spaces)
439.536	Signature of researcher___________________	(too few spaces)
439.536	Date__________________	(too few spaces)
439.542	I  have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the child  understands that the following will be done:	(no match)
440.518	A copy of this assent form  has been provided to the participant.	(no match)
441.021	Signature of Researcher /person taking the assent __________________________	(no match)
441	{{Signature of Researcher /person taking the consent__________________________}}	94
441.715	Copy provided to the participant ________(initialed by researcher/assistant)	(no match)
442.343	Parent/Guardian has signed an informed consent ___Yes   ___No  _____(initialed by researcher/assistant)	(no match)
443.279	-------	(too few spaces)
443.279	Informed Consent Form Template for	(too few spaces)
443.283	Consent for Storage and Future Use of	(no match)
443.396	Unused Samples	(too few spaces)
443.404	Additional Consent to [Name of Project]	(no match)
443.534	Include the following section if the research protocol calls for storage and future use of samples	(no match)
444.499	This Statement of Consent consists of two parts:	(no match)
444.775	Information Sheet (to share information about unused samples with you)	(no match)
445.36	Certificate of Consent (to record your agreement)	(no match)
445.611	h	(too few spaces)
445.611	Part 1.	(too few spaces)
445.618	Explain that you are seeking permission to store their unused samples for possible future use in either your own research or someone else's research.	(no match)
446.707	State that they need to make some decisions about their blood/tissue/sperm/sputum sample because they gave you permission only to use it for the current research.	(no match)
447.717	Explain that sometimes people don't want their samples used for research into areas they might not agree with, for example, research into birth control or reproductive technology.	(no match)
448.727	[x]Use lay terms to explain research possibilities.	(no match)
448.983	If genetic research is a possibility, explain what this is and any implications for them.	(no match)
449.774	State that they can tell you if there is something they don't want their sample used for, or if they don't want their sample used at all.	(no match)
450.839	Inform the participant that at present, the researchers can trace which blood/tissue/sperm/sputum sample belongs to the participant.	(no match)
451.891	In most cases, the participant must decide whether they want to let the researchers keep the sample but get rid of all identifying information, or whether they are comfortable with the researchers knowing whose sample it is.	(no match)
452.404	Explain the risks and benefits of each of these options.	(no match)
452.734	Inform the participant of researcher obligations in cases where the sample remains linked.	(no match)
453.483	These obligations include informing the participant of results which have immediate clinical relevance.	(no match)
454.349	Inform participants that their sample will not be sold for profit and that any research which uses their sample will have been approved.	(no match)
455.336	Right to Refuse and Withdraw	(too few spaces)
455.341	Explain that the participant may refuse to allow samples to be kept or put restrictions on those samples with no loss of benefits and that the current research study will not be affected in any way.	(no match)
456.033	Inform the participant that they may withdraw permission at anytime and provide them with the name, address, and number of the person and sponsoring institution to contact.	(no match)
456.897	Confidentiality	(too few spaces)
456.902	Briefly explain how confidentiality will be maintained including any limitations.	(no match)
457.676	You can ask me any more questions about any part of the information provided above, if you wish to.	(no match)
458.477	Part II.	(too few spaces)
458.482	If any of the (TYPE OF SAMPLE i.e. blood, tissue)   I have provided for this research project is unused or leftover when the project is completed (Tick [x]one choice from each of the following boxes)	(no match)
459.153	[x]I wish my [TYPE OF SAMPLE] sample to be destroyed immediately.	(no match)
459.597	I want my [TYPE OF SAMPLE] sample to be destroyed after ____ years.	(no match)
460.06	I give permission for my [TYPE OF SAMPLE] sample to be stored indefinitely	(no match)
460.6	AND (if the sample is to be stored)	(no match)
460.682	I give permission for my (TYPE OF SAMPLE) sample to be stored and used in future research but only on the same subject as the current research project :	(no match)
461.577	[give name of current research]	(too few spaces)
461.582	I give my permission for my [TYPE OF SAMPLE] sample to be stored and used in future research of any type which has been properly approved	(no match)
462.559	I give permission for my [TYPE OF SAMPLE] sample to be stored and used in future research except for research about [NAME TYPE OF RESEARCH]	(no match)
463.519	AND	(too few spaces)
463.523	I want my identity to be removed from my (TYPE OF SAMPLE) sample.	(no match)
463	{{I want my identity to be kept with my (TYPE OF SAMPLE) sample.}}	86
463.951	I have read the information, or it has been read to me.	(no match)
464.223	I have had the opportunity to ask questions about it and my questions have been answered to my satisfaction.	(no match)
465.075	I consent voluntarily to have my samples stored in the manner and for the purpose indicated above.	(no match)
465.808	Print Name of Participant__________________	(too few spaces)
465.808	Signature of Participant ___________________	(too few spaces)
465.818	I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions.	(no match)
466.748	I  have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:	(no match)
467.475	I confirm that the participant was given an opportunity to ask questions about the nature and manner of storage of the samples, and all the questions asked by the participant have been answered correctly and to the best of my ability.	(no match)
467.907	A copy of this ICF has been provided to the participant.	(no match)
468.204	[x][x]Page [x] of 10	(too few spaces)
468.208	http://www.who.int/ethics/review-committee	(too few spaces)
468.208	Clinical Studies	(too few spaces)
468.212	(This template is for either clinical trials or clinical research)	(no match)
468.63	[YOUR INSTITUTIONAL LETTERHEAD]	(too few spaces)
468.634	[Informed Consent form for  ______________ _______]	(no match)
468	{{[Informed Consent Form for _________________________________]}}	86
