Teleconferencing, web broaden member roster
Meetings go on-line
The four-year-old Goodwyn IRB of Cincinnati has a unique challenge when it’s time for the board to meet and discuss protocols because the members are scientific and ethical experts who are spread out across North America.
However, this obstacle was quickly resolved through teleconferencing and Internet technologies.
Goodwyn IRB members receive all of their protocol packets and information through secure electronic channels, and they discuss these meeting dockets during telephone conference calls, says Ellen Holt, CIP, managing member and administrative vice chair.
"We didn’t want to limit ourselves geographically," she explains. "We wanted to look for people who fit the requirements we had for the IRB rather than just look in a geographic area to see who was available, so we decided to do meetings through teleconferencing."
Once the decision was made to recruit board members from across the country, it was an easy decision to turn the IRB’s work into a paperless process.
"It’s hard enough to control what people leave on their desks when people are close by, but when people are far away, the best way to protect confidentiality is to avoid paper," Holt says.
The teleconferencing meetings have worked very well, partly because the IRB holds one weekend educational retreat each year, and all board members are required to attend, she says.
"That’s an important part of what makes the whole thing work," Holt explains. "Being together face-to-face over a weekend is long enough for people to become reacquainted with review issues and to achieve and maintain camaraderie and trust."
IRB members often are on the telephone with each other throughout the rest of the year, but the annual retreat gives them an opportunity to build a team dynamic and learn each other’s facial expressions and senses of humor, she says.
"It seems to be almost the same in our telephone conversations as it does in our face-to-face, but it wouldn’t seem that way unless we had a chance to meet face to face," Holt notes.
Also, the programs presented at the annual retreats have been published by peer review journals, she says.
How and who?
Holt, who had worked for 21 years in clinical research, administration, and regulatory affairs for pharmaceutical manufacturers and contract research organizations, founded the Goodwyn IRB in 1999 when she saw that there was an increasing need for private IRBs.
"The other impetus was the idea of participating in this arena and making a contribution to protecting human subjects," Holt says.
Here’s how the IRB was formed and is run:
• Recruiting members: After creating an organizational plan that includes information on researchers’ needs for IRB review, Holt made a two-page outline of the IRB’s objectives, including one that called for a board with some experts in the area of pediatric research, she says.
Board members and alternates include people with backgrounds in regulatory science, bioethics, medical anthropology, statistics, genetics, clinical physicians, pediatrics, bioinformatics, and community representatives who also are parents, Holt says.
"We wanted a board comprising people experienced with dealing with complicated issues and who had experience in an in-depth way with the ethical issues posed by all kinds of research and also posed by transferring information electronically," she explains.
IRB members are paid an hourly fee that is somewhere between what they could earn as an hourly rate working in their field of expertise and a token payment, Holt says.
• Using IRB consultants: Some of the IRB’s participants are members of a local IRB and have expertise in a field that sometimes is needed by the Goodwyn IRB. So they are asked to consult on certain subjects and participate in those meetings, Holt says.
By having consultants participate the board often is reassured about various concerns, and it opens up the discussion, she notes.
Sometimes IRB members find that their concerns about a particular protocol are alleviated when they hear from a consultant expert who has more knowledge of that particular patient population, Holt says.
• Assigning tasks to board members: "For each review, board members have specific tasks assigned to them," Holt says.
There are primary, secondary, and sometimes tertiary reviewers, she adds.
"For a core protocol, the primary reviewer is responsible for a total and thorough look at the entire protocol, and the reviewer reiterates that description to all board members at the meeting, highlighting some points of discussion," Holt says.
Primary reviewers discuss whether a study poses greater than minimal risk, privacy issues, interventions proposed, and benefits to subjects.
After the primary reviewer has completed a 10- to 15-minute talk, then the secondary reviewer speaks at the teleconference meeting. The secondary reviewer will bring up any description of the study or points that the first reviewer did not.
Finally, the third reviewer takes a turn discussing the protocol, and this is followed by the statistician’s discussion of whether the study design is appropriate to achieve its objectives, Holt says.
"It doesn’t really meet the ethical test to put people at risk if you’re not going to achieve anything, so the statistician makes sure the study is appropriately powered and has a proper objective for the endpoint and analysis plan," she adds.
The core study review, including discussions about informed consent and other issues, may last two hours, Holt says.
• Teleconferencing regular meetings: The IRB meets via teleconference several times a week. "We thought we’d employ more videoconferencing, but we haven’t found that to be necessary," she says.
"We have certain important requirements, and one is that it has to be transparent to everybody who is on the teleconference at the moment," Holt says.
Also, if someone leaves the teleconference for a moment then the board may lose quorum. The technology is set up to note when that happens.
The teleconference system introduces each board member entering the meeting and it announces to everyone who has just left. There’s also a computer-generated display of all of the members present, Holt explains.
"The system doesn’t determine who can talk," she says. "We manage that through rules of teleconference etiquette in which no one interrupts another person while they are giving points of discussion, and all points are noted and put on a cumulative list."
Teleconferencing etiquette also requires each speaker to say his or her name before talking, and the IRB chairman serves as a moderator.
After all the discussion points are collected, the IRB looks at them and decides which issues were resolved and which need further discussion, Holt says.
So far, there has been no electronic or other glitches with the teleconferencing system, she says.
"We have a backup teleconference system, and we all have our passwords for accessing codes for the teleconference meetings," Holt says.
• Sending protocols electronically: All protocol packages are sent electronically, and the entire process is handled on computer, she reports.
IRB members also receive other board information electronically, such as determining conflicts of interest, education, and the meeting minutes, Holt says.
"It’s a managed electronic work flow that makes the meeting time more efficient, and produces the documentation that is required to make the official records," she explains.
One of the big advantages to working entirely electronically is that when an investigator or study coordinator calls to ask for a copy of an IRB letter or memo, it will take the IRB staff a few seconds to send them the copy, Holt says.
"One of the delightful things about our electronic documents is that you can’t lose them," she says. "So they’re always within our grasp, and we can always re-supply anyone who needs a document."