Each year, human subjects protection programs worldwide prepare for accreditation, making changes and improving processes. But which problems crop up most frequently?
“Depending on guidance changes, it goes in spurts of which items are the hot button issues,” 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. Kiskaddon and Candice Yekel, MA, of Pennsylvania State University, spoke about the top 10 findings from 2014 AAHRPP applications and site visits at the 2015 annual AAHRPP Conference, held May 19-21, 2015, in Chicago.
Kiskaddon reviews the most common findings each year and has found a shift in where problems appear: Previously, AAHRPP site visitors found more problems during site visits; now, there is more emphasis on correcting policies and procedures early in the step 1 review process.
“We’re doing a little different process,” Kiskaddon says. “The policies are revised more in the step 1 reviews and are very good before we go to the site visit.”
This is why AAHRPP now identifies more issues with the P&Ps and fewer during the site visits.
“When we’re doing site visits, we verify that the site is following its P&Ps, and because the first part is more rigorous, we don’t waste anybody’s time at the site visit,” Kiskaddon says. “I think this is more efficient.”
Here are the most common issues found during reviews of P&Ps and standard operating procedures (SOPs) by the Council on Accreditation in 2014:
• Element I.1.A – What activities are overseen by HRPP. “This has to do with defining what is research and what has to go to the IRB for review,” Kiskaddon notes.
Research organizations need to research in relation to quality improvement and other activities in their P&Ps so it’s clear to faculty and researchers when they have to seek IRB approval for a project, she adds.
“Eighty-one percent of organizations need some tweaking of the definitions of systematic investigation and generalizable knowledge,” Kiskaddon says.
Specifically, P&Ps should provide examples for researchers of the kind of research that meets the definition and needs to be reviewed by the IRB.
• Element I.7.A – Confirm test articles have regulatory approval. “The HRPP needs to confirm that test articles have regulatory approval,” Kiskaddon says. “Confirm the IND number or verify that there is no need for an IND.”
About 71% of organizations’ step 1 application materials required an addition or revision to satisfy this element.
“Occasionally we find that IRBs accept whatever is told to them and do not check to see if the study needs an IND,” Kiskaddon explains. “An IND number should match the number on the investigator’s brochure, protocol, and application form.”
Also, IRBs should ask to see correspondence from the Food and Drug Administration (FDA) if there is no IND, she adds.
“They shouldn’t rely entirely on investigators that say, ‘I’ve been told I don’t need an IND,’” she says. “IRBs should look into it.”
• Element II.2.D – Conducting a review by convened IRB/Ethics Committee. “We require IRBs to have someone with the general perspective of research participants, which exceeds the federal requirement of having an unaffiliated member,” Kiskaddon says. “We say that you should have someone on your IRB who recognizes the general perspective of research participants.”
For example, an IRB could have on their board a parent of a child who was enrolled in a lot of clinical trials due to a chronic illness, she suggests.
“It has to be someone with the perspective of the research participant,” she adds. “Another requirement is a standard for attendance of unaffiliated members at convened meetings.”
The regulations are silent on their attendance, but AAHRPP says organizations should have a minimum requirement for attendance and track it, Kiskaddon says.
“For example, you might say that if they miss two meetings in a row they will be approached for discussion and replaced if needed,” she adds.
About 66% of IRBs seeking accreditation in 2014 had problems with this standard.
• Element I.6.B – Managing individual conflict of interest. This requirement was a problem for 62.7% of accreditation applicants. It also was a problem at the site visit for 30.4% of organizations.
Typically, the problem was they didn’t track the regulations closely enough or didn’t have a policy for requiring conflict of interest information, Kiskaddon says.
“We require you to define the process, have a disclosure form and do education around it, and if there is a disclosure, you manage it in some way, and it always goes to the IRB for final approval of the management plan,” she explains.
Problems that occur include IRBs having a policy that needs tweaking or having a separate COI committee that develops a management plan, but does not close the loop by sending it to the IRB for final approval, Kiskaddon says.
During site visit reports, IRBs sometimes were not presented with management plans, or members had insufficient knowledge of the COI policies and procedures.
• Element II.4.A – Additional protections for vulnerable participants. IRBs should follow written P&Ps for determining risks to vulnerable subjects. Problems with this standard were common — 62.7% of application materials. They had problems with subpart requirements and requirements of other sponsoring agencies and with describing additional safeguards and protocol-specific findings.
“For example, organizations need to justify their determination with a subpart D determination, and this has to be documented in the minutes of the meeting,” Kiskaddon says. “Sometimes, we find inconsistent application of those procedures; they may be doing it and not documenting it.”
• Element I.5.D – Allegations and findings of non-compliance. Organizations need clear P&Ps for addressing allegations of noncompliance, Kiskaddon says.
“Sixty-one percent of organizations have to make some changes,” she adds. “They might need to revise their policies and procedures or make sure they record what actions the IRB takes.”
For instance, the IRB might have a discussion about an issue of noncompliance without documentation of whether it’s determined to be serious or continuing, she explains.
“They also need a process to review it and a timeframe for reporting it and what actions they take, if needed,” Kiskaddon says. “What we require is that you define all the terms, identify who’s responsible for making those determinations, when and to whom to report it, how you manage it, and how you document the determination.”
• Element I.1.D – SOPs made available to the research community. An IRB’s policies and procedures should be made available to researchers, sponsors, and staff, Kiskaddon says.
“Develop a method for disseminating SOPs and know what your policies and procedures are,” she adds. “If things change, describe the method of disseminating the change; for example, describe whether it’s on the website.”
AAHRPP has found that 59.3% of organizations had to make some change in how they disseminate their revised SOPs.
AAHRPP tries to keep its extra-regulatory requirements to a minimum, but these are the ones that are well-represented in the list of top problems found during the accreditation process, Kiskaddon notes.
“These include things like quality improvement plans, evaluating IRB members, and contract provisions,” she explains. “These are things you don’t have to do by law, but you’re doing them for AAHRPP accreditation, and they’re new policies that we tweak a little.”