Research Ethics: Case 3
After having completed a study that involved the collection of tissue from the subjects, an investigator wishes to perform additional analysis of the archived tissue samples. This nature of this analysis was not explicitly stated in the original consent form.
Should the investigator be required to obtain explicit consent for the new research?
While de-identified tissues and data are currently permitted for secondary research uses under the regulations the Common Rule and such practices are under sharp debate given the inherent identifiability of genetic information and the requirements of respect for persons. Institutional Review Boards have increasingly required that explicit consent be obtained, if practical, before archived tissue can used for research. Even if participants may be willing in general to have surplus tissue used for research purposes, they should still be asked for their consent when specific new uses for their samples are identified. (For further discussion of this topic, see Ludman et al., 2010.)