By Melinda Young

There are many ways IRBs could conduct post-approval monitoring (PAM) programs. These can range from simple email questions and answers to full reviews at the research site.

These programs often are designed to be educational, as well as adding a layer of accountability in the human research protection process.

“Once we developed post-approval monitoring tools, we realized what a good opportunity it is, in terms of education,” says Cecilia Brooke Cholka, MA, CIP, IRB specialist at the University of Nevada, Reno. Cholka is scheduled to speak about PAM at the Social, Behavioral, and Educational Research Conference at the 2019 Advancing Ethical Research Conference, held Nov. 17-20, 2019, in Boston.

Cholka learned a great deal about post-approval monitoring when she worked to help develop various PAM models at prior institutions. She describes, from that experience, these sample PAM models:

• Administrative check-in. Projects that do not require continuing review can use administrative check-in. IRB staff send an email to the principal investigator (PI) to assess the status of the project. Questions in the email include:

- Is the project is still collecting data?

- Were there any adverse events?

- What are the unanticipated problems involving risk or protocol deviations?

- Are there are any new findings that may affect risk to participants?

One purpose of the email check-in is to remind PIs of their obligation to submit amendments and event reports.

• Full on-site assessment. For these studies, there would be a full assessment, conducted by IRB staff. The IRB professional would review research documents, interview researchers, and check the site’s storage and other activities, comparing their practices to what the protocol described.

• Self-assessment. “This is where we take paperwork for the full audit and cut down its questions to make it a tool that researchers can use themselves,” Cholka says.

The IRB sends the PI a self-assessment checklist to complete within a set period. Then, researchers return the self-assessment to be reviewed by the IRB.

• Consent document review. This is an abbreviated review that researchers can perform themselves, Cholka says.

Self-assessments could be limited to consent forms, or there might be some other limited scope to screen for potential quality issues. For a consent-only assessment, the IRB might ask the researcher to submit all signed consent/assent signature pages for all participants enrolled during a specified period.

• Consent process review. This review is conducted by the researcher. When a project is viewed as sensitive, high risk, or when the IRB expresses concerns regarding the process for obtaining informed consent, the IRB might request a consent observation of one or more participants. Researchers use a checklist to verify that the consent conversation contains all components.

• Consent process observation. “This is best practice for consenting participants,” Cholka says. “The IRB looks at what it expects in terms of a good consent process.”

Conducted by IRB staff, this consent process observation takes place when a project is sensitive, high risk, or the IRB voices other informed consent concerns. Consent observation may be requested for one or more participants. Researchers are required to coordinate with the IRB for the observation.

• Project team review. Projects with large teams or special team training requirements could be selected for a project team review. The PI submits a project team form and training certificates. IRB staff verify that all team members meet training requirements and have signed a conflict of interest disclosure.

IRB reviewers assess studies to see which type of post-approval monitoring would be good for that study, Cholka says. After the reviews, the IRB sends researchers a letter of findings. “We always include what they’re doing right because we’re trying to make this a positive, collaborative experience,” Cholka says. “We put in there, ‘You are right on target with these things — you’re doing exactly the right thing.’”

“When there are minor findings, the letter might say, ‘We notice you said this; it should be this way, instead, and we recommend XYZ,’” she adds. “If there are major findings, we would generally escalate it to a full audit.”

Feedback from investigators has shown that the PAM process is helpful, and it has given the IRB and reviewers a better understanding of studies’ actual progress, Cholka says. PAM also helps improve education, outreach, and research protection, she adds.