Improving meeting minutes documentation
Address regulatory points in minutes
The cliché about documentation should be a maxim at IRBs, an expert advises: “If you don’t document it, you didn’t do it.”
Documentation is proof, and all IRBs should envision the day when regulators will ask for that proof, says Cheryl A. Savini, CIP, principal and chief operating officer for HRP Consulting Group Inc. of Clifton Park, NY.
“When I go into an institution and look at their IRB meeting minutes, my questions are, ‘Is the IRB doing what they’re supposed to do and having a full discussion of each protocol? Are they going through the regulatory criteria for approval? And are they making the determinations they need to make?’” Savini says. “Are they or aren’t they doing that, or are they doing it but the person recording the minutes isn’t recording what they’re supposed to?”
On the other hand, IRB staff should not record meeting minutes like they are legal transcriptionists, capturing every syllable, she notes.
“Don’t go overboard and write 60 pages of minutes,” Savini says. “There’s a balance there.”
Instead, the minutes should be used to document the important regulatory compliance information discussed and add clarity to any issues arising from discussion of a particular study. It’s helpful to use a minutes template to ensure that all the necessary information is included in the IRB meeting minutes, Savini recommends.
“When you’re looking for someone to record IRB meeting minutes, you should find someone who is familiar with research terminology as well as medical terminology, if reviewing medical research,” Savini suggests. “Also, the person should be trained in human research protection regulations and what documentation is required.”
For example, one criterion for study approval is whether subject selection is equitable.
“In order to make this determination, you need to know what the inclusion and exclusion criteria are; who the study is including or excluding and why,” she says. “Who is going to benefit and not benefit due to their participation?”
“The regulations state the IRB must make determinations for approval under 45 CFR 111,” she says. “It doesn’t specifically say that in order to make a determination of equitable selection you have to write down selection criteria, but it only makes sense that you have this information to make that determination.”
The goal here is to protect research subjects from exploitation, particularly if they are part of a vulnerable population, Savini explains.
“We don’t want researchers going into third-world countries, prisons, dealing with minors or vulnerable populations [only] because they’re easily accessible,” Savini explains. “The possibility exists that they — the subjects — may suffer the risks and not benefit from the research.”
IRBs need to document that reviews address regulatory issues regarding the protocol and informed consent, including but not limited to the following, Savini says:
• Are risks minimized? The protocol submitted to the IRB by the researcher should describe the risks and explain how they are minimized, Savini says.
The minutes should record the same information and demonstrate that there is sufficient information for the IRB to determine whether the study’s risks are adequately described, she adds.
Here is an example: The principal investigator says there is a risk of headaches, emotional distress, and heart attack in the study being reviewed. At least one member of the IRB should have the expertise to evaluate whether those risks are valid for the type of research being conducted. That reviewer might note that vomiting also is a risk for people taking drugs of a particular class, and note that the investigator had not indicated vomiting as a risk. All of this should be recorded in the minutes, she explains.
The IRB would then decide whether this risk must be added to the protocol and to the informed consent document provided to the subjects, she adds.
Risk is based on both the magnitude of a possible harm and the likelihood of that harm occurring. When an investigator lists a risk, such as emotional distress, for example, it is important to indicate whether the likelihood of this risk is high or low and how severe the emotional distress might be, Savini says.
“Are you talking about child abuse or domestic violence? Could someone not be screened properly? All of these things come into play when determining the risks/benefit ratio,” she says.
“Are there procedures in place to minimize these risks?” she adds.
“You should list how risks are minimized and how the IRB came up with that determination,” Savini says.
• Is there a resolution of controverted issues? “Are there issues that the members of the IRB disagree on or are having trouble deciding?” Savini says. “If, for example, five people on the IRB mention an issue and two don’t understand, those may be considered controverted, so how does the IRB come to a resolution?”
The IRB’s decision about a protocol should be based on ethical standards as well as 45 CFR 111. Using the 111 criteria helps the IRB to make solid ethical decisions.
• Does the protocol include documentation for special circumstances? “There are times when vulnerable populations are included, and you’ll need additional documentation for that,” Savini says. “There could be instances when you are going to waive some of the regulatory requirements, and you need justification for that.”
An example might be if the IRB is being asked to waive informed consent or documentation of informed consent.
“You may want to waive signed documentation of informed consent in a study that includes domestic violence victims,” Savini explains. “The justification for that would be that the signed document could potentially be more harm than good for the subject.”
If the signed documentation is kept confidential, it could pose harm because the subject may have a copy that might be discovered by the abusive domestic partner, for instance. Just being in the study could pose harm even without disclosing any individual information.
• Are conflicts of interest described? IRBs often deal with conflict of interest issues involving either investigators or IRB members.
“There needs to be documentation in your minutes that the IRB was polled before any protocol discussion about potential conflicts of interest,” Savini says. “The person with the conflict of interest can be present at the meeting to provide information, but when the IRB begins to discuss the study, that person should not be there.”
The minutes should state that the IRB member or investigator with a conflict of interest left the room, and the voting record should show how many voted for, against, and abstained or were recused because of a conflict of interest, she adds.