High 'Hope": Private institute overcomes IRB obstacles

Accreditation process took about two years

Accreditation for an academic research institution is a time-consuming and difficult process for the research office and the institution's IRB office. But for a small, private research organization, the task is Herculean.

Since the private research site doesn't have its own IRBs, it has to rely on private and regional IRBs. And since the research site may use only accredited IRBs when it submits its application for accreditation, the accreditation process becomes a maze of trying to match research contracts that come with their own recommended IRBs to different IRBs that are accredited.

These were the obstacles that Hope Research Institute of Phoenix, AZ, overcame to become the first private research site accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.

"We use only AAHRPP-accredited IRBs," says Patricia Adams, managing partner with Hope Research Institute.

When Hope Research Institute first sought accreditation, there were far fewer accredited regional IRBs, Adams notes.

"The first step was finding enough IRBs that were approved by AAHRPP for us to attain accreditation," Adams says.

"At first there were only a few IRBs that were approved, so it was an almost impossible obstacle for us to overcome," she explains. "Sponsors typically suggest that sites use a central IRB."

Unless the central IRB was accredited, Hope needed to request an exception to using an accredited institution, Adams adds.

"Some sponsors turned us down," she notes. "Hope had a challenge to balance our business' financial needs against the desire to become accredited."

Over a two-year period, this changed as increasing numbers of independent IRBs became accredited through AAHRPP.

"As we moved in the direction of using accredited IRBs, the IRBs moved in the direction of becoming accredited," Adams says. "It was remarkable that the process was going on in a parallel motion."

However, there were some growing pains.

At times sponsors would offer the research site a contract and tell the site that a particular IRB will be serving as a central IRB on the project. If the IRB was not AAHRPP-accredited, then Hope Research's partners would have to say they couldn't use that IRB, and they'd suggest alternative IRBs, all of which were accredited, Adams says.

"Then the sponsor would say, 'Yes, you can use one of those other ones,' or 'No, you can't use any except this IRB,'" she recalls.

Some sponsors were flexible; others were not.

"Some sponsors have understood and have come to us with protocols, saying, 'We're supporting this IRB, but you can use any you want,'" Adams says.

"One of our challenges has been if we're approached for an in-hospital study, and the doctors want us to do that study in a hospital that has its own IRB," she explains. "And if that IRB is not AAHRPP-accredited, but the study is important to us to do, then I have to encourage our investigators to use a regional IRB that is accredited."

Aligning the organization with accredited IRBs was the biggest hurdle, but there were other challenges, as well.

Small research institutions typically have one person who has to work on the accreditation package, and Adams was the point person for writing policies and procedures.

"One challenge was learning how to use Adobe so that our application was acceptable to AAHRPP," Adams says.

Her first application was formatted strangely, and she asked AAHRPP for help in formatting it according to the accreditation organization's requirements.

"The uniqueness of Hope's site was a chance for AAHRPP to learn, as well," Adams says. "The challenges of 'fitting a square peg in a round hole' helped AAHRPP fine-tune its directions and application process."

Another challenge was making certain all 15-plus investigators who work with the research site were trained according to the written policies, she says.

Prior to seeking accreditation, the research organization had been following the right policies and practices, but these weren't put in writing, Adams says.

"I realized that we were practicing what we weren't preaching," she says. "Because we were a small business we didn't have written policies a larger institution is founded upon."

Once the policies were put into writing as the organization sought accreditation, it was time to train investigators and staff about those policies.

"They're encouraged to do things our way, which is consistent with good clinical practices and AAHRPP standards," Adams says. "And they're used to being private practitioners and small business people who run things their own way."

Investigators also have to take Web-based training, such as the National Institutes of Health (NIH) training course or the CITI online training course.

"More and more, IRBs are looking at investigators and saying, 'We want you to have clinical research-specific training, especially if you're a new investigator,'" Adams says. "There are a number of different options for training, and I provide them to the investigators."

Investigators who will be working on clinical trials that are funded in part by federal money will have to be trained as part of the Federal Wide Assurance, she adds.

Adams keeps investigators up-to-date on new safety reports and regulatory news.

"If the news is related to a study we have, then I print out a hardcopy of the information and make sure investigators sign it," Adams notes.

Since AAHRPP requires all investigators to be aware of how to report adverse events, safety issues, and other pertinent information, Adams has created a one-sheet list of regulatory agencies and important information, including contacts to call. She updates that list each year, and it's kept in the investigator records. (See regulatory list.)

This type of list could be personalized with the names, phone numbers, and emails of people at the regulatory agencies with whom the research institution has worked in the past.

"We laminate it for them and stick it on a bulletin board or anywhere else it can be seen," Adams says.