Procedures of Protection |
Informed Consent
According to the NIH (National Institute of Health) "Informed consent is the process of giving clinical trial participants all of the facts about a trial. This happens before they agree to take part and during the course of the trial. Informed consent includes details about the treatments and tests you may receive and the benefits and risks they may have" (NIH, 2015, para. 7). Risk/Benefit Assessments The IRB is responsible for evaluating the potential risks and weighing the probability of the risk occurring and the harm that may result. It must then judge whether the anticipated benefit, either of new knowledge or of improved health for the research subjects, justifies inviting any person to undertake the risks. Confidentiality Procedures Maintaining confidentiality of information collected from research participants means that only the investigator(s) or individuals of the research team can identify the responses of individual subjects. Providing anonymity of information collected from research participants means that either the project does not collect identifying information of individual subjects. References National Institute of Health. (2015). How do clinical trials protect participants? Retrieved from http://www.nhlbi.nih.gov/studies/clinicaltrials/protect |