Strike fine balance when placing ads to recruit research subjects
Keep in mind what IRB will say
Research investigators need to find a balance between giving enough information about potential subjects in study advertisements to giving too little information and being inundated with unnecessary calls.
Subject recruitment marketing is the first stage in the subject consent process, so investigators should pay close attention to how this is handled.
"If you don't find that balance of giving enough information in the ad then you'll have unqualified people call, and sites will be inundated," says Matt Baker, CIP, founder and chief executive officer of Compass IRB of Mesa, AZ.
When sites give too little information on their recruitment materials, but include just the dollar amount subjects will be compensated, they run the risk of soliciting calls based solely on the subject fee offered.
"We see ads that say, 'Call Dr. So-and-So and earn up to $2,500,' and that's all they say," Baker notes.
For example, an ad might read: "Hey ... are you a healthy volunteer? Call this number and you may earn up to $2,500."
The study might require subjects to have six overnight visits, multiple blood draws and take an investigational drug, but potential subjects would not learn this from the ad, and that can be a mistake, he adds.
"You don't want people to respond to advertisements for the wrong reason or after they've seen way too little information," he says. "There should be enough information in the ad to find the study volunteers you are looking for without enticing them for the wrong reason."
Some research ethics experts have suggested that research sites should not include dollar amounts in their recruitment advertising because it could be too much of an inducement.
The regulations do not prohibit this practice, but IRBs might limit or change the study recruitment advertising, making decisions about whether or not the dollar amount should be included, Baker says.
IRBs might decide that recruitment ads should not include dollar figures unless they specify all the activities subjects will need to do to complete the study and earn the compensation.
Baker offers this suggestion for a way to write a recruitment ad without mentioning a specific dollar amount of subject compensation: "If you are selected for this study, you will receive compensation for your time and travel."
Compass IRB usually asks investigators to include information in their recruitment advertising about how long the study subject will be participating in the study and whether there are requirements of overnight observation stays or other burdensome procedures or requirements, Baker says.
Investigators sometimes argue that their recruitment ads will appear in a banner ad on Facebook or other online social media, so they don't have room to provide details about the study. An online banner advertisement might be one inch by two inches, leaving little room for text.
Investigators realize they have maybe 10 seconds of that flashing banner ad to attract potential subjects, so they want to make this one or two-line space as appealing as possible.
"Our question is 'Are you trying to lure people in with the dollar amount and hoping they'll be okay with the details of the study after the fact?'" Baker says.
However, there are other debatable issues raised when investigators use online advertising or place study information on a social media site.
Using social media for recruitment advertising is not against the regulations, but it starts to open some ethical issues, Baker notes.
"Also, how do you ethically use social media advertising?" he adds. "The board has concerns about research sites opening a new page on Facebook or accounts on MySpace to tell people about a study."
An IRB's questions about this type of study recruitment marketing might include these:
- What are the ethical issues raised by this type of advertising?
- Is there someone from the investigator site watching the post?
- Is there someone who has to accept the post or who can reject the comment if it's inappropriate?
- Can someone host the discussion board?
- Could the research site limit the ability for people to provide feedback?
"If sites don't have that level of moderation, it opens the door to problems," Baker says. "A disgruntled subject or a well-meaning subject might accidentally misrepresent the study and give a false impression."
There might be family members of research subjects who place inappropriate comments about the study on their Facebook page. Or someone else might say they were on the study drug and found that it cured their disease even though they were in a placebo-controlled study and subjects have no way of knowing whether or not they received the study drug or a placebo, he explains.
"Our concern would be if there are ongoing discussions about studies," Baker says. "There are websites out there dedicated to professional research subjects, and this might offer them an opportunity to debate whether this site is better than that site."
When research sites use social media for recruitment marketing without a moderator, it opens up ethical issues that might lead to lengthy IRB debates.
Obviously, IRBs have no control over what individuals might put on their social media pages, unless it reaches the point of requiring legal action. But IRBs will want to make certain that research sites are not using social media in a way that opens the door to irresponsible posts.
IRBs typically pay close attention to how research sites advertise and market study recruitment because it is the research site's first interaction with the subject, Baker says.
"We want sites and investigators to realize this truly is the beginning of the consent process, and we want potential subjects to have a good first impression," he adds.