It’s not enough to follow rules. Get a new attitude
OHRP moving from compliance to quality
In 1998, the Health and Human Services’ (HHS) Office of Inspector General (OIG) released a report that warned of weaknesses in the IRB system. Titled Institutional Review Boards: A Time for Reform, the report listed a number of weaknesses auditors pinpointed in the system. Among them were:
- IRBs review too much, too quickly, with too little expertise;
- IRBs conduct minimal continuing review of approved research;
- IRBs face conflicts that threaten their independence;
- IRBs provide little training for investigators and board members; and
- IRBs do not devote much attention to evaluating their effectiveness.
A follow-up released in April 2000, reports that few of the original recommendations had been enacted. For example, few IRBs engage in ongoing monitoring of research projects, no educational requirements have been mandated for investigators or IRB members, and conflicts of interest still are problematic.
"If we aren’t more proactive in strengthening the system, the public trust may be threatened," says George Gasparis, director of the division of assurances and quality improvement in the Office for Human Research Protections (OHRP). "In consideration of OIG and GAO [General Accounting Office] reports suggesting that the IRB infrastructure is weak or crumbling," he continues, "we felt there was a need to help try to improve understanding of the regulations."
In an open letter to the human research community, Greg Koski, PhD, MD, OHRP director, challenged researchers and oversight committees alike to move from mere compliance with federal guidelines regarding protecting human research participants to a program of quality improvement and assurance. "A key element of the remodeling process in human research protections is the move from a system focused on regulatory compliance to a system focused on the prevention of harm," wrote Koski.
"Our primary goal is to improve quality, performance and efficiency," says Gasparis. "An IRB that deals with a larger volume of research — academic, community, or large teaching hospitals — tends to have systems in place to deal with the volume that they review. They have submission forms, a database to keep track of information, and processes and forms. They have been thinking through how to best operate. What we want to do is share the best ideas, serve as a networking outfit, and broker relationships with IRBs in need of improvement with those who are stronger."
QI program helps improve oversight methods
To that end, OHRP last December launched a quality initiative. The primary purpose of the quality improvement (QI) program is to help those involved in human research improve their oversight methods. The QI program will be conducted in three phases: quality assurance, quality improvement, and continuous quality improvement. Phase I comprises evaluation of the level of compliance with federal regulations. The OHRP division of assurances and quality improvement (DAQI) will take a look at forms, processes and records to determine the level of compliance.
Phase II involves sharing of best practices. This will be achieved through networking as well as posting best-practice procedures and tools on OHRP’s web site. Gasparis stresses that this sharing will be done with the permission of participating IRBs. Phase III will consist of assistance with and evaluation of institution-initiated quality improvement programs.
Step one of Phase I, which is now under way, is self-assessment. DAQI developed an assessment tool designed to gauge an institution’s compliance with federal regulations. It takes about two hours to complete, and DAQI staff, after review of the submitted tool, will be able determine the strengths and weaknesses of the human subjects protection program, says Gasparis.
Participating institutions must be willing not only to complete the self-assessment, but also be open to interaction with DAQI staff through any number of methods including on-site consultation visits. DAQI also may ask to review written operating procedures to determine how effective they are in promoting human subject protection. "Then we would make a decision as to what follow-up method would be most productive — on-site consultation, videoconference, or telephone conference with or without written correspondence."
The QA Self-Assessment Tool should be available later in the summer. In the meantime, the tool will be posted on OHRP’s web site (http://ohrp.osophs.dhhs.gov/irbasur.htm) for public comment. Until Office of Management and Budget approval of the tool is obtained, DAQI reviewers are conducting the first stage of the QI program by evaluating written operating procedures and minutes to determine the level of compliance and then conducting interviews with key staff members of a human subjects protection program.
The program’s pilot study, launched July 2001, involved six institutions. Since January’s official open-enrollment date, six more have signed on, and another 15-20 are expected to be scheduled soon, says Gasparis. Participation is voluntary, and information provided will be kept confidential "to the extent allowable by law," he says. Should weaknesses be found, DAQI will offer consultation and education to improve the institution’s existing program. "At first, we were going to require reporting to the division of compliance oversight," says Gasparis. "Now we will notify the institution about deficiencies and work with them. We will consider our discovery of noncompliance situations as satisfying the reporting requirements to OHRP."
"Should a serious problem or serious systemic noncompliance that has or may cause harm to subjects be found, DAQI would expect the institution to submit a corrective action plan promptly to address such deficiencies and will provide necessary consultation to facilitate this process," he continues. "DAQI would also report this situation to the director of OHRP, who will contact the institutional official about the matter."
Gasparis points out the information obtained during the OHRP QI program from participating institutions and independent IRBs may be considered exempt from being released to the public under the Freedom of Information Act. "We had to structure the program in a way that would make institutions and independent IRBs want to invite us in. On the other hand, if we find a serious problem or serious systemic noncompliance that has or may result in harm to subjects, we have an obligation to do something about it," he assures.
There are no plans to make the QI program mandatory. "It’s contradictory to the notion of quality improvement," he says. "You want to motivate people to want to do this as opposed to forcing people to do this."
For more information, visit the OHRP web site at: http://ohrp.osophs.dhhs.gov. Institutions interested in volunteering should write: Office for Human Research Protections, Division of Assurances and Quality Improvement, Attn: George Gasparis, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
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