Ethical, Legal, and Social Issues
Respect for Persons requires that the autonomy, dignity, and all rights of the participants are respected throughout the research process. Participants should be fully informed of procedures, risks, and benefits before starting. In this research, it means participants understand this is an early diagnostic device and should not replace consultation with a licensed clinician. Respect is maintained through clear communication with participants, families (if consent is given), and medical professionals.
Justice ensures fair and equitable treatment of participants. Inclusion/exclusion criteria should be based on relevant factors, such as age or likelihood of developing Alzheimer's, rather than arbitrary factors. Recruitment should be diverse so no group is denied benefits of the research.
Biosafety involves training, protocols, equipment, and environments to protect researchers, the community, and the environment from accidental release of bioagents. Potential losses must be identified and evaluated, and emergency plans developed.
| Hazard | Description | Associated Loss | Refined Hazard ID | Refined Hazard Description |
|---|---|---|---|---|
| H1 | Biosensor produces false positive results | L1, L4 | H1.1 | False positive occurs due to sample contamination before use |
| H1 | H1.2 | False positive occurs due to unrelated biomarker readings | ||
| H1 | H1.3 | Biosensor is used incorrectly | ||
| H2 | Biosensor produces false negative results | L1, L4 | H2.1 | False negatives occur due to low biomarker sensitivity |
| H2 | H2.2 | Signal interference causes false readings | ||
| H2 | H2.3 | Biosensor is used incorrectly | ||
| H3 | Biosensor component degradation | L3 | H3.1 | Manufacturing inconsistencies cause degradation before use |
| H3 | H3.2 | Storage conditions affect stability and performance | ||
| H4 | Biosensor components contaminate environment upon disposal | L2 | H4.1 | Releases toxic chemicals upon degradation |
| H4 | H4.2 | Lack of proper disposal channels in underserved regions |
Social
Concern for Welfare ensures the physical, mental, and social well-being of participants is protected. Risks should be minimized and benefits maximized, and patient privacy maintained. Researchers must consider societal impacts and not use data to identify participants without explicit consent.