Subject Selection

The design of the study should reflect the ethical principle of justice, fairness in distribution in its selection of participants, i.e., who will receive the benefits of research and bear its burdens. The systematic selection of some classes of individuals simply because of their easy availability, their compromised position, or manipulability, rather than for reasons directly related to the problem being studied must be avoided.

Your research protocol should provide your inclusion/exclusion criteria. Describe the target subject population including relevant demographic (e.g., age, ethnicity), biomedical (e.g., disease status, laboratory values, pregnancy, contraindicated medications), and behavioral characteristics (e.g., cognitive abilities, mood) relevant for inclusion and exclusion. Describe on what basis you will exclude persons from participating in your research. Provide clear justification(s) for exclusions. Reflect on psychosocial variables that may impact subject risk and study compliance. Note any efforts you will take to overcome any anticipated barriers to participation.

Does the selection of subjects demonstrate an awareness of possible use of populations already being studied at Rutgers? NJ ACTS can help you integrate special populations into your research study (e.g., children, older adults, racial and ethnic minorities, low income populations, people living with Opioid Use Disorders, HIV/AIDS, serious mental illness, or prisoners. See Special Populations in Research.