Respect

Beneficence (prevent or remove harms or to simply improve the situation of others).       

Justice

(a) competence in making a meaningful decision to participate; (b) knowledge of research, alternatives available, risks & benefits; (c) volition free from coercion, constraint, pressures, duress, absence of penalty, including withdrawing from research. (See University IRB for requirements of consent including language and rules for assent): Purpose of the research. Procedures involved in the research. Alternatives available should a subject decide not to participate in the research. All foreseeable risks and discomforts to the subject. *Note that these include not only physical injury but also possible psychological, social, or economic harm, discomfort, or inconvenience. Benefits of the research to society and possibly to the individual human subject. Length of time the subject is expected to participate. Payment for participation (if applicable).

 Person to contact for answers to questions or in the event of a research-related injury or emergency.

Statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive. Subjects' right to confidentiality

Generally, consent & assent are required. Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent (DHHS). Many complicated examples such as developmental characteristics; possible direct benefits of research to child great, not available outside research, assent may not be needed.

IRB 7-17 but variations

Federal regulations protecting research subjects (IRB)

Respect, Beneficence, Justice

Relationships with persons and organizations that may impair objectivity, possible harm or exploitation