Intellectual Property and Data Protection

Following the fundamental rules of intellectual property and good practices in data protection is necessary to avoid missteps that could jeopardize the outcomes and cause harm to researchers and study subjects.

Read this scenario and think about the implications of data handling practices.

Peter: Hey, Mary, the transcribed survey data is finally here. All 189 of them! I'll be spending lots of time at the coffee shop with my laptop this weekend analyzing the results.

Mary: Great! Have you backed up the data on the research group server?

Peter: Not yet. I'll do that on Monday. These papers are my backup.

Mary: It may sound like a pain, but you've got to get all those surveys under lock and key. There's a lot of personal information in there, and we promised the respondents who consented to be in the study that we'd protect their privacy.

Peter: I guess that's true. I'll do it right away then.

Mary: And you really should back up the data on the server. Flash drives can get lost so easily.

Peter: I've never lost a flash drive, and besides, I thought this was my data. I collected it all myself. I should be able to take it with me wherever I go.

Mary: But it's our research advisor's project, so the data really belongs to this university and the federal agency that funded it. Remember, when the IRB approved the project and the participants signed the consent forms, we entered an agreement to protect the identity of the subjects. It's OK to work on the data outside campus, but make sure nobody can see your screen. Work directly from the server, make a working copy of the data, and leave the original intact.

Data Sensitivity Levels

Research data may have various levels of sensitivity. The type of data protection needed depends on the type of information it contains. For example, in human subjects research there are generally three levels of sensitivity:

Level 1 data does not contain sensitive information, so unintentional disclosure should not result in harm to the subjects.

Level 2 data contains individually identifiable information that could result in moderate harm if disclosed.

Level 3 data contains very sensitive information that if released could result in serious harm, such as injury, loss of employment, or loss of insurability to an individual or a group. The level of protection needed increases with the level of sensitivity.

Similarly, research data that is patentable represents the potential for economic gain and must be protected.

Finally, it is important to differentiate between anonymous or confidential participation in a research study. A study is anonymous if it is impossible for anyone to determine the identity of participants. It is confidential when the researchers know who participated in the study but are obligated to protect the identity of subjects according to consent documents.