Yale reviewer worksheet helps with risk assessment
A "cheat sheet" for reviewers
IRBs might help board members improve their protocol review process through the use of a tool that guides them through questions to ask about each study.
One such tool, created at Yale University in New Haven, CT, is four pages and comprehensively covers a protocol.
"This is almost a cheat sheet," says Jean Larson, MBA, human research protection program education and community outreach manager.
"It’s the document that helps reviewers ensure they have considered all the things we need to consider and that they’ve outlined and identified any specific items that need significant discussion," Larson says.
The worksheet explains that the presentation of a new protocol begins with a description of the research study. "In reviewing the protocol, the following criteria should include information necessary for the committee to make an informed decision regarding approval of the protocol, a critique that describes any pertinent deficiencies and criticisms of the protocol and consent documentation and a recommendation regarding approval," the worksheet states.
There are 15 points on the worksheet, and after each point, the reviewer has space for comments.
Here are a few examples of the points in the Yale University human investigation committee’s protocol review worksheet that help assess risk:
• Additional safeguards are in place for vulnerable populations.
• Subject privacy and confidentiality are maximized. "The risk of a breach of confidentiality is always a concern," Larson says. "So what we’re looking for are measures the investigator has taken to provide the best privacy and confidentiality, like are they having an informed consent conversation in the waiting room, or are they talking in a private area with the potential participants?"
• Informed consent process is appropriate. "Informed consent documents must have all of the elements of informed consent, and it must match the protocol that the IRB is reviewing," Larson says.
• Risks to subjects are minimized.
• Subject selection is equitable. "One of the things we look for in the exclusion and inclusion criteria is whether there is a reason people with a particular lab result or condition are being excluded," Larson explains. "We look at whether recruitment methods or materials are appropriate so people are not using recruitment materials that are misleading or don’t make it clear that it’s research."
• Subject safety is maximized.
• Benefits are stated appropriately. "They should describe the fact that the study may or may not benefit participants, and they should include information about how the study is designed to help people in the future with this disease or condition and to improve knowledge about the disease or condition," Larson says.
• Alternatives to participation are stated.
• Economic considerations are equitable. Larson suggests researchers consider these questions: "How does the compensation of the group with the condition compare with compensation of the group that is the control? If there are differences, are those differences reasonable? If the study is able to offer a significant payment to the subject, is that payment appropriate in relation to the activity?"
• In case of injury, plans are clear.
The Yale University IRB reviewers are expected to use their personal and professional expertise to assess whether certain study risks are reasonable for a particular population, Larson says.
Also, reviewers look for studies to describe accurately the potential benefits from participation, she says.
"Our pre-review process looks at that, and the committee looks at that, as well," Larson adds.
