Managers of IRBs can save time with tech
More input and education
One of the chief benefits of installing an electronic IRB system is that it will automatize many of the standard administrative duties for IRBs and give managers and staff more time for work that will enhance human subjects protection. It also makes it easier for a research site to grow and IRB reviews to increase.
As an IRB office at the New York Blood Center (NYBC) in New York City completes implementation of its new electronic system, the IRB manager has made plans for how human subjects protection education and work can be improved as daily task priorities shift and change.
"Our research here is slated to grow, and our goal is to increase the amount of research done in this institution," says Nancy Moynihan, RN, BSN, MS, manager of human subjects research protection IRB at the NYBC.
"An inordinate amount of time is spent in managing paper," Moynihan says. "With a computerized assistant accepting and sending out notices automatically, I could focus more on the teaching aspects of the IRB."
Here are some other ways an IRB could improve quality of services and expand its role with time freed by an electronic IRB system:
Make site visits: Moynihan has accompanied the organization's senior director of research administration on site visits, and she envisions a future where this could be a part of IRB staff work.
"Site visits could be an asset to an investigator," Moynihan notes. "I prefer a friendly approach, rather than an adversarial approach, and we could provide site visits as a way to show we're here to work with them."
IRB staff could use the visits as mini-educational opportunities, a way to answer quick questions and serve as an ambassador liaison between the IRB and clinical trial sites.
Improve human subjects protection education: IRB members, investigators, and others involved in human subjects research at New York Blood Center already take CITI courses and sometimes training from the National Institutes of Health (NIH), Moynihan says.
They also use a free CD course called Investigator 101, which is distributed by the Office for Human Research Protection (OHRP). Information is available at http://www.hhs.gov/ohrp/references/cdrom.pdf. "It's a wonderful asset," Moynihan says. "My goal is to give it to every investigator."
The CD course has modules that are intensive but can be taken at one's own pace. It also contains a continuing medical information test and a participant evaluation form. "We started using this by giving it to our IRB members, asking for their feedback," Moynihan says.
IRB directors and staff could provide research staff with more detailed education about obtaining informed consent. IRBs have input on how the informed consent form looks, but they rarely learn how it's used once a trial begins.
The assumption by IRBs is that there is little or no training that's specific to the mechanics of providing informed consent. Mentoring researchers on informed consent should focus on the interpersonal aspect of the informed consent process. There should be an assessment of the potential participant's knowledge and an opportunity for questions related to the research study to be fully answered, Moynihan says.
Monitor informed consent sessions: "Once the research staff have been trained in the consent process, monitoring informed consent sessions is reasonable," she says.
IRB staff might use any extra time available to occasionally monitor researchers when they provide informed consent to potential study participants, she adds.
The assumption by IRBs is that there is little or no training that's specific to the mechanics of providing informed consent. IRBs could find out how this process is conducted in the real world setting by monitoring the researchers or coordinators who are meeting with potential participants to go over the informed consent form.
"I'd like to focus on that," Moynihan says.
Educate researchers and IRB members on adverse event reporting: Education sessions on adverse event reporting might answer these common questions:
How do you determine if something is related to the study?
How do you report the event?
What attributions would you need to make?
What are some of the gray areas of reportable adverse events?
Train staff to improve research record documentation: "My other focus would be on research record documentation and how to write a note that coincides with the study visit, capturing the essentials," Moynihan says.
"At this time, the NYBC does not conduct any inpatient clinical trials, and the notes for a chart are not part of what is expected for the types of protocols presently under way," she adds.
But for inpatient, hospital-based research, the notes are important. "The value of the note cannot be minimized," she says. "If a form is simply signed and put in a chart, and something happens in the course of a study, then that notes goes a long way to protecting the investigator."
For instance, an investigator might write a note about informed consent, capturing the essence of the informed consent experience with the potential participant, she says.
"It doesn't have to be a page and a half," she explains. "The investigator just takes the time to write a note that describes what happened in that session."
Study monitors or federal auditors might require seeing these notes, and these could answer questions that arise during a study visit.
Survey investigators about their needs: When IRB directors plan to expand their office's reach and services, a first step might be to survey researchers to find out what they need from the IRB office, Moynihan suggests.
"Take a survey of their perception of what's needed," she says.
The IRB office then can use that information to prioritize quality improvement projects and educational focus.
These needs and questions also could be addressed in email or newsletter communications so that all research sites could benefit from questions raised by one investigator.
"I send out monthly educational items that come to my attention, including updates from the Food and Drug Administration," Moynihan says. "And I make it clear that if you have a topic you are interested in, I'll address it."
One of the chief benefits of installing an electronic IRB system is that it will automatize many of the standard administrative duties for IRBs and give managers and staff more time for work that will enhance human subjects protection.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content