Biological Sample Study

Biological sample studies are used for a variety of reasons during or after an emergency, for example, to identify deceased victims of a mass disaster or individuals infected with a chemical agent or virus. In humanitarian settings, collecting tissue samples for the purpose of research may be conflated with clinical care or aid, so a clearly defined reason for requesting samples for research should be incorporated into the consent process. Potential participants should be informed why their or their families’ tissue samples are necessary to achieve a public health or humanitarian goal, even if for an unknown, future research project.

The methods of collecting and storing samples should also be carefully evaluated. Collecting a tissue sample from a participant may cause discomfort; further, if the sample reveals stigmatizing health information or is presented in a culturally insensitive way, this may cause additional distress or harm. Anonymity is an important measure to protect and respect subject’s privacy. De-identified samples, meaning, the sample does not include identifiable information (name, date of birth, etc.) and/or that its genetic makeup cannot be traced back to the subject in an identifiable way (ethnicity, family group, etc.), is a clear way to reduce ethical concerns associated with confidentiality when possible.

More broadly, communities may be exploited if their samples are collected to develop some intervention that they will not be able to access in the future. How a research team stores samples, where the storage facility exists, and if the samples will be sent to a third-party country should be considered to avoid inappropriate, exploitative uses of samples. Finally, secondary analysis or future use needs to be incorporated into consent process. The research team should be transparent with participants if the samples may be used for other research purposes and that subjects can request to have their samples destroyed if they don’t want their samples to be used in this way.

Which of the following are features of your study?

PREA Version 1.0. This site is under construction. Please continue to check back for more content or leave us a comment on how we can improve.