IRBs can implement and adapt own auditing programs, depending on need
Time, staff, money are chief limiting factors
As public and federal scrutiny increasingly focuses on human subjects research, IRBs are becoming more interested in forming ongoing auditing/monitoring programs of protocols and principal investigators. "It’s obvious from federal regulations and guidance documents that there’s a responsibility for IRBs to make sure researchers are meeting their obligations when conducting studies," says Dennis Freeman, MPH, director of the division of research compliance at the University of South Florida in Tampa.
Another good reason for initiating a formal auditing or monitoring program is that there will soon be accreditation standards requiring more detailed documentation of policy compliance and procedures, and an auditing program can help an IRB prepare for state and federal audits.
Also, it’s just good practice. "It’s a philosophy that the university wants to follow and implement," Freeman says. "We recently completed a recruitment search for an individual who can implement and develop our program."
The IRB at Sentara Hampton General Hospital in Hampton, VA, also has implemented a monitoring program that will be handled on a contractual basis by a certified IRB administrator of a neighboring IRB, says David Plummer, MDiv, LMST, manager of the department of pastoral care. "We wanted to make sure we’re reviewing adequately the activities of our patients and of those who are undergoing research trials with research associates from the hospital," he says. "We’re aware that the field of research in human protection is a rapidly growing area within the medical industry."
Since the IRB represents a small, community-based hospital, funding a full-time auditor isn’t a feasible option, Plummer says. Plummer met with the director of clinical research to discuss how the third-party audit might be conducted, including parameters and time frames. "For us, our audit needs to focus on Food and Drug Administration [FDA]-type compliance issues," he reports.
The consultant will monitor research protocols, conduct on-site record reviews, review enabling documents, memorandums, policies, and procedures, standard operating procedures, and the IRB’s conduct. Other tasks will include:
- periodically attending IRB meetings to observe and evaluate compliance with federal rules and regulations;
- assisting the IRB in developing written critiques that identify program strengths and weaknesses;
- helping to formulate an action plan;
- monitoring the program on an ongoing basis, at least quarterly for the first year.
Since the auditor will be paid on a contractual basis, the financial investment is minimal to start and can be evaluated and changed as needed, Plummer says.
Another advantage to hiring an auditing consultant is that it ensures objectivity. Sentara’s certified IRB administrator will have no conflicts of interest because her full-time work is with an IRB that has no overlap in research with the hospital’s IRB, he explains. "She’s doing her job, and we’re grateful for it; we hope to improve upon our processes."
While small and medium-sized IRBs might find it most practical to hire auditing consultants for the monitoring program, larger IRBs could develop a highly specific and involved auditing program that utilizes on-line education and information.
A model-auditing program of this nature can be found at the University of Pittsburgh, which has developed dozens of auditing forms and guidelines. "What we try to do with our auditing program, as much as possible, is make it educational," says Dennis Swanson, RPH, MS, CIP, director of research conduct and compliance. "We started auditing five years ago, and we got into it thinking we’d go out and find that everyone was doing things according to clinical research practices, and there’d be no problems," Swanson says. "What you actually find when you go out there is there’s a background-noise level of problems, and there are certain things that principal investigators [PIs] are not aware of."
By this, Swanson means that PIs may forget to have a research subject initial each page of a consent document to indicate that he or she has read it. Or the audit might find filing problems in which investigators cannot readily reproduce records or have problems with source documentation.
These are minor problems that need to be resolved, but are not in themselves cause for a report to the Office of Human Research Protections (OHRP). That’s another issue that IRBs need to consider as they establish a monitoring/auditing program, Swanson suggests. "I think it’s important to realize that when you go out and do auditing and look for problems, you’re going to find them," Swanson says. "Then the big question is whether you are obligated to report them to federal agencies where the problems are subject to the Freedom of Information Act."
The argument that must be made to the OHRP and other federal agencies is that having an IRB conduct its own audit is a positive step that must be encouraged. If IRBs voluntarily audit their programs and protocols, but then are required to report every single discrepancy to federal officials, then it will shed the institution in a bad light, Swanson explains.
"So there’s a hesitancy for institutions to do audits because if they look for problems and find them, then they’ll have to report them," Swanson says. "That’s why it’s very important when you put the auditing program in place that you have clearly defined the policies and procedures of what types of problems will be reported and what you will not report."
For example, all major violations, including those that result in the IRB removing a PI from a study because of noncompliance, should be reported to the OHRP, Swanson says. "But if you identify background noise-level problems, then you should be able to take care of those internally."
On a positive note, an internal auditing program is the one truly effective way for an IRB to efficiently investigate research problems, Swanson adds.
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