Guidelines for Informed Consent

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Under Construction / Draft / 

These ethical guidelines have been developed in Prosperity4All, building upon work of Cloud4All. They should be adapted to be valid for the whole GPII.


Guidelines of Prosperity4All (Ethics Manual)

These ethical guidelines have been developed in Prosperity4All, building upon work of Cloud4All. They should be adapted to be valid for the whole GPII.

The consent forms and all ethical material has to be checked by all pilot sites ethics responsible board-person and approved prior to the test been carried out. The basis for achieving an adequate Informed Consent is to prepare a Project Information Sheet and to explain this to the potential user participant and then to confirm that they have understood and agree to participation by signing a Consent Form. Further information and clear instructions about this are to be found in: Annex III. Considerations for Informed Consent.

Even though a general template has been provided, it needs to be adapted each time an activity would take place, and therefore further considerations are necessary:

The following general considerations regarding the consent forms should be taken into consideration by the test sites Local Ethics Committees.

  1. Informed consent is a fundamental mechanism to ensure respect for people through provision of thoughtful consent for as 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, experimental 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. Additionally, jargon should be avoided and gesture (signing), 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 consent document will be revised when deficiencies are noted or when additional information will improve the consent process.
  2. The researcher 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, incorrectly, relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a participant.
  3. 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.
  4. It should be ensured that auxiliary aids or services to assist communication are available where necessary.
  5. Participants should be encouraged to ask questions and the supervisors should ensure that they have understood the explanations/clarifications provided.
  6. It should be ensured that participants have the option to change their mind and withdraw at any moment without giving any reason and without any impact on them.
  7. It is preferable to see the person on his/her own (unless a carer/interpreter needs to be present) but if she/he wishes partners, carers 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.
  8. Potential participants should not be overwhelmed with unnecessary information.

Also in the informed consent, a fundamental part in the management of ethical issues, the following information should be presented:

  • What the research is about
  • Who is carrying out the research
  • Who is funding it
  • Any benefits to individuals or groups
  • Any possible adverse effects
  • What the participants will have to do
  • Length of the research
  • Location of the research
  • What the research findings will be used for
  • What will happen to the results
  • Whether they will receive a summary of the results
  • Confidentiality agreements
  • Entitlement to service statement

[edit]Further reading 

In addition to the above, please see also more elaborated information about the general Informed Consent template as well as further information related to the delivery of the information to different groups of users in Considerations for Informed Consent .

Find results of SP4 here: