Start by asking “Is it research?”

On February 28, 2013, PRIM&R hosted a webinar titled Key Decision Points: Is it Research Involving Human Subjects? It is Exempt? Is IRB Review Required? Following the webinar, I had a chance to connect with the presenters, Karen Hale, RPh, MPH, CIP, and Daniel Nelson, MSc, CIP, to discuss some of the questions that came in that they were unable to cover during the allotted time. Below, they share their perspectives on a few of the questions.

Q: Why can’t I determine if a study involves “human subjects” before I determine if it is “research”?

A: From a regulatory standpoint, the definition of a “human subject” requires one to have first determined that research is being conducted.  Department of Health and Human Services (DHHS) regulations state: “Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” Similarly, Food and Drug Administration (FDA) regulations refer to: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control.” Both definitions require a prior determination that an individual in involved in “research” before a determination that the individual is a  “human subject.”

From a more practical standpoint, as stressed in the webinar, many activities involve human beings, but not all are research. Failure to consider these definitions in the proper order may lead to unintended or counterproductive consequences. For example, if webinar participants who responded to polling questions or a course evaluation were considered “human subjects,” prior consent might be considered necessary for participating in the webinar.. Such a result would be illogical and serve to protect no one.

Whether you rely on regulatory or practical lines of reasoning, it simply works better to first determine that an activity is “research” before you consider the status of the humans in that activity!

Q: If professors at our institution partner with other institutions, we assume our institution is not engaged in research. Yet, how do we know that all proper review occurred at the other institution without asking to see that paperwork?

A: The first sentence is not necessarily true, if it was intended as a blanket “rule,” since engagement depends on the nature and level of involvement. Merely partnering with other institutions does not mean that your institution is not engaged (or that it is).  We would advise institutions to use the OHRP engagement guidance to determine if/when the institution is engaged in non-exempt human subjects research. When an institution is not engaged, there are no requirements to determine what reviews (if any) are occurring at a collaborating institution. However, when two or more institutions are engaged, this presents an opportunity for institutions to cooperate or streamline IRB review. Often this takes the form of an IRB authorization agreement, which should spell out the responsibility of both institutions (including sharing of “paperwork”). See also OHRP’s Terms of the Federalwide Assurance for the Protection of Human Subjects for more information.

Q: My question concerns records-based studies. We are currently engaged in a public health surveillance collaboration with the Centers for Disease Control and Prevention (CDC) to develop a data repository. This is a retrospective study and no subjects will be consented. Medical charts will be reviewed and the data will be de-identified. The data will be linked later by the CDC, but it will remain de-identified.  Is there a resource or a set of rules that are relevant to this kind of study? Ultimately, we had to start over and submit a data repository submission for review, but is there a resource available that addresses public health surveillance studies, for instance?

A: Here, we would ask some of the same questions regarding the purpose of developing the data repository to determine if the data will be collected and retained for future research purposes. If so, since medical records (the data source in this case) contain private, identifiable information, it appears that the study involves human subjects. On the other hand, if the purpose of the repository is to collect information to potentially identify and implement prevention and/or interventional strategies for public health issues, then creating the repository may not constitute research. Often, since repositories are created for multiple purposes, one of which may be research, obtaining IRB review for developing a repository provides additional flexibility for future research projects.

Note: Subsequent “secondary” uses of the data from the repository may not meet the definition of human subjects research if the data is coded or de-identified. For more information, see OHRP’s Guidance on Research Involving Coded Private Information or Biological Specimens.

In addition to these questions, Dan and Karen weighed in on a number of other challenging dilemmas facing research professionals with regard to exempt and expedited review. Take a peek at their complete question and answer session. If you’re interested in learning more about this topic, but did not have a chance to participate in last week’s webinar, the archive is available for purchase.