Minimal Risk Research
More than Minimal Risk Research
The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [46.102 i.]. Research involving venipunctures and most psychological assessments routinely fit under this category.
For research presenting greater than minimal risk, potential subjects must be informed of the availability of medical treatment and compensation in the case of research-related injury, including who will pay for the treatment and the availability of other financial compensation. Research involving fetuses and pregnant women, prisoners, and children strictly limit research presenting more than minimal risk. The greater the risk, the greater the value placed on direct benefit to the participant population in the risk-benefit calculus.
For all research, IRB's must determine that steps will be taken to minimize risk. IRB's should determine whether the investigators are competent in the area being studied, whether they serve dual roles that might complicate their interactions with subjects, and whether there are potential conflicts of interests that must be resolved. Data monitoring should also be used to ensure that a clinical trial does not continue after reliable results have been obtained. This may require establishing a specialized data and safety monitoring board. When investigator's propose single- or double masked studies, IRBs should insure that appropriate mechanisms for breaking the code are in effect to safeguard the welfare of the subject. Risk can also be minimized by piggybacking research procedures onto regularly scheduled medical procedures or by selecting the minimum levels of experimental manipulation necessary.