Compliance Corner

Compliance course teaches ethics and best practices

Investigators improve submissions after course

A successful compliance program begins with education, which is why a research compliance director at the University of Texas at Arlington has created a comprehensive compliance educational program that has been exported to research institutions around the country.

"We have a very large compliance focus because the University of Texas is a large institution, and there is much responsibility and accountability with all that," says Patricia W. Myrick, BS, CCRP, CIP, director of research compliance at the University of Texas at Arlington.

"There are institutional compliance offices on each of the campuses," Myrick says.

Myrick has created a 3.5 hour compliance education training program called, "Responsibility in Human Subject Research."

Using videos, a PowerPoint presentation and case study review, the program provides a three-year certification for all who score at least 85 points out of 100 on the exam, she says.

The course is open to all IRB members, investigators, and key research personnel, and she has taught it to about 4,000 research professionals and IRB members, including people at institutions across the country.

The course has contributed to a dramatic change in the way that protocols come into the IRB office, Myrick says.

"They are written better, are more complete, and investigators understand the process in the ways we'd expect," Myrick says. "Their protocol is presented to the IRB in a straightforward and streamlined way, making the whole process of review a better place."

Myrick's idea was to give research professionals a broad overview of human subject research, compliance, regulations, and ethics.

"I teach people how to understand the regulations," she says. "They learn that if they are doing this, they will need to know where they need to go and how to find help because sometimes the hardest task is finding the right [regulatory] person to call."

Here is an overview of the compliance education:

1. Historical background and research design:

"We review guidance documents, the Belmont Principles, the Nuremberg Code and Declaration of Helsinki, research ethics, and conflicts of interest," Myrick says.

Before research volunteer Jesse Gelsinger died in 1999, the clinical trial community wasn't talking much about conflict of interest, Myrick notes.

Gelsinger's death during a gene transfer trial resulted in a mantle of change in the industry, leading to closer looks at how money might influence research decisions, Myrick says.

Myrick discusses statistics in research design because this is an area that causes consternation for investigators when they are working through the IRB review process, she says.

"Investigators don't like anyone to look at the scientific merit of their research," Myrick says. "But when you look at section 111 of the regulations, research design is first on the list that an IRB is responsible for reviewing because if the design is off, then the hypothesis is not the best."

This means a study could put participants at increased risk because of a poor design, she adds.

2. Regulations — both application and audit:

"Our technology is changing very quickly, so regulations have to evolve more rapidly to keep up with the changing environment," Myrick says.

The training course covers Federalwide Assurance, the Common Rule, for-cause and no-cause audits by the Office of Human Research Protection (OHRP) and sponsor or cooperative group monitoring.

The University of Texas has its own monitoring program, and Myrick has given presentations in which she lists monitoring as part of the model for success in compliance.

Her model of success in compliance is as follows:

  • Conduct a risk assessment;
  • Review internal policies and standard operating procedures;
  • Audit/monitor research sites and records for both internal and external entities;
  • Provide continuing education opportunities;
  • Implement internal quality improvement programs;
  • Make bi-directional recommendations for improvements;
  • Establish an IRB advisory committee;
  • Put in place review and reporting mechanisms;
  • Provide an annual research forum for investigators and human subject research participants.

3. Research definitions:

"Imagine the number of discussions that take place in regards to what research actually is," Myrick says. "We clarify that issue and say only the activities included in 45CFR46.102(d), which is where you find the definition for research or systematic investigation, are included."

Crossing the line can be tricky, particularly for academic institutions that are always involved in systematic investigations, including Internet searches, Myrick notes.

So it has to be added that the investigation contributes to generalizable knowledge, she says.

"Suppose a faculty member asks the class to survey a block in the community to see if people know about available health services, and the goal of the assignment is to have the students write a paper that is presented in class and graded," Myrick says. "That's simply homework."

However, if the same scenario is slightly tweaked to have a different end goal in which the students will write a paper that is presented at a meeting or is submitted to a professional journal, then the activity has crossed the line and is now contributing to generalizable knowledge, she explains.

"You are now putting out findings so that others can contribute to research, and that study will need to be brought to the IRB," Myrick says.

4. IRB committee's authority, requirements, reports, and other considerations:

The course covers who IRB members are and why these ethics boards were established, including a look at the approval process, modifications, suspensions, how they vote, and what the quorum is, Myrick says.

Typically, the class discussion centers around how the committee is not a typical committee but is independent of the institution and has a higher level of commitment and responsibility, Myrick says.

"We talk about the federal regulations for membership, reporting, and what our office does for them in terms of administrative support," Myrick says. "We talk about institutional considerations, since any successful compliance program starts from the top down."

Also, research professionals are told that IRBs have the responsibility for reviewing grant proposals when they are attached to human subjects protocols, Myrick says.

"In years past, investigators would give one scenario to a granting agency to ensure funding, and then they'd give a slightly different scenario to the IRB to gain approval for research," Myrick says. "Many times those didn't match, and that was a problem, so the IRBs were asked to review grant proposals as well."

When OHRP issues a compliance report on its significant findings and noncompliance concerns, that is number two on their list — the failure of the IRB to review Department of Health and Human Services (HHS) grant applications, Myrick notes.

"OHRP found numerous discrepancies between the title and relevant documentation in IRB records," she adds.

5. The IRB office's function and IRB reviews:

The IRB staff are involved in pre-screening submissions, research monitoring, and handling a variety of regulatory details.

The course helps research professionals understand what is meant by minimum risk and the IRB's criteria for approving a protocol, Myrick says.

Other issues covered are subject recruitment, the required elements of informed consent, and the levels of review, including exempt, expedited review, and full review.

Even if an informed consent signature is waived, it's important for investigators to maintain the spirit of consent by explaining to subjects what's going on, including the purpose of the research, Myrick says.

"We talk about the waiver because it has to be clarified and carefully documented in study records and minutes to be sure the research does qualify with the provisions of the waiver," Myrick explains.

"We talk about required documentation of the informed consent process, and we talk about the process in terms of it beginning even before research starts," Myrick says.

The class includes information about how investigators submit a proposal for review and what pieces of information are required, Myrick says.

The training goes into the details of how files are maintained and archived for both safety and security considerations.

Then, at the end of the course, attendees are divided into two groups, in which they represent IRB members of a clinical and a non-clinical board. Each are given a case study in which they discuss the study, determine the level of risk, and discuss the subject population's vulnerability, Myrick says.

"They present their cases and use all of the information we had just presented in that activity," Myrick says.

"Personally, I hate skits, but this is one activity that I have found to be worthwhile because they actually get to pretend to be an IRB member and face the same questions they would in that role," Myrick says.

6. The exam's opportunities for teaching:

Once the case studies are complete, students are handed a written exam, which they can complete while in the classroom, or they can take it with them and return it within 30 days, Myrick says.

"We also allow them to take it with a buddy," Myrick says. "I strongly believe the way the exam is written that if they take it with a buddy there will be a dialogue, and they'll talk about safety issues and ethical issues, which means the learning is still going on."

The idea is that research professionals should talk about the course and exam as another means to help them retain the knowledge, Myrick says.

"We see a change in the research work coming in here," Myrick says. "It's a big change, and I'd like to say the class is part of the reason why."

[Editor's note: Patricia W. Myrick, is available to provide the research compliance education course to other institutions at a fee of $500 to $800 plus travel costs. For more information, contact Myrick at (817) 272-0834 or pwmyrick@uta.edu.]