New Ways to Protect Research Volunteers

Using both new technology and improvements to old-fashioned person-to-person contact, a large scale Medical College of Wisconsin initiative is underway to better protect the many people who volunteer to participate in medical research projects.

The Human Research Protection Office (HRPO) was formed in August 2003 to, among other things, streamline the research review process and make sure that human volunteers really know the risks and benefits of being involved in treatment that is often at the experimental stage.

"We've brought together the Institutional Review Boards (IRB) and Research Education under the umbrella of human research protection," said HRPO Director Maggi Cage, PhD. "A third program, Quality Assurance and Compliance, was also formally added.

"There are three aspects of the program: the review and approval of ongoing research protocols, the auditing of those protocols, and then providing education to investigators and research coordinators here in the Medical College in order to help them improve the quality of the research they do with an eye toward protecting human volunteers.

"Our whole goal is to protect the community volunteers who come here to the Medical College and sign up for research. We do that in several ways. One of the most important things in protecting human subjects is to make sure that they are fully informed about what's going to happen in the research, the risks, and the benefits."

Improving "Informed Consent"
All research volunteers sign "informed consent" forms that say they understand and agree to the treatment or other research functions they will undergo. Making sure the consent form is clear and appropriate to the project is one of the key roles of the HRPO.

"This is critical to our job from the Institutional Review Board standpoint," said Dr. Cage. "Our job is to look at the proposed research, look at the informed consent, and to make sure that the research is going to be conducted in a way that has scientific integrity, that it minimizes the risks to the human volunteers, and to the extent that it can, maximizes the benefits. We're here to make sure that the informed consent, as a written document, truly reflects the risks and benefits to the potential volunteers.

"We're also concerned about the person obtaining informed consent from the volunteer. This is where our research education comes into play. We're very interested in working with investigators and their research staffs on the question 'how do you really, truly obtain informed consent?' Dr. (William R.) Hendee, who is the Vice-President for Research here at the Medical College, has an NIH grant that others and I have worked on entitled 'Eliciting Truly Informed Consent'.

"We've spent a lot of time in this office trying to understand how we as professionals can best communicate to the community about the risks and benefits of participating in research and how we can then also help to train our research staffs to truly connect with these volunteers."

Electronic Review of Thousands of Projects
There are close to 2,000 active research protocols underway at the Medical College, Dr. Cage said. "We get in the ballpark of 500 to 600 new applications every year. Clearly, Froedtert & Medical College is the largest research program in southeastern Wisconsin.

"There are two big changes that are happening since our office was formed. We are now in the process of implementing an electronic Institutional Review Board, what we call e-IRB. It will improve the accuracy of the submissions to the Institutional Review Boards and provide educational opportunities for investigators. The e-IRB will allow for more effective, efficient review of research protocols so we can be more responsive to investigators on a timeline for approval. And we'll be able to track more information."

The e-IRB is actually a brand new web site that, Dr. Cage said, should be up and running "live" by September 2005. This huge undertaking has been in development for two years, she said, and the HRPO has used lessons learned from other top-flight research centers using such systems.

"The electronic site is on its own server, and the investigator will be able to log onto it from anyplace in the world," said Dr. Cage. "It includes lists of all the studies an investigator has submitted to the IRB and their current status, links to the massive and complicated databases of federal regulatory data, access to forms that are automatically filled out online without downloading them and typing in the information, and automatically generated informed consent material specific to the research involved."

"Smart Form" Enhances Process
A "smart form" and other features of the e-IRB will make the entry of data much faster, easier and more consistent, said Dr. Cage. The system even checks for missing pieces, tells applicants which pages of forms can be skipped, checks spelling, and will allow reviews by IRB members to be conducted online prior to IRB meetings.

"And at the end of the form is a consent builder that asks a series of questions," said Dr. Cage. "We're taking the guesswork out of writing an informed consent, which has been a real problem in the past. There is language for informed consent required both by the federal government and by the Medical College.

"The investigator will push a button that says 'build a consent.' This will all help that community volunteer who comes out here to know that what's written in the informed consent is really the information they need to know in order to truly give informed consent to the research.

A new brochure will also help the HRPO inform people about what they need to know before consenting to being research subjects. "It's absolutely essential that a potential research volunteer asks questions," said Dr. Cage. "We hope that this brochure will guide them in the types of questions that they should be asking.

"Oftentimes, research volunteers are in difficult situations. They may have a very serious medical condition for which the standard of care either doesn't work for them or for which there's simply not much available except for experimental treatment. So they're vulnerable. Our job is to make sure that we help volunteers understand that they should be asking a lot of different kinds of questions and making sure that they really understand what they're getting into, perceive what the risks are, and they're willing to accept that risk."

Dan Ullrich
HealthLink Contributing Writer

MCW Health News presents up-to-date information on patient care and medical research by the physicians of the Medical College of Wisconsin.