Research hospital's online consent process is winning accolades
More subjects enrolled than previously
Recruiting patients in many areas of clinical trial research is a very slow process, contributing to delays in getting new treatments through the research pipeline.
Physician researchers at one major research medical center decided the conventional way of recruiting participants needed to be changed from a paper process to an electronic one. Their goal was to create a registry of potential research participants using an IRB-approved electronic informed consent process, says BJ Rimel, MD, a gynecologic oncologist in the Women's Cancer Program at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute. Rimel also serves as associate director of Gynecologic Oncology Clinical Trials and assistant professor in the David Geffen School of Medicine at University of California, Los Angeles.
The online consent process for the Internet-based data registry Research for Her won an award of excellence for best practice in December 2013 from the Health Improvement Institute of Bethesda, MD.
"The accrual to clinical trials in my world was less than 1% of patients participating in a study," Rimel says. "The national figure is 3% to 4%, and while it is shockingly low, our 1% is not that much lower than the national average."
Rimel concluded that too few patients were registered through the paper format, so she worked with the Cedars-Sinai Medical Center IRB and other researchers to develop an online registry for recruiting women in a project they call Research for Her.
The results have been promising: Within 10 months of using the electronic informed consent process, they've recruited 280 women for the Research for Her project, and 21 of those women have enrolled in one of four different studies, Rimel says.
The IRB welcomes the electronic solution and had begun to explore using online consent for minimal risk research around the same time that Rimel was revamping the registry to include online capabilities, notes Rebecca Flores Stella, CIP, manager of IRB operations and education at the Cedars-Sinai Medical Center office of research compliance and quality improvement.
"So when Dr. Rimel's team came to us with their concerns and needs, their timeline pushed us to finalize this policy and develop a template for online consent," Stella explains.
"We developed a two-tiered level of consent that had the IRB ask for more information if they had concerns," she adds.
In the first tier of the online consent form, a simplified one-page consent covers the consent requirement for most minimal risk research. Respondents verify their identity and click on "yes" for consent, Stella says.
In the second tier, the IRB requires that the consent process allow potential subjects to speak with a study coordinator by telephone or in person, she says.
"In our two-tiered system, if information is more sensitive the IRB can require that there is a stop and the person cannot proceed until that in-person meeting occurs," she explains.
The IRB will consider the complexity and potential risks associated with the proposed data registry in deciding whether an online consent tool is appropriate for the research study, and, if so, which option can best address the informed consent requirements.
For the Research for Her registry, the online form asks participants how they would like to be contacted. Most say they would prefer an email or phone call, Rimel notes.
"We want to make sure participants feel extremely confident and know what they are signing up for and what they're giving us," she says. "The registry contains all patient-sourced information: family medical history, cancer history, reproductive questions."
It's a survey with two pages, and completing it is even faster online because there are skip sequences for non-relevant questions, Rimel says.
"There are more questions opening up all the time, and we find that by using skip sequences we can include a few more questions for our clinical partners," she adds.
When Rimel and colleagues designed the registry survey, they asked questions that would provide a simple screening for existing studies. The survey can be adjusted for additional studies, but each change would require an amendment and IRB approval, Rimel says.
The institute's ovarian cancer screening study provides a good example of how well the registry and its online consent and screening have worked for researchers. Investigators are enrolling participants from three different risk groups for the ovarian cancer screening study, Rimel says.
"The first two groups were quick to enroll," she adds. "The study has been open for four years, and the third risk group could not enroll a single patient in 2.5 years."
The third risk group contains women who answer "no" to all three of these questions:
- Have you ever used birth control pills?
- Have you had a tubal ligation?
- Have you ever been pregnant?
The registry's screening process contained those three questions. So when the registry opened, investigators used it to enroll nine women in six months, Rimel says.
In all, the registry had 35 women who were eligible for the study, and nearly one-third of them wanted to sign up and participate, she adds.
The IRB's leadership is most concerned with subject welfare, privacy, and confidentiality, Stella notes.
"They look very carefully at queries to minimize anything that could be upsetting or evoke strong emotions," she says. "One of the IRB's big steps in developing a policy was setting parameters under which online consent is possible."
The new policy is called Guidance for Internet Based Research Activities Involving Human Subjects.
By working with Rimel's team, the IRB was able to identify specific benefits of an online consent process and to develop the policy that would make these possible. The IRB made sure the online process would meet all required elements for informed consent and would be used for non-sensitive screening questionnaires, Stella explains.
"These can be used to conduct preliminary screening on an iPad at health fairs," she says. "The online consent explains what is being done, how the information will be used, and if the person is deemed eligible, then we can collect some contact information for the person."
The electronic application is user-friendly and provides appropriate privacy and protection, she adds.
"And you don't have someone dealing with a 10-page consent form to answer basic medical questions about their medical history," she says.
The IRB now has a template for Web-based applications. It has been used for minimal risk biobank collections, such as banks that collect remnant materials after routine medical procedures, Stella says.
This online consent process is building a bridge to future uses that also incorporate tablet technology and are more mobile than standard informed consent processes, she says.
"What we're trying to do is facilitate research and prevent people from making an unnecessary trip to a medical center to answer questions that they can easily answer online," Stella explains.