Informed consent perspective in light of the Henrietta Lacks movie

In the HBO movie “The Immortal Life of Henrietta Lacks” based on the best-selling book written by Rebecca Skloot, text appears across the screen in the very last frame that reads “Patient consent is not required for research on human tissue obtained during medical treatment if the “donor’s” identify is removed”.  The failure of John Hopkins University to obtain consent from Henrietta Lacks or her family for the use of her cells, which have come to be known as HeLa cells, is also mentioned throughout the movie.  As captured by the emotional response of the family in this movie and the perspective of ethicists in the research community, this exemption can be very controversial given the uncertainty as to whether it offers the best protection of privacy to subjects involved in research. In fact, it was just at the beginning of this year that the Department of Health and Human Services along with 15 other federal departments and agencies released updates to the Common Rule that maintained this regulatory position after previously releasing proposed changes to the rule that would have eliminated the ability to do this and would have required consent for all research using human tissues whether it was associated with the patients identify or not.  Given there tends to be a consensus in the research community that human tissue is the most valuable when there is enough identifiable information available to link it back to the patient to allow new data to be added over time, tissue collection is often now accompanied by complex consent forms outlining what will be done and sometimes what won’t be done with the tissue along with the timeframe the tissue will be stored for. It may also specify that reconsent of patients is needed for subsequent future research uses and/or give the subjects choices about what research can be done.  All this complexity along with the sheer volume of consent documents that need to be tracked, highlights the critical need to ensure that the researchers collecting specimens are tracking these critical aspects associated with consent of the specimens in an easily accessible and searchable way. It is also critical for the researchers to be able to confirm at any given time where the specimens are located on the path between collection, use, destruction and/or future storage to ensure specimens can easily be pulled for destruction if a patient withdrawals consent or if the specimen is needed for a downstream research use, particularly if there is an urgency around the timeline for the data generation, for instance in the case of FDA requests for additional testing in clinical trials.  Given the importance of tracking specimens and codifying informed consents, the proprietary GlobalCODE® system offered by Global Specimen Solutions, Inc. was developed precisely to meet these needs, and in addition to the reassurances that the collection of informed consent can bring as highlighted in this movie, the ability to vigilantly track the specimens and consent parameters would provide additional reassurance to and increase trust with patients, patient advocates and regulatory agencies. In addition, the ability of organizations to access specimen chain of custody and consent permissions at any time through a system like GlobalCODE® would provide significant advantages.