Questionnaire on ethical and legal issues - ASK-IT
Questionnaire on ethical and legal issues - ASK-IT
Questionnaire on ethical and legal issues - ASK-IT
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INFORMATION SOCIETY TECHNOLOGIES (IST)<br />
PROGRAMME<br />
511298<br />
Template <strong>on</strong> <strong>ethical</strong> <strong>and</strong> <strong>legal</strong> <strong>issues</strong><br />
Deliverable No. D5.6.1<br />
SubProject No. SP5 SubProject Title Horiz<strong>on</strong>tal Activities<br />
Workpackage No. WP5.6 Workpackage Title Ethical <strong>and</strong> <strong>legal</strong> isues<br />
Activity No. A5.6.1<br />
A5.6.2<br />
Activity Title Project <strong>ethical</strong> policy;<br />
Legal <strong>issues</strong> <strong>and</strong> IPR.<br />
Authors Dr. Alex Bullinger; Thomas Senn (COAT)<br />
Stavroula Maglavera (Pouliadis)<br />
Dr Eleni Hadjic<strong>on</strong>stantinou (NM)<br />
Nikos Floratos; Karel van Isacker (E-ISOTIS)<br />
Dr. John Gill (RNIB)<br />
Dr. Evangelos Bekiaris (CERTH/H<strong>IT</strong>)<br />
Status Final revised<br />
File Name: <strong>ASK</strong>-<strong>IT</strong>-D5.6.1_revised.doc<br />
Project start date <strong>and</strong> durati<strong>on</strong> 01 October 2004, 48 M<strong>on</strong>ths
<strong>ASK</strong>-<strong>IT</strong> Deliverable 5.6.1 Public C<strong>on</strong>tract N. 511298<br />
To be filled-in by all <strong>ASK</strong>-<strong>IT</strong> partners who c<strong>on</strong>duct trials<br />
Introducti<strong>on</strong><br />
This is a template <strong>on</strong> <strong>ethical</strong> <strong>and</strong> <strong>legal</strong> <strong>issues</strong> that has to be completed by all partners who<br />
c<strong>on</strong>duct trials. The questi<strong>on</strong>s <strong>and</strong> the documents of the different secti<strong>on</strong>s are based <strong>on</strong> the<br />
<strong>ASK</strong>-<strong>IT</strong> Ethics Manual D5.6.2, in which background informati<strong>on</strong> c<strong>on</strong>cerning the different<br />
questi<strong>on</strong>s <strong>and</strong> subsecti<strong>on</strong>s is provided in more detail. Within the Ethics manual the c<strong>on</strong>tent of<br />
the template will also be justified <strong>on</strong> scientific <strong>and</strong> <strong>legal</strong> basis in depth. Now a general<br />
introductory overview will be given.<br />
The template is divided two parts: <str<strong>on</strong>g>Questi<strong>on</strong>naire</str<strong>on</strong>g> <strong>on</strong> <strong>ethical</strong> <strong>and</strong> <strong>legal</strong> <strong>issues</strong> <strong>and</strong> the<br />
documents for the informed c<strong>on</strong>sent. After a complete revisi<strong>on</strong>, the issue of privacy protecti<strong>on</strong><br />
was given more emphasis. This is primarily reflected in the ethics manual (D5.6.2). The<br />
document at h<strong>and</strong> (D5.6.1) was enlarged with an informed c<strong>on</strong>sent template named; ‘<strong>ASK</strong>-<strong>IT</strong><br />
informed c<strong>on</strong>sent c<strong>on</strong>cerning private informati<strong>on</strong>.’<br />
The questi<strong>on</strong>naire <strong>on</strong> <strong>ethical</strong> <strong>and</strong> <strong>legal</strong> <strong>issues</strong> has to be filled in by the investigator who<br />
c<strong>on</strong>ducts experiments. It is a sort of checklist in which the researcher is reminded to take into<br />
account relevant <strong>ethical</strong> aspects before c<strong>on</strong>ducting any experiment. This questi<strong>on</strong>naire <strong>on</strong><br />
<strong>ethical</strong> <strong>and</strong> <strong>legal</strong> <strong>issues</strong> is divided into different subsecti<strong>on</strong>s (Informed c<strong>on</strong>sent, <strong>ethical</strong> c<strong>on</strong>trol<br />
instruments, privacy, safety, risk assessment).<br />
The informed c<strong>on</strong>sent is a process through which the participant will be given informati<strong>on</strong><br />
about the research. In seeking informed c<strong>on</strong>sent according to the American Psychological<br />
Associati<strong>on</strong> (2002) the following informati<strong>on</strong> shall be provided to each subject:<br />
1. The purpose of the research, expected durati<strong>on</strong>, <strong>and</strong> procedures;<br />
2. Explanati<strong>on</strong>s <strong>on</strong> c<strong>on</strong>fidentiality of the data <strong>and</strong> the protecti<strong>on</strong> of privacy see; ‘<strong>ASK</strong>-<strong>IT</strong><br />
informed c<strong>on</strong>sent c<strong>on</strong>cerning private informati<strong>on</strong>;<br />
3. The possible risks, discomfort, adverse effects, <strong>and</strong> side-effects (if any);<br />
4. A descripti<strong>on</strong> of any benefits to the subject or to others which may reas<strong>on</strong>ably<br />
