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For example, participation in an online survey would be considered anonymous if that survey could not be linked in any way to the individual. Confidential When participation is confidential, the research team knows that a particular individual has participated in the research but the team members are obligated not to disclose that information to others outside the research team, except as clearly noted in the consent document.
As such, principal investigators PIs and their study teams may be required to outline the data manangement and security procedures in the eResearch IRB application for IRB review.
Core Controls Details on what tools can be used for which institutional data types can be found in the Sensitive Data Guide.
All data collection and storage devices must be password protected with a strong password. A strong password requires a level of complexity. Please follow the link for crafting a strong password. All sensitive research information on portable devices must be encrypted.
Access to identifiable data should be limited to members of the study team. If it is necessary to use portable devices for initial collection of identifiers, the data files should be encrypted and the identifiers moved to a secure system as soon as possible.
The portable device s should be locked up in a secure location when it is not in use. The PI should consult with their departmental IT Security Liaison to discuss how to correctly configure desktop computers, laptops, and other external devices for safe use in the collection and storage of research data.
The Sensitive Data Guide provides information on what specific IT resources may be used with sensitive human subjects research data and protected health information. If utilizing any cloud-computing services, the PI must follow the U-M safecomputing guidelines see Resources below.
All data collected on portable devices should be transferred to an approved service as soon as possible after collection, and deleted from the portable collection devices. If research includes sensitive identifiable data, outside consultants or vendors should be required to sign a confidentiality agreement.
If the research design allows, the PI should delete or destroy identifiable information as soon as possible after collection. Knowing the correct use of these terms can help you determine the appropriate data management and security procedures for your project.
Anonymous Data are anonymous if no one, not even the researcher, can connect the data to the individual who provided it. For example, a study participant who is a member of a minority ethnic group might be identifiable from even a large data pool.
The research team is obligated to protect the data from disclosure outside the research according to the terms of the research protocol and the informed consent document. Methods to reduce the risk of inadvertent disclosure include: Institutional Data Institutional data is defined as any data that is owned, licensed by, or under the direct control of the University, whether stored locally or with a cloud provider.
References and Resources Data Classification Levels U-M institutional data is classified into one of four classifications or sensitivity levels. Researchers should become familiar with these levels and consider whether additional procedures should be implemented to adequately protect and manage human subject research data.
Protect Sensitive Data U-M Safecomputing website providing best practices for accessing, working with, and storing sensitive data.Lists the core controls for minimum data security for human subject research data, and defines the key terms "anonymous", "confidential", and "de-identified" as it relates to the collection and maintenance of that data.
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Computer Science Department, Purdue Unwers~ty, West Lafayette, Indiana The rising abuse of computers and increasing threat to personal privacy through data banks.
have stimulated much interest m the techmcal safeguards for data.
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