Determining how best to obtain valid consent for the use of human biological samples collected for research is a challenging issue for investigators, sponsors, and institutional review boards (IRBs) because the goals of maximizing participants’ autonomous decisionmaking and advancing scientific research may conflict. Some participants want control over their samples to avoid research projects that they find morally objectionable. In this article, we argue that the use of exclusion clauses in informed consent can minimize risks to participants and social groups and promote accountability and trust without significantly deterring research.
Exclusion clauses are written statements used during informed consent to (1) exclude the use of biological samples and personal health information for certain types of research and (2) limit sharing of biological samples and personal health information with specific researchers, biobanks, or organizations—for example, investigators working on certain types of research projects, insurance companies, government or law enforcement agencies, advocacy organizations, and private companies, that is, employers. Exclusion clauses are meant to capture contentious research that could risk discrimination or stigmatization of individuals or groups and sharing with organizations the public perceives as less trustworthy. Exclusion clauses are statements included in consent forms by the researchers on areas of contentious research in which they will not take part in the future and organizations they are unlikely to share with. Although exclusion clauses may limit unrestricted use and global sharing, they can be useful for smaller biobanks with specific purposes.
Biobanking and Informed Consent
Biobanking involves the collection of human biological materials and health information that are used for a current study and stored for future research. Samples can be tested to detect the presence of cell types, proteins, metabolites, antibodies, DNA sequences, and other biomarkers in a given population.1 With the accompanying health information of participants, investigators can analyze data derived from biological samples (such as genomic information), as well as other types of data (such as demographic and health information), to discover statistical relationships between various factors and diseases and patterns of heritability within families and populations. Sharing of biological samples is important for promoting scientific progress, because investigators can take advantage of one another’s labor and resources and can access diverse populations and include more samples in their studies. Sometimes, samples come from populations where individuals are thought to have unique genetic predispositions or environmental exposures.
MASTER, Z., & RESNIK, D. (2013). Incorporating Exclusion Clauses into Informed Consent for Biobanking. Cambridge Quarterly of Healthcare Ethics, 22(2), 203-212. doi:10.1017/S0963180112000576