be expected from the research;<br />
5. Their right to decline to participate <strong>and</strong> to withdraw from the research <strong>on</strong>ce<br />
participati<strong>on</strong> has begun <strong>and</strong> the foreseeable c<strong>on</strong>sequences of declining or withdrawing.<br />
6. Whom to c<strong>on</strong>tact for questi<strong>on</strong>s about the research <strong>and</strong> research participants<br />
rights.<br />
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<strong>ASK</strong>-<strong>IT</strong> Deliverable 5.6.1 Public C<strong>on</strong>tract N. 511298<br />
The questi<strong>on</strong>naire <strong>on</strong> <strong>ethical</strong> <strong>and</strong> <strong>legal</strong> <strong>issues</strong> will be filled in by all partners who are planning<br />
to c<strong>on</strong>duct experiments. All filled-in questi<strong>on</strong>naires will be sent to COAT. Then the ETHICS<br />
ADVISORY BOARD will carefully scrutinise the results. Within further versi<strong>on</strong>s of the<br />
ethics manual, the results are reported.<br />
The document at h<strong>and</strong> will be c<strong>on</strong>tinuously adapted to the <strong>ASK</strong>-<strong>IT</strong> research performed. So it<br />
is possible, that some questi<strong>on</strong>s will be slightly modified during the durati<strong>on</strong> of the project.<br />
2 of 29 COAT
<strong>ASK</strong>-<strong>IT</strong> Deliverable 5.6.1 Public C<strong>on</strong>tract N. 511298<br />
<str<strong>on</strong>g>Questi<strong>on</strong>naire</str<strong>on</strong>g> <strong>on</strong> <strong>ethical</strong> <strong>and</strong> <strong>legal</strong> <strong>issues</strong><br />
Is your experiment approved by a local research ethics committee?<br />
�Yes � No<br />
If yes, please c<strong>on</strong>tinue with questi<strong>on</strong> 1.<br />
If no, please c<strong>on</strong>tact the Secretary of the Ethics Advisory Board.<br />
Informed c<strong>on</strong>sent clarificati<strong>on</strong>s<br />
Note: If private informati<strong>on</strong> is recorded, please use the additi<strong>on</strong>al document ‘<strong>ASK</strong>-<strong>IT</strong><br />
informed c<strong>on</strong>sent’ c<strong>on</strong>cerning private informati<strong>on</strong>.<br />
1. Do you c<strong>on</strong>duct experiments with mentally incapacitated participants (people unable to<br />
underst<strong>and</strong> the informed c<strong>on</strong>sent form)?<br />
�Yes � No<br />
If yes, no experiment will be performed.<br />
If no, please c<strong>on</strong>tinue with the next questi<strong>on</strong>.<br />
2. Is there any doubt about the individual’s mental capacity to c<strong>on</strong>sent?<br />
�Yes � No<br />
If yes, no experiment will be performed.<br />
If no please c<strong>on</strong>tinue with the next questi<strong>on</strong>.<br />
3. a) Is the informed c<strong>on</strong>sent provided in very simple language<br />
�Yes � No<br />
If no, why not?<br />
…………………………………………………………………………………………………<br />
…………………………………………………………………………………………………<br />
…………………………………………………………………………………………………<br />
b) Will the participant be given a lot of time to reflect his/her decisi<strong>on</strong> of giving or<br />
withholding c<strong>on</strong>sent?<br />
�Yes � No<br />
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If no, why not?<br />
…………………………………………………………………………………………………<br />
…………………………………………………………………………………………………<br />
…………………………………………………………………………………………………<br />
4. Is the participant unable to c<strong>on</strong>sent?<br />
�Yes � No<br />
If yes, no experiment will be performed.<br />
If no, please c<strong>on</strong>tinue with the next questi<strong>on</strong>.<br />
…………………………………………………………………………………………………<br />
5. Does the participant included in research object in either words or acti<strong>on</strong>?<br />
�Yes � No<br />
If no (no objecti<strong>on</strong>) please c<strong>on</strong>tinue with the next questi<strong>on</strong>.<br />
If yes (he/she does object) no experiment will be performed!<br />
6. Is the participant unable to read the form?<br />
�Yes � No<br />
If yes, please c<strong>on</strong>tinue with b)<br />
If no, please c<strong>on</strong>tinue with the next questi<strong>on</strong>.<br />
b) There are a range of people who are unable to read the c<strong>on</strong>sent form; these include those<br />
who have a severe visual problem, those with severe dyslexia, those who are illiterate <strong>and</strong><br />
those whose knowledge of the language may be limited (eg a recent immigrant). For these<br />
people the informati<strong>on</strong> will be provided in appropriate alternative media (eg large print, audio<br />
tape, braille).<br />
7. Is the participant deaf?<br />
�Yes � No<br />
If yes, please c<strong>on</strong>tinue with b)<br />
