Best Practice Report
Create how-to booklet to be used when IRB administrator is gone
Little black binder is 30-40 pages
Small IRB offices often do not have cross-trained or back-up staff in the event the IRB administrator is unexpectedly absent. So what happens when the people filling in cannot find the right forms or records or schedules?
IRB Administrator Paulette M. Vandzura, MA, CIP, of Memorial Medical Center in Johnstown, PA, first gave this dilemma serious thought as she was preparing for an international vacation.
"The vacation triggered for me to think about what would happen if I never came back to this desk," Vandzura says. "It's just me and the IRB chair, who is very busy and is also a PharmD and director of the PharmD residency program."
It occurred to Vandzura that there was no one else who could easily step into her shoes at the office without receiving guidance that would help them get through the first four to six weeks of work.
"When we talk about a larger IRB there usually are several staff members," she says. "Even if they aren't purposely cross-trained to each other's work, they at least have some familiarity or exposure to it."
But at small IRB offices, the replacement would be someone who has never ventured into the office, she notes.
Once Vandzura realized there might be a problem, she took action. First, she opened a new file called "day-to-day procedures," and each time she did a new task or procedure, she typed in a brief description of that activity, including why she did it, how it links to the next step, and where the activity was located on the computer, Vandzura says.
She filled this new file with information over a week's time, eventually organizing it by daily, weekly, and quarterly activities.
Some of the items she included were:
- How to organize and prepare for an IRB meeting;
- What transpires at the meeting; and
- What has to be accomplished following the meeting;
"Then I took an even broader look at things," Vandzura says.
So she came with initial instructions, which include advice to familiarize her replacement with files and folders on the computer.
The collected information was organized into a how-to booklet (a black binder) that provides an overview and day-to-day instructions on the IRB administrator's duties.
For example, the replacement person is instructed to ask the information technology department to access Vandzura's portion of the server.
"Within the black binder, I have certain key documents and hard copies of items like in-and-out logs," Vandzura says. "I have a hard copy of my currently active studies log, so that if someone called up and said, 'I want to talk about study 0640,' they could go to that log, look up the study by number and see who the principal investigator is, as well as other basic information."
There is another listing for annual reviews, and the rest of the binder contains key regulatory documents, including a memorandum by the Office of Human Subjects Protection (OHRP) about what constitutes human subjects research. Other included items are, as follows:
- Exempt review categories;
- Expedited review categories; and
- HIPAA information and how it impacts research.
"Those are just the documents I look at on almost a daily basis," Vandzura says. "Almost everything else is on the computer in a word processing file or spread sheet format."
The how-to booklet contains 30-40 pages, including three type-written pages of instructions and the supporting documents, she says.
Instructions cover how to assign IRB tracking numbers, meeting preparation, information about meetings and follow-up, as well as how to present quarterly reports.
"There's a section on how to track, follow, and achieve all the continuing review deadlines, and then there's a short description of end-of-the-month items," Vandzura says.
Each week, Vandzura updates the hard copy of the log of active studies, which also is filed on the computer as a spread sheet.
"The regulatory documents can all be found on the Internet, but I find it so much easier to have a hard copy at my fingertips," Vandzura says.
Small IRB offices often do not have cross-trained or back-up staff in the event the IRB administrator is unexpectedly absent. So what happens when the people filling in cannot find the right forms or records or schedules?You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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