468.857	Name the group of individuals for whom this informed consent form 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.	(no match)
469.033	This Informed Consent Form is for men and women who attend clinic Z, and who we are inviting to participate in research on X. The title of our research project is "…………………………."	(no match)
469.76	)	(too few spaces)
469.765	You may provide the following information either as a running paragraph or under headings as shown below.	(no match)
470.584	[Name of Principal Investigator]	(too few spaces)
470.584	[Name of Proposal and version]	(too few spaces)
470.593	Certificate of Consent (for signatures if you agree to take part)	(no match)
471.041	Briefly state who you are and explain that you are inviting them to participate in the research you are doing.	(no match)
471.861	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.	(no match)
472	{{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
472.573	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.	(no match)
472	{{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.}}	94
473.242	I am X, working for the Y Research Institute.	(no match)
473.391	We are doing research on  Z disease, which is very common in this country.	(no match)
473.941	You do not have to decide today whether or not you will participate in the research.	(no match)
474.57	If you have questions later, you can ask them of me, the study doctor or the staff.)	(no match)
475.171	Purpose of the research	(too few spaces)
475.176	Explain [x]in lay terms why  you are doing the research.	(no match)
475.446	The language used should clarify rather than confuse.	(no match)
475.669	Use local and simplified terms for a disease, e.g. local name of disease instead of malaria, mosquito instead of anopheles, “mosquitoes help in spreading the disease” rather than “mosquitoes are the vectors”.	(no match)
476.189	Avoid using terms like pathogenesis, indicators, determinants, equitable etc.[x] There  are guides on the internet to help you find substitutes for words which are overly scientific or are professional jargon.	(no match)
476.673	Malaria is one of the most common and dangerous diseases in this region.	(no match)
477.208	The drugs that are currently used to help people with malaria are not as good as we would like them to be.	(no match)
478.007	In fact, only 40 out of every 100 people given the malaria  drug XYZ are completely cured.	(no match)
478.721	There is a new drug which may work better.	(no match)
478.827	The reason we are doing this research is to find out if the new drug ABX is better than drug XYZ which is currently being used.)	(no match)
479.711	Briefly state the type of  intervention that will be undertaken.	(no match)
480.086	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.	(no match)
480	{{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.}}	86
480.408	This research will involve a single injection in your arm as well as four follow-up visits to the clinic.	(no match)
481.174	Participant selection	(too few spaces)
481.178	State why this participant has been chosen for this research.	(no match)
481.49	People often wonder why they have been chosen to participate and may be fearful, confused or concerned.	(no match)
482.243	We are inviting all adults with malaria who attend clinic Z  to participate in the research on the new malaria drug.)	(no match)
483.092	Do you know why we are asking you to take part in this study?	(no match)
483.387	Indicate clearly that they can choose to participate or not.	(no match)
483.676	State, what the alternative  - in terms of the treatment offered by the clinic - will be, if they decide not to participate.	(no match)
484.534	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.	(no match)
484	{{State, [x]only if it is applicable, that they will still receive all the services they usually do if they choose not to participate.}}	87
485.392	This can be repeated and expanded upon later in the form as well, but it is important to state clearly at the beginning of the form that participation is voluntary so that the other information can be heard in this context.	(no match)
485.738	Your participation in this research is entirely voluntary.	(no match)
486.011	It is your choice whether to participate or not.	(no match)
486.158	Whether you choose to participate or not, all the services you receive at this clinic will continue and nothing will change.	(no match)
487.012	If you choose not to participate in this research project, you will offered the treatment that is routinely offered in this clinic/hospital for disease Z, and we will tell you more about it later.	(no match)
487.567	You may change your mind later and stop participating even if you agreed earlier.)	(no match)
488.099	The drug we are testing in this research is called ABX.	(no match)
488.326	It has been tested  before with people who do not have malaria but who live in areas where malaria is common.	(no match)
489.131	We now want to test the drug on people who have malaria.	(no match)
489.362	The drug ABX is made by Company C.  You should know that it has a few side effects.	(no match)
489.915	One of the side effects, or problems, is that you may feel tired for the first day after being given the drug.	(no match)
490.645	We know of no other problem or risks.	(no match)
490.719	It does not, however, cure malaria as often as we would like.)	(no match)
491.018	Procedures and Protocol	(too few spaces)
491.022	Describe or explain the exact procedures that will be followed on a step-by-step basis, the tests that will be done, and  any drugs that will be given.	(no match)
491.81	Explain from the outset what some of the more unfamiliar procedures involve (placebo, randomization, biopsy, etc.) Indicate which procedure is routine and which is experimental or research.Participants should know what to expect and what is expected of them.	(no match)
492.099	Use active, rather than conditional, language.	(no match)
492.22	Write "we will ask you to…." instead of "we would like to ask you to….".	(no match)
492.638	In this template, this section has been divided into two: firstly, an explanation of unfamiliar procedures and, secondly,  a description of process.	(no match)
493.492	A. Unfamiliar Procedures	(too few spaces)
493.497	This section should be included if there may be procedures which are not familiar to the participant.	(no match)
494.161	[x]If the protocol is for a clinical trial:	(no match)
494.259	1) involving randomization or blinding, the participants should be told what that means and what chance they have of getting which drug (i.e. one in four chances of getting the test drug).	(no match)