If no, please c<strong>on</strong>tinue with the next questi<strong>on</strong>.<br />
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b) The informati<strong>on</strong> has to be provided to the participant in a modality with which he is<br />
able to underst<strong>and</strong> the informed c<strong>on</strong>sent form informati<strong>on</strong> (e.g. in written form)!<br />
An oral explanati<strong>on</strong> of the informed c<strong>on</strong>sent is not appropriate.<br />
8. Is the participant illiterate?<br />
�Yes � No<br />
If no, please c<strong>on</strong>tinue with the next questi<strong>on</strong>.<br />
If yes, please note that the informed c<strong>on</strong>sent informati<strong>on</strong> has to be provided in a modality that<br />
the illiterate participant is able to underst<strong>and</strong> (e.g. the statements have to be read to the<br />
participant) the informed c<strong>on</strong>sent form informati<strong>on</strong>.<br />
The participant has to give oral c<strong>on</strong>sent which has to be witnessed at least by <strong>on</strong>e pers<strong>on</strong><br />
Informed c<strong>on</strong>sent form 3.6 has to be used.<br />
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Legislati<strong>on</strong><br />
9. Is an oral c<strong>on</strong>sent of an illiterate participant that is witnessed in accordance with your<br />
nati<strong>on</strong>al legislati<strong>on</strong>?<br />
Please comment:<br />
…………………………………………………………………………………………………<br />
…………………………………………………………………………………………………<br />
…………………………………………………………………………………………………<br />
…………………………………………………………………………………………………<br />
…………………………………………………………………………………………………..<br />
10. Is there an internati<strong>on</strong>al or nati<strong>on</strong>al legislati<strong>on</strong>, which you must follow when performing<br />
tests?<br />
a) with healthy <strong>and</strong> able-bodied human participants?<br />
�Yes � No<br />
If Yes, please give details (reference number <strong>and</strong> short descripti<strong>on</strong> of procedure):<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
b) with participants with cognitive impairments / learning difficulties?<br />
If Yes, please give details (reference number <strong>and</strong> short descripti<strong>on</strong> of procedure):<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
c) with blind, deaf, motor disabled or illiterate participants?<br />
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If Yes, please give details (reference number <strong>and</strong> short descripti<strong>on</strong> of procedure):<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
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Ethical c<strong>on</strong>trol instruments<br />
11. At which level of organizati<strong>on</strong>, <strong>ethical</strong> c<strong>on</strong>trols are audited?<br />
� laboratory or workgroup<br />
� divisi<strong>on</strong> or department<br />
� instituti<strong>on</strong><br />
� regi<strong>on</strong>al<br />
� nati<strong>on</strong>al<br />
12. Is there an ethics c<strong>on</strong>trolling body in your country?<br />
�Yes � No<br />
If Yes, please give details about the procedure:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
13. Is there a local ethics c<strong>on</strong>trolling committee, that your organisati<strong>on</strong> is obliged to get<br />
approval from, for the experimental procedures before beginning with the<br />
experiment?<br />
�Yes � No<br />
If Yes, please give details about the procedure:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
14. Is there an established <strong>ethical</strong> c<strong>on</strong>trol procedure which you must follow before<br />
performing tests with<br />
a) human participants?<br />
�Yes � No<br />
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If Yes, please give a brief descripti<strong>on</strong> of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
b) with human participants with cognitive impairments / learning difficulties ?<br />
If Yes, please give a brief descripti<strong>on</strong> of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
c) with blind, deaf, motor disabled or illiterate participants?<br />
If Yes, please give a brief descripti<strong>on</strong> of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
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<strong>ASK</strong>-<strong>IT</strong> Deliverable 5.6.1 Public C<strong>on</strong>tract N. 511298<br />
Privacy<br />
Please note: If private informati<strong>on</strong> will be recorded, the <strong>ASK</strong>-<strong>IT</strong> informed c<strong>on</strong>sent template;<br />
‘<strong>ASK</strong>-<strong>IT</strong> informed c<strong>on</strong>sent c<strong>on</strong>cerning private informati<strong>on</strong>’ – to be found in the annex - has to<br />
