All methods for the collection and transfer of research data are subject to the same considerations, no matter what medium is used..
All procedures and materials intended for use in collecting data, and all procedures for storing, communicating and transmitting or sharing data, can have an impact on the confidentiality of the data, and thus on the level and kind of risk to subjects. The security of data is a central issue in human subjects review. For this reason, all such materials and procedures need the appropriate level of review and approval before they can be implemented.
To be approvable, web-based data collection and communication must meet all relevant requirements. (For example, if protected health information is involved, the procedures must comply with HIPAA requirements.) Fortunately, it is no longer necessary for each researcher to build the entire apparatus for doing so from the ground up.
University of Washington researchers are able to use the Catalyst WebQ facility to collect, store and manage questionnaire and survey data, and maintain either anonymity or confidentiality of subjects as appropriate. While the specific study (including questionnaire materials and procedures) must still be submitted for review and approval, the WebQ data protocols are known to be in compliance with regulatory requirements, and do not require re-review with each application.Unfortunately, useful though WebQ is, it is not a universal tool, there are many studies for which it would not be useful. While many other data collection and management facilities may exist, their protocols have not received prior review. If a researcher wishes to use some other facility, all relevant protocols (data collection, transfer, management, security, etc.) must be documented in the application covering the proposed research. It is important to remember that, for a variety of reasons, e-mail is seldom appropriate for collection, transfer or storage of data.
If questions arise in the course of preparing an application, investigators will find it very helpful to contact one of the relevant teams in the Human Subjects Division to find out what materials to submit to make review as efficient as possible.
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