IRBs and human subjects research protection programs continue to have some concerns discovered during site visits in the accreditation process, but these in recent years have impacted fewer programs than have problems found with policies and procedures.

Typically, organizations have to do more work on their policies than on their site visits, and most issues are resolved before the site visit, says Sarah H. Kiskaddon, JD, MA, director, global business development and public affairs at the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.

The following are the top issues discovered in 2014 during draft site visit reports:

Element II.1.B – Qualified leadership. This element relates to draft site visit reports and pertains to the IRB having qualified members, staff, and leaders.

“IRB membership should be periodically reviewed and adjusted as appropriate,” Kiskaddon says. “We found that 47.8% of draft site visit reports had an observation with this element.”

For example, they found some issues on the evaluation of the IRB membership and leadership, she adds.

“You have to look at the overall membership periodically, as well as the ethics committee chairs and staff and members,” Kiskaddon says. “They also need to provide feedback to those IRB members.”

AAHRPP found that sometimes periodic feedback did not occur, or the IRB members did not remember ever being evaluated, she explains.

“Also, it’s clear that more evaluation is needed if the members are not knowledgeable about things like the Belmont Report or the federal regulations,” she says. “Either of those findings can trigger an observation with this element.”

This element also pertains to IRBs having the right composition of members. For instance, if an IRB reviews a lot of oncology research, then the board should have at least one oncologist member, Kiskaddon adds.

Element I.6.A – Financial conflicts of interest. Organizations have to follow written P&Ps to identify, manage, and minimize or eliminate financial conflicts of interest.

“You have to have a policy that relates to the organization as a whole or to senior leadership that might have a financial stake in research,” Kiskaddon says. “If an institution has a patent on research that’s being conducted there, then the IRB or conflict of interest committee needs to know that the organization has the patent and that the university as a whole will benefit from the research.”

Also, this issue will need to be managed in some way, she adds.

Just a few years ago, most institutions did not have a policy on financial COIs regarding organizations, but now they do, she notes.

Some institutions will send research with an organizational COI to an independent IRB. This isn’t a requirement, but institutions do need to have a plan that the IRB knows about, Kiskaddon adds.

Element II.5.B – Follow legal and regulatory requirements. “This has to do with documentation,” Kiskaddon says. “The IRB has to document discussions and decisions relative to the approval of the research.”

This element impacted 34.8% of sites visited. The chief problems were poorly-documented minutes and documentation issues.

“For example, decisions related to regulatory requirements are not documented,” Kiskaddon says. “These could be related to protocol specific findings.”

An IRB might have a long discussion at its meeting about whether a skin biopsy is above minimal risk, but then there is no documentation in the minutes about what the board concluded, she explains.

“You have to make those determinations and put those in the minutes,” she adds.

Element I.4.B. – Outreach activities. “Outreach activities to the community have to be evaluated regularly for improvement,” Kiskaddon says.

The 21.7% of organizations that had observations on this element on the draft site visit report typically lacked evaluation of outreach effectiveness, she notes.

“They might do things on a website that is accessible to the community, but no one evaluates whether people use the website and whether revisions are made when things change,” Kiskaddon explains. “Either there is no process or no one is documenting that it’s being followed.”

Element I.5.A – Audits or surveys to assess compliance. Organizations need to conduct audits or surveys to assess compliance with organizational P&Ps, laws, regulations, codes, and guidance. Of the draft site visit reports in 2014, 21.7% had problems with this element.

“We require that quality assurance and quality improvement measures be done periodically,” Kiskaddon says.

“You should pick out what you want to check on — for example, the IRB minutes — and measure it,” she says. “If you find they are missing information and not complying, then do some intervention and check it again.”

IRBs also may want to ensure that they are accessible to researchers who might have questions; they may want to do a survey of the research community to see what their weaknesses and strengths are and then make improvements and measure it again, she adds.

“IRBs need to distinguish between compliance and quality improvement,” Kiskaddon says. “They should have sufficient goals and measures of compliance.”

AAHRPP’s feedback from accredited programs has been that this element has made the biggest difference in their operations, Kiskaddon notes.

“They say this standard, which requires them to make improvements as well as to measure compliance every year, makes a difference in the long run,” she says.

Element I.5.B – Audits or surveys to assess quality. This element also was an issue for 21% of organizations with site visits. It’s different from Element I.5.A in that it looks at quality improvement rather than compliance, Kiskaddon says.

For instance, an organization might find a weakness in its human research protection program and collect data, but when AAHRPP visits, the organization has not completed its quality improvement process, she says.

“The need to do a quality improvement process and not just collect data,” she adds.

Element I.8.B – Agreements with sponsors. “This is one of the hardest standards,” Kiskaddon notes.

“In studies whose sponsors conduct site monitoring visits, they have to have a written agreement with the sponsor,” Kiskaddon says. “We look through clinical trial agreements and find that many sponsors monitor onsite, but if they find something that impacts the participant, they need to notify the IRB or organization in some way.”

IRBs must have P&Ps that outline how this notification will take place.

For example, a drug company might audit a research site, finding that 10% of visits were missing blood pressure measurements, Kiskaddon says.

“This could be a safety measurement, and if it’s not done then the sponsor might find that out, so we are now obligating the sponsor to report that back to the site,” she adds.

In all, 21.7% of draft site visit reports had observations with this element. “Organizations won’t be accredited unless they can correct this,” Kiskaddon says.

Element I.8.C – Data safety monitoring boards. This element is similar to I.8.B, but pertains to the sponsor’s responsibility to conduct data and safety monitoring. Organizations should have an agreement with sponsors that provides for the investigator or IRB to receive DSMB reports and to ensure participants’ safety.

“Findings from the DSMBs should go to the researchers or the IRB,” Kiskaddon says. “About 21% lacked sufficient contractual provision that required the sponsor to send DSMB reports to researchers or IRBs when appropriate.”

Element I.8.E – Disclosing results agreement. With this element, AAHRPP requires that institutions have a written agreement with sponsors that the IRB will be notified with the results of a study in order to inform participants. It pertains to studies in which participant safety could be directly affected by study results after the study ends.

Draft site visit reports found that 21.7% of sites had concerns with this element, including problems with the contract and the process.

“Sponsors have resisted this over the years, but are conforming more and more now,” Kiskaddon says. “They continue to analyze data up until they publish it, and during the analysis phase of study, you need a process to notify an organization if you find some information that affects the health or welfare of study subjects.”