IRBs grappling with tissue requests from biotech firms
Informed consent is an issue
Technology advances have driven increased interest in molecular studies involving tissue analyses. As a result, biotech firms increasingly are asking scientists to sell human tissues for study by outside enterprises.
This trend has come to the Thomas Jefferson University IRB’s attention in recent years, says J. Bruce Smith, MD, CIP, director of the office of human research and division of human subjects protection at Thomas Jefferson University in Philadelphia.
"There’s a big push to get these studies done, and it’s increased," Smith adds.
Since the financial and federal budget crises have made research funding scarcer, academic researchers have been looking for alternative funding sources for their labs. The biotech firms’ offers have appealed to them, says Kyle Conner, MA, CIP, associate director of the division of human subjects protection at Thomas Jefferson University.
"All investigators are looking for ways to generate money," Conner adds. "We say, It’s okay to get paid, but it has to be a scholarly pursuit.’"
Smith, Conner, and other Thomas Jefferson University officials began to discuss this trend at a meeting when an investigator asked if he could provide tissue to a company that would send it to another company for research.
"We were concerned because it didn’t seem like an ethical thing to do," Smith says.
After discussions with the IRB and institutional leaders, they decided on an ethical approach that is outlined in the institution’s tissue policy and a tissue consent form, he adds.
"We developed a consent form to allow people to bank anonymized tissue for future research," Smith says. "Also the policy and consent form state that we would not sell their tissue for profit."
If researchers are approached about sending tissue to other research facilities, they are permitted to do so only if the researcher meets criteria for having a scholarly or academic interest in the research.
"The motivation for creating these forms was to address studies comprised exclusively of tissue collection," Conner says. "We don’t want investigators to fill out forms they don’t need, and a lot of tissue studies don’t need to include informed consent."
A number of academic medical centers have developed similar policies in recent years because they also have been confronted with the business of selling tissue, Smith notes.
"We all want our investigators to have some sort of scholarly or academic interest in this," he says.
Human tissue for study increasingly will be in demand as scientific advances open up research possibilities, but IRBs and academic research institutions have a responsibility to be accountable to the public interest and perceptions, Smith and Conner say.
"Academic medical centers have to be concerned with their reputations," Conner says.
"It’s not our main concern, but it is a concern of our office; we don’t want lurid headlines to appear in the paper about selling tissue for profit," he adds. "We want to keep the community enthusiastic for research."
Complex informed consent issues
While for-profit sale and use of human tissue might bother some people, the bigger issue is informed consent, says Marshall B. Kapp, JD, MPH, director of the Center for Innovative Collaboration in Medicine and Law at Florida State University in Tallahassee.
Kapp also is a professor in the college of medicine and college of law.
"Does that person giving consent know that their tissue is going to be used for research generally, and do they know the specific kinds of research in which their tissue will be used?" Kapp says.
"I don’t have an objection to selling tissue to a commercial entity to do research if the human being from whom the tissue was taken knows about that and consents to it," he adds.
Ideally, each person who has provided specimens being stored at a medical research facility would be contacted by the university or another group about providing informed consent for any and all uses of their tissue, Kapp says.
Obtaining consent in this way is impractical, if not impossible, he acknowledges.
"So the open-ended consent might be a good compromise, but it should say something about the possibility that the tissue sample will be transferred to the for-profit entity for research purposes," Kapp says. "People won’t know what kind of specific research project will be involved, but they at least will know about the possibility."
Thomas Jefferson University’s IRB follows federal regulations regarding waivers of informed consent for stored tissue, Conner says.
"With any prospective collection of tissue we would require informed consent and have an informed consent template," he says. "If the tissue already is stored, we may waive consent because the subjects are no longer available, and it’s not really practical to obtain consent for tissue that’s already stored."
The IRB has seen different types of consent approaches, including forms that are very general with open-ended consent and those that give people the opportunity to check a box or specify which types of research they would like their tissue to be used for, he adds.
"We would like the consent to be as specific as possible, but in a lot of cases they don’t know what the tissue will be used for, so we have them explain what they do know: They’re going to put the specimen in a tissue bank at this location, it will be stored for x number of years, and the subject can withdraw the tissue," Conner says.
Thomas Jefferson University’s OHR 15 form, recently revised, reflects a contract in which a company that has interest in a biological specimen sends money to the university or medical college for the tissue.
"The contractual agreement between the company and university says this investigator will collect data that’s generated, help with writing a manuscript, help analyze and be part of the team that writes the manuscript for publication," Smith says. "These are the sorts of things we feel would constitute a scholarly activity on the part of our faculty, and that’s what we ask them to confirm on the form."
Since forming the new policy, the institution has seen a modest increase in researchers participating in studies involving biological specimens, he adds.
After making the change to require investigators to engage in scholarly activity, the IRB notified the research community of the change in its newsletter and through emails, Smith says.
"We had some push back from a couple of people who didn’t understand it, who didn’t get the concept of scholarly activity, but by and large it’s been accepted by most researchers," he adds.
The informed consent and biological specimen issue is more complex.
Some ethicists and others do not believe the blanket consent is enough for stored biological specimens, Kapp notes.
"They believe true consent relies on enough information about the particulars of the research protocol to make it more meaningful," he says.
This concern is not based on the potential of harm because in the case of research involving tissue samples, the only risk is the breach of confidentiality, Kapp says.
"However, you have to look at autonomy more broadly," he explains. "I might say, as the source of tissue, that I don’t philosophically or religiously want my tissue used for certain purposes even if there’s no risk to me other than offending my moral principles."