﻿0.02	19091	(no match)
0.05	15360	(no match)
0.078	976	(no match)
0.107	1423	(no match)
0.136		(no match)
0	{{}}	100
0.161	Source:	(no match)
0.198	https://www.who.int/ethics/review-committee/informed_consent/en/	(no match)
1.371	==	(no match)
1.394	{!{!{!{ \ethics-ICFparentalConsent-qualitative.doc.sdlxliff }!}!}!}	(no match)
2	{{{!{!{!{ \ethics-InformedConsent-qualitativestudies.doc.sdlxliff }!}!}!}}}	84
2.578	Page	(no match)
2.606	Research Ethics Review Committee	(no match)
2.797	(WHO ERC)	(no match)
2.842	[x]20, avenue Appia – CH-1211 Geneva 27 – Switzerland – [x]http://www.who.int/ethics/review-committee	(no match)
3	{{[x]20, avenue Appia – CH-1211 Geneva 27 – Switzerland –  [x]http://www.who.int/ethics/review-committee}}	99
4.783	http://www.who.int/rpc/research_ethics	(no match)
5.097	Informed Parental Consent Template for	(no match)
5.373	Research Involving Children (Qualitative Studies)	(no match)
5.938	l C	(no match)
5.965	(For use with Participant Observation, Focus Group Discussions, Interviews, and Surveys)	(no match)
7.693	(language used throughout form should be at the level of a local student of class 6[x]th/8[x]th)	(no match)
9.438	Notes to Researchers:	(no match)
9.533	1.	(no match)
9.56	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)
11.383	It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study.	(no match)
13.461	The logo of the Institution must be used on the ICF and not the WHO logo.	(no match)
14.62	2.	(no match)
14.647	The informed consent form consists of two parts: the information sheet and the consent certificate.	(no match)
15	{{The informed assent form consists of two parts: the information sheet and the consent certificate.}}	96
16.358	3.	(no match)
16.385	Do not be concerned by the length of this template.	(no match)
16.955	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)
17	{{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
17	{{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
18.115	4.	(no match)
18.141	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)
19.116	These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.	(no match)
24.041	5.	(no match)
24.066	In this template:	(no match)
24.22	square brackets indicate where specific information is to be inserted	(no match)
27.635	bold lettering indicates sections or wording which should be included	(no match)
31.1	standard lettering is used for explanations to researchers only and must not be included in your consent forms.	(no match)
32	{{standard lettering is used for explanations to researchers only and must not be included in your assent forms.}}	97
36.886	The explanation is provided in black, and examples are provided in red in italics.	(no match)
41.335	Suggested questions to elucidate understanding are given in black in italics.	(no match)
45.307	TEMPLATE ON FOLLOWING PAGE	(no match)
45.61	[YOUR INSTITUTIONAL LETTER HEAD]	(no match)
45	{{[YOUR INSTITUTIONAL LETTERHEAD]}}	96
46.085	Please do not submit consent forms on the WHO letter head	(no match)
46	{{Please do not submit assent forms on the WHO letter head}}	94
48.362	[Informed Consent Form for _____________________]	(no match)
48	{{[Informed Assent Form for _____________________]}}	93
49	{{[Informed Consent form for  ______________ _______]}}	94
49	{{[Informed Consent Form for _________________________________]}}	88
50.028	Name the group of individuals for whom this consent is written.	(no match)
50	{{Name the group of individuals for whom this assent is written.}}	95
52.835	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)
53	{{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
54	{{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
54.579	[x](e.g. This informed consent form is for parents of adolescent girls and boys participating in the research [x]titled.	(no match)
60.788	"What do we want:	(no match)
60.946	Adolescents and health systems ")	(no match)
61.485	[Name of Principle Investigator]	(no match)
61	{{[Name of Principal Investigator]}}	93
61.939	[Name of Organization]	(no match)
62.174	[Name of Sponsor]	(no match)
62.339	[Name of Project and Version]	(no match)
62	{{[Name of Proposal and version]}}	83
62.69	This Informed Consent Form has two parts:	(no match)
62	{{This Informed Assent Form has two parts:}}	92
63.597	Information Sheet (to share information about the study with you)	(no match)
64	{{Information Sheet (gives you information about the study)}}	76
65	{{Information Sheet (to share information about the research with you)}}	91
66.499	Certificate of Consent (for signatures if you agree that your child may participate)	(no match)
71.204	You will be given a copy of the full Informed Consent Form	(no match)
71	{{You will be given a copy of the full Informed Assent Form}}	94
72	{{You will be given a copy of the full Statement of Consent}}	81
73.517	Part I:	(no match)
73	{{PART II:}}	87
73	{{PART 2:}}	85
73	{{Part II.}}	81
73.564	Information Sheet	(no match)
73.705	Introduction	(no match)
73.797	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)
80.09	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)
84.391	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)
89.096	(Example:	(no match)
89	{{(Examples:}}	90
89	{{(Example:.}}	95
89	{{Example:}}	88
89.16	I am X, and I work at Y organization in _____.	(no match)
90.426	I am doing some research which might help your clinic/hospital  do more to help teenagers become and stay healthier.	(no match)
96.841	In our research we will talk to many teenagers, both girls and boys, and ask them a number of  questions.	(no match)
102.424	Whenever researchers study children, we talk to the parents and ask them for their permission.	(no match)
107.382	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)
113.387	Both of you have to agree independently before I can begin.	(no match)
114.435	You do not have to decide today whether or not you agree to have your child participate in this research.	(no match)
116.157	Before you decide, you can talk to anyone you feel comfortable with.	(no match)
116	{{Before you decide, you can talk to anyone you feel comfortable with about the research.}}	87
117.188	There may be some words that you do not understand.	(no match)
117	{{There  may be some words that you do not understand.}}	98
117.699	Please ask me to stop as we go through the information and I will take time to explain.	(no match)
119.152	If you have questions later, you can ask them of me or of another researcher.)	(no match)
120.334	Purpose	(no match)
120	{{Purpose:}}	93
120.364	Explain[x] in lay terms why the research is being done and what is expected from the results.	(no match)
121.948	Explain why you need to conduct the research with children.	(no match)
122.683	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)
124.6	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)
126.263	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)
127.969	Type of Research Intervention	(no match)
128.1	Briefly state the intervention.	(no match)
128.242	This will be expanded upon in the procedures section.	(no match)
128.822	A questionnaire OR a focus group OR an interview)	(no match)
129.29	Selection of Participants	(no match)
129.396	State clearl[x]y why you have chosen their child to participate in this study.	(no match)
130.597	Parents may wonder why their children have been chosen for a study and may be fearful, confused or concerned.	(no match)
132.396	We want to talk to many teenagers about their health and what information or services they want for themselves.	(no match)
134.142	One part of health that we want to talk to them about is sexuality.	(no match)
135.064	We would like to ask your daughter/son to participate because she/he is a teenager and lives in this region.)	(no match)
136.825	Example of question to elucidate understanding:	(no match)
136	{{Examples of question to elucidate understanding:}}	97
137.241	Do you know why we are asking your child  to take part in this study?	(no match)
138.237	Do you know what the study is about?	(no match)
138.462	Voluntary Participation	(no match)
138	{{[x]VOLUNTARY PARTICIPATION}}	96
138.553	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)
139.956	Also inform them that their child will also have input into the decision.	(no match)
141.013	This can be repeated and expanded upon later in the form as well.	(no match)
141.882	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)
143.584	Participants may also be more alert at the beginning.	(no match)
144.133	You do not have to agree that your daughter/son can talk to us.	(no match)
144.977	You can choose to say no and any services that you and your family receive at this centre will not change.	(no match)
146.674	We know that the decision can be difficult when it involves your children.	(no match)
147.762	And it can be especially hard when the research includes sensitive topics like sexuality.	(no match)
149.231	You can ask as many questions as you like and we take the time to answer them.	(no match)
150.365	You don't have to decide today.	(no match)
150.503	You can think about it and tell me what you decide later.)	(no match)
151.172	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)
152.966	Do you know that your child does  not have to take part in this research study, if you do not wish so?	(no match)
154.586	Do you have any questions?	(no match)
154.682	Procedure	(no match)
154	{{Procedures:}}	90
154	{{Procedures}}	95
154.711	Explain what each of the steps or procedures involve.	(no match)
155.249	Indicate when the research will take place and where.	(no match)
155.789	If there are surveys, indicate where and how the surveys will be collected and distributed.	(no match)
