Strategies for handling poorly-written protocols

A jumble of jargon, tech terms, acronyms

Put any group of IRB administrators into the same room and soon you'll hear a discussion about how they have to deal with so many poorly-written protocols.

"I have about five years of IRB experience, and this is a common theme: poorly-written protocols," says Michelle Gibel, IRB administrator at Rutgers, The State University of New Jersey, office of research and sponsored programs in New Brunswick, NJ.

And it's not just the protocols. IRB professionals also deal with incomprehensible informed consent forms. Investigators and their staff are accustomed to using jargon, technical terms, and acronyms, which are useful in their every day clinical activities, but are not necessarily understandable to non-medically-trained individuals, says Steward A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.

"From my perspective, and this is a personal opinion, informed consent forms should provide information in a short, simple fashion and in such a way that people get an idea of what they're being asked to take part in," Laidlaw explains. "You don't have to explain every potential risk, no matter how unlikely it may be."

Gibel has kept track of protocol problems and finds that many informed consent (IC) forms are written in language that does not meet the criteria of being readable at a sixth to eighth grade level.

"Basically, the readability is the key because you can have great information, but if it's not written in a language or in a way that the average person you're targeting will understand, then it's worthless," Gibel says. "It's important that you write in 'you' language, lower the reading level, and provide contact information so that if people have questions about the study or study procedures then the full contact information is included."

For studies that are conducted by a student, the student's advisor's contact information also should be included, Gibel adds. And by contact information, Gibel means they should include telephone numbers and email addresses, as well as names and full addresses. So how do you inform and educate investigators and clinical trial staff about how to improve the writing in their informed consent forms and protocol submissions?

LA BioMed has an informed consent template that IRB staff can use to make certain the forms contain all that is needed, and IRB staff analysts work to make the IC forms more readable, Laidlaw says.

University IRBs receive protocols from both experienced faculty researchers and neophyte student researchers, and often the students will submit work that suggests they could have used a bit more mentoring, Gibel notes. "Sometimes people will recycle their old material and try to fit it into their current application," she adds. "Perhaps we're not always clear enough in terms of what we expect for a protocol."

The IRB at Rutgers has tackled this problem by starting a pilot program called the IRB Advisor in which senior IRB members will coach applicants in terms of how to successfully submit a protocol to the IRB.

"It's available to faculty, staff, and students," Gibel says. "Here at Rutgers we have people in the staff role who may not teach, but they do conduct research," Gibel says. "It could be the person in the library who wants to study the usership of library services, so our target audience for the IRB Advisor program is anyone who does research."

IRB professionals are reaching out to the university's research community to announce the new program and to provide advice on their protocol submissions. "You can have as much great information as you like on the Web site, but it will only reach a handful of people who seek out the information," Gibel says. "So we utilized a list service to announce the program."

Also the IRB has hired an advisor to travel to different campuses to teach investigators what is needed in a complete submission. "One thing mirrors another," Gibel says. "If you have an application that's poorly written, then the subsequent material may not be well written either."

The IRB office also has other educational outreach. "Another administrator and I will go out and talk with faculty, students, and staff about how to navigate the IRB process," Gibel says.

All investigators at Rutgers have to take a human subjects certification program, which can be taken on-line with different modules.

"There are case study examples of things that potentially could go wrong," Gibel says. "It also has education about specific requirements in New Jersey and at Rutgers."

This material is available on-line at all times, and it's an alternative to a classroom session that shows participants a film about human subjects protection. Anyone who already has been certified may request the film and show it to other investigators, Gibel says.

The important thing is to enhance any human subjects protection education with specific information about how to write clear protocols and informed consent forms. The Rutgers IRB and compliance staff will contact faculty who submit a poorly-written protocol to discuss the specifics of the missing information, Gibel says.

"We give examples, and we ask them for specific language, providing them with any guidance we can offer," she says. "If it's a student who turned in the protocol then we'll normally reach out to the student's faculty advisor and first discuss it with that person."

After meeting with the faculty advisor, the IRB staff will ensure that the advisor and student are both clear of how to improve the protocol submission, Gibel says. Then the IRB staff will follow-up with an email.

"We always follow-up by email as part of the discussion," Gibel says. "We're sensitive to how they've sacrificed time to conduct research and we respect their ideas and will give guidance and assistance where needed to make a smooth transition to something that's acceptable for IRB review."

Gibel offers these tips for investigators on how to improve their protocol submissions:

Make sure you answer all application questions clearly: "We tend to see a lot of questions where they write, 'Not applicable,' or they leave a lot of blank areas, suggesting they didn't complete this very carefully," Gibel says.

Go into details: "It doesn't have to be arduous detail or have long paragraphs," Gibel says. "But let it be a well-written paragraph that defines all basic questions."

For example, if the question involves subjects, then the answer should be more specific than saying simply "students," she explains.

"If they are using Rutgers students, the form allows for them to say all students at Rutgers or students in a given course or given department at Rutgers," Gibel says. "We want them to explain this as best as possible."

Describe methodology as it pertains to subjects: "We see with protocols that investigators haven't specified the methodology but give a lot of background and their literature review," Gibel says. "We'll look at specifics of a protocol's methodology — not for critique purposes — but to understand how the subject is going to do what is written in the protocol."

For instance, if a study is looking at anxiety, then the IRB would like to see details on these items:

  • What is the risk level for participation?
  • Who are the subjects?
  • How is this population chosen?
  • What procedures are employed?
  • How will problems be handled?
  • What are the identified risks?
  • What are the identified benefits?
  • What is the trial's duration?
  • "We want investigators to take time to illustrate that they understand their protocol," Gibel says.