494.815	(Example:.	(too few spaces)
494.818	Because we do not know if the new malaria drug is better than the currently available drug for treating malaria, we need to compare the two.	(no match)
495.623	To do this, we will put people taking part in this research into two groups.	(no match)
496.085	The groups are selected by chance, as if by tossing a coin.	(no match)
496.341	Participants in one group will be given the test drug while participants in the other group will be given the drug that is currently being used for malaria.	(no match)
497.065	It is important that neither you nor we know which of the two drugs you are given.	(no match)
497.577	This information will be in our files, but we will not look at these files until after the research is finished.	(no match)
498.317	This is the best way we have for testing without being influenced by what we think or hope might happen.	(no match)
498.996	We will then compare which of the two has the best results.	(no match)
499.233	The healthcare workers will be looking after you and the other participants very carefully  during the study.	(no match)
499.944	If we are concerned about what the drug is doing , we will find out which drug you are getting and make changes.	(no match)
500.665	If there is anything you are concerned about or that is bothering you about the research please talk to me or one of the other researchers)	(no match)
501.42	2) involving an inactive drug or placebo, it is important to ensure that the participants understand what is meant by a placebo or inactive drug.	(no match)
502.172	A placebo or inactive medicine looks like real medicine but it is not.	(no match)
502.569	It is a dummy or pretend medicine.	(no match)
502.623	It has no effect on a person because it has no real medicine in it.	(no match)
502.96	Sometimes when we want  to know whether a new medicine is good, we give some people the new medicine and some people the pretend or  dummy medicine.	(no match)
503.707	For the research to be good, it is important that you do not  know whether you have been given the real medicine or  the pretend or dummy medicine.	(no match)
504.594	This is one of the best ways we have for knowing what the medicine we are testing really does.)	(no match)
505.187	3) which may necessitate a rescue medicine, then provide information about the rescue medicine or treatment such as what it is and the criterion for its use.	(no match)
505.885	For example, in pain trials, if the test drug does not control pain, then intravenous morphine may be used as a rescue medicine.	(no match)
506.637	If we find that the medicine that is being used does not have the desired effect, or not to the extent that we wish it to have, we will use what is called a “rescue medicine.”	(no match)
507.167	The medicine that we will use is called QRS  and it has been proven to control pain.	(no match)
507.677	If you find that the drug we are testing does not stop your pain and it is very uncomfortable for you, we can use the rescue medicine to make you more comfortable.)	(no match)
508.309	If the protocol is for clinical research:	(no match)
508.375	Firstly, explain that there are standards/guidelines that will be followed for the treatment of their condition.	(no match)
509.071	Secondly, if as part of the research a biopsy will be taken, then explain whether it will be under local anesthesia, sedation or general anesthesia, and what sort of symptoms and side effects the participant should expect under each category.	(no match)
509.362	You will receive the treatment of your condition according to national guidelines.	(no match)
509.822	This means that you will be (explain the treatment).	(no match)
509.971	To confirm the cause of your swelling, a small sample of your skin will be taken.	(no match)
510.442	The guidelines say that the sample must be taken using a local anesthesia which means that we will give you an injection close to the area where we will take the sample from.	(no match)
510.97	This will make the area numb so that you will not feel any pain when we take the sample.)	(no match)
511.512	For any clinical study (if relevant):	(no match)
511.567	If blood samples are to be taken explain how many times and how much in a language that the person understands.	(no match)
512.239	It may, for example, be inappropriate to tell a tribal villager that blood equal to a wine-glass full will be taken but it may be very appropriate to use pictures or other props to illustrate the procedure if it is unfamiliar.	(no match)
512.517	If the samples are to be used only for this research, then explicitly mention here that the biological samples obtained during this research procedure will be used only for this research, and will be destroyed after ____ years, when the research is completed.	(no match)
512.747	If the tissues/blood samples or any other human biological material will be stored for a duration longer than the research purpose, or is likely to be used for a purpose other than mentioned in the research proposal, then provide information about this and obtain consent specifically for such storage and use in addition to consent for participation in the study - (see last section)	(no match)
512.811	We will take blood from your arm using a syringe and  needle.	(no match)
513.071	Each time we will take about this much blood (show a spoon, vial or other small container with a small amount of water in it.	(no match)
513.808	In total, we will take about ……..this much blood in x number of weeks/months.	(no match)
514.238	At the end of the research, in 1 year, any left over blood sample will be destroyed.)	(no match)
514.717	B. Description of the Process	(too few spaces)
514.722	Describe to the participant what will happen on a step-by-step basis.	(no match)
515.069	It may be helpful to the participant if you use drawings or props to better illustrate the procedures.	(no match)
515.661	A small vial or container with a little water in it is one way of showing how much blood will be withdrawn.	(no match)
516.287	During the research you make five visits to the clinic.	(no match)
516.475	In the first visit, a small amount of blood, equal to about a teaspoon, will be taken from your arm with a syringe.	(no match)
517.143	This blood  will be tested for the presence of substances that help your body to fight infections.	(no match)
517.675	We will also ask you a few questions about your general health and measure how tall you are and how much you weigh.	(no match)
