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Institution establishes best practices for IRB, research
Policies are continually revised and improved
For many IRB offices, it's difficult to find time to handle the daily ethics review work, and so revising policies and implementing new policies can be a difficult challenge.
However, one Maryland institution has made best practices and policy revisions and improvements a major focus and priority, and the improvements have resulted in positive feedback from investigators and rapid responses to industry changes.
"In 2004, there was an institutional awareness that we needed to put resources into creating a more viable human research protection program," says Debarati Dasgupta, MS, CIP, an IRB administrator with Adventist HealthCare Inc. of Rockville, MD. The IRB office handles work from two IRBs, both located at acute care hospitals in Maryland.
"Institutional administrators looked at the current system and said, 'There must be a way to bring our processes and procedures together to make sure we're running on one set of wheels,'" Dasgupta says.
Administrators formed a committee consisting of current IRB chairs, legal counsel, a regulatory counselor, IRB staff members, and administrators from various entities that conduct research. The committee helped to create policies and procedures for an IRB handbook and templates, including these: an informed consent form template, an IRB application form, a consent form template for the use of humanitarian use devices, and protocol and informed consent checklists, Dasgupta says.
"Now we've rolled out the first three versions of some of our policies and procedures, and we revise these on an ongoing basis, as the regulatory environment changes," Dasgupta says.
Other changes include the implementation of an IRB customer service and policies feedback survey, the continued operation of an IRB oversight committee that meets quarterly, and revised forms, such as those for reporting adverse events and unanticipated problems.
The result has been a very responsive human subjects protection program that receives feedback from investigators and others and immediately implements their suggestions, Dasgupta says.
"What we've tried to do is reach out to the research community and make sure we hear their gripes, as well as their praise of what we do well," Dasgupta says. "It's a win-win situation."
Here are details about how the IRB office and institution have made these best practice improvements:
1. Improve quality through survey feedback.
"We stress customer service," Dasgupta says. "There are units at Adventist Healthcare that use a customer service survey that is built on a Web-based platform, and we were able to build a Web link that holds a customer service survey."
Called the "IRB Customer Service and Policies Feedback Survey," it has two parts, including a rating of customer service and comments on the IRB protocol review process, she says.
"They receive a short, one-page memo with a link to the survey, and it's addressed to the principal investigator and research coordinator," Dasgupta says. "They are requested to distribute it to all research team members so we can capture their input."
The survey asks investigators and their clinical trial staff to answer various questions related to the IRB office's service during the protocol review process. The survey is distributed whenever a new investigator receives an initial IRB decision on his or her protocol application with the IRB, and so it is an ongoing survey in which feedback is tabulated on a regular basis, she explains.
The survey allows users to rate statements from strongly agree to strongly disagree and provide input on the strengths and areas of improvement for customer service, the protocol review process, and policies and procedures. Here are some sample items from the survey:
The survey was first sent out in February 2007, and the feedback, so far, has been very helpful, Dasgupta says.
Many of the comments have helped provide continual quality checks of the IRB office staff, including the positive feedback that one executive assistant in the IRB office had been very helpful in getting a researcher's application processed in a timely manner and a comment that the IRB staff has sound knowledge of the regulations, Dasgupta recalls.
"One user said the application and protocol template was very well laid out, and the assistance was skilled and efficient," she adds.
In other cases, the feedback has drawn attention to deficits in the program, and these will be addressed, Dasgupta says.
For instance, one respondent asked for additional education on using the IRB forms. After receiving this feedback, the office will be offering customized educational sessions for clinical trial staff.
Another survey respondent requested the conditional approval letter to be sent out in a more timely fashion, and the office is working on providing a quicker turn-around time, Dasgupta notes.
Comments have ranged from the formatting of IRB forms to questions on the use of forms and templates, she says.
2. Form an IRB oversight committee.
The IRB oversight committee consists of the same professionals who were on the original committee that wrote the IRB handbook and developed templates, Dasgupta says.
"We meet four times a year to discuss system-wide issues of human research protection across the Adventist Healthcare System," she says. "At these meetings we review revised policies, and it's my responsibility, along with the IRB staff, to take a look at our current policies and make sure we're in compliance."
Here's an example of topics discussed in the past:
• The director of the institution's Center on Health Disparities spoke about the resources available and in development to help with the issue of the recruitment and enrollment of non-English speaking research participants, Dasgupta says.
"We've been working with the center to operationalize a policy in terms of making sure we are reaching out to community members and including them in our research program," she says.
• The revisions to policies and procedures are reviewed.
"We recently voted to approve a revised policy regarding the IRB appeals process," Dasgupta says. "The committee reviewed two revised policies and five revised forms from the IRB handbook and developed a new unanticipated problems reporting form."
• The committee has discussed the need to revisit the areas of conflict of interest and financial disclosure and the plan to address the most favorable IRB structure for the system, Dasgupta notes.
These meetings typically are very productive, requiring considerable work prior to the meeting and afterwards as a follow-up, she adds.
• Also, the IRB oversight committee is the appropriate forum to address system-wide issues and issues that the IRB committee may not have the time to handle, Dasgupta says.
For example, the IRB oversight committee has, in the past, discussed a study in which a research team was interested in participating. The committee reviewed study factors such as study design, the risks and anticipated benefits to subjects to determine if the institution's involvement is acceptable, she says.
3. Create new templates and revise existing ones.
Once forms are distributed, feedback is received from research staff, and that feedback is taken into consideration when revisions are made, she adds.
"At this stage, we anticipate revising forms and policies on a quarterly basis, Dasgupta notes.
"Revisions are based on the feedback from users and new guidance and regulations out in the field to make sure we're in constant compliance."
Revisions also are discussed by the IRB oversight committee, she notes.
The adverse event reporting policy and form, and the unanticipated problems form, were among the more challenging ones addressed, Dasgupta says.
"Our biggest challenge has been on handling non-local serious adverse events (SAEs) and determining where our local IRB responsibility rests," she says.
"Our IRB needs to be notified of risk study-wide, but how do we handle the huge load of external SAEs that are coming through our door?" Dasgupta says. "How do we process efficiently and capture the data presented to us and put it into perspective?"