What are the primary issues of concern to the HSIRB?
There are four major areas of concern that are evaluated in determining whether participants’ rights and welfare are protected. They are 1) the design of the research, 2) the balance of harm and benefit, 3) the process of informed consent, and 4) the selection of subjects. Many people question why research design is a consideration. Consider this: If a research project is poorly designed, no valuable information is likely to be gained. Such a protocol cannot justify any risks or inconveniences to the participant. This is the risk-benefit analysis. A second issue is that many people think of “informed consent” as a form containing details of the research that is signed by the participant. In developing your research, think of informed consent as a process. Informed consent means that the participants truly understand what they are agreeing to and all of the risks and benefits inherent in the activity.