518.33	At the next visit, which will be two weeks later, you will again be asked some questions about your health and then you will be given either the test drug or the drug that is currently used for malaria.	(no match)
518.683	As explained before, neither you nor we will know whether you have received the test or the dummy/pretend drug.	(no match)
519.291	After one week, you will come back to the clinic for a blood test.	(no match)
519.574	This will involve….)	(too few spaces)
519.58	Include a statement about the time commitments of the research for the participant including both the duration of the research and follow-up, if relevant.	(no match)
520.183	The research takes place over ___ (number of) days/ or ___ (number of) months in total.	(no match)
520.675	During that time, it will be necessary for you to come to the clinic/hospital/health facility _______(number of) days , for ____ (number of) hours each day.	(no match)
521.322	We would like to meet with you three  months after your last clinic visit for a final check-up.	(no match)
521.812	In total, you will be asked to come 5 times to the clinic in 6 months.	(no match)
522.156	The research project?	(too few spaces)
522.156	Side Effects	(too few spaces)
522.16	Potential participants should be told if there are any known or anticipated side effects and what will happen in the event of a side effect or an unexpected event.	(no match)
522.689	As already  mentioned, this drug can have some unwanted effects.	(no match)
522.967	It can make you tired and it can cause some temporary swelling around the place where the injection goes into your arm.	(no match)
523.622	It is possible that it may also cause some problems that we are not aware of.	(no match)
523.987	However, we will follow you closely and keep track of any unwanted effects or any  problems.	(no match)
524.544	We may use some other medicines to decrease the symptoms of the side effects or reactions.	(no match)
525.011	Or we may stop the use of one or more drugs.	(no match)
525.102	If this is necessary we will discuss it together with you and you will always be consulted before we move to the next step.)	(no match)
525.719	Risks	(too few spaces)
525.724	Explain and describe any possible or anticipated  risks.	(no match)
525.917	Describe the level of care that will be available in the event that harm does occur, who will provide it, and who will pay for it.	(no match)
526.575	A risk can be thought of as being the possibility that harm may occur.	(no match)
526.877	Provide enough information about the risks that the participant can make an informed decision.	(no match)
527.379	By participating in this research  it is possible that you will be at greater risk than you would otherwise be.	(no match)
527.922	There is, for example, a risk that your disease will not get better and that the new medicine doesn't work even as well as the old one.	(no match)
528.518	If, however,  the medicine is not working and your fever does not go down in 48 hours we will give you quinine injections which will bring your fever down and make you more comfortable.	(no match)
528.984	While the possibility of this happening is very low, you should still be aware of the possibility.	(no match)
529.453	We will try to decrease the chances of this event  occurring, but if something unexpected happens, we will provide you with______.)	(no match)
530.073	Mention only those activities that will be actual benefits and not those to which they are entitled regardless of participation.	(no match)
530.673	Benefits may be divided into benefits to the individual, benefits to the community in which the individual resides, and benefits to society as a whole as a result of finding an answer to the research question.	(no match)
530.978	If you participate in this research, you will have the following benefits: any interim illnesses will be treated at no charge to you.	(no match)
531.563	If your child falls sick during this period he/she will be treated free of charge.	(no match)
531.951	There may not be any benefit for you but your participation is likely to help us find the answer to the research question.	(no match)
532.519	There may not be any benefit to the society at this stage of the research, but future generations are likely to benefit.)	(no match)
533.06	WHO does not encourage incentives.	(too few spaces)
533.064	However, it recommends that reimbursements for expenses incurred as a result of participation in the research be provided.	(no match)
533.636	These may include, for example, travel costs and money for wages lost due to visits to health facilities.	(no match)
534.124	We will give you  [amount of money] to pay for your travel to the clinic/parking and we will give you [amount] for lost work time.	(no match)
534.675	You will not be given any other money or gifts to take part in this research.)	(no match)
535.049	Explain how the research team will maintain the confidentiality of data, especially with respect to the information about the participant which would otherwise be known only to the physician but would now be available to the entire research team.	(no match)
535.248	Note that[x] because something out of the ordinary is being done through research, any individual taking part in the research is likely to be more easily identified by members of the community and is therefore more likely to be stigmatized.	(no match)
535.436	With this research, something out of the ordinary is being done in your community.	(no match)
535.801	It is possible that if others in the community are aware that you are participating, they may ask you questions.	(no match)
536.307	We will not be sharing the identity of those participating in the research.	(no match)
536.622	Sharing the Results	(too few spaces)
536.626	Where it is relevant, your plan for sharing the information with the participants should be provided.	(no match)
537.059	You should also inform the participant that the research findings will be shared more broadly, for example, through publications and conferences.	(no match)
537	{{You may also inform the participant that the research findings will be shared more broadly, for example, through publications and conferences.}}	97
537.578	The knowledge that we get from doing this research will be shared with you through community meetings before it is made widely available to the public.	(no match)
538.069	Confidential information will not be shared.	(no match)
538.153	There will be small meetings in the community and these will be announced.	(no match)
538.449	After these meetings, we will publish the results in order that other interested people may learn from our research.)	(no match)
