Indigenous people, skin disease, genetic sampling, biological samples, exploratory study, consent, blanket consent, assent, cultural competency, community engagement, return of results
A secluded group of Indigenous people in Malaysia are dispersed widely throughout the rainforest reserves and rely heavily on forest resources for survival.7 They consist of 18 genetically distinct subtribes. In part because of its social isolation, unique diet, and traditional practices, this unique and genetically distinct population is of interest to the scientific world.
Control and management of diseases among this Indigenous community is challenging because of the characteristics of their lifestyle. Moreover, the population has limited utilization of formal health care services because of poverty, linguistic barriers, and cultural beliefs. Some of the subtribes are nomadic, migrating from one place to another (usually remote) several times per year, which also makes it challenging to track their whereabouts for health care or research purposes.
A university research team decided to conduct a 3-year exploratory study to document the health conditions of this Indigenous community, aiming to uncover the prevalence and associated risk factors for skin disease. The researchers also sought to study the association between host genotype and disease risk. The researchers collected both skin and epithelial cell samples from study participants aged 7 years old and older. To obtain blanket informed consent, the research team spoke in person with potential participants, describing the study both verbally and through printed informational materials indicating that collected samples will be stored for 7 to 10 years and might be used for future research.
The research team submitted an application to the research ethics committee (REC) at their institution. After reviewing the study protocol, the REC noted two major concerns. First, it questioned the adequacy of blanket consent from participants for cross-sectional research and asked the team to specify the types of compensation provided to participants and processes for study follow-up. The REC also expressed concern about the readability of the study information sheets offered to potential participants with limited literacy. In response to the REC’s review, the research team amended their research protocol to include compensation for participation (hygiene kits or food) and a clause within the consent form explicitly indicating that participants who become sick will receive health care from the research team working in the community. Study information sheets were rewritten, replacing scientific jargon with simplified language. Satisfied with the updated protocols, the REC granted approval.
Questions
What do you think about the approach to informed consent used in this study? What do you think about the use of “blanket consent” (consent that would permit the researchers to conduct any number of other analyses with the samples in the future without seeking additional permission)? What consent process would be best for this study, and why?
What recommendations would you make to help ensure the research is carried out in a culturally competent manner? What additional processes would you ask the researchers to undertake?
What do you think about the researchers’ plan to provide hygiene kits or food for compensation and health care for those who become sick during the study? Is it appropriate? Does it address the REC’s concern? Why or why not?
Do you have any concerns about the inclusion of minors (under 18 years old)? If so, what concerns do you have? What might help to address those concerns?
What do you think are the researchers’ obligations when it comes to 1) returning aggregate findings from the research to the study community and 2) returning individual-level results to those who provided samples? What are some important considerations that need to be taken into account?
