ANNEX C.4: Ethical Code of Conduct for Evaluation Activities
On the basis of the local rules and legislation described in section 0, the Ethical Code of Conduct for evaluation in Prosperity4All has been developed, which abides with the overall Ethics Policy of the project (D501.2). The basic principles of the Ethical Code of Conduct for Evaluation are as follows:
- Ethics Control and Monitoring
Testing processes with end-users in Prosperity4All will be monitored by local ethics responsible persons, authorized to monitor the conformance to the established ethics rules. These persons are namely the ones mentioned in Table 10. They may however change during the project. Commitment and abidance or not to the Prosperity4All Ethics Policy and Ethics Code of Conduct for Evaluation will be reported by these persons to both the project Ethics Advisory Board and the local/regional authorized committees. The project Ethics Advisory Board will take remedial actions, if needed. See more in section 9.2.1, respectively.
- Informed Consent
Prior to any testing, the researchers ought to outline to the participants the main objectives of the study/test and ask their consent (i.e. permission) to take part. It is not always possible to gain informed consent and this is acceptable as long as what may happen to participants during testing is something that could easily happen to them in everyday life. The latter holds true for direct naturalistic observation (e.g. being in public and observing how other people behave). This is not the case, though, when participants are observed in their working or home environment and researchers acting as supervisors are present for this exact reason. Before giving their consent, participants should be informed about: a) the purpose and the procedures involved in the research, b) all foreseeable risks and discomforts to the participants (including both physical and psychological), c) the benefits of the research to society and possibly to the individual human participant, d) explanations on confidentiality (and limits) of the data, e) their right to decline to participate and to withdraw from the research once participation has begun and the foreseeable consequences of declining or withdrawing, f) whom to contact for questions about the research and research participants rights, g) information about insurance or indemnity for the participant
The consent form documentation is provided in Annex C, whereas some specific considerations to be taken into account regarding informed consent are following below:
· Informed consent is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent are designed to educate the participant population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, testing procedures, alternatives, risks, and benefits) must be written in "layman’s language" (i.e. understandable by the people being asked to participate). The document is primarily thought of as a teaching tool, not as a legal instrument. In addition, jargon should be avoided and gesture diagrams and pictures should be used if appropriate. The written presentation of information is used to document the basis for consent and for the participants' future reference.
· The investigator should be aware of the fact that the use of the first person (e.g., "I understand that ...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a participant.
· Whenever possible, it should be arranged to obtain consent in good time before the beginning of the actual testing so that the person is not rushed at the last minute.
· It should be ensured that auxiliary aids or services to assist communication are available where necessary.
· The legal rights of participants will not be waived in any way. The participants should not be given the impression that they have agreed to and are without recourse to seek satisfaction beyond the institution's voluntarily chosen limits.
· Participants should be encouraged to ask questions and the supervisors should ensure that they have understood the explanations/clarifications provided.
· It should be ensured that the participants may change their mind and withdraw at any moment without any impact.
· It is preferable to see the person on his/her own (unless a carer needs to be present) but if s/he wishes partners or family to be present, it should be made sure that they do not put undue pressure on the person either to consent or to withhold consent.
· Testing in Prosperity4All will include also testing with people with disabilities. Special provisions may be needed regarding in some cases, as follows. Informed consent documentation of Annex C addresses these provisions. Further improvement may emerge however.
A local ethics pilot responsible will be named and trained (by the Ethical Advisory Board) in each test site, to monitor and guarantee that the overall Ethics Policy of the project as well as the national laws are being respected.
In addition, the supervisors should ask the participant if they are taking any specific medication or other info that would be needed to be known by a medical emergency centre (part of the consent forms).
Further to their personal data recording, there might emerge an issue of video / sound recording sessions and screen capturing in the context of the trials. If this is applicable, the participants should give their consent before the beginning of the trials (part of the consent forms). If the user does not agree to this, none of the above will take place.
