A well-designed data collection process will have a significant impact on protecting participants; thus it is essential that your protocol demonstrates a data collection process that includes the best practice methodology for your discipline as well as procedures that protect the privacy and confidentiality of your participants.
This section will deal primarily with protecting privacy and confidentiality from the initial collection point until the data are destroyed. Researchers must ensure their participants’ privacy and confidentiality when conducting research studies. The IRB Guidebook defines privacy as “control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.” In contrast, confidentiality is “the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.” In other words, privacy pertains to participants (specifically the methods of gathering information about them), and confidentiality pertains to data (handling the information that has been gathered).The methods and tools used to collect data, as well as the way data are stored, used for other studies, and destroyed has a significant impact on participant privacy and confidentiality and ultimately your ability to protect participants from significant risk.