157.258	[x]1) the following applies only to focus group discussions[x]:	(no match)
157	{{1) The following applies only to focus group discussions:}}	92
158.117	[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)
159.864	The girls and boys will be in separate groups.	(no match)
160.245	This discussion will be guided by[ give name of moderator] or me.	(no match)
161.11	[x]2) the following applies only to  interviews[x]:	(no match)
161	{{[x]2) The following applies only to interviews:}}	96
161.58	Your daughter/son will participate in an interview with [name of interviewer] or myself.	(no match)
162.995	[x]3) the following applies only to questionnaire surveys[x]:	(no match)
163	{{3) The following applies only to questionnaires and surveys:}}	86
163.763	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)
164.203	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)
165	{{B. Explain the type of questions that the participants are likely to be asked in the focus group, the interviews, or the survey.}}	77
166.138	If the questions are sensitive, acknowledge this, try to anticipate parents' concerns and protective responses, and address these.	(no match)
168.055	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)
169.861	Other concerns may include disbelief that their child is ready to talk about sexuality, or parents may be personally embarrassed.	(no match)
171.75	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)
173.291	We will also answer questions about the research that they might have.	(no match)
174	{{We can also answer questions about the research that you might have.}}	88
174.249	Then we will ask questions about the health system in this community.	(no match)
175.178	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)
177.006	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)
178.865	These are the types of questions we will ask.	(no match)
179	{{These are the types of questions we will ask…...}}	95
179.216	We will not ask them to share personal stories or anything that they are not comfortable sharing.	(no match)
180.714	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)
181	{{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
182.042	The entire discussion will be tape-recorded, but no-one will be identified by name on the tape.	(no match)
183	{{The entire interview will be tape-recorded, but no-one will be identified by name on the tape.}}	89
183.573	The tape will be kept [explain how the tape will be stored].	(no match)
184.256	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)
185.925	[The tapes will be destroyed after ____period of time.]	(no match)
185	{{[The tapes will be destroyed after ________period of time.]}}	98
186.474	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)
188.025	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)
189.431	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)
189	{{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
190.617	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)
192.21	[The questionnaires will be destroyed after _____period of time.])	(no match)
193.049	Duration	(no match)
193.074	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)
194.818	Include both the duration of the study and follow-up, if relevant.	(no match)
195.659	We are asking your child to participate in an interview which will take about 1 hour of her/his  time.	(no match)
197.233	We can do this outside of school/work hours.	(no match)
197.555	There is also a questionnaire that we will either provide to your child or which we will do together with her/him.	(no match)
199.224	This also takes about an hour.	(no match)
199.352	[x]Altogether, we are asking for about 2 hours of your child's  time.[x])	(no match)
200.349	If you decide that your child can  take part in the study, do you know how much time will the interview take?	(no match)
201.997	Where will it take place?	(no match)
202.096	Do you know that we will be sending a  transport to pick  up your child from your home?	(no match)
203.443	Do you know how much time will the discussion with other people take?	(no match)
204.379	If you agree that your child can  take part, do you know if he/she can stop participating?	(no match)
205.795	Do you know that your child  may not respond to the questions that he/she  deso not wish to respond to?	(no match)
207.358	Etc. Do you have any more questions?	(no match)
207	{{Etc. Do you have any other questions?}}	89
207.579	Risks and Discomforts	(no match)
207.651	Explain any risks or discomforts including any limits to confidentiality.	(no match)
208.669	(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)
208.931	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)
210.321	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)
212.074	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)
212.194	However, we do not wish for this to happen.	(no match)
212.5	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)
213.331	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)
215.065	We will not be sharing with you either the questions we ask nor the responses given to us by your child.)	(no match)
216.648	Benefits	(no match)
216	{{Benefits:}}	94
216.675	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)
218.422	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)
218.806	Reimbursements	(no match)
218	{{Reimbursements:}}	96
218.854	State clearly what you will provide the participants with as a result of their participation.	(no match)
220.294	WHO does not encourage incentives beyond reimbursements for expenses incurred as a result of participation in research.	(no match)
220	{{WHO does not encourage incentives beyond reimbursements for expenses incurred  as a result of participation in the research.}}	91
221	{{WHO does not encourage incentives beyond reimbursements for expenses incurred as a result of participation in the research.}}	99
222.017	The expenses may include, for example, travel expenses and reimbursement for time lost.	(no match)
222	{{These expenses may include, for example, travel expenses and reimbursement for time lost.}}	98
223.373	The amount should be determined within the host country context.	(no match)
224.172	Your daughter/son will not be provided with any payment to take part in the research.	(no match)
225.473	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)
227.235	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)
228.935	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)
230.651	Do you have any other questions?	(no match)
230.797	Confidentiality:	(no match)
230	{{Confidentiality}}	96
230.858	Explain how the research team will maintain the confidentiality of data, especially with respect to the information about the participant.	(no match)
232.546	Outline any limits there are to confidentiality.	(no match)
232.936	Note that with focus groups confidentiality cannot be guaranteed because what is said within the group becomes common knowledge.	(no match)
234.669	Participants can be asked not to share outside of the group but this does not guarantee confidentiality.	(no match)
236.187	Because something out of the ordinary is being done through research in your community, it  will draw attention.	(no match)
237.779	If your daughter/son participates, she and you may be asked questions by other people in the community.	(no match)
239.278	We will not be sharing  information about your son or daughter outside of the research team.	(no match)
240.643	The  information that we collect from this research project will be kept confidential.	(no match)
241	{{The information that we collect from this research project will be kept confidential.}}	98
241	{{The information that we collect from this research project will be kept private.}}	86
241.942	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)
243.587	Any information about your child will have a number on it instead of his/her name.	(no match)
244.774	Only the researchers will know what his/her number is and we will lock that information up with a lock and key.	(no match)
245	{{Only the researchers will know what your number is and we will lock that information up with a lock and key.}}	96
246.326	[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)
246	{{[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
247.703	[x]The following applies to focus groups[x]:	(no match)
247	{{The following applies to focus groups:}}	88
248.043	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)
249.668	We will, in other words, ask each participant to keep what was said in the group confidential.	(no match)
251.039	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)
252.665	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)
252	{{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
254.018	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)
255.292	Sharing of Research Findings	(no match)
255.408	Include a statement indicating that the research findings will be shared in a timely fashion but that confidential information will remain confidential.	(no match)
256.854	If you have a plan and timeline for the sharing of information, include the details.	(no match)
257	{{If you have a plan and a timeline for the sharing of information, include the details.}}	98
257	{{If  you have a plan and a timeline for the sharing of information, include the details.}}	97
258.085	Also inform the parent that the research findings will be shared more broadly, for examples, through publications and conferences.	(no match)
259.699	At the end of the study, we will be sharing what we have learnt with the participants and with the community.	(no match)
261.133	We will do this by meeting first with the participants and then with the larger community.	(no match)
