Current laws about federally funded human subject research were last updated in 1991. Since then, the Human Genome Project was completed, and an entire field, known as epigenetics, has arisen from this. Just recently, a new robust gene-editing tool, CRISPR-Cas9, blew away older versions of gene editing. It is now “fast” and “easy” to analyze and make DNA in the laboratory, and if a researcher has access to your genetic material that material can be traced back to you. A lot has happened in genetics since 1991.
The current law for federally funded human subject research is known as the Common Rule. It does not require the donor to provide informed consent a biospecimen is collected in the clinic and used for future research purposes. For example, if I have a tumor removed as a clinical precaution (i.e., for therapeutic purposes), and a doctor decides to keep the tumor cells for use for other experiments, he is not required to obtain my consent for using that tumor. The qualifier is that all identifying markers, including typical genetic identifiers, must be removed. The tumor must be anonymized.* However, if I enrolled in a clinical trial in which researchers remove tumors for the purpose of conducting a particular study, then that study undergoes institutional review, and I must sign off on the use of my tumor for that study.
Current technologies have thrown a wrench in this plan. Donors can be identified even after the biospecimen has been stripped of typical identifiers.
This lead to a NIH-sponsored workshop comprised of sixteen federal departments and agencies that discussed ways to revise the Common Rule so that donors are protected. Those proposed revisions were released last September as “notice of proposed rulemaking,” and are open for commentary. In the revisions to the Common Rule donors of biospecimens, when collected in the clinic, must provide broad initial consent for future research use, otherwise their tissue cannot be used for research purposes.
The recent issue of the American Journal of Bioethics target article authored by several of the workshop attendees discussed the results of the meeting and proposed ways that donors can provide broad consent while not necessarily consenting to controversial research. The article is available by subscription only, but if you would like to read a summary, see my write up for Medical Xpress, here.
We are living in a time when big data are part of scientific research. Sometimes researchers will use medical or genetic records or biospecimes that were collected five or ten years ago for new research that the donor or the doctors may have never anticipated at the time. The AJOB article discusses some possible solutions to ethical concerns with using biospecimens for future research, including their proposal of “broad consent with oversight” in regards to research that some groups may find morally objectionable.
*The most famous exception to this rule is HeLa cells, named after Henrietta Lacks. These cells are still used in current research and are still referred to as “HeLa” in the academic literature.