Q&A: Demystifying Gaylord Specialty Healthcare’s Institutional Review Board

Every organization that participates in research must have any new research project reviewed by an Institutional Review Board (IRB). This is to ensure that research participants’ rights and safety are protected.

Gaylord's Senior Director of Clinical Services, Lorraine Cullen , MS, RRT, RRT-ACCS, is the chairman of Gaylord's IRB. All IRB members voluntarily serve on the committee, and Cullen said that being on the committee fits her love of learning and penchant for details. Her role consumes between two to 20 hours a month, depending on the number of submissions and other responsibilities.

In the past year, Gaylord's IRB took on a new role as the approving IRB for other organizations participating in research, known as a single IRB (sIRB) or the IRB of record. This expansion resulted in Cullen taking several courses to ensure that the IRB developed the appropriate policies and best practices for this new role. "We've successfully done our first study as an IRB of record," she said.

Understanding the role of the IRB helps everyone within an organization grasp the protocols and safeguards involved in the research process. From an interview with Cullen, the Q and A format below addresses some of the most common questions about Gaylord’s IRB.

What is an Institutional Review Board (IRB)?

An IRB is a committee accredited, registered with the U.S. government, and issued an ID number certifying approval. Research can only occur after first receiving approval from an IRB. Gaylord's IRB is a group of individuals from various backgrounds who review research proposals and submissions, generally every month. The committee's primary focus is providing guidance that protects human subjects. They review each study’s protocol and consent forms and either approve a study or ask for revisions so that it can be approved.

How often does the IRB meet?

Gaylord's IRB meets monthly. However, the meeting may be canceled if there is not a study or something else that needs to be reviewed.

Who is involved in the IRB committee?

In addition to Cullen, the IRB is made up of staff members and individuals from the community. Everyone on the IRB is a volunteer. There are some adjunct members who can't attend monthly but who can offer knowledge and feedback on specific questions or projects.

What are the IRB's responsibilities related to research?

The role of the IRB is to protect the rights of patients or other individuals involved with research at Gaylord. The committee reviews the study, including the consent process and forms that will be used by anyone participating in the study. The goal is to ensure that patients'/participants' rights are protected, including their data, and that they are thoroughly informed and understand the risks and benefits of participation in the research project.

 Does the IRB have to review every research project?

All research that is completed at Gaylord must go through the IRB, whether it is research initiated by and done by Gaylord staff or research that Gaylord is participating in with another organization off-site. The only exceptions are case reports that generally involve only one person and take an in-depth focus on a particular situation or issue.

What is the process?

The committee first reviews the study's protocol, which should clearly convey what the researchers will do, how it will be done, and who the responsible parties are for each aspect of the research. It should also include how participants' data will be protected and if something is done outside the scope of their usual treatment. The goal is to ensure that the study will meet the standards needed to protect study participants.

Next, informed consent is evaluated to confirm that everything is stated clearly, including any possible risks or complications and inclusion and exclusion criteria for the study. It also must be worded so that anyone with a sixth-grade reading level can understand it.

Depending on the researchers' needs, the standard patient consent template is adjusted for each study. For example, a researcher might be looking for someone to participate in a study using equipment in therapy. In that case, the IRB looks for details documenting what the participants are being asked to do and stating whether it is in addition to or as part of their regular therapy. 

What is informed consent, and why is it important?

The informed consent process and documentation prevent research participants from being talked into participating in something they don't fully understand. It is crucial that study participants clearly understand what is happening, what will happen, and what will happen to their protected health information or data.

Gaylord’s IRB recently developed a new process related to patient consent to allow legally authorized representatives to consent for someone unable to consent themselves. As Gaylord's research group grew, it started looking at studies involving some patient populations that could not consent independently, such as some patients with a stroke. Many of these individuals were appropriate candidates for a study but were unable to consent. This problem resulted in exceptionally long recruitment periods to get the number of patients targeted for a study.

