UNM ends fetal tissue research, for now - Albuquerque Journal

UNM ends fetal tissue research, for now

Copyright © 2018 Albuquerque Journal

Dr. Robin Ohls

University of New Mexico has permanently banned one of its faculty members from conducting fetal tissue research following two internal investigations into her working relationship with a Michigan company, putting an indefinite end to any such research at the state’s largest university.

The investigations by separate UNM committees each found Dr. Robin Ohls had violated UNM Health Sciences Center policy by not having certain documentation governing her relationship with the Zietchick Research Institute, a Michigan company to which she had sent fetal tissue, and not seeking internal review of the related research project.

HSC’s chancellor, Dr. Paul Roth, forever barred Ohls from acquiring, transferring or performing research on fetal tissue, writing in a June 18 memo that he was “disappointed that I have to impose these actions and remedies.”

Ohls had been the only researcher at UNM using fetal tissue.

But Ohls – who has used fetal tissue in her research even before coming to UNM in 1995 – describes the penalty as too drastic for what she said amounts to a paperwork error. She said her UNM lab has used fetal tissue to explore various “developmental questions,” evaluating issues that affect premature infants, such as heart and eye disease and brain growth.

She is also a practicing neonatologist, a doctor who specializes in caring for ill newborns.

“I don’t think that what happened merits stopping fetal tissue research in our lab,” Ohls said in an interview.

Ohls also questioned the relevance of one committee’s findings, contending that it does not have oversight of her type of research. That body, the Human Tissue Oversight Committee, took a much harsher stance on her actions, determining that she was “negligent and knowingly violated” HSC policies and that her shipments to Zietchick could be considered a “donation,” given the policy lapses.

The university’s Human Research Review Committee, meanwhile, felt Ohls did not intentionally commit violations and acknowledged “some ambiguities” within the policy, according to documents the Journal obtained through a public records request.

Both investigations concluded that Ohls did not break any laws and she did not sell fetal tissue, a Health Sciences Center spokeswoman said. Federal law bans the sale of fetal tissue.

Compliance with policy

In issuing the permanent suspension, Roth emphasized the importance of adhering to UNM policy.

“As a faculty member in the School of Medicine, I expect our research faculty members to familiarize themselves with policies applicable to their research activities, to comply with those policies, and if they have any questions about those policies to seek out the advice of institutional leaders with content expertise with respect to those policies,” Roth wrote.

“I also expect that our research faculty members will not ignore or – by their actions – marginalize or attempt to ‘end run’ our research policies.”

Ohls’ attorney signaled a possible lawsuit via a tort notice sent to UNM in January. The doctor said last week that she had not determined whether to pursue a lawsuit, but said she may try appealing Roth’s decision to UNM President Garnett Stokes.

Roth did determine that Ohls can resume clinical trial research if it does not involve fetal tissue.

Ohls, chief of UNM’s neonatology division, continues to treat patients.

Roth had suspended Ohls from all research activity last October amid questions about her shipments to Zietchick of fetal tissue obtained from the Southwestern Women’s Options abortion clinic in Albuquerque.

Ohls, who said she was in the early stages of a research collaboration with Zietchick, had asked officials if it were allowable for Zietchick to reimburse UNM for a lab assistant’s time preparing the samples for shipment.

HSC staff did not know about the shipments until that point, even though the transfers started about eight months prior, according to a memo Roth and a university attorney wrote to the UNM Board of Regents on Oct. 26, 2017.

Ohls never executed an official “material transfer agreement,” or MTA, with Zietchick, and both UNM investigations noted that issue.

Ohls told the Journal she sent Zietchick the wrong transfer agreement form to complete. Once Zietchick sent it back, Ohls also never submitted the form through the internal UNM process. She said she had executed only one such agreement previously and was not experienced in the process.

“I absolutely incorrectly filed the MTA, no doubt about it. Yes, I made a mistake with that MTA,” Ohls said, though she contends UNM’s policy only advises, but does not mandate, an MTA in such circumstances.

Differing reports

The two committees investigating Ohls came to different conclusions about why Ohls erred.

The Human Research Review Committee “felt that the MTA was not executed due to a misunderstanding of policy,” according to a March 21 letter to Ohls from Dr. Walter Dehority, HRRC chairman. His letter also cites some “ambiguities” in the policy requiring an MTA.

That committee ultimately determined that Ohls must in the future submit “any and all research studies or collaborations involving human tissues” to HRRC and other committees and also get institutional approval via a fully executed MTA before transferring human tissue to an external entity.

The Human Tissue Oversight Committee, meanwhile, reached a different conclusion.

“After a thoughtful, considered discussion the HTOC agreed that Dr. Ohls was aware of HSC policies, knowingly violated these on multiple occasions, and intended to mislead the HTOC,” according to a June 7 memo to Roth from Dr. Corey Ford, who chairs the committee.

That committee said the terms of the arrangement should have been outlined in a “collaboration agreement” or material transfer agreement. It also ruled that she did not “fulfill the HSC definition of collaboration” with Zietchick, which Ohls disputes.

A UNM spokesman declined to respond to Ohls’ specific statements about the two committees’ roles, but said the committees’ reviews considered different aspects and that Roth considered both reports when rendering his judgment.

“There are appropriate and required avenues for all research projects to be approved and processes that must be followed. Both the HTOC and the HRRC were asked to review Dr. Ohls’ actions because they were looking at specific aspects of the processes/approval/conduct in question,” spokesman Michael Haederle said in a written statement. “Dr. Roth took both committees’ reports into consideration, as each considered different questions regarding Dr. Ohls’ actions.”

UNM has moved all 72 fetal tissue from Ohls’ lab for storage in a central repository, and Roth’s memo said he has not yet decided whether to destroy it in accordance with HTOC’s recommendations.

Ohls, who called it a privilege to perform fetal tissue research, said she has always worked to follow the rules.

“There was no willful disregard for policy at all,” she said.

Ohls said she has asked that the tissue be spared.

“If someone else can use it for research, why would you destroy tissue people have donated with the thought they might be able to help babies? Why would you do that?” she asked.

No other UNM researcher is using fetal tissue, and it’s not clear if any will in the future, though a spokeswoman indicated it was possible.

“Research is a fundamental foundation for the advancement of medicine,” HSC spokeswoman Alex Sanchez said in written answers to Journal questions. “Research with fetal tissue is legal. Future research would need to be approved through the proper processes.”

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