be filled-in <strong>and</strong> signed by the participant <strong>and</strong> the investigator.<br />
15. Is private informati<strong>on</strong> recorded?<br />
�Yes � No<br />
If yes, please use also the informed c<strong>on</strong>sent template c<strong>on</strong>cerning private informati<strong>on</strong>.<br />
If no, please c<strong>on</strong>tinue with questi<strong>on</strong> no. 16.<br />
16. Is there an established Data Protecti<strong>on</strong> Authority which you must follow before<br />
performing tests with human participants <strong>and</strong> their pers<strong>on</strong>al data?<br />
�Yes � No<br />
If Yes, please give a brief outline of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
If No, please explain the reas<strong>on</strong>s briefly or what corrective acti<strong>on</strong>s you take?<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
17. Do you follow written procedures for protecting privacy?<br />
�Yes � No<br />
If Yes, please give a brief outline of it:<br />
………………………………………………………………………………………………<br />
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………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
If No, please explain the reas<strong>on</strong>s briefly or what corrective acti<strong>on</strong>s you take?<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
18. Do you follow or are aware of any official nati<strong>on</strong>al or internati<strong>on</strong>al guidelines <strong>on</strong><br />
protecting privacy?<br />
�Yes � No<br />
If Yes, please give a brief outline <strong>and</strong> provide references.<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
19. Do you clarify to the participants that all data collected in the activities they are<br />
participating is kept c<strong>on</strong>fidential <strong>and</strong> that their an<strong>on</strong>ymity will be protected?<br />
�Yes � No<br />
If Yes, please give a brief outline <strong>and</strong> provide references.<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
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20. Do you identify pers<strong>on</strong>s <strong>and</strong> their professi<strong>on</strong>s who are authorised to have access to<br />
the data collected?<br />
�Yes � No<br />
If Yes, please give a brief outline <strong>and</strong> provide references.<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
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Safety<br />
21. Will you provide informati<strong>on</strong> to the participants if you get aware of an illness?<br />
�Yes � No<br />
If Yes, please give a brief outline of it <strong>and</strong> provide some references<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
22. Is every experiment evaluated for any side-effects?<br />
�Yes � No<br />
If Yes, please give a brief outline of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
……………………………………<br />
23. Do have written procedures for safety for employees <strong>and</strong> volunteers within your own<br />
group or instituti<strong>on</strong>?<br />
�Yes � No<br />
If Yes, please give a brief outline of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
If No, please explain the reas<strong>on</strong>s briefly or what corrective acti<strong>on</strong>s you take?<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
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Risk assessment<br />
24. Do you have procedures to perform risk-assessment c<strong>on</strong>cerning breach of privacy,<br />
<strong>and</strong> safety?<br />
�Yes � No<br />
If Yes, please give a brief outline of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
If No, please explain the reas<strong>on</strong>s briefly or what corrective acti<strong>on</strong>s you take?<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
25. Is your organisati<strong>on</strong> insured against risks as a result of breach of privacy <strong>and</strong> safety?<br />
�Yes � No<br />
If Yes, please give a brief outline of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
If No, please explain the reas<strong>on</strong>s briefly or what corrective acti<strong>on</strong>s you take?<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
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26. For c<strong>on</strong>ducting research <strong>and</strong> manage the risk, do you need to involve other<br />
organisati<strong>on</strong>s (unit, divisi<strong>on</strong>, department etc.) that also c<strong>on</strong>trol your research<br />
activity?<br />
�Yes � No<br />
If Yes, please give a brief outline of it:<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
………………………………………………………………………………………………<br />
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<strong>ASK</strong>-<strong>IT</strong> informed c<strong>on</strong>sent c<strong>on</strong>cerning private informati<strong>on</strong><br />
