However, communicating genomic results to participants requires tailored consent documents that carefully consider ethical responsibilities and social obligations to participants and their relatives.
Shared efforts on the part of researchers and their institutions, Research Ethics Boards as well as participants' representatives are needed to delineate a tailored consent process so as to better protect research participants.
Regulations should be developed through the common efforts of researchers, their institutions, and REBs, on the one hand, and participants' representatives, on the other, so as to arrive at a tailored consent process able to protect those research participants who suffer from, or risk suffering from, mental health conditions.
In a series of articles, Tekola, Bull, Farsidesm, Newport Adeyemo, Rotimi, Davey, for example, examined a range of issues associated for genetic research on podoconiosis in Ethiopa, including the potential for social stigma on the process of obtaining consent, and tailoring consent to enhance its effectiveness for study participants [ 19- 21].
We highlight and briefly discuss the importance of ten core scientific, cultural and social factors that are particularly relevant to tailoring informed consent in genomic research, and we draw attention to the need for the informed consent document and process to be responsive to the evolving nature of genomic research.
Research subjects can be presented with specific projects and information and, in turn, continuously tailor their consent preferences according to their desires and needse.
Relevant, rapid assessment processes in rural communities prior to the commencement of genomic studies in particular communities can used to subsequently tailor the consent process in a culturally appropriate manner [ 78, 90].
Gaps in the consent process are reported elsewhere related to information and communication and decision making and indicate the need for informed consent processes tailored to the context [ 1, 8- 10, 21- 26].
The aim of this two-stage process was to ensure that fundamental human subject protections were preserved across all the MalariaGEN sites recruiting participants, while ensuring that the protocols were also tailored to optimize the consent process at each site.
Biobanks, cohorts, clinical trials and consortia have different interactions with individuals and need to be able to tailor the available consent, information and communication settings accordingly.
These findings provide initial insights into the value these early adopters place on information generated by high-throughput sequencing studies, and help us tailor the informed consent process to this group of individuals.
