IRBs prefer standardized documents on sites

Tool also collects valuable data

Research institutions could improve recruitment data collection and efficiency, as well as make their IRBs happy, if they develop a standardized recruitment tool for use with new studies, an expert says.

"The IRBs I work with love this," says Kimberley Hunt, MA, a research consultant in Montreal, Canada.

The recruitment document can serve as a recruitment and training tool by providing a framework for consistent discussions with potential study participants. It also can be useful for data collection.

"The tool is more for preparing interviewers, who could then use it during the recruitment process," Hunt says. "It collects information that anticipates the questions the IRB might ask and lays out information in a very logical way."

Hunt has created these tools for research studies and finds that it's important to seek feedback before piloting the tool prior to the formal study. Some institutions and studies might need the tool to be approved by the IRB or ethics board, as well, she says.

Here are the steps/sections included in the recruitment tool for new studies:

• First step: Explain the study's goal in simple language for research participants, Hunt suggests.

"It's easy to get too complicated when talking with people, so keep in mind the ethics parameter of consent documents," she says. "Keep it very simple and straight-forward in one or two sentences."

• Step two: "I look at the exclusion criteria first and then at the inclusion criteria," she says.

Hunt will write these in bullet-point form, including any parameters in the exclusion/inclusion criteria. The idea is to quickly assess whether or not the potential participant is eligible for enrolling in the study while asking questions in a way that does not cause them distress.

• Step three: This is the part of the recruitment tool in which the recruiter will let potential subjects know whether they are eligible to be in the study.

"You want to leave people who don't wind up eligible for the study feeling respected and valued and open to future research," Hunt says. "It can take very little to leave people feeling rejected, so the language you use is very important here."

For instance, the rejection should be framed in a positive way that does not highlight or suggest any inadequacies on the part of the potential participant.

An example might be to say this: "So you are 39 and will be 40 in August? Well, we'd love to have you in our study, but to be eligible you must be 40 in July, so you're not old enough," Hunt suggests.

Or for a person who has diabetes, the response could be: "Okay, I appreciate that you have a lot of information and experience and knowledge that would be very valuable in our study. However, for this particular study we are seeking participants who have had diabetes for three years, which is longer than you have had it," Hunt adds.

It's key to leave the person with a sense of value, a belief that he or she has something important to offer, she says.

This is easier to convey when a recruiter approaches potential participants randomly, Hunt notes.

"But when you approach people and are using their relationship with the doctor or clinic or institution, it's even more delicate in how you say they are not eligible," she explains. "Especially if you are dealing with a vulnerable population where there are not a lot of potential participants in your population, then you want to guard that goodwill as much as you can."

If a recruiter determines that the potential participant is eligible to be in the study, then this is the step where the recruiter will discuss the issues of privacy, confidentiality, and ethical considerations should the person decide to participate in the study, Hunt says.

• Step four: The last part of the recruitment tool and step in the process is to outline some situations that might occur in the study and describe how the participant can contact someone for more information or for assistance with any questions they might have.

Recruiters can use the tool to collect demographics and other information from potential participants. This information might prove valuable down the road as the study begins and recruitment patterns emerge, Hunt notes.

"You could collect a solid base of information that gives you data that you need to do your data analysis and which you can use to say something valuable from a scientific perspective about people who participated and who didn't participate in the study," Hunt says. "The information might have to do with why these people are willing to participate."

For instance, some people who agree to participate might change their minds at some point in the recruitment process, and the demographic data collected could prove useful for later use and comparison with participants who completed the study, she adds.

"You'll have collected meaningful data because once they give permission to participate it will keep them in the database up to a certain point," Hunt says. "You can go back and get some meaningful data out of it that might help you modify your recruitment strategy."