by Keli Holzapfel, MJLST Student Editor-in-Chief
Given the importance of results discovered by biorepositories and their implications for an individual’s health care choices, I believe that the individual has the right to receive his results despite their lack of verification. However, this right to receive results should be premised upon the individual’s explicit consent to receive his results, and upon the understanding that by receiving these results, the burden of their verification shifts from the biorepostory to the individual.
Biorepositories are collections of biospecimens that are tested and analyzed for scientific purposes. The testing performed on these biospecimens has become the basis for development of various molecular tests, which is becoming critical for the shift toward personalized medicine. Therefore, as technology advances, the quality and management of biorepositories is becoming more important. This is especially critical for the return of accurate patient data resulting from biospecimen analysis. However, managing and conducting a biorepository in the way necessary for return of results can be very complex and expensive. There must be many measures in place to prevent mistakes in identification and to ensure the quality of the biospecimen being tested. Currently, there are many existing biorepositories that do not meet the needed Clinical Laboratory Improvement Amendments (CLIA) standards for return of results. For an in-depth discussion of the current state of biorepositiories and issues surrounding return of results, see the article “Perspective on Biorepository Return of Results and Incidental Findings” written by Steve Jewell. For an example on what biorespositories need to do to improve their management and specimen oversight, see the College of American Pathologists, Accrediation Information.
As alluded to above, some of the important questions that arise from the return of results to an individual are inherently linked to the reliability of the result. For example, what should be the necessary standard for a result to be returned to the individual? Is the current threshold for returning results too high? As mentioned, many biorepositories do not meet the necessary guidelines for CLIA certification, which is required for returning of results. This means that potentially critical information is not shared with the individual involved. Is this ethical? Should biorepositories that discover critical information be required to return results to an individual even though the results are not CLIA certified? But if the results are wrong, is the emotional distress that may ensue from the return of results as unethical as withholding the results?
Due to the current state of biorepositories, and the huge implications that return of results may have, I think the best solution is to allow for consent-based return to an individual, with the understanding that any returned result needs to be independently CLIA certified. Therefore, only individuals who consent to receive results would get them, the individuals would receive the results with the understanding they could be incorrect, and then further testing would be done to validate the results to the necessary high standards. For additional in-depth discussion of issues surrounding CLIA and non-CLIA certified return of results, see “Ethical and Practical Guidelines for Reporting Genetic Research Results To Study Participants: Updated Guidelines from an NHLBI Working Group.”
For other insights and recommendations regarding return of research results, see MLST’s Winter 2012 symposium issue, “Debating Return of Incidental Findings and Research Results in Genomic Biobank Research–Law, Ethics, and Oversight“
The written description requirement for patents often resembles the proverbial neglected middle child–it is left to its own devices and entrusted with its own care. The typical patent practitioner carefully chisels away at the claims with a thesaurus, and then proceeds to encase the exquisite sculpture with a glob of written description. Yes, the detailed description of the drawings and alternative embodiments may follow the core structure of the claims, but let’s face it–the average specification is hardly as painfully beautiful as the average claim.
Once just the province of 
