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Research Data Management

Human Subjects in Research

Human subjects research is important in the fields of medicine, behavioral and social sciences. It can involved direct interventions with participants in clinical or programmatic settings, direct interaction through interviews or surveys, and observational by watching participants and recording behavior.

U.S. Based Research: The U.S. Department of Health and Human Services (DHHS) sets the requirements for what is considered Human Subjects Research, and has codified these requirements in Title 45, Subtitle A, Subchapter A, Part 46 of the Code of Federal Regulations (45 CFR 46), more commonly known as the Common Rule. The Common Rule is very heavily influenced by the 1979 Belmont Report, published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. If you are working with human subjects, you will become very familiar with the ethical considerations in both of these documents. 

International Research: Different countries have varying regulations. The DHHS does provide a compilation of of over 1,000 laws, regulations, and guidelines on human subjects protections in 133 countries and from many international organizations. It is important to be aware of what regulations and laws you may be facing as you plan your research. 

Human Subjects and Consent for Data Sharing

In order to share human subjects data with the broader research community (often referred to as data publishing), you must address data sharing in your IRB protocol and consent form. If you do not, you will likely need to seek re-consent from your participants as well as amend your IRB protocol, which isn't always easy and further complicated if your protocol is closed. 

Some sample consent language:  If you choose to be in this study, data collected from you and all the other people who take part may be stored long-term in a repository following the completion of the study. Any personal information that could identify you will be removed or changed before files are shared with other researchers or results are made public. The removal of this information allows your data to be used without anyone knowing which person in the study it comes from.

The Duke Campus IRB and Duke Office of Clinical Research are happy to assist Duke researchers with coming up with appropriate language.  ICPSR also provides several recommendations on how to write consent forms that allow for data sharing. 


The removal of identifiers from human subjects data is important prior to publishing. There are both direct and indirect identifiers, and some require explicit removal or sufficient masking in order to be released. The Health Insurance Portability and Accountability Act (HIPAA) has a list of 18 identifiers. In order for something to be considered fully identified it must have all 18 identifiers removed or expertly masked.

Deidentification Methods Required by HIPAA

When data is not coming from the health record, it still needs to be protected to the same ethical standards to lower deductive disclosure risk. To learn more about deductive disclosure risk please see ICPSR's Data Sharing for Demographic Research Archive guidance on this topic. ICPSR also provides an expanded list of what constitutes both direct and indirect identifiers in social and behavioral research.

If there is still some risk of deductive disclosure, you may still be able to share your data through a repository that offers restricted data access. In order for others to request access to the data there is an application process that typically involves providing credentials, a project proposal, IRB approval and data use agreement. If you need to share data under these conditions please feel free to contact us