Research and Technology

Advancing Medicine, Protecting Volunteers

How researchers ensure study participant safety and confidentiality

Medical research takes many forms – some studies consist of a ten-minute survey, others are far more involved and take weeks, months or even years to complete. In some studies there is a great deal of face-to-face contact between researchers and subjects, while in others the two groups never meet. No matter how a study is conducted, it needs volunteers – members of the public who will participate as subjects in the study, providing researchers with the information and data they need. It is in everyone’s interests to ensure the safety and confidentiality of all study participants. This is the function of the Human Subject Protection Program (HSPP) at Carle Foundation Hospital. “One of our visions at Carle is to be a world-class research enterprise, and a critical component of that is to ensure protections for our research volunteers,” says Carla Barnwell, the program’s interim director. “We look at the entire research study, from recruiting to long-term follow-up and ask, ‘What are the risks to the subjects, what are the potential benefits and is it appropriate to involve our community in this study?’” As we help foster research and inquiry at Carle, our nurses, residents, students and physicians are continually proposing new studies. Many are collaborating with other medical campuses or the University of Illinois at Urbana-Champaign. Currently Carle has over 400 active studies. With each study proposed, human subject protection is a priority from the start.

Pamela Talbott, resident research coordinator in the Foundation Research Office (FRO), emphasizes this point. “I think the HSPP is really good at identifying the risks versus the benefits. They’re aggressively on the side of
the subject throughout the life of every study.” Before a planned study is submitted to the Carle Institutional Review Board (IRB) for final approval, it is first vetted by an assigned research coordinator in the FRO and a member of the HSPP. These two groups examine the study thoroughly and look for ways to make improvements and ensure that the researchers have left no stone unturned in ensuring maximum patient safety at every stage.

Scientific Review

When the study is submitted via Carle’s online submission system (IRBNet) it is first reviewed by the Scientific Review Committee. This group of expert reviewers takes a close look at the scientific merit of the study. Is the study
necessary? Is it adding to the body of knowledge or replicating something that has been done elsewhere? Will its results be measurable and significant? What are the possible risks and benefits to the subjects? Anna Keck, director of the FRO and chair of the Scientific Review Committee, says “Having a scientific review increases the probability of success of a research study.” After the study is approved by the Scientific Review Committee it is automatically forwarded to the Carle IRB for human subject protection review.

Recruiting Subjects

Depending on the kind of study and the number of subjects needed, researchers may print out fliers or place ads in newspapers. They may also call potential subjects at home, or ask physicians to look for possible recruits among their patients. Whatever the method, there is careful oversight by the Carle IRB to ensure that participation is voluntary, and that volunteers understand what is involved. For example, phone recruiters, are given a Carle IRB approved script to follow so that consistency is maintained and there is no risk of misrepresenting the study. Before a subject signs a consent form, they will receive a detailed explanation of everything the study will entail so they can make an informed decision.

Privacy

In order to be approved by the Carle IRB, every research study that uses human subjects must guarantee subject confidentiality. If potentially sensitive records are being reviewed, for example, a so-called linking document will be created in which pertinent medical details are stripped of any identifying features and listed anonymously. This way, researchers can have access to the information they need, while maintaining research ethics and complying with
rules governing access to patient records.

Compliance

Even after a study has been approved by the Carle IRB and is up and running, it is still carefully monitored to ensure that researchers are sticking to their original study protocols and not deviating from them in any way. If those carrying out a study want to make even a small change to their protocols, the whole study, not just the revised portion, must be resubmitted to the Carle IRB before the change can be implemented. Subjects already involved are notified and asked to reaffirm their willingness to participate.