262.4	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)
263.886	A written report will also be given to the participants which they can share with their families.	(no match)
265.22	[x][x]We will also publish the results in order that other interested people may learn from our research[x].)	(no match)
266.678	Right to refuse or withdraw	(no match)
266	{{Right to Refuse or Withdraw:}}	98
266	{{Right to Refuse and Withdraw}}	89
266.778	Explain again the voluntary nature of consent.	(no match)
267.113	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)
268.665	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)
270.056	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)
271.591	You and your child will still have all the benefits that would otherwise be available at this Centre.	(no match)
272.966	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)
274.362	Who to Contact	(no match)
274	{{Who to Contact:}}	96
274.404	Provide the name and contact information of someone who is involved, informed and accessible (a local person who can actually be contacted.	(no match)
275.975	State also that the proposal has been approved and how.	(no match)
276.512	If you have any questions you may ask them now or later, even after the study has started.	(no match)
277.773	If you wish to ask questions later, you may contact any of the following:	(no match)
279.354	[name, address/telephone number/e-mail]	(no match)
279	{{[name, address/telephone number/e-mail])}}	98
279.863	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)
281.265	If you wish to find about more about the IRB, contact [name, address, telephone number.])	(no match)
282	{{If you wish to find about more about the IRB, contact [name, address, telephone number.]).}}	99
282.498	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)
283.93	You can say No if you wish to?	(no match)
284.051	Do you know that you can ask me questions later, if you wish to?	(no match)
284.823	Do you know that I have given the contact details of the person who can give you more information about the study?	(no match)
286.239	Etc.	(no match)
286.268	Certificate of Consent	(no match)
286	{{Certificate of Assent}}	86
286.337	This section can be written in the first person.	(no match)
286	{{This section must be written in the first person.}}	91
286.712	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)
287	{{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
288	{{It should include a few brief statements about the research and be followed by a statement similar the one in bold below.}}	99
288.239	If the participant is illiterate but gives oral consent a witness must sign.	(no match)
288	{{If the participant is illiterate but gives oral consent, a witness must sign.}}	98
289.2	A researcher or the person going over the informed consent must sign each consent.	(no match)
290.263	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)
291	{{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
291.553	[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)
292.22	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)
293	{{I have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction.}}	92
294.086	I consent voluntarily for my child to participate as a participant in this study.	(no match)
295.176	Print Name of Parent or Guardian __________________	(no match)
295	{{Signature of Parent of Guardian___________________}}	77
295.632	Date ___________________________	(no match)
295	{{Date ________________________}}	95
295.771	Day/month/year	(no match)
295.807	If illiterate	(no match)
295	{{If illiterate:}}	96
295	{{If illiterate }}	96
295.843	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)
297	{{[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
297.208	Participants who are illiterate should include their thumb print as well.	(no match)
297	{{Participants who are illiterate should include their thumb-print as well.}}	98
298.101	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)
299.303	I confirm that the individual has given consent freely.	(no match)
299	{{I confirm that the individual has given assent  freely.}}	94
299.844	Print name of witness_____________________             AND         Thumb print of participant	(no match)
301.14	[x]Signature of witness ______________________	(no match)
301	{{Signature of witness    _____________}}	83
301.502	Statement by the researcher/person taking consent	(no match)
301.863	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)
302.79	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)
302	{{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
303.8	I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.	(no match)
305.263	A copy of this Informed Consent Form has been provided to the parent or guardian of the participant  ____	(no match)
306.607	[x]Print Name of Researcher[x][x]/person taking the consent_[x]_______________________	(no match)
307	{{[x]Print Name of Researcher[x][x]/person taking the assent_[x]_______________________}}	96
307.851	An Informed Assent Form will ____ OR will not ____ be completed.	(no match)
308.594	{!{!{!{ \ethics-InformedAssent.doc.sdlxliff }!}!}!}	(no match)
309.032	[x]Page [x] of	(no match)
309	{{[x]Page [x] of }}	96
309.069	http://www.who.int/ethics/review-committee_	(no match)
309	{{http://www.who.int/ethics/review-committee}}	98
309.358	Informed Assent Form Template for Children/Minors	(no match)
309.717	(language should be at a level appropriate to the child's age and development)	(no match)
310.672	This template is written for a pre-adolescent or young adolescent.	(no match)
311.43	An Informed Assent Form does[x] [x]not replace a consent form signed by parents or guardians.	(no match)
312.683	The assent is in addition to the consent and signals the child's willing cooperation in the study.	(no match)
313.9	( 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)
315.235	Certificate of Assent (this is where you sign if you agree to participate)	(no match)
316.097	This is a brief introduction to ensure the child knows who you are and that this is a research study.	(no match)
317.347	Give your name, say what you do[x] and clearly state that you are doing research.	(no match)
318.411	Inform the child that you have spoken to their parents and that parental consent is also necessary.	(no match)
319.668	Let them know that they can speak to anyone they choose about the research before they make up their mind.	(no match)
321.009	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)
321.466	I am going to give you information and invite you to be part of a research study.	(no match)
321	{{I am going to give you information and invite you to be part of this  research.}}	90
322	{{I am going to give you information and invite you to be part of this research.}}	92
322.532	You can choose whether or not you want to participate.	(no match)
323.008	We have discussed this research with your parent(s)/guardian and they know that we are also asking you for your agreement.	(no match)
324.443	If you are going to participate in the research, your parent(s)/guardian also have to agree.	(no match)
325.619	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)
327.065	You may discuss anything in this form with your parents or friends or anyone else you feel comfortable talking to.	(no match)
328.394	You can decide whether to participate or not after you have talked it over.	(no match)
329.244	You do not have to decide immediately.	(no match)
329.445	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)
330.843	Please ask me to stop at anytime and I will take time to explain).	(no match)
331.527	Why are you doing this research?	(no match)
331.657	Explain the purpose of the research in clear simple terms.	(no match)
332.246	(Example:We want to find better ways to prevent malaria before it makes children sick.	(no match)
333.354	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)
334.718	In order to find out if it is better we have to test it.)	(no match)
335.304	Choice of participants:	(no match)
335.381	Why are you asking me?	(no match)
335.452	Children, like adults, like to know why they are being invited to be in the research.	(no match)
336.593	It is important to address any fears they may have about why they were chosen.	(no match)
337.495	(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)
338.863	We are only  testing the vaccine on children who do not have malaria.)	(no match)
339.614	Participation is voluntary:	(no match)
339.703	Do I have to do this?	(no match)
339.769	State clearly and in child-friendly language that the choice to participate is theirs.	(no match)
340.847	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)
342.177	(Example:You don't have to be in this research if you don't want to be.	(no match)
342.938	Its up to you.	(no match)
342.974	If you decide not to be in the research, its okay and nothing changes.	(no match)
343.751	This is still your clinic, everything stays the same as before.	(no match)
344.426	Even if you say "yes" now, you can change your mind later and its still okay.	(no match)
345.307	If applicable:	(no match)
345.339	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)
346.709	If you decide not to take part in this research study, do you know what your options are?	(no match)
347.822	Do you know that you do not have to take part in this research study, if you do not wish to?	(no match)
348.895	I have checked with the child and they understand that participation is voluntary __(initial)	(no match)
350.015	Information on the Trial Drug [Name of Drug]:	(no match)
350	{{Information on the Trial Drug [Name of Drug]}}	98
350.316	What is this drug and what do you know about it?	(no match)
350.656	Include the following section only if the protocol is for a clinical trial:	(no match)
351.494	1) give the phase of the trial and explain what that means.	(no match)
352.027	Explain to the participant why you are comparing or testing the drugs.	(no match)
352.741	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)
353.831	3) explain the known experience with this drug	(no match)
354.114	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)
355.178	(Example:The vaccine we are testing in this research is called ABX.	(no match)
355.847	It has been tested twice before with adults who do not have malaria but who live in areas where malaria is common.	(no match)
357.072	We now want to test the vaccine  on teenagers who do not have malaria.	(no match)
357.763	This second research is called a "phase 2" trial.	(no match)
358.089	The vaccine ABX is made by Company C.  It has very few side effects.	(no match)
358.764	It can make you feel tired for the first 24 hours after being given the drug.	(no match)
359.554	Also, 20% of the people who tried the drug in previous research experienced temporary swelling where the injection entered the skin.	(no match)
360.92	We know of no greater risk or other side effects.	(no match)
361.232	Some participants in the research will not be given the drug which we are testing.	(no match)
362.127	Instead, they will be given the drug XYZ, the drug which is most commonly used in this region to treat malaria.	(no match)
363.347	There is no risk associated with that drug and no known side effects.)	(no match)
363	{{There is no risk associated with that drug and no known problems.}}	89
364.043	What is going to happen to me?	(no match)
364.138	Explain the procedures and any medical terminology in simple language.	(no match)
364.825	Focus on what is expected of  the child.	(no match)
365.016	Describe which part of the research is experimental.	(no match)
365.355	(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)
366.157	Neither you nor the researchers will know which vaccine you were given until after the study is over.	(no match)
367.283	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)
368.445	If you decide that you want to do this, there will be three  things that happen.	(no match)
369.307	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)
370.533	This is either the vaccine that we are testing or the vaccine that is usually used to prevent malaria.	(no match)
372.586	2..	(no match)
372.611	At the clinic we will also give you a mosquito net to take home and sleep under.	(no match)
373.533	Maybe you have seen these before.	(no match)
373.642	They stop mosquitoes from biting you during the night when you sleep.	(no match)
374.34	Once a month for six months after that, you will come to the clinic and the nurse will take your temperature.	(no match)
375.569	She will also take a little bit of your blood, about three or four drops, from your finger with a finger prick.	(no match)
376.803	This might hurt a little but the hurt will go away before very long.	(no match)
377.459	Altogether you will come to the clinic 7  times over 7 months.	(no match)
377.993	At the end of seven months, the research will be finished.	(no match)
378	{{At the end of six months, the research will be finished.)}}	93
378.459	I have a picture here to show you what will happen.	(no match)
378.775	You can ask me to stop and explain again at any time and I will explain more about the process).	(no match)
380.022	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)
381.549	How many times extra will you have to come if you decide to take part in the research study?	(no match)
382.538	How many injections will you be given?	(no match)
382.694	How many tablets?	(no match)
382.735	How much blood will be taken from your veins, using a syringe and needle?	(no match)
383.433	Over how many weeks?	(no match)
383.494	Do you want me to go through the procedures again?	(no match)
383.781	I have checked with the child and they understand the procedures ________(initial))	(no match)
384.647	Risks:	(no match)
384	{{Risks}}	91
384	{{[x]RISKS}}	81
384.671	Is this bad or dangerous for me?	(no match)
384.77	Explain any risks using simple, clear language.	(no match)
385.034	(Example:The vaccine is considered safe.	(no match)
385.202	It has already been tested on adults and on other children.	(no match)
385.646	There has been nothing that has worried us at all.	(no match)
385.919	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)
387.186	Another way of us knowing how you are is by having you come to the clinic every month for a check-up.	(no match)
388.252	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)
389.502	You don't have to wait for a scheduled visit.)	(no match)
389.742	Discomforts:	(no match)
389.768	Will it hurt?	(no match)
389.792	If there will be any discomforts state these clearly and simply.	(no match)
390.341	State that they should tell you and/or their parents if they are sick, experience discomfort or pain.	(no match)
391.385	Address what may be some of the child's worries, for example,  missing school or extra expense to parents.	(no match)
392.539	(Example:There are a few  other things that I want you to know.	(no match)
393.073	The injection might hurt for just a second when it goes into your arm.	(no match)
393.708	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)
394.927	If it hurts longer than that, or if it stays hard for longer or swells up, tell your parents or me.	(no match)
396.078	If you feel bad or strange, tell us.	(no match)
396.228	Sleeping under a mosquito net can be uncomfortable because it can be hot and stuffy.	(no match)
397.229	Sometimes you may not want to come to the clinic to get your blood checked or have your temperature taken.	(no match)
398.427	Its important that you try to come.	(no match)
398.558	It won't take very long.	(no match)
398.627	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)
399.936	Do you understand that, while the research study is on-going, no-one may know which medicine you re receiving?	(no match)
401.062	Do you know that the medicine that we are testing  is a new medicine, and we do not know everything about it?	(no match)
402.213	Do you understand that you may have some unwanted side-effects from the medicines?	(no match)
403.175	Do you understand that these side-effects can happen whether or not you are in the research study?	(no match)
404.269	I have checked with the child and they understand the risks and discomforts ____(initial)	(no match)
405.227	Is there anything good that happens to me?	(no match)
405.46	Describe any benefits to the child.	(no match)
405.591	(Example:Nothing really good might happen to you.	(no match)
405.902	The vaccine may not stop you from getting malaria.	(no match)
406.226	But this research might help us to find a vaccine now or later that could help other children.	(no match)
407.218	There are a couple of good things if you do decide that you want to do this.	(no match)
408.047	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)
409.364	And you will keep the mosquito net which will help keep mosquitoes away from you.	(no match)
410.261	Because mosquitoes cause malaria, this is important.)	(no match)
410.604	I have checked with the child and they understand the benefits_____ (initial)	(no match)
411.347	Do  I get anything for being in the research?	(no match)
411.607	Mention any reimbursements or forms of appreciation that will be provided.	(no match)
412.471	Any gifts given to children should be small enough to not be an inducement or reason for participating.	(no match)
413.535	(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)
414.771	Can you tell me if you have understood correctly the benefits that you will have if you take part in the study?	(no match)
415.965	Is everybody going to know about this?	(no match)
416.092	Explain what confidentiality means in simple terms.	(no match)
416.421	State any limits to confidentiality.	(no match)
416	{{Outline any limits to confidentiality.}}	86
416.545	Indicate what their parents will or will not be told.	(no match)
416.862	(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)
417.946	After the research is over, you and your parents will be told which of the two injections you received and the results.	(no match)
419.167	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)
419	{{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
420.47	Any information about you will have a number on it instead of your name.	(no match)
420	{{Any information about you will have a number on it instead of your  name.}}	98
421.154	Do you have any questions about them?	(no match)
421.274	Compensation:	(no match)
421	{{[x]COMPENSATION}}	90
421.305	What happens if I get hurt?	(no match)
421.371	Describe to the ability of the child to understand and explain that parents have been given more information.	(no match)
422.491	(Example:If you become sick during the research, we will  look after you.	(no match)
423.142	We have given your parents information about what to do if you are hurt or get sick during the research.)	(no match)
424.231	Sharing the Findings:	(no match)
424.288	Will you tell me the results?	(no match)
424.352	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)
425.361	Also tell the child that the research will be shared more broadly, i.e. in a book, journal, conferences, etc.	(no match)
426.423	(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)
427.647	I will also give you a paper with the results written down.	(no match)
428.04	Afterwards, we will be telling more people, scientists and others, about the research and what we found.	(no match)
429.106	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)
