Online guide can help IRB with tissue banking review
Administrative support, knowledge of company key
When an IRB is confronted with reviewing an unfamiliar commercial collaboration to collect human tissue, it doesn't have to work in a vacuum.
The online guide created by Julien Murphy, PhD, a professor of philosophy at the University of Southern Maine, in Portland, ME, can help clear confusion about the process, and lead to a more informed decision.
The guide (see editor's note above for URL) is laid out in a question and answer format, covering everything from the basics of tissue banking (Is there a need for clinical data to be associated with a tissue sample?) to legal, regulatory and ethical issues (How does the Privacy Rule apply to repositories? Is open-ended consent ethical?)
In addition, Murphy, and Jan Trott, director of the Office of Research Affairs at Maine Medical Center, Scarborough, ME, say there are a number of key steps IRBs need to take when considering a proposed commercial agreement:
• Gaining institutional support. Trott says it's important to bring all the potential players on board as soon as possible. When her medical center was approached, the first step was to take it to the president and chief executive officer for approval, she says.
"You have to make sure that the senior administration has bought into this, even including the public relations department," Trott says. "They have to understand what this means and agree to it."
In addition, she says, the hospital's surgeons should be consulted, since the project would affect them.
"Knowing you have all these internal approvals in place before it comes to the IRB makes it easier to get through the IRB," Trott says.
• Learning about the company. "Is this a reputable company? Is this company taking the high road when it comes to ethical issues? How much assurance do we have that this company will take every opportunity to put up the right mechanisms to protect donor confidentiality?" says Murphy, who serves on the Maine Medical Center's tissue banking steering committee. "There are some very good companies that care very much about the community and donors and doing business in the right way. And then there are others."
• Creating an appropriate consent form. Murphy says it's not enough to simply amend the standard research consent form; commercial tissue donation requires a specific sort of consent. "You have to disclose the usual things, including the commercial nature of the repository," she says. "And you also must clearly explain the nature of the collection protocol — that the tissue will be banked, that protocols usually are not specified at the time of collection, and that there may be many end-users, research projects, etc.
"Because of the open-ended feature of tissue repositories, it is important to make sure patients know how to withdraw from a collection protocol," Murphy says. "The risks of privacy and confidentiality should be clearly explained, as well as the mechanisms the hospital uses to protect donors."
She says the online guide provides a number of talking points regarding what needs to go into a consent form.
• Confidentiality concerns. The IRB must carefully review any protocols for unlinking identifiable patient information from tissue samples.
Murphy says some IRB members she's spoken with have suggested that researchers should be able to contact donors if significant advances are obtained from working with that patient's tissue. The contact could serve as a benefit to the donor for agreeing to have his or her tissue collected.
But she says that would be next to impossible, given the confidentiality mechanisms in place.
"Once it's delinked, it can't be traced back," Murphy says. "And even if you could locate the donor, how is the donor's physician supposed to really evaluate the finding of the research?"
• Institutional integrity. The board should review any financial incentives the hospital receives for its collaboration, as well as potential conflicts of interest. "They have to make sure there can be no conflict between patient care and tissue collection, so that one maintains the first priority of the hospital, which is quality patient care," Murphy says.
When an IRB is confronted with reviewing an unfamiliar commercial collaboration to collect human tissue, it doesn't have to work in a vacuum.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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