Some IRBs have been preparing for months for the Jan. 19, 2018, implementation of the new Common Rule. Others have taken a more casual, wait-and-see-if-it’s-delayed approach.
IRBs that are preparing for a January rollout have found that preparation is time-consuming and resource-intensive.
For instance, one IRB put most of its resources into software system changes, policy changes, and outreach and education to the research community. “We’re still working through a lot of these changes,” says Shawn Axe, CIP, director of the human research protection program at Indiana University in Indianapolis.
Kinetiq, the consulting division of Quorum Review IRB in Seattle, has been preparing institutional and health system clients with updated procedures for informed consent and continuing review, aiming for the Jan. 19 deadline, says James Riddle, MCSE, CIP, CPIA, vice president of client services at Kinetiq.
The informed consent document is a good example of what IRBs can do to prepare. It will need to change to meet the revised Common Rule’s new requirements for informed consent, including adding concise language and some key information, Riddle says.
“The informed consent document will need to have different information and a new look and feel to it,” he explains. “Not every institution is ready to have their informed consent form updated, and some institutions are struggling with whether they update the informed consent form for all research at the institution, or have one template for federally funded research and another for non-federally funded research.”
The danger of keeping an old informed consent template is that rules could change for studies that are not federally funded. For example, if the IRB reviews a study that is not federally funded but is subject to FDA rules, then it might be wiser to switch everything to the template inspired by the new Common Rule. The FDA soon could harmonize its own rules to reflect the same changes.
The disadvantage to having only one informed consent template is that industry sponsors might not update their own templates, as their research is not government-funded, Riddle notes.
“So, if an institution updates its informed consent form template to include disclosures in the new Common Rule, industry sponsors may not be prepared for that and may push back on the institution, asking why the consent form has additional information that is not required,” Riddle explains.
“Some IRBs are more prepared than others,” Riddle adds. “Quorum IRB is already in the process of updating policies, procedures, forms, technology systems, and will have everything ready well before the implementation date.”
One of the first changes the Indiana University IRB will have ready is a revised informed consent template. The new Common Rule has requirements for a concise summary at the beginning of the informed consent document, and it requires language about returning results and commercialization of intellectual property, Axe notes.
Indiana University’s draft IC template lists, on the first of nine pages, an “Important Information” section with the following questions that investigators can answer to summarize subjects’ research participation:
- Why is this research being performed?
- What will happen to me during the study?
- How long will I participate?
- Will I benefit from the study?
- Will participating expose me to risks?
- Do I have other options besides taking part in this study?
- Will it cost me anything to participate?
- Will I be paid to participate?
The new template has a section titled, “Return of Research Results.” In this section, investigators are provided with optional language, depending on their decision regarding returning results.
For example, if the investigator plans to return clinically relevant results, then the following language could be used: “During this research, we may find out information about you which could be important to your health or to your treatment. If this happens, these research results will be provided to you.”
Then, the investigator is instructed to insert a description that explains what circumstances could lead to subjects receiving research results and how they’ll be notified. The additional template language suggests: “You may need to meet with professionals with expertise to help you learn more about your research results. The study team/study will not cover the costs of any follow-up consultations or actions.”
Another puzzle piece that institutions are dealing with involves how to handle elimination of continuation review for projects that were approved via expedited review, Riddle notes.
“Under the current Common Rule, when an IRB approves minimal risk research, the IRB has to conduct a continuing review at least once a year for the life of the study,” he says. “The new Common Rule is eliminating that requirement.”
For minimal-risk research, IRBs will no longer be required to conduct continuation reviews each year, Riddle says.
“However, many institutions attach other institutional activities to the IRB’s continuing review,” Riddle says. “For instance, the institution might double-check conflicts of interest status of the investigator at the continuing review; they might double-check training at the time of the continuing review.”
If an institution eliminates continuing review, how will the institution and IRB complete the other administrative activities that are tied to the continuing review?
“In general, institutions and health systems will need to take a hard look at how they’re going to implement the Common Rule,” Riddle says.
IRBs will need new standard operating procedures to reflect the revised Common Rule, says John Baumann, PhD, associate vice president for research compliance at Indiana University.
“We’ve already drafted, but haven’t released, new standard operating procedures,” Baumann says. “There are new categories for exempt research, so we’ve modified our questionnaire for exempt research to capture as much as necessary under the new criteria.”
The Indiana University IRB also has developed a new limited IRB review process, which some categories will require, and they’re making plans for the changes to continuing review, he adds.
“We’re going to keep up to date on research carried out in our institution’s name, and none of those switches are being turned on until the effective date,” Baumann says.
The IRB has organized working groups and advisory committees involving faculty members and the research community, and has engaged in conversations with peer institutions, he says.
Thinking about the Common Rule change began as far back as 2011 when the Advance Notice of Proposed Rulemaking was released for comment, Baumann says. “This has been something we have been dealing with, and Shawn has been leading the effort on it since 2011, to some extent.”
What’s made preparation especially difficult and time-consuming is the electronic submission system, both Baumann and Axe say.
“Because of our technology, we have to work with other organizations within our institution, which have other priorities, as well, so it’s much more complex with upfront planning and making sure we’re in queue with the technology people,” Baumann says.
“The limiting factor was our software,” Axe adds. “It’s a glacier. Any changes to that software system require a heavy technical lift in regards to planning.”
By contrast, IRBs that do not have electronic submission processes could probably make the switch much more easily and quickly, Baumann says.
With the need for a major electronic information change, Axe reorganized the IRB office to work with information technology staff.
“We have to have our work done and ready to go early, so we can have them programmed into the system in enough time to have them tested as early as possible,” Axe says.
Some members of the IRB team were assigned to interpret any new or proposed regulations operationally. There was a systems group that takes those operations and translates them into the IRB’s own system, making them workable, Baumann explains.
“We hired a technical writer so we could get the policies and staff manuals and websites rewritten,” he says. “We had to redirect some operational resources in preparation for this huge regulatory change, and I definitely think those are in positions we can maintain long term.”