99 - Scoping Review of the Ethical Regulations for Alzheimer’s Disease and Alzheimer’s Disease Related Dementia Research in Africa

Background:  Research ethics regulations enable protection of research participants, however, participants with Alzheimer’s Disease and Related Dementia (AD/ADRD) require additional protections. Given the expected growth in prevalence and research into AD/ADRD and the need to diversify participants, ascertaining the current landscape of ethics regulations for AD/ADRD research in Africa is important.

Methods:  We conduct a scoping review of ethical regulations of AD/ADRD research in Africa using Arksey and O’Malley’s framework. We searched the International Compilation of Human Research Standards by the Office of Human Research Protections (OHRP) and the internet, and used a deductive approach to derive key terms and extracted texts from our primary sources.

Results:  Our review included regulations from 14 African countries published between 1997 and 2019. Most of the regulations were guidelines (14/20) and none was published to address ethical issues in AD/ADRD research specifically. Guidelines for AD/ADRD research were part of broader population sub-group provisions, such as persons unable to consent for themselves, or those under legal disability. Regulations mostly required the designation of a Legally Authorised Representative (LAR), as a major safeguard for persons with AD/ADRD in research. However, only regulations from South Africa provided practical guidance on the identification and appointment of LARs. Conversely, only about five countries had regulations recommending capacity assessment, and only two countries each had regulations with provisions for advance directives and respecting assent or dissent, respectively. Finally, none of the regulations cited the Convention on the Rights of Persons with Disabilities (CRPD) as a basis for its stipulations on the appointment of LARs.

Limitations: We used one database to source the documents for our review. However, this is a database dedicated to the compilation of research regulations globally, thereby improving the likelihood of our review’s representativeness. We may have excluded regulations from countries without English text versions that are readily accessible online. We hope to expand this review with updated data from the OHRP database, further hand-searching, and reaching out to experts in countries not covered in this review.

Discussion:  There is a paucity of regulations specifically for research with AD/ADRD or other cognitively impaired persons in Africa. Provisions applicable to AD/ADRD research protections are part of broader categories and mostly lack the specificity needed for practical implementation. Taken broadly, the provisions that apply for protection of persons with AD/ADRD could also apply to persons with other conditions characterized by cognitive impairment. There is a need for more research on how the provisions in the existing regulations could apply in practice to help research ethics committees (RECs) and researchers in African countries provide adequate protection for persons with AD/ADRD and other cognitive impairments in research.