Best Practices Report: Improve orientation, training

[Editor's note: This is the first of an occasional series on best practices in the IRB world. This issue of IRB Advisor will focus on how to develop a successful orientation and training program for new IRB members. In the March issue, there will be a second perspective on this same topic.]

Institution provides IRB members with thorough, ongoing training/education

IRB's program is notable best practices

IRB offices no longer can use the trial-by-fire method of new board member training.

For today's IRB, which often deals with a variety of research topics and expects a great deal of regulatory and scientific knowledge from members, a thorough orientation and training program is necessary.

Duke University in Durham, NC, has a comprehensive training and continuing education program for IRB members. The program was improved after the research institution expanded from having one to having eight IRBs. The expansion has occurred in the nine years since the former Office for Protection of Research Risks (now the Office of Human Research Protection), suspended all federally funded research at Duke until "serious deficiencies" were corrected.

"As the IRBs grew, the membership grew, and we had fewer experienced members to help train new members, so it was obvious we needed to do a little more training," says Charlotte Coley, MACT, CIP, director of the IRB education programs at Duke University Medical Center.

For the first few years after the expansion, Coley would have an orientation meeting with new IRB members, providing them with checklists to use for reviewing protocols and showing them how things were done at Duke.

Goal to prepare for primary review

Then Coley met with one the IRBs' vice chairs and asked him to help develop a mentoring program for new members. The program would focus on how to be a primary reviewer.

They piloted the mentoring program. It was a success and has been implemented for all of the IRBs, Coley says.

The basic orientation component works this way:

  • First, new members observe a meeting, but don't vote.
  • For the second meeting, the new members shadow the vice chair and prepare the primary reviewer checklist. "This is a dry run as if they were going to present the protocol themselves, but they don't," Coley explains.
  • "They meet in the hour before the meeting to discuss with the vice chairs any questions they have about the process or the protocol," Coley says.
  • At the second meeting, the new IRB members will vote, and at the third meeting they are on their own, Coley adds.

"But they always have the vice chair to call as their ongoing mentor," Coley says. "They spend time with the vice chair, develop a relationship, and know that the vice chair is willing and able to answer any questions they have down the road."

Extended program for community members

This process is enhanced with community members.

Community members who are not affiliated with the university and who are not medical doctors are given the opportunity to shadow the vice chair multiple times until both they and the vice chair feel they are ready to do a primary review on their own, Coley says.

"We have some community members who are retired PhDs, and they can do most any study," Coley says. "We have some engineers, some retired public health professors."

For community members who are not scientifically trained, the IRB will assign them the less challenging protocols, including straightforward renewals and amendments, she adds.

Expanded training for all members

The IRB has also expanded its continuing training and education for all IRB members. Coley provides this look at the additional training sessions:

• Develop monthly meetings for community members. "I have a series of monthly presentations for community IRB members," Coley says. "I start out with the background of human subjects research and information on why there are IRBs and what the responsibilities are for IRBs."

One session will cover informed consent. For this program, Coley will show IRB members a clip from the HBO movie, "Miss Evers' Boys," which is about the Tuskegee syphilis study.

"My favorite clip from that study is where the public health doctors have all the subjects in a room in a semi-circle, and they explain in scientific terms what the Tuskegee study is all about," Coley says. "And Miss Evers asked if she could speak with the men, and she starts explaining in lay terms, and you could see a change in their body language, which makes it obvious that now they understand, while before they were being polite."

Coley invites speakers to the monthly meetings, including another IRB member who is a pharmacist and is on the faculty of the university's school of nursing. He does a presentation on different styles of research and research studies.

Another speaker talks about data safety monitoring boards (DSMBs), and other sessions have focused on HIPAA and privacy issues.

The meetings last two hours, and some research coordinators also attend them, Coley notes.

These meetings are especially helpful to the IRB's non-scientist members, who represent several members of each 16-18-member board, Coley says.

"We have mathematicians, engineers, a retired film critic, a retired chairman of the department of statistics," Coley says.

Since there are so many non-scientists on each board, no one need feel intimidated or afraid to ask a question at an IRB meeting, she notes.

"I encourage them to ask questions at IRB meetings," Coley says. "They can participate and make very good points, seeing things that sometimes those of us who are much closer to the research don't see."

Community members enrich an IRB's meeting deliberations, but the additional training is important, Coley adds.

Coley repeats the monthly sessions annually, so if members have missed it the first time, they can hear it later.

Each meeting includes a continental breakfast and free parking, which are the only incentives offered to the IRB members to attend the training sessions, Coley says.

• Educate at meetings and workshops. "We also have 10-15 minute brief educational sessions at each IRB meeting," Coley says.

These sessions are kept short so that the IRB members have time to review protocols and vote, but they can provide updates on regulatory changes and issues that arise during IRB meetings.

Another educational forum that's useful is the half-day workshop for IRB members only.

"We bring in outside speakers, like Robert Levine of Yale University, who has been a keynote speaker," Coley says. "He's a well-known researcher and ethicist who attended Duke as an undergraduate."

Duke faculty also speak on the various topics covered at the workshops.

"We're going to do a workshop in January on the informed consent process," Coley says. "We'll cover the IRB's responsibility and what to note in reviewing protocols."

The workshops, which include breakfast and snacks, typically are held once a year and they're attended by IRB chairs and members at Duke, as well as IRB members from other local IRBs, Coley says.

"We use a hall that has 172 seats, and we generally fill that," Coley says. "This is another way to pay back our members and thank them for their service."

The institution also sends IRB members to national conferences where they might receive additional training, Coley says.

"This strengthens and improves their abilities as IRB members, and it also brings back value to the departments they serve in as more knowledgeable human subjects protections people," Coley says.

• Offer special education and training for medical students. Since the third year of medical school is devoted to research, Duke medical students can conduct the research anywhere around the world, Coley says.

For those who decide to stay in Durham, there is an option to serve on the IRB, attending as if they were regular IRB members, she says.

These third-year medical students have to apply to be an IRB member, saying why they want to be a member. This is in addition to their research project.

"So I do a two-hour orientation for them about the IRB and regulations," Coley says.

The medical students also receive mentoring from the vice chair as they see first-hand how human subjects research is viewed from the perspective of IRB members.

"We think it's wonderful when we get medical students in combined degree programs, working on their PhDs," Coley says. "We had one student who was getting a PhD in philosophy, and so he was an active IRB member for five years, and now he's back as a medical student, completing his medical degree."

There typically are two to four medical students each year, although this year there are seven medical students and several more who have stayed on the IRB after completing one year of service, she says.