An independent review board stresses training
While many IRBs must plan and develop strategies for training researchers, independent IRBs have an even greater challenge since they often do not have the advantage of working with the same investigators year after year. Researchers they encounter might be entirely new to the research process or have never conducted studies that were reviewed by a hospital-based or university-based IRB, which means the independent IRB needs to provide both basic education about human subjects protection and specialized training about their policies and procedures.
"We have worked with doctors who have not received any official investigator training," says Matt Baker, director of operations for Coast IRB in San Clemente, CA. Baker founded a research company that provided coordinating services for physicians in northern Utah, and it was his experience that investigator training was nonexistent. "That was my experience with every independent IRB I worked with for five years," Baker says, adding that the IRBs would answer investigators’ questions, but had no formal training or educational programs available.
So when Baker became the director of operations for Coast IRB, an independent review board that is paid by sponsoring companies to review research by investigators who are researching a particular product, he decided that investigator training would be a top priority. "When a company comes to us with 30 doctors who will be doing research, part of our service is to provide quarterly training for staff and investigators at those 30 sites," Baker says.
High-tech, but simple
Here’s how the training program works:
• Step 1: Investigators visit the conference web site and sign on with a pass code they are given. At the same time, they are connected via conference call. The web conference can be held anywhere in the world, and up to 2,500 people can participate at one time. "People don’t have to travel; and it’s cheap to do this because they can participate on-line, and we can run the conference any time of the day," says Darren McDaniel, chief executive officer and founder of Coast IRB.
The cost of the web conferences is free for investigators and is conducted by Interactive Meetings, which charges study sponsors minimal fees based on the number of sites participating and the length of the conference session. McDaniel, who is affiliated with Interactive Meetings, has coordinated the web-training sessions. "We can archive these meetings, record them, and [create] a web link specifically for training sessions," he says. "So if there’s a long study, and there’s turnover, we can give training to the new subinvestigator and coordinators through the web link."
• Step 2: Participants view slides with material relevant to their particular study and also general information about research involving human subjects, policies, regulations, etc. Slides are used instead of video/audio over the web because of the bandwidth problems that may frustrate participants who have slow computer links. "We try to keep things simple," McDaniel says. "The audio is over the telephone on the conference call because you have to have speakers on your computer to hear voices on-line."
The slides, which are similar to PowerPoint slide presentations, list a few sentences or bulleted items on each, staying on the screen a few moments before moving to the next item. Included among the slides are brief questionnaires that ask investigators to select an answer, usually multiple choice, which will be instantly tabulated so that the conference coordinator can give both the participants and other interested parties feedback about how well investigators understand various educational materials.
"We have the ability to ask polling questions and quiz investigators about their understanding of different items," McDaniel says. "They click on a circle with the answer; and after they answer, I can go ahead and publish the results on-line," McDaniel says. "These data go into a report for the folks at Coast IRB to show who answered them correctly and who didn’t."
• Step 3: Much of the information investigators need to know can be found on government and other web sites. So rather than duplicate the information on the slides, the conference coordinator will electronically move participants to a web link, such as the U.S. Food and Drug Administration (www.fda.gov), the Office for Human Research Protections (http://ohrp.osophs.dhhs.gov), or another site that has information about the Health Insurance Portability and Accountability Act and how that will affect research.
This web tour also can take participants to Coast IRB’s site to show investigators how the IRB expects them to submit information and forms. Participants also can visit the sponsor’s web site to review clinical practice guidelines. If investigators wanted to see an example of a particular form, such as an initial review submission form, they could be directed to a web site that publishes sample forms. "We could go to any web site in the world and bring anyone on the web tour," McDaniel says.
• Step 4: Once the web tour is complete, the coordinator will bring participants back to the conference web site for more slides and polls. The conference often will include information about how the IRB reviews protocols, how to submit a safety report, how to submit advertisements, what the process is, what the final study notes should be, how to prepare financial disclosure, and how to close out a study, McDaniel says. Also, investigators are asked to learn about the study communities’ attitudes toward research as well as state and local laws regarding human subjects research on their own. "We’ll take a rookie doctor and make him an investigator," Baker says. "Our motto is that when investigators are being reviewed by us, we hope we’ve made them better investigators by making them better informed."
Although the web conference training is not mandatory, it has been widely used. Baker estimates that up to 80% of investigators will take the course. Even investigators who do not participate often will have a coordinator from their site take the training, he adds. "This gives us more contact with doctors, so if they have any questions or concerns, they can have better communication with us," Baker says. "We hope this kind of communication and openness will help to protect the patients better."