538	{{Following the meetings, we will publish the results so that other interested people may learn from the research.)}}	85
538.957	This is a reconfirmation that participation is voluntary and includes the right to withdraw.	(no match)
539.358	Tailor this section to ensure that it fits for the group for whom you are seeking consent.	(no match)
539.743	The example used here is for a patient at a clinic.	(no match)
539.862	You do not have to take part in this research if you do not wish to do so and refusing to participate will not affect your treatment at this clinic in any way.	(no match)
540.283	You will still have all the benefits that you would otherwise have at this clinic.	(no match)
540.614	You may stop participating in the research at any time that you wish without losing any of your rights as a patient here.	(no match)
541.092	Your treatment at this clinic will not be affected in any way.)	(no match)
541.318	You do not have to take part in this research if you do not wish to do so.	(no match)
541.592	You may also stop participating in the research at any time you choose.	(no match)
541.851	It is your choice and all of your rights will still be respected.)	(no match)
542.11	Alternatives to Participating	(too few spaces)
542.115	Include this section only if the study involves administration of investigational drugs or use of new therapeutic procedures.	(no match)
542.636	It is important to explain and describe the [x]established standard treatment.	(no match)
542.955	If you do not wish to take part in the research, you will be provided with the established standard treatment available at the centre/institute/hospital.	(no match)
543.446	People who have malaria are given….)	(no match)
543.486	[name, address/telephone number/e-mail])	(too few spaces)
543.49	This proposal has been reviewed and approved by [name of the local IRB], which is a committee whose task it is to make sure that research participants are protected from harm.	(no match)
543.877	It has also been reviewed by the Ethics Review Committee of the World Health Organization (WHO), which is funding/sponsoring/supporting the study.	(no match)
544.342	This section should be written in the first person and have a statement similar to the one in bold below.	(no match)
544.748	The certificate of consent should avoid statements that have "I understand…." phrases.	(no match)
545.079	The understanding should perhaps be better tested through targeted questions during the reading of the information sheet (some examples of questions are given above), or through the questions being asked at the end of the reading of the information sheet, if the potential participant is reading the information sheet him/herself.	(no match)
545.152	I have read the foregoing information, or it has been read to me.	(no match)
545.368	I consent voluntarily to participate as a participant in this research.	(no match)
545.612	I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability.	(no match)
545.903	{!{!{!{ \ethics-InformedConsent-qualitativestudies.doc.sdlxliff }!}!}!}	(too few spaces)
545.903	[x]Page [x] of 	(too few spaces)
545.904	Qualitative Studies	(too few spaces)
545.907	(This template is for research interventions that use questionnaires, in-depth interviews or focus group discussions )	(no match)
546.376	[Informed Consent Form for _________________________________]::!!!::	(too few spaces)
546.383	This informed consent form is for social service providers in the community X and who we are inviting to participate in research Y, titled  "The Community Response to Malaria Project".)	(no match)
546.71	• [x]Information Sheet (to share information about the study with you)	(no match)
546.953	• [x]Certificate of Consent (for signatures if you choose to participate)	(no match)
547.224	Briefly state who you are and that you are inviting them to participate in research which you are doing.	(no match)
547.616	I am X, working for the Y organization.	(no match)
547.66	I am doing research on the disease malaria which is very common in this country and in this region.	(no match)
547.998	This consent form may contain words that you do not understand.	(no match)
548.184	Explain the research question [x]in lay terms which will clarify rather than confuse.	(no match)
548.493	Use local and simplified words rather than scientific terms and professional jargon.	(no match)
548.779	In your explanation, consider local beliefs and knowledge when deciding how best to provide the information.	(no match)
549.177	Investigators however need to be careful not to mislead participants, by suggesting research interests that they do not have.	(no match)
549.614	For example, if the study wants to find out about treatments provided by local practitioners, wording should not suggest that they want to find out about how the practitioners are advertising themselves.	(no match)
549.839	Misleading participants may be essential and justified in certain circumstances, but that needs to be carefully argued, and approved by an ethics committee.	(no match)
550.222	Malaria is making many people sick in your community.	(no match)
550.34	We want to find ways to stop this from happening.	(no match)
550.421	We believe that you can help us by telling us what you know both about malaria and about local health practices in general .	(no match)
550.846	We want to learn what people who live or work here know about the causes of malaria and why some people get it.	(no match)
551.213	We want to learn about the different ways that people try to stop malaria before someone gets it or before it comes to the community, and how people know when someone has it.	(no match)
551.549	We also want to know more about local health practices because this knowledge might help us to learn how to better control malaria in this community.)	(no match)
551.93	This research will involve your participation in a group discussion that will take about one and a half hour, and a one hour interview).	(no match)
552.309	Indicate why you have chosen this person to participate in this research.	(no match)
552.545	People wonder why they have been chosen and may be fearful, confused or concerned.	(no match)
552.804	You are being invited to take part in this research because we feel that your experience as a social worker (or as a mother, or as a responsible citizen)  can contribute much to our understanding and knowledge of local health practices.)	(no match)
552.949	Explanation:	(too few spaces)
