By Eric Krebs
In her second appearance on Proof over Precedent, institutional review board (IRB) expert Shannon Sewards joins host James Greiner for an in-depth discussion on a deceptively complex question: what is human subjects research? (You can read about Seward’s first appearance on the history and mission of IRBs here.)
Sewards breaks this question down into two big steps: is the study research, and does it involve human subjects?
For work to qualify as human subjects research under the Common Rule the investigator must be engaged in “systematic investigation … designed to develop or contribute to generalizable knowledge.” Though simple at first glance, this definition—drawn from 45 CFR 46.102, part of the “common rule”—is far trickier to apply in practice.
Research, Intent, and Generalizable Knowledge
Sewards and Greiner illustrated the point with a hypothetical situation: Imagine a professor wants to find out what type of study guide works best, and so he randomizes the type of guide he gives to his students. Whether it would be “research” — and thus subject to IRB regulations — depends, in part, on whether the professor planned to disseminate his findings.
“According to a strict interpretation of the regulations, as long as [the results and application are] contained within how you’re improving your own specific teaching, that would not be considered research subject to IRB review,” says Sewards. Thus, if a professor wanted simply to conduct a personal, non-published, non-generalizable review of materials, that would not, as Sewards explains, constitute regulated research under the common rule.
But what if the professor did plan on publishing? Would that—as many think—then render his plans automatically “human subjects research”?
Not exactly, says Sewards. “There are many instances where it could be a very subjective interpretation,” Sewards notes. If the outcome of a randomized trial asking if study guide A is better than study guide B is only of interest to the professor conducting it or their institution, then the knowledge created might not be “generalizable.” Moreover, determinations vary between institutions. The conversation emphasizes how different institutions interpret these standards inconsistently. Some universities, for example, treat any randomized design or any project intended for publication as automatically requiring IRB oversight, even if such an outcome is not mandated by the letter of federal regulations.
Similar issues arise if a researcher goes into a study without the intention to publish but later decides that they want to share their work—especially if they find encouraging results. “If the results are favorable, [the researcher] may want to expand on it, and at that point in time, that may transition over into something where…the intent is to develop something that is generalizable,” says Sewards.
Here—as practically everyone in IRB debate—interpretive issues of the common rule abound. Section I of 45 CFR 46.102 defines research as a “systematic investigation … designed to develop contribute to generalizable knowledge.” And so, as Greiner and Sewards discuss, IRB scholars debate whether a researcher’s original intent (even though the word intent does not appear in the regulation) going into a project is relevant to whether they can publish it after the research is done. “That’s the key word—designed,” says Seward.
Public vs. Private Information
The definition of “private” information presents major challenges, especially in legal research. Many law professors rely on court records, which are public in the U.S. Yet, some IRBs treat this data as private out of unfamiliarity or discomfort with how accessible such information is. Whereas most medical information is locked behind the doors of HIPAA and other privacy-protecting rules, the U.S. legal system is surprisingly open source. Court dockets and legal records are, for the most part, open to the public—if one knows where to look.
However, when information in research is private—where its dissemination or the identification of its source would upset the “reasonable expectations” of the corresponding individual—the IRB has a role to play in protecting the human subject. “Our role in the larger scheme of things is to act as a safeguard for those who choose to volunteer in research, to ensure that it’s conducted ethically, and to ensure that no undue harm happens to those that volunteer,” says Sewards.
Oversight and Irregularities
Finally, Sewards identifies concerns about the current state of federal oversight. The Office for Human Research Protections (OHRP), the agency responsible for enforcing the Common Rule, has experienced staffing reductions and defunding of key advisory committees like SACHRP (Secretary’s Advisory Committee on Human Research Protections). This uncertainty leaves IRBs with even more interpretive leeway and fewer federal resources to rely on.
Moreover, IRBs within different institutions have their own interpretations and supplemental policies. The 2019 Common Rule revisions mandated the use of a single IRB in most multi-site studies, but local policies still play a role, especially regarding state laws or unique populations (e.g., minors or prisoners). In practice, IRBs may still disagree about which studies even require review, leading to frustrating inconsistencies.
Sewards identifies a need for greater clarity and uniformity in regulation and IRB practice, especially as interdisciplinary and multi-institution research becomes more common. She emphasizes that the Common Rule sets a floor, not a ceiling—institutions can add protections, but they must do so carefully and consistently.
Listen to the full Proof Over Precedent podcast episode on this topic.