This is where participants are misled or wrongly informed about the aims of the research. This is sometimes necessary in order to avoid demand characteristics (i.e. the clues in a test which lead participants to think they know what the researcher is looking for). However, participants must be deceived as little as possible, and any deception must not cause distress. If you have gained participants’ informed consent by deception then they will have agreed to take part without actually knowing what they were consenting to. The true nature of the research should be revealed at the earliest possible opportunity, or at least during debriefing. If the participant is likely to object or be distressed once they discover the true nature of the research at debriefing, then the study is unacceptable. There are objections to deception in research community because of how it affects both the participant and the researchers:
- Violates individual’s right to choose to participate.
- A questionable basis on which to build a discipline.
- Leads to general distrust of research activities in the community.
No deception is anticipated within the evaluation framework of Prosperity4All, except in testing conditions where the system functionality will be emulated (i.e. WoZ trials). This will be communicated to the user before the tests.
- Risk assessment, Safety & Insurance
A fundamental aspect of risk assessment for participants is the perceived presence and importance of risk which is mainly affected by the life experiences of the participant. The end point of the process is the consent given by the person to be part of the research project having considered all aspects of the process and asked all relevant questions. All relevant information is given to the participants. This means that the objectives of Prosperity4All project will be carefully explained during briefing (i.e. informed consent). The choice that is made and the consent that is given will be without coercion or undue pressure being applied.
The participant can ask questions prior to testing, during testing and after tests have completed. Participants will be informed about the duration of involvement and the pilot site contact person for answers to questions or in the event of injury or emergency.
Categories of risk:
· There will be no risk of physical damage within the tests taken in Prosperity4All;
· Psychological consequences are carefully examined;
· Social inconveniences will be minimised (no additional stress for families, cost reimbursement for additional transportation costs, …);
· If private information is recorded, the participant will be informed according to the aspects mentioned in the informed consent template concerning privacy.
The major identified risk that could be assumed is the risk of invoking unrealistic hopes and expectations for personal benefits in terms of access to new and better accessible solutions, and the subsequent risk of disappointment. This will be counteracted by very explicit and adequately communicated information about the limitations of such personal benefit.
Apart from this, the evaluation tasks that will be foreseen will relate to everyday activities of the participants. Thus, normally, the risk of harm must be no greater than in ordinary life, i.e. participants should not be exposed to risks greater than or additional to those encountered in their normal lifestyles. Thus, none of these tests should have a (side-) effect on the physical or mental integrity or health of the participant. However, researchers should pay attention not to embarrass, frighten, offend or harm participants.
However, given the variety of target groups (healthy, able-bodied, disabled, cognitive impaired, blind, deaf people, etc.), all sites will review internally the appropriateness of the tests for each of the target groups and alter the tests in case it foresees incompatibilities with the situation of (one or more of) the expected participants.
Even after that, participants will be monitored all the time to ensure that no strains are put on them (i.e. no equipment with epileptic triggering flashing light sources will be used), will be explicitly asked about their perceived level of effects (on psychological or physical level) and will be at any time free to suspend / stop the test (as they will be made aware of at the beginning of the tests and as written in the informed consent form).
In any case, and although this is not applicable in Prosperity4All, the supervisor should explain to the participants if there any kinds of harm that could be experienced during the trials and what are the measures that have been taken in order to prevent that and reduce any such chances. In Prosperity4All case, and since the scheduled testing does not imply any kind of harm for the participant, it would be enough if the supervisor assured the participant for their safety and security. Also, it should be assured that all necessary precautions have been taken in case some (irrelevant to the testing) injuries incur during their stay in the test sites premises (i.e. constant cooperation and contact with doctors and other specialists, etc.). Those test sites that are applying an insurance policy in such cases, they will apply it here as well. In the rest of the cases, an indemnity will be foreseen. In all cases, the test sites will abide with the internal and/or national safety regulations applying in their case. In addition, social inconveniences will be minimised (no additional stress for families, cost reimbursement for additional transportation costs, ).