552.954	It may be more applicable to assure them that their choosing to participate or not will not have any bearing on their job or job-related evaluations.	(no match)
553.326	Although, if the interview or group discussion has already taken place, the person cannot 'stop participation' but request that the information provided by them not be used in the research study.	(no match)
553.558	If you choose not to participate all the services you receive at this Centre will continue and nothing will change.	(no match)
553.928	The choice that you make will have no bearing on your job or on any work-related evaluations or reports.	(no match)
554.252	Procedures	(too few spaces)
554.256	A. Provide a brief introduction to the format of the research study.	(no match)
554.446	We are asking you to help us learn more about malaria in your community.	(no match)
554.671	We are inviting you to take part in this research project.	(no match)
554.795	If you accept, you will be asked to….:)	(no match)
554.839	If the research involves questions or discussion which may be sensitive or potentially cause embarrassment, inform the participant of this.	(no match)
555.199	(Example 1 (for focus group discussions)	(no match)
555.24	take part in a discussion with 7-8 other persons with similar experiences.	(no match)
555.45	This discussion will be guided by [name of moderator/guider] or myself.	(no match)
555.647	The group discussion will start with me, or the focus group guide or moderator (use the local word for group discussion leader), making sure that you are comfortable.	(no match)
555.944	Then we will ask you questions about the malaria and give you time to share your knowledge.	(no match)
556.207	The questions will be about malaria in your community, how is it recognized, what  people do to  stop it from spreading to other people, who  people go to for help and what happens when people become sick with it.	(no match)
556.363	We will also talk about community practices more generally because this will give us a chance to understand more about  malaria but in a different way.	(no match)
556.693	We will not ask you to share personal beliefs,  practices or  stories and you do not have to share any knowledge that you are not comfortable sharing.	(no match)
557.016	The information recorded is confidential, and no one else except [name of person(s)] will have access to the tapes.	(no match)
557.369	The tapes will be destroyed after ______number of days/weeks.	(no match)
557.514	Example 2 (for interviews)	(too few spaces)
557.518	participate in an interview with [name of interviewer] or myself.	(no match)
557.671	During the interview, I  or another interviewer will sit down with you in a comfortable place at the Centre.	(no match)
557.986	If it is better for you, the interview can take place in your home or a friend's home.	(no match)
558.222	If you do not wish to answer any of the questions during the interview, you may say so and the interviewer will move on to the next question.	(no match)
558.518	No one else but the interviewer will be present unless you would like someone else to be there.	(no match)
558.761	The information recorded is confidential, and no one else except [name of person(s)] will access to the information documented during your interview.	(no match)
559.075	Example 3 (for questionnaire surveys)	(too few spaces)
559.08	fill out a survey which will be provided by [name of distributor of blank surveys] and collected by [name of collector of completed surveys].OR You may answer the questionnaire yourself, or it can be read to you and you can say out loud the answer you want me to write down.	(no match)
559.205	If you do not wish to answer any of the questions included in the survey, you may skip them and move on to the next question.	(no match)
559.539	[Describe how the survey will be distributed and collected].	(no match)
559.672	The information recorded is confidential, your name is not being included on the forms, only a number will identify you, and no one else except [name of person(s) with access to the information] will have access to your survey.)	(no match)
559.761	During that time, we will visit you three times for interviewing you at one month interval  and each interview will last for about one hour each.	(no match)
560.042	The group discussion will be held once and will take about one and a half hour.)	(no match)
560.253	If you decide to take part in the study, do you know how much time will the interview take?	(no match)
560.488	Do you know that we will be sending you transport to pick you up from your home?	(no match)
560.685	If you agree to take part, do you know if you can stop participating?	(no match)
560.849	Do you know that you may not respond to the questions that you do not wish to respond to?	(no match)
561.081	Explain and describe any risks that you anticipate or that are possible.	(no match)
561.241	The risks depend upon the nature and type of qualitative intervention, and should be, as usual, tailored to the specific issue and situation.	(no match)
561.515	(If the discussion is on sensitive and personal issues e.g. reproductive and sexual health, personal habits etc. then an example of text could be something like "We are asking you to share with us some very personal and confidential information, and you may feel uncomfortable talking about some of the topics.	(no match)
561.581	You do not have to answer any question or take part in the discussion/interview/survey if you don't wish to do so, and that is also fine.	(no match)
561.858	You do not have to give us any reason for not responding to any question, or for refusing to take part in the interview"	(no match)
562.14	OR If for example, the discussion is on opinions on government policies and community beliefs, and in general no personal information is sought, then the text under risks could read something like "There is a risk that you may share some personal or confidential information by chance, or that you may feel uncomfortable talking about some of the topics.	(no match)
562.147	You do not have to answer any question or take part in the discussion/interview/survey if you feel the question(s) are too personal or if talking about them makes you uncomfortable.)	(no match)
562.322	There will be no direct benefit to you, but your participation is likely to help us find out more about how to prevent and  treat malaria in your community).	(no match)
562.549	These may include, for example, travel costs and reimbursement for time lost.	(no match)
562.721	Example:	(too few spaces)
562.725	You will not be provided any incentive to take part in the research.	(no match)
