Juggling the work of an IRB of record and becoming a relying IRB can be challenging. But one underlying goal can keep an IRB on track with both roles: consistency.
One way to keep processes consistent and efficient is to use the SMART IRB reliance agreement. IRBs also can set up templates and documents that relying institutions can use and complete.
It is important to work with multiple institutions, says Janelle A. Maddox-Regis, MS, associate director of the IRB reliance program at Johns Hopkins University School of Medicine.
Create Master Consent
The IRB of record can create a master consent form. Each relying IRB can provide its own standard consent with site-specific information added to the master consent as an addendum. “Part of their local review is completing a local context form that tells us all about their site, state laws, and local policies,” Maddox-Regis explains. “There’s a standard template they complete that says, ‘Give us your research subject injury language, your HIPAA language, and any signature line requirements.’”
Relying IRBs also can use any processes and policies of the IRB of record, including training requirements and conflicts of interest policies, says Hallie Kassan, MS, CIP, director of the human research protection program at Northwell Health in Manhasset, NY.
“We’ve been the IRB of record for a lot of sites that don’t have any of their own policies and procedures,” Kassan says. “Those sites piggyback on Northwell’s policies and procedures, and agree to follow the policies and procedures we have in place.” As the IRB of record, Northwell also will give relying sites a training session on the electronic submission system, she adds.
Sharing policies and procedures is a way to remain consistent. It is the study team’s responsibility to bring information, such as local policies and procedures, to the attention of the IRB of record, Kassan says.
Informed Consent Consistency
Consistency is more challenging with informed consent documents. Each research institution uses its own consent template that reflects its institutional policies, as well as state and local laws, Maddox-Regis says. For example, a Maryland state law addresses enrollment of non-English speakers or people lacking decision-making capacity.
“We knew when working on a study that has 30 different sites that we have to think strategically about how we meet the requirement on collecting local information from the site,” Maddox-Regis explains. “We have to make sure that information is in that version of the consent form.”
This could require a two-part consent form in which one copy is the master consent form that describes study procedures, risks and benefits, and all required elements of consent. This part cannot be changed by sites, and it is approved by the study/reviewing IRB.
“As part of the site onboarding process — which happens after the master consent — the study [team] creates an addendum consent form, and we call that part two consent,” she says. “This allows us to collect information from the site, which is required from their consent form.”
For instance, HIPAA authorization language could vary from site to site. “We as a reviewing IRB are required to obtain any relevant local context information relevant to research studies,” Maddox-Regis explains. “Sites, as part of the site approval process, have to tell us everything they know about their site that is relevant to the study.”
If a study team enrolls pregnant women, they have to explain which study language needs to be included in the part two consent.
Part one consent is a timestamped and IRB-approved PDF. Part two includes signature lines that are site-specific.
“When we’re approving the site, we take the master consent form that’s approved by the reviewing IRB, and the part two consent, and turn them into PDFs or combine them and stamp it so that version is provided to the relying IRB and study team,” Maddox-Regis explains. “The reason why is so the site has one version of an approved consent, and they’re not able to obtain consent from participants with only partial consent, such as having only part two.”