Build human subject protection education into research office practices

Education takes on many different forms

When the federal government suspended human subjects research at Virginia Commonwealth University of Richmond, VA, in 2000, the institution's leaders turned the bad news into an opportunity to create a new and improved human subjects research program.

"We built the human subjects protection program from scratch," says Monika Markowitz, PhD, director of the office of education and compliance oversight in the vice president's office for research at Virginia Commonwealth University.

And in the seven years since that research nadir, the institution has achieved the success of becoming fully accredited by AAHRPP. The institution is cosponsoring with the Office for Human Research Protection (OHRP) a regional conference about human subjects research protection in September, 2008.

The university's research shut-down was due to inadequate IRB processes, but there was no evidence of any serious adverse event involving a research participant, Markowitz notes.

The institution's new education and training about research protection for human subjects is provided to everyone who is involved in research, from the IRB staff and members to research coordinators and investigators, she says.

"The emphasis on education is on the ethical perspective of the regulations," Markowitz explains. "It's not just having IRB members and investigators understand the regulations, but it's understanding the ethical underpinnings."

Here are some of the educational forums provided to research staff and others:

Basic human subject research education: There is a baseline requirement that all investigators and key personnel take a Collaborative Institutional Training Initiative (CITI) course on human subject research, and there are regular program series that focus on either biomedical research or social-behavioral research and working with the IRB.

"We offer those throughout the year, and we advertise them to the entire research community," she says. "We also have extensive communication on our web site with IRB news, and we've recently instituted a bulletin for human research protections, which is another venue for communication and education."

Fourth Friday featured program: All research coordinators are invited to the fourth Friday programs each month. These target individuals involved in research, focusing on human subject protection and IRB updates.

A recent program featured the institution's HIPAA officer, who could answer questions about privacy, confidentiality, and the institution's HIPAA privacy board's work.

Markowitz selects topics for the program by looking at what's current in human subject research and repeating some of the more important topics. "We recently had the director of the investigational drug pharmacy speak," she says.

The talk included a description of the research drug cycle and procedures and explanations about what is changing and what research coordinators need to know as they do their work.

Fifth Thursday programs: Several times a year there are five Thursdays in a month, and on these fifth Thursdays, the institution provides a special educational program for IRB members.

The program typically features new processes IRB members need to know or considerations they need when reviewing protocols. Research coordinators and investigators are invited to the second part of these sessions.

"For example, our last program in August was a conversation with one of our biostatisticians, and the title was, 'Do size and power matter in human subjects research?'" Markowitz recalls.

"So there was quite a bit of interest, and we had more than 35 people there, including coordinators and investigators," she says.

Post-approval monitoring: "We have instituted a post-approval monitoring and education initiative which we call the IRB support visit," Markowitz says.

"This is a visit that is scheduled. It's a not-for-cause visit that targets protocols that are of high risk, that are very complex, or that involve vulnerable populations, and any combination of those," she explains. "They are conversationally based visits, and we try to include the IRB staff and reviewers in those visits, so they can associate a name with all of the communications they might have had with a particular investigator and research coordinator."

Markowitz, a research ethicist, and a nurse and two others within the office conduct the visits.

"Prior to the visit we have read the protocol and amendments and any reports of unanticipated problems and material submitted through continuing review," Markowitz says. "We start with the request that the investigator walk us through the process of what happens after a subject is referred to them or is identified as a potential participant."

Then the site visitors review the site's informed consent process and learn about the interactions between research staff and participants, she adds.

"We look for evidence of organization of regulatory and study documents," Markowitz says. "We're not looking directly at all the paperwork that might be of interest in an audit because it's more about determining whether or not the investigator is following the IRB-approved protocol."

They look at how data are protected and assess what happens when subjects begin to participate in a study. The monitoring visit takes about an hour, and the preparation time and post-monitoring visit time take longer than that, Markowitz says.

"We have a tool that is available on our web site, which is a post-approval, self-evaluation tool that we refer the investigator to when we set up the visit," she says. "They're not required to fill it out, but they can look to see the kinds of things we're interested in."

It's viewed as an educational tool for themselves and their coordinators, and it's a way to prepare for audits from sponsors or prepare for monitoring by clinical research organizations, Markowitz adds.

Update staff about policy changes: Through e-mails and meetings, IRB and research staff are updated about any changes or revisions to the institution's written policies and procedures, which are referred to as WPPs, Markowitz says.

"Whenever we're introducing a new WPP or making revisions to a current one, we run those ideas past our IRB chairs," she says. "The IRB chairs meet every month and they can give their blessing and approve the revisions or new WPPs or suggest changes."

Once approved, the IRB staff and members are educated about the new WPPs, and the same educational information is given to clinical research investigators and staff.

"We announce on our IRB's web site that there are new WPPs out there, and we have a tutorial PowerPoint presentation that describes any changes and anything new in the WPPs," Markowitz says. "We send out broadcast e-mails to IRB staff and IRB members, and we try to give inservices within the IRB meetings."