Providing Amounts for Further Expenses of the Committee on Energy and Commerce in the One Hundred Fourteenth Congress

Floor Speech

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Mr. HARRIS. Madam Speaker, I am glad the gentlewoman talked about the need for ethical medical research because one of our panel's accomplishments is to show how StemExpress undermined the very foundations of ethical American scientific research.

First, Federal regulations require researchers to obtain informed consent from each person used as a subject. The basic element of informed consent includes a detailed explanation of the purposes of the research for which tissue is being obtained. StemExpress, as we found, simply did not follow that requirement.

HHS regulations also require that in obtaining consent, researchers ``minimize the possibility of coercion or undue influence.'' Well, StemExpress documents that we uncovered shows that its employees were already promising to deliver baby body parts even before the abortions were performed. That raises serious concerns that there may have been coercion or undue influence on women to donate parts of their aborted babies.

Now, second, Federal regulations require that all research that involves human subjects needs approval from an institutional review board, or IRB. As a medical researcher, I had to file IRB applications and receive IRB approval from my university's IRB.

Now, it turns out that StemExpress received their IRB approval from a company called BioMed IRB, a California firm that is basically an online, mail order IRB that the Federal Government actually barred for 2 years because they violated FDA rules in granting their IRB approval.

The FDA gave the panel its file on BioMed IRB. Madam Speaker, that file literally was more than a foot high.

HHS regulations require IRBs to ``prepare and maintain adequate documentation'' of their activities, including: copies of all research proposals reviewed, records of continuing review activities, and copies of all correspondence between the IRB and the investigators, in this case, StemExpress' founder and CEO, Cate Dyer.

Now, the panel subpoenaed BioMed IRB for all documents related to its approval of StemExpress' research protocol. BioMed IRB's executive director informed the panel that, in regards to those records, ``there are none.'' In other words, BioMed clearly violated Federal regulations on IRBs.

The head of BioMed went further. He told the panel to just bring on a contempt proceeding. That is the IRB StemExpress used. That says a lot about StemExpress' motives and it says a lot about the accomplishments of the select panel. None of these shameful practices would have been discovered if not for the panel's investigative work this year.

As a physician and researcher, I know that if I had used the same shady tactics as StemExpress and BioMed IRB, at best, my research reputation would be at risk and, at worst, I would be facing prison.

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