562.855	However, we will give you [provide a figure, if money is involved] for your time, and travel expense (if applicable).	(no match)
563.136	Explain how the research team will maintain the confidentiality of data with respect to both  information about the participant and information that the participant shares.	(no match)
563.33	Outline any limits to confidentiality.	(too few spaces)
563.334	Inform the participant that because something out of the ordinary is being done through research, any individual taking part in the research is likely to be more easily identified by members of the community and therefore more likely to be stigmatized.	(no match)
563.396	If the research is sensitive and/or involves participants who are highly vulnerable - research concerning violence against women for example -  explain to the participant any extra precautions you will take to ensure safety and anonymity.	(no match)
563.439	The research being done in the community may draw attention and if you participate you may be asked questions by other people in the community.	(no match)
563.664	We will not be sharing information about you to anyone outside of the research team.	(no match)
563.839	It will not be shared with or given to anyone except [name who will have access to the information, such as research sponsors, DSMB board, your clinician, etc])	(no match)
564.029	Focus groups provide a particular challenge to confidentiality because once something is said in the group it becomes common knowled[x]ge.	(no match)
564.25	Explain to the participant that you will encourage group participants to respect confidentiality, but that you cannot guarantee it.	(no match)
564.501	We will ask you and others in the group not to talk to people outside the group about what was said in the group.	(no match)
564.738	We will, in other words, ask each of you to keep what was said in the group confidential.	(no match)
564.938	Do you understand that the we cannot guarantee complete confidentiality of information that you share with us in a group discussion Do you have any more questions?	(no match)
565.086	Your plan for sharing the findings with the participants should be provided.	(no match)
565.25	Nothing that you tell us today will be shared with anybody outside the research team, and nothing will be attributed to you by name.	(no match)
565.461	The knowledge that we get from this research will be shared with you and your community before it is made widely available to the public.	(no match)
565.651	Each participant will receive a summary of the results.	(no match)
565.745	There will also be small meetings in the community and these will be announced.	(no match)
565.896	The example used here is for a community social worker.	(no match)
565.976	Participants should have an opportunity to review their remarks in individual interviews and erase part or all of the recording or note.	(no match)
566.148	You do not have to take part in this research if you do not wish to do so, and choosing to participate will not affect your job or job-related evaluations in any way.	(no match)
566.27	You may stop participating in the [discussion/interview] at any time that you wish without your job being affected.	(no match)
566.481	I will give you an opportunity at the end of the interview/discussion to review your remarks, and you can ask to modify or remove portions of those, if you do not agree with my notes or if I did not understand you  correctly.)	(no match)
566.512	Provide the name and contact information of someone who is involved, informed and accessible -[x] [x] a local person who can actually be contacted.	(no match)
566.654	State also the name (and contact details) of the local IRB that has approved the proposal.	(no match)
566.818	State also that the proposal has also been approved by the WHO ERC.	(no match)
566.919	If you have any questions, you can ask them now or later.	(no match)
567.005	If you wish to find about more about the IRB, contact _____ .)	(no match)
567.098	I have been invited to participate in research about malaria and local health practices.	(no match)
567.255	(This section is mandatory)	(too few spaces)
567.263	I consent voluntarily to be a participant in this study	(no match)
567.326	If illiterate 	(too few spaces)
567.333	Print name of witness____________[x]    	(no match)
567.355		(too few spaces)
567.355	 Thumb print of participant	(too few spaces)
567.359	Signature of witness    _____________	(no match)
567.375	{!{!{!{ \Informed_Consent Template.doc.sdlxliff }!}!}!}	(too few spaces)
567.375	Informed Consent	(too few spaces)
567.38	Template for Creating an Informed Consent Letter	(no match)
567.411	Page  of 	(too few spaces)
567.411	Participant’s Initials:	(too few spaces)
567.411	________	(too few spaces)
567.411	Note to Investigators:	(too few spaces)
567.415	When creating informed consent letters, investigators are encouraged to keep language and vocabulary as basic and straightforward as possible.	(no match)
567.547	Investigators are also encouraged to use this template when creating informed consent letters.	(no match)
567.712	Use of alternative wording or format is permitted, but doing so may slow down the review process.	(no match)
567.868	All sections of the consent form, except the "Consent" section, should be written in second person ("You are invited...").	(no match)
568.052	Headers should include “Informed Consent” followed by the title of the study (e.g., the header in this document).	(no match)
568.2	Footers should include page numbers.	(too few spaces)
568.204	If your consent letter is more than one page, the footer should also include a space for the participant’s initials (e.g., the footer in this document).	(no match)
568.303	Be sure to include any basic components of informed consent that are appropriate to your study[x].	(no match)
568.443	If components apply to your study, they must be included.	(no match)
568.516	Please refer to the document entitled “components of informed consent” for more information.	(no match)
568.658	If you have any further questions, contact the Director of Institutional Research at (865) 354-3000, ext. 4822.	(no match)
568.797	**Information in italics is for your information and should be deleted from the actual consent form.	(no match)
568.936	Material in brackets should be completed with relevant information.**	(no match)
569.022	TITLE OF STUDY	(too few spaces)
569.022	[Insert title]	(too few spaces)
569.022	[x]PRINCIPAL INVESTIGATOR 	(too few spaces)
569.022	[Name]	(too few spaces)
569.022	[Department]	(too few spaces)
569.022	[Address]	(too few spaces)
