The 2011 changes to the National Institutes of Health (NIH) Public Health Service (PHS) regulations for reporting investigator conflicts of interest may still be causing confusion for researchers and IRBs.
The NIH COI rules lowered the significant financial interest from $10,000 to $5,000, received in the previous 12 months. The interests can include stock options from a pharmaceutical company, speaking fees, etc. But the 12 months was not defined as a calendar year, leaving IRBs to determine the 12-month window at their discretion.
"That raises a lot of questions in terms of when the disclosure information changes, and when it’s appropriate to remove it [the conflict disclosure] from the informed consent," says Rebecca Flores Stella, CIP, manager of IRB operations and education at Cedars-Sinai Medical Center Office of Research Compliance and Quality Improvement in Los Angeles. "It’s important for the institution to define when the 12-month window is starting."
COI management plans
Not all IRBs follow the NIH’s $5,000 threshold. "Some institutions have a zero-dollar threshold," says Julie Blasingim, MBA, CIP, board chair at Schulman Associates IRB in Cincinnati and Ft. Lauderdale. "We have found the $5,000 threshold to be sufficient for subject safety, and always have the option to request a management plan for financial conflicts that are lower than $5,000."
If an investigator discloses a significant financial interest, management plans are created by the investigator or the IRB to minimize the conflict’s effect on the study. "Supplemental forms for additional information [on the conflict] are geared toward understanding what the conflict is and how the investigator plans to manage it," Blasingim says. "What we have found is oftentimes the investigators are looking to the IRB to provide their expertise on ways they can manage the conflict, particularly for investigator-initiated studies."
Usually, Schulman IRB requires the investigator to notify study participants of the conflict in the informed consent process and forms, Blasingim says. "It’s rare that we would not have such disclosure in the informed consent," she says. "The disclosure could include how much stock the person has [in the sponsor company]. If a person has substantial ownership in the company, we might say that they could be on the research team but not be involved in the consent process." If there is a possibility that the conflicted person could bias the study data, he or she may be asked not to be involved with the data analysis. "An independent monitor may be requested as an added safeguard for certain types of conflicts," she adds.
Cedars-Sinai has an algorithm to determine the conflicted investigator’s participation in a study, taking into account the size of the study and the number of sites involved, among other criteria. "We could limit the conflicted investigator’s participation in the recruitment and consent processes, and/or could restrict their ability to be the one who signs off on eligibility of final subjects," Flores Stella says. "We could also restrict them from participating in the research intervention, depending on the study design. We haven’t restricted investigators from participation in data analysis because findings would likely undergo scientific merit consideration when submitted to peer-reviewed journals."
Management tips
IRB professionals offer these tips for managing investigator COI:
Mandatory education for researchers and investigators on institutional and NIH requirements.
Unclear institutional criteria can lead to unintentional non-disclosure of COI information, particularly when rules differ between IRBs. For instance, an investigator who has worked with IRBs using the $5,000 NIH COI threshold may go to an IRB with a zero-dollar threshold. If he or she is unaware of the different threshold, it could lead to noncompliance issues. "If investigators are used to working with Schulman and go to someone else with a zero-dollar threshold, [non-disclosure] is an honest mistake," Blasingim says. "In the IRB world, there needs to be consistency and clarity provided to investigators so they know what to expect and what type of information to submit."
Have an algorithm in place for consistent management plans.
Not all conflicts are the same in terms of severity or effect on the study. Some conflicts may only require a disclosure on informed consent documents, while others may mean the investigator should take on a smaller role in the study. Having sets of criteria to determine the extent of COI can aid in management plan consistency. "Build an algorithm to look at particular circumstances to help guide decisions and determine whether the person can make impartial decisions for the study," Flores Stella says.
Creating an algorithm can be complicated if everyone on the IRB is not on the same page. Hold in-depth discussions to get everyone in agreement, Flores Stella says. "It’s something that all institutions struggle with because it’s a judgment call," she says. "Some believe that any level of financial interest affects impartiality, and others believe the financial interest has to be very significant to have that kind of impact on the decision-making and integrity of the study. That’s a tough question for anyone to deal with."
Institutions must also consider what constitutes a conflict, and what may be payment received for product education or development. "One of the hardest things to track in this is when someone is paid legitimately to do a study," says Susan Rose, PhD, executive director for the office for the protection of human subjects at the University of Southern California in Los Angeles. "If they do it [a study], they have to get money. But if they do a speaking tour or advisory committee, we want to know how a pharmaceutical company is paying for their speech — through the education department or through marketing. Paying for education is different from paying for marketing. The costs of doing the study are not conflict of interest costs; they’re the costs of doing business."
Have a solid system in place for COI reporting.
Electronic IRB systems help ensure that COI information is up to date, and that information doesn’t fall through the cracks. "In the prior system there were challenges getting information across, but the new electronic system helps to cross-check everyone and that’s been very helpful," Flores Stella says.
It’s also less likely that a study would get underway before a conflict is discovered, Rose says. "It’s so rare that a study gets so far [without disclosure] because there are such good filters to check it before a study gets approved," she says.
When USC’s disclosure system indicates that there’s a financial COI, the study can’t go forward until the university’s conflict of interest committee reviews it. "They have to make a decision before the study gets approved," Rose says. "Sometimes it happens the other way and a disclosure is made on the annual review form. The system stops the approval until the committee says it’s OK; then the IRB can approve."
Conflict of interest committees are also important tools for COI management, Blasingim says. "We have a conflict of interest committee, and it’s a great way of having experts in the areas of COI, including legal representatives, to evaluate each conflict of interest and their management plan," she says. "They can monitor the submissions that come in from the investigator to make sure we’re getting accurate information."
Keep communication open and constant with multisite research.
If the central IRB criteria don’t match your institution’s criteria, work together to ensure that both sets of requirements are met, Blasingim says. "A lot of investigators will send submissions to central IRBs, and also be required to have their own internal or local COI committees assess and clear the conflict before they can proceed with a central IRB," she says. "When we serve as the local IRB, we work closely with those groups. Communication and clarity up-front are key to ensuring conflicts are appropriately disclosed and managed for human subject protection."
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