Finally, in case, the participants are occupied during their working hours, they are responsible themselves for taking the permission by their employers, although involvement during working hours is not recommended by Prosperity4All.
- Withdrawal from a trial
From the very start of a trial/test, participants must be aware of their right to stop participating in the study, irrespective of whether or not payment or other inducement has been already offered (although this should be done at the end of the test). It is recognised that this may be difficult in certain observational or organisational settings, but nevertheless the investigator must attempt to ensure that participants know of their right to withdraw. Even at the end of the study the participant has a final opportunity to withdraw the data they have provided for the research. In the light of experience of the investigation, or as a result of debriefing, the participant has the right to withdraw retrospectively any consent given, and to require that their own data, including recordings, will be destroyed.
- Reimbursement and incentives for participation
There is considerable confusion regarding the ethical appropriateness of using incentives in research with human participants. Incentives might be considered as a form of undue influence or coercive offer. However, for most parts, the use of compensation to recruit and retain participants is innocuous. During pilots, users will be compensated in the following occasions which are viewed as non-problematic:
- Participants have no dependency relationship with researchers (external users)
- When incentives are not relatively large because there is a possibility for study aversion (this is not true for Prosperity4All pilots; no physical or psychological interventions)
- Incentives should not normally be paid to respondents who are being interviewed in their professional capacity. Instead, they may need to be recruited through their employer and the involved Prosperity4All Partners should normally seek to gain their executive’s permission to conduct the research during working hours. There may, however, be instances where it is appropriate to pay incentives to certain research groups (relevant to pilot tests with developers).
Participants, who will be reimbursed for their participation, will receive either:
- Small amounts of money as a one-off payment and will be the same for all participants of specific test. The actual amounts will be decided when the testing plans are available, as they depend upon test duration, effort, complexity and test type (e.g. face-to-face interview, focus group, survey, etc.). It is anticipated that monetary reimbursement will not exceed the amount of 50€. However, the exact amount will be decided by pilot site partners in each iteration phase.
- A gift voucher to be redeemed by the participant. This might be the case for implementers (external participants) who can receive vouchers relevant to their occupational interests.
Respondents should be paid after test completion and a record of the payment received is kept by the researcher. Prosperity4All Partners involved are expected to use their discretion to decide the most appropriate method of payment.
In cases where reimbursement incentive is foreseen, claimants (research interviewees) should be made aware of the status of the payment in opt-out letters during recruitment phase.
- Accessible facilities and services
All test sites facilities are accessible. However, all test participants should be asked, prior to testing, for any special requirements. All consent forms, questionnaires, etc. should be provided to test participants in suitable format (i.e. symbol supported text, TTS or audio supported documents, applying if needed sign language interpreters, etc.). Communication with people with disabilities in terms of testing and beyond should follow the respective rules (indicative guidelines are provided in Annex C).
- Gender distribution
Prosperity4All will ensure that during all its phases, an as much as possible equal gender participation in evaluation will be maintained. This will be obvious in the selection criteria adopted for the recruitment of users. Apart from this, all end-user groups have to be sufficiently represented and be given equal opportunities for trying the Prosperity4All solutions. Obviously, if any reimbursement or incentives will be provided, it will be the same for both men and women, as well as for all categories of end-users.
Participants must be thoroughly debriefed on all the above before they sign the consent form. They must be given a general idea of what the researcher is investigating, how and why, and their role in the research should be explained. They must be asked if they have any questions and those questions should be answered honestly and as fully as possible. They should be acknowledged all their rights (right to withdraw, etc.), any reimbursement they will receive, safety precautions, accessibility of facilities, personal data protection and other policies as explained above. The debriefing prior to testing has to be documented and signed by both sides.
After the studies, they should be allowed to ask questions and give comments and also be confirmed that they will be provided with copies of the research results. Summaries and copies of research reports will be given to research participants in appropriate accessible formats (e.g. odt, *.pdf, html, printed, in Braille oral communication, etc.).