If the participant is likely to express objections or be concerned once they have discovered the true nature of the research during debriefings, the study is unacceptable. While their consent is not sufficient to allow them to participate in the absence of an authorized third party, their words or signs that they do not want to participate must be respected. IPEPs should check whether it is in the best interest of participants to be informed of the research (and to what extent), if not before, after (Article 3.7B). If the design of the research does not require prior agreement and debriefing, participants can never know their participation. This raises ethical questions that are somewhat different from other changes in consent requirements, as these participants do not have the opportunity to ask questions about the nature and purpose of the study or to require the removal of their human data and/or biological materials (where possible, passable [see glossary] and appropriate). In light of these issues, the REB should further consider the rationale for a waiver of prior consent and a derogation from the debriefing requirement (Article 3.7B). Participants may feel that they should not withdraw, as this can “spoil” the study. Many participants are paid or receive course credits, they may fear that they will not get this if they retire Also, at the end of the study, the participant has the last opportunity to withdraw the data he has provided to the research. A related but not identical source of references to potentially relevant considerations is cultural knowledge, which is particularly important for conducting research outside known cultural contexts. This type of knowledge of potentially relevant information may come from sociological research, but also from anthropological research or from the experience of various research or health organizations that have experience in cultural contexts.
The requirements of cultural sensitivity, which are present in a large number of international documents, are precisely of this diversity. For example, the Council of International Medical Science Organizations finds that, where it is ethically defensible not to allow the removal of human biological data and/or material, member states must verify whether data withdrawal is possible or feasible.