430.273	Can I choose not to be in the research?	(no match)
430.408	Can I change my mind?	(no match)
430.462	You may want to re-emphasize that participation is voluntary and any limits to this.	(no match)
431.337	(Example:You do not have to be in this research.	(no match)
431.597	No one will be mad or disappointed with you if you say no. Its your choice.	(no match)
432.226	You can think about it and tell us later if you want.	(no match)
432.555	You can  say "yes"  now and change your mind later and it will still be okay.)	(no match)
433.243	Who can I talk to or ask questions to?	(no match)
433.364	List and give contact information for those people who the child can contact easily (a local person who can actually be contacted).	(no match)
434.608	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)
435.78	(Example:You can ask me questions now or later.	(no match)
436.02	You can ask the nurse questions.	(no match)
436.1	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)
437.068	If you want to talk to someone else that you know like your teacher or doctor or auntie, that's okay too.)	(no match)
438.027	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)
439.015	You can ask your parents to look after it if you want.	(no match)
439.326	Do you know that you do not have to take part in this study if you do not wish to?	(no match)
440.083	You can ask me any more questions about any part of the research study, if you wish to.	(no match)
440.845	If the child is illiterate but gives oral assent, a witness must sign instead .	(no match)
441.589	A researcher or the person going over the informed assent with the child must sign all assents.	(no match)
442.511	(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)
443.469	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)
444.523	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)
445.62	I agree to take part in the research.	(no match)
445.728	OR	(no match)
445.744	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)
447.228	Only if child assents:	(no match)
447.428	Print name of child ___________________	(no match)
447	{{Print name of researcher_________________}}	80
447	{{Print Name of Participant__________________}}	81
448.006	Signature of child:	(no match)
448.327	____________________	(no match)
448	{{Date:________________}}	83
448	{{Date__________________}}	90
448.643	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)
449.724	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)
450.965	Print name of witness (not a parent)_________________  AND    Thumb print of participant	(no match)
451.834	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)
452.805	Signature of researcher___________________	(no match)
452	{{Signature of Participant ___________________}}	77
452.967	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)
453.972	A copy of this assent form  has been provided to the participant.	(no match)
454.524	Signature of Researcher /person taking the assent __________________________	(no match)
454	{{Signature of Researcher /person taking the consent__________________________}}	94
455.218	Copy provided to the participant ________(initialed by researcher/assistant)	(no match)
455.879	Parent/Guardian has signed an informed consent ___Yes   ___No  _____(initialed by researcher/assistant)	(no match)
456.847	-------	(no match)
456.869	Informed Consent Form Template for	(no match)
456.95	Consent for Storage and Future Use of	(no match)
457.051	Unused Samples	(no match)
457.078	Additional Consent to [Name of Project]	(no match)
457.183	Include the following section if the research protocol calls for storage and future use of samples	(no match)
458.081	This Statement of Consent consists of two parts:	(no match)
458.306	Information Sheet (to share information about unused samples with you)	(no match)
458.898	Certificate of Consent (to record your agreement)	(no match)
459.136	h	(no match)
459.151	Part 1.	(no match)
459.172	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)
460.336	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)
461.562	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)
462.54	[x]Use lay terms to explain research possibilities.	(no match)
462.819	If genetic research is a possibility, explain what this is and any implications for them.	(no match)
463.616	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)
464.729	Inform the participant that at present, the researchers can trace which blood/tissue/sperm/sputum sample belongs to the participant.	(no match)
465.868	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)
466.416	Explain the risks and benefits of each of these options.	(no match)
466.813	Inform the participant of researcher obligations in cases where the sample remains linked.	(no match)
467.917	These obligations include informing the participant of results which have immediate clinical relevance.	(no match)
469.02	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)
470.233	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)
470.986	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)
471.885	Briefly explain how confidentiality will be maintained including any limitations.	(no match)
472.63	You can ask me any more questions about any part of the information provided above, if you wish to.	(no match)
473.63	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)
474.338	[x]I wish my [TYPE OF SAMPLE] sample to be destroyed immediately.	(no match)
474.906	I want my [TYPE OF SAMPLE] sample to be destroyed after ____ years.	(no match)
475.525	I give permission for my [TYPE OF SAMPLE] sample to be stored indefinitely	(no match)
476.056	AND (if the sample is to be stored)	(no match)
476.129	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)
477.136	[give name of current research]	(no match)
477.189	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)
478.32	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)
479.335	AND	(no match)
479.349	I want my identity to be removed from my (TYPE OF SAMPLE) sample.	(no match)
479	{{I want my identity to be kept with my (TYPE OF SAMPLE) sample.}}	86
479.802	I have read the information, or it has been read to me.	(no match)
480.065	I have had the opportunity to ask questions about it and my questions have been answered to my satisfaction.	(no match)
480.995	I consent voluntarily to have my samples stored in the manner and for the purpose indicated above.	(no match)
481.81	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)
482.765	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)
484.86	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)
486.294	A copy of this ICF has been provided to the participant.	(no match)
487.217	[x][x]Page [x] of 10	(no match)
487.314	Clinical Studies	(no match)
487.367	(This template is for either clinical trials or clinical research)	(no match)
488.72	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)
489.3	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)
491.677	)	(no match)
491.692	You may provide the following information either as a running paragraph or under headings as shown below.	(no match)
494.479	Certificate of Consent (for signatures if you agree to take part)	(no match)
495.836	Briefly state who you are and explain that you are inviting them to participate in the research you are doing.	(no match)
498.63	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)
499	{{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
500.949	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)
502	{{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
503.071	I am X, working for the Y Research Institute.	(no match)
503.494	We are doing research on  Z disease, which is very common in this country.	(no match)
505.14	You do not have to decide today whether or not you will participate in the research.	(no match)
507.125	If you have questions later, you can ask them of me, the study doctor or the staff.)	(no match)
509.136	Purpose of the research	(no match)
509.227	Explain [x]in lay terms why  you are doing the research.	(no match)
510.093	The language used should clarify rather than confuse.	(no match)
510.828	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)
512.564	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)
514.204	Malaria is one of the most common and dangerous diseases in this region.	(no match)
515.692	The drugs that are currently used to help people with malaria are not as good as we would like them to be.	(no match)
518.217	In fact, only 40 out of every 100 people given the malaria  drug XYZ are completely cured.	(no match)
520.418	There is a new drug which may work better.	(no match)
520.731	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)
523.662	Briefly state the type of  intervention that will be undertaken.	(no match)
524.873	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)
525	{{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
525.936	This research will involve a single injection in your arm as well as four follow-up visits to the clinic.	(no match)
528.508	Participant selection	(no match)
528.582	State why this participant has been chosen for this research.	(no match)
529.564	People often wonder why they have been chosen to participate and may be fearful, confused or concerned.	(no match)
531.985	We are inviting all adults with malaria who attend clinic Z  to participate in the research on the new malaria drug.)	(no match)
534.884	Do you know why we are asking you to take part in this study?	(no match)
535.837	Indicate clearly that they can choose to participate or not.	(no match)
536.854	State, what the alternative  - in terms of the treatment offered by the clinic - will be, if they decide not to participate.	(no match)