This form will be used by all <strong>ASK</strong>-<strong>IT</strong> investigators who record private informati<strong>on</strong>.<br />
It will be signed by the investigator <strong>and</strong> by the participant. One copy will be given to the<br />
participant.<br />
Please clearly explain to the participant how the following <strong>issues</strong> regarding privacy are<br />
h<strong>and</strong>led:<br />
• What kind of data will be recorded, stored <strong>and</strong> why?<br />
• Will the data be transferred?<br />
• Data ownership?<br />
• Is the data c<strong>on</strong>nected to other informati<strong>on</strong>?<br />
• Will the data possibly be commercially exploited?<br />
• Length of storage?<br />
• Where will the data be stored, - according to which nati<strong>on</strong>al legislati<strong>on</strong>?<br />
• Who will access the data?<br />
• Who will supervise the data protecti<strong>on</strong>?<br />
Investigator<br />
Date.......................................<br />
Name (in block letters)....................................................................................……….<br />
Signed ................................................................<br />
Participant<br />
Date.......................................<br />
Name (in block letters)....................................................................................……….<br />
Signed ................................................................<br />
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<strong>ASK</strong>-<strong>IT</strong> Informed c<strong>on</strong>sent form template<br />
1. GENERAL INFORMATION<br />
This part will be pre-filled by the investigator for each study<br />
The <strong>ASK</strong>-<strong>IT</strong> Ethics Advisory Board reviewed this pilot study from the st<strong>and</strong>point of the<br />
protecti<strong>on</strong> of human research participants. The <strong>ASK</strong>-<strong>IT</strong> Ethics Advisory Board found the<br />
study to be in compliance with the relevant regulati<strong>on</strong>s.<br />
1.1 This versi<strong>on</strong> of the c<strong>on</strong>sent document was prepared <strong>on</strong>:<br />
1.2 This trial was approved by the <strong>ASK</strong>-<strong>IT</strong> Ethics Advisory Board <strong>on</strong>:<br />
1.3 Names of the investigators resp<strong>on</strong>sible for this project:<br />
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2. INFORMATION ON THE RESEARCH STUDY<br />
the following <strong>issues</strong> should be explained by the investigator for each study to the participant<br />
before beginning the trial.<br />
2.1 Title of the study<br />
2.2 What is the purpose of this research study?<br />
You are asked to take part in a research study under the directi<strong>on</strong> of<br />
_______________________________. Other professi<strong>on</strong>al pers<strong>on</strong>s who work with him/her<br />
may assist or act for them.<br />
These investigators are undertaking a research study to determine whether<br />
___________________________. We expect to find ________________________________,<br />
which could lead to better methods of diagnosis / treatment / m<strong>on</strong>itoring.<br />
2.3 Who can take part in this study?<br />
2.4 Why should I c<strong>on</strong>sider joining this study as a research participant?<br />
2.5 Do I have to become a participant in this study? If I joined the study, can I change<br />
my mind <strong>and</strong> drop out before it ends?<br />
2.6 What exactly will be d<strong>on</strong>e to me, <strong>and</strong> what kinds of treatments or procedures will I<br />
receive, if I agree to be a research participant in this study?<br />
2.7 What kinds of harm can I experience in this study, <strong>and</strong> what will the investigators do<br />
to reduce the chances of harm?<br />
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2.8 What will the investigators do to make sure that the informati<strong>on</strong> they will collect <strong>on</strong><br />
me will not get in the wr<strong>on</strong>g h<strong>and</strong>s?<br />
2.9What kinds of benefit can I expect pers<strong>on</strong>ally from taking part in this study?<br />
2.10 What kinds of benefit to others can come out of this study?<br />
2.11 What will the investigators do, if I get injured in the study?<br />
2.12 Will I get paid for taking part in this study?<br />
2.13 Will I or my health insurance company be charged for any of the costs of this<br />
study?<br />
2.14 Once I start in this study as a participant, what do I do if I want to find out more<br />
about the study, or to complain about the way I get treated?<br />
2.15 Who gets to keep this document, <strong>on</strong>ce I sign it?<br />
2.16 Which others may view or use the data of this document, if any?<br />
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3. DOCUMENTATION OF CONSENT<br />
