The opt-in consent process may pose a particular problem for trauma patients, as the ability of an individual to understand and consider the interventions posed may be impaired through head injury, pain, shock, medication or numerous another causes.
There is growing evidence that opt-in consent processes can result in selection biases that may affect conclusions as to various causal associations.
Additional opt-in consent processes (e.g., a tiered consent approach) should be explored more closely in future research; Develop protocols that allow for feedback to donors that is in line with patient preferences.
Research in these settings poses ethical challenges, not least because many residents of nursing and residential homes are cognitively impaired, 2 and therefore may have difficulty in understanding information usually provided in consent processes or may lack capacity to consent to participate.
This situation is not optimal for several reasons, including: the missed opportunity for adolescents and parents to effectively communicate about important health issues and to support adolescents developing autonomy; there are important ethical reasons why adolescents should participate in consent processes regarding their own health [ 7, 21, 23].
Further research will be required to understand how to balance these observations in the consent process in medical research in South Africa.
There are different practical challenges in the consent process in Internet research, given the fluidity and temporal nature of Internet spaces.
Study physicians and research nurses were not involved in the consent process, in case the power differential between health care providers and the study population influenced parents' decisions about whether to enrol their children in the study.
The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia.
Rapid identification and implementation of a suitable legal representative for participation in the consent process can be difficult and, in some instances, not feasible.
These mabaraza have the potential to serve a role in research investigation and development, as well as in the consent process.
