Protecting the privacy and confidentiality of individuals’ health information and data and an organization’s sensitive data is critical in health care organizations. Patient and family advisors (PFAs) should all sign a confidentiality agreement when they are being oriented to the general PFA role. These agreements should be reviewed annually and breaches should not be accepted. PFA orientation should include training on protecting privacy and confidentiality and should clearly state the consequences of not following the guidelines.

When PFAs or PFACs are partnering in research, the orientation they received for their PFA role is usually appropriate for many levels of collaboration with researchers as long as personal data from studies are not shared. If PFAs are being asked to serve on research teams, or on research committees, they will need additional training specifically in human subject protection (e.g., IRB training). Determine whether they need this training by asking?

  • Will they have access to human subject data?
  • Will they have responsibility for upholding research ethics?
  • Will they be directly involved in shaping research methodology?
  • Will they participate in conducting the study?

Engage compliance, ethics, legal, and regulatory staff to determine if IRB training should be part of PFA orientation to research process.

Institutional Review Board (IRB). The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. (Source: USFDA)

Highlights from the Field

In response to the need for IRB training for PFAs, institutions are creating innovative training programs that are aimed at patient and family advisors and community members. The Children’s Hospital of Philadelphia has developed advisor-focused IRB training in the form of a three-part online training. The University of Maryland-Baltimore and University of Colorado-Denver have both recognized the need for specialized IRB training for PFAs and have developed group training that includes classroom content introduction with group discussion followed by knowledge testing. At Michigan Medicine, interactive IRB training is provided to community partners, focusing on the history, relevance, and significance of current regulations, the applicability of informed consent requirements in community settings, and ethical importance of IRBs and research.

Martie Carnie


Martie Carnie, Senior Patient Advisor, talks about how IRB concerns about PFAC involvement in research are managed.