| |
|
Conducting Human Subjects Research |
From the Federal Code - Title 45, Part 46 Protection of Human Subjects
- (d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- (f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
- • data through intervention or interaction with the individual, or
- • identifiable private information.
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. ( § 46.102)
From the Belmont Report - Three Ethical Principles
- Respect for Persons - Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
- Beneficence - Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. ... In this document, beneficence is understood ... as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
- Justice - Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved."
Case IRB Policies & Procedures
Links & Resources
|
|