In response to this need, the IRB developed a process and policy clarification to allow legally authorized representatives to consent for someone. This effort included evaluating how to verify that someone is a legally authorized representative. A committee was established that met with a few individuals outside of the IRB, from a clinical perspective, to get different opinions. Once the intricacies were approved and shaped into a policy, the new process was put into place, resulting in more research participation. 

Are there exceptions to informed consent?

Yes, with some caveats. Informed consent is not necessary if research is based on retrospectively reviewing charts, which means the data being evaluated is typically collected by Gaylord or is currently looked at.

Does the full IRB committee always review each study?

The staff in Gaylord’s Milne Institute for Healthcare Innovation Center for Research is well-versed in study submissions, and they usually help with every submission. Clinicians who have never done research before work with one of the MIHI team members who will help guide them through the process. Researchers are encouraged to talk with the IRB before formally submitting a study so they can evaluate if the process is on the right track.

Everything is usually thoroughly documented by the time a researcher comes before the IRB. Sometimes, a researcher is looking for an expedited review rather than a full committee review. In this situation, the IRB must evaluate what researchers are looking for and if their application meets the standards.

Cullen and temporary IRB vice-chair Pete Grevelding, PT, MSPT, Gaylord's vice president of Clinical Operations and executive director of the Milne Institute for Healthcare Innovation, receive and organize the studies. They then decide whether or not the study needs a full or expedited review. Only a few IRB members will review the study when an expedited review is requested. 

If it is a full committee review, it is sent to all committee members, indicating that the study will be reviewed at the next meeting. It is reviewed independently without the person submitting it at the meeting. If an IRB member is part of the research submission, they refrain from voting when the committee reviews an application. The IRB develops any questions, provides feedback, and then votes on whether it is approved.

Has there been an increase in the number of research projects since Gaylord’s Milne Institute for Healthcare Innovation (MIHI) was created?

Before the creation of the Milne Institute, there were only a handful of studies reviewed each year by the IRB. It was also more challenging for the IRB due to a lack of staff/researcher familiarity with research requirements, leading to a lot more back and forth during the review process. This interaction has changed significantly with the MIHI team available to support staff. This support has allowed for an increase in the number of studies that the IRB sees and approves every year. Studies that come to the IRB now need very little change because someone on the MIHI team has already reviewed them. 

Can Gaylord's IRB perform the same function for other sites?

Not every organization that wants to do research has its own IRB. In this situation, organizations can belong to a centralized IRB or a single IRB, also known as an sIRB. Gaylord became an sIRB for the first time this past year for a multi-site study using the Zero G® Gait & Balance System. In this case, three other organizations utilized the Gaylord-approved study protocol. 

Acting as an sIRB impacts the work of the IRB by having to track more components from the different organizations. Additional responsibilities include:

• Tracking every person who is listed as having an activity in the study
• Ensuring that every researcher has proof of current completion of a human subject protection course
• Ensuring that clinical researchers have permission from their manager or supervisor to participate, including details about their study-related activities

Everyone also has to have a completed conflict of interest form. If outside researchers come to Gaylord for activities related to a study, they must have packets that include separate confidentiality forms, a CV, and so forth. Keeping track of who is involved in research and ensuring that Gaylord has all of the proper paperwork is part of being an sIRB.  

Can participants in a study be compensated?

Sometimes, there may be compensation for the study participants, and sometimes, an organization may pay Gaylord if it is doing a device-related study, for example. In this case, the organization may be compensating Gaylord for backfilling clinician time – such as the time involved in consenting patients or doing data analysis.

Who are the current members of Gaylord's IRB?

Lorraine Cullen , MS, RRT, RRT-ACCS, IRB Chair

Pete Grevelding, PT, MSPT , temporary Co-Chair

David Rosenblum , MD

Ann Dwyer, RN, CRRN

Dani Jupe, RN

Jaclyn Magnuszewski , COTA/L

Barbara Banning, RPh, PharmD (adjunct/as-needed member)

Attorney Richard Feldman (community member)

Diana Pernigotti, MSG (community member)

Caitlin Cote MSN, RN, PCCN, NPD-BC , (adjunct/as-needed member)