Educating and onboarding IRB members should include more than perfunctory online human subjects research training. The goal could be to provide new members with comprehensive information in a well-organized training program.1
At least one IRB has accomplished this goal through a combination of interest sessions, electronic education, in-person training, individual electronic submission system training, and mentoring.1
The IRB also has a new member handbook that summarizes information the IRB members will need, says Meghan Wright, MEd, MBA, IRB training manager at Virginia Commonwealth University (VCU) office of research in Richmond.
The following are some additional strategies for improving new IRB member training:
• Use interactive educational activities. The VCU IRB has a drag-and-drop interactive activity in which a board member can select one of the yellow highlighted bubbles, all related to potential reviewer notes, into a blue box with the appropriate criteria for IRB approval.
“It’s a way for us to see whether they understand what they’re learning,” Wright says.
For example, one yellow reviewer note reads, “Please revise your informed consent documents to include more lay language.” The corresponding criteria for approval box could be this: “Informed consent will be sought by each prospective subject or their LAR.”
Another drag-and-drop sample is the yellow reviewer note that says, “Please explain how your subject recruitment will be representative of the population.” This can be dropped in the criteria for approval box that reads, “Selection of subjects is equitable.”
A third example is the yellow reviewer note: “Please describe who will have access to the encrypted data.” The corresponding criteria for approval box would be this: “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.”
• Follow up online training with an in-person meeting. New IRB members could spend about eight to 10 hours, over a month if necessary, on their online instruction.
When they’re done, they will meet with Wright to discuss how to perform a review and learn more about the IRB’s electronic smart form.
“I meet with each person individually to go over the electronic submission system,” Wright says.
After asking and answering questions, the new board member will meet with the IRB’s quality assurance and quality improvement (QAPI) manager to go through an IRB review. The review was already conducted, and they can learn from recreating it.
“They’re not actually reviewing it to make a decision on it, but the QAPI manager will walk through it with them,” Wright says.
In-person training could take about three hours.
• Assign new IRB members to a mentor. “New IRB members complete their required paperwork, and then we assign them to a mentor,” Wright says.
They can meet or communicate with their mentors on an as-needed basis. Together, the new member and mentor will review a first study and then complete a post-training evaluation.2
New member training is continuous, and having a mentor available helps with the transition to become a more seasoned IRB member.
• Make available IRB monthly educational sessions. The VCU IRB also provides training for researchers, including CITI training and regular, free sessions on human research protection topics and regulatory news, Wright says.
IRB staff and experts lead the midday sessions, which are attended by five to 50 people. IRB members also can attend the sessions, which have covered the following topics:
- Introduction to the IRB;
- Revised Common Rule: Single IRB;
- Revised Common Rule: Overview;
- Data Security and Records Management in Research.
• Solicit feedback on new IRB member training. New IRB members complete a survey about the training experience, the format, organization, their level of preparedness, and other topics.1 They rank their experiences on a scale of one to five, with five being optimal. So far, the average response is 4.8 out of 5.1
REFERENCES
1. Davison C, Wright M. New IRB member training and onboarding program. Poster presented at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference, Nov. 5-8, 2017, San Antonio. Abstract: 12.
2. Wright M, Davison C. Training and onboarding new IRB members. Poster presented at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference, Nov. 5-8, 2017, San Antonio.
Educating and onboarding IRB members should include more than perfunctory online human subjects research training. The goal could be to provide new members with comprehensive information in a well-organized training program.
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