539.788	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)
541	{{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
542.64	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)
543.814	Your participation in this research is entirely voluntary.	(no match)
544.702	It is your choice whether to participate or not.	(no match)
545.166	Whether you choose to participate or not, all the services you receive at this clinic will continue and nothing will change.	(no match)
548	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)
549.831	You may change your mind later and stop participating even if you agreed earlier.)	(no match)
551.603	The drug we are testing in this research is called ABX.	(no match)
552.301	It has been tested  before with people who do not have malaria but who live in areas where malaria is common.	(no match)
554.777	We now want to test the drug on people who have malaria.	(no match)
555.548	The drug ABX is made by Company C.  You should know that it has a few side effects.	(no match)
557.333	One of the side effects, or problems, is that you may feel tired for the first day after being given the drug.	(no match)
559.76	We know of no other problem or risks.	(no match)
559.941	It does not, however, cure malaria as often as we would like.)	(no match)
561.029	Procedures and Protocol	(no match)
561.118	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)
563.628	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)
564.588	Use active, rather than conditional, language.	(no match)
564.958	Write "we will ask you to…." instead of "we would like to ask you to….".	(no match)
566.362	In this template, this section has been divided into two: firstly, an explanation of unfamiliar procedures and, secondly,  a description of process.	(no match)
569.093	A. Unfamiliar Procedures	(no match)
569.176	This section should be included if there may be procedures which are not familiar to the participant.	(no match)
571.387	[x]If the protocol is for a clinical trial:	(no match)
571.651	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)
573.605	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)
576.273	To do this, we will put people taking part in this research into two groups.	(no match)
577.768	The groups are selected by chance, as if by tossing a coin.	(no match)
578.586	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)
580.941	It is important that neither you nor we know which of the two drugs you are given.	(no match)
582.523	This information will be in our files, but we will not look at these files until after the research is finished.	(no match)
584.948	This is the best way we have for testing without being influenced by what we think or hope might happen.	(no match)
587.203	We will then compare which of the two has the best results.	(no match)
588.015	The healthcare workers will be looking after you and the other participants very carefully  during the study.	(no match)
590.425	If we are concerned about what the drug is doing , we will find out which drug you are getting and make changes.	(no match)
592.774	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)
595.263	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)
598.867	A placebo or inactive medicine looks like real medicine but it is not.	(no match)
600.217	It is a dummy or pretend medicine.	(no match)
600.35	It has no effect on a person because it has no real medicine in it.	(no match)
601.505	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)
603.951	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)
606.425	This is one of the best ways we have for knowing what the medicine we are testing really does.)	(no match)
608.314	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)
610.484	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)
612.919	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)
614.682	The medicine that we will use is called QRS  and it has been proven to control pain.	(no match)
616.287	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)
618.531	If the protocol is for clinical research:	(no match)
618.746	Firstly, explain that there are standards/guidelines that will be followed for the treatment of their condition.	(no match)
621.146	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)
622.071	You will receive the treatment of your condition according to national guidelines.	(no match)
623.611	This means that you will be (explain the treatment).	(no match)
624.068	To confirm the cause of your swelling, a small sample of your skin will be taken.	(no match)
625.562	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)
627.309	This will make the area numb so that you will not feel any pain when we take the sample.)	(no match)
629.028	For any clinical study (if relevant):	(no match)
629.166	If blood samples are to be taken explain how many times and how much in a language that the person understands.	(no match)
631.35	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)
632.234	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)
633.025	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)
633.225	We will take blood from your arm using a syringe and  needle.	(no match)
634.079	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)
636.556	In total, we will take about ……..this much blood in x number of weeks/months.	(no match)
637.974	At the end of the research, in 1 year, any left over blood sample will be destroyed.)	(no match)
639.673	B. Description of the Process	(no match)
639.758	Describe to the participant what will happen on a step-by-step basis.	(no match)
640.999	It may be helpful to the participant if you use drawings or props to better illustrate the procedures.	(no match)
643.114	A small vial or container with a little water in it is one way of showing how much blood will be withdrawn.	(no match)
645.404	During the research you make five visits to the clinic.	(no match)
646.039	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)
648.551	This blood  will be tested for the presence of substances that help your body to fight infections.	(no match)
650.558	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)
652.944	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)
654.237	As explained before, neither you nor we will know whether you have received the test or the dummy/pretend drug.	(no match)
656.366	After one week, you will come back to the clinic for a blood test.	(no match)
657.394	This will involve….)	(no match)
657.455	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)
659.646	The research takes place over ___ (number of) days/ or ___ (number of) months in total.	(no match)
661.433	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)
663.743	We would like to meet with you three  months after your last clinic visit for a final check-up.	(no match)
665.532	In total, you will be asked to come 5 times to the clinic in 6 months.	(no match)
666.714	The research project?	(no match)
666.775	Side Effects	(no match)
666.804	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)
668.68	As already  mentioned, this drug can have some unwanted effects.	(no match)
669.654	It can make you tired and it can cause some temporary swelling around the place where the injection goes into your arm.	(no match)
671.977	It is possible that it may also cause some problems that we are not aware of.	(no match)
673.277	However, we will follow you closely and keep track of any unwanted effects or any  problems.	(no match)
675.105	We may use some other medicines to decrease the symptoms of the side effects or reactions.	(no match)
676.706	Or we may stop the use of one or more drugs.	(no match)
676.973	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)
679.219	Explain and describe any possible or anticipated  risks.	(no match)
679.851	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)
682.098	A risk can be thought of as being the possibility that harm may occur.	(no match)
683.182	Provide enough information about the risks that the participant can make an informed decision.	(no match)
684.949	By participating in this research  it is possible that you will be at greater risk than you would otherwise be.	(no match)
686.91	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)
689.042	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)
690.62	While the possibility of this happening is very low, you should still be aware of the possibility.	(no match)
692.327	We will try to decrease the chances of this event  occurring, but if something unexpected happens, we will provide you with______.)	(no match)
694.665	Mention only those activities that will be actual benefits and not those to which they are entitled regardless of participation.	(no match)
696.889	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)
697.95	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)
700.268	If your child falls sick during this period he/she will be treated free of charge.	(no match)
701.897	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)
704.022	There may not be any benefit to the society at this stage of the research, but future generations are likely to benefit.)	(no match)
706.379	WHO does not encourage incentives.	(no match)
706.477	However, it recommends that reimbursements for expenses incurred as a result of participation in the research be provided.	(no match)
708.753	These may include, for example, travel costs and money for wages lost due to visits to health facilities.	(no match)
710.958	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)
713.165	You will not be given any other money or gifts to take part in this research.)	(no match)
714.504	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)