569.022	[Phone]	(too few spaces)
569.023	[Email]	(too few spaces)
569.023	[x]PURPOSE OF STUDY	(too few spaces)
569.028	You are being asked to take part in a research study.	(no match)
569.077	Before you decide to participate in this study, it is important that you understand why the research is being done and what it will involve.	(no match)
569.179	Please read the following information carefully.	(no match)
569.202	Please ask the researcher if there is anything that is not clear or if you need more information.	(no match)
569.31	The purpose of this study is to [Briefly describe purpose of study.]	(no match)
569.395	[x]STUDY PROCEDURES	(too few spaces)
569.399	[x]List all procedures, preferably in chronological order, which will be employed in the study.	(no match)
569.505	Point out any procedures that are considered experimental.	(no match)
569.554	Clearly explain technical and medical terminology using non-technical language.	(no match)
569.65	Explain all procedures using language that is appropriate for the expected reading level of participants.	(no match)
569.765	State the amount of time required of participants per session, if applicable, and for the total duration of the study.	(no match)
569.864	If audio taping, videotaping, or film procedures are going to be used, provide information about the use of these products.	(no match)
569.968	[x]RISKS	(too few spaces)
569.971	[x]List all reasonably foreseeable risks, if any, of each of the procedures to be used in the study, and any measures that will be used to minimize the risks.	(no match)
570.028	You may decline to answer any or all questions and you may terminate your involvement at any time if you choose.	(no match)
570.124	[x]BENEFITS	(too few spaces)
570.128	[x]List the benefits you anticipate will be achieved from this research.	(no match)
570.193	Include benefits to participants, others, or the body of knowledge.	(no match)
570.248	If there is no direct benefit to the participant, state so.	(no match)
570.288	For example, “There will be no direct benefit to you for your participation in this study.	(no match)
570.371	However, we hope that the information obtained from this study may….”	(no match)
570.421	[x]When applicable, disclose alternative procedures or courses of treatment, if any, which might be advantageous to participants.	(no match)
570.509	Your responses to this [survey] will be anonymous.	(no match)
570.527	Please do not write any identifying information on your [survey].	(no match)
570.576	[x]OR For the purposes of this research study, your comments will not be anonymous.	(no match)
570.639	Every effort will be made by the researcher to preserve your confidentiality including the following:	(no match)
570.72	[State measures taken to ensure confidentiality, such as those listed below:	(no match)
570.769	Assigning code names/numbers for participants that will be used on all research notes and documents	(no match)
570.83	Keeping notes, interview transcriptions, and any other identifying participant information in a locked file cabinet in the personal possession of the researcher.]	(no match)
570.88	Participant data will be kept confidential except in cases where the researcher is legally obligated to report specific incidents.	(no match)
570.944	These incidents include, but may not be limited to, incidents of abuse and suicide risk.	(no match)
570.994	[x]COMPENSATION	(too few spaces)
570.998	[x]If there is no compensation, delete this section.	(no match)
571.014	Indicate what participants will receive for their participation in this study.	(no match)
571.055	Indicate other ways participants can earn the same amount of credit or compensation.	(no match)
571.089	State whether participants will be eligible for compensation if they withdraw from the study prior to its completion.	(no match)
571.14	If compensation is pro-rated over the period of the participant's involvement, indicate the points/stages at which compensation changes during the study.	(no match)
571.169	[x]CONTACT INFORMATION 	(too few spaces)
571.172	If you have questions at any time about this study, or you experience adverse effects as the result of participating in this study, you may contact the researcher whose contact information is provided on the first page.	(no match)
571.187	If you have questions regarding your rights as a research participant, or if problems arise which you do not feel you can discuss with the Primary Investigator, please contact the Institutional Review Board at (865) 354-3000, ext. 4822.	(no match)
571.188	[x]VOLUNTARY PARTICIPATION	(too few spaces)
571.192	Your participation in this study is voluntary.	(no match)
571.201	It is up to you to decide whether or not to take part in this study.	(no match)
571.22	If you decide to take part in this study, you will be asked to sign a consent form.	(no match)
571.246	After you sign the consent form, you are still free to withdraw at any time and without giving a reason.	(no match)
571.283	Withdrawing from this study will not affect the relationship you have, if any, with the researcher.	(no match)
571.304	If you withdraw from the study before data collection is completed, your data will be returned to you or destroyed.	(no match)
571.328	Note[x]:	(too few spaces)
571.332	Please delineate the "Consent" section of the Informed Consent Form by drawing a line across the page (like the one above this paragraph).	(no match)
571.349	This delineation is important because the consent form grammar shifts from second person to first person, as shown in this example.	(no match)
571.362	[x]CONSENT	(too few spaces)
571.367	I have read and I understand the provided information and have had the opportunity to ask questions.	(no match)
571.376	I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost.	(no match)
571.38	I understand that I will be given a copy of this consent form.	(no match)
571.393	I voluntarily agree to take part in this study.	(no match)
571.397	Participant's signature ______________________________ Date __________ 	(no match)
571	{{Investigator's signature _____________________________ Date __________}}	86



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Input file: extracted text (unique lines only).txt
Output file: balanced - extracted text (unique lines only).txt_output.txt
Fuzzy threshold: 75%
Length threshold: 0.75
Space limit: 5
Global space limit: No
Length limit: N
Upper length limit: N
Method used: fuzzy trim, type 1 (levenshtein) v.3

Total time: 571.4 seconds
# of segments: 981
# of matches: 69

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