this part will be filled in by the participant.<br />
The original will be kept be the investigator; a copy will be given to the participant.<br />
3.1 Research participant's identity, <strong>and</strong> the identity <strong>and</strong> dated signatures of the<br />
participant affirming that c<strong>on</strong>sent was given<br />
The informati<strong>on</strong> shown below identifying the participant should be entered in the designated<br />
spaces at the time of executi<strong>on</strong> of the c<strong>on</strong>sent document.<br />
Participant's Name: _________________________________<br />
Participant's Birth Date: ___________________<br />
Participant's Reference Number:____________________<br />
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3.2 Participant C<strong>on</strong>sent Form<br />
Title of the study:<br />
Place of the study:<br />
I was informed about the effect to be expected, about possible<br />
disadvantages <strong>and</strong> about possible risks verbally <strong>and</strong> in writing by<br />
the test leader of the study.<br />
I was informed about the purpose of research, the expected<br />
durati<strong>on</strong> <strong>and</strong> the procedures verbally <strong>and</strong> in writing by the test<br />
leader of the study.<br />
I was informed about the of any benefits to me or to<br />
others which may reas<strong>on</strong>ably be expected from the<br />
research.<br />
I was informed about the explanati<strong>on</strong>s <strong>on</strong> c<strong>on</strong>fidentiality (<strong>and</strong><br />
limits) of the data.<br />
I was informed about the right to decline to participate <strong>and</strong> to<br />
withdraw from the research <strong>on</strong>ce participati<strong>on</strong> has begun <strong>and</strong> the<br />
foreseeable c<strong>on</strong>sequences of declining or withdrawing.<br />
I was informed about whom to c<strong>on</strong>tact for questi<strong>on</strong>s about the<br />
research <strong>and</strong> research participants rights.<br />
I have read <strong>and</strong> understood the written informati<strong>on</strong> h<strong>and</strong>ed out for<br />
the study menti<strong>on</strong>ed above. My questi<strong>on</strong>s in c<strong>on</strong>necti<strong>on</strong> with the<br />
study have been answered satisfactorily. I can keep the written<br />
informati<strong>on</strong> <strong>and</strong> receive a copy of my written declarati<strong>on</strong> of<br />
c<strong>on</strong>sent.<br />
Please circle<br />
as necessary<br />
Yes No<br />
Yes No<br />
Yes No<br />
Yes No<br />
Yes No<br />
Yes No<br />
Yes No<br />
I had sufficient time to take my decisi<strong>on</strong>. Yes No<br />
In case an incident arises c<strong>on</strong>trary to expectati<strong>on</strong>, an insurance Yes No<br />
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c<strong>on</strong>sists for me in the <strong>legal</strong>ly specified scale. The insurance was<br />
c<strong>on</strong>structed by …………… for this study.<br />
I have spoken to: Dr./Mr./Ms.<br />
I underst<strong>and</strong> that I am free to withdraw from the study<br />
♦ at any time<br />
♦ without having to give a reas<strong>on</strong> for withdrawing<br />
♦ <strong>and</strong> without affecting my future medical care<br />
I agree to take part in the study.<br />
The c<strong>on</strong>fidentiality of my pers<strong>on</strong>al data was assured to me.<br />
Pers<strong>on</strong>al date will used an<strong>on</strong>ymised at the publicati<strong>on</strong> of the<br />
studies results. I approve of the fact however under a strict<br />
compliance with the c<strong>on</strong>fidentiality that the resp<strong>on</strong>sible experts of<br />
the authorities <strong>and</strong> the ethics commissi<strong>on</strong> may take a look for<br />
examining <strong>and</strong> c<strong>on</strong>trol purposes of my original data.<br />
If aftereffects appear, I will c<strong>on</strong>tact Dr./Mr./Ms.<br />
Signed ................................................................<br />
Date.......................................<br />
Yes No<br />
Yes No<br />
Yes No<br />
Name (in block letters)....................................................................................……….<br />
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3.3 Investigators' c<strong>on</strong>firming statement<br />
This part will be filled in by the investigator.<br />
The original will be given to the participant; a copy will be kept by the investigator.<br />
I have given this research participant informati<strong>on</strong> <strong>on</strong> the study, which in my opini<strong>on</strong> is<br />
accurate <strong>and</strong> sufficient for the participant to underst<strong>and</strong> fully the nature, risks <strong>and</strong> benefits of<br />
