The trusted source for
healthcare information and
One chief hurdle in human research protection program (HRPP) accreditation is the mindset that it’s all about the IRB, an expert says.
"When you want to accredit the organization, there is more to it than just the IRB," says Russ Price, MArch, federal compliance manager, Utah State University in Logan. Price has served as a reviewer and site visitor for the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Price also was scheduled to speak about the accreditation process at the AAHRPP conference, held April 22-25, 2014, in Salt Lake City.
"There are other units involved, including the sponsored program office, compliance, legal counsel, and academic administration," Price says.
"For example, there is a standard that talks about making sure all of the facilities doing research are trained in human research protection," he adds. "So the first thing you have to do is have them start to think about where that might happen."
The principal investigator’s research site typically is compliant with all HRPP training requirements, but what about the laboratory that only occasionally is involved in research, or a site that does behavioral research that has limited oversight?
"If [AAHRPP] site visitors see that you work with outside groups that are not accredited, then they want to know how you do quality assurance within the organization that’s not accredited," Price says.
There are other nuances to seeking accreditation and research protection compliance that organizations should know. Price offers these suggestions and observations based on best practices and mistakes in self-assessment:
• Policies and procedures (P&Ps). It’s a mistake to adopt another organization’s policies and procedures, Price says.
Developing policies and procedures is time-consuming and challenging, so some organizations might seek best practice examples of P&Ps at other institutions and adopt one of those, he explains.
"The reality is a little different from that," Price says.
No two organizations are exactly alike, and so if one institution tries to adopt the P&Ps of another, it likely will not be a good fit, he adds.
AAHRPP recommends organizations start with their IRB when writing or revising P&Ps because IRBs know their own procedures and policies, he says.
Starting with the IRB also can help build commitment and trust in the process of revising P&Ps, and this serves as an example for the rest of the organization, he adds.
• Focus on the organizational domain. The goal is to build teams and achieve buy-in for the work necessary to conduct a self-assessment and become accredited, Price says.
"By buy-in, I mean I’m going to participate as this affiliated unit in helping to make sure we’re doing what needs to be done," he says.
"In my own institution, I have a lot of educational clinics, and we have to reach those," Price adds. "They might work with special education rehabilitation, early childhood education; all clinics have outreach capacity and also are doing research."
Every unit involved in research will need P&Ps, and these need to be crafted with flexibility to account for differences in how they’re providing service.
• Follow AAHRPP standards. Accreditation standards contain a lot of information about regulations, and they list the outcomes AAHRPP is trying to achieve by having the standard, Price says.
It’s not necessary to create a checklist, he says.
"What we’re really after is: What does your university do that is unique and that makes it possible for you to meet this standard in a way that other people could learn from?’" Price explains.
"One of the great things about doing site visits is I get to see so many great things people are doing out there," he says.
"We tend to call them best practices, but that makes it sound like everyone has to do it," he adds. "To me, best practices have to do with how you are applying them in your circumstances, given the way you’ve set up your program, affecting the type of research your organization is capable of doing."
• Practice effectively. Just as highly skilled musicians become professionals in their craft through years of practice, so might research organizations become experts in HRPP through practiced self-assessment.
"Look at what you’re doing in your organization with a goal in mind," Price advises. "Make sure you are using your talent base to get to that end product."
There’s a long period of time when a young musician practices piano on the bench beside a teacher because he hasn’t learned how to practice on his own, Price notes.
Likewise, an organization will need some assistance with self-assessment in the beginning, but eventually should find this to be a routine exercise.
"Self-assessment is seeing your talent base and using it to make your organization better," he adds. "Waiting for someone else to tell you what to do is a mistake people make."
• Hold focus groups. Having a focus group can show an organization whether goals are being met, and it is another method for giving information and holding an IRB accountable.
Through a focus group consisting of stakeholders, an IRB will discover its weaknesses, where it is less effective, and where it should direct new focus, Price says.
For instance, Price learned from a focus group that people found privacy and confidentiality issues confusing.
"We had not been adequately clear on how to differentiate between them," Price says. "So we strengthened both our training materials and online materials and online application."
This is an opportunity for improvement that would not have occurred without the input of a focus group, he notes.
"Focus groups strengthen that process with the people in the field," he says.
• Develop shortcuts that enhance the mission. "Four years ago, when our organization initially was accredited, we took our policies and procedures and standard operating procedures and created an investigator handbook," Price recalls.
The goal was to create something simpler and more useful for investigators to use, so they wouldn’t have to read through all of the SOP material that was intended to drive how the IRB operated, he explains.
The SOPs still contained all of the necessary information, but the investigator handbook was shortened and set up in a procedure-by-procedure basis, telling investigators what they needed to know. The SOPs have 400 to 500 pages, and the handbook is a more manageable 60-80 pages, Price says.
"We found the investigator handbook to be a powerful tool to help new faculty, especially, to know how to respond to our IRB," he says.