715.246	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)
715.95	With this research, something out of the ordinary is being done in your community.	(no match)
717.227	It is possible that if others in the community are aware that you are participating, they may ask you questions.	(no match)
719.05	We will not be sharing the identity of those participating in the research.	(no match)
720.215	Sharing the Results	(no match)
720.253	Where it is relevant, your plan for sharing the information with the participants should be provided.	(no match)
721.761	You should also inform the participant that the research findings will be shared more broadly, for example, through publications and conferences.	(no match)
722	{{You may also inform the participant that the research findings will be shared more broadly, for example, through publications and conferences.}}	97
723.663	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)
725.486	Confidential information will not be shared.	(no match)
725.732	There will be small meetings in the community and these will be announced.	(no match)
726.82	After these meetings, we will publish the results in order that other interested people may learn from our research.)	(no match)
727	{{Following the meetings, we will publish the results so that other interested people may learn from the research.)}}	85
728.716	This is a reconfirmation that participation is voluntary and includes the right to withdraw.	(no match)
730.209	Tailor this section to ensure that it fits for the group for whom you are seeking consent.	(no match)
731.563	The example used here is for a patient at a clinic.	(no match)
732.058	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)
733.584	You will still have all the benefits that you would otherwise have at this clinic.	(no match)
734.972	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)
736.895	Your treatment at this clinic will not be affected in any way.)	(no match)
737.736	You do not have to take part in this research if you do not wish to do so.	(no match)
738.766	You may also stop participating in the research at any time you choose.	(no match)
739.734	It is your choice and all of your rights will still be respected.)	(no match)
740.597	Alternatives to Participating	(no match)
740.663	Include this section only if the study involves administration of investigational drugs or use of new therapeutic procedures.	(no match)
742.555	It is important to explain and describe the [x]established standard treatment.	(no match)
743.679	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)
745.389	People who have malaria are given….)	(no match)
745.494	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)
746.918	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)
748.587	This section should be written in the first person and have a statement similar to the one in bold below.	(no match)
750.073	The certificate of consent should avoid statements that have "I understand…." phrases.	(no match)
751.302	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)
751.564	I have read the foregoing information, or it has been read to me.	(no match)
752.308	I consent voluntarily to participate as a participant in this research.	(no match)
753.178	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)
754.289	Qualitative Studies	(no match)
754.323	(This template is for research interventions that use questionnaires, in-depth interviews or focus group discussions )	(no match)
756.024	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)
757.229	• [x]Information Sheet (to share information about the study with you)	(no match)
758.101	• [x]Certificate of Consent (for signatures if you choose to participate)	(no match)
759.048	Briefly state who you are and that you are inviting them to participate in research which you are doing.	(no match)
760.448	I am X, working for the Y organization.	(no match)
760.56	I am doing research on the disease malaria which is very common in this country and in this region.	(no match)
761.827	This consent form may contain words that you do not understand.	(no match)
762.511	Explain the research question [x]in lay terms which will clarify rather than confuse.	(no match)
763.614	Use local and simplified words rather than scientific terms and professional jargon.	(no match)
764.661	In your explanation, consider local beliefs and knowledge when deciding how best to provide the information.	(no match)
766.133	Investigators however need to be careful not to mislead participants, by suggesting research interests that they do not have.	(no match)
767.863	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)
768.689	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)
770.127	Malaria is making many people sick in your community.	(no match)
770.545	We want to find ways to stop this from happening.	(no match)
770.822	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)
772.367	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)
773.718	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)
774.936	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)
776.338	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)
777.766	Indicate why you have chosen this person to participate in this research.	(no match)
778.616	People wonder why they have been chosen and may be fearful, confused or concerned.	(no match)
779.541	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)
780.078	Explanation:	(no match)
780.107	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)
781.465	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)
782.27	If you choose not to participate all the services you receive at this Centre will continue and nothing will change.	(no match)
783.636	The choice that you make will have no bearing on your job or on any work-related evaluations or reports.	(no match)
784.819	A. Provide a brief introduction to the format of the research study.	(no match)
785.545	We are asking you to help us learn more about malaria in your community.	(no match)
786.332	We are inviting you to take part in this research project.	(no match)
786.778	If you accept, you will be asked to….:)	(no match)
786.877	If the research involves questions or discussion which may be sensitive or potentially cause embarrassment, inform the participant of this.	(no match)
788.232	(Example 1 (for focus group discussions)	(no match)
788.328	take part in a discussion with 7-8 other persons with similar experiences.	(no match)
789.103	This discussion will be guided by [name of moderator/guider] or myself.	(no match)
789.825	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)
790.883	Then we will ask you questions about the malaria and give you time to share your knowledge.	(no match)
791.852	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)
792.4	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)
793.593	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)
794.775	The information recorded is confidential, and no one else except [name of person(s)] will have access to the tapes.	(no match)
796.037	The tapes will be destroyed after ______number of days/weeks.	(no match)
796.557	Example 2 (for interviews)	(no match)
796.6	participate in an interview with [name of interviewer] or myself.	(no match)
797.147	During the interview, I  or another interviewer will sit down with you in a comfortable place at the Centre.	(no match)
798.317	If it is better for you, the interview can take place in your home or a friend's home.	(no match)
799.149	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)
800.256	No one else but the interviewer will be present unless you would like someone else to be there.	(no match)
801.149	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)
802.276	Example 3 (for questionnaire surveys)	(no match)
802.334	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)
802.769	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)
803.957	[Describe how the survey will be distributed and collected].	(no match)
804.427	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)
804.748	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)
805.827	The group discussion will be held once and will take about one and a half hour.)	(no match)
806.596	If you decide to take part in the study, do you know how much time will the interview take?	(no match)
807.433	Do you know that we will be sending you transport to pick you up from your home?	(no match)
808.129	If you agree to take part, do you know if you can stop participating?	(no match)
808.705	Do you know that you may not respond to the questions that you do not wish to respond to?	(no match)
809.568	Explain and describe any risks that you anticipate or that are possible.	(no match)
810.129	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)
811.156	(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)
811.381	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)
812.365	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)
813.315	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)
813.323	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)
813.94	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)
814.673	These may include, for example, travel costs and reimbursement for time lost.	(no match)
815.277	You will not be provided any incentive to take part in the research.	(no match)
815.777	However, we will give you [provide a figure, if money is involved] for your time, and travel expense (if applicable).	(no match)
816.79	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)
817.594	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)
817.784	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)