the study, <strong>and</strong> the rights of a research participant. There has been no coerci<strong>on</strong> or undue<br />
influence. I have witnessed the signing of this document by the participant.<br />
Investigator's Name: ___________________________<br />
Investigator's Signature:________________________________<br />
Date: ____________________________<br />
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3.4 Informed C<strong>on</strong>sent (proxy c<strong>on</strong>sent) of the physician the mentally incapacitated<br />
participant is in care.<br />
I c<strong>on</strong>firm that I was present when the trial was c<strong>on</strong>ducted with the participant<br />
………………………………………. The following points were clearly explained to me:<br />
• The purpose of the research, expected durati<strong>on</strong>, <strong>and</strong> procedures<br />
• the possible risks, discomfort, adverse effects, <strong>and</strong> side-effects (if any)<br />
• a descripti<strong>on</strong> of any benefits to the subject or to others which may reas<strong>on</strong>ably<br />
be expected from the research<br />
• c<strong>on</strong>fidentiality (<strong>and</strong> limits) of the data<br />
• Their right to decline to participate <strong>and</strong> to withdraw from the research <strong>on</strong>ce<br />
participati<strong>on</strong> has begun <strong>and</strong> the foreseeable c<strong>on</strong>sequences of declining or withdrawing.<br />
• C<strong>on</strong>tact for questi<strong>on</strong>s about the research <strong>and</strong> research participants rights.<br />
I think it is appropriate to c<strong>on</strong>duct the trial with the participant<br />
…………………………………<br />
Physician's Name: ___________________________<br />
Physician's Signature: ________________________________<br />
Date: ____________________________<br />
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3.5 Informed C<strong>on</strong>sent (proxy c<strong>on</strong>sent) of a pers<strong>on</strong> that was previously accepted by<br />
the Local Research Ethics Committee to seek c<strong>on</strong>sent for the mentally incapacitated<br />
participant.<br />
I c<strong>on</strong>firm that I was present when the trial was c<strong>on</strong>ducted with the participant<br />
………………………………………. The following points were clearly explained to me:<br />
• The purpose of the research, expected durati<strong>on</strong>, <strong>and</strong> procedures<br />
• the possible risks, discomfort, adverse effects, <strong>and</strong> side-effects (if any)<br />
• a descripti<strong>on</strong> of any benefits to the subject or to others which may reas<strong>on</strong>ably<br />
be expected from the research<br />
• c<strong>on</strong>fidentiality (<strong>and</strong> limits) of the data<br />
• Their right to decline to participate <strong>and</strong> to withdraw from the research <strong>on</strong>ce<br />
participati<strong>on</strong> has begun <strong>and</strong> the foreseeable c<strong>on</strong>sequences of declining or withdrawing.<br />
• C<strong>on</strong>tact for questi<strong>on</strong>s about the research <strong>and</strong> research participants rights.<br />
I think it is appropriate to c<strong>on</strong>duct the trial with the participant<br />
…………………………………<br />
Pers<strong>on</strong>'s Name: ___________________________<br />
Pers<strong>on</strong>'s Signature:________________________________<br />
Date: ____________________________<br />
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3.6 Informed C<strong>on</strong>sent documentati<strong>on</strong> for an illiterate participant<br />
I c<strong>on</strong>firm that I was present when the trial was c<strong>on</strong>ducted with the participant<br />
………………………………………. The participant has given oral informed c<strong>on</strong>sent to the<br />
following points:<br />
• The purpose of the research, expected durati<strong>on</strong>, <strong>and</strong> procedures.<br />
• The possible risks, discomfort, adverse effects, <strong>and</strong> side-effects (if any).<br />
• A descripti<strong>on</strong> of any benefits to the subject or to others which may reas<strong>on</strong>ably<br />
be expected from the research.<br />
• C<strong>on</strong>fidentiality (<strong>and</strong> limits) of the data.<br />
• Their right to decline to participate <strong>and</strong> to withdraw from the research <strong>on</strong>ce<br />
participati<strong>on</strong> has begun <strong>and</strong> the foreseeable c<strong>on</strong>sequences of declining or withdrawing.<br />
• C<strong>on</strong>tact for questi<strong>on</strong>s about the research <strong>and</strong> research participants rights.<br />
I think it is appropriate to c<strong>on</strong>duct the trial with the participant<br />
…………………………………<br />
Witness's Name: ___________________________<br />
