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UC Berkeley DNA and Investigation of Committee for the Protection of Human Subjects I

By Jude Ya
Tuesday June 29, 2010 - 02:48:00 PM

When UC Berkeley planned the “On the Same Page” project to request first year students provide DNA for analysis and subsequent discussion it is doubtful anyone anticipated the vigor of public reaction. One concern cited was is the accuracy of the genetic testing kits and that the testing technology under scrutiny of the FDA. 

The reality is that accurate genetic testing technology was established some time ago. Currently DNA is collected from convicted offenders, analyzed, and profiled electronically in all 50 states. Typically labs analyzing offender DNA use a pre-assembled set of reagents that allows the lab to conduct a standard DNA extraction, quantitation or amplification. For the “On the Same Page” project the research scientist will probably run a standard set of reagents, but only report the results for folic acid, lactose and alcohol metabolism to students.  

The scientist will still have the entire DNA profile for each student submitting a sample. The idea that the students' DNA samples will be destroyed after analysis is disingenuous. It is the DNA profile which is derived from the DNA analysis that is key. In 1994 the FBI was authorized to create an offender DNA database, the Combined DNA Index System (CODIS), to contain offender DNA profiles from across the country. States do not submit offender DNA samples to CODIS, but the DNA analysis profile. 

The States also store all offender DNA profiles electronically for access by law enforcement and criminal justice agencies. Research scientists can also gain access to offender profiles. Scientists carried out a familial/kinship study in 2005 to identify offenders based on their DNA who are related, but may not know each other. "Finding Criminals Through DNA of their Relatives," was published May 11, 2006 in Science Express. The results described in a Berkeley Memo to the Media: “ We may not be our brother's keeper, but our brother's DNA could help land us in jail...investigators could reap a significant boost in leads if they were to use DNA kinship analysis methods to search offender DNA databases to aid in locating potential criminal suspects that use matching DNA samples from other databases.” 

Kinship searching of the offender database can help catch a novice criminal, who is not himself in the database, through his brother or father who is a cataloged offender," says Charles Brenner, a visiting scholar in the Forensic Science Group at UC Berkeley's School of Public Health and one of the authors of the report. Does this mean that the first year student DNA could be analyzed for a offender kinship study? Yes, for the “On the Same Page” project the collected DNA data is considered anonymous which was approved by the UC Berkeley Committee for Protection of Human Subjects. 

Any Berkeley scientist is now able to propose research to the UC Berkeley Committee for the Protection of Human Subjects and request an exemption from review based on 45 Code of Federal Regulations Part 46 Protection of Human Subjects 101(b)(4) “Research involving the study of such a manner that subjects cannot be identified...”. 

One would expect and hope that UC Berkeley would ensure human subject protection is in place for its students who take part in this project and should be the responsibility of the UC Berkeley Committee for the Protection of Humans Subjects. Unfortunately the UC Berkeley Committee for the Protection of Human Subjects has for some time fail to adequately administer the UC Berkeley human subject protection program and is currently undergoing a site visit audit by investigators from Washington for the Department of Health and Human Services' Office for Human Research Protection regarding serious violations of the Federal Regulations for the Protection of Human Subjects. 

Interesting irony should the federal audit become a criminal investigation and a CPHS administrator is convicted of wrongdoing and required to give a DNA sample. UC Berkeley should replace the “On the Same Page” DNA testing project with a project about the ethical conduct of DNA research.