817.927	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)
818.76	We will not be sharing information about you to anyone outside of the research team.	(no match)
819.349	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)
819.966	Focus groups provide a particular challenge to confidentiality because once something is said in the group it becomes common knowled[x]ge.	(no match)
820.723	Explain to the participant that you will encourage group participants to respect confidentiality, but that you cannot guarantee it.	(no match)
821.518	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)
822.25	We will, in other words, ask each of you to keep what was said in the group confidential.	(no match)
822.933	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)
823.419	Your plan for sharing the findings with the participants should be provided.	(no match)
823.981	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)
824.697	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)
825.318	Each participant will receive a summary of the results.	(no match)
825.606	There will also be small meetings in the community and these will be announced.	(no match)
826.142	The example used here is for a community social worker.	(no match)
826.402	Participants should have an opportunity to review their remarks in individual interviews and erase part or all of the recording or note.	(no match)
826.996	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)
827.376	You may stop participating in the [discussion/interview] at any time that you wish without your job being affected.	(no match)
828.125	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)
828.225	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)
828.725	State also the name (and contact details) of the local IRB that has approved the proposal.	(no match)
829.307	State also that the proposal has also been approved by the WHO ERC.	(no match)
829.646	If you have any questions, you can ask them now or later.	(no match)
829.907	If you wish to find about more about the IRB, contact _____ .)	(no match)
830.207	I have been invited to participate in research about malaria and local health practices.	(no match)
830.767	(This section is mandatory)	(no match)
830.807	I consent voluntarily to be a participant in this study	(no match)
831.038	Print name of witness____________[x]    	(no match)
831.119	 Thumb print of participant	(no match)
831.154	{!{!{!{ \Informed_Consent Template.doc.sdlxliff }!}!}!}	(no match)
831.394	Informed Consent	(no match)
831.415	Template for Creating an Informed Consent Letter	(no match)
831.526	Page  of 	(no match)
831.549	Participant’s Initials:	(no match)
831.578	________	(no match)
831.596	Note to Investigators:	(no match)
831.62	When creating informed consent letters, investigators are encouraged to keep language and vocabulary as basic and straightforward as possible.	(no match)
832.084	Investigators are also encouraged to use this template when creating informed consent letters.	(no match)
832.603	Use of alternative wording or format is permitted, but doing so may slow down the review process.	(no match)
833.138	All sections of the consent form, except the "Consent" section, should be written in second person ("You are invited...").	(no match)
833.713	Headers should include “Informed Consent” followed by the title of the study (e.g., the header in this document).	(no match)
834.201	Footers should include page numbers.	(no match)
834.231	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)
834.571	Be sure to include any basic components of informed consent that are appropriate to your study[x].	(no match)
835.027	If components apply to your study, they must be included.	(no match)
835.243	Please refer to the document entitled “components of informed consent” for more information.	(no match)
835.691	If you have any further questions, contact the Director of Institutional Research at (865) 354-3000, ext. 4822.	(no match)
836.175	**Information in italics is for your information and should be deleted from the actual consent form.	(no match)
836.648	Material in brackets should be completed with relevant information.**	(no match)
836.921	TITLE OF STUDY	(no match)
836.934	[Insert title]	(no match)
836.944	[x]PRINCIPAL INVESTIGATOR 	(no match)
836.955	[Name]	(no match)
836.964	[Department]	(no match)
836.977	[Address]	(no match)
836.99	[Phone]	(no match)
836.999	[Email]	(no match)
837.007	[x]PURPOSE OF STUDY	(no match)
837.02	You are being asked to take part in a research study.	(no match)
837.165	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)
837.516	Please read the following information carefully.	(no match)
837.592	Please ask the researcher if there is anything that is not clear or if you need more information.	(no match)
837.95	The purpose of this study is to [Briefly describe purpose of study.]	(no match)
838.19	[x]STUDY PROCEDURES	(no match)
838.2	[x]List all procedures, preferably in chronological order, which will be employed in the study.	(no match)
838.579	Point out any procedures that are considered experimental.	(no match)
838.731	Clearly explain technical and medical terminology using non-technical language.	(no match)
839.075	Explain all procedures using language that is appropriate for the expected reading level of participants.	(no match)
839.448	State the amount of time required of participants per session, if applicable, and for the total duration of the study.	(no match)
839.787	If audio taping, videotaping, or film procedures are going to be used, provide information about the use of these products.	(no match)
840.141	[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)
840.323	You may decline to answer any or all questions and you may terminate your involvement at any time if you choose.	(no match)
840.632	[x]BENEFITS	(no match)
840.64	[x]List the benefits you anticipate will be achieved from this research.	(no match)
840.855	Include benefits to participants, others, or the body of knowledge.	(no match)
841.045	If there is no direct benefit to the participant, state so.	(no match)
841.173	For example, “There will be no direct benefit to you for your participation in this study.	(no match)
841.45	However, we hope that the information obtained from this study may….”	(no match)
841.621	[x]When applicable, disclose alternative procedures or courses of treatment, if any, which might be advantageous to participants.	(no match)
841.935	Your responses to this [survey] will be anonymous.	(no match)
841.992	Please do not write any identifying information on your [survey].	(no match)
842.131	[x]OR For the purposes of this research study, your comments will not be anonymous.	(no match)
842.336	Every effort will be made by the researcher to preserve your confidentiality including the following:	(no match)
842.594	[State measures taken to ensure confidentiality, such as those listed below:	(no match)
842.763	Assigning code names/numbers for participants that will be used on all research notes and documents	(no match)
842.995	Keeping notes, interview transcriptions, and any other identifying participant information in a locked file cabinet in the personal possession of the researcher.]	(no match)
843.143	Participant data will be kept confidential except in cases where the researcher is legally obligated to report specific incidents.	(no match)
843.361	These incidents include, but may not be limited to, incidents of abuse and suicide risk.	(no match)
843.551	[x]If there is no compensation, delete this section.	(no match)
843.598	Indicate what participants will receive for their participation in this study.	(no match)
843.731	Indicate other ways participants can earn the same amount of credit or compensation.	(no match)
843.837	State whether participants will be eligible for compensation if they withdraw from the study prior to its completion.	(no match)
844.013	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)
844.121	[x]CONTACT INFORMATION 	(no match)
844.127	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)
844.17	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)
844.18	Your participation in this study is voluntary.	(no match)
844.194	It is up to you to decide whether or not to take part in this study.	(no match)
844.254	If you decide to take part in this study, you will be asked to sign a consent form.	(no match)
844.336	After you sign the consent form, you are still free to withdraw at any time and without giving a reason.	(no match)
844.451	Withdrawing from this study will not affect the relationship you have, if any, with the researcher.	(no match)
844.513	If you withdraw from the study before data collection is completed, your data will be returned to you or destroyed.	(no match)
844.606	Note[x]:	(no match)
844.612	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)
844.667	This delineation is important because the consent form grammar shifts from second person to first person, as shown in this example.	(no match)
844.718	[x]CONSENT	(no match)
844.723	I have read and I understand the provided information and have had the opportunity to ask questions.	(no match)
844.747	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)
844.752	I understand that I will be given a copy of this consent form.	(no match)
844.794	I voluntarily agree to take part in this study.	(no match)
844.798	Participant's signature ______________________________ Date __________ 	(no match)
844	{{Investigator's signature _____________________________ Date __________}}	86



=========|=========|=========|=========|=========

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

Total time: 844.804 seconds
# of segments: 981
# of matches: 109

=========|=========|=========|=========|=========