Witness’s Signature:________________________________<br />
Date: ____________________________<br />
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References<br />
American Psychological Associati<strong>on</strong> (2002). Ethical Principles of Psychologists <strong>and</strong> Code of<br />
C<strong>on</strong>duct. American Psychologist, 57, 1060-1073.<br />
Bohn, J., Coroama, V., Langheinrich, M., Mattern, F., Rohs, M., (2005). Social, Ec<strong>on</strong>omic,<br />
<strong>and</strong> Ethical Implicati<strong>on</strong>s of Ambient Intelligence <strong>and</strong> Ubiquitous computing, In: W.<br />
Weber, J. Rabaey, E. Aarts (Eds.): Ambient Intelligence. Springer-Verlag. Pp. 5-29.<br />
Charter of fundamental rights of the European Uni<strong>on</strong>. (2000) Nice.<br />
Council of Europe (1997). C<strong>on</strong>venti<strong>on</strong> for the Protecti<strong>on</strong> of Human Rights <strong>and</strong> Dignity of the<br />
Human Being with regard to the Applicati<strong>on</strong> of Biology <strong>and</strong> Medicine: C<strong>on</strong>venti<strong>on</strong> <strong>on</strong><br />
Human Rights <strong>and</strong> Biomedicine, Oviedo.<br />
Committee of Ministers Council of Europe ( 1990). Recommendati<strong>on</strong> (No. R(90)3).<br />
Data Protecti<strong>on</strong> Working Party (2000). Privacy <strong>on</strong> the Internet – An integrated EU approach<br />
to On-line Data Protecti<strong>on</strong>, 5063/00/EN Final.<br />
Directive 95/46/EC.of the European parliament <strong>and</strong> the Council (1995). On the protecti<strong>on</strong> of<br />
individuals with regard to the processing of pers<strong>on</strong>al data <strong>and</strong> <strong>on</strong> the free movement of<br />
such data.<br />
Directive 97/66/EC of the European parliament <strong>and</strong> the council (1997). C<strong>on</strong>cerning the<br />
processing of pers<strong>on</strong>al data <strong>and</strong> protecting of privacy in the telecommunicati<strong>on</strong>s sector.<br />
Directive 2001/20/EC (2001). On the approximati<strong>on</strong> of the laws, regulati<strong>on</strong>s <strong>and</strong><br />
administrative provisi<strong>on</strong>s of the Member States relating to the implementati<strong>on</strong> of good<br />
clinical practice in the c<strong>on</strong>duct of clinical trials <strong>on</strong> medicinal products for human use.<br />
Directive 2002/58/EC of the European Parliament <strong>and</strong> the council c<strong>on</strong>cerning the processing<br />
of pers<strong>on</strong>al data <strong>and</strong> the protecti<strong>on</strong> of privacy in the electr<strong>on</strong>ic communicati<strong>on</strong>s sector.<br />
Disability Rights Commissi<strong>on</strong> (2004). Guidelines for Ethical research.<br />
European human rights c<strong>on</strong>venti<strong>on</strong> (1950)<br />
Johns<strong>on</strong>, D. H. & Sabourin, M. H. (2001). Universally accessible databases in the<br />
advancement of knowledge from psychological research. Internati<strong>on</strong>al Journal of<br />
psychology, 36, 212-220.<br />
Kemppainen, E. Moral <strong>and</strong> Legislative Issues with regard to Ambient Intelligence. Nati<strong>on</strong>al<br />
research <strong>and</strong> Development Center for Welfare <strong>and</strong> Health (STAKES), Finl<strong>and</strong>.<br />
Knapp, S. & V<strong>and</strong>eCreek, L. (2003). A guide to the 2002 Revisi<strong>on</strong> of the American<br />
Psychological Associati<strong>on</strong>’s Ethics Code. Professi<strong>on</strong>ell Resource Press, Sarasota Florida.<br />
Medical Research Council (1993). The <strong>ethical</strong> c<strong>on</strong>duct of research <strong>on</strong> the mentally<br />
incapacitated, L<strong>on</strong>d<strong>on</strong>.<br />
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Medial Research Council (2000). Pers<strong>on</strong>al informati<strong>on</strong> in medical research. In: Manual for<br />
Research Ethics. S. Eckstein (eds.). 367-390, University Press, Cambridge.<br />
OECD (1980). Guidelines governing the protecti<strong>on</strong> of privacy <strong>and</strong> transborder flows of<br />
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Patry, P. (2000). Experimente mit Menschen. Einführung in die Ethik der psychologischen<br />
Forschung. Hans Huber. Bern.<br />
Royal College of Psychiatrists (2000). Guidelines for Researchers <strong>and</strong> research Ethics<br />
Committees <strong>on</strong> Pychiatric Research involving Human Participants, Gaskell, L<strong>on</strong>d<strong>on</strong>.<br />
Social Research Associati<strong>on</strong> (2003). Ethical Guidelines.<br />
Warren, S. & Br<strong>and</strong>eis, L. (1890). The Right to Privacy. Harvard Law Review, 4(1): 193-220,<br />
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