By Melinda Young
As research institutions move toward a single IRB model and more studies are deemed exempt, there is a greater need for all stakeholders to understand the differences between an IRB and a human research protection program (HRPP).
“Many people think about the IRB as the HRPP, and that has never been true,” says Ann Johnson, PhD, MPH, CIP, IRB director and adjunct professor at the University of Utah. “The IRB is a large component of human research protection programs, and everyone knows what an IRB is, so there’s a case of mistaken identity. With the new changes of the Common Rule and a single IRB coming through, you should make sure you know the two are separate. They work together, but are separate.”
HRPPs still are necessary under the new Common Rule. Some functions will be shifted to the single IRB, but many activities will need to stay with the HRPP, says Julie Ozier, MHL, CHRC, CIP, director of the HRPP at Vanderbilt University and Medical Center. “How do we structure the HRPP so we don’t miss anything?” Ozier asks.
One method is to start with a SMART IRB agreement. This helps IRBs decide which will handle the privacy review and study investigator qualifications, Ozier suggests.
SMART (Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) helps streamline the IRB review process for multisite studies. It was launched in 2016 and is funded by the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) program. SMART IRB information and tools, including a SMART IRB agreement, are available at no charge at: https://smartirb.org.
“There are a lot of pieces that HRPPs take on that are outside the IRB, such as ancillary committees, oversight of what’s being billed for research, and how it fits with Medicare, auditing, and compliance,” Ozier explains.
Research institutions should be flexible in deciding which group will be responsible for monitoring and which is responsible for auditing if something does not look right, Ozier says. “Those things have to be hammered out,” she adds.
Ozier and Johnson offer these suggestions for delineating the activities of the IRB from those of the HRPP:
• Educate researchers on the difference between IRBs and HRPPs. “It’s really important to educate our investigators to understand the difference between the IRB and HRPP,” Johnson says. “Tell investigators what they have to do at the institution, even if they are using a single IRB for the review.”
One helpful educational tool is a work chart for the HRPP. “The HRPP work chart can list out all of its components and show that the IRB is just one component,” Johnson explains. “HRPP has leadership and a reporting structure, and this chart helps researchers understand that it’s different from the IRB, although we work together.”
Education includes teaching investigators about federal regulations and the IRB review process. “We essentially help them understand how those regulations list out criteria for IRB approval,” Johnson says. “HRPP components that are not on that list are things the HRPP will help them with.”
• Describe who is responsible for which duties. “Decide who is responsible for monitoring, who is responsible for auditing, and if something doesn’t look right, who is responsible for reporting that to the federal government,” Ozier says.
Institutions can use a written policy and procedural document to determine which role each party is fulfilling, Johnson says. “We want to ensure our institutional policies and state laws are met,” she says. “Every state is different, and those differences could affect a lot of different parts of a study.”
For example, state laws could affect consent language related to studies that use fetal tissue, or whether certain participants could be recruited for research, she adds.
Institutions often use separate reviews for conflicts of interest, radiation safety, and institutional biosafety. These boards and reviews are part of the process, and the local HRPP could be the one communicating those review results to the single IRB.
“If our local IRB staff communicate with the single IRB staff, it goes better,” Johnson says. “We know the same words, jargon, and we have the same purpose, so it’s better if my staff communicate directly with the IRB reviewer, rather than have each committee speak with them.”
• Review studies to see which could be reviewed by the central IRB. “See the type of studies that happen at your institution and which ones have the potential to be required for a single IRB,” Ozier says. “You don’t have to outsource, if it’s not required, but a lot of institutions choose to outsource the commercial, industry studies.”
Make these assessments up front:
- Should the IRB outsource federally funded research that requires a single IRB?
- Should the IRB outsource industry-sponsored research?
- What process does the HRPP use to handle outsourced research?
- What processes are established to determine exempt research?
IRBs need a process for making exempt determinations, Ozier says. “Those are studies that don’t rise to the level of being required for review by a single IRB,” she explains. “While there are some commercial IRBs that will make exempt determinations, that’s not really common.”
As the Common Rule was discussed, there was a debate over who would have the authority to determine whether a study is exempt, Ozier notes. The final Common Rule stated that the IRB does not have to be the sole organization making that determination. But this does not mean that IRBs and HRPPs need to leave this determination to investigators, she says.
“Most of the time, the study is not exempt,” Ozier says. “It’s hard for investigators to make that determination on their own because they’re too close to the project.”
HRPPs probably should keep the privacy board in-house because the external IRB wouldn’t have access to some important information, such as medical records within the covered entity, Ozier says.
• Decide on activities that will stay with the HRPP. “If you decide to outsource some things that are done by a single IRB, then the next step is to determine which things you want to keep in your HRPP,” Ozier says. “For example, do you want to maintain oversight of the privacy board? Do you want to maintain oversight of verifying qualifications of investigators and study personnel? Those are the kinds of things that help a HRPP decide how involved, or not, they want to be. It gives them some tools for things they will be able to monitor if they need to.”
Local HRPPs are better poised to evaluate researchers’ qualifications than are single IRBs, Johnson says. “Local institutions know their investigators and have a documented history of training and qualifications,” Johnson says. “We verify everyone who has received training and has a curriculum vitae on file.”
The local HRPP also is in a better position to evaluate whether investigators at their institution have the resources to conduct the study. “This would be hard for a single IRB to know,” Johnson adds.
• Determine how the single IRB process will work. Here are some questions IRBs and HRPPs can ask as they figure out the new process:
- What will the process look like?
- Will the organization require every investigator to submit through the IRB office so the office can maintain a record?
- What activities will you retain locally?
- Will the organization make assessments?
“If you don’t have that process in place and don’t look at these studies, then the other IRB might not know the nuances specific to your institution,” Ozier says. “They will need to know these local considerations to make an assessment.”
Local consideration worksheets can help with this process, she notes. “Investigators can fill these out with their HRPP, covering everything they can provide to the reviewing IRB,” Ozier says. “We have worksheets we’ve done, and they are electronic surveys with a piece the investigator has to fill out and a piece for the IRB to fill out.”
As research institutions move toward a single IRB model and more studies are deemed exempt, there is a greater need for all stakeholders to understand the differences between an IRB and a human research protection program.
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